U.S. patent application number 11/244386 was filed with the patent office on 2006-06-15 for enhanced visibility cartridge with improved retainer.
Invention is credited to Daniel L. Kennedy.
Application Number | 20060124485 11/244386 |
Document ID | / |
Family ID | 37001608 |
Filed Date | 2006-06-15 |
United States Patent
Application |
20060124485 |
Kind Code |
A1 |
Kennedy; Daniel L. |
June 15, 2006 |
Enhanced visibility cartridge with improved retainer
Abstract
A substantially translucent cartridge is provided for retaining
surgical clips, such as those used in surgical ligating procedures.
The cartridge includes a polymeric composition base and a separable
polymeric composition clip retainer supported by the base wherein
the polymeric composition of the base and retainer includes a
particulate, light diffusing material for imparting a substantially
translucent optical effect for rendering, surgical clips visible
within the cartridge. The polymeric composition may further include
a radiopaque additive for rendering the cartridge imageable during
radiographing.
Inventors: |
Kennedy; Daniel L.; (Wake
Forest, NC) |
Correspondence
Address: |
BAKER & HOSTETLER LLP
WASHINGTON SQUARE, SUITE 1100
1050 CONNECTICUT AVE. N.W.
WASHINGTON
DC
20036-5304
US
|
Family ID: |
37001608 |
Appl. No.: |
11/244386 |
Filed: |
October 6, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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60635361 |
Dec 10, 2004 |
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Current U.S.
Class: |
206/340 |
Current CPC
Class: |
A61B 2017/0053 20130101;
A61B 17/128 20130101; A61B 17/1222 20130101 |
Class at
Publication: |
206/340 |
International
Class: |
B65D 85/24 20060101
B65D085/24 |
Claims
1. A substantially translucent cartridge for retaining a plurality
of surgical clips, each clip having a pair of legs extending from a
hinge point to form a substantially symmetrical shape and adapted
to be removed from the cartridge by a clip applier, the
substantially translucent cartridge comprising: (a) a polymeric
composition base having a base longitudinal axis and comprising:
(i) a plurality of axially spaced-apart walls extending along the
base and transversely disposed in relation to the base axis, the
walls defining a plurality of axially spaced-apart clip
compartments therebetween wherein each compartment comprises
laterally opposing first and second openings; and (ii) a plurality
of clip hinge support members, each clip hinge support member
disposed within a respective compartment and adapted to prevent
downward motion of a surgical clip by supporting the clip adjacent
its hinge point; (b) a polymeric composition clip retainer
supported by the base and comprising a plurality of opposing pairs
of first and second resilient tabs, wherein each tab extends from a
proximal end secured to the clip retainer to a free distal end
which extends into a corresponding compartment through a
corresponding lateral opening, and further wherein each tab
terminates at the distal end with a groove having diverging sides
extending outwardly therefrom; and (c) wherein the polymeric
composition of the base and retainer comprises a particulate, light
diffusing material for imparting a substantially translucent
optical effect for rendering surgical clips visible within the
cartridge.
2. The cartridge of claim 1 wherein the polymeric composition of
the base and retainer is selected from the group consisting of
polypropylene, nylon, polyethylene terephthalate (PET),
polyeutylene terephthalate (PBT), polyoxymethylene, and
acrylonitrile butadiene styrene (ABS).
3. The cartridge of claim 1 wherein the particulate, light
diffusing material is present in the amount of about 0.01% to 15%
by weight.
4. The cartridge of claim 3 wherein the particulate, light
diffusing material comprises an average maximum particle size of
about 0.1 microns to about 200 microns.
5. The cartridge of claim 3 wherein the particulate, light
diffusing material is selected from the group consisting of calcium
sulfates, talc, silicates, kaolin, silicas, mica flakes, mica
platelets, mica pearls, titanates, metal sulfates, metal
carbonates, sulfides, metal oxides, borides, wollastonite, basalt,
boron, ceramics, single crystal fibers, boron nitrides, naturally
occurring calcium carbonates, and mixtures thereof.
6. The cartridge of claim 1 wherein the polymeric composition of
the base and retainer further comprises a radiopaque additive being
present in the amount from about 1.0% to 5.0% by weight for
rendering the cartridge imageable during radiographing.
7. The cartridge of claim 6 wherein the radiopaque additive is
barium sulfate.
8. The cartridge of claim 6 wherein the radiopaque additive is
present in the amount of 2.0% by weight.
9. The cartridge of claim 1 wherein the distal end of each clip
retainer tab further comprises a slot positioned between the
diverging sides and extending inwardly toward the tab proximal
end.
10. The cartridge of claim 1 further comprising a surgical clip
disposed in at least one of the compartments and supported by the
corresponding clip hinge support member.
11. The cartridge of claim 10 wherein the surgical clip is a metal
surgical clip.
12. The cartridge of claim 10 for use with a forceps-type clip
applier having a pair of jaws for receiving the clip, wherein each
jaw has a groove for receiving a clip leg and the groove abuts a
distal end-dam for limiting distal movement of an end of the clip
leg received in the groove.
13. A cartridge for retaining a plurality of surgical clips, each
clip having a pair of legs extending from a hinge point to form a
substantially symmetrical shape and adapted to be removed from the
cartridge by a clip applier, the cartridge comprising: (a) a
polymeric composition base having a base longitudinal axis and
comprising: (i) a plurality of axially spaced-apart walls extending
along the base and transversely disposed in relation to the base
axis, the walls defining a plurality of axially spaced-apart clip
compartments therebetween wherein each compartment comprises
laterally opposing first and second openings; and (ii) a plurality
of clip hinge support members, each clip hinge support member
disposed within a respective compartment and adapted to prevent
downward motion of a surgical clip by supporting the clip adjacent
its hinge point; and (b) a separable polymeric composition clip
retainer supported by the base and comprising a plurality of
opposing pairs of first and second resilient tabs, wherein each tab
extends from a proximal end secured to the clip retainer to a free
distal end which extends into a corresponding compartment through a
corresponding lateral opening, and further wherein each tab
terminates at the distal end with a groove having diverging sides
extending outwardly therefrom and further comprising a slot
positioned between the diverging sides and extending inwardly
toward the tab proximal end.
14. The cartridge of claim 13 wherein the polymeric composition of
the base and retainer is selected from the group consisting of
polypropylene, nylon, polyethylene terephthalate (PET),
polybutylene terephthalate (PBT), polyoxymethylene, and
acrylonitrile butadiene styrene (ABS).
15. The cartridge of claim 13 wherein the polymeric composition of
the base and retainer further comprises a radiopaque additive being
present in the amount from about 1.0% to 5.0% by weight for
rendering the cartridge imageable during radiographing.
16. The cartridge of claim 15 wherein the radiopaque additive is
barium sulfate.
17. The cartridge of claim 15 wherein the radiopaque additive is
present in the amount of 2.0% by weight.
18. The cartridge of claim 15 wherein the polymeric composition of
the base and retainer further comprises a particulate; light
diffusing material for imparting a substantially translucent
optical effect for rendering surgical clips visible within the
cartridge.
19. The cartridge of claim 18 wherein the particulate, light
diffusing material is present in the amount of about 0.01% to 15%
by weight.
20. The cartridge of claim 18 wherein the particulate, light
diffusing material comprises an average maximum particle size of
about 0.1 microns to about 200 microns.
21. The cartridge of claim 18 wherein the particulate, light
diffusing material is selected from the group consisting of calcium
sulfates, talc, silicates, kaolin, silicas, mica flakes, mica
platelets, mica pearls, titanates, metal sulfates, metal
carbonates, sulfides, metal oxides, borides, wollastonite, basalt,
boron, ceramics, single crystal fibers, boron nitrides, naturally
occurring calcium carbonates, and mixtures thereof.
22. The cartridge of claim 13 further comprising a surgical clip
disposed in at least one of the compartments and supported by the
corresponding clip hinge support member.
23. The cartridge of claim 22 wherein the surgical clip is a metal
surgical clip.
24. The cartridge of claim 13 adapted for use with a forceps-type
clip applier having a pair of jaws for receiving the clip, each jaw
having a groove for receiving a clip leg, the groove abutting a
distal end-dam for limiting distal movement of an end of the clip
leg received in the groove.
25. A method for loading a selected surgical clip into a surgical
clip applier, wherein the clip comprises a first leg, a second leg,
and a hinge point joining the first and second legs, and wherein
the clip applier comprises a pair of opposing first and second jaws
adapted to engage the first and second legs of the clip, the method
comprising the steps of: (a) providing a substantially translucent
clip cartridge comprising: (i) a polymeric composition base
including a plurality of compartments and a plurality of clip hinge
support members, each clip hinge support member disposed in a
corresponding compartment and adapted to prevent downward motion of
a clip by supporting the clip adjacent its hinge point; (ii) a
polymeric composition clip retainer supported by the base and
comprising a plurality of opposing pairs of first and second
resilient tabs, wherein each tab extends from a proximal end
secured to the clip retainer to a distal end which extends into a
corresponding compartment, and further wherein each tab terminates
at the distal end with a groove having diverging sides extending
outwardly therefrom; (iii) wherein the polymeric composition of the
base and retainer comprises a particulate, light diffusing material
for imparting a substantially translucent optical effect for
rendering surgical clips visible within the cartridge; (b) viewing
the clip cartridge to ascertain the location of the clips in the
clip cartridge; (c) inserting a clip applier into a selected one of
the plurality of compartments to engage a selected clip; and (d)
removing the selected clip from the cartridge.
26. The method of claim 25 including providing a slot positioned
between the diverging sides of the tab groove of each resilient tab
and extending inwardly toward the tab proximal end.
27. The method of claim 25 including providing a radiopaque
additive to the polymeric composition of the base and retainer for
rendering the cartridge imageable during radiographing.
28. The method of claim 25 including providing metal surgical clips
in the clip cartridge.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Patent Application Ser. No. 60/635,361, filed Dec. 10, 2004; the
disclosure of which is incorporated herein by reference in its
entirety.
TECHNICAL FIELD
[0002] The present subject matter generally relates to the storage
and subsequent extraction of clips, particularly surgical ligating
clips, in preparation for use of the clips in a surgical procedure
such as hemostasis. More particularly, the present invention
relates to an enhanced visibility cartridge adapted for retaining
clips in an improved manner.
BACKGROUND ART
[0003] Many surgical procedures require vessels or other tissues of
the human body to be ligated during the surgical process. For
example, many surgical procedures require cutting blood vessels
(e.g., veins or arteries), and these blood vessels may require
ligation to reduce bleeding. In some instances, a surgeon may wish
to ligate the vessel temporarily to reduce blood flow to the
surgical site during the surgical procedure. In other instances, a
surgeon may wish to permanently ligate a vessel. Ligation of
vessels or other tissues can be performed by closing the vessel
with a ligating clip, or by suturing the vessel with surgical
thread. The use of surgical thread for ligation requires complex
manipulations of the needle and suture material to form the knots
required to secure the vessel. Such complex manipulations are
time-consuming and difficult to perform, particularly in endoscopic
surgical procedures, which are characterized by limited space and
visibility. By contrast, ligating clips are relatively easy and
quick to apply. Accordingly, the use of ligating clips in
endoscopic as well as open surgical procedures has grown
dramatically.
[0004] Various types of hemostatic and aneurysm clips are used in
surgery for ligating blood vessels or other tissues to stop the
flow of blood. Such clips have also been used for interrupting or
occluding ducts and vessels in particular surgeries such as
sterilization procedures. Typically, a clip is applied to the
vessel or other tissue by using a dedicated mechanical instrument
commonly referred to as a surgical clip applier, ligating clip
applier, or hemostatic clip applier. The clip is permanently left
in place after application to the tissue.
[0005] Ligating clips can be classified according to their
geometric configuration (e.g., symmetric clips or asymmetric
clips), and according to the material from which they are
manufactured (e.g., metal clips or polymeric clips). Symmetric
clips are generally "C", "U", or "V" shaped and thus are
substantially symmetrical about a central, longitudinal axis
extending between the legs of the clip. Symmetric clips are usually
constructed from metals such as stainless steel, titanium,
tantalum, or alloys thereof. An example of one such clip is
disclosed in U.S. Pat. No. 5,509,920 to Phillips et al. By means of
a dedicated clip applier, the metal clip is permanently deformed
over the vessel. Asymmetric clips are usually constructed of
polymeric material.
[0006] Because clips of the type just described are small and
several clips are often used in a surgical procedure, clip holding
devices are employed to store and retain multiple clips between the
time of their manufacture and/or packaging and ultimate use in a
surgical procedure. Numerous clip cartridges have been developed,
some of which strive to prevent the clips from becoming unduly
loosened or even completely dislodged during shipment and handling.
Clip cartridges are intended for use with "manual" clip
appliers.
[0007] As used herein, the term "automatic" denotes the kind of
clip appliers that retain a plurality of hemostatic clips adjacent
to the jaws of a clip applier in a way such that a new clip is
automatically fed to the jaws after the previous clip has been
crimped into place. An example of an applier that dispenses a
plurality of clips for sequential application is disclosed in U.S.
Pat. No. 4,509,518 to McGarry et al.
[0008] By contrast, the term "manual" denotes the kind of clip
appliers that receive one clip at a time between the jaws, and
which have to be reloaded manually after the previous clip has been
crimped. These manual instruments usually have a forceps-type
design and the reloading operation is generally accomplished by
inserting the jaws of the applier into a clip holder or cartridge
and engaging or grasping a clip contained therein. The jaws of the
clip applier generally have longitudinal grooves to receive the
clip legs and can have end-dams at the distal end of each groove to
limit distal movement of the clip. The clip is secured in the jaws
by the natural resiliency of the clip legs and by the end-dams if
they are present. An example of a forceps-type applier having
conformal jaws used to grip and maintain alignment of the clip
during deformation is disclosed in U.S. Pat. No. 3,326,216 to
Wood.
[0009] Many types of clip cartridges currently available contain a
plurality of longitudinally spaced clip retaining chambers. A
single clip is retained in each chamber by a variety of means, and
is removed from its chamber by a forceps-type clip applier that is
inserted into the selected clip chamber and secured to the clip
sufficiently to overcome whatever clip retention means is utilized,
thereby enabling the clip to be removed from the clip chamber.
[0010] Various mechanisms are known by which clips can be retained
within the chambers of clip cartridges. In all instances, a
desirable goal of such cartridges is to minimize the forces
required to load the clip into the applier and to then remove it
from the cartridge while maximizing the security with which the
clip is held in the cartridge and, subsequently, the applier jaws
prior to use. With respect to metallic clips, friction between the
clip and the side walls of its individual chamber is often
sufficient to retain the clip. The clip cartridges are generally
made of molded plastic material, such that the walls of each clip
chamber are somewhat resilient and able to be pushed away from each
other when the clip applier jaws are inserted into the chamber to
retrieve the clip. An example of a cartridge holding the clips in
their respective clip chambers by means of frictional engagement
with the side walls of each chamber is shown in U.S. Pat. No.
4,076,120 to Carroll et al.
[0011] In some prior art clip cartridges designed for metallic
clips, each individual clip chamber is provided with a central post
generally conforming to the shape of the open clip although being
slightly larger so that when the clip is pushed onto the central
post, frictional contact between the legs of the clip and the
central post retains the clip within its chamber. Cartridges of
this type are shown in U.S. Pat. Nos. 3,270,745; 3,326,216;
3,363,628; 3,439,522; and 3,439,523, all issued to Wood.
[0012] Prior art cartridges are also known that retain clips in a
partially straightened state by maintaining each clip under tension
within its chamber, through the interaction between the central
post in the chamber and the central part of the clip and
protrusions extending into each chamber toward the central post
(from the ends). The clip is retained by having its central hinge
part pushed upwardly by the central post and its ends pushed
downwardly by the protrusions. Such a cartridge is shown in U.S.
Pat. No. 3,713,533 to Reimels and U.S. Pat. No. 4,146,130 to
Samuels et al.
[0013] U.S. Pat. No. 4,696,396 to Samuels discloses another type of
cartridge that has a plurality of ribs extending from each side
wall of each clip chamber inwardly toward the clip to retain the
clip by frictional engagement with the ribs. The aforementioned
U.S. Pat. No. 4,146,130 to Samuels et al. shows an alternative
embodiment for the situation where clips are intended to be loosely
maintained in the cartridge without frictional engagement between
the clips and the chamber, the clips in such an event being
retained in each cartridge by a covering tape which can be easily
severed by the applier as desired.
[0014] While these prior art cartridges for metal and polymeric
clips have been used with adequate results, there are several
disadvantages to the composition and structural design of the
cartridges that limits their functionality during use.
[0015] First, due to the small size of the surgical clips being
contained within the cartridge and the visible light opaqueness of
the prior art cartridge material, it has in the past been difficult
for surgeons to accurately determine how many clips remain within
the cartridge, especially under lighting conditions present in
modern day surgical operating rooms. Therefore, it would be
advantageous to provide an improved clip cartridge that would allow
the surgeon to quickly determine the number of clips remaining in a
cartridge just by visually assessing the cartridge body.
[0016] Second, as with any small surgical instrument used in an
operation procedure, there exists a likelihood that the clip
cartridge may be accidentally dropped into a patient's body cavity
during the procedure and left in place. Therefore, it would be
advantageous to provide an improved clip cartridge that would be
imageable through radiograph techniques so that the presence of a
cartridge left in the body cavity of a patient can be readily
detected.
[0017] Finally, the retainer mechanism structure of many prior art
cartridges has been designed to act merely as a place holder for
the clip during transport and preparation for use by the surgeon.
These retainers have not functioned well if the cartridge is
dropped or otherwise agitated, leading to premature release of the
clips from the cartridge. Therefore, it would be advantageous to
provide an improved clip cartridge that incorporates a novel
structural design that functions not only to statically retain the
clips but also as a shack absorber to dynamically retain the clip
if the cartridge is agitated.
DISCLOSURE OF THE INVENTION
[0018] According to one embodiment of the present subject matter, a
substantially translucent cartridge for retaining a plurality of
biocompatible surgical clips formed from any suitable material
including metals and polymeric compositions, each clip having a
pair of legs extending from a hinge point to form a substantially
symmetrical shape and adapted to be removed from the cartridge by a
clip applier, comprises a polymeric composition base and a
separable polymeric composition clip retainer supported by the base
wherein the polymeric composition of the base and retainer
comprises a particulate, light diffusing material for imparting a
substantially translucent optical effect for rendering surgical
clips visible within the cartridge. The polymeric composition may
also optionally include a radiopaque additive for rendering the
cartridge imageable during radiographing. The base has a base
longitudinal axis and comprises a plurality of axially spaced-apart
walls extending along the base and transversely disposed in
relation to the base axis, the walls defining a plurality of
axially spaced-apart clip compartments therebetween wherein each
compartment comprises first and second lateral openings. The base
further comprises a plurality of clip hinge support members, each
clip hinge support member disposed within a respective compartment
and adapted to prevent downward motion of a surgical clip by
supporting the clip adjacent its hinge point. The clip retainer
comprises a plurality of opposing pairs of first and second
resilient tabs, wherein each tab extends from a proximal end
secured to the clip retainer to a free distal end which extends
into a corresponding compartment through a corresponding lateral
opening. Further, each tab terminates at the distal end with a
groove having diverging sides extending outwardly therefrom.
[0019] According to another embodiment of the present subject
matter, a cartridge for retaining a plurality of surgical clips,
each clip having a pair of legs extending from a hinge point to
form a substantially symmetrical shape and adapted to be removed
from the cartridge by a clip applier, comprises a polymeric
composition base and a separable polymeric composition clip
retainer. The polymeric composition may optionally include a
radiopaque additive for rendering the cartridge imageable during
radiographing or may optionally include a particulate, light
diffusing material for rendering surgical clips visible within the
cartridge. The base has a base longitudinal axis and comprises a
plurality of axially spaced-apart walls extending along the base
and transversely disposed in relation to the base axis, the walls
defining a plurality of axially spaced-apart clip compartments
therebetween wherein each compartment comprises first and second
lateral openings. The base further comprises a plurality of clip
hinge support members, each clip hinge support member disposed
within a respective compartment and adapted to prevent downward
motion of a surgical clip by supporting the clip adjacent its hinge
point. The clip retainer comprises a plurality of opposing pairs of
first and second resilient tabs, wherein each tab extends from a
proximal end secured to the clip retainer to a free distal end
which extends into a corresponding compartment through a
corresponding lateral opening. Further, each tab terminates at the
distal end with a groove having diverging sides extending outwardly
therefrom and further comprises a slot positioned between the
diverging sides and extending inwardly toward the tab proximal
end.
[0020] According to an additional aspect of the present subject
matter, a method is provided for loading a selected surgical clip
into a surgical clip applier. Preferably, the clip is of the type
that comprises a first leg, a second leg, and a hinge point joining
the first and second legs. The clip applier is preferably of the
type that comprises a pair of opposing first and second jaws
adapted to engage the first and second legs of the clip. According
to the method, a substantially translucent clip cartridge is
provided. The clip cartridge comprises a polymeric composition base
and a separable polymeric composition clip retainer wherein the
polymeric composition of the base and retainer comprises a
particulate, light diffusing material for imparting a substantially
translucent optical effect for rendering surgical clips visible
within the cartridge. The polymeric composition of the base and
retainer may optionally include a radiopaque additive for rendering
the cartridge imageable during radiographing. The method further
includes viewing the clip cartridge to ascertain the location of
the clip in the clip cartridge. The clip applier is then inserted
into one of the plurality of compartments to engage a selected
clip. At this point, the selected clip is removed from the
cartridge.
[0021] Therefore, it is an object of the present subject matter to
provide an enhanced visibility cartridge adapted for retaining
clips in an improved manner, such clips having a pair of legs
extending from a hinge point to form a substantially symmetrical
shape and adapted to be removed from the cartridge by a clip
applier.
[0022] An object of the present subject matter having been stated
hereinabove, and which is addressed in whole or in part by the
present subject matter, other objects will become evident as the
description proceeds when taken in connection with the accompanying
drawings as best described hereinbelow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] FIG. 1 is a perspective view of one example of a plurality
of substantially symmetrical shaped clips suitable for use in
conjunction with the clip cartridge of the present subject
matter;
[0024] FIG. 2 is a perspective view of an assembled clip cartridge
provided in accordance with the present subject matter with a
plurality of clips loaded therein;
[0025] FIG. 3 is an exploded perspective view of the clip cartridge
shown in FIG. 2;
[0026] FIG. 4 is an enlarged perspective view of the clip retainer
tabs provided with the clip cartridge shown in FIG. 2;
[0027] FIG. 5 is a perspective view of a clip cartridge provided in
accordance with the present subject matter, showing a clip applier
being inserted into a compartment thereof and engaging a clip
loaded in one of the compartments of the clip cartridge; and
[0028] FIG. 6 is another perspective view of the clip cartridge
shown in FIG. 5, showing the clip being extracted from a
compartment of the clip cartridge.
DETAILED DESCRIPTION
[0029] Referring now to FIG. 1, one example is illustrated of a
substantially symmetrical surgical clip, generally designated 100,
that is suitable for use in conjunction with the cartridge
described herein. Clip 100 and others of similar design are
particularly useful as hemostatic clips that can be latched around
a vessel or other type of tissue to ligate the vessel and thereby
stop or reduce the flow of fluid through the vessel. Clip 100 can
be constructed from any suitable biocompatible material, including
certain metals and polymeric compositions. Clip 100 is
substantially symmetrical and is generally "C", "U", or "V" shaped.
The body of clip 100 comprises a first leg 102 and second leg 104,
first and second legs 102, 104 being joined at their proximal ends
by an integral hinge section 106.
[0030] Referring now to FIG. 2, a preferred embodiment of an
assembled clip cartridge, generally designated 200, is provided in
accordance with the present subject matter. As will be described in
further detail , below, clip cartridge 200 is designed with a
plurality of substantially identical clip chambers, each adapted
for storing one clip 100, which preferably has a substantially
symmetrical design as described above and illustrated in FIG. 1.
FIG. 2 illustrates clip cartridge 200 of the present embodiment as
adapted for storing six clips 100, although other embodiments can
be provided that store more or less clips 100. If desired, an
adhesive backing (not shown) can be provided on the underside of
clip cartridge 200 to facilitate securing clip cartridge 200 to a
tray or other supporting component during use.
[0031] As will be described structurally in more detail below with
reference to FIGS. 2 and 3, clip cartridge 200 comprises a base
portion, generally designated 210, and a separable clip retainer
element, generally designated 250. Preferably, base 210 and
retainer 250 are constructed from a polymeric composition. This
polymeric composition can include polypropylene, nylon,
polyethylene terephthalate (PET), polybutylene terephthalate (PBT),
polyoxymethylene, and acrylonitrile butadiene styrene (ABS) or
other types of compositions known to those of skill in the art.
[0032] In order to provide an improved clip cartridge that would
allow a surgeon to quickly determine the number of clips remaining
in a cartridge by visually assessing the cartridge body, one
embodiment of cartridge 200 of the present subject matter is
designed to be substantially translucent. The substantially
translucent optical effect provided to cartridge 200 in accordance
with the present subject matter is achieved by mixing very small
quantities of light diffusing particles, having an average maximum
particle size of about 0.1 to about 200 microns, with a
thermoplastic polymer prior to molding or extruding the mixture.
The particulate, light diffusing material can be present in the
amount of 0.01% to 15% by weight of the composition mixture. The
light diffusing particles can be in any form, such as powders,
fibers, whiskers, platelets, flakes, aggregates, agglomerates or
mixtures of these. Suitable particles include, but are not limited
to, naturally occurring calcium carbonates, including reagent-grade
calcium carbonate, ground chalk, ground limestone, ground marble
and ground dolomite; ground or fiber calcium sulfates; silicates,
such as glass fibers, glass flakes, solid and hollow glass spheres,
aluminum silicate, synthetic calcium silicate and zirconium
silicate; talc; kaolin; mica flakes, platelets and pearls; natural
silicas, such as sand, quartz, quartzite, perlite, tripoli and
diatomaceous earth; fumed silicas; titanates, such as barium
titanate; sulfates, such as barium sulfate; sulfides, such as zinc
sulfide and molybdenum sulfide; metallic oxides, such as aluminum
oxide, zinc oxide, beryllium oxide, magnesium oxide, zirconium
oxide, antimony oxide, titanium dioxide and aluminum hydroxide;
aluminum diboride flakes; inorganic fibers, such as wollastonite,
basalt, boron, boron nitrides and ceramic; single crystal fibers
(i.e. whiskers), such as those of alumina trihyrdrate; short
fibers, such as those of aluminum silicate with aluminum and
magnesium oxides and calcium sulfate hemihydrate; organic flatting
agents, such as wood flour and starch; and mixtures of any of the
foregoing.
[0033] It is also envisioned that cartridge 200 of the present
subject matter can include a radiopaque additive in order to
provide that cartridge 200 would be imageable through radiograph
techniques so that the unintentional presence of cartridge 200 in
the body cavity of a patient can be readily detected. The
radiopaque additive is preferably present in the polymeric
composition in the amount from about 1.0% to 5.0% and can consist
of ceramic material, such as tungsten carbide or tungsten boride;
metallurgic material, such as metal (for example, platinum,
tantalum, iridium, tungsten, rhenium, gold, and stainless steel),
conductive ink, or a heavy metal salt such as barium sulfate; or
combinations thereof although other materials could be utilized.
Most preferably, the radiopaque additive is barium sulfate present
in the amount of 2.0% by weight.
[0034] Referring to FIG. 3, the structure of clip cartridge 200
will now be described. Clip cartridge 200 comprises a base portion
210 which can include base recesses 212 formed in base portion 210
along a longitudinal base axis BA during the fabrication of clip
cartridge 200 to reduce the amount of structural material needed.
First and second axial end walls 214 and 215, and first and second
side walls 216 and 217 extend upwardly from the perimeter of a base
floor 218 of base portion 210. Posts 219 extend upwardly from base
floor 218 to facilitate the mounting of clip retainer element 250
which is described in detail below. As will become evident from the
description below, clip cartridge 200 is structured to enable
symmetrical clips 100 to be loaded in only one orientation, with
all clips 100 being loaded in that same orientation. Accordingly,
as shown in FIG. 3, the first and second legs 102, 104 of each clip
100 will always extend in a downward direction within clip
cartridge 200 when clips 100 are stored therein.
[0035] Referring further to FIG. 3, a plurality of transverse,
axially spaced clip compartment walls 222 extend upwardly from base
floor 218 and are spaced apart along base axis BA of clip cartridge
200. The two transverse walls nearest to the axial ends of clip
cartridge 200 (i.e., the first and seventh transverse walls in the
specific example illustrated), are designated as outermost
transverse walls 222A and 222B, respectively. Each pair of adjacent
spaced-apart transverse walls 222 (including outermost transverse
walls 222A and 222B) define a respective clip compartment 226
therebetween. As shown in FIG. 3, each transverse wall 222 is
substantially symmetrical about base axis BA and each transverse
wall 222 can be tapered outwardly from base axis BA to reduce
cartridge mass and improve the accessibility of clips 100.
[0036] Referring further to FIG. 3, each transverse wall 222
comprises a pair of oppositely facing transverse wall surfaces that
define the boundaries of each compartment 226. For simplicity, wall
surfaces facing to the rear in FIG. 3 are labeled as 223A and those
facing to the front are identified as 223B. To define a given clip
compartment 226, wall surface 223A of one transverse wall 222 faces
to the rear of base portion 210, and wall surface 223B of next
adjacent rearward transverse wall 222 faces forwardly to the front
of base portion 210. The oppositely facing transverse wall surfaces
223A, 223B associated with each clip compartment 226 define a pair
of lateral openings, generally designated 228A and 228B into clip
compartment 226 with one opening defined on each side of base axis
BA of clip cartridge 200. As described below, portions of clip
retaining element 250 extend into each clip compartment 226 through
lateral openings 228A and 228B.
[0037] Referring further to FIG. 3, each clip compartment 226 of
clip cartridge 200 includes a clip supporting element 232 in the
form of a saddle or post to prevent downward motion of clip 100 by
supporting clip 100 adjacent its hinge point 106. Each clip
supporting element 232 is preferably formed between the medial
portion of corresponding adjacent transverse walls 222 and along
base axis BA. Clip supporting element 232 preferably extends from
base floor 218. As alternatives, clip support element 232 could be
joined between adjacent transverse walls 222 without being
supported by base floor 218, or element 232 could be supported by
base floor 218 without being joined to adjacent transverse walls
222.
[0038] Referring now to FIGS. 3 and 4, clip cartridge 200 further
comprises a separable clip retainer element 250. Clip retainer
element 250 generally includes a box-like outer frame structure
including a retainer floor 252 and end walls 253A, 253B and side
walls 254A, 254B. An aperture 255 is preferably formed at each
corner of floor 252 for receiving a corresponding post 219 of
cartridge base 210 and being mounted to clip cartridge base
210.
[0039] A series of opposing pairs of resilient fingers or tabs
262A, 262B are attached at proximal ends 262A', 262B' to side walls
254A, 254B, respectively, and extend inwardly toward each other
with distal ends 262A'', 262B'', respectively. Each pair of tabs
262A, 262B is spaced apart from adjacent pairs of tabs 262A, 262B
along the lengthwise axis of clip retainer element 250. Preferably,
tab distal ends 262A'', 262B'' each comprises a groove, generally
designated G (see FIG. 4), having diverging sides G1, G2 extending
outwardly therefrom toward the outermost point of tab distal ends
262A'', 262B''. In an alternative embodiment of the present subject
matter, tab distal ends 262A'', 262B'' further comprise a slot,
generally designated S, extending inwardly toward tab proximal ends
262A', 262B'. Slot S acts as a shock absorber wherein diverging
sides G1, G2 of groove G statically retain clip 100 in place during
normal use and transport and slot S allows for absorption of energy
in the situation where clip 100 is agitated. Slot S allows for
better dynamic retention of clip 100 within cartridge 200 in
situations where premature release of clip 100 was previously
caused by the dropping or other agitation of cartridge 200 (as seen
in prior art cartridges).
[0040] As shown in FIGS. 2 and 3, once clips 100 have been loaded
into respective clip compartments 226 prior to sealing and
packaging clip cartridge 200, clip retainer element 250 is mounted
onto and into engagement with clip cartridge base 210. To secure
clip retainer element 250 on clip cartridge base 210, each aperture
255 fits onto each corresponding post 219 projecting upwardly from
clip cartridge base floor 218. In the mounted position of clip
retaining element 250, each pair of tabs 262A 262B extends into
each corresponding clip compartment 226 from corresponding opposing
lateral openings 228A, 228B thereof. Diverging sides G1,G2 of tab
groove G of each tab 262A, 262B contacts a respective first or
second leg 102, 104 of clip 100. In this manner, clips 100 are
prevented from undue movement within clip compartments 226 (with
additional shock absorbency provided by slot S as discussed above),
which is primarily important during handling and shipping of a
packaged clip cartridge 200.
[0041] Referring now to FIGS. 5 and 6, a method by which clips 100
can be seen and extracted from clip cartridge 200 will now be
described. When first provided with a substantially translucent
cartridge as described in more detail above, a surgeon is able to
view the cartridge at substantially any angle to ascertain the
number and location of clips 100, within cartridge 200. A
representative manual forceps-type clip applier, generally
designated 300, is shown in position to engage a clip 100 in a
chosen clip compartment 226. Applier 300 has a pair of jaws 302,
304 at its distal tip, which are provided with grooves 306, 308,
respectively, on opposing inside surfaces thereof and corresponding
end-dams 310, 312, respectively. It should be understood that
virtually any clip applier will be suitable for use with cartridge
200 provided it is operable with the particular clip loaded into
the cartridge. Consequently, the subject matter described herein
provides a clip cartridge usable with appliers having end-dams as
well as appliers not having end-dams.
[0042] As applier jaws 302, 304 are first introduced into
compartment 226, distal ends 262A'', 262B'' of tabs 262A, 262B
assist in centering the applier over clip 100. When fully seated
within compartment 226, end-dams 310, 312 of jaws 302, 304 will
pass beyond the ends of the clip legs 102, 104 and because of the
inherent resiliency in the clip, clip (legs 102, 104 will expand
slightly into grooves 306, 308. Finally, once jaws 302, 304 have
successfully engaged clip legs 102, 104, jaws 302, 304 are pulled
out of clip compartment 226 with clip 100 fully engaged therein, so
as to allow clip 100 to be removed from clip cartridge 200 in
preparation for use in a desired surgical procedure.
[0043] It will be understood that various details of the subject
matter may be changed without departing from the scope of the
subject matter. Furthermore, the foregoing description is for the
purpose of illustration only, and not for the purpose of
limitation, as the subject matter is defined by the claims as set
forth hereinafter.
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