Patent Application
20100168509
The present application is directed to an implantable penile prosthesis having kink resistant tubing. More specifically, the present invention is directed to a protective surface preventing the kink resistant tubing from damaging the implantable penile prosthesis while also maintaining the effectiveness of an anti-bacterial coating applied to the implantable penile prosthesis.
Implantation of an implantable penile prosthesis (IPP) is a common surgical procedure for treating erectile dysfunction and other penile ailments. Typically, implantable penile prostheses and comprise an inflatable cylinder connected to a pump by kink resistant tubing. In other versions, an implantable penile prosthesis can further comprise a reservoir that stores solution for inflating and deflating the inflatable cylinder with a pump that is connected to the inflatable cylinder via kink resistant tubing. These versions of the implantable penile prosthesis are available under the trade names AMBICO and AMS 7000 from American Medical Systems of Minnetonka, Minn. Typically, the pump is not affixed to any fixed bodily structure and freely hangs from the inflatable cylinder and the reservoir by the kink resistant tube. Movement of the unfixed pump or movements of the patient can cause the kink resistant tubing to repeatedly impact or rub against the inflatable cylinder, ultimately resulting in damage to the inflatable cylinder. Similarly, damage can occur within the kink resistant tubing connecting the reservoir to the pump.
The kink resistant tubing can comprise a sleeve preventing the kink resistant tubing from directly contacting the inflatable cylinder. The sleeve generally comprises materials with low frictional coefficients such as, for example, expanded PolyTetraFluoroEthylene (ePTFE), to minimize the abrasive forces applied to the inflatable cylinder as the kink resistant tubing rubs against the inflatable cylinder. The sleeve typically does not cover the entire length of the kink resistant tubing, but instead, covers only a predetermined portion of the kink resistant tubing that is most likely to rub against the inflatable cylinder.
One drawback of the sleeve approach is that tissue in-growth into the sleeve can occur if any portion of the sleeve extends beyond the corporotomy in the corpora cavernosa. Tissue in-growth complicates subsequent revision surgeries as the in grown tissue and the portion of the sleeve containing the in grown tissue must be first excised by the surgeon before the revision surgery can proceed, lengthening the procedure and increasing the risk of complications. Surgeons often seek to avoid tissue in-growth by removing any portion of the sleeve extending beyond the corporotomy to avoid tissue in-growth. However, this additional removal step lengthens the time required for the initial procedure and can damage the kink resistant tubing.
An additional drawback is that materials having low frictional coefficients as used in the sleeve can affect the application of an antibiotic coating to the implantable penile prosthesis. Antibiotic coatings such as, for example, the INHIBIZONE antibiotic surface treatment produced by American Medical Systems of Minnetonka, Minn. can be absorbed more readily by some materials than others. For example, ePTFE far more readily absorbs INHIBIZONE than the other materials used in the implantable penile prosthesis often resulting in an uneven distribution of the antibiotic coating. Uneven distributions of the antibiotic coating can compromise the effectiveness of the overall antibiotic coating.
Consequently, there is a need for an apparatus capable of protecting the inflatable cylinder from damage due to repeated contact with the kink resistant tubing. There also exists a need for an apparatus that avoids tissue in-growth and maintains or improves the effectiveness of the antibiotic coating on the implantable penile prosthesis.
One representative embodiment of the present disclosure is directed to an implantable penile prosthesis having a protective surface protecting an inflatable cylinder from damage caused by repeated contact with kink resistant tubing. The protective surface generally comprises materials having low frictional coefficients to reduce abrasive damage caused by repeated rubbing of the kink resistant tubing against the inflatable cylinder. The protective surface can also comprise materials having cushioning or force distributing qualities to reduce impact forces caused by repeated impact of the kink resistant tubing against the inflatable cylinder. The protective surface can be adapted to expand and contract with the inflatable cylinder such that the protective surface does not deform the inflatable cylinder nor does the protective surface separate from the inflatable cylinder as the inflatable cylinder changes in size.
In another representative embodiment, an implantable penile prosthesis can comprise an inflatable cylinder, a pump, and kink resistant tubing connecting the inflatable cylinder to the pump. The inflatable cylinder can further comprise a protective surface disposed on an outer surface of the inflatable cylinder proximate the junction of the inflatable cylinder and the kink resistant tubing. The protective surface can cover the entire exterior of the inflatable cylinder or alternatively, can cover only a predetermined area to protect a portion of the inflatable cylinder exterior most likely to contact the kink resistant tubing. The protective surface can also be sized so as to minimize the effect of the materials used in the protective surface on the effectiveness of an antibiotic coating applied to the implantable penile prosthesis. The protective surface in an unstretched state can be affixed to the inflatable cylinder such that the protective surface can expand when the inflating inflatable cylinder is inflated. Alternatively, the protective surface in a stretched state can be affixed to the inflatable cylinder when inflated such that the protective surface can compress when the inflatable cylinder is deflated.
In another representative embodiment, an implantable penile prosthesis can further comprise a reservoir, an inflatable cylinder and a pump operably connected with kink resistant tubing. The inflatable cylinder can further comprise a second protective surface on the inflatable cylinder at a predetermined location in which the kink resistant tubing joining the pump to the reservoir contacts the inflatable cylinder. Alternatively, a single protective surface can cover areas where the inflatable cylinder is most likely to contact the kink resistant tubing leading to the pump and the kink resistant tubing extending between the reservoir and pump.
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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Protective surface 360 generally covers a predetermined area on the exterior portion 312 of the inflatable cylinder 310 surrounding a junction 318 of the kink resistant tubing 320 and the inflatable cylinder 310. The predetermined area is determined based on the area of the inflatable cylinder 310 most likely to contact the kink resistant tubing 320. Protective surface 360 can have width ranging from a 1 cm width intended to encompass 95% of the potential area on the inflatable cylinder 310 typically contacted by kink resistant tubing 320 all the way to width of 2 cm that encompasses 100% of the area on inflatable cylinder 310 typically contacted by the kink resistant tubing 320. Alternatively, protective surface 360 can be expanded to cover the entire exterior portion 312 of the inflatable cylinder 310.
Protective surface 360 can comprise ePTFE, poly(p-xylylene) (PARYLENE), or other suitable materials having low frictional coefficients. A representative embodiment of protective surface 360 comprises a 2 cm wide PARYLENE surface providing a tough and easily adhered protective surface 360 having a low frictional coefficient. PARYLENE is frequently used in the inflatable cylinders 310 of conventional implantable penile prosthesis for other purposes, thereby reducing the manufacturing conversion costs of adding a PARYLENE protective surface 360 to the exterior portion 312 of each inflatable cylinder 310. Another representative embodiment can comprise a 2 cm wide ePTFE protective surface 360 providing the same protection as the ePTFE sleeve 122 on conventional implantable penile prosthesis 100.
Implantable penile prosthesis 300 as a whole can be treated with an antibiotic coating such as INHIBIZONE. The width of protective surface 360 is adjusted depending on the zone of inhibition created by the antibiotic coating and the absorption of the antibiotic coating by the material comprising the protective surface 360. Protective surface 360 comprising material that does not readily uptake the antibiotic coating can be limited in width to the size of the zone of inhibition created by that antibiotic coating. Protective surface 360 can also be limited in width if the protective surface 360 comprises a material having a better uptake of the antibiotic coating than the other materials used in the implantable penile prosthesis 300 to maintain a balanced distribution of the antibiotic coating.
Protective surface 360 is sufficiently elastic to expand and contract with the inflatable cylinder 310 as the inflatable cylinder 310 is inflated or deflated. The protective surface 360 in an unstretched state can be affixed to a deflated inflatable cylinder 310 such that the protective surface 360 stretches with the inflating inflatable cylinder 310 without separating from the inflatable cylinder 310 or deforming the exterior portion 312 of the inflatable cylinder 310 as it inflates. Alternatively, the protective surface 360 in a stretched state can be affixed to an inflated inflatable cylinder 310 such that the protective surface 360 contracts with the inflatable cylinder 310 as it deflates and does not separate from the inflatable cylinder 310 or deform the exterior portion 312 of the inflatable cylinder 310.
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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. 61/140,367, filed Dec. 23, 2008, and entitled “TREATMENT OF KINK RESISTANT TUBING (KRT),” which is herein incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 61140367 | Dec 2008 | US |
