This invention relates generally to medical devices and methods and more particularly to devices and methods for laparoscopically measuring the length of an internal anatomic structure, e.g., the bowel, of a patient.
Numerous laparoscopic and robotic surgical procedures require measurement of the small bowel. Bowel length can be especially important in certain bariatric surgeries, where the bowel is rerouted, and the length of the newly created bowel limbs is crucial in these standardized procedures. In bariatric procedures such as SADI-S and Roux En Y, if the bowel functional length is too short, known as short bowel syndrome, the patient will not absorb enough nutrients as food passes through, leading to malnutrition and if the bowel is left too long, there will not be a significant amount of weight loss and the surgery will have been ineffective, possibly resulting in a revision surgery.
Measuring bowel in surgery is not as simple as rolling out the bowel and using a standard measuring tape because the bowel is “raveled” in the abdomen and distances measured can be up to 3 meters and sometimes more. To measure these distances in a laparoscopic/robotic surgery, the surgeon “walks” the bowel with his/her graspers, beginning at an anatomical landmark and passing bowel between graspers in grasper-to-grasper steps, each of a fixed increment (usually 5 or 10 cm increments), while counting the number of increments (grasper-to-grasper steps) until the desired length has been reached.
While the above prior art procedure may be generally suitable for its intended purpose it nevertheless leaves much to be desired from the standpoint of accuracy and ease of measurement. In this regard some surgeons estimate these grasper-to-grasper distances by eye, not directly measuring each increment. This method can result in incorrect bowel length determination. Other surgeons utilize some external reference, such as a suture measured to a desired increment length or ruler. This method can result in increased time because for each increment counted, there is an extra step of holding the bowel up to the remote measurement reference.
Though it is well known that accurate measurement is crucial, currently there is no widespread consensus on the best means of doing so. When measuring lengths up to 300 cm, estimating each increment based purely on eyesight can introduce compounding error and result in larger error. Using an external reference still introduces some slight error but more importantly it can be time consuming to have to hold the bowel up to the reference with every pass.
Thus, a need exists for a device which is simple in construction and easy to use to effectively laparoscopically measure a length of bowel. The subject invention addresses that need by providing devices and methods for enabling surgeons to accurately and quickly measure the bowel, or other internal anatomic structures, without interrupting the current laparoscopic surgical technique.
One aspect of this invention is a measuring device for measuring internal anatomy in the body of a patient. The measuring device is configured for mounting on a laparoscopic grasper or being an integral component of the laparoscopic grasper. The laparoscopic grasper has an elongated shaft having a longitudinal axis and pair of grasping jaws located at a distal end of the shaft. The measuring device comprises at least one elongated wing and a retention structure. The at least one elongated wing has a predetermined length as measured along a longitudinal axis of the at least one elongated wing. The at least one elongated wing is configured for orientation in a state extending generally parallel to the longitudinal axis to enable the at least one elongated wing to be introduced through a trocar or some other port into the body of the patient. The at least one elongated wing is also configured for orientation in a state extending transverse to the longitudinal axis. The retention structure is configured for holding the at least one elongated wing on the elongated shaft of the laparoscopic grasper when the measuring device is mounted on the laparoscopic grasper and the at least one elongated wing is located within the body of the patient, whereupon when the at least one elongated wing is in the orientation extending transverse to the longitudinal axis the at least one elongated wing can be used to measure a length of the internal anatomy of the patient.
In accordance with one preferred aspect of the measuring device, the state extending generally parallel to the longitudinal axis comprises a collapsed or closed state and the state extending transverse to the longitudinal axis comprises a extended or open state. The measuring device additionally comprises a pivotable hinge biased to normally hold the at least one elongated wing in the open state. The pivotable hinge is also configured to be pivoted in response to an applied force to pivot the at least one elongated wing to said closed state, whereupon when said at least one elongated wing is in the closed state the measuring device can pass through a trocar or some other port into the body of the patient and when the measuring device is in the body of the patient the pivotable hinge automatically pivots the at least one elongated wing to the open state so that the at least one elongated wing can be used to measure a length of the internal anatomy of the patient.
In accordance with another preferred aspect of this invention the measuring device is configured for releasable mounting of the laparoscopic grasper. The measuring device additionally comprises a body portion configured to receive a distal portion of the laparoscopic grasper to releasably secure the measuring device on the laparoscopic grasper at a desired position.
In accordance with another preferred aspect of this invention the body portion comprises tubular sidewall including a central passageway, a longitudinally extending axis, a distal end and a proximal end. The tubular sidewall has an outer periphery. The central passageway has an inner surface configured to receive a distal portion of the shaft of the laparoscopic grasper to releasably secure the measuring device on the grasper at a desired position, and wherein the at least one wing is located at the distal end of the tubular sidewall.
In accordance with one preferred aspect of this invention the at least one wing comprises a pair of wings, each of which is pivotable between the open state and the closed state, and vice versa. Each of the wings of the pair of wings when in the closed state extend parallel to each other and to the longitudinal axis of the shaft to enable the laparoscopic grasper with the measuring device mounted thereon to be introduced through the trocar into the body of the patient, whereupon the pair of wings automatically pivot to the open state, wherein the wings extend in opposite radial directions transverse to the longitudinal axis of the shaft. Each of the pair of wings has a predetermined length to serve as measuring tool to enable the user to measure a length of the internal anatomy of the patient.
In accordance with one preferred aspect of this invention the laparoscopic grasper includes a peripheral portion configured to be engaged by a portion of the measuring device, and wherein the central passageway includes a retention structure configured to frictionally engage the peripheral portion of the laparoscopic grasper to hold the measuring device in place on the laparoscopic grasper at a desired position and is resistant to displacement from the desired position. The desired position is such that when the wings are in the open state the grasping jaws of the laparoscopic grasper are exposed and able to open and close as desired.
In accordance with one preferred aspect of this invention each of the wings of the pair of wings is connected to the tubular sidewall by a respective living hinge.
In accordance with another preferred aspect of this invention the body portion and the pair of wings constitute a molded one-piece member.
In accordance with another preferred aspect of this invention the retention structure includes a necked-down section located intermediate the proximal end and the distal end.
In accordance with another preferred aspect of this invention the retention structure includes an elastic ring located at the proximal end. The elastic ring provides additional friction for holding the measuring device at the desired position.
In accordance with another preferred aspect of this invention the retention structure includes a pair of slots in the necked-down section and extending parallel to the longitudinal axis. The slots facilitate stretching of the necked down section.
In accordance with another preferred aspect of this invention the retention structure includes a helical spring in the necked-down section. The helical spring is configured to provide additional friction for holding the measuring device at the desired position.
In accordance with another preferred aspect of this invention the retention structure comprises a front section of the central passageway. The front section tapers in a distal direction and includes a pair of slots extending parallel to the longitudinal axis from the distal end of the sidewall to a position adjacent the proximal end of the sidewall.
In accordance with another preferred aspect of this invention an internal diameter of the front section of the central passageway at the distal end is less than an external diameter of the distal end of the laparoscopic grasper, wherein the distal end of the laparoscopic grasper is configured to be introduced into the central passageway from the proximal end of the tubular sidewall and out of the central passageway at the distal end of the tubular sidewall. The pair of slots is configured to splay apart to enable the distal end of the laparoscopic grasper to exit out of the central passageway at the distal end of the tubular sidewall, with portions of the inner surface of the central passageway frictionally engaging portions of the periphery of the laparoscopic grasper.
In accordance with another preferred aspect of this invention the proximal end of the measuring device comprises a loop configured to be grasped by the jaws of a first laparoscopic grasper to enable the measuring device to be mounted on a distal end of a second laparoscopic grasper extending into the body of the patient.
In accordance with another preferred aspect of this invention the loop is configured to be grasped by the jaws of the first laparoscopic grasper by the second laparoscopic grasper to dismount the measuring device from the first laparoscopic grasper.
In accordance with another preferred aspect of this invention the measuring device comprises an integral component of a laparoscopic grasper.
Another aspect of this invention is a method of laparoscopically measuring internal anatomy of a patient comprising providing a first and second laparoscopic grasper, each laparoscopic grasper having a shaft and movable jaws located at a distal end of the shaft. A measuring device is provided for releasable mounted on the first laparoscopic grasper. The measuring device has a longitudinal axis and comprises at least one wing having a predetermined length, a proximal end and a distal end. The measuring device is mounted on a distal end of the first laparoscopic grasper with the jaws of the first laparoscopic grasper extending distally beyond the at least one wing. A second laparoscopic grasper is introduced into the body of the patient via a trocar. The first laparoscopic grasper is moved to a first position wherein one of the ends of the at least one wing is located at a starting point. The jaws of the first laparoscopic grasper are caused to grasp the internal anatomy at the first position. The second laparoscopic grasper is moved to a second position immediately adjacent one of the ends of the at least one wing and the pair of jaws of the second laparoscopic grasper is caused to grasp the internal anatomy at the second position. The jaws of the first laparoscopic grasper are caused to release the internal anatomy at the first position and the first grasper is moved to a third position wherein one of the ends of the at least one wing is located at the second position. The jaws of the first laparoscopic grasper are caused to grasp the internal anatomy at the third position. If desired, the movements of the first and second laparoscopic graspers are repeated a desired number of times and the number of movements of the first laparoscopic grasper is counted to measure a desired length of the internal anatomy.
In accordance with one preferred aspect of the method of this invention the measuring device comprises a pair of elongated wings whose distal ends extend opposite each other and transverse to the longitudinal axis, wherein when the first laparoscopic grasper is in the first position the distal end of one of the pair of wings is located at the starting point, and the distal end of the other of the pair of wings is located at the second position. When the first laparoscopic grasper is in the third position the distal end of one of the pair of wings of the first laparoscopic grasper is located at the third position, and the distal end of the other of the pair of wings is located at a fourth position. The method additionally comprises causing the jaws of the second laparoscopic grasper to be opened to release the second laparoscopic grasper from the internal anatomy and moving the second grasper to the fourth position.
In accordance with another preferred aspect of the method of this invention the measuring device comprises a single elongated wing extending transversely to the longitudinal axis when the first laparoscopic grasper is in the first position. The proximal end of the at least one wing is located at the starting point and the distal end of the at least one wing is located at the second position. When the first laparoscopic grasper is in the third position the proximal end of the at least one wing is located at the third position, and the distal end of the at least one wing is located at a fourth position. The method additionally comprises causing the jaws of the second laparoscopic grasper to be opened to release the second laparoscopic grasper from the internal anatomy and moving the second laparoscopic grasper to the fourth position.
In accordance with another preferred aspect of the method of this invention the at least one wing is pivotable between an open state and a closed state, and vice versa. The at least one wing is normally biased into the open state wherein the at least one wing extends transversely to the longitudinal axis, the at least one wing is collapsible to the closed state by a force applied thereto wherein the at least one wing extends parallel to the longitudinal axis, and wherein the method comprises causing the at least one wing to be in the closed state to enable the measuring device to be introduced laparoscopically into the body of the patient via a trocar, whereupon once within the body of the patient the at least one wing automatically pivots to the open state.
In accordance with another preferred aspect of the method of this invention the measuring device comprises a tubular body portion, and wherein the method comprises mounting the measuring device on the distal end of the first laparoscopic grasper by extending the jaws of the first laparoscopic grasper when in the closed state through the tubular body portion to releasably mount the measuring device on the first laparoscopic grasper outside the body of the patient. The distal end of the first laparoscopic grasper with the measuring device mounted thereon is introduced through a trocar into the body of the patient adjacent the internal anatomy. Thereafter a length of the internal anatomy is measured via use of the at least one wing.
In accordance with another preferred aspect of the method of this invention the measuring device comprises a tubular body portion, and wherein the method comprises introducing the measuring device by itself through a trocar into the body of the patient adjacent the internal anatomy whereupon the at least one wing automatically pivots to the open state. The measuring device is releasably mounted on a distal end of a first laparoscopic grasper that is extended through a trocar into the body of the patient adjacent the anatomic structure. Once the measuring device is mounted on the distal end of the first laparoscopic grasper a length of the internal anatomy is measured via use of the at least one wing.
Referring now to the various figures of the drawing wherein like reference characters refer to like parts, there is shown in
Turning now to
As best seen in
The tubular sidewall 22 of the measuring device 20 includes a retention structure that constrains the position of the measuring device on the distal end portion of the grasper shaft 4 so that it isn't accidentally displaced from that position during use of the device. The retention structure of the measuring device 20 of
The grasper 2 with the measuring device 20 mounted thereon as just described is now ready for use to measure a section of the patient's bowel laparoscopically by being introduced into the patient's body through a trocar or some other access port.
To accomplish that action a second grasper 2′ is required, like shown in
Since each of the wings is of a length D1, if that length is 5 cm, when the first grasper 2 has been walked as just described to the fifth position a total of 25 cm will have been measured off by the successive incremental movements of those graspers. Accordingly, the 25 cm of the bowel between the starting point and the ending point can then either be bypassed or used as the total length for the common bowel channel. If a section of bowel greater than 25 cm is desired to be measured additional incremental walking movements of the graspers can be accomplished to measure off the desired section of bowel. If a section of bowel less than 25 cm is desired to be measured off, the above described method could be carried out stopping at whatever position is the desired end point of the measured bowel section. It should be readily apparent to those skilled in the art that the measuring device of this invention can make use of wings which are shorter than 5 cm or longer than 5 cm, depending upon the application. In any case all that the user of the measuring device 20 has to do is to count the number of movements of the grasper on which the measuring device is mounted to ensure that the desired length of the bowel has been measured.
It should be noted that the method of measuring the desired length of bowel as just described is somewhat similar to the current prior-art technique of measuring bowel without a length indicating device. That prior-art technique entails the surgeon “walking” two graspers in an overlapping sequential fashion along the bowel. However, by using the measuring device of the subject invention on one of the graspers the same overlapping walking method can be used, but the surgeon will know with certainty where to grab the bowel for each increment as indicated by the wings of the measuring device, utilizing the left arm 24A and the right arm 24B sequentially.
Once the measurement of the bowel has been accomplished using the measuring device and method of this invention the first grasper with the measuring device thereon can be withdrawn from the patient's abdominal cavity 14 by merely pulling on the grasper 2 by its handle to retract the grasper. That retraction action will bring the wings 24A and 24B of the measuring device into engagement with the distal end 16 of the trocar 10, whereupon continued retraction will cause the wings to pivot from their open state (i.e., perpendicular orientation) to their closed state (parallel orientation), whereupon they will enter and pass through the trocar until they reach the proximal end of the trocar and exit the trocar. Once they are free of the proximal end of the trocar the wings will automatically flex back to their open (perpendicular) state. The measuring device can then be removed from the shaft of the grasper to dispose of the measuring device.
It should be pointed out at this juncture that the exemplary measuring device 20 as described above is exemplary of various devices that can be constructed in accordance with this invention. Thus, various modifications can be made to the measuring device within the scope of this invention. For example, various other possible retention features can be implemented in the device to hold the device to the shaft of the grasper in a manner that allows ease of installation while not allowing movement during surgery. Three of such retention features are a retention ring, expansion slits, and a spring.
For example in
In
In
Turning now to
Before describing the details of the measuring device 420 a brief description of the robotic grasper 2R is in order. To that end, as can be seen in
The measuring device 420 is similar in many respects to the measuring devices 20, 120, 220 and 320 in that it basically comprises an integral unit having a body portion in the form of a tubular sidewall 422 from which a pair of wings 424A and 424B project outwards. The sidewall 422 includes a distal end 422A and a proximal end 422B, with a central passageway 426 extending between the distal and proximal ends along a longitudinal axis X. As best seen in
The central passageway 426 is configured to receive a distal portion of the shaft of the grasper on which the measuring device 420 is to be releasably mounted. A portion of the central passageway 426 forms a retention structure to hold the measuring device in place on the grasper at a desired position so that it is resistant to displacement from that desired position. That retention structure constitutes the tapering inner surface 426A of the passageway 426 in the front section 422C which is configured to frictionally engage a peripheral portion of the shaft of the laparoscopic grasper. In particular, as shown in
As best seen in
Once mounted on the grasper 2 and inserted into the body of the patient the grasper with the measuring device mounted thereon can be used in the same manner as the measuring devices 120, 220, and 320 described earlier to measure a section or length of an internal anatomic structure, e.g., the patient's bowel.
The mounting of the measuring device 420 on a robotic laparoscopic grasper 2R is different from the manner in which it is mounted on a manual grasper 2. In particular, the measuring device 420 is designed to be installed onto the shaft 4R of the robotic laparoscopic grasper inside of the patient's body instead of outside the patient's body, as is the case of mounting the measuring device 420 on a manual grasper 2.
The procedure of mounting the measuring device 420 on a robotic grasper 2R can be accomplished by use of a first robotic grasper (which will be referred to hereinafter as the “introducing grasper”) pushing the measuring device 420 through a trocar into the patient's abdomen. To accomplish that end, the wings 424A and 424B are pivoted to their closed position and once in that position they are introduced into the open outside (proximal) end of a trocar that is extended into the patient's abdomen. Once the measuring device 420 is inside the trocar, the introducing grasper 2R can grasp the tail section 422D of the device at the open outside end of the trocar to push the measuring device through the trocar and into the patient's abdomen. Once inside the patient's abdomen and free of the trocar, the wings 424A and 424B of the measuring device 420 will automatically assume their open position, so that the measuring device is now ready to be mounted on the distal end of a second robotic grasper 2R (which will be referred to hereinafter as the “measuring grasper”) to measure a section of the patient's bowel. To that end, as shown in
After the measuring procedure has been accomplished, the measuring device 420 can be removed from the distal end of the measuring grasper 2R as follows. The jaws of the measuring grasper on which the measuring device is mounted are moved to their closed position or state. Once in that state the jaws of another robotic grasper 2R (hereinafter called the “removal grasper”) can grasp the loop 430 of the measuring device to hold the measuring device 420 in place, whereupon the measuring grasper 2R can be moved in the proximal direction so that its closed jaws are pulled through the central passageway of the measuring device and out its open proximal end 422B. Once that has been accomplished the measuring grasper will be free of the measuring device, so that the measuring device can be removed from the abdomen of the patient. That action is accomplished by the removal grasper 2R, whose jaws are grasping the loop 430 of the measuring device 420, being retracted through the trocar in which the removal grasper extends, whereupon the loop of the measuring device enters into the open distal end of that trocar. Continued pulling of the removal grasper in the proximal direction draws further portions of the measuring device into the trocar, whereupon the wings 424A and 424B engage the distal end of the trocar to pivot the wings to their closed position or state to enter into the distal end of the trocar. Continued pulling of the removal grasper in the proximal direction will draw the measuring device out of the trocar, and hence out of the patient's abdomen.
It should be pointed out at this juncture that the measuring device 420 like the other measuring devices discussed previously is preferably formed, e.g., molded as a unit, of a plastic (e.g., Polyether block amide (PEBA)) or some other self-supporting but somewhat resilient material (e.g., Nylon). The thickness of the body of the device varies from 1-1.2 mm and the wings of the device are approximately 1.78 mm thick.
While all of the embodiments of the measuring devices described heretofore have included a pair of extendable/collapsible wings, this invention is broader than that. Thus, this invention contemplates measuring devices making use of only a single extendable/collapsible wing. One such exemplary embodiment 420S of that type of measuring device is shown in
The grasper 2 with the measuring device 420S mounted thereon is introduced into the patient's body through a trocar or some other access port in the same manner as described earlier with respect to the measurement of the patient's bowel by the measuring device 20 on the grasper 2. In particular, the grasper 2 with the measuring device 420S thereon (and referred to hereinafter as the “first grasper”) is inserted through an access port of a trocar 10, like that described above with respect to the measuring device 20, whereupon the force applied to the collapsible/extendable wing 424B of the measuring device 420S by the engagement of its wing with the access port of the trocar will pivot the wing to its closed or collapsed state, so that it can pass into and through the trocar into the patient's abdomen. Once the wing is free (past) the distal end 16 of the trocar it's living hinge 428B automatically flexes or pivots the wing outward so that the wing assumes its normal unbiased, i.e., open state, like shown in
It should also be pointed out that any of the measuring devices of this invention need not be a separate unit configured for releasable mounting on a laparoscopic grasper. Rather, the measuring device can itself be integrated into the grasper, i.e., form a portion of either a manual grasper or a robotic grasper. For example,
Use of the integrated laparoscopic grasper to measure the bowel or other internal anatomic structure can be accomplished in the same manner as discussed above with respect to
As should be appreciated by those skilled in the art from the above description of the measuring devices and their methods of use, the subject invention provides increased accuracy for surgeons who do not currently measure bowel increments, reducing complications and/or reoperations. Moreover, the subject invention decreases procedure time for surgeons who currently measure the bowel. Further still the flexible wings do not impede current surgical technique or cause damage to bowel or other soft tissue. It should be pointed out at this juncture and should be appreciated by those skilled in the art that while the above description of the structure and use of the measuring devices of this invention have centered on measuring the bowel, that is merely exemplary of various internal anatomic structures that may be measured laparoscopically using the measuring devices and methods of this invention.
Without further elaboration the foregoing will so fully illustrate our invention that others may, by applying current or future knowledge, adopt the same for use under various conditions of service.
This non-provisional utility application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application Ser. No. 63/211,155 filed on Jun. 16, 2021 and entitled Laparoscopic Bowel Length Indicating Devices And Methods Of Use, the entire disclosure of which is incorporated by reference herein for all purposes.
Number | Date | Country | |
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63211155 | Jun 2021 | US |