U.S. patent application number 14/290092 was filed with the patent office on 2014-09-18 for extracting device for surgical fasteners.
This patent application is currently assigned to I.B.I. Israel Biomedical Innovations Ltd.. The applicant listed for this patent is I.B.I. Israel Biomedical Innovations Ltd.. Invention is credited to Gilad HEFTMAN, Eitan HOD.
Application Number | 20140276962 14/290092 |
Document ID | / |
Family ID | 37632854 |
Filed Date | 2014-09-18 |
United States Patent
Application |
20140276962 |
Kind Code |
A1 |
HOD; Eitan ; et al. |
September 18, 2014 |
EXTRACTING DEVICE FOR SURGICAL FASTENERS
Abstract
Provided is a device for extracting from a body tissue surgical
fasteners having a crown, a baseplate and prongs extending from the
crown to the baseplate. The device includes a shaft having a lumen
with a cross-sectional shape and dimensions to allow the crown to
enter the lumen while preventing the baseplate from entering the
lumen. Also provided is a method for extracting from a body tissue
a fastener having a crown, a baseplate and prongs extending from
the crown to the baseplate. According to the method of the
invention, the crown of a fastener is introduced into the hollow
portion of the device of the invention while preventing the
advancement of the baseplate by the distal part of the hollow
shaft.
Inventors: |
HOD; Eitan; (Zichron
Ya'akov, IL) ; HEFTMAN; Gilad; (Kibbutz Ein Gev,
IL) |
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Applicant: |
Name |
City |
State |
Country |
Type |
I.B.I. Israel Biomedical Innovations Ltd. |
Caesarea Industial Park |
|
IL |
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|
Assignee: |
I.B.I. Israel Biomedical
Innovations Ltd.
Caesarea Industrial Park
IL
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Family ID: |
37632854 |
Appl. No.: |
14/290092 |
Filed: |
May 29, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12084317 |
Apr 30, 2008 |
8747420 |
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PCT/IL2006/001273 |
Nov 2, 2006 |
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14290092 |
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60732101 |
Nov 2, 2005 |
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Current U.S.
Class: |
606/138 |
Current CPC
Class: |
A61B 17/076
20130101 |
Class at
Publication: |
606/138 |
International
Class: |
A61B 17/076 20060101
A61B017/076 |
Claims
1-8. (canceled)
9. A device for extracting a surgical fastener, the surgical
fastener having a crown, a baseplate and prongs extending from the
crown, and a filament passing between the crown and the baseplate,
the device comprising: (a) a shaft having a proximal end and a
distal end; (b) a hollow cylindrical element located at the distal
end of the shaft and defining a lumen, the cylindrical element
having a longitudinal groove on an external surface of the
cylindrical element, said hollow cylindrical element having an
inner diameter greater than a diameter of the crown and less than a
diameter of the base plate to allow the crown to enter the lumen
while preventing the baseplate from entering the lumen; and (c) a
ring element incompletely surrounding a circumference of said
hollow cylindrical element, the ring element being rotatable about
said hollow cylindrical element between a position in which a gap
in the ring element is in register with the longitudinal groove of
said hollow cylindrical element, and a position in which the gap is
not in register with the longitudinal groove.
10. The device according to claim 9, wherein said hollow
cylindrical element is configured for receiving a distal portion of
said filament within the lumen of said hollow cylindrical element
via said longitudinal groove.
11. The device according to claim 9, wherein said shaft comprises a
handle at said proximal end.
12. The device according to claim 11, wherein said device is
configured for enabling said handle to be grasped by one hand while
the proximal end of the filament is grasped by another hand.
13. The device according to claim 9, wherein said longitudinal
groove is coextensive with the longitudinal length of said hollow
cylindrical element.
14. The device according to claim 9, wherein said device is
configured for enabling a proximal portion of said filament, distal
of said handle and proximal from said hollow cylindrical element,
to be laterally spaced from said shaft during operation of the
device for extracting a fixed said surgical fastener.
15. A method for extracting a deployed surgical fastener from a
body tissue, the surgical fastener having a crown, a baseplate and
prongs extending from the crown, and a filament passing between the
crown and the baseplate, the method comprising: (d) providing an
extracting device, the extracting device comprising: (i) a hollow
cylindrical element located at the distal end of the shaft, said
hollow cylindrical element having a longitudinal groove on an
external surface of said hollow cylindrical element, the hollow
cylindrical element having an inner diameter greater than a
diameter of the crown and less than a diameter of the base plate;
and (ii) a ring element incompletely surrounding a circumference of
said hollow cylindrical element, the ring element being rotatable
about the cylindrical element between a position in which a gap in
the ring element is in register with the longitudinal groove of
said hollow cylindrical element, and a position in which the gap is
not in register with the longitudinal groove; (e) bringing the ring
element to its position in which the gap is in register with the
longitudinal groove; (f) inserting the filament into the
longitudinal groove, the filament being immobilized between the
crown and the baseplate of the fastener in its deployed
configuration; (g) bringing the ring element to its position in
which the gap is not in register with the longitudinal groove; and
(h) pulling on the filament bringing the crown into the interior of
said hollow cylindrical element, while preventing the baseplate
from entering said interior.
16. The method according to claim 15, wherein in step (c), a distal
portion of said filament is received within said hollow cylindrical
element via said longitudinal groove.
17. The method according to claim 15, wherein said shaft comprises
a handle at said proximal end.
18. The method according to claim 17, wherein a proximal portion of
the filament, distal of said handle and proximal of said
cylindrical element, is laterally spaced from said shaft at least
in part of step (e).
19. The method according to claim 17, wherein said handle is
grasped by one hand while the proximal end of the filament is
grasped by another hand at least in step (e).
20. The method according to claim 15, wherein said longitudinal
groove is coextensive with the longitudinal length of said
cylindrical element.
Description
FIELD OF THE INVENTION
[0001] This invention relates to surgical devices, and more
particularly to devices related to surgical fastening.
BACKGROUND OF THE INVENTION
[0002] Surgical anchors are used instead of surgical suturing,
which is often both time consuming and inconvenient, in order to
join two tissue locations. A surgeon can often use a stapling
apparatus to implant an anchor into a body tissue and thus
accomplish in a few seconds, what would take a much longer time to
suture. A surgical anchor is used, for example in inguinal hernia
surgery to fasten polypropylene mesh to the abdominal wall in order
to reinforce the abdominal wall.
[0003] Surgical fasteners are known in the form of a staple in
which a pair of prongs extends from a crown. In some applications,
the body tissue is accessible from two opposite direction so that a
deployment device may be used having an anvil that is used to bend
the prongs towards each other after the prongs have penetrated
through the tissue. In applications where access to the tissue is
from one direction only, deployment device is used that delivers a
force to the crown that deforms the crown and thus causes the
prongs to project towards and grasp the tissue.
[0004] Applicant's co-pending application PCT/IL2006/000783 filed
on Jul. 6, 2006, the contents of which are included herein in their
entirety by reference, discloses surgical fasteners having two or
more prongs, each of which is connected to a crown by hinge. In an
undeployed configuration of the fastener, the tips of the prongs
are inserted into slots in a base plate. The crown is thus
separated from the baseplate in the undeployed configuration of the
fastener by the length of the prongs. This configuration is
stabilized by an engagement between the prongs and the baseplate,
for example, by friction between the prongs and slot edges or by
filling the slots with adhesive, glue or by a plug of softer
material such as a biodegradable material. Deployment of such a
fastener involves positioning the fastener at the site of a tissue
surface where it is to be deployed and urging the crown towards the
baseplate. As the prongs pass through the slots, they enter the
tissue while the force applied to the prongs by the slot edges
causes them to rotate at the hinges and splay radially outward from
the crown so as to become embedded in the tissue. Only the prongs
penetrate into the tissue, while the crown and baseplate become
attach to the tissue surface without penetrating into it. The
fastener may be used to attach a graft or a mesh to a body
tissue.
[0005] As further disclosed in PCT/IL2006/000783, the above
described fastener may become locked in its deployed configuration.
Locking of the fastener in its deployed configuration allows the
fastener to better withstand forces acting on it within the tissue
and thus prevents inadvertent release of the fastener from the body
tissue. The locking is accomplished by means of an engagement
between components of the fastener that increases the force
necessary to bend the extended prongs of the deployed fastener
closer to the longitudinal axis of the fastener compared to
situation in which locking means are not provided. The locking may
be due to an engagement between the prongs and the crown, the
prongs and the baseplate, or the crown and the baseplate. For
example, the locking may result from increased friction between the
prongs and slots due to a region along the length of the prongs of
increased width or thickness that enters the slot during
deployment, so that the prong becomes jammed in the slot. The
prongs may be locked in the deployed configuration by engagement of
a tongue extending from each slot of the second element into an
opening in the prong. Alternatively, a tongue in the prong may
engage an opening in the second element.
SUMMARY OF THE INVENTION
[0006] In its first aspect, the present invention provides an
extracting device for extracting a deployed surgical fastener from
a body tissue. The extracting device of the invention is used to
extract surgical fasteners having a crown and a baseplate, for
example, surgical fasteners as disclosed in PCT/IL2006/000783. The
extracting device may be used for surgical fasteners that become
locked in the deployed configuration.
[0007] The extraction device of the invention has a slender shaft.
At least a distal portion of the shaft is hollow. In accordance
with the invention, the hollow distal portion has a lumen having a
cross-sectional shape and dimensions that allow the crown to enter
lumen while preventing the baseplate from entering the lumen. As
the crown is pulled into the distal portion, the baseplate becomes
immobilized at the distal end of the shaft causing the crown and
baseplate to be pulled apart.
[0008] In one preferred embodiment, the extracting device of the
invention has a slender shaft that may be stiff or flexible, as
required in any application. The shaft comprises an internal rod
that terminates at its distal end in a hook. The rod is slidable
inside a hollow sheath between a retracted position in which the
hook is contained within the distal end of the sheath and an
extended position in which the hook extends beyond the distal end
of the sheath.
[0009] To extract a deployed surgical fastener the rod is brought
to its extended configuration with the hook extending beyond the
distal end of the sheath. The hook is then inserted between the
crown and baseplate of the deployed fastener and the rod is made to
move towards its retracted position pulling the fastener towards
the distal end of the sheath. The sheath has an interior lumen that
has a cross-sectional shape and dimensions that allow the crown to
enter the lumen, while the baseplate is prevented from entering the
lumen. Thus, as the hook enters the interior of the sheath, the
crown is pulled by the hook into the interior of the sheath while
movement of the baseplate is arrested with the baseplate in contact
with the distal end of the sheath. As the crown moves away from the
baseplate, the prongs slide through the slots until the tips of the
prongs are at or near the tissue surface. The extraction device can
then be removed from the body together with the un-deployed
fastener.
[0010] In another preferred embodiment, the extracting device has a
shaft having at its distal end a hollow tubular unit. The
tubularunit includes a hollow cylindrical element having a
longitudinal groove along its length. The cylindrical element has a
lumen having a cross-sectional shape and dimensions that allow the
crown to enter the lumen, while the baseplate is prevented from
entering the lumen. This embodiment is used when a filament has
been inserted between the crown and the baseplate of the deployed
fastener. The filament is inserted into the longitudinal groove and
grasped in the groove. The filament is then pulled away from the
tissue surface in which the fastener is deployed. As the filament
is pulled away, the crown of the fastener enters into the lumen of
the cylindrical element, while movement of the baseplate is
arrested when the baseplate contacts the distal end of the
cylindrical element. As the crown moves away from the baseplate,
the prongs slide through the slots until the tips of the prongs are
at or near the tissue surface. The extraction device, with the
fastener is then removed from the body.
[0011] In its second aspect, the invention provides a method for
removing a deployed surgical fastener having a crown and baseplate.
In accordance with this aspect of the invention, a surgical
extraction device of the invention is used to extract the fastener
by bringing the rod to its extended position and inserting the hook
between the crown and baseplate of the deployed fastener. The rod
is then brought to its retracted position to pull the fastener
towards the distal end of the sheath. As the crown moves away from
the baseplate, the prongs slide through the slots until the tips of
the prongs are at or near the tissue surface. The extraction device
can then be removed from the body together with the undeployed
fastener.
[0012] Thus, in its first aspect, the invention provides a device
for extracting a surgical fastener, the surgical fastener having a
crown, a baseplate and prongs extending from the crown, the
surgical fastener having an undeployed configuration in which the
crown is separated from the baseplate by a first distance and a
deployed configuration in which the crown is separated from the
baseplate by a second distance that is less than the first
distance, the device comprising: [0013] (a) a shaft having a
proximal end and a distal end, at least a distal portion of the
shaft having a lumen with a cross-sectional shape and dimensions to
allow the crown to enter the lumen while preventing the baseplate
from entering the lumen.
[0014] In its second aspect, the invention provides a method for
extracting a deployed surgical fastener from a body tissue, the
surgical fastener having a crown, a baseplate and prongs extending
from the crown, the surgical fastener having an undeployed
configuration in which the crown is separated from the baseplate by
a first distance and a deployed configuration in which the crown is
separated from the baseplate by a second distance that is less than
the first distance;
[0015] the method comprising: [0016] (a) providing an extracting
device, the extracting device comprising: [0017] i) a shaft having
a proximal end and a distal end, at least a distal portion of the
shaft having a lumen with a cross-sectional shape and dimensions to
allow the crown to enter the lumen while preventing the baseplate
from entering the lumen.; and [0018] (b) Introducing the crown into
the hollow portion while preventing the advancement of the
baseplate by the distal part of the hollow shaft.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] In order to understand the invention and to see how it may
be carried out in practice, a preferred embodiment will now be
described, by way of non-limiting example only, with reference to
the accompanying drawings, in which:
[0020] FIG. 1 shows a device for extracting a surgical fastener in
accordance with one embodiment of the invention, in a side view
(FIG. 1a), a longitudinal section with the hook retracted (FIG.
1b), and a longitudinal section with the hook extended (FIG.
1c);
[0021] FIG. 2 shows a surgical fastener having a crown and a
baseplate in an undeployed configuration;
[0022] FIG. 3 shows the fastener of FIG. 2 at a tissue surface in
an undeployed configuration (FIG. 3a) and in a deployed
configuration (FIG. 3b);
[0023] FIGS. 4a to FIGS. 4d show use of the device of FIG. 1 for
removing a surgical fastener having a baseplate and crown;
[0024] FIG. 5 shows a device for extracting a surgical fastener in
accordance with another embodiment of the invention, with the ring
element in register with the longitudinal groove (FIG. 5a) and with
the ring element out of register with the longitudinal groove (FIG.
5b);
[0025] FIG. 6 shows a surgical fastener having a crown and a
baseplate in an undeployed configuration (FIG. 6a) and in a
deployed configuration (FIG. 6b) with a filament passing between
the crown and the baseplate; and
[0026] FIGS. 7a to 7e show use of the device of FIG. 5 for removing
a surgical fastener having a crown and a baseplate and a filament
passing between the crown and the baseplate.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0027] FIG. 1 shows an extracting device 2 for extracting a
surgical fastener in accordance with one embodiment of the
invention. The extracting device 2 is shown in a side view in FIGS.
1a and 1c, and in a longitudinal sectional view in FIG. 1b. The
extracting device 2 has a proximal end, 10 and a distal end 12. The
extracting device 2 has a slender shaft 4 that may be stiff or
flexible, as required in any application. The shaft 4 comprises an
internal rod 6 surrounded by an external sheath 8. The rod 6
terminates at its distal end in a hook 14. The rod 6 is slidable
inside the sheath between a retracted position shown in FIGS. 1a
and 1b in which the hook 14 is contained within the distal end of
the sheath 8 and an extended position shown in FIG. 1c in which the
hook extends beyond the distal end of the sheath 8. The rod 6 is
spring 17 biased in its extended position by means of a spring 17.
The rod 6 is brought to its retracted position by pulling a handle
18 in a proximal direction towards a knob 16. The handle 18 is
attached to the proximal end of the rod 6, and as the handle is
pulled, the spring 17 is compressed. The palm of a user's hand is
applied to the knob 16 and the user's fingers are hooked on the
handle 18. The user then squeezes the handle towards the knob. When
the handle is released, the rod reverts to its extended position
under the influence of the spring 17.
[0028] As shown in FIGS. 1b and 1c (enlarged views), the hook 14
has a flat top surface and a flat bottom surface, the top and
bottom surfaces being substantially perpendicular to a direction of
motion of the hook when the hook moves between the retracted
position and the extended position.
[0029] FIG. 2 shows an exemplary prior art surgical fastener 20
having a crown 22 and a baseplate 24 in its undeployed
configuration. A number of prongs 26 extend from the crown. The
prongs 26 are bent at hinge regions 30. Each of the prongs 26
terminates in a tip 28 that is inserted into a slot 32 in the
baseplate.
[0030] FIG. 3 shows the fastener 20 after delivery to a body tissue
site. As shown in FIG. 3a, the fastener 20 has been delivered to a
surface 33 of a body tissue 34, with the baseplate 24 and prong
tips adjacent to the tissue surface 33. The body tissue 34 is
indicated in FIG. 3 by broken lines. A surgical material 38 such as
a sheet or mesh-like structure may first be applied to the tissue
surface 33. Using a deployment device (not shown), the crown 22 of
the fastener 20 is displaced towards the base plate 24. As the
crown 22 approaches the baseplate 24, the prongs 26 enter the
tissue 34 and splay radially outward inside the tissue, as shown in
FIG. 3b. The prongs 26 become embedded in the tissue 34, so that
the fastener 20 is immobilized at the tissue surface 33 with the
crown 22 and the baseplate 24 on the tissue surface 33. The
surgical material 38, if present has thus been grasped at the
tissue surface. The fastener 20 may become locked in the deployed
configuration.
[0031] FIG. 4 shows use of the extracting device 2 to extract the
surgical fastener 20 after its deployment as shown in FIG. 3b. This
is by way of example only, and the extracting device of the
invention may be used to extract any surgical fastener having a
crown and baseplate. FIG. 4a shows the extracting device 2 with the
rod 6 in its extended configuration so that the hook 14 extends
beyond the distal end of the sheath 8. In FIG. 4b, the hook 14 has
been inserted between the crown 22 and the baseplate 24. As the
handle 18 is pulled (FIG. 4c), the hook 14 moves towards its
retracted position, pulling the crown of the fastener 20 towards
the distal end of the sheath 8. The sheath 8 has an inner lumen
having a cross-sectional shape and dimensions that allow the crown
to enter the lumen, while the baseplate is prevented from entering
the lumen. Thus, as the hook 14 enters the lumen of the sheath, the
crown 22 is pulled by the hook 14 into the lumen of the sheath 8
while movement of the baseplate 24 is arrested when the baseplate
24 contacts the distal end of the sheath 8, as shown in FIG. 4d. As
the crown 22 moves away from the baseplate 24, the prongs 26 slide
through the slots 32 until the tips 28 of the prongs 26 are at or
near the tissue surface 33. With the handle 18 remaining pulled
towards the knob 16 so that the fastener 20 is firmly held at the
distal end of the sheath 8 by the hook 14, the extraction device 2
is removed from the body.
[0032] FIG. 5 shows an extracting device 42 for extracting a
surgical fastener in accordance with another embodiment of the
invention. The extracting device 42 has a proximal end 50 and a
distal end 53. The extracting device 42 has a shaft 44 that may be
stiff or flexible, as required in any application. The shaft 44 may
have a uniform diameter along its length, or may have a thinner
portion 46 at its distal end as shown in FIG. 5. The shaft 44 has
at its distal end a hollow tubular unit 48 The tubularunit 48
includes a hollow cylindrical element 58 having a longitudinal
groove 49 along its length. The tubular unit 48 is rigidly fixed to
the distal end of the shaft 44 and has a lumen having a
cross-sectional shape and dimensions that allow the crown to enter
the lumen, while the baseplate is prevented from entering the
lumen. The tubular unit 48 also includes a ring element 52. The
ring element 52 incompletely surrounds the cylindrical element 58
and thus has a gap 60 between its ends. The ring element 52 is
rotatable about the cylindrical element 58 from a position in which
the gap 60 is in register with the longitudinal groove 49, as shown
in FIG. 5a, and a position in which the gap 60 is completely out of
register with the groove 49, as shown in FIG. 5b. The extraction
device also includes a handle 62 for manipulating the device during
extraction of a deployed surgical fastener, as explained below.
[0033] FIG. 6 shows again the surgical fastener 20 in its
undeployed configuration. In FIG. 6a, a filament 62 has been
inserted between the crown 22 and the baseplate 24. After
deployment of the fastener 20, at a body tissue site, as explained
above, the filament becomes pinched and immobilized between the
crown 22 and the baseplate 24, as shown in FIG. 6b.
[0034] FIG. 7 shows use of the extracting device 42 to extract the
surgical fastener 20 after its deployment as shown in FIG. 6b. This
is by way of example only, and the extracting device of the
invention may be used to extract any surgical fastener having a
crown and baseplate provided that a filament was inserted between
the crown and baseplate prior to deployment in such a way that the
filament becomes pinched and immobilized between the crown and
baseplate after deployment. In FIG. 7a, a user 70 has grasped the
extracting device 42 in one hand and has grasped the filament 62
with his or her other hand, with the gap 60 of the ring element 52
in register with the longitudinal groove 49 of the cylindrical
element 58. The filament 62 and the device 42 are then manipulated
so as to insert the filament into the longitudinal groove 49 (FIG.
7b). The ring element 52 is then rotated into its position in which
the gap 60 is not in register with the groove 49 (FIG. 7c). In this
configuration, the filament 62 is prevented from escaping from the
groove 49. Then, as shown in FIG. 7d, the extraction device is
moved towards the tissue and applied to the fastener. The filament
62 is then pulled away from the tissue surface 33 of the body
tissue 34. As the filament 62 is pulled away, the crown 22 of the
fastener 20 enters into the interior of the cylindrical element 58.
The cylindrical element 58 has a lumen having a cross-sectional
shape and dimensions that allow the crown to enter the lumen, while
thebaseplate isprevented from entering the lumen. Thus, as the
filament 62 continues to be pulled away from the tissue surface 33,
the crown 22 is pulled by the filament 62 into the interior of the
cylindrical element 58 while movement of the baseplate 24 is
arrested when the baseplate 24 contacts the distal end of the
cylindrical element 58, as shown in FIG. 7e. As the crown 22 moves
away from the baseplate 24, the prongs 26 slide through the slots
32 until the tips 28 of the prongs 26 are at or near the tissue
surface 33. The extraction device 42, with the fastener 20 firmly
held at the distal end of the cylindrical element by the pulled
filament 62 is then removed from the body.
* * * * *