U.S. patent application number 14/312342 was filed with the patent office on 2019-10-24 for expandable needle suture apparatus and associated handle assembly.
This patent application is currently assigned to DePuy Mitek, LLC. The applicant listed for this patent is DePuy Mitek, LLC. Invention is credited to Martin Padget, Thomas Weisel.
Application Number | 20190321027 14/312342 |
Document ID | / |
Family ID | 33033158 |
Filed Date | 2019-10-24 |
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United States Patent
Application |
20190321027 |
Kind Code |
A9 |
Weisel; Thomas ; et
al. |
October 24, 2019 |
Expandable Needle Suture Apparatus and Associated Handle
Assembly
Abstract
A surgical suturing device having an axis extending between a
proximal end and a distal end is operable to move a suture through
body tissue. An actuating rod extends between the handle assembly
and the shaft. A needle assembly at the distal end of the actuating
rod is movable with the actuating rod between an extended state and
a retracted state. Bifurcated portions of the needle assembly
define a suture slot, the bifurcated portions have a proximate
relationship when the needle assembly is in the retracted state and
having a separated relationship when the needle assembly is in the
extended state. The needle assembly is biased to the retracted
state and the bifurcated portions are biased to the separated
relationship. A handle assembly is configured to releasably receive
the needle assembly and is operable to move the needle assembly
between a free suture state and a captured suture state.
Inventors: |
Weisel; Thomas; (Ventura,
CA) ; Padget; Martin; (Latrobe, PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
DePuy Mitek, LLC |
New Brunswick |
NJ |
US |
|
|
Assignee: |
DePuy Mitek, LLC
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20140303653 A1 |
October 9, 2014 |
|
|
Family ID: |
33033158 |
Appl. No.: |
14/312342 |
Filed: |
June 23, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13305637 |
Nov 28, 2011 |
8758368 |
|
|
14312342 |
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|
|
10803406 |
Mar 17, 2004 |
8066718 |
|
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13305637 |
|
|
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|
60455859 |
Mar 18, 2003 |
|
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60500046 |
Sep 3, 2003 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/2924 20130101;
A61B 17/0469 20130101; A61B 2017/06042 20130101; A61B 2017/06009
20130101; A61B 2017/292 20130101; A61B 17/06109 20130101; A61B
17/06004 20130101 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1-21. (canceled)
22. A method for placing suture across a body wall of a patient,
comprising the steps of: providing a suture device including a
hollow shaft with a proximal end and a distal end, an actuating rod
disposed in the shaft, and a needle assembly carried by the rod
between a deployed position and a retracted position; providing the
needle assembly with a needle having a sharp distal tip;
bifurcating the needle to form at least one pair of arms defining a
suture slot, the arms being movable between a proximate position
associated with a first slot size and a spaced position associated
with a second slot size greater than the first slot size;
penetrating the body wall with a needle assembly in the retracted
position and the arms in the proximate position; and advancing the
needle assembly to the deployed position to move the arms to the
spaced position associated with the second slot size.
23. The method recited in claim 22 further comprising the step of:
forming a channel in one of the arms to provide for side-loading of
the suture into the suture slot.
24. The method recited in claim 23 wherein the slot has a proximal
end and a distal end and the forming step includes the step of
forming the channel in proximity to the distal end of the slot.
25. The method recited in claim 23 wherein the slot has a proximal
end and a distal end and the forming step includes the step of
forming the channel in proximity to the proximal end of the
slot.
26. The method recited in claim 22 wherein the providing step
further comprises the step of rounding at least the distal end of
the slot.
27. The method recited in claim 22 wherein the providing step
includes the step of forming at least one proximally-facing
shoulder on the needle to define the retracted position where the
shoulder contacts the hollow shaft.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This is a non-provisional application claiming the benefit
of Provisional Application Ser. No. 60/455,859 filed on Mar. 18,
2003, and entitled, "EXPANDABLE NEEDLE SUTURE APPARATUS AND
METHOD," and Provisional Application Ser. No. 60/500,046 filed on
Sep. 3, 2003, and entitled, "EXPANDABLE NEEDLE SUTURE APPARATUS AND
ASSOCIATED HANDLE ASSEMBLY," both of which are fully incorporated
herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates generally to surgical suture
apparatus and, more specifically, to needle suture manipulating
apparatus and methods.
[0004] 2. Discussion of Related Art
[0005] One of the more challenging aspects of endoscopy/arthroscopy
is to properly place a suture in identified tissue. This task is
complicated by the fact that all work must be done through a 5-8
millimeter cannula while viewing one's efforts on a monitor.
[0006] With these difficult size configurations, it has been a
significant challenge to incorporate all of the tasks into a single
instrument. As a result, the tasks for initially passing a suture
through target tissue and subsequently retrieving the suture from
the far side has often required use of more than one
instrument.
[0007] Various needle configurations have been contemplated, some
with the needle permanently attached to the suture and others
wherein the needle merely engages the suture. Attempts to
miniaturize the needle structure have often produced needles that
were so small they tended to yield under compressive stresses.
[0008] The handles associated with suturing devices have been
limited in the number of functions that could be performed. In some
cases, handle assemblies have required two-handed operation. It has
also been typical to provide needle assemblies that were
permanently attached to the handle rather than assemblies that were
removable from the handle and perhaps disposable.
SUMMARY OF THE INVENTION
[0009] In one embodiment of the device contemplated, a needle
assembly with a sharp tip is shaped from a wire. The wire is
partially sliced near the tip so that it has two bifurcated
portions that define a slot. The wire is processed in a manner that
permits these bifurcated portions to move between two positions. In
a first position, the bifurcated portions are biased to extend
outwardly in which case the slot is generally open. In the second
position, the bifurcated portions can be forced inwardly in which
case the slot is substantially closed. As noted, the bifurcated
portions are biased outwardly so that the wire, in its relaxed
position has an open slot.
[0010] In this expanded state, the open slot can be easily loaded
with a suture. The needle assembly can then be pulled into a
carrier tube that compresses the two bifurcated sides of the slot
to shrink the profile of the distal tip and engage the loaded
suture. With its sharp tip, the needle assembly, compressed within
the outer tube, can then be easily passed with the suture through
the tissue. On the other side of the tissue, the needle assembly
can be deployed thereby permitting the slot to automatically expand
in the relaxed state. This enlarges the slot thereby enabling the
suture to be released. The needle assembly can then be removed from
the tissue leaving the suture in place.
[0011] In one aspect of the invention, a surgical device extends
along an axis and has a proximal end and a distal end. The device
is operable to move a suture through body tissue and includes a
shaft having a hollow configuration. A handle assembly is coupled
to the shaft, and an actuating rod having a proximal end and a
distal end is disposed to extend between the handle assembly and
the shaft. A needle assembly is disposed at the distal end of the
actuating rod and is movable with the actuating rod between an
extended position and a retracted position. Bifurcated portions of
the needle assembly define a suture slot and have a proximate
disposition when the actuating rod is in the retracted state and a
separated state when the actuating rod is in the extended state.
The actuating rod is biased to the retracted position while the
bifurcated portions are biased to the separated state.
[0012] In another aspect of the invention, a surgical suturing
device includes a needle assembly with a needle movable in a needle
housing between a free suture state and a captured suture state. A
handle assembly includes a longitudinal handle housing sized and
configured to releasably receive the needle assembly. A thumb slide
assembly is releasably coupled to the needle and movable
longitudinally on the handle housing between a distal position and
a proximal position. The distal position of the thumb slide
assembly is associated with the needle in the free suture state,
while the proximal position of the thumb slide assembly is
associated with the needle in one of a captured state and a locked
state.
[0013] In another aspect, the invention includes a method for
placing a suture across a body wall of a patient. Initially, a
suturing device is provided that includes a hollow shaft with a
proximal end and a distal end, an actuating rod disposed in the
shaft, and a needle assembly carried by the rod. The arms are
movable between a proximate disposition associated with a first
slot size and a spaced disposition associated with a second slot
size greater than the first slot size. The body wall is then
penetrated, with the needle assembly in the retracted position and
the arms in the proximate disposition. The needle assembly can then
be advanced to the deployed position to move the arms to the spaced
disposition associated with the second slot size.
[0014] These and other features and advantages of the invention
will become more apparent with a description of preferred
embodiments in reference to the associated drawings.
DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 is an axial cross section view of one embodiment of
the present invention illustrating a bifurcated needle
assembly;
[0016] FIG. 2 is an axial cross section view showing the needle
assembly in a retracted position;
[0017] FIG. 3 is an enlarged view of the distal end of the device
illustrated in FIG. 2;
[0018] FIG. 4-FIG. 9 illustrate steps in a method for using the
suture device of FIG. 1;
[0019] FIG. 4 is a side elevation view illustrating the device in a
normal state with the needle assembly retracted;
[0020] FIG. 5 is a side elevation view showing operation of a thumb
slide to deploy the needle assembly to an extended position
characterized by automatic formation of an enlarged slot in the
needle assembly;
[0021] FIG. 6 is a side elevation view illustrating the loading of
a suture into the slot of the needle assembly;
[0022] FIG. 7 is a side elevation view showing retraction of the
needle assembly and capture of the loaded suture;
[0023] FIG. 8 is the side elevation view illustrating passage of
the needle assembly and suture through tissue;
[0024] FIG. 9 is a side elevation view illustrating deployment of
the needle assembly to the extended position to enlarge the slot
and release the suture prior to withdrawal of the device from the
tissue;
[0025] FIG. 10 is a side elevation view showing a further
embodiment wherein the needle is fabricated at the proximal end of
the slot;
[0026] FIGS. 11-14 illustrate a further embodiment wherein the
needle is bifurcated at the distal end of the slot;
[0027] FIG. 11 is a side elevation view showing a backing arm and a
gathering arm widely separated to receive a suture;
[0028] FIG. 12 is a side elevation view illustrating the needle
slightly retracted;
[0029] FIG. 13 is a side elevation view showing the needle further
retracted;
[0030] FIG. 14 is a side elevation view showing the needle fully
retracted;
[0031] FIG. 15 is a side elevation view of an embodiment similar to
FIG. 11, but including a built-in stop;
[0032] FIG. 16 is a side elevation view of a further embodiment
wherein the needle is tapered to facilitate manipulation through
drastically bent tubes;
[0033] FIG. 16A is a cross section view taken along lines 16A-16A
of FIG. 16 showing an embodiment with two arms;
[0034] FIG. 16B is a cross section view taken along lines 16B-16B
of FIG. 16 showing an embodiment with four arms;
[0035] FIG. 17 is a side elevation view of a further embodiment
wherein a helical slot is cut around the circumference of the
needle;
[0036] FIGS. 18-22 illustrate a preferred method particularly
applicable to the embodiment of FIG. 11;
[0037] FIG. 18 is a side elevation view showing the needle
retracted and passed through the tissue;
[0038] FIG. 19 is a side elevation view showing the needle fully
deployed to receive the suture;
[0039] FIG. 20 is a side elevation view showing the needle
retracted with the suture disposed in the needle slot;
[0040] FIG. 21 is a side elevation view showing the needle removed
from the tissue drawing the suture through the needle hole in the
tissue;
[0041] FIG. 22 is a side elevation view showing the needle fully
deployed to release the suture from the needle leaving the suture
extending through the tissue;
[0042] FIG. 23 is a side elevation view of a further embodiment of
a needle assembly including a straight backing arm and a curved
gathering arm;
[0043] FIG. 24 is a side elevation view of another embodiment
including a curved gathering arm and a curved backing arm;
[0044] FIG. 25 is another embodiment of a needle assembly with
angled portions defining a slot;
[0045] FIG. 26 is a further embodiment of the needle assembly with
large and small diameter portions;
[0046] FIG. 27 is a side elevation view of another needle assembly
including a notch in the needle tube;
[0047] FIG. 28 is a side elevation view illustrating a notch-free
needle tube and a needle in a suture-sliding position;
[0048] FIG. 29 is a side elevation view similar to FIG. 28 with the
needle in a suture-locked position;
[0049] FIG. 30 is a side elevation view of a needle assembly having
a bendable section;
[0050] FIG. 31 is a perspective view of the needle assembly having
a radius to prevent suture fraying;
[0051] FIG. 32 is a side elevation view of a needle assembly having
an opening into the suture slot;
[0052] FIG. 33 is a side elevation view illustrating the preferred
disposition of the opening;
[0053] FIG. 34 is a side elevation view illustrating a taper in the
needle housing;
[0054] FIG. 35 is a cross-section view of a preferred embodiment of
a handle assembly;
[0055] FIGS. 36a-36d are progressive views of a structure and
method for coupling the needle assembly and the handle
assembly;
[0056] FIGS. 37a and 37b are side elevation views illustrating use
of a pin to restrict movement of a needle rod;
[0057] FIG. 38 is a perspective view of a needle assembly
bifurcated by a slot;
[0058] FIG. 39 is a perspective view illustrating the needle of
FIG. 38 in its bifurcated configuration;
[0059] FIG. 40 is a side elevation view of an additional embodiment
of a bifurcated needle assembly; and
[0060] FIG. 41 is a side elevation view of a further embodiment of
a bifurcated needle assembly.
DESCRIPTION OF PREFERRED EMBODIMENTS
[0061] A suture device is illustrated in FIG. 1 and designated by
the reference numeral 10. The device is an elongate structure and
includes a handle 12 at its proximal end and a hollow shaft 14 at
its distal end. An actuating rod 16 is disposed within the hollow
shaft 14 and extends from the handle 12 through the shaft 14. In
the handle 12, the actuating rod 16 is engaged by a thumb slide 18.
At its distal end, the actuating rod 16 is coupled to a needle
assembly 20. This assembly 20 includes a sharp tip 22 and
bifurcated portions 24 and 26, which define a slit or slot 28
proximately of the tip 22.
[0062] Operation of the thumb slide 18 relative to the handle 12
moves the actuating rod 16 and the attached needle assembly 20
between an extended position as illustrated in FIG. 1, and a
retracted position as illustrated in FIGS. 2 and 3. In this
particular embodiment, a spring 30 is used to bias the rod 16 and
needle assembly 20 proximally to the retracted position. It will
also be noted with reference to FIG. 3 that the needle assembly 20
can be provided with shoulder stops 31 which are separated by a
width greater than the internal diameter of the shaft 14. These
shoulder stops 31 prevent the distal tip 22 of the needle assembly
20 from entering the shaft 14 in the retracted position.
[0063] The bifurcated portions 24 and 26 are also moveable between
two positions. In a first position, the bifurcated portions 24 and
26 are separated radially to enlarge the slot 28. In a second
position, the bifurcated portions 24 and 26 are brought into close
proximately by the tube, closing the slot 28. In a preferred
embodiment, these bifurcated portions 24 and 26 are biased to the
separated state as illustrated in FIG. 1 so the slot 28
automatically opens when the needle assembly 20 is in the extended
position.
[0064] Operation of the suture device 10 is illustrated in FIGS.
4-9. Initially, the device 10 in a relaxed, stored state will have
the needle assembly 20 biased to the retracted position as
illustrated in FIG. 4. In order to initially load the device 10
with a suture 32, the needle assembly must be moved to the extended
position as illustrated in FIG. 5. This is accomplished by pushing
the thumb slide 18 distally to force the actuating rod 16 and the
needle assembly 20 in the distal direction. When the needle
assembly 20 clears the distal end of hollow shaft 14, the
bifurcated portions 24 and 26 are free to expand laterally thereby
automatically enlarging the slot 28 as illustrated in FIG. 5. With
the slot 28 enlarged, the suture 32 can now be passed through the
slot as illustrated if FIG. 6. Releasing the thumb slide 18 permits
the spring 30 to move the actuating rod 16 and needle assembly 20
proximally to the retracted position. As the needle assembly is
drawn into the hollow shaft 14, the restricted radial dimension
forces the bifurcated portions 24 and 26 to move toward each other
thereby closing the slot 28 and fully engaging the suture 32. In
this retracted state, illustrated in FIG. 7, the device is now
loaded and prepared for disposition through the patient's tissue,
which is designated by the reference numeral 34 in FIG. 8. The
actuating rod 16 can be biased to the retracted position so that
the device in the relaxed state automatically orients itself for
use in crossing the tissue 34 as illustrated in FIG. 8.
[0065] With the needle assembly 20 and the suture 32 extending
through the tissue 34, it is now desirable to release the suture
from the device 10. This is accomplished by again pushing the thumb
slide distally to move the needle assembly from the retracted
position to the extended position. As before, the bias of the
bifurcated portions 24 and 26 will permit the needle assembly 20 to
enlarge the slot 28 thereby facilitating release of the suture 32
from the device 10. This is illustrated in FIG. 9. As a final step,
the device 10 can be removed from the tissue 34 leaving the suture
32 operatively disposed across the tissue 34.
[0066] Notwithstanding the specific features of this embodiment, it
will be noted that the needle assembly 20 includes a sharp point
which facilitates passage through the tissue 34 even when the
assembly 20 is in the retracted state. The bifurcated portions 24
and 26 function as a gripping means which automatically opens to
facilitate loading the suture 32, but which is capable of being
closed with a force sufficient to retain the suture in the slot 28
as the device 10 is pushed through the tissue 34. The hollow shaft
14 in this case functions primarily as a vehicle for moving the
bifurcated portions 24 and 26 between the open state and the closed
state. In the illustrated embodiment the hollow shaft 14 is shown
with a straight configuration; but it can also be provided with
many different curved configurations to enhance usage in various
anatomically restricted areas. It will be apparent to those skilled
in the art that this function can be accomplished by many different
structures in other embodiments of the concept.
[0067] In an additional embodiment illustrated FIG. 10, elements of
structure similar to those previously discussed are designated with
the same reference numeral followed by the lower case letter "a."
Thus, this embodiment includes the actuating rod 16a, needle
assembly 20a and distal tip 22a. In this case however, the
bifurcated portions 24 and 26 function as a backing arm 36 and
gathering arm 38, respectively. The gathering arm 38 can be
integral with the backing arm 36 at the distal end of the slot 28a,
but preferably is separated from the backing arm 36 at the proximal
end of the slot 28a. At this location, the gathering arm 38a is cut
from the backing arm 36a to form a passage 40, which allows the
needle to be more flexible as it is passed thru curves. The passage
40 can also facilitate drawing the suture into the slot 28a if the
passage 40 is exposed distal of the hollow shaft 14a during
deployment.
[0068] A similar embodiment is illustrated in FIGS. 11-14 wherein
elements of structure similar to those previously discussed are
designated with the same reference numeral followed by the lower
case letter "b." In this embodiment, the hollow shaft 14b receives
the actuating rod 16b in the manner previously discussed. This
embodiment also includes the backing arm 36b as well as the
gathering arm 38b. However, in this case, the gathering arm 38b is
integral with the backing arm 36b at the proximal end of the slot
28b. The gathering arm 38b is separated from the backing arm 36b at
the distal end where a passage 42 permits the suture to enter the
slot 28b. This passage 42 is cut along the gathering arm 38b so
that a small portion of the arm 44 remains with the distal tip 22b.
This enables the needle assembly 20b to retain the suture without
damage when the needle assembly 20b is fully retracted. The
gathering arm 38b in this embodiment can be shaped in a variety of
ways. In the illustrated example, three bends 46, 48 and 50 create
a wide passage 42 to facilitate capture of the suture.
[0069] In FIG. 12, the needle assembly 20 has been slightly
retracted into the hollow shaft 14b and the bend 46 has been
generally straightened. The angle of the bend 50 has created a lip
that gathers the suture toward the backing arm 36b as the bend 46
is straightened by the hollow shaft 14b.
[0070] In FIG. 13, the needle assembly 20b is even further
retracted. This has caused the bend 48 to straighten bringing the
gathering arm 38b into contact with the backing arm 36b while still
maintaining the passage 42 for the suture.
[0071] When fully retracted as illustrated in FIG. 14, the short
portion 44 of the gathering arm 38b is received in the hollow shaft
14 leaving a small opening 52 to retain the suture.
[0072] A further embodiment is illustrated in FIG. 15 where
elements of structure similar to those previously discussed are
designated with the same reference numeral followed by the lower
case letter "c." In this embodiment, the backing arm 36c also
defines the slot 28c with the gathering arm 38c. In this
embodiment, the gathering arm 38c is also cut to form the passage
42c. However, the cut forming this passage 42c forms an oblique
angle with the length of the needle assembly 20c so that a stop 54
is formed at the distal end of the gathering arm 38c. This stop 54
is formed with a proximal tang on the gathering arm 38c, which
interferes with a distal tang on the short portion 44. It is the
purpose of this stop 54 to prevent the gathering arm 38c from
contacting the backing arm 36c and thereby restricting free
movement of a captured suture.
[0073] Another embodiment is illustrated in FIGS. 16, 16A and 16B
where elements of structure similar to those previously discussed
are designated with the same reference numeral followed by the
lower case letter "d". In this embodiment, the horizontal slot 28d
is formed between the bifurcated portions 24d and 26d. With only
the single horizontal slot 28d, this embodiment has a cross-section
such as that illustrated in FIG. 16a.
[0074] In a similar embodiment, a vertical slot 60 can be added,
leaving the needle assembly 20d with four arms which are designated
by the reference numerals 36d', 36d'', 38d' and 38d'' in FIG. 16B.
This particular configuration of the needle assembly 20d allows
manipulation through drastically bent tubes. Of course, any number
of multiple arms could facilitate this advantage. A taper 62 can be
formed at the proximal ends of the arms 36d and 38d. This tapered
profile keeps the walls of the needle assembly 20d relatively
consistent and flexible to minimize stress concentrations.
[0075] FIG. 17 illustrates a further embodiment wherein a helical
slot 64 is cut around the circumference of a cylindrical needle 66.
In this case the helical slot 64 is adapted to receive the suture
and to hide the suture within the needle 66 as it penetrates the
tissue. In this particular embodiment, the helical slot 64 may have
a depth greater than zero but preferably not greater than 0.75
times the radius of the needle 66.
[0076] FIGS. 18-22 illustrate a method for using the needle
assembly 20 and particularly the needle assembly 20b illustrated in
FIG. 11.
[0077] In FIG. 18, the needle assembly 20b has been retracted and
the hollow shaft 14b passed through the tissue 34b. The suture 32b
is shown on the far side of the tissue 34b. With this disposition
of the suturing device 10b, the thumb slide 18b can now be moved
distally to deploy the bifurcated needle assembly 20b as
illustrated in FIG. 19. In this position, the suture 32b can be
introduced through the distal passage 42 and into the slot 28b. As
the thumb slide 18b is drawn proximally, the needle assembly 20b is
retracted into the hollow shaft 14b in the matter discussed with
reference to FIG. 14.
[0078] With the suture captured in the opening 52, as illustrated
in FIG. 20, the suture device can be withdrawn from the tissue 34b
pulling the suture 32b through the needle hole left in the tissue
34b. This step in the process is illustrated in FIG. 21. Finally,
the thumb slide 18b can again be moved distally to deploy the
needle assembly 20b. This will produce a wide separation of the
backing arm 36b and gathering arm 38b resulting in release of the
suture 32b from the suture device 10b. In this manner, the suture
32b can be threaded through the tissue 34b.
[0079] A further embodiment of the invention is illustrated in FIG.
23 where the needle assembly 20 is shown with a unique shape that
enhances performance in some embodiments. In this case, the needle
assembly 20 includes a backing arm 70 and a gathering arm 72. The
gathering arm 72 is curved so that an opening is provided with
minimal needle deployment to facilitate capture of the suture. This
feature enhances use of the needle assembly 20 where the suture
must be engaged in small spaces and the needle cannot be fully
deployed.
[0080] In FIG. 24, a similar embodiment is illustrated where the
backing arm 70 is also curved. In this manner, the needle assembly
20 can be provided with a shape that is closer to that of the
hollow shaft 14 (FIG. 1). This embodiment is representative of a
concept wherein the hollow shaft can have many different curved
configurations, each adapted for a particular anatomical area or
indication; and the associated needle assembly including the
backing arm 70 and gathering arm 72 can be matched to the
configuration of the shaft.
[0081] FIGS. 25 and 26 show two variations where the needle
assembly 20 includes a thick needle section 74 that is proximal of
a pointed end 76. In these embodiments, the thick needle section 74
defines a portion of the suture slot 67 that, as previously noted,
can have a variety of configurations. Proximal of the thick section
74, a diameter can be made smaller so that a thinner section 78 is
created. This thin section 78 makes it easier for the needle to be
moved through the curves of the hollow shaft 14.
[0082] In the embodiment of FIG. 27, a notch 81 is created in the
distal end of the hollow tube 63. This notch 81, in connection with
a needle tip 64, creates a suture slot 83 which holds the suture.
With the notch 81 buried in the hollow tube 63, the needle tip 64
can be made shorter so that a curved device can have a lower
profile adapting it for use in a smaller diameter cannula.
[0083] FIGS. 28 and 29 illustrate two positions of a needle tip 64
relative to a hollow tube 65. In these two positions, the size of
the suture slot 66 can differ. The suture slot 66 in FIG. 28 is
sufficiently large to enable the suture to slide or slip easily
relative to the hollow tube 65. By comparison, the suture slot 66
in FIG. 29 is relatively small because the needle tip 64 has been
retracted slightly into the hollow tube 65. In this second
position, the needle tip 64 is retracted to reduce the size of the
suture slot 66 and hold or lock the suture in place against the
hollow tube 65. A variety of mechanisms can be used to provide
various detented positions between the first position illustrated
in FIG. 28 and the second position illustrated in FIG. 29. A
mechanism could also be provided to require a force of progressive
magnitude in order to move between the slipping position of FIG. 28
and the locking position of FIG. 29.
[0084] In some cases it is advantageous to provide the hollow shaft
14 with a drastically bent configuration. Under these
circumstances, a needle assembly 20 formed from a metal material
such a Nitinol, can be made to slide more easily within the
drastically bent tube if it is made thinner at those locations
where it is to be bent during deployment or retraction. The distal
end of the needle assembly 20 can be kept larger so that the
diameter of the needle tip is sufficiently thick to withstand any
bending stresses. The proximal end need not be made thicker since
it functions primarily as a push/pull rod in compression/tension
during deployment and retraction.
[0085] FIG. 30 shows an example of a tapered needle that can be
provided in a multitude of configurations. Beginning generally at
the distal end, the needle 90 can be provided with a distal taper
81. This taper can start at any location between a point just
proximal of the needle point to a location just proximal of the
slot. In the latter location, the starting position tends to
maximize the amount of material defining the slot. Depending on the
strength required, a proximal taper 83 can also be provided back to
the diameter of the needle point. This proximal taper 83 would be
of particular advantage where a thicker shaft might be required for
strength purposes.
[0086] As illustrated in FIG. 31, many of the foregoing embodiments
can benefit from a radius 92 provided in the distal end of the
slot. Such a radius 92 will insure that a sliding suture is less
likely to be frayed on a sharp edge.
[0087] In the embodiment of FIG. 32, an opening 94 is provided
between two tangs 96 and 98, which also define the needle slot.
This opening 94 is preferably defined at a location that is more
distal along the slot so that it can be exposed when the needle is
only slightly deployed from the needle tube. Thus, even with a
slight deployment of the needle, a suture can be slid through the
opening 94 and into the slot. This can be of particular importance
in an embodiment wherein the suture is very close to where the
needle exits the tissue. Under these circumstances, it would be
more difficult to capture the suture if the needle had to be fully
deployed. Notwithstanding the preferred distal location of the
opening 94 relative to the slot, it is desirable that the opening
94 be positioned sufficiently proximally that a basin 96 is formed
at the proximal end of the slot, as illustrated in FIG. 33.
[0088] FIG. 34 illustrates an embodiment wherein a hollow tube
housing 101 is provided with a taper 103 at its distal end. This
taper 103 will tend to minimize the insertion forces required for
the device.
[0089] A handle assembly 110 is illustrated in FIG. 35 as a
preferred embodiment of the handle 12 discussed with reference to
FIG. 1. In the manner previously discussed, the handle assembly 110
is adapted to receive the needle assembly 20, including the hollow
shaft 14 and the rod 16. In addition, the needle assembly 20 in
this embodiment is provided with a hub 112 having an enlargement 74
and a cylindrical extension 116 disposed proximally of the
enlargement 74.
[0090] In this embodiment, the handle assembly 110 includes a frame
118, and the thumb slide 18 that can be moved by a thumb of the
user. In this manner, the thumb slide 18 can be moved between a
rearward position, to the left in FIG. 35, and a forward position,
illustrated to the right in FIG. 35.
[0091] The thumb slide 18 is part of a unit that moves in
combination with a slider 121 and a needle latch 123. The needle
latch 123 is rotatable on the slider 121 about a pivot pin 125, and
includes a leaf spring 127. A tooth 130 is also carried by the
slider 121 and cooperates with a slot 132 and ratchet 134 in the
frame 118.
[0092] A locking lever 136 is pivotal on the frame 118 at a pivot
pin 138. This enables the locking lever 136 to move as shown by an
arrow 141 between an unlocking position and a locking position
illustrated in FIG. 35.
[0093] A lever latch 143 is biased by a spring 145 to lock the
locking lever 136 in the locking position illustrated in FIG. 35.
Movement of the lever latch 143 longitudinally along an arrow 144
and against the bias of the coil spring 145 frees the locking lever
136 to move from the illustrated locking position to the unlocking
position under the bias of a coil spring 147.
[0094] When the locking lever 136 is in the unlocking position, a
hub lock 150 is removed from proximity with the hub 112 of the
needle assembly 20. This enables the cylindrical extension 116 of
the needle assembly 20 to be inserted into and removed from a
channel 152 at the distal end of the handle assembly 110. With the
hub 112 inserted into the channel 152, the locking lever 136 can be
moved to its locking position where the hub lock 150 engages a slot
154 in the cylindrical extension 116. The lever latch 143
automatically retains the locking lever 136 in the locking position
illustrated in FIG. 35.
[0095] In order to initially prepare for operation of the suture
device 10, the removable needle assembly 20 must be mounted in the
handle assembly 110. For purposes of discussion, it will be assumed
that the thumb slide 18 is pushed forward into the distal position
illustrated in FIG. 35.
[0096] As an initial step in the mounting process, the locking
lever 136 is moved to the unlocked position, downwardly along the
arrow 141 in FIG. 35. This is accomplished by moving the lever
latch 143 rearwardly or proximally to the left in FIG. 35. This
movement, against the bias of the coil spring 145, will cause the
lever latch 143 to disengage the locking lever 136, which will then
automatically drop to the unlocking position under the bias of the
coil spring 147.
[0097] With the hub lock 150 withdrawn from the slot 154, the
cylindrical extension 152 of the needle assembly 20 can be moved
into the channel 152 along with the needle rod 16. With the needle
assembly 20 inserted and the enlargement 114 butted against the
handle assembly 110, a notch 155 at the proximal end of the needle
rod 16 will engage the needle latch 123. At this point, the locking
lever 136 can be closed against the bias of the spring 147 causing
the hub lock 150 to engage the slot 154 in the cylindrical
extension 152. The closing of the locking lever 136 also provides a
positive force through the leaf spring, which maintains the needle
latch 123 in the notch 155. As the locking lever 136 moves upwardly
to the locking position, the coil spring 145 will bias the lever
latch 143 to engage, lock, and retain the locking lever 136 in the
locking position. In this operating position, movement of the thumb
slide 18 relative to the frame 118 will cause the needle rod 16 to
move relative to the hub 114 of the needle assembly 20.
[0098] The foregoing procedure for mounting the needle assembly 20
into the handle assembly 110 was begun with the assumption that the
thumb slide 18 would be in the forward, distal position. If this is
not the case, the needle latch 123 will not initially engage the
proximal end of the needle rod 16. Even under these circumstances,
the mounting operation can be completed in the foregoing manner so
that the hub 114 is retained by the locking lever 136, which is in
turn locked by the lever latch 143. With this step completed, the
thumb slide 18 can be slid forward in the distal direction to
enable the needle latch 123 to engage the notch 155 at the proximal
end of the rod 16. This engagement and locking of the rod 16 by the
needle latch 123 will be accommodated by deflection of the leaf
spring 127. In accordance with either of these processes, the
needle assembly 20 can be coupled to the handle assembly 110 and
prepared for use by the surgeon.
[0099] In operation, the suture 32 can be positioned between the
bifurcated portions 24 and 26 of the needle when the needle is
deployed. At this point the needle assembly 20 can be fully
deployed by moving the thumb slide 10 and the rod 16 distally. In
this position of the needle assembly 20, the suture 32 can be
loaded, unloaded, picked up, or dropped off as required in
different stages of operation.
[0100] With the suture 32 thus loaded in the needle assembly 20,
the surgeon can pull the thumb slide 18 proximally, rearwardly
until the tooth 130 on the slider 121 engages the slot 132 on the
frame 118. In this position, the suture 32 is captured within the
needle but is still free to slide laterally in the slot of the
needle. Note that the springiness of the thumb slide 18 forces the
tooth 130 to remain in the slot 132 where it is held in contact
with the frame 78.
[0101] If it becomes desirable to further engage the suture 32 and
eliminate its ability to slide within the needle slot, the thumb
slide 18 can be depressed and further retracted causing the tooth
130 to leave the slot 132 and move further rearwardly along the
ratchet 134. This slight movement will cause the rod 16 of the
needle assembly 20 to move further rearwardly drawing the needle
assembly 20 slightly further into the hollow shaft 14. In this
position, the suture 32 is not only captured within the needle
assembly 20, but is sandwiched and locked between the needle
assembly 20 and the hollow shaft 14. During operation of the device
10, the thumb slide 18 in this embodiment is not intended to move
further rearwardly.
[0102] As it becomes of interest in different stages of operation,
the suture 32 can be disengaged by moving the thumb slide 18 from
this rearward-most position, forwardly and distally. If the thumb
slide is not depressed, the tooth 130 will fall back into the slot
132 where the suture is captured but nevertheless free to slide
within the needle eye. In this position, the suture 32 can be
removed. By depressing the thumb slide 18 the tooth 130 can be
removed from the slot 132 permitting the thumb slide 18 to be moved
further in the distal direction. This distal movement will open the
bifurcated portions 24 and 26 of the needle assembly 20 and fully
releasing the suture 32.
[0103] Once the fully operative procedure is completed, the needle
assembly 20 can be removed from the handle assembly 110 by
reversing the mounting steps previously discussed.
[0104] A preferred structure for releasably engaging the needle rod
16 with the needle latch 123 is illustrated in the progressive
views of FIGS. 36A-36D. In these views it is shown that the notch
155 can be formed with a ramp 156 that is machined into the
proximal end of the needle rod 16. This ramp 156 allows the needle
rod 16 to be pushed into the handle assembly 110 when the
enlargement 114 of the hub 112 butts against the handle assembly
110, the proximal end of the needle rod 16 can ride up over a ramp
158 on the needle latch 123 as illustrated in FIG. 36B. When fully
seated as illustrated FIG. 36C, this locking mechanism keeps the
needle assembly attached to the handle assembly until the ramp 158
is moved laterally permitting the ramp 156 and associated needle
rod 16 to be moved distally.
[0105] Apparatus for restricting the range of needle movement
between its retracted position and its forward position is
illustrated in FIGS. 37A and 37B. In this embodiment, a pin 161 is
provided for disposition in a transverse slot 163 within the hub
112. In this embodiment, the rod 16 of the needle assembly 20 is
also provided with a channel 165 of predetermined length. In this
sub-assembly, the rod 16 is initially positioned to extend
longitudinally through the hub 112. When the channel 165 intersects
the slot 163, the pin 161 can be inserted longitudinally through
the slot 163 in the hub 112 and transversely through the channel
165 in the rod 16. This sub-assembly is illustrated in FIG. 37B.
The restricted movement provided by this sub-assembly is needed so
that the needle is always in a position to be loaded into the
handle. With the accommodation of this restricted movement, the
needle cannot be jammed in the handle assembly 110.
[0106] Another unique needle configuration is illustrated the
prospective views of FIGS. 38 and 39. In this embodiment, the
distal slot is similar to that previously discussed, but the distal
tip is bifurcated by a cut 167 that extends into the slot. In
operation, deployment of the needle causes the bifurcated portions
169 and 170 to split, as illustrated in FIG. 39. Of course there
are many variations of this bifurcated configuration. Two such
variations are illustrated in FIGS. 40 and 41. By way of
comparison, it will be noted that the cut 167 in FIG. 38 is
disposed along the axis of the needle tip so that the tip portions
are symmetrical. In the views of FIGS. 40 and 41, the cut 167 does
not produce symmetrical tip portions. Although the cut is planar in
FIG. 41 and in FIG. 38, it is nevertheless offset from the axis of
the tip in FIG. 40. In the embodiment in FIG. 41, the cut 167 is
non-planar.
[0107] Although the invention has been discussed with reference to
specific embodiments, it will be apparent that the concept can be
otherwise embodied to achieve the advantages discussed.
* * * * *