Abstract: The present application is generally directed to an expandable sleeve component of an implantable penile prosthesis, to a prosthesis containing the sleeve, and to related methods of preparation and use. More specifically, the present application is directed to an implantable penile prosthesis having a cylindrical polymeric (e.g., extruded, molded, etc.) sleeve for controlling cylinder expansion upon placement of the prosthesis within a corpus cavemosum and expansion during use.

Abstract: The present application is generally directed to an expandable sleeve component of an implantable penile prosthesis, to a prosthesis containing the sleeve, and to related methods of preparation and use. More specifically, the present application is directed to an implantable penile prosthesis having a cylindrical polymeric (e.g., extruded, molded, etc.) sleeve for controlling cylinder expansion upon placement of the prosthesis within a corpus cavemosum and expansion during use.

Abstract: A needleless injection system is provided to deliver therapeutic fluids to an internal treatment site in a patient, where the system is pressurized and is capable of compensating for differences in injection media viscosity and mechanical system characteristics. In one aspect, a needleless therapeutic fluid injection system is provided that includes modular, interchangeable components. In particular, the system includes a console that generally includes the electronic and/or hydraulic control components for the system, an injection chamber, and a shaft or catheter tube.

Abstract: A needleless injection system is provided to deliver therapeutic fluids to an internal treatment site in a patient, where the system is pressurized and is capable of compensating for differences in injection media viscosity and mechanical system characteristics. In one aspect, a needleless therapeutic fluid injection system is provided that includes modular, interchangeable components. In particular, the system includes a console that generally includes the electronic and/or hydraulic control components for the system, an injection chamber, and a shaft or catheter tube.

Abstract: A needleless injection system is provided to deliver therapeutic fluids to an internal treatment site in a patient, where the system is pressurized and is capable of compensating for differences in injection media viscosity and mechanical system characteristics. In one aspect, a needleless therapeutic fluid injection system is provided that includes modular, interchangeable components. In particular, the system includes a console that generally includes the electronic and/or hydraulic control components for the system, an injection chamber, and a shaft or catheter tube.

Abstract: Apparatus and associated methods useful in Implantable Penile Prosthesis, including an expandable polymeric sleeve that may be positioned over an inner inflatable body to limit a maximum expansion of the inner body.

Abstract: Surgical procedures, kits and implants for alleviating human incontinence, and particularly providing improved methods and apparatus to secure a urethral sling (30) to pubic bone (24, 26) to support the urethra and alleviate incontinence are disclosed. Bone anchors (64) are driven into pubic bones with elongated bone anchor sutures (84) configured to be passed through openings of a urethral sling. Suture retainers are applied to the sutures to apply retentive force to the urethral sling to maintain the fixation of the urethral sling proximate to the pubic bone.

Abstract: A surgical tool including an elongated body having a proximal end and a distal end, first and second sets of tissue approximating structures having deployed and retracted positions relative to the elongated body, an actuating mechanism at the proximal end of the elongated body for independently deploying and retracting each of the first and second sets of tissue approximating structures, and a drainage lumen extending from a drainage aperture at the distal end of the elongated body to the proximal end. The tool further includes a main balloon adjacent to the distal end of the elongated body, and a second balloon spaced from the main balloon toward the proximal end of the elongated body, wherein the second balloon has an expanded condition in which it diverts one of the set of tissue approximating structures away from the main balloon.

Abstract: A surgical tool which comprises an elongated body having a proximal end and a distal end, first and second sets of tissue approximating structures having deployed and retracted positions relative to the elongated body, an actuating mechanism extending from the proximal end of the elongated body for independently deploying and retracting each of the first and second sets of tissue approximating structures, a drainage lumen extending from a drainage aperture at the distal end of the elongated body to the proximal end, a main balloon adjacent to the distal end of the elongated body, and a strap connector extending from the elongated body that is connectable with a stabilization strap.

Abstract: An anastomosis device providing increased functionality, reliability and safety through the use of designs addressing potential puncture of an inflation balloon being used to hold and approximate tissue. The anastomosis device can include bladder retention structures configured to engage and retain tissue without pointed or sharpened surfaces that can rupture the inflation balloon. The anastomosis device can include a reinforced or otherwise protected inflation balloon to resist puncturing by a bladder retention structure. The anastomosis device can include a catheter wall profile selected to physically prevent bladder retention structures from being forcibly bent back so as to avoid potential contact with and puncture of the inflation balloon. The anastomosis device can include a catheter funnel with an internal spring for preventing kinking of the catheter lumen while providing for flexibility and stretch of the funnel to absorb pulling or shock force which can rupture the inflation balloon.

Abstract: A needleless injection system is provided to deliver therapeutic fluids to an internal treatment site in a patient, where the system is pressurized and is capable of compensating for differences in injection media viscosity and mechanical system characteristics. In one aspect, a needleless therapeutic fluid injection system is provided that includes modular, interchangeable components. In particular, the system includes a console that generally includes the electronic and/or hydraulic control components for the system, an injection chamber, and a shaft or catheter tube.

Abstract: A fluid reservoir for a penile implant device that includes a body portion having a sleeve from which a tube may extend. The body portion includes support structure positioned at an interior surface of the body portion near an orifice of the reservoir, which orifice leads to a fluid passage of the tube. The support structure may comprise a plurality of protrusions that are arranged around the orifice and that extend from a base portion of the body portion. The invention also relates to a method of manufacturing a fluid reservoir for a penile implant device, which includes positioning a tube in a mold and injection molding a reservoir body onto the tube. More particularly, the method may include providing a mold, positioning a tube in the mold, injecting material into the mold, curing the material, and opening the mold to remove the reservoir body and tube assembly.

Abstract: The invention is directed to a medical device, particularly a penile prosthesis, that includes an implantable element and a reservoir. The implantable element is configured to be implanted within the pelvic region of a patient and is designed to be capable of inflation and deflation via fluid transfer to and from the element. The reservoir is coupled to the implantable element. The fluid is drawn from the reservoir for inflation of the implantable element and returned to the reservoir for the deflation. The reservoir is approximately one inch or less in depth. The minimal depth enables the fluid reservoir to be placed in front of the puborectalis muscle and behind the abdominal fascia without being seen on an external view of the patient.

Abstract: A surgical tool including an elongated body having a proximal end and a distal end, first and second sets of tissue approximating structures having deployed and retracted positions relative to the elongated body, an actuating mechanism at the proximal end of the elongated body for independently deploying and retracting each of the first and second sets of tissue approximating structures, and a drainage lumen extending from a drainage aperture at the distal end of the elongated body to the proximal end. The tool further includes a main balloon adjacent to the distal end of the elongated body, and a second balloon spaced from the main balloon toward the proximal end of the elongated body, wherein the second balloon has an expanded condition in which it diverts one of the set of tissue approximating structures away from the main balloon.

Abstract: A surgical tool including an elongated body having a proximal end and a distal end, first and second sets of tissue approximating structures having deployed and retracted positions relative to the elongated body, an actuating mechanism at the proximal end of the elongated body for independently deploying and retracting each of the first and second sets of tissue approximating structures, and a drainage lumen extending from a drainage aperture at the distal end of the elongated body to the proximal end. The tool further includes a main balloon adjacent to the distal end of the elongated body, wherein the first set of tissue approximating structures has a different configuration than the second set of tissue approximating structures.

Abstract: A fluid reservoir for a penile implant device that includes a body portion having a sleeve from which a tube may extend. The body portion includes support structure positioned at an interior surface of the body portion near an orifice of the reservoir, which orifice leads to a fluid passage of the tube. The support structure may comprise a plurality of protrusions that are arranged around the orifice and that extend from a base portion of the body portion. The invention also relates to a method of manufacturing a fluid reservoir for a penile implant device, which includes positioning a tube in a mold and injection molding a reservoir body onto the tube. More particularly, the method may include providing a mold, positioning a tube in the mold, injecting material into the mold, curing the material, and opening the mold to remove the reservoir body and tube assembly.

Abstract: A surgical tool which comprises an elongated body having a proximal end and a distal end, first and second sets of tissue approximating structures having deployed and retracted positions relative to the elongated body, an actuating mechanism extending from the proximal end of the elongated body for independently deploying and retracting each of the first and second sets of tissue approximating structures, a drainage lumen extending from a drainage aperture at the distal end of the elongated body to the proximal end, a main balloon adjacent to the distal end of the elongated body, and a strap connector extending from the elongated body that is connectable with a stabilization strap.

Abstract: A fluid reservoir for a penile implant device that includes a body portion having a sleeve from which a tube may extend. The body portion includes support structure positioned at an interior surface of the body portion near an orifice of the reservoir, which orifice leads to a fluid passage of the tube. The support structure may comprise a plurality of protrusions that are arranged around the orifice and that extend from a base portion of the body portion. The invention also relates to a method of manufacturing a fluid reservoir for a penile implant device, which includes positioning a tube in a mold and injection molding a reservoir body onto the tube. More particularly, the method may include providing a mold, positioning a tube in the mold, injecting material into the mold, curing the material, and opening the mold to remove the reservoir body and tube assembly.

Abstract: A surgical tool which comprises an elongated body having a proximal end and a distal end, first and second sets of tissue approximating structures having deployed and retracted positions relative to the elongated body, an actuating mechanism extending from the proximal end of the elongated body for independently deploying and retracting each of the first and second sets of tissue approximating structures, a drainage lumen extending from a drainage aperture at the distal end of the elongated body to the proximal end, a main balloon adjacent to the distal end of the elongated body, and a strap connector extending from the elongated body that is connectable with a stabilization strap.

Abstract: Improved anastomosis devices having structural upgrades to increase ease of use while simultaneously increasing patient safety. The anastomosis device can include a distal treatment end and a proximal connection end. The anastomosis device has a catheter portion with a plurality of inflation lumens and a funnel portion. The funnel portion includes access ports in fluid connection to a catheter receiving aperture for attaching to the catheter portion. Also, the access ports including a drainage port, a control port and a plurality of inflation ports.