The invention provides methods and devices for performing such procedures as vaginal hysterectomies. It will be appreciated however that application of the invention is not limited to removal of the uterus, but may also be applied for ligation of nearby structures such as the ovaries (oophorectomy), ovaries and fallopian tubes (salpingo-oophorectomy), fallopian tubes, uterine artery, and the like. It will further be appreciated that the invention is not limited to a vaginal approach, but may also allow for removal of the uterus via open abdominal hysterectomy, which is also within the scope of the invention. Additionally, laparoscopic visualization may be used to guide the procedures of the invention. Finally, the invention is likewise applied to other parts of the body in connection with other surgical procedures.
The first and second jaws 48, 54 may be introduced either on a left hand side or right hand side of the patient at the same time or sequentially. As shown in
The first and second jaw elements 50, 52 of the first jaw 48 are introduced and advanced possibly, but not necessarily, under laparoscopic visualization. The first jaw element 50 is above the broad ligament 24 and fascial plane while the second jaw element 52 is below the broad ligament 24 and fascial plane. If the fallopian tubes and ovaries are to be retained, the jaw elements 50, 52 are advanced until the first jaw 48 extends up to or past the round ligament 18 and the fallopian tube 12. The first and second jaw elements 50, 52 are then laterally moved inwards until they are against the body of the uterus 10 so as not to grasp the ureter 20 within the jaw elements 50, 52. At this point, the first and second energy transmitting elements 50, 52 are engaged against a lateral side of the uterus 10 and positioned against opposed surfaces of a tissue mass from the fallopian tube 12 to a portion of the cervix 14, as shown in
Typically, the first energy transmitting element 60 spans a surface area of 5 cm2 to 10 cm2, against a first tissue surface and the second energy transmitting element 62 spans an area of 5 to 10 cm2, against a second tissue surface. More typically, the electrodes may each span a surface area between ½-10 cm2, although in some embodiments, each electrode may comprise two or more elements, in which case each element may be less than 1 cm2. For example, an electrode may be bifurcated longitudinally to define a channel therebetween along which a blade may pass, as discussed herein.
Again, the introduction and engagement of the third and fourth jaw elements 56, 58 may be viewed and guided with a laparoscope. Again, another option is to introduce jaws 48 and 54 simultaneously.
Referring back to
After sealing of the tissue mass by high energy and pressure from compression of the first and second forceps jaws 48, 54, the coagulated tissue may be cut along a lateral plane on each side of the uterus 10 by a variety of integrated cutting mechanisms, as described below with respect to
Such a vaginal hysterectomy results in numerous benefits. For example, procedure complexity is significantly reduced because the uterus is removed in one piece. Additionally, the time associated with such a procedure may be significantly shorter when compared to conventional hysterectomy procedures that require more than a hour of surgical time. This results in enhanced surgeon efficiency, improved patient outcomes, and overall cost savings to the healthcare system. Further, a surgeon with average skill may perform this procedure because laparoscopic visualization is used to guide the procedure.
A radio frequency electrosurgical generator 76 may be coupled to the forceps 46 via a multi-pin electrical connector 78 for delivering radio frequency power to electrode energy transmitting elements in a sufficient frequency range. Treatments according the invention are usually effected by delivering radio frequency energy through the tissue masses in a bipolar manner, where paired treatment electrodes are employed to both form a complete circuit and to heat tissue therebetween uniformly and thoroughly. For example, the first and third electrodes 60, 64 may be of one polarity (+) and the second and fourth electrodes 62, 66 may be of an opposite polarity (−) so that current flows between the first and second electrode pair 60, 62 and between the third and forth electrode pair 64, 66. The bipolar electrode elements heat the tissue masses to a sufficient temperature for a sufficient time period.
In some embodiments, a first trigger mechanism 68 may be coupled to a handle 70 of the forceps 46. Actuation of this first trigger mechanism 68 may clamp the jaw elements 50, 52, 56, 58 of the first and second jaws 48, 54 together and automatically trigger electrical circuitry that initiates the radio frequency power application though the energy transmitting elements 60, 62, 64, 66. This safety feature ensures that the tissue is properly positioned and engaged before it can be heated. Further, a change in impedance, voltage, or current draw (assuming constant voltage operation) may be measured by the circuitry/electronics of the power generator 76 to detect completion of the coagulation and sealing process. This feedback method confirms completion of coagulation before any tissue resection methods, as described above, can be undertaken. Actuation of a second trigger mechanism 74 coupled to the handle 70 or though increased pressure in the first trigger mechanism 68 may allow for tissue resection once complete tissue mass coagulation and sealing has been confirmed to prevent premature cutting. In such an embodiment, an audible alarm may be sounded or a visual alarm displayed, indicating complete tissue mass coagulation and sealing. The trigger system may be activated via solenoid activation of a pin which engages a linkage between the trigger and a cutting blade. A motor that advances the pin that engages the trigger can also be employed. Conversely, such solenoid or motor activation means advances a pin or linkage that removes a safety stop or brake that otherwise prevents the trigger mechanism from activating the cutting blade.
The cutting blade 84 in this embodiment comprises a flexible blade that is actuated by a pulling motion that moves it down and across the desiccated tissue 86 in a unidirectional saw-like motion along the entire length of the energy transmitting elements 64, 66. In one embodiment, the blade comprises a v-shaped cutter which defines a groove that captures the tissue as the blade is advanced longitudinally and that forces the captured tissue against a pair of cutting surfaces defined by the v-shaped cutter. In this embodiment, the energy transmitting elements are compound elements, divided by the recess for the cutting blade 84 in a first of the jaw elements 56 and by the channel 88 in a second of the jaw elements 58, respectively. In such embodiment, a total surface area of each compound energy transmitting element spans 5-10 cm2, with each element of the compound element spanning a portion of the total surface area, e.g. 1.25-2.5 cm2 or less.
The cutting blade 84 is guided by a number of diagonal slots (not shown) that are located at set intervals, e.g. several centimeters apart, along the length of the cutting blade 84. Pins placed in the slots that are fixed in the jaw element 56 serve as guides that limit the motion of the blade 84. As transverse motion is exerted on a proximal end of the blade 84, due to the diagonal slots, the blade 84 moves both backwards and down in single unidirectional sawing motion. The depth of blade exposure is in the range from about 1 mm to about 20 mm. Accordingly, the jaw elements 50, 52, 56, 58 should accommodate the blade depth.
It will be appreciated that the all the above depictions are for illustrative purposes only and do not necessarily reflect the actual shape, size, or dimensions of the forceps device 46.
Although certain exemplary embodiments and methods have been described in some detail, for clarity of understanding and by way of example, it will be apparent from the foregoing disclosure to those skilled in the art that variations, modifications, changes, and adaptations of such embodiments and methods may be made without departing from the true spirit and scope of the invention. For example, the methods and devices of the invention may be employed to remove the uterus via laparotomy, through an abdominal incision. Energy is applied until complete coagulation and vessel sealing is achieved. The coagulated tissue is then resected, freeing up the organ which may be removed through the abdominal incision.
The following embodiment of the invention is based on the observation that numerous surgical procedures require division of long, complex sheets of tissue, composed of blood vessels, nerves, ligaments, fat, connective tissue, and additional critical structures. Routinely, these complex tissue sheets are divided via a long and repetitive process in which blood vessels and other critical structures, such as fallopian tubes, are first individually dissected free from surrounding tissues and subsequently individually divided and ligated. Next, the remaining connective tissue is divided, often in piece-meal fashion. As noted above, the entire process is time and labor-intensive. In addition, adjacent vital structures are repeatedly at risk for injury during the repeated dissection, division, and ligation procedures. Post-operatively, inflammation and necrosis within the suture-ligated tissues generate significant pain. The above-described inventive radio frequency energy (RF) power supply and platform of procedure-specific devices allows for the rapid, safe, and simple division of complex tissue sheets. The procedure-specific devices that may be provided with the invention share some of the features discussed above in connection with the preferred embodiment, including a handle and two blades, which can be opened to be placed across the tissue sheet in the manner analogous to scissors across paper, and enclosed, thereby capturing and containing a tissue sheet. The invention also comprises a long, narrow bi-polar electrode embedded into two blades, which cauterizes the contained tissue when RF is delivered from the power supply. The invention further may comprise either a mechanical scalpel or RF feature which allows for division of the cauterized tissue. Broadly, the invention comprising these elements cauterizes a complex tissue sheet and divides same in seconds, without the need for dissection or piece-meal division or ligation. The above embodiment concerning a hysterectomy is an example of this.
Further, with the invention, operative time and cost are reduced, and operative safety is improved because adjacent vital structures are only at risk for injury one time, during visualized placement of the device, and post-operative pain is reduced due to the absence of significant tissue inflammation and necroses when RF is used to divide tissue, as is supported in the medical literature.
The resection of all or part of an organ, such as the spleen, or tissue structure, such as a muscle, frequently involves a division of associated complex tissue sheets, including all vascular structures, lymphatics, nervous system tissue, connective tissue, adipose tissue, and the like. The complex tissue sheets associated with different organs are tissue structures in their composition. For example, the small bowel (duodenum, jejunum, and ileum) is supported by a complex tissue sheet, as is the small bowel mesentery, which includes arterioles and arteries, venules and veins, lymphatic vessels, and lymph nodes, microscopic nerve fibers, minimal adipose tissue, and avascular connective tissue. The omentum, on the other hand, contains a large volume of adipose tissue, a great number of emphatic vessels and lymph nodes, and numerous large arteries and veins. Thus, the power supply and device used to resect one organ or tissues structure, such as a small bowel, must differ from the power supply and device used resect a different organ or tissue structure, such as the omentum, in a number of characteristics including, but not limited to:
In a variety of surgical procedures, procedure-specific surgical equipment as described above is used to divide complex tissue sheets.
Different power supply and device characteristics are required in connection with the equipment used to divide different organs or tissue structures. For example, division of lung tissue must normally address hemostatic sealing of arterioles, venules, and capillaries, but must also abide closure of alveolar (microscopic air) sacs to limit or prevent post-resection air leak. However, the division of the pancreas must address cauterization of fatty glandular tissue and creation of the seal across the pancreatic duct. Thus, as with the approach to division of complex tissue sheets, the approach to division of organs and tissue structures also requires procedure-specific power supply and device features. Those skilled in the art will appreciate that the invention described above in connection with the performance of the hysterectomy is readily adapted for these procedures.
In a variety of surgical procedures, procedure-specific surgical equipment in accordance with the invention herein is used to divide the organs and tissues structures.
As discussed above, certain bodily organs, such as the lung, may require sealing above and beyond that which may be achieved with the thin band of thermal sealing, as provided by the above described electrocautery device. In this embodiment of the invention, a benefit is provided by having an additional sealing capability within the device. The presently and preferred embodiment invention incorporates a mechanical sealing means, such as a stapling device, as shown in
Stapling devices are commonly used in surgical procedures. RF energy is also a common energy source that is used to seal tissue and blood vessels surgically. There are benefits to each approach and it in not uncommon to combine both in a single device. For example U.S. Pat. No. 6,821,273 (Mollenauer) discloses a medical device for the simultaneous cutting of tissue with a heating element, cauterizing of the tissue with sealing elements, and stapling the tissue together. Unfortunately, such device is a traditional type of electrocautery device and it is of limited use for performing such procedures as a hysterectomy.
In contrast to such teachings as are provided in Mollenauer's patent, the subject invention dissects tissue with a mechanical cutting blade rather than the heat wire. Further, the invention herein provides a longer thermal surface. As such, it is contemplated that in at least some embodiments of the invention, multiple cartridges or stapling means 202, 204, 206 may be provided to coincide with variations in tissue thickness along the length of the electrocautery device herein disclosed, or a track or other mechanism along which a stapler cartridges is slidable may be previous to allow one or more stapler cartridges to be positioned at desired locations along a sealing surface of the device. In one embodiment of the invention, such cartridges individually float on a spring-like or fluid bed 203, 205, 207 to compensate for tissue thickness and compressibility differences, such that sealing process is optimal over a relatively long, i.e. up to and exceeding 12 cm, heterogeneous tissue. Previous devices, such as the Molllenauer device which exist are provided for a sealing zone in the 2-4 cm range. Accordingly, these devices do not need to compensate for tissue variations along the length of a seal.
The cartridges in the subject invention may be associated with various electrode zones in the multiple electrode device disclosed herein. The staple cartridges run along the entire RF sealing zone, or may be placed preferentially in specific regions along the length of the device to secure the seals and regions that are most critical for certain surgical procedures. The actual cartridges themselves may be mechanically actuated by a trigger 208 or other human operable mechanism, or they be electrically actuated.
Although the invention is described herein with reference to the preferred embodiment, one skilled in the art will readily appreciate that other applications may be substituted for those set forth herein without departing from the spirit and scope of the present invention. Accordingly, the invention should only be limited by the Claims included below.
This application is a continuation-in-part of U.S. patent application Ser. No. 11/382,680 filed 10 May 2006, which is incorporated herein in its entirely by this reference thereto.
Number | Date | Country | |
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Parent | 11382680 | May 2006 | US |
Child | 11696018 | US |