Surgery: kinesitherapy – Kinesitherapy – Ultrasonic
Reexamination Certificate
2000-09-11
2003-07-29
Lateef, Marvin M. (Department: 3737)
Surgery: kinesitherapy
Kinesitherapy
Ultrasonic
C601S003000, C604S022000, C600S439000
Reexamination Certificate
active
06599256
ABSTRACT:
BACKGROUND OF THE INVENTION
In numerous medical and veterinary procedures, it is desirable to occlude a tubular anatomical structure such as a blood vessel or a tubular structure in the respiratory, digestive, reproductive or urinary tract of a mammalian subject. These procedures have been performed by surgical intervention as, for example, by making an artificial opening in the body to expose the tubular structure and ligating the tubular structure, by tying a suture around the structure and pulling the suture tight so as to clamp the structure shut. Alternatively, the structure may be cut apart and the open ends may be left in place. The open ends do not reunite with one another, and therefore the structure is occluded. In other procedures, tubular structures have been cauterized by application of heat or other forms of energy within the body. For example, U.S. Pat. No. 5,891,141 discloses an instrument with a set of electrodes which can be inserted through a surgically-created opening in the body to grasp a tubular structure between the electrodes so that radio frequency (“RF”) electrical energy can be applied directly to the tissue forming the wall of the structure. Coagulation of the tissue occludes the structure, whereupon the structure is severed by a cutting blade carried on the instrument. Surgical invasion of the body poses at least some risks even if minimally-invasive surgical procedures are employed. Other techniques for occluding anatomical structures include insertion of artificial plugs into such structures as, for example, by threading a catheter or other invasive device into the structure and dispensing a mass of biologically compatible plug material from the tip of the catheter. These techniques require careful selection of the plug material and careful attention to dispensing technique and also require insertion of an instrument into the body.
One example of a procedure which involves occlusion of a tubular anatomical structure is vasectomy, a common male sterilization procedure. A vasectomy is a procedure which occludes or severs the vas deferens so that it cannot serve as a passage for sperm from the testes to the urinary tract. Vasectomies have been performed by surgically opening the scrotum and cutting the vas deferens. Although this is a minor surgical procedure, there is nonetheless some risk associated with it. Also, if the subject later desires to reverse the vasectomy, it is difficult to locate the severed ends to reconnect them with one another. Typically, the ends of the vas deferens retract away from one another with time.
Techniques have been developed for applying hyperthermia to tissue within a living subject by directing energy into the subject from outside the subject's body. For example, in high intensity focused ultrasound (“HIFU”) techniques, ultrasonic energy is applied from a source disposed outside the subject's body and directed into the subject body in such a manner that the ultrasonic energy comes to a focus at a selected focal point within the body. The focused ultrasonic energy heats the tissue at the focal point. Such techniques have been applied, for example, to ablate unwanted tissues such as tumors, or to potentiate the action of a drug at a particular location within the body. As used in this disclosure, the term “outside the subject's body” refers to a location which is either outside of the skin or within the alimentary tract, respiratory tract, or another structure of the body which is naturally open to the outside environment. Thus, a location inside of the mouth or rectum would be considered outside of the body. Because the ultrasonic energy can be applied from outside the body, the ultrasonic hyperthermia procedure can be essentially non-invasive. Techniques of this general type are described in PCT International Publication WO 98/52465, the disclosure of which is incorporated by reference herein. Other techniques for performing hyperthermia utilize radio frequency (“RF”) energy instead of ultrasonic energy.
SUMMARY OF THE INVENTION
One aspect of the present invention provides methods of occluding a tubular anatomical structure in the body of a mammalian subject. Methods according to this aspect of the invention desirably include the step of directing ultrasonic energy from outside of the subject's body, into the body and onto the tissue constituting the tubular anatomical structure to thereby kill at least some of such tissue at a location along the length of the anatomical structure, whereby scar tissue will form and occlude the anatomical structure. Desirably, this is accomplished without substantially destroying tissue other than the tissue defining the wall of the tubular anatomical structure. Most preferably, the step of directing ultrasonic energy into the body is performed using a probe having one or more ultrasonic transducers associated therewith and adapted to emit ultrasonic energy so that the ultrasonic energy will be focused in a focal region at known disposition relative to the probe. The probe is positioned and maintained at a preselected disposition relative to a portion of the subject's body incorporating the tubular anatomical structure so that the focal region encompasses the anatomical structure.
In certain methods according to this aspect of the invention, the probe is positioned relative to the body of the subject without using an image of the internal structures within the body. For example, the step of maintaining the probe in a preselected disposition relative to the portion of the subject's body containing the tubular anatomical structure may be performed by engaging one or more guide members connected to said probe with such portion of the subject's body. The guide members desirably include a pair of opposed guide members projecting from the probe so that a portion of the subject's body, such as a fold of skin containing the tubular anatomical structure is pinched between the opposed guide members. Thus, the tubular anatomical structure is held in registration with the transducer and with the focus of the ultrasonic energy by the guide members.
A further aspect of the invention provides techniques for sterilizing a male mammalian subject, such as a human or non-human mammal. The spermatic ducts of such a subject, including the vas deferens, lie close to the skin of the scrotum. Thus, a portion of the scrotum such as a fold of scrotal tissue containing the vas deferens or other spermatic duct can be engaged with guide members of a probe as discussed above and ultrasonic energy can be directed through the skin of the scrotum covering this fold, onto the spermatic duct, to heat the tissue constituting the wall of the spermatic duct and preferably to kill at least some of this tissue. Scar tissue formed as a result of this procedure effectively occludes the spermatic duct, rendering the subject sterile. The procedure can be performed rapidly, typically in a few minutes or less, and can be performed entirely non-invasively. Further, because the ends of the spermatic duct are not separated from one another, they can be more readily reunited with one another at a later date.
A further aspect of the invention provides apparatus for occluding a tubular anatomical structure. Apparatus according to this aspect of the invention preferably includes a probe including a housing having an operative region and one or more ultrasonic transducers operatively associated with said housing. The transducer or transducers are adapted to deliver ultrasonic energy at a focal region having a known disposition relative to the operative region of the housing. Apparatus according to this aspect of the invention preferably also includes one or more guide members projecting from the housing for engaging a portion of a subject's body containing the anatomical structure to be occluded so as to hold that portion of the body in position relative to the operative region of the housing so that the focal region will lie at a known disposition relative to the body portion engaged by t
Acker David E.
Ebbini Emad S.
Kavoussi Louis R.
Lopath Patrick David
Pant Bharat B.
Lerner David Littenberg Krumholz & Mentlik LLP
Lin Jeoyuh
Transurgical, Inc.
LandOfFree
Occlusion of tubular anatomical structures by energy... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Occlusion of tubular anatomical structures by energy..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Occlusion of tubular anatomical structures by energy... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3011884