The Next Generation Prep for Urological Examinations USPTO Application #: 90522709
Urological Device
The uniqueness of the DirectCath™ Anesthetizing Device is that once it has dispensed the medication and/or an anesthetic gel to thoroughly anesthetize the urethra from the glans penis to the sphincter muscles, it can remain in place and act as a protective sheathe.
· This concept will allow other devices, of any combination i.e.: endoscope, biopsy needle, surgical fiber, culture swab, etc., to safely pass into the bladder thus preventing multiple insertions exposing the urinary tract to wide variety of pathogens not to mention exposing the patient to excessive pain associated with a urological procedure.
· DirectCath™ Anesthetizing Device is sterilized and packaged individually in a sealed pouch, if package is damaged or visibly tampered with, do not use.
Details
- Gen II of the DirectCath® will be called UroDirect™
- With any urological examination, multiple insertions into the urethra, subjects the patient to significant discomfort not to mention the added exposure to pathogenic bacteria that can induce a urinary tract infection.
- Once the medication has been dispensed to thoroughly irrigate and anesthetize the urethra, the object of the UroDirect™ is that will remain in place to act as a protective urethral sheathe.
- The scope of the UroDirect™ is to then become a delivery device for endoscopes, biopsy needles, culture swabs, surgical fibers, etc. to accommodate any and all in office urological procedures.
- Our position is that the UroDirect™ is designed to “dispense things” essentially this device has the capability that of a long syringe.
- The concept is that along with other “delivery” type medical devices the UroDirect™ has the capability to deliver other devices such as endoscopes, surgical fibers, biopsy punch, culture swabs, etc.
- Our goal is to have the FDA consider the UroDirect™ device as a product line extension of the DirectCath™ given that it is still a “one in the same” device.
- Provided that the FDA concurs with the Class I approach for the DirectCath™ we will immediately begin the approval process for the UroDirect™