The present invention is directed to an apparatus and related methods for transporting components of implantable penile prostheses. More specifically, the present invention is directed to a delivery tool for transporting a pre-assembled implantable penile prosthesis so as to avoid entanglement and damage to connected components during transport.
Implantation of an implantable penile prosthesis (IPP) is a common treatment device for treating erectile dysfunction and other penile ailments. Typically, an implantable penile prosthesis comprises at least two inflatable cylinders connected to a pump by kink resistant tubing. In other versions, an implantable penile prosthesis can further comprise a reservoir for storing a liquid solution for inflating the inflatable cylinder and is connected to the pump or the inflatable cylinder by kink resistant tubing. Representative implantable penile prosthesis devices can include the AMBICOR or AMS 700, both available from American Medical Systems of Minnetonka, Minn.
Many of the components of the implantable penile prosthesis can be pre-assembled by the manufacturer rather than having operating room personnel fully assemble the prosthesis prior to or during the procedure. For example, the manufacturer can pre-connect the inflatable cylinder to the pump or reservoir by kink resistant tubing such that minimal assembly is required in the operating room before the prosthesis is implanted. Other components are pre-connected by the manufacturer for specific surgical purposes and are later disconnected by operating room personnel when the purpose is met. For example, each inflatable cylinder can be pre-connected to a pre-loaded syringe containing an inflating solution for loading the inflatable cylinder during the operation. During the operation, the inflating solution is transferred from the syringe into the inflatable cylinder, after which the pre-loaded syringe is disconnected from the inflatable cylinder and discarded. Pre-connecting the syringe to the inflatable cylinder insures that the proper amount of inflating solution is transferred to the inflatable cylinder. Pre-assembling components reduces operating time and decreases the likelihood that the procedure will be performed incorrectly or that the prosthesis will be incorrectly assembled.
Although pre-assembling components decreases the operating time and reduces the likelihood of surgical error, pre-connecting the various components can result in the components becoming tangled during transport. Typically, all the components of an implantable penile prosthesis are packaged and transported together in a single sterile package. Generally, the components are loosely packed into the sterile package which can result in the components becoming tangled as the components shift during transport. If the pre-assembled components are tangled during transport, operating room personnel must untangle the components before continuing the procedure, substantially increasing the time necessary to complete the procedure and causing frustration for operating room personnel.
An additional consideration is that the components of an implantable penile prosthesis are generally discrete and lightweight due to their implantable nature. As such, the components can be easily damaged. The pre-assembled components often comprise fragile materials such as, for example, elastomers that are particularly susceptible to damage. The tangling and subsequent untangling of the components can result in damage to the components and compromise the effectiveness of the implantable penile prosthesis. Similarly, as the components are typically placed in the sterile package unrestrained, the components can jostle together further damaging the components.
As such, there exists a need for improvements in the manner in which connected components of a pre-assembled implantable penile prosthesis are prevented from becoming entangled or otherwise damaged during transport.
A representative embodiment of the current disclosure is directed to a delivery tool for transporting connected components for a pre-assembled implantable penile prosthesis. More specifically, the delivery tool comprises receptacles for receiving the components of the pre-assembled implantable penile prosthesis and retaining the components during transport to prevent tangling of the pre-connected components or jostling of the components. The receptacles can be adapted for receiving in the individual components, tubing used to connect the components, and unconnected components that are subsequently connected as part of the surgical procedure. The delivery tool can further comprise cushioning elements so at to protect the components from damage caused by shifting during transport.
In another representative embodiment, a delivery tool can comprise a cap having a cushioning element disposed within the cap. The cushioning element can define a plurality of receptacles for receiving components and holding the components until manually removed by operating room personnel. The component can be inserted into one of the receptacles such that the receptacle grips the component end and secures the cap to the component. The cushioning element can further comprise notches connecting multiple receptacles. Pre-connected components linked by tubing can be inserted into receptacles linked by notches such that each pre-connected component is individually held by a receptacle and the tubing linking the pre-connected components is disposed within the notch.
Another representative embodiment of the delivery tool can comprise a first and a second cap each having a cushioning element defining a plurality of receptacles. The receptacles defined by the first cap are adapted to receive the first ends of components, while second receptacles defined by the second cap are adapted to receive the opposed second ends of components. The first and second caps can simultaneously grip both ends of the components providing added structure to the delivery tool, thereby preventing the components from shifting and contacting the other components as well as generally protecting both ends of the components from damage during transport. The first and second caps can be adapted to receive both ends of all components to be transported. Alternatively, in a single delivery tool, some of the components are gripped at both ends by the first and second caps, while other components are gripped by only the first or second cap respectively.
The above summary of the various representative embodiments of the invention is not intended to describe each illustrated embodiment or every implementation of the invention. Rather, the embodiments are chosen and described so that others skilled in the art can appreciate and understand the principles and practices of the invention. The figures in the detailed description that follow more particularly exemplify these embodiments.
The invention can be completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:
While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.
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In one embodiment, cap 110 can comprise a molded silicone elastomer having sufficient rigidity to secure the components. Alternatively, cap 110 can comprise other sufficiently rigid or semi-rigid materials providing sufficient support to secure the components. Cushioning element 120 can comprise elastic foam, rubber or other elastic material that reduces impact sustained at cap 110 and stretches when either first or second pre-connected component 132, 140 is inserted into the corresponding receptacle 122, 124 to provide a gripping pressure for retaining the first or second pre-connected component 132, 140 within the cap 110. Cushioning element 120 can also comprise a high friction material such as, for example, an resilient foam, rubber or similar material that can statically grip the first or second pre-connected component 132, 140 without stretching, while also protecting first or second pre-connected component 132, 140.
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Although specific examples have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that any arrangement calculated to achieve the same purpose could be substituted for the specific examples shown. This application is intended to cover adaptations or variations of the present subject matter. Therefore, it is intended that the invention be defined by the attached claims and their legal equivalents, as well as the following illustrative embodiments.
The present application claims priority to U.S. Provisional Application Ser. No. 61/140,382, filed Dec. 23, 2008, and entitled “SYSTEM TO MANAGE CYLINDERS AND PRE-LOADED NEEDLE HOLDER,” which is herein incorporated by reference in its entirety.
Number | Date | Country | |
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61140382 | Dec 2008 | US |