U.S. patent application number 10/807396 was filed with the patent office on 2004-09-09 for method and apparatus for suturing.
This patent application is currently assigned to Orthopaedic Biosystems Ltd., Inc., a Delaware corporation. Invention is credited to Baldwin, Jeffrey P., Gartsman, Gary M., Hatch, Laird L., Oren, Ran, Skiba, Jeffry B..
Application Number | 20040176802 10/807396 |
Document ID | / |
Family ID | 32072727 |
Filed Date | 2004-09-09 |
United States Patent
Application |
20040176802 |
Kind Code |
A1 |
Skiba, Jeffry B. ; et
al. |
September 9, 2004 |
Method and apparatus for suturing
Abstract
The present invention provides new and useful devices and
techniques for use in suturing. These devices and techniques are
particularly useful in laparoscopic, arthroscopic, and/or open
surgical procedures. A method according to the present invention is
characterized by releasably coupling a suture to a suture device,
causing the tip of the suture device and a portion of the suture to
penetrate a tissue, and releasing the suture from the suture
device, so the suture may be drawn through the tissue for
completion of a suturing procedure. One type of suturing device
according to the invention is characterized by a handle with an
elongated shaft with a sharpened tip configured to hold a suture at
a selected point on the suture. Another type of device according to
the principles of the invention is characterized by new and useful
structures and techniques for loading the suture into the device.
According to still another aspect of the present invention,
different shaped suture tips are provided for the selection of the
most effective tip shape for a given application. A suturing device
according to the present invention may also be configured for use
with a needle point swedged to a suture. Yet another type of
suturing device according to the principles of present invention
includes a tissue support structure disposed adjacent the sharpened
tip, which may move relative to the sharpened tip to facilitate
penetration of the tip through a tissue.
Inventors: |
Skiba, Jeffry B.; (Santa
Rosa, CA) ; Baldwin, Jeffrey P.; (Phoenix, AZ)
; Hatch, Laird L.; (Cave Creek, AZ) ; Gartsman,
Gary M.; (Houston, TX) ; Oren, Ran; (Gaaton,
IL) |
Correspondence
Address: |
Joel R. Petrow, Esq.
Chief Patent Counsel
Smith & Nephew, Inc.
1450 Brooks Road
Memphis
TN
38116
US
|
Assignee: |
Orthopaedic Biosystems Ltd., Inc.,
a Delaware corporation
|
Family ID: |
32072727 |
Appl. No.: |
10/807396 |
Filed: |
March 24, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10807396 |
Mar 24, 2004 |
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09550975 |
Apr 18, 2000 |
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6723107 |
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60129993 |
Apr 19, 1999 |
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Current U.S.
Class: |
606/222 ;
606/148 |
Current CPC
Class: |
A61B 17/06061 20130101;
A61B 17/06066 20130101; A61B 2017/06009 20130101; A61B 2017/061
20130101; A61B 2017/0608 20130101; A61B 17/0469 20130101; A61B
2017/06042 20130101; A61B 17/06109 20130101; A61B 2017/06019
20130101; A61B 2017/06076 20130101; A61B 2017/06047 20130101 |
Class at
Publication: |
606/222 ;
606/148 |
International
Class: |
A61B 017/04; A61B
017/06 |
Claims
1. A suturing device comprising: a handle; an elongated shaft
attached to said handle; and a sharpened tip on said elongated
shaft, said sharpened tip configured to trap a suture at a selected
point.
2. A suturing device as defined in claim 1, wherein said sharpened
tip includes an opening configured to trap a suture at a selected
point.
3. A suturing device as defined in claim 2, wherein a least a
portion of the opening is dimensioned to wedge and hold a suture in
the selected position
4. A suturing device as defined in claim 3, wherein said opening
comprises a central portion which has said tapered
configuration.
5. A suturing device as defined in claim 2, wherein said opening
comprises a tapered opening.
6. A suturing device as defined in claim 2, wherein said opening
comprises an elongated opening.
7. A suturing device as defined in claim 6, wherein at least a
portion of said elongated opening is curved.
8. A suturing device as defined in claim 1, wherein said sharpened
tip includes an opening; and a locking mechanism having at least a
locked position and an unlocked position, said locking mechanism
when in said locked position being configured to trap a suture in
said opening.
9. A suturing device as defined in any of claims 2-8, wherein the
suture comprises a length of material, and wherein said opening is
configured to allow the suture to pass lengthwise through said
opening.
10. A suturing device as defined in claim 9, wherein said opening
is further configured to allow the suture to be side-loaded into
said opening.
11. A suturing device as defined in claim 1, wherein said sharpened
tip includes an opening into which a suture can be inserted, and
wherein said opening is configured to allow the suture to be side
loaded into said opening.
12. A suturing device as defined in claim 1, wherein said sharpened
tip has a hooked configuration.
13. A suturing device as defined in claim 1, wherein said sharpened
tip is angularly bent relative to said shaft in a selected
direction.
14. A suturing device as defined in claim 1, wherein said sharpened
tip is configured with at least one spiral loop at the distal end
of the shaft.
15. A suturing device as defined in claim 1, wherein said sharpened
tip is bent so the distal tip generally points towards the proximal
end of the shaft.
16. A suturing device as defined in claim 1, wherein said sharpened
tip is curved at least partially about the distal end of the
shaft.
17. A suturing device as defined in claim 1, wherein said sharpened
tip extends at an angle and to one side of the distal end.
18. A suturing device as defined in claim 1, wherein said sharpened
tip extends at least partially forward from the distal end with a
concave configuration.
19. A suturing device as defined in claim 1, wherein said sharpened
tip extends substantially straight and forward from said distal
end.
20. A suturing device as defined in claim 1, wherein said sharpened
tip is selectively moveable relative to said shaft.
21. A suturing device as defined in claim 1, wherein said sharpened
tip is selectively detachable from said shaft.
22. A suturing device comprising: a handle; an elongated shaft
attached to said handle at a proximal end of said shaft; and a
detachable needle at a distal end of said elongated shaft, said
needle having a suture attached thereto.
23. A suturing device as defined in claim 22, wherein said distal
end has a hooked configuration.
24. A suturing device as defined in claim 22, wherein said distal
end is angularly bent relative to said shaft in a selected
direction.
25. A suturing device as defined in claim 22, wherein said distal
end is configured with at least one spiral loop at the distal end
of the shaft.
26. A suturing device as defined in claim 22, wherein said distal
end is bent so the distal tip generally points towards the proximal
end of the shaft.
27. A suturing device as defined in claim 22, wherein said distal
end is curved at least partially about the distal end of the
shaft.
28. A suturing device as defined in claim 22, wherein said distal
end extends at an angle and to one side of the distal end.
29. A suturing device as defined in claim 22, wherein said distal
end extends at least partially forward from the distal end with a
concave configuration.
30. A suturing device as defined in claim 22, wherein said distal
end extends substantially straight and forward from said distal
end.
31. A suturing device as defined in claim 22, wherein said needle
and suture are detachably affixed to said suturing device by
threading the suture through a portion of said suturing device.
32. A suturing device as defined in claim 22, wherein said needle
and suture are detachably affixed to said suturing device by
threading the suture through at least the distal end and the shaft
of said suturing device.
33. A suturing device as defined in claim 22, wherein said needle
and suture are side-loaded into said suturing device.
34. A suturing device comprising: a handle; an elongated shaft
attached to said handle at a proximal end of said shaft; a
sharpened tip at a distal end of said elongated shaft; and a tissue
support device disposed adjacent said sharpened tip, configured to
move relative to said sharpened tip to facilitate penetration of
said sharpened tip through a tissue.
35. A suturing device as defined in claim 34, wherein a suture is
connected with said sharpened tip and moves with the sharpened tip
as the sharpened tip penetrates through the tissue.
36. A suturing device as defined in claim 34, wherein a suture is
connected with said tissue support device, and is located to be
engaged by said sharpened tip as said sharpened tip is withdrawn
from the tissue.
37. A method of delivering a suture comprising: providing a suture
device; releasably coupling a suture with the distal end of said
suture device; penetrating a substrate with the distal end of said
suture device such that said suture is partially passed through the
substrate; and releasing the suture from said suture device.
38. A method as defined in claim 37, wherein said step of
releasably coupling a suture with the distal end of said suture
device comprises releaseably trapping the suture in an opening at
the distal end of said suture device.
39. A method as defined in claim 37, wherein the opening is
configured to trap and hold a suture, and said step of releasably
coupling comprises releasably trapping and holding the suture in
the opening.
40. A method as defined in claim 37, wherein a locking mechanism
associated with the opening has a locked position in which it
releasably traps the suture in the opening, at least a portion of
the suture being disposed in the opening, and said step of
releasably coupling comprises placing said locking mechanism in its
locked position.
41. A method as defined in any of claims 38 through 40, wherein
said step of releasably coupling comprises the step of side-loading
the suture into the opening.
42. A method as defined in claim 37, wherein the distal end of said
suture device is selectively adjustable relative to the suture
device.
43. A method as defined in claim 37, wherein the distal end of said
suture device is selectively detachable from the suture device.
44. A method as defined in claim 43, wherein a differently shaped
distal end may be attached to the distal end of said suture
device.
45. A method as defined in claim 37, wherein a detachable needle is
disposed at the distal end of the suture device, said needle having
a suture attached thereto, and wherein said step of penetrating a
substrate with the distal end of the suture comprises penetrating
the substrate with said detachable needle.
46. A method as defined in claim 37, wherein a second penetrating
step is performed through said substrate with said distal end of
said suture device prior to said releasing step.
47. A method as defined in claim 37, wherein the distal end
comprises a sharpened tip, a tissue support device is disposed
adjacent the sharpened tip, and said step of penetrating a
substrate comprises locating the tissue support device adjacent a
selected portion of tissue and moving the sharpened tip relative to
the tissue support device to facilitate penetration of the
sharpened tip through the selected portion of tissue.
48. A method as defined in claim 47, wherein a suture is connected
with the sharpened tip and moves with the sharpened tip as the
sharpened tip penetrates through the tissue.
49. A method of delivering a suture comprising: providing a
suturing device having a sharpened tip configured to penetrate a
tissue, a tissue support device disposed to be located adjacent a
selected portion of tissue, and being moveable relative to the
sharpened tip to facilitate penetration of the sharpened tip
through the selected portion of tissue and to enable the sharpened
tip to be withdrawn from the selected portion of tissue; providing
a suture disposed to be engaged by the sharpened tip as the
sharpened tip is being withdrawn from the selected portion of
tissue; locating the tissue support device adjacent a selected
portion of tissue and moving the sharpened tip relative to the
tissue support device to pierce the selected portion of tissue, and
engaging the suture with the sharpened tip as the sharpened tip is
withdrawn from the selected portion of tissue; and releasing the
suture from the sharpened tip after the sharpened tip has been
withdrawn from the selected portion of tissue.
50. A method as defined in claim 49, wherein the step of moving the
sharpened tip relative to the tissue support device comprises
rotating the tissue support device and the sharpened tip relative
to each other so that the sharpened tip rotates towards the tissue
support device as the sharpened tip pierces the tissue and rotates
away from the tissue support device as the sharpened tip is
withdrawn from the selected portion of tissue, and engaging the
suture with the sharpened tip and drawing the suture through the
selected portion of tissue as the sharpened tip rotates away from
the tissue support device and is withdrawn from the selected
portion of tissue.
51. A suturing device comprising: a handle; an elongated shaft
attached to said handle; a sharpened tip on said elongated shaft,
said sharpened tip being configured to engage a suture; and a
locking mechanism having at least a locked position and an unlocked
position, said locking mechanism when in said locked position being
configured to hold the suture in a selected position.
52. A suturing device as defined in claim 51, wherein said locking
mechanism has at least one partially closed position for capturing
the suture and for controlled adjustment of the suture relative to
the sharpened tip.
53. A suturing device comprising: a handle; an elongated shaft
attached to said handle; a sharpened tip on said elongated shaft,
said sharpened tip having an opening configured to allow the suture
to be side-loaded onto said device.
54. A suturing device as defined in claim 53, wherein said opening
comprises a tapered opening.
55. A suturing device comprising: a handle; an elongated shaft
attached to said handle; a sharpened tip on said elongated shaft,
said sharpened tip having a piercing portion configured to pierce
tissue during a suturing procedure; and a suture coupled with said
sharpened tip, said suture having a suture portion extending
outward from said sharpened tip to permit said suture to be grasped
and manipulated relative to said sharpened tip, said suture portion
disposed to be carried by the sharpened tip through tissue which
has been pierced by said piercing portion.
Description
RELATED APPLICATION/CLAIM OF PRIORITY
[0001] This Application is related to and claims priority from
Provisional Application Serial No. 60/129,993 entitled "Suture
Leader for Shuttleless suturing", filed Apr. 19, 1999.
FIELD OF INVENTION
[0002] The present invention relates to methods and apparatus for
use in surgical suturing.
BACKGROUND OF INVENTION
[0003] Suture is often used bring two pieces of tissue together and
hold the tissues as they heal. Needles allow a surgeon to pierce
tissue and pull suture through that tissue. In many procedures,
there is adequate space in the wound or incision to manipulate
needles and needle holding instruments. The move by surgeons toward
less invasive and minimally invasive surgeries has created the need
for instruments to be designed to function in limited space and
with longer reaches. Standard surgical instruments are being
stretched and downsized to pass through tunnels in the tissue
called cannulas or portals measuring as small as 5 millimeters in
diameter and in a variety of lengths. There is a need for improved
surgical instruments to manipulate and control sutures during
surgical operations.
SUMMARY OF THE INVENTION
[0004] The present invention provides new and useful devices and
techniques for use in suturing. These devices and techniques are
particularly useful in laparoscopic, arthroscopic, and/or open
surgical procedures.
[0005] One type of suturing device according to the invention is
characterized by a handle with an elongated shaft with a sharpened
tip configured to hold a suture at a selected point on the suture.
Several different types of structures for holding the suture to the
sharp tip are provided according to the principles of the
invention. For example, one such structure comprises a tapered
opening formed in the tip, and configured to enable a suture to be
wedged and held in the opening. In another example, an elongated
opening is provided, which may be curved, for holding the suture.
In yet another example, a locking mechanism is provided, which has
a locked position for holding the suture, an unlocked position for
releasing the suture, and a partially locked position for
controlled adjustment of the suture position relative to the
tip.
[0006] Another type of device according to the principles of the
invention is characterized by new and useful structures and
techniques for loading the suture into the device. In one example
of this aspect of the present invention, a suture may be
side-loaded into the device. This provides numerous advantages,
including eliminating the need to thread the suture, and allowing
side-release of the suture.
[0007] According to still another aspect of the present invention,
different shaped suture tips are provided for the selection of the
most effective tip shape for a given application. In one example of
this aspect of the present invention, each tip may be detached from
the suturing device and replaced by another tip. In another example
of this aspect of the present invention, the position of each tip
is adjustable relative to the shaft of the suturing device for
further refinement of the suturing device for a given
application.
[0008] A suturing device according to the present invention may
also be configured for use with a needle point swedged to a
suture.
[0009] Yet another type of suturing device according to the
principles of present invention includes a tissue support structure
disposed adjacent the sharpened tip, which may move relative to the
sharpened tip to facilitate penetration of the tip through a
tissue. In one example of this aspect of the present invention, a
suture is carried through the tissue by the tip as the tip
penetrates the tissue. In another example of this aspect of the
present invention, the tip engages the suture after penetration of
the tissue, and draws the suture through the tissue as the tip is
withdrawn from the tissue.
[0010] A method according to the present invention is characterized
by releasably coupling a suture to a suture device, causing the tip
of the suture device and a portion of the suture to penetrate a
tissue, and releasing the suture from the suture device, so the
suture may be drawn through the tissue for completion of a suturing
procedure.
[0011] These and other features and techniques of the present
invention will become further apparent from the following detailed
description and the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] A more complete understanding of the present invention may
be derived by referring to the detailed description and claims when
considered in connection with the following illustrative Figures,
which may not be to scale. In the following Figures, like reference
numbers refer to similar elements throughout the Figures.
[0013] FIG. 1 is a perspective view of a suturing device in
accordance with the present invention;
[0014] FIG. 2 is a close-up perspective view of the sharpened tip
at the distal end of the suturing device of FIG. 1;
[0015] FIGS. 3-5 illustrate the relative positions of a suture and
a suturing device during coupling of a suture with the suturing
device in accordance with the principles of the present
invention;
[0016] FIGS. 6A-6B schematically illustrate the manner in which a
suture is trapped and held by an opening in the sharpened tip of a
suturing device in accordance with the principles of the present
invention;
[0017] FIGS. 7-10 illustrate successive steps in applying a suture
to tissue using a suturing device in accordance with the principles
of the present invention;
[0018] FIGS. 11-17 schematically illustrate sharpened tips and
different configurations for an opening for use in coupling a
suture with the sharpened tip in accordance with the principles of
the present invention;
[0019] FIG. 18-21 schematically illustrate a suturing device with a
locking mechanism according to the principles of the present
invention;
[0020] FIG. 22 schematically illustrates a sharpened tip with a
combination of openings for use in coupling a suture with the
sharpened tip in accordance with the principles of the present
inventions;
[0021] FIGS. 23-29 schematically illustrate different
configurations for a sharpened tip with an opening for coupling a
suture with the sharpened tip in accordance with the principles of
the present invention;
[0022] FIGS. 30-32 schematically illustrate different ways for
coupling a needle with a swedged suture to a suturing device in
accordance with the principles of the present invention;
[0023] FIG. 33 schematically illustrates another way for coupling a
suture to a suturing device in accordance with the principles of
the present invention; and
[0024] FIG. 34-36 illustrate a suture device in which a tissue
support device is provided in accordance with the principles of the
present invention.
DETAILED DESCRIPTION
[0025] As set forth above, the present invention provides several
types of devices and techniques which are useful in suturing, for
example in connection with laparoscopic, arthroscopic, and/or open
surgical procedures. Examples of devices and techniques according
to the principles of the present invention are described below in
connection with particular embodiments, but it will be clear to
those skilled in the art that aspects of the present invention
found in one example may be practiced alone or in combination with
(or even in lieu of) devices and techniques of the other
examples.
[0026] One type of suturing device in accordance with the present
invention is shown in FIG. 1. Suturing device 100 has a handle 102,
a shaft 104 connected to the handle, and a tip 106 connected to the
other (distal) end of the shaft. Typically, the handle 102 may be 4
to 6 inches long, and the shaft 104 may typically be from 1 to 24
inches, depending on the application. The shaft is typically 2 to 3
millimeters in diameter and formed of a rigid substance Tip 106
includes a sharpened point 108 and an eyelet (or opening) 110.
[0027] FIG. 2 shows a close-up view of tip 106. Tip 106 has a
curved, hook-like shape for convenient delivery of a suture, as
discussed further below. Eyelet 110 has an top portion 112
configured to be wider than a suture used in connection with the
suturing device, and a narrowed bottom portion 114 for trapping the
suture.
[0028] Referring now to FIGS. 3 through 6B, a method according to
the present invention is shown. Suture 302 is threaded through
eyelet 110 as shown in FIG. 3 and 4 until a selected length of
suture (labeled "d") is extended through suturing device 100 as
shown in FIG. 4. Preferably, length d is about 2 inches. Once the
selected point of suture is in eyelet 110, length d is drawn
downward, as shown in FIG. 5, trapping the suture in eyelet 110.
FIG. 6A shows the position of the suture in the wider top portion
112 of eyelet 110 prior to the drawing downward step. 6B shows the
suture wedged into the narrowed bottom portion 114 of eyelet 110
after the downward drawing step of FIG. 5. The suture in FIG. 6B is
thus trapped in the narrowed bottom portion 114 in accordance with
one aspect of the invention.
[0029] FIGS. 7 through 10 show the use of the above described
embodiment of the present invention in the repair of a gap 702
formed in tissue 704. As shown in FIGS. 7 and 8, suturing device
100 with suture 302 is partially inserted into a portion of tissue
704. Sharpened tip 106 of suturing device 100 penetrates tissue
704, thereby delivering suture 302 to the other side of tissue 704.
A second tool 902 (FIG. 9) is used to assist in the release of
suture 302 from eyelet 110, and to draw the short end of suture 302
the rest of the way through tissue 704 and fully disengage suture
302 from device 100 (See FIG. 10). Exhibit A shows color
illustrations similar to FIGS. 7 through 10 and which may more
clearly illustrate the contrast between the tool, the suture, and
the tissue that is being sutured.
[0030] FIG. 11 shows a close-up of a tapered eyelet 110 of the type
described in FIGS. 1 through 10, and further illustrating the
orientation of the tapered eyelet 110 relative to the sharpened tip
106.
[0031] FIG. 12 shows a close-up of a sharpened tip 1202 with an
alternative embodiment of an eyelet 1204 in accordance with the
principles of the present invention. Eyelet 1202 has a tapered
central portion 1206 which may trap a suture from either the top
wider portion 1208 or the bottom wider portion 1210 of eyelet 1204.
One advantage of this embodiment is that the device operator may
disengage suture 302 from device 100 either by pulling the suture
towards the wider top portion 1208 or the wider bottom portion
1210. It will be clear to one skilled in the art that this
embodiment of the present invention provides added flexibility in
the manner in which the suture can be released.
[0032] FIG. 13 shows a close-up of a sharpened tip 1302 with
another alternative embodiment of an eyelet 1304 in accordance with
the principles of the present invention. Eyelet 1304 is configured
for side-loading of the suture into the eyelet. Eyelet 1304 is
advantageous where the end of a suture is frayed, or it is
otherwise difficult or time-consuming to pass lengthwise through an
eyelet (as shown in FIGS. 3 and 4). The eyelet configuration shown
in FIG. 13 allows for very easy loading, sliding, and release of
the suture from the suturing device.
[0033] FIG. 14 shows another sharpened tip 1402 with still another
embodiment of an eyelet 1404 with the feature of side-loading of a
suture according to the principles of the present invention. The
T-shaped configuration of eyelet 1404 substantially traps the
suture in eyelet 1404 while allowing the suture to slide lengthwise
through the eyelet.
[0034] FIG. 15 shows yet another sharpened tip 1502 with another
configuration of an eyelet 1504 with side-loading capability
according to the principles of the present invention. Eyelet 1504
is configured with a deep diagonal slot 1506 which substantially
traps the suture while allowing the suture to slide lengthwise
through the eyelet.
[0035] FIG. 16 shows yet another sharpened tip 1602 with another
embodiment of an eyelet 1604 with side-loading capability according
to the principles of the present invention. In FIG. 16, eyelet 1604
has a tapered configuration so that a suture may be side-loaded
into a suturing device and then wedged into the tapered portion of
the eyelet for improved trapping of the suture.
[0036] FIG. 17 shows yet another sharpened tip 1702 with another
embodiment of an eyelet 1704 with a side-loading capability
according to the principles of the present invention. In FIG. 17,
eyelet 1704 has an elongated and curved configuration for
substantially trapping a suture while allowing the suture to slide
lengthwise through the eyelet. The elongated and curved
configuration of the eyelet makes it very unlikely that a suture
will be unintentionally released from the suturing device.
[0037] FIGS. 18 through 21 illustrate a suturing device with a
locking mechanism for trapping a suture in an opening in a
sharpened tip in accordance with the principles of present
invention. As shown in FIG. 18, suturing device 1800 has a handle
1802 with locking mechanism button 1804, shaft 1806, and sharpened
tip 1808.
[0038] FIG. 19 illustrates a close-up of sharpened tip 1808, having
opening 1902 and locking element 1904. Locking element 1904 is
controlled by the device operator with button 1804 (FIG. 18).
Locking element 1804 may be selectively placed in (1) an open
position for inserting a suture into an opening in the sharpened
tip and for release of the suture from the opening in the sharpened
tip; (2) at least one partially closed position for capturing the
suture and for controlled adjustment of the suture relative to the
tip; and (3) a locked position for trapping a suture in the opening
in the sharpened tip at a selected point.
[0039] FIG. 20 further illustrates the use of the locking mechanism
in accordance with the principles of the invention. FIG. 20 shows a
schematic view of the sharpened tip 1808 with opening 1902.
Sharpened tip 1808 has side-loading capability and locking element
1904, which can be selectively placed in any of the foregoing
positions by movement of the locking element in the direction of
arrow 2002. When a suture is first side-loaded, locking element
1904 is in the open position as shown in FIG. 20. As locking
element 1904 is pushed forward and the side-opening 2004 is
blocked-off, the suture is captured in the tip, but is not yet
trapped in a particular position. In this state, the suture may
slide lengthwise relative to sharpened tip 1808, but may not be
removed from sharpened tip 1808 unless the full length of the the
suture is drawn through opening 1902. As element 1904 is moved
further forward, it engages the suture with a light amount of
friction, giving the device operator the ability to control the
lengthwise movement of the suture without damaging the suture.
Finally as locking element 1904 is pushed fully forward, the suture
becomes wedged in opening 1902, and fixed in a locked position.
Release of the suture is achieved by moving the locking button to
move the locking element away from the locked position.
[0040] In the embodiment of the present invention shown in FIG. 21,
the locking element moves in the same manner as in FIG. 20, and the
same locking principles apply, but no side-loading capability is
provided.
[0041] Referring to FIG. 22, various combinations of eyelets may be
formed on a sharpened tip in accordance with the principles of the
present invention. For example, a round eyelet 2202 may be formed
in addition to a deep diagonal slot 2204 on a device tip to allow
selection of fully enclosing a suture (round eyelet) or
side-loading of a suture with substantial trapping of the suture
(deep diagonal slot) on the same tool. As another example, the
eyelet with a tapered central portion as shown in FIG. 12 may also
be combined with a side-loading feature. These and other
combinations in accordance with the principles of the invention are
intended to be included within the scope of the present
invention.
[0042] FIGS. 23 through 29 show different sharpened tips for use in
different applications of the present invention. The sharpened tip
2302 illustrated in FIG. 23 extends substantially straight and
forward from the distal end of the device shaft. Alternatively, as
shown in FIG. 24, a the sharpened tip 2402 may be angularly bent
relative to the shaft in a selected direction, and angled to a
side. As illustrated in FIG. 25, and sharpened tip 2502 may be
further bent so that the distal portion of the tip generally points
towards the proximal end of the shaft.
[0043] Referring now to FIG. 26, an alternative embodiment
according the present invention is shown wherein a sharpened tip
2602 is curved at least partially about the distal end of the
shaft.
[0044] In a further embodiment according to FIG. 27, a sharpened
tip 2702 is formed with at least one spiral loop at the distal end
of the shaft. In the illustrated example, the spiral shaped tip
2702 has about 1.5 loops. According to this embodiment of the
present invention, with a suture held near the front of the spiral
(see location of eyelet 2704), the suture may be passed through a
tissue two or more times prior to releasing the stitch from a
suturing device.
[0045] As shown in FIG. 28, a sharpened tip 28 may be configured to
extend directly to one side of the distal end of the shaft.
[0046] Further, as shown in FIG. 29, a sharpened tip 2902 may be
configured to extend at least partially forward from the. distal
end of the shaft with a concave configuration.
[0047] Each of the above sharpened tip configurations may be
selected for a particular application to allow a surgeon to pierce
tissue in precisely the position chosen for the optimal
re-approximation of tissue. Further, each of the above sharpened
tip configurations may be combined with the other various aspects
of the present invention to provide a wide selection of
combinations to best pass suture through a substrate. For example,
each of the above sharpened tip configurations may be combined with
any of the eyelet configurations. Moreover, any of the eyelets
could have side-loading capability and/or a locking mechanism.
[0048] In accordance with a further principle of the present
invention, each tip may be configured for adjustability relative to
the axis of the suturing device shaft, for providing further
flexibility as to the orientation in which the suture may be
applied to a gap in tissue. For example, the angle of the tip in
FIG. 24 relative to the shaft may be adjusted at point in the
direction of arrow 2404. Similarly, the looped tip in FIG. 27 may
be rotated in the direction of arrow 2706. Each of the sharpened
tips disclosed thus may be pivoted, rotated, or otherwise further
adapted for improved application of the sharpened tip and the
suture.
[0049] In accordance with a further principle of the present
invention, various tips may be removed from the suturing device and
replaced with an alternative tip or with a new, sharper tip. For
example, referring to FIG. 24, the tip may be removed at point 2406
and replaced with the tip as shown in FIG. 25. Alternatively, the
tip may be detached at other positions on the suturing device, such
as by removing the shaft at point 116 (FIG. 1), and replacing it
with a shaft carrying a differently shaped tip.
[0050] Referring now to FIGS. 30 through 32, further embodiments of
the present invention configured for use with a needle point
swedged to a suture are shown. As shown in FIG. 30, suture 3002
with needle tip 3004 may be side-loaded into a suturing device with
a shaft 3006 with a curved distal end portion 3008. In accordance
with this aspect of the invention, needle tip 3004 is sharpened and
acts to penetrate and lead suture 3002 through a tissue. Once the
tissue is punctured, the needle tip is grasped with a suture
grasper (e.g. similar to second tool 902 in FIG. 9) and removed
from the shaft in the direction of arrow 3010. The shaft is
withdrawn and the suture is pulled through the tissue to complete
the stitch. This embodiment also allows the simple replacement of
sharp needles for tips that may have become dull. Further, tissue
abrasion associated with pulling the short end of a suture through
an opening already containing a length of suture is eliminated.
[0051] The shaft as in FIG. 30 may be modified as a cannula with
the suture passing through a partial length of the device (FIG. 31)
or the full length of the device (FIG. 32). These structures are
advantageous in reducing or eliminating the amount of loose suture
from the procedure area. Each of the devices in FIGS. 30 through 32
will preferably have a configuration for firmly holding the needle
tip while it is piercing the tissue.
[0052] Referring to FIG. 33, alternatively, a suturing device 3300
may have a sharpened tip 3302, as in FIGS. 1 through 29, and be
configured as a cannula with the suture passing through the full
length of the device with a section 3304 protruding from the tip,
in position for grasping as soon as the sharpened tip pierces a
substrate. Section 3304 is located behind the first portion of the
tip sharpened tip that pierces a tissue, so that the outwardly
extending portion is carried through the tissue which has been
pierced by the sharpened tip.
[0053] Referring now to FIG. 34, another embodiment of the
invention including a tissue support structure 3402 disposed
adjacent sharpened tip 3404 is shown (Exhibit B is a color
illustration similar to FIG. 34, but also showing a suture). Tissue
support structure 3402 is located on rotatable sheath 3406, which
encases a shaft (shaft is not shown but is attached to handle 3408
and tip 3404). Rotatable sheath 3406 is preferably rotated by
turning serrated handle 3410. Referring briefly to FIG. 35, a
close-up view of the distal tip of a suturing device according to
the principles of FIG. 34 is shown.
[0054] On occasion, the tissue to be sutured is difficult to pierce
and requires pressure from behind to "push" the tissue against the
sharpened tip. Use of tissue support structure 3402 is accomplished
by positioning a portion of tissue to be sutured in between
sharpened tip 3404 and tissue support structure 3402. The sharpened
tip is rotated through the tissue while the tissue support rotates
in an opposite direction, forcing the tissue against and to be
pierced by the sharpened tip. The relative rotational motion
between tissue support structure 3402 and sharpened tip 3404
provides the device operator with tactile feedback as to the amount
of force being applied to a tissue.
[0055] In accordance with the principles of the present invention,
tissue support structure 3402 and sharpened tip 3404 are suitably
configured to approach and engage a portion of tissue from a broad
range of angles or positions. Combination of the various sharpened
tip configurations in accordance with the present invention and the
adjustability of those tips with the tissue support structure
provides an even broader range of options for engaging a tissue
between a sharpened tip and tissue support structure 3402.
[0056] With continue reference to FIG. 35, a suture 302 is
connected with the sharpened tip and passed through the tissue as
the sharpened tip pierces the tissue. After piercing, the suture is
grasped on the other side of the tissue, as described above,
released from the sharpened tip, and then pulled through the tissue
for further use in suturing.
[0057] Referring now to FIG. 36, an alternative configuration for
drawing a suture through a tissue is disclosed (Exhibit C is a
color illustration of the elements of FIG. 36). A suture 302 is
connected with a sling 3602 in a tissue support device 3604. The
sharpened tip pierces the tissue with the assistance of the tissue
support device, and engages the suture as the sharpened tip is
drawn back through the tissue and the suturing device is rotated
open. In this way, if a suture is preferably applied from a side of
a tissue inaccessible to the sharpened tip, the sharpened tip may
be engaged from the opposite (and accessible) side of the tissue,
and then made to draw the suture back through the tissue.
[0058] The present invention has been described above with
reference to preferred embodiments. However, those skilled in the
art having read this disclosure will recognize that changes and
modifications may be made to the preferred embodiment without
departing from the scope of the present invention. For example, the
combination of the various opening configurations with the
configurations of the sharpened tip is clearly contemplated by this
disclosure. Similarly, the use of the various eyelets, tip
configurations, and locking mechanisms with the different tissue
support features is intended. These and other changes or
modifications are intended to be included within the scope of the
present invention, as expressed in the following claims.
* * * * *