U.S. patent application number 13/333411 was filed with the patent office on 2012-06-14 for vascular suturing device with needle capture.
This patent application is currently assigned to ABBOTT LABORATORIES. Invention is credited to Brian A. Ellingwood, Anthony J. Pantages, Erik K. Walberg.
Application Number | 20120150201 13/333411 |
Document ID | / |
Family ID | 37718519 |
Filed Date | 2012-06-14 |
United States Patent
Application |
20120150201 |
Kind Code |
A1 |
Pantages; Anthony J. ; et
al. |
June 14, 2012 |
VASCULAR SUTURING DEVICE WITH NEEDLE CAPTURE
Abstract
A surgical device of suturing vascular vessels is described, as
well as methods for suturing tissue employing the surgical device.
The device includes at least one needle advanceable through tissue
and into a needle capture element within a distal end of the
surgical device to draw lengths of suture material which can then
be used to close various puncture wounds, particularly in vascular
tissue.
Inventors: |
Pantages; Anthony J.; (San
Jose, CA) ; Ellingwood; Brian A.; (Sunnyvale, CA)
; Walberg; Erik K.; (Redwood City, CA) |
Assignee: |
ABBOTT LABORATORIES
Abbott Park
IL
|
Family ID: |
37718519 |
Appl. No.: |
13/333411 |
Filed: |
December 21, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11199496 |
Aug 8, 2005 |
8083754 |
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13333411 |
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11199496 |
Aug 8, 2005 |
8083754 |
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11199496 |
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Current U.S.
Class: |
606/147 |
Current CPC
Class: |
A61B 2017/00637
20130101; A61B 17/0482 20130101; A61B 17/0487 20130101; A61B
2017/06009 20130101; A61B 17/06004 20130101; A61B 2017/0454
20130101; A61B 2017/0464 20130101; A61B 17/0469 20130101; A61B
2017/00663 20130101; A61B 17/0057 20130101 |
Class at
Publication: |
606/147 |
International
Class: |
A61B 17/062 20060101
A61B017/062 |
Claims
1. A suturing device for suturing a wall portion of a vascular
vessel, said device comprising: a proximal member including an
elongate body with a channel sized to receive a needle therein; a
distal member comprising a receptacle therein, said distal member
configured to be inserted into a vascular vessel, and wherein the
receptacle is sized to receive at least one needle therein; an
intermediate member disposed between the proximal member and distal
member, said intermediate member defining a tissue receiving area
and including a first passageway from the channel to the tissue
receiving area and second passageway from the receptacle in the
distal member to the tissue receiving area; and a needle capture
element positioned in the receptacle of the distal member
configured to retain a needle inserted into the receptacle.
2. The device of claim 1 wherein the receptacle of the distal
member is sized to receive two or more needles.
3. The device of claim 2 wherein the needle capture element is
configured to secure each of the two or more needles inserted into
the receptacle.
4. The device of claim 1 wherein the needle capture element
comprises a plug of resilient material.
5. The device of claim 4 wherein resilient material is selected
from the group consisting of: polyurethane, polyethylene,
poly(tetrafluoroethylene), poly(vinyl chloride), polyolefin, and
silicon rubber.
6. The device of claim 4 wherein the plug of resilient material
defines an internal wall portion of the receptacle.
7. The device of claim 1 wherein the needle capture element
comprises at least one projection extending from an internal wall
of the receptacle.
8. The device of claim 10 wherein the projection is configured to
bias a needle inserted into the receptacle against an internal wall
surface of the receptacle.
9. The device of claim 1 wherein the needle capture element
comprises one or more leaves.
10. The device of claim 1 wherein the needle capture element
comprises a pair of leaves extending radially inward from an
internal wall portion of the receptacle and in a distal
direction.
11. The device of claim 1 wherein the needle capture element
comprises at least one tab extending radially inwardly from a
surface of the receptacle of the distal member to engage with a
recessed engagement surface of the needle.
12. The device of claim 1 wherein the proximal member comprises a
needle cartridge slidably mounted thereon.
13. The device of claim 13 wherein said needle cartridge comprises
a two or more needle slots capable of being sequentially aligned
with a single needle channel.
14. The device of claim 1 comprising a first needle and slidably
disposed in the needle cartridge.
15. The device of claim 14 comprising a second needle attached to a
second end of the length and slidably disposed in the needle
cartridge.
16. The device of claim 15 comprising a needle pusher slidably
disposed in the needle channel to sequentially advance the first
and second needles along the needle channel.
17. The device of claim 15 wherein the first needle is attached to
a first end of a length of suture material, and the second needle
is attached to a second end of the length of suture material.
18. The device of claim 1 wherein the intermediate member is curved
or angled to offset the first and second passageways from wall
portion of the vascular vessel disposed in the tissue receiving
area.
19. The device of claim 18 wherein the intermediate member is
configured to provide a linear pathway for a needle from the first
passageway through the tissue receiving area to the second
passageway.
20-33. (canceled)
34. A suturing device for suturing a wall portion of a vascular
vessel, said device comprising: a proximal member having a needle
channel and a first needle and a second needle therein, said first
needle and said second needle carrying a length of suture material;
a distal member configured to be inserted into the lumen of the
vascular vessel, the distal member having a receptacle comprising a
needle capture element and being sized to receive said first needle
and said second needle therein, the needle capture member including
an interior wall portion and a first plurality of projections and a
second plurality of projections, the first and second pluralities
of projections extending at an angle away from the interior wall
portion toward a distal end of the distal member, the first
plurality of projections being longitudinally offset from the
second plurality of projections; an intermediate member disposed
between the proximal member and distal member, said intermediate
member defining a tissue receiving area and configured to provide a
linear needle pathway between the needle channel and the
receptacle; and a needle capture element positioned in the
receptacle of the distal member configured to retain a needle
inserted into the receptacle.
Description
BACKGROUND OF THE INVENTION
[0001] The present invention generally relates to surgical
instruments and methods of suturing tissue.
[0002] A number of diagnostic and treatment procedures are
conducted intravascularly. Typically, a catheter is introduced into
the vascular system at a convenient access location and is then
guided to the target treatment site. The Seldinger Technique is one
of the well-known early examples of this type of procedure which
can include catheterization and angioplasty techniques. Procedures
such as this require a vascular access. Typically an introducer
sheath with or without a guide wire is inserted through a puncture
wound in a vessel such as the femoral artery at a location near the
groin. A catheter and other instrumentation can then be inserted
through the sheath and guided to the targeted treatment site. After
the diagnostic and/or treatment procedure has been completed, the
puncture wound must be closed. Closing the wound can be difficult
because of the substantial bleeding that can occur through an open
wound in the vascular vessel. One technique for hemostasis includes
applying pressure near or upstream of the puncture site. This
approach suffers from many deleterious effects, not the least of
which are that it can be time consuming and extremely
uncomfortable--even painful--for the patient because the pressure
is applied directly on or adjacent to the traumatized site.
Frequently anticoagulants are employed for the original
diagnostic/treatment procedures. This delays clot formation during
the procedure, and this effect lasts through the initial recovery
period, lengthening the time during which pressure must be applied
to the wound for up to twelve hours or more. During this initial
recovery period, it is imperative that the patient remain still,
further adding to the patient's discomfort.
[0003] Alternatively, the puncture wound can be closed with
sutures. This can be extremely difficult because the vascular
vessel with the puncture lies underneath the patient's outer skin.
Some vascular vessels, notably the femoral artery, appear to be
relatively large; however, in practice, even the largest arteries
cannot be readily sutured. Therefore, devices have been developed
to facilitate subcutaneous suturing of arteries and veins. These
devices can extend through the outer tissue to the puncture wound
in the vascular vessel. Needles are then deployed from the device
to suture the tissue adjacent the puncture wound.
[0004] Certain devices are inserted through the wound and initially
deploy a needle to pierce the tissue in from outside the vascular
vessel and continue on into a receptacle in the portion of the
device located within the lumen of the vessel. The suturing device
can be removed from the vessel (and the patient) by withdrawing the
needles and suture material at the same time. However, under
certain conditions the needles may not be fully captured within the
depository or the needles can become dislodged upon removal of the
device from the patient. This can be particularly prone to occur
when the needles remain attached to the suture material. For
example, as the device (with the suture attached to needles) is
withdrawn, friction from drawing the suture material through tissue
tends to pull the needles out of the depository. In any event, the
dislodged needles catch on tissue. This can result in snagging and
possibly tearing of the vascular tissue or the upper tissue layers
depending upon when the needles become dislodged.
[0005] In view of the above background, there remain needs for
improved and/or alternative methods and devices for closing
vascular opening or punctures. The present invention is addressed
to these needs.
SUMMARY OF THE INVENTION
[0006] The present invention relates to a suturing device and the
use thereof. Various aspects of the invention are novel,
nonobvious, and provide various advantages. While the actual nature
of the invention covered herein can only be determined with
reference to the claims appended hereto, certain forms and
features, which are characteristic of the preferred embodiments
disclosed herein, are described briefly as follows.
[0007] In one form, the present invention provides a suturing
device for suturing. The suturing device provides particular
advantages, for suturing a wall portion of a vascular vessel. The
device comprises: a proximal member including an elongate body with
a channel sized to receive a needle therein; a distal member
comprising a receptacle therein, where the distal member is
configured to be inserted into a vascular vessel, and wherein the
receptacle is sized to receive at least one needle therein; an
intermediate member disposed between the proximal member and distal
member, where the intermediate member defines a tissue receiving
area and provides a first passageway from the channel to the tissue
receiving area and second passageway from the receptacle in the
distal member to the tissue receiving area. In preferred
embodiments a needle capture element positioned in the receptacle
of the distal member. The needle capture element is configured to
secure a needle inserted into the receptacle.
[0008] In another form, the present invention provides a method of
suturing vascular tissue adjacent an opening in a vascular vessel.
The method uses a suturing device which can be inserted through the
opening in the vascular vessel. The device comprises: a proximal
member with a needle channel formed therein; a distal member
configured to be inserted into the lumen of the vascular vessel,
where the distal member has a receptacle that includes a needle
capture element and which is sized to receive at least one needle;
and an intermediate member disposed between the proximal member and
the distal member. The intermediate member defines a tissue
receiving area and is configured to provide a linear needle pathway
between the channel and the receptacle. A needle is advanced
through or along the needle channel to pierce the vascular tissue
drawing a portion of the length of suture material through the
vascular tissue. The needle is further advanced so that a portion
of the needle engages with the needle capture element in the
receptacle. Preferable the needle capture element prevents and in
adverting dislodging of the needle from the receptacle during the
surgical procedure. However, the same needle capture element also
allows the surgeon to remove the needle when and if desired.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1 is a cross-sectional view of one embodiment of a
suturing device with a needle capture element in accordance with
the present invention.
[0010] FIG. 2 is an enlarged view in cross section of the distal
member of the suturing device of FIG. 1.
[0011] FIG. 3 is an enlarged view in cross section of the distal
member of the suturing device of FIG. 1 with a needle disposed
within a receptacle in the distal member.
[0012] FIG. 4 is an enlarged view in cross section of an
intermediate member with needle engaging projections of an
alternative suturing device in accordance with the present
invention.
[0013] FIG. 5 is an enlarged view in cross section of the distal
member illustrated in FIG. 4 with a needle disposed in the
receptacle.
[0014] FIG. 6 is a perspective view of an alternative embodiment of
a suturing device with a needle cartridge for use in accordance
with the present invention.
[0015] FIGS. 7-12 illustrate methods of use of the suturing device
according to the present invention.
[0016] FIG. 13 is a perspective view of one embodiment of a suture
securing device for use in the present invention.
[0017] FIG. 14 is a perspective view of an alterative embodiment of
a suture securing device for use in the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0018] FIG. 1 shows a suturing device 110 for suturing vascular
vessels in accordance with the present invention. Device 110
includes a proximal member 112, a distal member 114, and an
intermediate member 116 located therebetween. Device 110 includes
one or more needles 118a, 118b, 118c . . . disposable within needle
channel 124 of proximal member 112.
[0019] Each of needles 118a, 118b, 118c . . . can include a length
of suture material 120a, 120b, 120c . . . secured to the proximal
end of the needles . Needle pusher 126 can be used to advance the
needles 118a,118b, 118c, . . . through channel 124 out through
first opening 150 into a tissue receiving area 145 defined by
intermediate member 116. Preferably, proximal member 112 and/or
distal member 114 define a longitudinal axis and (either/both)
is/are essentially linear about this axis. In one embodiment, the
intermediate member 116 can be configured to deviate from the
lineality defined by either the proximal member (or the distal
member). First opening 150 and second opening 152 in intermediate
member can be axially aligned to permit needles 118a, 118b, 118c .
. . to travel in an essentially linear needle path that extends
through tissue received within tissue receiving area 145. In one
form, suture material can be attached to the needle 118a. The
needle is then advanced in a distal direction through tissue. A
second needle 118b (and subsequent needles) can be similarly
configured and manipulated to place sutures about tissue adjacent a
puncture wound in a vascular vessel. The suture material(s)
threaded through the vascular tissue can be drawn taut closing the
puncture wound. A surgical knot or other suture securing device can
complete the wound closure.
[0020] As used herein, the term "proximal" refers to a direction
toward the surgeon and away from the patient or a location closer
to the surgeon, while the term "distal" refers to a direction
towards the patient and away from the surgeon or a location closer
to the patient.
[0021] Proximal member 112 is provided as an elongated portion and
can exhibit a substantially cylindrical or oval radial cross
section. Member 112 includes a first end of sufficient dimensions
to be readily grasped by the surgeon to manipulate the device
during the procedures. Proximal member 112 can also include a
gripping portion 135 to facilitate handling during the surgical
procedure. Needle channel 124 runs longitudinally along at least a
portion of proximal member 112. In one embodiment, channel 124
extends along the entire length of proximal member from a first end
positioned proximal to the surgeon to a second end adjacent to
intermediate member 116. In this embodiment, one or more needle(s)
118a, 118b, 118c, . . . and a needle pusher 126 and grip 136 can be
inserted into and retrieved from channel 124 at the first end. In
other embodiments, channel 124 extends only partly through the
proximal member 112. Needle channel 124 can be centrally located
along proximal member 112. In preferred embodiments, proximal
member 112 includes a single needle channel 124 through which one,
two, three, or more needles can be advanced. Alleviating multiple
needle channels within the suturing device provides a more compact
member, which can be particularly advantageous for subcutaneous
procedures. Channel 124 is sized and dimensioned to allow one or
more needles 118a, 118b, 118c . . . to be advanceable therethrough
and into vascular tissue around the puncture wound. Furthermore,
channel 124 can be either partly or completely encased within the
body of proximal member 112. However, in a preferred embodiment,
channel 124 is not encased within the body of proximal member 112.
Rather, channel 124 is provided as a slot formed into the surface
of proximal member 112. Preferably the slot is configured to retain
one or more needles within the slot. For example, the slot can be
formed to have an opening at the exterior surface of proximal
member that is narrower than the diameter of the needles (and
optionally the pusher 126) while the internal portion or diameter
of the slot can be dimensioned to permit facile movement of the
needle therethrough. An exit opening is located at the distal end
of channel 124.
[0022] Proximal member 112 includes a blood return line 125 that
terminates in a fitting 127, for example, a luer lock that can be
mated to a syringe. Alternatively, line 125 can terminate in a
valve or shunt to control and stop blood flow therethrough. It is
preferable that blood line 125 allow visible observation of blood
originating from inside the vascular vessel. This can facilitate
proper placement of the device for suturing.
[0023] Referring additionally to FIGS. 2 and 3, distal member 114
is sized and/or configured to be received within a lumen of a
patient's vascular vessel similar to distal member 114. In
additional embodiments, distal member 14 can be coated or
impregnated with a lubricant, bioactive agent, such as an
anticoagulant material, and the like. In certain embodiments, it is
preferable that at least distal member 14 be formed of a flexible
or elastomeric material that is biocompatible--particularly with
blood. For example, distal member 14 can be composed of a
biocompatible polymeric material commonly used for catheters, such
as silicone rubber, polyethylene, polyolefin, polyurethane,
polytetrafluoroethylene, polyvinyl chloride and the like.
[0024] Distal member 114 includes a receptacle 122 sized and
configured to receive and retain at least one needle 118a, and
preferably two or more needles 118b, 118c . . . Preferably,
receptacle 122 is sized to retain one or more needles such that the
proximal end of each of the needles does not extend beyond opening
152.
[0025] A needle catching element 123 located in receptacle 122 is
provided to engage with at least a portion of needles 118a, 118b,
118c . . . Element 123 can be configured as a plug of pierceable
material. The material can be any biocompatible material pierceable
with a surgical needle. Representative examples include materials
such as silicone rubber, polyethylene, or polyurethane. In certain
embodiments, the plug of material is composed of the same material
as that used to form the distal member. The plug of material can be
friction fit, adhesively bound, or mechanically retained inside
receptacle 122. In other embodiments, the plug of material can
include a molded flap extending from an interior wall portion of
receptacle 122. In still other embodiments, the needle catching
element 123 can be integral with, or alternatively define, a bottom
wall portion of receptacle 122. Needle capture element 123 can
completely close off or block receptacle 122. In other forms,
element 123 need not completely block receptacle 122.
[0026] Referring back to FIG. 1, distal member 14 can also include
a lumen 139 extending at least partially therethrough. Preferably,
lumen 139 is separate from receptacle 122. Lumen 139 can be
provided to receive or follow a guide wire left in place after a
particular diagnostic or treatment procedure. This can allow the
facile insertion of distal member 114 into the patient's vascular
vessel. In a preferred embodiment, lumen 139 exits through a side
of distal member 114 at opening 140 to permit a guide wire (not
shown) to extend out without interfering with the needles, needle
path, or suture material. The guide wire can be removed after
placement of the suture device or left in as desired or considered
medically prudent by the surgeon.
[0027] Intermediate member 116 is located between proximal member
112 and distal member 114. Intermediate member 116 defines a
tissue-receiving area 145. In the illustrated embodiment,
intermediate member is configured to include an arcuate portion or
a crooked section. The arcuate portion or crook can defines a
concave interior surface 147 and a convex exterior surface 148.
Intermediate member 116 includes a first opening 150 providing
access from the channel 124 to the tissue receiving area 145 and a
second opening 152 from the receptacle 122 providing to the tissue
receiving area 145. Preferably, first and second openings 150 and
152 are linearly or axially aligned. Intermediate member 116 can be
composed of a biocompatible material that is substantially
resistant to deformation and therefore can maintain the linearity
between channel 124 and receptacle/chamber 122 and the respective
first and second openings 150 and 152. Examples of suitable
materials include TEFLON, NYLON, polyamids, and the like.
[0028] Intermediate member 116 also includes means and structure
for reliable positioning of the device during surgery to facilitate
closing the vascular puncture wound with sutures. Part of the
positioning structure includes an opening 154 providing fluid
communication to blood return line 125 in proximal member 112. In a
preferred embodiment, opening 154 is located on a portion of the
convex surface 148 of the intermediate member 116 opposite the
tissue receiving region 145. In use, with the distal member of the
device suitably positioned within the lumen of a vascular vessel,
opening 154 is also located in the interior of the lumen. This
permits blood from the vessel to enter blood return line 125, which
can then be visibly observed by the surgeon. If blood is not
observed in blood return line 125, then the distal member may not
have been inserted to a sufficient depth into the lumen of the
vascular vessel.
[0029] Additionally, a ridge or stop 156 extends from the concave
surface into the tissue receiving region. Stop 156 is configured to
bear against vascular tissue adjacent the puncture wound. In a
preferred embodiment, first opening 150 extends through a portion
of stop 56 permitting needle 118 to pierce tissue adjacent thereto.
Stop 156 is sized to bear against the vascular tissue and avert
further insertion of the device 110 into the vascular vessel. When
provided together, stop 156 and opening 150 with blood return line
125 cooperate to ensure accurate placement of the suturing device
in the patient's vascular vessel. Ridge or stop 156 can also extend
radially about the entire circumference of intermediate member
116.
[0030] FIG. 2 shows needle 118a entering opening 152 in distal
member 114 and traversing receptical 122 in response to distal
movement of needle pusher 126.
[0031] FIG. 3 illustrates the capture of needle 118a within
receptacle 122. Element 123 is positioned in receptacle 122 to
engage with at least the distal tip 132 of needle 118a. Preferably
element 123 is positioned at a location or depth within receptacle
122 such that the proximal end 134 of a captured needle does not
extend out of opening 152 of receptacle 122 to snag on any tissue
or other structure as the suturing device is manipulated and
eventually removed from the vascular vessel.
[0032] FIGS. 4 and 5 illustrate partial views of an alternative
embodiment of a suturing device 210 with a needle capture element
223. The illustrated distal and intermediate members 214 and 216
are configured similarly to distal and intermediate members 114 and
116. However, distal member 214 includes a receptacle 222.
Receptacle 222 is configured to receive one or more needles
therein. Needle capture element 223 comprises at least one
projection 229 and preferably at a second projection 231 each
extending radially inwardly from an interior wall portion 233. It
will be understood that receptacle 222 can include a plurality of
projections similarly configured as illustrated and/or described
for projections 229 and 231. The projections 229 and 231 are
configured to engage and capture or retain one or more needles 218
within the interior of receptacle 222. The projections 229 and 231
can frictionally engage the tips or sides of inserted needles to
prevent their accidental dislodgement during surgical manipulation.
In the illustrated embodiment, projections 229 and 231 are
configured as a plurality of paired leaves projecting from the
interior wall portion 233 of receptacle 222. It will be understand
that in other embodiments, the leaves need not be paired; or, if
paired, the leaves can be axially and/or radially offset from each
other. In still other embodiments, projections 229 and 231 can be
configured as protuberances, bumps, ridges, or threads extending
from an internal wall portion of receptacle 222 to engage and
retain one or needles 218 therein. Further, one or more of needles
118a, 118b, and 118c can include a recessed surface configured for
engagement with at least one of the projections 229 and 231. For
example, a needle can be configured with a barbed point or
alternative with a tip similar to a tip as described in copending
US Patent Application, filed on Aug. 8, 2005, (Attorney Docket No.
7323USO1, which is incorporated by reference herein.)
[0033] Referring specifically to FIG. 5, a needle 218 with a length
of suture material 220 is illustrated as captured within lumen 222.
As can be observed in the illustration, a plurality of projections
229 and 231 frictionally engage with the sides of the inserted
needle 218. Preferably, the projections 229 and 231 are angled in
the distal direction from their point of connection to wall 233 of
receptical 222. This causes the frictional engagement resisting
needle movement in a proximal direction to be greater than the
frictional engagement resisting a needle movement in a distal
direction. This engagement effectively prevents the inserted needle
218 from being dislodged by manipulation of suturing device 210
within the patient or upon withdrawing the suturing device from the
vascular vessel.
[0034] FIG. 6 is a perspective view of another embodiment of a
suturing device 80 with a needle cartridge in accordance with the
present invention. Device 80 includes a proximal member 81, a
distal member 82, and an intermediate member 83 therebetween.
Proximal member 81 includes a needle cartridge 84 slidably mounted
in body 85. Needle cartridge 84 can include a plurality of needle
slots, for example, two, three, four, or more slots 86a. 86b, 86c .
. . , each for a separate needle. Each needle in needle cartridge
84 is individually advanceable through a central needle channel
along a length of proximal member 81. Needle cartridge 84 is
slidably disposed within body 85 to axially align the selected
needle slot 86a. 86b, 86c . . . with a single needle channel 87. If
desired, needle cartridge 84 can be biased to automatically align
the successive needle slots with the needle channel after the
preceding needle has been advanced along the channel.
Alternatively, suturing device 80, body 85, and/or cartridge 84 can
include one or more of ratchetings, positive stops, or locks to
individually align the desired needle slot with the channel. In
other embodiments, needle cartridge 84 can be provided as a
revolving barrel that can hold two, three, or more needles in
respective needle slots radially disposed about the barrel. The
barrel can be rotatably mounted on or about proximal member 81.
Distal member 82 and intermediate member 83 can be configured
substantially as described above for members 114 and 116,
respectively.
[0035] FIGS. 7 through 13, illustrate the use of suturing device
110 for closure of a puncture wound 96 in a vascular vessel 93. A
puncture wound in a vascular vessel can be sutured closed using the
suturing device 110. Suturing device 110 can be inserted distally
into the vascular vessel. This can be accomplished with or without
the use of a guide wire. In a procedure where a guide wire has been
previously used, suturing device can be threaded onto a guide wire
92 which extends from internal vessel lumen 94 through vessel 93
and a portion of the overlying tissue 95 to be exposed to the
surgeon. In that regard, opening 140 of lumen 139 can be threaded
onto guide wire 92 which then extends out through opening 140.
Thus, the flexible portion of distal member 114 can be gingerly
threaded into the lumen 94 of vessel 93. The distal member 114 of
device 110 can be positioned within lumen 94 such that intermediate
member 116 engages with a portion of the tissue surrounding
puncture 96. Distal member 114 is advanced in a distal direction
until blood is observed in blood return line 125. Additionally,
when provided, stop 156 abuts or bears against the external surface
of the vascular vessel. This can be detected by the increased
resistance to further advancement of the device in the distal
direction. Both blood return line 125 and stop 156 can be used to
ascertain that the device has been correctly positioned within the
lumen 94 of the vascular vessel 93 to allow suturing of puncture
96. It should be noted that observance of blood in needle channel
124 is an indication that device 110 has been inserted too far into
the lumen 94 such that first opening 150 is exposed to the interior
or blood side of vessel 93. If desired, guide wire 92 can then be
withdrawn from lumen 139 and out of vascular vessel 93--if it is no
longer needed for subsequent procedures.
[0036] After the distal member is positioned as desired, the
vascular tissue adjacent the puncture wound is received within the
tissue receiving area 145. As noted above, intermediate member 116
provides an essentially linear needle pathway between needle
channel 124, receptacle 122, and the vascular tissue in the tissue
receiving area 145.
[0037] Consequently, when needle 118a is advanced through channel
124, it pierces the vascular tissue 93 at a first suture site 97
adjacent the puncture wound 96.
[0038] FIG. 8 illustrates suturing device 110 at a first suture
position. Intermediate member 116 provides an essentially linear
needle pathway between channel 124 and receptacle 122. A first
needle 118a advancing through channel 124 using needle pusher 126
pierces vascular tissue in tissue receiving area 145 at the first
suture site 97. Needle 118a trails a length of suture material 120a
pulling it through the vascular at suture site 97 adjacent wound
96. From there, needle tip 132 is advanced into to receptacle 122
to engage needle capture element 123. Thereafter, needle 118a and
optionally a portion of the suture material 120 are inserted into
receptacle 122 where at least a portion of the needle 118a engages
with needle capture element 123. Needle capture element 123
reliably retains needle 118a within receptacle 122 during the rest
of the suturing procedure or until the surgeon decides to withdraw
the needle.
[0039] As shown in FIG. 9 suturing device 110 is rotated into a
second suture position. Suture device 110 can be rotated
approximately 180.degree. so that in the second suture position,
suture device 110 is positioned to operate on a second side of
wound 96 diametrically opposite first suture site 97.
[0040] FIG. 10 illustrates suturing device 110 in the second suture
position. A second needle 118b can be advanced through or along
receptacle 122 using the needle pusher 126, either the same needle
pusher or a second, different needle pusher. Needle 118b exits
first opening 150 to pierce vascular tissue received in the tissue
receiving area 145 at a second suture site 100. Continuing the
advancement of needle 118b through the needle path draws the
attached suture material 120b through second suture site 100
adjacent wound 96. Thereafter at least a portion of needle 118b is
captured and retained by needle capture element 123 within
receptacle 122. If desired, suturing device 110 can again be
repositioned to draw suture material through a third and any
desired subsequent suturing sites. It will be understood that
suture material 120a and 120b can be opposite ends of the same
piece of suture material. Alternatively, suture material 120a and
120b can be two separate lengths of suture material.
[0041] FIG. 11 illustrates device 110 being removed in a distal
direction from vascular vessel 93. As suture device 110 is
withdrawn in the distal direction, needles 118a and 118b remain
embedded within the needle catching element 123 in receptacle 122.
Consequently, the attached lengths of suture material 120a and 120b
are pulled in a distal direction through the vascular tissue at the
first and second suture sites 97 and 100, respectively and then out
through the wound 96. One implementation of the suturing device can
be a common length of suture material 120 attached to the proximal
ends of needles 118a and 118b. As illustrated in FIG. 12, the
resulting suture path extends from the proximal side of vessel 94
across the wound opening and through the first and second suture
sites 97 and 100 into the lumen 94. The suture material 120 then
extends out through wound opening 96 back to the distal side of
vessel 93.
[0042] FIG. 12 depicts wound closure. The free ends of the suture
material 120 can be gathered and a suture knot tied. As with the
other procedures described above, a knot pusher 115, knot boxes as
described in WO 01/19258, and knot replacement technologies (see
FIGS. 13 and 14) can be used to close the wound and secure the
suture material. The lengths of suture material can be gathered.
The length of suture material can be separated from the needles.
Pulling the lengths of suture material taut closes the wound in the
vessel. A surgical knot can be tied securing the wound closure. A
knot pusher, for example, the knot pushers described in U.S. Pat.
No. 5,304,184 issued to Hathaway et al., U.S. Pat. No. 5,746,755
issued to Wood et al., and U.S. Pat. No. 6,132,439 issued to
Kontos, can be used to advance the loosely tied knot to the
exterior surface of the vascular vessel. In selected embodiments,
the surgeon can then tie a suitable surgical knot using the
respective lengths of suture material to close the puncture wound
96.
[0043] In other embodiments, the suture material can be secured
using a variety of knot replacement technologies such as that
disclosed in U.S. patent application Ser. No. 10/164,606 (US Patent
Publication No. 2003/0229377) and in Ser. No. 10/305,923 (US Patent
Publication No. 2004/0102809) and depicted in FIGS. 13 and 14. Each
of the above-noted references are incorporated by reference in
their entirety.
[0044] FIG. 13 is a perspective view a suturing securing device 102
for use in the present invention. Suture securing device 102 is
described and illustrated in US Patent Publication No. 2004/0102809
which is incorporated herein by reference. In use device 102 can
secure ends of one, two, three or more lengths of suture material.
Two lengths of suture material 120a and 120b are illustrated with
device 102. The lengths of suture material are threaded into the
flexible elements 105a and 105b which are then locked or fixed
together securing the suture material therein.
[0045] FIG. 14 is another embodiment of suture securing devices
106a and 106b for use in the present invention. Devices 106a and
106b are described in US Patent Publication No. 2003/0229377 which
is incorporated herein by reference in its entirety. Devices 106a
and 106b cooperate by separately clipping onto a selected length of
suture material 104a or 104b which have previously pulled taut to
close wound or complete the surgical procedure. The devices prevent
the suture material from regressing back through the sutured
tissue.
[0046] The present invention provides a variety of means, devices
and methods for closing wounds in tissue and is particularly but
not exclusively suitable for vascular tissue. It will be understood
that the present invention contemplates modifications as would
occur to those skilled in the art without departing from the spirit
of the present invention. In addition, the various structures,
elements, and procedural steps or stages have been described with
reference to specified embodiments and devices. Each of the
individual or a combination of the structures, elements, and
procedural steps or stages are contemplated to be combinable with
each of the other embodiments and devices described herein and as
such are contemplated to be within the scope of the present
invention.
[0047] All publications, patents, and patent applications cited in
this specification are herein incorporated by reference as if each
individual publication, patent, or patent application was
specifically and individually indicated to be incorporated by
reference and set forth in its entirety herein. Further, any theory
of operation, proof, or finding stated herein is meant to further
enhance understanding of the present invention and is not intended
to make the scope of the present invention dependent upon such
theory, proof, or finding.
* * * * *