U.S. patent application number 12/844260 was filed with the patent office on 2012-02-02 for surgical tack and tack drive apparatus.
Invention is credited to Steven M. Reeser.
Application Number | 20120029538 12/844260 |
Document ID | / |
Family ID | 45527491 |
Filed Date | 2012-02-02 |
United States Patent
Application |
20120029538 |
Kind Code |
A1 |
Reeser; Steven M. |
February 2, 2012 |
Surgical Tack and Tack Drive Apparatus
Abstract
A fastener is provided for attaching body tissue to body tissue
or another material to body tissue. The fastener includes a head
portion, a body portion, and an anchoring element. The anchoring
element is on the distal end of the fastener, and has one or more
barbs or similar anchoring devices that are configured to prevent
removal of the fastener once it is attached to the body tissue. The
head is located on the proximal end of the fastener, and anchors
the body tissue or other material when the fastener is attached to
the body tissue. The disclosure also provides a driver apparatus
for inserting the fasteners. The applicator device includes an
indexer for sequentially indexing one or more fasteners, and a
driver for applying an insertion force to a fastener that is
sufficient to insert the fastener and attach it to body tissue. The
disclosure also provides a method of using the fastener and
applicator device.
Inventors: |
Reeser; Steven M.;
(Jacksonville, FL) |
Family ID: |
45527491 |
Appl. No.: |
12/844260 |
Filed: |
July 27, 2010 |
Current U.S.
Class: |
606/151 ;
227/175.1 |
Current CPC
Class: |
A61B 17/0682 20130101;
A61B 17/064 20130101; A61B 2017/0647 20130101; A61B 17/068
20130101; A61B 17/07207 20130101 |
Class at
Publication: |
606/151 ;
227/175.1 |
International
Class: |
A61B 17/064 20060101
A61B017/064; A61B 17/068 20060101 A61B017/068 |
Claims
1. A fastener for attaching to a body tissue, having a longitudinal
direction, a proximal end, and a distal end, and comprising: a head
portion disposed near the proximal end of the fastener, and having
a proximal surface, a distal surface, and a passage that extends
through the head portion from the proximal surface to the distal
surface; a body portion extending from the distal surface of the
head portion in the longitudinal direction; and an anchoring
element extending from the body portion, and comprising at least
one barb at least partially disposed adjacent the distal end of the
fastener.
2. The fastener of claim 1, wherein the at least one barb has a
proximal end and a distal end, and wherein the barb's proximal end
is wider than the barb's distal end, as measured in a direction
orthogonal to longitudinal direction.
3. The fastener of claim 1, wherein the at least one barb further
comprises an upper facet and a lower facet, said facets tapering to
an angled leading edge.
4. The fastener of claim 1, wherein the anchoring element comprises
two barbs disposed on opposite sides of the fastener.
5. The fastener of claim 4, wherein the two barbs are
longitudinally offset from each other.
6. The fastener of claim 2, wherein the anchoring element comprises
two barbs disposed on opposite sides of the fastener.
7. The fastener of claim 6, wherein distal ends of the two barbs
are longitudinally offset from each other.
8. The fastener of claim 1, wherein the head portion further
comprises at least one anchor tab disposed on the distal surface of
the head portion.
9. The fastener of claim 1, wherein the passage is a bore.
10. The fastener of claim 9, wherein the bore is rectangular.
11. The fastener of claim 1, wherein the fastener is made of
absorbable material.
12. The fastener of claim 1, wherein the passage is a channel.
13. The fastener of claim 1, wherein the distal head face and
proximal head face are substantially flat surfaces.
14. An applicator for applying a barbed fastener to a body tissue,
the applicator comprising: an elongated tubular portion having a
longitudinal axis extending from a proximal end to a distal end and
having a tube interior accessible by proximal and distal tube
openings, the tube interior being sized and configured for
receiving the barbed fastener; an indexer disposed at least
partially inside the tube interior, the indexer having an elongated
indexer body member and a fastener engaging portion adapted to
engage the barbed fastener and move the barbed fastener from an
initial fastener position in the tube interior to a firing position
as the indexer moves from a first longitudinal position to a
second, more distal longitudinal position; and a driver disposed at
least partially inside the tube interior, the driver having a
driver engaging portion at its distal end, the driver engaging
portion being adapted to engage the barbed fastener in the firing
position and selectively apply an ejection force to the barbed
fastener, thereby ejecting the barbed fastener from the tube
interior through the distal opening.
15. The applicator of claim 14, wherein the ejection force is
applied to the barbed fastener by the driver as the driver is moved
distally from a pre-firing driver position to a distal-most driver
position adjacent the distal tube opening.
16. The applicator of claim 15 wherein a biasing force is applied
to the driver by a spring when said driver is in the pre-firing
driver position, said biasing force serving to bias the driver
toward the distal-most driver position.
17. The applicator of claim 15 wherein the applicator is configured
for operation through a repeatable operation cycle comprising: an
initial stage, in which the indexer is in its first longitudinal
position and the driver is in its distal-most position; a
pre-firing stage, in which the indexer is in its second, more
distal longitudinal position and the driver is in its pre-firing
position; and a post-firing stage, in which the indexer is in its
second, more distal longitudinal position, and the driver is in its
distal-most position.
18. The applicator of claim 17, wherein the indexer and driver are
operably coupled with an actuation assembly configured to
selectively control and coordinate movement of the indexer and
driver from their initial stage positions to their pre-firing stage
positions, from their pre-firing stage positions to their
post-firing stage positions, and from their post-firing stage
positions back to their initial stage positions.
19. The applicator of claim 18, wherein the actuation assembly
comprises a trigger configured for rotational movement between an
initial trigger position, a pre-firing trigger position and a
post-firing trigger position, the trigger and actuation assembly
being adapted so that movement of the trigger from the initial
trigger position to the pre-firing trigger position causes the
indexer and driver to move from their initial stage positions to
their pre-firing stage positions, further movement of the trigger
to the post-firing trigger position causes the indexer and driver
to move from their pre-firing stage positions to their post-firing
stage positions, and movement of the trigger back to the initial
trigger position causes the indexer and driver to move from their
post-firing stage positions back to their initial stage
positions.
20. The applicator of claim 14, wherein the barbed fastener
comprises a head portion having a fastener passage formed
therethrough and wherein the elongated indexer body member is
configured for slidable disposition through the fastener
passage.
21. The applicator of claim 14, wherein: the tube interior is sized
and configured for receiving one or more additional fasteners
substantially identical to the barbed fastener, the additional
fasteners being serially positionable within the tube interior
proximal to the barbed fastener along the longitudinal axis, the
indexer has one or more additional engaging portions adapted to
engage the additional fasteners and to move each of the additional
fasteners from a first longitudinal fastener position to a second
more distal longitudinal fastener position at the same time the
indexer moves the barbed fastener from its initial fastener
position to its firing position.
22. The applicator of claim 21, wherein the second longitudinal
position of the distal-most of the additional fasteners is the same
as the initial fastener position of the barbed fastener.
23. The applicator of claim 21 further comprising: means for
preventing the additional fasteners from moving in a proximal
direction when the indexer returns from its second, more distal
longitudinal position to the first longitudinal position.
24. The applicator of claim 21, wherein the elongated tube portion
comprises one or more lance tabs projecting inward from an inner
surface of the elongated tube portion at an angle toward the distal
end of the elongated tube portion and capable of flexing outward,
the lance tabs being configured to engage and prevent the proximal
movement of the additional fasteners while allowing their distal
movement by the indexer.
25. A method of applying a fastener to a pre-determined target
insertion point on a body tissue, comprising: providing a fastener
having a head portion having a passage formed therethrough, an
anchoring element configured for engaging the body tissue, and a
body portion extending distally from the head portion to connect
the anchoring element thereto; providing a fastener applicator
comprising an elongated tubular portion having a longitudinal axis
extending from a proximal end to a distal end and having a tube
interior accessible by proximal and distal tube openings, an
indexer disposed at least partially inside the tube interior, the
indexer being adapted to selectively move the fastener from an
initial position to a firing position adjacent the distal tube
opening, and a driver disposed at least partially inside the tube
interior, the driver being adapted to engage the fastener in the
firing position and selectively apply an ejection force to the
fastener; placing the fastener in the initial position within the
tube interior; causing the indexer to selectively move the fastener
from the initial position to the firing position; positioning the
distal opening of the tube assembly adjacent the target insertion
point; and causing the driver to apply the ejection force to the
fastener, thereby ejecting the fastener through the distal opening
and into the body tissue at the target insertion point.
26. The method of claim 25, wherein the ejection force is applied
to the barbed fastener by the driver as the driver is moved
distally from a pre-firing driver position to a distal-most driver
position adjacent the distal tube opening.
27. The method of claim 26 wherein a biasing force is applied to
the driver by a spring when said driver is in the pre-firing driver
position, said biasing force serving to bias the driver toward the
distal-most driver position.
28. The method of claim 25, wherein the applicator includes an
actuation assembly having a trigger configured for rotational
movement between an initial trigger position, a pre-firing trigger
position and a post-firing trigger position, the trigger and
actuation assembly being adapted so that movement of the trigger
from the initial trigger position to the pre-firing trigger
position causes the indexer to move the fastener from the initial
position to the firing position, further movement of the trigger to
the post-firing trigger position causes the driver to apply the
ejection force to the fastener, thereby ejecting the fastener
through the distal opening and into the body tissue at the target
insertion point.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to surgical
fasteners and drive apparatus for use with surgical fasteners. More
specifically, the present invention relates to soft tissue surgical
tacks and a tack drive system for the fixation of hernia mesh.
DESCRIPTION OF RELATED ART
[0002] Fasteners are used in various surgical procedures to secure
tissue and objects to tissue. One such surgical procedure is the
repair of a hernia. A common solution in hernia repair is to attach
a mesh patch over the defect so that bowel and other abdominal
tissue are blocked from forming an external bulge that is typical
of abdominal hernias.
[0003] At present, there are a variety of devices and fasteners
available to attach the mesh patch to the inguinal floor or
abdominal wall. Such devices and fasteners include sutures,
surgical staples, and tacks. The role of the devices and fasteners
is to keep the mesh in proper position until tissue in-growth is
adequate to hold the mesh in place under various internal and
external conditions.
[0004] A hernia repair surgery can be performed either through the
traditional open procedure or through the current trend of less
invasive procedures such as laparoscopic procedures. Certain
previously used devices and fasteners are better suited for open
procedures while other devices and fasteners are better suited for
laparoscopic procedures.
SUMMARY
[0005] In view of the foregoing, there exists a need for a hernia
mesh fastener that is simple to deploy, securely fastens to bodily
tissue, and can be absorbed by the body after a period of time when
the tissue in-growth to the mesh obviates the need for a fastener.
A need also exists for a simple inexpensive fastener drive
apparatus that is easy to handle and use by a surgeon and is
adaptable for use in both open and laparoscopic procedures.
Accordingly, various embodiments disclosed herein provide a
fastener, a drive apparatus, and a method for using the drive
apparatus to apply a fastener
[0006] It is therefore a feature of an embodiment to provide a
fastener for attaching to a body tissue, having a longitudinal
direction, a proximal end, and a distal end. The fastener comprises
a head portion disposed near the proximal end of the fastener and
having a proximal surface, a distal surface, and a passage that
extends through the head portion from the proximal surface to the
distal surface. The fastener further comprises a body portion
extending from the distal surface of the head portion in the
longitudinal direction. The fastener further comprises an anchoring
element extending from the body portion, and including at least one
barb that is at least partially disposed adjacent the distal end of
the fastener.
[0007] It is another feature of an embodiment to provide an
applicator for applying a barbed fastener to a body tissue, the
applicator comprising an elongated tubular portion having a
longitudinal axis extending from a proximal end to a distal end and
having a tube interior accessible by proximal and distal tube
openings. The tube interior is sized and configured for receiving
the barbed fastener. The applicator further comprises an indexer
disposed at least partially inside the tube interior. The indexer
has an elongated indexer body member and a fastener engaging
portion adapted to engage the barbed fastener and move the barbed
fastener from an initial fastener position in the tube interior to
a firing position as the indexer moves from a first longitudinal
position to a second, more distal longitudinal position. The
applicator also comprises a driver disposed at least partially
inside the tube interior. The driver has a driver engaging portion
at its distal end. The driver engaging portion is adapted to engage
the barbed fastener in the firing position and selectively apply an
ejection force to the barbed fastener, thereby ejecting the barbed
fastener from the tube interior through the distal opening.
[0008] It is another feature of an embodiment to provide a method a
method of applying a fastener to a pre-determined target insertion
point on a body tissue. The method comprises providing a fastener
having a head portion having a passage formed therethrough, an
anchoring element configured for engaging the body tissue, and a
body portion extending distally from the head portion to connect
the anchoring element thereto. The method further comprises
providing a fastener applicator comprising an elongated tubular
portion having a longitudinal axis extending from a proximal end to
a distal end and having a tube interior accessible by proximal and
distal tube openings, an indexer disposed at least partially inside
the tube interior, the indexer being adapted to selectively move
the fastener from an initial position to a firing position adjacent
the distal tube opening, and a driver disposed at least partially
inside the tube interior, the driver being adapted to engage the
fastener in the firing position and selectively apply an ejection
force to the fastener. The method still further comprises placing
the fastener in the initial position within the tube interior and
causing the indexer to selectively move the fastener from the
initial position to the firing position. The method also comprises
positioning the distal opening of the tube assembly adjacent the
target insertion point and causing the driver to apply the ejection
force to the fastener, thereby ejecting the fastener through the
distal opening and into the body tissue at the target insertion
point.
[0009] These and other objects, features, and advantages of the
present invention will appear more fully from the following
description of the exemplary embodiments, taken in conjunction with
the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a perspective view of a fastener in accordance
with an exemplary embodiment;
[0011] FIG. 2 is a top view of a fastener in accordance with an
exemplary embodiment;
[0012] FIG. 3 is a front view of a fastener in accordance with an
exemplary embodiment;
[0013] FIG. 4 is a perspective view of a fastener in accordance
with an exemplary embodiment;
[0014] FIG. 5 is a partial sectional side view of a tube assembly
of a drive apparatus and fasteners, in accordance with an exemplary
embodiment;
[0015] FIG. 6 is a partial sectional perspective view of a distal
portion of a tube assembly of a drive apparatus and fasteners, in
accordance with an exemplary embodiment;
[0016] FIG. 7 is a partial sectional bottom view of a distal
portion of a tube assembly of a drive apparatus and fasteners, in
accordance with an exemplary embodiment;
[0017] FIG. 8 is a partial sectional top view of a distal portion
of a tube assembly of a drive apparatus and fasteners, in
accordance with an exemplary embodiment;
[0018] FIG. 9 is a partial sectional top view of a distal portion
of a tube assembly of a drive apparatus and fastener, in accordance
with an exemplary embodiment;
[0019] FIG. 10 is a partial sectional side view of a
handle/actuation portion of a drive apparatus in an initial
position, in accordance with an exemplary embodiment;
[0020] FIG. 11 is an enlargement of portion A-A of FIG. 10, in
accordance with an exemplary embodiment;
[0021] FIG. 12 is a partial sectional side view of a
handle/actuation portion of a drive apparatus in an intermediate
position in accordance with an exemplary embodiment;
[0022] FIG. 13 is a partial sectional side view of a
handle/actuation portion of a drive apparatus in a pre-fired
position in accordance with an exemplary embodiment; and
[0023] FIG. 14 is a partial sectional side view of a
handle/actuation portion of a drive apparatus in a post-fired
position in accordance with an exemplary embodiment.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0024] Hereinafter, aspects of methods and apparatuses in
accordance with various exemplary embodiments will be described. As
used herein, any term in the singular may be interpreted to be in
the plural, and alternatively, any term in the plural may be
interpreted to be in the singular.
[0025] As used herein, the term "proximal" refers to the portion of
a fastener or fastener drive apparatus closest to the user (i.e.,
the person inserting the fastener), while the term "distal" refers
to the portion of a fastener or fastener drive apparatus furthest
from the user.
[0026] Exemplary embodiments include a fastener and fastener drive
apparatus for use in surgical procedures. B y way of example, the
embodiments are illustrated and described in reference to devices
and methods used in conjunction with a hernia repair procedure
using a mesh patch. Thus, in the exemplary embodiments, the
fasteners may be referred to as a hernia mesh tack and the drive
apparatus may be referred to as a tack drive apparatus. However, it
is appreciated that the exemplary embodiments are applicable to
various other surgical procedures that require the use of a
fastener and a fastener drive apparatus.
[0027] The fasteners of the exemplary embodiments are configured to
secure body tissue to body tissue, or to secure another material,
such as a mesh, to body tissue. For example, a fastener of the
exemplary embodiments may be used as a hernia tack that secures a
mesh structure to body tissue in a hernia repair procedure. In the
exemplary embodiments, the hernia tack is of the axial insertion or
"push" type variety and is configured for insertion upon
application of a rapid axial insertion impulse, as compared to a
steady, drawn out insertion force. The hernia tack of the exemplary
embodiments includes barbs that enable easy penetration of the
tissue with minimal tissue cutting. The fasteners of the exemplary
embodiments can be used in conjunction with a drive apparatus that
is configured to position a fastener for insertion, and to apply a
rapid insertion impulse to the fastener to permanently insert the
fastener into a body tissue. Various exemplary embodiments of such
fasteners and drive apparatuses are described in more detail
below.
[0028] Referring now to FIGS. 1-4, in which like reference numerals
identify similar or identical elements, the details of an exemplary
embodiment of a fastener 100 are described in greater detail.
Generally, the fastener 100 has a longitudinal direction L.sub.F,
as indicated by the arrow in FIG. 1. Along the longitudinal
direction, the fastener 100 has a distal end 104, and a proximal
end 102. In the exemplary embodiments, the distal end 104 of the
fastener 100 generally is the portion of the fastener 100 that is
first inserted through the body tissue. In the embodiments, the
fastener 100 includes an anchoring element 130 located near the
distal end 104 of the fastener 100, a head portion 110 located near
the proximal end 102 of the fastener 100, and a body portion 120
located intermediate the two ends 102, 104, connecting the
anchoring element 130 and the head portion 110.
[0029] In the exemplary embodiments, the head portion 110 of the
fastener 100, can be configured to engage with a body tissue, or
other material, such as a mesh, to hold the tissue or material in
place against a body tissue. As illustrated in FIGS. 1-4, in the
exemplary embodiments, the outer surface of head portion 110 of the
fastener 100 can include a distal head face 111, a proximal head
face 112, an upper head face 113, and a lower head face 114. Each
of the faces 111, 112, 113, 114, can be flat or substantially flat
surfaces, or they can be arcuate to provide a concave or convex
surface. For example, in the exemplary embodiment illustrated in
FIGS. 1-4, upper head face 113 is a flat surface, and lower head
face 114 is generally an arcuate surface with a convex shape, such
as one formed by a smooth arcuate surface, or a series of adjoining
arcuate or flat facets. In exemplary embodiments, the arc defined
by the lower head face 114 can extend at least about 180 degrees
and less than 360 degrees. In the embodiment illustrated in FIGS.
1-4, the arcuate lower head face 114 provides a 180 degree arc that
connects one transverse edge of the upper head face 113 to the
other transverse edge of the upper head face 113. It is appreciated
that any or all of the faces 111, 112, 113, 114, can be configured
to have any desired shape
[0030] In various embodiments, the head portion 110 may have a
passage 115 that extends through the head portion 110 from the
proximal head face 112 to the distal head face 111. The passage 115
is configured to enable the fastener 100 to slide along the drive
sequencing indexer mechanism, as will be discussed in more detail
later. In exemplary embodiments, the passage 115 may be shaped in
such a way as to compliment the shape of the indexer. For example,
the passage 115 may be in the form of a bore or a channel that at
least partially surrounds the indexer, enabling the fastener 100 to
slide along the indexer. For example, in embodiments in which the
indexer has a rectangular cross-sectional shape, the passage 115
may have a corresponding rectangular shaped bore. In other
exemplary embodiments, the passage 115 may be formed as a channel
rather than a closed passage, an that it surrounds only a portion
of the indexer. It will be understood that the passage 115 may be
configured in other suitable forms and shapes suitable for adapting
the fastener to slide along an indexer. The head portion 110 also
may be configured to facilitate deployment from an applicator.
[0031] In various exemplary embodiments, the head portion 110 may
include one or more anchoring devices such as anchor tabs 116
extending from the distal head face 111. The anchor tabs 116 may be
configured to assist in anchoring the mesh or other material in
place when the fastener 100 is inserted. The anchor tabs 116 may
provide an attachment that secures more readily to large-holed
mesh. For example, during hernia surgery, the anchor tabs 116 may
engage the hernia mesh strand to provide a more secure bond between
the mesh and the tissue. The anchor tabs 116 may have any shape
that would enable the tabs 116 to anchor the mesh. For example, in
embodiments such as those illustrated in FIGS. 1-4, the anchor tabs
116 may have a triangular shape. It will be understood that the
anchor tabs 116 may have many alternative shapes.
[0032] In various exemplary embodiments, the body portion 120 of
fastener 100 extends distally from the head portion 110, and has a
proximal body end 122 joined with the distal head face 111, and a
distal body end 121. In exemplary embodiments, the body portion 120
and the head portion 110 may be integrally formed to form a single
unit. However, it will be understood that the body portion 120 and
head portion 110 may be separately formed, and joined together to
form the fastener 100. The body portion 120 additionally may have
an upper body face 123 and a lower body face 124. In exemplary
embodiments, the upper body face 123 and the lower body face 124
may have flat or substantially flat surfaces, or surfaces that have
a partial curve. In some embodiments, the upper body face 123 may
be coplanar with the upper head face 113. In some embodiments, the
lower body face 124 may be coplanar with the upper passage surface
117.
[0033] In exemplary embodiments, the distal body end 121 may have
one or more anchoring elements 130. The anchoring element 130 and
body portion 120 may be integrally formed, or may be separately
formed and operably joined together. In the embodiment illustrated
in FIGS. 1-4, the anchoring element 130 has a pair of barbs 131,
132. Barbs 131,132 may have a proximal anchor point 136 that has a
width (measured at its widest point) that is wider than the distal
edge 137, which prevents expulsion or removal of the fastener 100
from the body tissue once the fastener 100 is applied. The barbs
131,132 also may have upper facets 133 and lower facets 134 that
taper to an angled leading edge 135. The leading edge 135 is
configured to have a cutting portion and a stretching portion. When
the fastener 100 is inserted, the width of the incision is only as
wide as the effective diameter from the proximal ends of the
cutting portions of the two barbs 131, 132. The stretching portion
serves to widen the incision to admit the tack without further
tissue cutting. When the barbs 131, 132 are fully inserted into the
tissue the stretched incision tends to close back up, thereby
improving the security of the tissue attachment to the inserted
fastener 100.
[0034] In some embodiments, the first barb 131 is longitudinally
offset from the second barb 132. Where the impact force is directed
through the centerline of the body portion 120, the offset barb
configuration provides a more acute angle of penetration than with
non-offset barbs. It is believed that the offset barb configuration
allows for easier tissue penetration by utilizing less force, and
also allowing the relationship to the proximal anchor point 136 and
the distal body end 121 to be geometrically enhanced allowing for
increased tissue pull out force. In addition, it is believed that
the offset allows less tissue cutting and stretching relative to
the effective width of the two proximal anchor points 136. While
the anchoring element 130 is shown with two offset barbs 131,132,
it will be understood that the anchoring element 130 may have more
barbs or fewer barbs, and the barbs configuration may vary.
[0035] The fastener 100 and components thereof may be made of any
of various materials suitable for insertion into the human body. In
various embodiments, the fastener 100 of the may be made of
biocompatible material, such as stainless steel or titanium. In
various exemplary embodiments, the fastener 100 may be made of an
absorbable material, such as a polymer. Exemplary absorbable
materials include homopolymers and copolymers of lactide,
glycolide, polyglycolide, polylactide, or various combinations or
mixtures thereof. It will be understood that there are various
suitable polymers and that each exhibits different absorption
rates, and different shear and tensile strengths when molded.
[0036] It will be understood that the fastener 100 will have
dimensions suitable for insertion into the human body, and suitable
to provide a stable anchoring structure. For example, in various
embodiments, the fastener 100 may have an effective overall length
(measured longitudinally from proximal end 102 to distal end 104)
in the range of about 4 mm to about 6 mm. In the various
embodiments, the diameter of the head portion 110 measured
transversely at the widest point may be in the range of about 4 mm
to about 10 mm
[0037] In exemplary embodiments, the fasteners 100 may be adapted
so that a plurality of fasteners 100 may be loaded for application
by a drive apparatus 200. In various exemplary embodiments, one or
more fasteners 100 may be loaded into a fastener drive apparatus
200 and inserted into the surgical field, either directly, as in
the case of open surgery, or through a trocar cannula. The
fasteners 100 should be sized to be compatible with the size of the
drive apparatus 200 and associated devices. For example, the
fasteners 100 may be sized to fit through different diameter tube
assemblies, thus different size trocar ports. Smaller fasteners 100
enable the use of smaller tube assemblies. For example, small
fasteners 100 having a diameter of about 4 mm make possible the use
of a trocar cannula with a diameter as small as about 5 mm.
[0038] Turning now to FIGS. 5-14 a drive apparatus 200 according to
an exemplary embodiment will be described. In various embodiments,
drive apparatus 200 is configured to enable a user such as a
surgeon to insert and secure a fastener 100 to a body tissue.
Preferably, the drive apparatus 200 is configured for easy
manipulation and one-handed use by a user. In an exemplary
embodiment, one or more fasteners 100 may be loaded into the drive
apparatus 200, so that they may be individually deployed by the
drive apparatus 200. In exemplary embodiments, the drive apparatus
200 may have a sequencer or indexer 260 to align and shift the
fasteners 100 inside the drive apparatus 200. The drive apparatus
200 further may have a driver mechanism 270 to provide a rapid
impulse force to a fastener 100, ejecting the fastener 100 from the
drive apparatus 200 with sufficient force to insert the fastener
100 into a body tissue.
[0039] As illustrated in FIG. 10, in various exemplary embodiments,
the drive apparatus 200 has a handle/actuation assembly 210 and a
tube assembly 250. The tube assembly 250 may be configured to house
a plurality of fasteners 100. The tube assembly 250 has a distal
end 254, from which the fasteners 100 are ejected. The
handle/actuation assembly 210 provides a handgrip 214 that enables
the user to manipulate the drive apparatus 200. In exemplary
embodiments, the handle/actuator assembly 210 further includes a
trigger 216 that, when triggered, actuates the indexer 260, the
driver mechanism 270, or both.
[0040] In exemplary embodiments, the tube assembly 250 has an
elongated tube portion 252, extending in a longitudinal direction,
L.sub.T, and having a length Y. At its proximal end, the elongated
tube portion 252 is joined with the handle/actuation assembly 210.
The distal end of the elongated tube portion 252 coincides with the
distal end 254 of the tube assembly 250, from which the one or more
fasteners 100 are ejected. The length Y of the elongated tube
portion 252, measured from its proximal end to its distal end, may
be selected according to the intended use of the drive apparatus
200. For example, in an embodiment in which the drive apparatus 200
is used in laparoscopic procedures, the elongated tube portion 252
may have a length of about 12 inches to about 15 inches. In an
embodiment in which the drive apparatus 200 is used for
non-laparoscopic applications, a length of about 4 inches to about
9 inches may be more suitable. As guided by the disclosure herein,
it will be understood by one of ordinary skill in the art how to
select a suitable length for the elongated tube portion 252,
depending on the intended use of the drive apparatus 200.
[0041] Turning now to FIGS. 5-9, the tube assembly 250 will be
described in more detail. As illustrated in the figures, in various
exemplary embodiments, the tube assembly 250 houses an indexer 260,
a driver 270, and a spacer. Generally speaking, the indexer 260
serves the purpose of indexing the one or more fasteners 100 within
the tube assembly 250, and moving them toward the distal end 254 of
the tube assembly 250 so that they may be ejected. The driver 270
generally serves the purpose of ejecting the distal-most fastener
100 from the distal end 254 of the tube assembly 250. The spacer
generally serves the purpose of aligning the driver 270, the
indexer 260 within the tube assembly 250. Each of these devices is
explained in more detail herein.
[0042] In various exemplary embodiments, the indexer 260 may have
an elongated member 262 adapted to temporarily secure the fasteners
100 within the tube assembly 250, and to index the fasteners 100 in
a distal direction along the longitudinal direction L.sub.T of the
tube assembly 250. For example, the indexer 260 may have an
elongated member 262 that is adapted to fit within the passage 115
of the one or more fasteners 100 loaded in the drive apparatus 200.
It will be understood that in other exemplary embodiments, the
elongated member 262 may be disposed along one or more sides of the
fasteners 100, rather than through the central passage 115 of the
fasteners 100.
[0043] In exemplary embodiments, the elongated member 262 may move
in a direction substantially parallel to the longitudinal direction
L.sub.T of the tube assembly 250. The elongated member 262 may have
one or more features that enable it to transport the one or more
fasteners 100 within the tube assembly 250. For example, the
indexer 260 may further have a plurality of indexer engagers 264,
266, that temporarily secure the fasteners 100 to the indexer 260,
so that the fasteners 100 move with the indexer 260. In the
exemplary embodiment illustrated in FIG. 6, the indexer 260 has an
elongated member 262 that is coupled with a distal index engager
264 and a proximal index engager 266. The elongated member 262 fits
inside the passage 115 of one or more fasteners 100 (see FIGS. 5
and 7). The proximal index engager 266 is configured to engage with
the proximal head face 112 of fastener 100. The distal index
engager 264 is configured to temporarily engage with the distal
head face 111 of fastener 100. In this configuration, the index
engagers 264, 266, temporarily secure the fastener 100 to the
elongated member 262 so that the fasteners 100 move with the
elongated member 262.
[0044] In various embodiments, the indexer 260 may be configured to
enable the fasteners 100 to move independently from the indexer
260. For example, index engagers 264, 266, may be configured to
enable the fasteners 100 to slide in a distal direction along the
elongated member 262, but prevent the fasteners 100 from moving in
a proximal direction. In the exemplary embodiment illustrated in
FIG. 6, the proximal index engager 266 has two angled arms 267 that
extend toward the proximal head face 112 of the fastener 100. At
its widest point, which is adjacent the proximal head face 112, the
arms 267 render the proximal index engager 266 wider than the
passage 115 of the fastener 100, providing a stop that prevents the
proximal movement of the fastener 100 relative to the indexer 260.
The arms 267 are sufficiently flexible to enable the fastener 100
to slide over the proximal index engager 266 in a distal direction.
However, once the fastener 100 has slid past the proximal index
engager 266, the arms 267 shift back to their initial
configuration, preventing the proximal movement of the fastener 100
relative to the indexer 260. In the exemplary embodiment of FIG. 6,
the distal index engager 264 has two arms 265 extending toward the
distal head face 111 of the fastener 100. The arms 265 have rounded
ends that are capable of limiting the distal movement of the
fastener 100 relative to the indexer 260, but when a force that
exceeds a predetermined threshold is applied to the fastener 100,
the arms 265 flex inward, enabling the fastener 100 to slide in a
distal direction over the distal index engager 264. It will be
understood how to specify the predetermined threshold, consistent
with the guidance provided herein.
[0045] In various exemplary embodiments, the tube assembly 250 may
be configured to limit the proximal movement of the fasteners 100
relative to the tube assembly 250. In the exemplary embodiment
illustrated in FIG. 6, the elongated tube portion 252 may have,
along its inner surface, one or more lance tabs 256 that provide an
interference point along the elongated tube portion 252, preventing
the proximal movement of the fasteners 100 relative to the
elongated tube portion 252. For example, in the embodiment
illustrated in FIG. 6, lance tabs 256 project from the inner
surface of the elongated tube portion 252, at an angle toward the
distal end of the elongated tube portion 252. At its distal end,
the lance tabs 256 reduces the width of the elongated tube portion
252 so that it is narrower than the width of the head portion 110
of the fastener 100, providing a stop that prevents the fastener
100 from moving in a proximal direction relative to the elongated
tube portion 252. However, the lance tabs 256 are capable of
flexing outward when the fastener 100 slides past them in a distal
direction. In exemplary embodiments, the lance tabs 256 may be
provided in pairs, disposed on opposite sides of the elongated tube
portion 252. In certain embodiments, the lance tabs 256 are made of
punch-outs on the elongated tube portion 252, that are flexed or
bent toward the center of the elongated tube portion 252. In this
configuration, the lance tabs 256 are integral with the elongated
tube portion 252. However, it will be understood that the lance
tabs 256 may be separately formed, and attached to the inner
surface of the elongated tube portion 252, to provide projections,
flanges, or other suitable structures along the interior of the
elongated tube portion 252. It will be understood that other
features may be provided as an alternative to, or in addition to
the lance tabs 256, to limit the proximal movement of the fasteners
100 relative to the elongated tube portion 252.
[0046] In various exemplary embodiments the indexer 260 is
configured to index multiple fasteners 100 within the elongated
tube portion 252. FIG. 5 illustrates aside elevation view of an
exemplary tube assembly 250, with a portion of the elongated tube
portion 252 cut away to reveal the internal elements. FIG. 7
illustrates a bottom view of an exemplary tube assembly 250, with a
portion of the elongated tube portion 252 cut away to reveal the
internal elements. In these exemplary embodiment, three fasteners
100a, 100b, and 100c are shown, but it will be understood that the
drive apparatus 200 may be configured to hold more, or fewer,
fasteners 100. Indexer 260 preferably has a number of proximal
index engagers 266, and distal index engagers 264 that is equal to
or greater than the number of fasteners 100 loaded in the drive
apparatus 200, so that each fastener 100 is secured to the indexer
260 prior to being expelled from the drive apparatus 200. Indexer
260 has an elongated member 262, that extends through the passage
(not shown) of the respective head portions 110a, 110b, 110c, of
each of the fasteners 100a, 100b, 100c. Adjacent the distal head
face (111a, 111b, 111c) of each head portion is a distal index
engager 264a, 264b, 264c, and adjacent each proximal head face
(112a, 112b, 112c) is proximal index engager 266a, 266b, 266c.
Lance tabs 256 are located on the inner surface of the elongated
tube portion 252, and are shown abutting the proximal head faces
(112a, 112b, 112c) of the fasteners 100a, 100b, 100c.
[0047] The operation of the indexer 260 will now be described in
reference to the embodiments of FIGS. 5, 7, and 8. For purposes of
discussion, the indexer 260 in FIGS. 5 and 7 is illustrated in its
initial, proximal-most position (i.e., the position it holds during
the initial stage of operation),which is also its reset position;
the indexer 260 in FIG. 8 is illustrated in its distal-most
position, which is its position at the pre-firing stage. From this
position, the indexer 260 may be described as having a cyclical
movement, during which it may move distally from its initial
position to its pre-firing stage position (the distal stroke) and
then proximally back to the initial position (the proximal stroke),
completing a full cycle of movement.
[0048] In an exemplary embodiment, during the indexer's 260 distal
stroke, the indexer 260 moves the fasteners 100a, 100b, and 100c
which are held in place by the respective index engagers 264a-c and
266a-c. The distal stroke of the indexer 260 may end when the
fasteners 100a, 100b, 100c advance beyond the next lance tab 256,
as illustrated in FIG. 8. This places the distal-most fastener 100a
in its firing position relative to the tube assembly 250; i.e., the
position at which it is ready to be ejected from the tube assembly
250, such as by driver 270. After the indexer 260 reaches its
pre-firing stage position, it may commence its proximal stroke.
During the indexer's 260 proximal stroke, the lance tabs 256
prevent the proximal movement of the fasteners 100a, 100b, 100c
relative to the tube assembly 250, as described above. Therefore,
the proximal movement of the indexer 260 creates a force between
the distal index engagers 264a, 264b, 264c, and the respective
distal head faces 111a, 111b, 111c. When this force reaches a
certain threshold, the distal index engagers 264a, 264b, 264c will
flex inward and slide through the passage (not shown) of the
respective fastener 100a, 100b, 100c, enabling the indexer 260 to
continue its proximal stroke without moving the fasteners 100a,
100b, 100c. The indexer's 260 proximal stroke continues until index
engagers 264a-c and 266a-c, engage with the next proximal fastener
(e.g., index engagers 264a and 266a may engage with next proximal
fastener 100b, and index engagers 264b and 266b may engage with
next proximal fastener 100c, etc.) At this point, the indexer 260
has returned to its initial position, completing a full cycle. In
exemplary embodiments, the length of the distal stroke of the
indexer 260 is about equal to the distance between adjacent lance
tabs 256. The indexer 260 may repeat this cycle one or more times,
advancing all of the fasteners 100 distally within the tube
assembly 250 as described above.
[0049] In exemplary embodiments, the indexer 260 is operably
coupled with the handle/actuation assembly 210 so that movement of
the indexer 260 is controlled by one or more mechanisms within the
handle/actuation assembly 210, which is described in more detail
below.
[0050] In various embodiments, the driver assembly 200 has a driver
270 that is configured to provide an ejection force to a fastener
100, expelling the fastener 100 from the distal end 254 of the tube
assembly 250. In exemplary embodiments, the vector of the ejection
force is substantially parallel to the longitudinal direction
L.sub.T of the tube assembly 250, and the force is applied to the
fastener 100 so that the fastener 100 is expelled in a direction
that is substantially parallel to the longitudinal direction
L.sub.T of the tube assembly 250. In exemplary embodiments, the
ejection force is sufficient to insert the fastener 100 into a body
tissue. In certain embodiments, the ejection force is an impulse
force that fires the fastener 100 from the distal end 254 of the
tube assembly 250.
[0051] As illustrated in FIG. 5, in various exemplary embodiments
the driver 270 may be an elongated member, such as a beam or shaft,
that terminates on its distal end at an ejector portion 276. The
elongated driver member may have a rectangular cross section;
however, it will be understood that the elongated driver member may
have any of a number of suitable different shapes and
configurations. In exemplary embodiments, the elongated member of
the driver 270 may have a straight portion 272, an angular portion
274 that is angled downward toward the ejector portion 276. In this
configuration, the straight portion 272 of the driver 270 may be
offset from the pathway of movement of the fasteners 100a, 100b,
100c, while the ejector portion 276 delivers the ejection force
along the pathway of movement of the fasteners 100a, 100b, 100c. It
will be understood that the driver 270 may have other physical
configurations consistent with its function of delivering the
ejection force to the fasteners 100a, 100b, 100c.
[0052] The operation of the driver 270 will now be described in
reference to the embodiments of FIGS. 5, 7, 8, and 9. For purposes
of discussion, the driver 270 in FIGS. 5 and 7 is illustrated in
its initial position (also the reset position); the driver 270 in
FIG. 8 is illustrated in its pre-firing position, and the driver
270 in FIG. 9 is illustrated in its firing position. From its
initial position, the driver 270 is at or near its distal-most
position. From this position, the driver 270 may be described as
having a cyclical movement, during which may move proximally toward
the handle/actuation assembly 210 of the driver apparatus 200 (the
proximal stroke) and then distally back to the initial position
(the distal stroke), completing a full cycle of movement. In
exemplary embodiments, the driver 270 may move in a direction
substantially parallel to the longitudinal direction L.sub.T of the
tube assembly 250.
[0053] In the exemplary embodiment illustrated in FIG. 5, the
driver 270 is shown in its initial position (also reset position)
with the ejector portion 276 of the driver 270 adjacent the distal
end 254 of the tube assembly 250. During its proximal stroke, the
driver 270 retracts away from the firing position 258 of the tube
assembly 250, while the indexer 260 indexes the distal-most
fastener 100 into the firing position 258. At the end of its distal
stroke, driver 270 is in its pre-firing position, as illustrated in
FIG. 8. In the pre-firing position, ejector portion 276 of the
driver 270 is adjacent to the proximal head surface 112 of the
fastener 100 that is in the firing position 258. During its distal
stroke, the driver 270 delivers an ejection force (e.g., an impulse
force) to the distal-most fastener 100 located in the firing
position 258. As illustrated in FIG. 9, when the driver 270 is in
its firing position, it is ejecting this fastener 100 from the
distal end 254 of the tube assembly 250. In exemplary embodiments,
the driver 270 ejects the fastener 100 with sufficient force and
speed that the fastener 100 is securely inserted into the surgical
field, such as into a hernia mesh or a body tissue. Once the
fastener 100 is ejected by the driver 270, the driver 270 is in its
initial position (or reset position), as illustrated in FIGS. 5 and
7,
[0054] As illustrated in FIG. 5, the driver 270 may be disposed
near the upper portion of the elongated tube portion 252, so that
it is above the indexer 260, and fasteners 100. In this
configuration, the straight portion 272 of the elongated member is
generally disposed above the fasteners 100. In various embodiments,
the ejector portion 276 of the driver 270 may move up and down
during the driver's 270 cycle of movement. For example, in the
driver's 270 proximal stroke, the driver 270 may flex or pivot
upward from its initial position so that the ejector portion 276
moves out of the indexing pathway of fasteners 100. During the
distal stroke of the driver 270, the ejector portion 276 may drop
down behind the fastener 100 that is in the firing position 258, so
that the ejector portion 276 pushes the fastener 100 along a path
of movement that is parallel to the longitudinal direction L.sub.T
of the tube assembly 250.
[0055] While the embodiments thus far have been described with
respect to a driver 270 that is located above the fasteners 100, it
will be understood that the driver 270 may be located instead in a
different area or region, such as above or to one or more sides of
the fasteners 100, or the driver 270 may be aligned with the path
of movement of the fasteners 100.
[0056] In exemplary embodiments, the direction and speed of the
movement of the driver 270 is independent of the movement of the
indexer 260. For example, the driver 270 may be in its distal
stroke when the indexer 260 is in its proximal stroke. In addition,
during their respective distal strokes, the rate of speed of the
driver 270 may be faster than the speed of the indexer 260.
[0057] In exemplary embodiments, the driver 270 is operably coupled
with the handle/actuation assembly 210 so that movement of the
driver 270 is controlled by one or more mechanisms within the
handle/actuation assembly 210, which is described in more detail
below.
[0058] In exemplary embodiments, the drive apparatus 200 may have a
spacer disposed with in the tube assembly 250, in the elongated
tube portion 252. The spacer may be configured to maintain the
alignment of the driver 270, the indexer 260, and the fasteners
100, within the elongated tube portion 252. In exemplary
embodiments, the spacer is stationary relative to the elongated
tube portion 252. However, it will be understood that the spacer
may move relative to one or more components of the tube
assembly.
[0059] As previously indicated, the drive apparatus 200 may have a
handle/actuation assembly 210 that provides a housing 212, a
handgrip portion 214, and a trigger 216. FIG. 10 illustrates a
section view of a handle/actuation assembly 210 according to an
exemplary embodiment. The housing 212 defines an interior space
that houses the mechanical elements of the handle/actuation
assembly 210. It will be understood that only one side of the
housing 212 is illustrated in FIG. 10, and that the complete
housing 212 may include a mirror image portion, fastened to the
illustrated portion, such as by screws or other mechanical
fasteners, or by welding. The distal end of the housing 212 has a
tube assembly opening 220, through which the tube assembly 250 is
inserted so that it may be operably coupled with one or more
mechanical elements inside the housing 212. The proximal portion of
the handle/actuation assembly 210 comprises a handgrip portion 214,
which is configured for easy manipulation for a user. It will be
understood how to design the handgrip portion 214 with various
contours and features suitable for this purpose.
[0060] In exemplary embodiments, a trigger 216 is pivotably coupled
with the handle/actuation assembly 210 at trigger pivot 218,
located at least partially within housing 212. Trigger 216 may be
configured so that it may be easily manipulated by a user from
outside of the housing. For example, in the embodiment illustrated
in FIG. 10, the trigger 216 may be a lever arm adjacent the
handgrip portion 214. The trigger 216 may be manipulated by the
user, for example, by squeezing the lever arm toward the handgrip
portion 214, causing the trigger 216 to rotate in a
counter-clockwise direction about trigger pivot 218. It will be
understood that trigger 216 may comprise one of various other
triggering devices now known or later developed, consistent with
the teachings provided herein. In exemplary embodiments, trigger
216 is biased toward the untriggered position. For example, the
trigger 216 may be biased by using a torsion spring, a spring clip,
or other suitable devices. One of ordinary skill in the art would
be able to design and configure various devices suitable for
biasing the trigger 216, using the guidance provided herein.
[0061] In exemplary embodiments, trigger 216 is operably coupled
with at least one actuator, such that manipulation of the trigger
216 actuates the indexer 260, the driver 270, or both. In exemplary
embodiments, trigger 216 is operably coupled with an indexer
actuator assembly 230 that is operably coupled with (either
directly or indirectly) the indexer 260. In exemplary embodiments,
trigger 216 is operably coupled with a driver actuator assembly 240
that is operably coupled with (either directly or indirectly) the
driver 270. In the various embodiments, indexer actuator assembly
230 and driver actuator assembly 240 are disposed at least
partially within housing 212, and are operably coupled with the
tube assembly 250, which at least partially extends from the tube
opening 220 in housing 212.
[0062] In exemplary embodiments, indexer actuator assembly 230 is
operably coupled with the indexer 260, to provide the mechanical
action necessary to move the indexer 260 through its full cycle of
motion. The indexer actuator assembly 230 of an exemplary
embodiment will now be described with reference to FIGS. 10-13. In
exemplary embodiments, the indexer actuator assembly 230 includes a
cam 232 that is operably coupled with the trigger 216 and
translates the rotational movement of the trigger 216 about the
trigger pivot 218, into longitudinal movement of pusher arm 231.
FIG. 10 illustrates the exemplary indexer actuator assembly 230 at
or near its initial position (also its reset position), in which
the trigger 216 has not been squeezed, and the pusher arm 231 is at
its proximal-most position. In the exemplary embodiment, as trigger
216 is squeezed, the trigger 216 pivots in a counter clockwise
direction about trigger pivot 218. When the trigger 216 pivots, the
cam 232 causes the pusher arm 231 to move in a distal direction.
FIG. 12 illustrates the exemplary indexer actuator assembly 230 in
this intermediate position, in which the trigger 216 has been
squeezed, so that it has partially rotated about trigger pivot 218,
and cam 232 has engaged with pusher arm 231 to push it in a distal
direction. The indexer 260 is operably coupled with indexer
actuator assembly 230, such that distal movement of the pusher arm
231 causes distal movement of the indexer 260 (i.e., the distal
stroke of the indexer 260). When the trigger 216 is fully squeezed,
as illustrated in FIG. 13, the pusher arm 231 reaches its
distal-most position, and the indexer 260 completes its distal
stroke. When the trigger 216 is thereafter released, a biasing
force acts on the indexer actuator assembly 230 to move the pusher
arm 231 in a proximal direction, thereby causing the indexer 260 to
move in its proximal stroke. The biasing force may be provided by
one or more biasing devices that are operably coupled with the
trigger 216, the trigger pivot 218, the cam 232, the pusher arm
231, or any combination thereof. The biasing force is sufficient to
return the pusher arm 231 (and therefore the indexer 260) to its
initial position (e.g., FIG. 10).
[0063] In exemplary embodiments, drive actuator assembly 240 is
operably coupled with the driver 270, to provide the mechanical
action necessary to move the driver 270 through its full cycle of
motion. The driver actuator assembly 240 of an exemplary embodiment
will now be described with reference to FIGS. 10-13. In exemplary
embodiments, the driver actuator assembly 240 includes a slideable
plunger 245 that is slidably coupled with a central shaft 247, so
that the plunger 245 may move in a proximal and distal direction
along the shaft 247. FIG. 10 illustrates the exemplary driver
actuator assembly 240 at or near its initial position (or reset
position), in which the pusher arm 245 is at its distal-most
position. The driver 270 may be coupled with the driver actuator
assembly 240 such that proximal movement of the slideable plunger
245 causes proximal movement of the driver 270 (e.g., its proximal
stroke), and distal movement of the slidable plunger 245 causes
distal movement of the driver 270 (e.g., its distal stroke). A
biasing spring 248 biases the plunger 245 toward the distal end of
the shaft 247, and therefore biases the driver toward the distal
end 254 of the tube assembly 250.
[0064] In exemplary embodiments, the slideable plunger 245 of
driver actuator assembly 240 is operably coupled with the trigger
216, so that the squeezing the trigger 216 moves the slideable
plunger 245 (and likewise the driver 270) in a proximal direction.
For example, scissor beams 241 may be attached at one end to the
handle/actuation assembly 210, such as at a beam pivot 242; the
free end 244 of the scissor beams 241 may be operably coupled with
the proximal end of the slideable plunger 245, such as at lip 246.
The scissor beams 241 are joined at elbow joint 243, and are biased
toward a closed position, such as with a torsion spring or other
suitable device. Elbow joint 243 may be operably coupled with the
trigger 216, such that squeezing of the trigger 216 causes the
scissor beams 241 to straighten at the elbow joint 243, so that the
free end 244 of the beams 241 pushes on the lip 246 of the
slideable plunger 245, causing plunger 245 to slide in a proximal
direction along shaft 247. FIG. 12 illustrates the driver actuator
assembly 240 in an intermediate position, in which the trigger 216
has not been fully squeezed, the scissor beams 241 are partially
straightened or extended, and the plunger 245 has moved in a
proximal direction along the central shaft 247. The proximal
movement of the plunger 245 causes the driver 270 to move along its
proximal stroke. When the trigger 216 is fully squeezed, the
plunger 245 reaches a pre-firing position (illustrated in FIG. 13),
at which point the plunger 245 is at its proximal-most point and
the beams 241 are still engaged with the lip 246. After the driver
actuation assembly 240 reaches the pre-firing position, when the
trigger 216 is further squeezed, the beams 241 are configured to
automatically disengage from the plunger 245, enabling the biasing
spring 248 to force the plunger 245 to slide in a distal direction.
FIG. 14 illustrates the driver actuator assembly 240 in a
post-firing position, just after the scissor beams 241 have
released from the plunger 245, and the plunger 245 has moved in a
distal direction along central shaft 247. The distal movement of
the plunger 245 causes the driver 270 to move along its distal
stroke, thereby "firing" fastener 100, or ejecting it from the
distal end 254 of the tube assembly 250. In exemplary embodiments
the biasing spring 248 is configured to deliver an impulse force to
the plunger 245 toward its initial distal-most position. This
impulse movement is translated along the driver 270, to the ejector
portion 276 of the driver 270, which delivers the impulse force to
the fastener 100 that is in the firing position 258 within the tube
assembly 250, thereby ejecting the fastener 100 with sufficient
force to insert the fastener 100 into the surgical field, such as
through a hernia mesh or body tissue. One of ordinary skill in the
art would understand how to configure spring 248 to exert such a
force, and would be able to apply such a spring to a drive
apparatus 200, using the guidance provided herein.
[0065] In various exemplary embodiments, when the trigger 216 is
released after it has been fully squeezed (so as to deliver the
impulse force), the driver actuation assembly 240 returns to its
initial position, as illustrated in FIGS. 10 and 11. During the
return to the initial position, the scissor beams 241 return to
their initial position, and the free end 244 of the beams 241
automatically re-engages with the lip 246 of plunger 245, so that
the driver actuator assembly 240 is ready for another cycle of
motion.
[0066] In various exemplary embodiments, the handle/actuation
assembly 210 also includes a trigger lock 233, that prevents the
trigger 216 from being released before it reaches its fully
squeezed position, which may cause the inadvertent sequencing of
fasteners 100, and release of the driver 270. For example, the
trigger lock 233 may include a device that mechanically interferes
with the rotation of the trigger 216 about pivot 218. One of
ordinary skill in the art will understand the various devices that
could be used as a trigger lock, and would be able to apply them to
the handle/actuation assembly 210 using the guidance provided
herein.
[0067] In exemplary embodiments, trigger 216 is operably coupled
with both indexer actuator assembly 230, and driver actuator
assembly 240, so that manipulation of the trigger 216 actuates both
assemblies 230, 240. In various embodiments, the indexer 260 and
driver 270 are independently coupled with the trigger 216 so that
the driver 270 and the indexer 260 may be moved independently of
each other when the trigger 216 is triggered. However, in exemplary
embodiments, from the perspective of the user, the triggered
actions of the drive apparatus 200 may appear to be
simultaneous.
[0068] The method of operation of the drive apparatus 200 to deploy
a fastener 100 may best be understood in reference to the exemplary
embodiments illustrated in FIGS. 10-14. In exemplary embodiments,
the drive apparatus 200 is manually operated by a user, such as a
surgeon, who manipulates the drive apparatus 200 such as by
grasping the handgrip portion 214, so as to position the distal end
254 of the tube assembly 250 adjacent the location where the
fastener 100 is to be inserted. The user then squeezes the trigger
216, pulling it toward the handgrip portion 214, which causes the
drive apparatus 200 to advance through a series of stages of
operation described in more detail below.
[0069] FIG. 10 illustrates an exemplary drive apparatus 200 in its
initial stage, in which the trigger 216 has not been squeezed. In
its initial position, plunger 245 of driver actuator assembly 240
is in its distal-most position, and corresponding driver 270 is in
its distal-most position, with ejector portion 276 adjacent the
distal end 254 of tube assembly 250. In its initial position,
pusher arm 231 of the indexer actuator assembly 230 is in its
proximal-most position, and corresponding indexer 260 is in its
proximal-most position. In the initial position, no fastener 100 is
in the firing position 258 of the tube assembly 250.
[0070] In the exemplary embodiment, as the trigger 216 is squeezed,
the drive apparatus 200 moves into an intermediate stage,
illustrated in FIG. 12. In the intermediate position, plunger 245
of driver actuator assembly 240 has moved in a proximal direction,
and corresponding driver 270 has progressed into its proximal
stroke, in which the ejector portion 276 of the driver 270 moves
away from the distal end 254 of tube assembly 250. In its
intermediate position, pusher arm 231 of the indexer actuator
assembly 230 has moved in a distal direction, and corresponding
indexer 260 has moved in a distal direction within the tube
assembly 250, indexing fasteners 100 in a distal direction toward
the distal end 254 of the tube assembly 250.
[0071] Just prior the trigger 216 being fully squeezed, the drive
apparatus 200 moves into a pre-firing stage, illustrated in FIG.
13. In the pre-firing position, pusher arm 231 of the indexer
actuator assembly 230 is in its distal-most position, and
corresponding indexer 260 has finished its distal stroke, so that
the distal-most fastener 100 is in the firing position 258 within
the tube assembly 250. In the pre-firing position, plunger 245 of
the driver actuator assembly 240 has moved to its proximal-most
position, and corresponding driver 270 has completed its proximal
stroke, whereby the ejector portion 276 of the driver 270 is
located adjacent the proximal head face 112 of distal-most fastener
100.
[0072] Just past the pre-firing position, as the user continues to
squeeze the trigger 216 to its fully squeezed position, the scissor
beams 241 release from lip 246 of plunger 245. Once released, the
plunger 245 retracts to its distal-most position, under the
compressive force of spring 248. This motion causes the
corresponding driver 270 to fire or eject the distal-most fastener
100 that has been loaded by indexer 260 into the firing position
258 of tube assembly 250. In the exemplary embodiment, after the
trigger 216 is fully squeezed, and the driver 270 fires the
distal-most fastener 100 from the tube assembly 250, the drive
apparatus 200 moves into a post-firing stage, illustrated in FIG.
14. In the post-firing position, scissor beams 241 have released
plunger 245, which has retracted to its distal-most position, and
corresponding driver 270 has ejected the distal-most fastener 100
from the firing position 258, through the distal end 254 of the
tube assembly 250. In the post-firing position, the pusher arm 231
of the indexer actuator assembly 230 is at or near its distal-most
position, and corresponding indexer 260 is at or near its
distal-most position.
[0073] In the exemplary embodiment, when the trigger 216 is
released after being fully squeezed, the drive apparatus 200
returns to its initial position, illustrated in FIG. 10. When
released, the driver actuator assembly 240 returns to its initial
position with the plunger 245 in its distal-most position, and the
scissor beams 241 retract to their initial position, re-engaging
with the plunger 245. When released, trigger 216 rotates in a
clockwise direction about trigger pivot 218, and cam 232 and pusher
arm 231 move in a proximal direction until pusher arm 231 reaches
its proximal-most position. When pusher arm 231 moves in the
proximal direction, the indexer 260 completes its proximal stroke
until the indexer engagers 264, 266 engage with the next proximal
fasteners 100.
[0074] From the perspective of the user, the triggered actions of
the drive apparatus 200 appear to be simultaneous. In other words,
the user places the distal opening 254 of the tube assembly 250
adjacent the portion of the hernia mesh to be fastened and squeezes
the trigger 216 to its fullest extent in one continuous motion.
This causes the distal fastener 100 to be ejected from the tube
assembly 250 and into the hernia mesh and underlying body tissue.
Upon release of the trigger 216, the drive apparatus 200 returns to
its initial position and is immediately ready to dispense another
fastener 100.
[0075] Many embodiments and adaptations of the present invention,
other than those herein described with reference to the exemplary
embodiments, will be apparent to those skilled in the art by the
foregoing description, without departing from the substance or
scope of the invention. While the present invention has been
described herein in detail in relation to its exemplary
embodiments, it is to be understood that this disclosure is only
illustrative and exemplary of the present invention. Accordingly,
the foregoing disclosure is not intended to be construed so as to
limit the present invention or otherwise to exclude any other such
embodiments, adaptations, variations, modifications, and equivalent
arrangements. The claimed invention is limited only by the
following claims.
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