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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Referring now to
Referring now to
As will be described structurally in more detail below with reference to
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.
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.
Referring to
Referring further to
Referring further to
Referring further to
Referring now to
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
As shown in
Referring now to
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.
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.
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.
Number | Date | Country | |
---|---|---|---|
60635361 | Dec 2004 | US |