Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Tissue
Reexamination Certificate
1999-03-31
2001-09-11
Willse, David H. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Tissue
C128S898000, C606S151000, C606S027000, C606S040000, C606S049000
Reexamination Certificate
active
06287344
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates, in general, to the surgical repair of tissue, and more particularly, to a new and useful method for repairing a defect in tissue such as an inguinal hernia utilizing a prosthetic and the application of ultrasonic energy.
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
The present invention is a novel method for repairing a defect in tissue. The method, according to the present invention, comprises the steps described below.
A prosthetic is initially provided and placed over a tissue defect and against surrounding tissue. The prosthetic is embedded into surrounding tissue by a first application of pressure and ultrasonic energy to the prosthetic and the surrounding tissue. The pressure and energy are applied on at least one location on the prosthetic and the surrounding tissue. The embedded prosthetic is welded into surrounding tissue by a second application of pressure and ultrasonic energy on the same location on the prosthetic and the surrounding tissue. The second application of energy is at a different intensity than the first application of energy.
Significantly, the method of this invention provides the surgeon with an improved method of attaching a prosthetic over a tissue defect by an application of ultrasonic energy to a site to embed the prosthetic and a second application ultrasonic 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 an object of the present invention to use ultrasonic energy for the first step of embedding the prosthetic into the surrounding tissue. The application of ultrasonic energy emulsifies the tissue directly beneath the prosthetic and the application of pressure embeds the prosthetic into the emulsified tissue.
It is another object of the present invention to use ultrasonic energy for the second step of coagulating the emulsified tissue. The second application of ultrasonic energy is applied to the initial site wherein the prosthetic is embedded in emulsified tissue. This second application of ultrasonic energy coagulates the emulsified tissue around the embedded prosthetic and welds the prosthetic to the surrounding tissue. To appropriately secure the prosthetic over the tissue defect, welds may be applied at each of several locations.
It is yet another object to provide another embodiment of the method of the present invention as described below.
The first step is providing an energy based surgical device having a housing, and an acoustic assembly for the generation of ultrasonic energy. The acoustic assembly includes a waveguide that extends from the housing. The waveguide has a solid core. An end effector is located at the distal end of the acoustic assembly. The end effector has an embedding surface and a coagulating surface.
Next, a prosthetic is placed over a tissue defect and against surrounding tissue. The prosthetic is embedded into surrounding tissue with a first application of ultrasonic energy at the embedding surface of the end effector. A second application of ultrasonic energy is applied to the embedded prosthetic and surrounding tissue at the coagulating surface of the end effector. The second application of ultrasound energy is applied at a different energy intensity to weld the embedded prosthetic to the surrounding tissue.
Thus, this embodiment provides the surgeon with a novel energy based surgical device having an embedding surface and a coagulation surface, and a method of using these surfaces to embed and weld the prosthetic to tissue.
Three embodiments of the end effector of the energy based surgical device, according to the present invention, are disclosed. A first embodiment of the preferred invention 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. Preferably, the coagulation surface is upon the outer curve of the curved member.
A second 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.
A third 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
Vaitekunas Jeffrey J.
Wampler Scott D.
Capezzuto Louis J.
Ethicon Endo-Surgery Inc.
Stewart Alvin
Willse David H.
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