Surgery – Means for introducing or removing material from body for... – With means for cutting – scarifying – or vibrating tissue
Reexamination Certificate
1998-10-09
2002-04-09
Sykes, Angela D. (Department: 3762)
Surgery
Means for introducing or removing material from body for...
With means for cutting, scarifying, or vibrating tissue
C604S035000, C604S542000, C604S902000, C601S002000
Reexamination Certificate
active
06368299
ABSTRACT:
CROSS-REFERENCE TO RELATED APPLICATION
Not Applicable
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH
Not Applicable
REFERENCE TO A MICROFICHE APPENDIX
Not Applicable
BACKGROUND OF THE INVENTION
This invention relates generally to surgical instruments, and, more particularly, to a surgical device for ultrasonic fragmentation or emulsification of soft tissues of a patient.
Liposuction is a surgical procedure for altering the human form, specifically by removal of localized deposits of fat tissues that are unresponsive to diet or exercise. The procedure is also known as suction lipectomy, lipolysis, and more recently as body contour surgery, body sculpting surgery, or suction-assisted liposuction. It is most often performed by plastic surgeons, although dermatologists, gynecologists, and other surgical specialties also perform the procedure.
The liposuction procedure is typically accomplished by inserting a small liposuction cannula through an incision in the skin, applying a suction source to the end of the liposuction cannula that remains outside of the body, and forcing the working end of the liposuction cannula forward and backward in the layer of fatty tissue. The fatty tissue is torn, crushed, or avulsed, and is then aspirated through small openings along the sides of the liposuction cannula near the tip and then through a central lumen in the liposuction cannula to a tissue canister placed in-line with the liposuction cannula and the suction source. The procedure may involve multiple incisions and many passes of the liposuction cannula in each incision to achieve the desired cosmetic effect for the patient.
A liposuction cannula is typically a small metal tube with a blunt, closed end at the tip of the liposuction cannula. The blunt, closed end at the tip of the liposuction cannula is intended to minimize damage to tissues as the device is thrust forward. Small openings along the sides of the liposuction cannula near the tip create passages between the tissue and the central lumen of the liposuction cannula, which is in fluid communication with a suction source, so that tissue and fluids can be aspirated. In general, the suction causes the adipose tissue to be sucked into the openings along the sides of the liposuction cannula, and the blunt dissection as provided by the surgeon's manipulation of the liposuction cannula, then tears the tissue. The fragments and released fluids are then aspirated through the openings along the sides of the liposuction cannula and then through the central lumen of the liposuction cannula.
The liposuction procedure can be traumatic for the patient. The liposuction cannula does not discriminate between adipose tissue and other tissues such as nerves, blood vessels, or lymph tissues. The mechanical disruption of the above-named tissues by the liposuction cannula may result in, among other things, bleeding, bruising, temporary numbness, or swelling. Further, the final cosmetic result achieved for the patient is a function of the skill of the surgeon, the patient, and the type of surgical instrumentation used in the surgery. Liposuction cannulae used in the liposuction procedure may remove more adipose tissue from one area than another area in the patient, resulting in skin contour irregularities and a final cosmetic result for the patient that is not smooth or uniform.
Therefore, there is a need to improve the design of liposuction cannulae to help the surgeon to better discriminate between adipose tissue and other tissues such as nerves, blood vessels, and lymph tissues, so that the adipose tissues can be fragmented and removed while the remaining tissues are damaged as little as possible or not at all. Further, there is a need to improve the design of current liposuction cannulae such that adipose tissue is removed in a uniform and predictable manner such that an improved cosmetic result is achieved for the patient.
Recently, several instruments have combined ultrasonic vibrations and the liposuction cannula to improve upon the tissue discrimination capability of the liposuction cannula and to provide an instrument, which removes adipose tissue more uniformly than current liposuction cannulae. This procedure is commonly referred to as ultrasound-assisted lipoplasty. In a typical ultrasound-assisted lipoplasty procedure, an ultrasonically vibrating cannula is inserted through an incision in the patient's skin and passed forward and backward through the adipose tissue layer. The ultrasonically vibrating cannula fragments or emulsifies the adipose tissues, which are then typically aspirated through a central lumen in the ultrasonically vibrating cannula.
Initial experiences with the ultrasound-assisted lipoplasty procedure have been mixed. A comparison of the suction-assisted liposuction and ultrasound-assisted lipoplasty approaches with currently available surgical instruments for both procedures was recently given in
Ultrasound-Assisted Lipoplasty Resource Guide
, published in PlasticSugery News, a publication of The American Society of Plastic and Reconstructive Surgeons, 1997. In the article the author cites the disadvantages of the current ultrasound-assisted lipoplasty procedure compared to the suction-assisted liposuction procedure as: 1) burns of the skin are possible, 2) longer incisions are needed, 3) seromas are more common, 4) longer operating times are required, and 5) greater expenses are incurred. Thus, current ultrasound-assisted lipoplasty surgical systems for fragmentation and aspiration of adipose tissues are more costly and slower than the suction-assisted liposuction procedure and have the potential to damage tissues beyond that of suction-assisted liposuction, including burns of the skin and seroma formation. There is, therefore, a need to reduce equipment expense, to increase the speed of the ultrasound-assisted lipoplasty procedure, and to minimize the potential for burns or seroma formation.
An ultrasonic probe for soft tissue fragmentation may be hollow, in which case the instrument may be referred to as an ultrasonic cannula, or it may be solid. The distal end of an ultrasonic probe experiences small, rapid excursions along an axis, which passes through proximal end and the distal end of the ultrasonic probe. A maximum distal end excursion of 350 &mgr;m peak-to-peak at 23 kHz has been obtained in a commercially available ultrasonic aspirator for neurosurgery, e.g., the CUSA of Valleylab Inc., Boulder, Colo. The small, rapid motions at the distal end of the ultrasonic probe fragment or emulsify soft tissues of the body, having the strongest effect upon tissues which come into direct contact with the frontal area of the distal end of the ultrasonic probe, in line with the long axis of the ultrasonic probe. These tissues experience powerful ultrasonic-frequency forces that may rupture cell membranes or dislodge entire cells or groups of cell from their attachments to the tissue bed. Tissues may also contact the surface area along and about the sides of the distal end of the ultrasonic probe. Rather than fragment, tissues that contact the sides of the distal end of the ultrasonic probe tend to heat and desiccate because the nature of the contact is a rapid rubbing motion as opposed to the powerful smashing motion at the frontal area of the distal end of the ultrasonic probe. Therefore, for effective and expedient soft tissue fragmentation and emulsification it is beneficial to maximize the frontal surface area at the distal end of the ultrasonic probe in that plane generally perpendicular to the long axis of the ultrasonic probe. To minimize the potential for tissue burns it is likewise beneficial to minimize the tissue contact area along and about the sides of the distal end of the ultrasonic probe. The frontal area of the distal end of the ultrasonic probe has a maximum value, which is a function of the diameter of the distal end of the ultrasonic probe. The diameter of the ultrasonic probe may be increased to increase the frontal area of the distal end of the ultrasonic probe but this requires larger incisi
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