Surgery – Instruments – Electrical application
Reexamination Certificate
1999-03-31
2001-06-26
Dvorak, Linda C. M. (Department: 3739)
Surgery
Instruments
Electrical application
C606S041000, C600S002000
Reexamination Certificate
active
06251110
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates, in general, to an energy based surgical device, and more particularly, to a new and useful combined radio frequency and ultrasonic surgical device for repairing a defect in tissue such as an inguinal hernia, utilizing a prosthetic and the application of both ultrasonic energy and radio frequency.
BACKGROUND OF THE INVENTION
It is established practice in the surgical field to repair defects in tissue, for instance, an inguinal hernia, through the use of PROLENE™ mesh (manufactured and sold by Ethicon, Inc., Somerville, N.J.). Generally the mesh is cut to a desired size for placement over the inguinal hernia. Once the sized mesh has been placed over the defect, the mesh is attached to the surrounding inguinal tissue using several known attachment means.
Once the mesh is in place, it is important that the mesh serve as a barrier over the defect in order to restrict the lower viscera in the patient's abdomen from protruding through the defect. Accordingly, it is essential that the attachment means used to secure the mesh to the inguinal tissue have an initial strength of several pounds of force in both the tensile and shear directions. Moreover, it is important that the mesh remain in place for several days so that natural adhesions can form to ensure that the mesh is sufficiently anchored to the tissue.
One common way of attaching the mesh to tissue is through the use of suture and needle. As would be expected, the suturing technique for this procedure requires a great deal of skill and is normally conducted by very experienced surgeons, especially for minimally invasive or laparoscopic procedures. Since the learning curve for laparoscopic suturing is extremely steep, many surgeons are slow to adopt this technique.
In response to the challenges associated with suturing, other fastening techniques have evolved. Accordingly, it is now common practice to use a surgical stapler such as the ENDOSCOPIC MULTI-FIRE STAPLER™, (manufactured and sold by Ethicon Endo-Surgery, Inc., Cincinnati, Ohio). U.S. Pat. No. 5,470,010 (Rothfuss et al.) discloses a disposable, endoscopic stapler that is used to place a number of staples at various locations of the placed mesh in order to properly secure the mesh to the tissue. Although the endoscopic stapler is efficient and easy to use for a surgeon, there is a cost issue associated with its use for this type of procedure.
In an effort to alleviate the costs associated with a disposable, multiple fire stapler, some surgeons prefer a re-usable, “single shot” stapler such as disclosed in U.S. Pat. No. 5,246,156 (Rothfuss et al.). Although there is a cost savings to the user, the procedure time is extended when using this type of stapler over the disposable, multiple fire stapler.
In addition to using surgical staplers to secure mesh to inguinal tissue to repair a hernia, other types of fasteners have been developed. One of these fasteners is a helical fastener such as disclosed in U.S. Pat. No. 5,258,000 (Gianturco). This type of fastener is also disclosed in WO 96/03925 (Bolduc et al.). However, although these types of fasteners are also easy to use and decrease the procedure time, cost is also an issue.
It is important to note that, presently, the known devices or attachment means for repairing tissue defects are mechanical devices such as endoscopic staplers or fasteners or simple needle and suture. Presently, there are no known energy-based delivery devices or energy-based methods that are capable of performing tissue repair such as that described above.
SUMMARY OF THE INVENTION
Accordingly, the present invention is a novel energy based surgical device. The surgical device has a housing, and an acoustic assembly for the generation of ultrasonic energy. The acoustic assembly includes an electrically conductive waveguide that extends from the housing. The waveguide has a solid core. A conductive element is operably coupled to the waveguide for conducting Radio Frequency energy to the waveguide. An end effector is located at the distal end of the acoustic assembly and conducts ultrasonic energy or Radio Frequency energy thereto.
Significantly, the novel ultrasonic and Radio Frequency surgical device provides the surgeon with an improved method of attaching a prosthetic over a tissue defect. The surgeon makes an initial application of ultrasonic energy to the prosthetic and surrounding tissue to embed the prosthetic, and a second application of Radio Frequency energy to weld the prosthetic in place. Consequently, the surgeon is provided with a time saving method of attaching a prosthetic onto tissue. In particular, if the tissue repair is the attachment of a patch over a tissue defect, such as an inguinal hernia, the timesaving can be significant. A preferred prosthetic of the present invention is a mesh patch.
It is a particular object of the present invention to provide end effectors particularly adapted for the attachment of a prosthetic to tissue, such as the attachment of a prosthetic patch to the inguinal floor to repair a defect in tissue, such as an inguinal hernia. In particular, these end effectors are adapted to attach a prosthetic mesh patch to tissue by the application of energy. It is an object of the present invention to provide end effectors have a distal embedding surface to both emulsify tissue, and to push the prosthetic mesh patch into the emulsified tissue. It is also an object of the present invention to provide a coagulation surface for the rapid coagulation of the emulsified tissue for the attachment of a prosthetic to tissue.
Three embodiments of the end effector, according to the present invention, are disclosed. A first embodiment of an end effector according to the present invention comprises a truncated cone end effector having an embedding surface at the distal tip. A circumferential coagulating surface is located about the truncated cone and is angled away from the embedding surface.
A second embodiment is a curved end effector having a curved member and at least one distal embedding surface. A coagulation surface extends along the curve of the curved member, and in the most preferred embodiment, the coagulation surface is upon the outer curve of the curved member.
A third embodiment of the end effector according to the present invention comprises an angled surface end effector having a cylindrical shaft. An embedding surface is located at the distal end of the cylindrical shaft and an angled coagulating surface extends distally from the embedding surface. The angled embedding surface is angled from a longitudinal axis of the cylindrical shaft and outwardly from the embedding surface.
With respect to all three embodiments of the prosthetic according to the present invention, the surgeon is provided with an embedding surface for emulsifying tissue and a coagulating surface for coagulating tissue. These surfaces enable the surgeon to rapidly attach a prosthetic to tissue, and save time in the operating room.
It is another object of the present invention to provide a generator assembly for the generation of electrical signals convertible to ultrasonic energy by the acoustic assembly, the generation of RF energy, and for the generation of the combination of RF energy and ultrasonic electrical signals.
It is yet another object of the present invention to provide a switch mounted upon the housing for the selection of the type of energy deliverable to the end effector from the generator assembly. The switch is moveable from a first position for ultrasonic energy, to a second position for Radio Frequency energy and a third position for the combination of Radio Frequency energy and ultrasonic energy.
The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of the disclosure. For a better understanding of the invention, its operating advantages and specific objects attained by its uses, reference is made to the accompanying drawings and descriptive matter in which the preferred embodiments
Capezzuto Louis J.
Dvorak Linda C. M.
Ethicon Endo-Surgery Inc.
Gibson Roy
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