Source: https://patents.google.com/patent/US10285837B1/en
Timestamp: 2019-07-16 17:13:38
Document Index: 487698175

Matched Legal Cases: ['Application No. 62', 'Application No. 2015241193', 'Application No. 2016208416', 'Application No. 2018203527', 'Application No. 15774247', 'Application No. 15772561', 'Application No. 201480075706', 'Application No. 14872137', 'Application No. 15772561', 'Application No. 14872137']

US10285837B1 - Systems and methods for measuring volume of potential sleeve in a sleeve gastrectomy - Google Patents
Systems and methods for measuring volume of potential sleeve in a sleeve gastrectomy Download PDF
US10285837B1
US10285837B1 US15/267,414 US201615267414A US10285837B1 US 10285837 B1 US10285837 B1 US 10285837B1 US 201615267414 A US201615267414 A US 201615267414A US 10285837 B1 US10285837 B1 US 10285837B1
US15/267,414
2015-09-16 Priority to US201562219564P priority Critical
2016-09-16 Application filed by Standard Bariatrics Inc filed Critical Standard Bariatrics Inc
2016-09-16 Priority to US15/267,414 priority patent/US10285837B1/en
2016-10-07 Assigned to STANDARD BARIATRICS, INC. reassignment STANDARD BARIATRICS, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ORTIZ, MARK STEVEN, THOMPSON, JONATHAN
2019-05-14 Publication of US10285837B1 publication Critical patent/US10285837B1/en
This application claims priority to U.S. Provisional Patent Application No. 62/219,564, filed Sep. 16, 2015, which is hereby incorporated by reference in its entirety.
In an example, the first medical device 10 may include a first occlusion device 14. In an example, the first occlusion device 14 may be positioned past a landmark 40 a such as a pylorus of the stomach 40 such that when positioned past the landmark 40 a the first occlusion portion 40 may occlude fluid or gas from passing or flowing beyond the landmark 40 a in direction A. As shown, the first occlusion device 14 may be a balloon on the distal end of the first medical device 10 that may be inflated to occlude the landmark 40 a. As such, in an example, the first occlusion device 14 may be integrated into the first medical device 10.
According to an additional or alternative example, the first occlusion device 14 may include another medical device such as clamp, penrose, band, and/or the like that may be used to occlude the landmark 40 a. For example, the first occlusion portion 14 may be a separate medical device (e.g., from the first medical device 10) that may be positioned at the landmark 40 a (e.g., on an exterior of the stomach 40 or wrapped therearound) to occlude fluid or gas from passing beyond the landmark 40 a in direction A.
In an example, a second occlusion device 16 may be provided. The second occlusion device 16 may be positioned at a landmark 40 b such as a GE junction or GEJ of the stomach 40 and wrapped around, for example, the esophagus to occlude fluid or gas from passing beyond the landmark 40 b in direction B. The second occlusion device 15 may be a clamp, penrose or elastomeric band that may be positioned at the landmark 40 b and wrapped around the esophagus to prevent fluid or gas from passing therebeyond.
According to an additional or alternative example (not shown in FIGS. 3-4, but shown, for example, in FIG. 12), the second occlusion device 16 may be integrated into the first medical device 10 and adjusted to be positioned at the landmark 40 b as described herein.
As shown, in performing the sleeve gastrectomy (e.g., a method or procedure thereof), the first medical device 10 may be inserted into the stomach 40 and adjusted proximally and distally such that first occlusion device 14 may be positioned at the landmark 40 a (e.g., near or around the pylorus). As shown, the second occlusion device 16 may be positioned at the landmark 40 b. The first occlusion device 14 may be inflated to occlude fluid or gas from passing in direction A beyond the landmark 40 a. For example, the first medical device 10 may be positioned along the lesser curve of the stomach 40 with the first occlusion device 12 beyond or past the landmark 40 a (e.g., the pylorus). The first occlusion device 12 may be inflated and withdrawn to withstand pressure (for example, 70 cm H20) and to enable gas to be trapped in a potential resultant sleeve (i.e., not allow gas to pass beyond the landmark 40 a or the occlusion point produced thereby). The second occlusion device 16 may be wrapped or secured around the landmark 40 b as shown in an example to occlude fluid or gas from passing in direction B beyond landmark 40 b.
In an example (e.g., upon occluding at the landmarks 40 a, 40 b and positioning the second medical device 20), an amount (e.g., a predetermined or predefined amount) of fluid such as water, saline solution, and/or the like or gas may be inserted into the first medical device 10 at a proximal end thereof (e.g., via the port not shown) and may pass therethrough out of the apertures or openings 12 and into the portion of the stomach 40 defined by the area created by the first and second occlusion devices 14, 16 at the landmarks 40 a, 40 b respectively and and the path along the second medical device 20. In an example, the amount of fluid or gas may be between from about 20 ml to about 200 ml.
Pressure may be measured (e.g., using a pressure measurement device not shown) and a volume of the potential resultant sleeve defined by the landmarks 40 a, 40 b and second medical device may be calculated based on the amount of fluid or gas used and the pressure measured therefrom.
According to an example, the volume may be used to determine whether the potential resultant sleeve may be suitable for resection and/or may provide a desired resected or permanent resultant sleeve size, shape, and/or the like. For example, if based on the measurement and/or calculation, the volume may be too low to provide a resected resultant sleeve desired by a surgeon, the second medical device 20 may be moved laterally along the exterior surface away from the landmarks 40 a, 40 b and/or the IA such that the potential resultant sleeve may become larger. Likewise, in an example, if based on the measurement and/or calculated, the volume may be too high to provide a resected resultant sleeve desired by a surgeon, the second medical device 20 may be moved medially along the exterior of the stomach toward the landmarks 40 a, 40 b and/or the IA of the stomach 40 such that the potential resultant sleeve may become smaller. The pressure may be re-measured in response to moving the second medical device 20 to determine whether subsequent medial or lateral movements as described herein may be needed thereto to achieve a desired resected or permanent resultant sleeve.
In an example, the second medical device 20 may be positioned before the first medical device. That is, the surgeon may position the second medical device on the exterior of the stomach to create a lateral boundary of a potential resultant sleeve as described herein and my then insert the first medical device 10 and create the additional boundaries at the landmarks 40 a, 40 b respectively as described herein.
FIGS. 5-18 depict additional or alternative devices that may be used to measure sleeve volume in one or more examples herein including the method or procedure described with reference to FIGS. 3-4. As shown in FIGS. 5-8, in an example, rather than occluding the gastric outlet and the gastric inlet (e.g., at the landmarks 40 a, 40 b as described above), the first medical device 10 may include a compliant balloon 30 that may be used to fill the space of the proposed or potential resultant sleeve (e.g., as shown in FIG. 7). The second medical device 20 may occlude the lateral border as described herein and the balloon may be filled until a desired pressure may reached at which point volume may be measured or assessed. In an additional or alternative example, a height of the compliant balloon may be adjusted with a sheath 32 as shown in FIGS. 7-8 so the balloon may be positioned distal to the landmark 40 b or the esophagus and proximal to the landmark 40 a or the pylorus as described herein. A pressure bag or elevation of an open syringe to a given height above the cricoid (e.g., 70 cm of water) may be used to assess the volume by the displacement recorded from the container into the proposed sleeve. This may be performed before or after stapling the stomach to assess volume of the sleeve pouch. According to an example, if done prior to stapling, the surgeon may have the ability to adjust the position of the stapler to achieve an optimal size and shape under pressure.
Further, in an example, as shown in FIGS. 9-11, the first medical device 10 may include a compliant balloon 30 that may be combined with a two-diameter tube, a three-diameter tube, a balloon tipped orogastric calibration tube, and/or the like. In this example, a desired position from the incisura angularis (IA) may be obtained and volume may be measured in the same orogastric calibration tube 34 as shown in FIG. 9. An additional cylindrical balloon 36 and/or 38 may be positioned along the upper portion and lower portion of the orogastric tube with a wider balloon 39 at the incisura angularis and a compliant balloon 30 therearound to measure volume of the sleeve as shown in FIGS. 10-11. In an example, the medical device 20 may include a single cartridge sleeve gastrectomy stapler that may be positioned alongside points of the stomach (e.g., points 1, 2, and 3 as described in U.S. patent application Ser. No. 14/846,764 or PCT/US15/48740, the contents of which are incorporated herein in their entirety by reference). Additionally, the balloon and tubes may enable different fill times to measure volume. For example, the balloon adjacent the incisura angularis (e.g., 40 c) may fill first, the first and/or second cylindrical balloons may fill second and third, and the large compliant balloon may fill last or fourth. The timing of the balloon filling may accomplished by the size of the openings or apertures (e.g., such as 12) to the lumen of the orogastric tube. The largest opening will fill first as it has the least resistance to flow. The balloon adjacent the incisura angularis may have the largest opening to the tube lumen and may fill first. The cylindrical balloons may have multiple openings that may have more resistance than the incisura angularis but less resistance than the volume balloon and may fill second and/or third. The volume balloon, even though more compliant, may fill after the incisura angularis and cylindrical balloons may be filled to capacity and are under pressure. Thus, the surgeon may be able to position the stapler at safe distances from key landmarks then measure volume. The volume may be measured by displacement or pressure as described herein.
As shown in FIG. 12-13, the second occlusion device 16 may be integrated or included in the first medical device 10. For example, as shown, the first medical device 10 may include a first tube with the first occlusion device 16 and a second tube that may be placed over the first tube that may include the second occlusion device 16 such that the first and second tubes may slides proximally and distally with respect to each other to position the first occlusion device 14 at the first landmark 40 a and the second occlusion device 16 at the landmark 40 b as described herein.
According to examples, the first medical device 10 described herein may also include one or more portions 60 that may be wider at a landmark 40 c such as the IA of the stomach 40 as shown in FIGS. 15-18. For example, the first medical device 10 may include a constant diameter along a portion thereof and may have a wider diameter (e.g., after inflation, actuation, and/or the like) along the lesser curve or the landmark 40 c (e.g., the IA).
positioning a second occlusion device at another landmark of the stomach, the second occlusion device defining a proximal boundary of the potential resultant sleeve; and
positioning a second medical device on the exterior of the stomach relative to the first medical device, the second medical device being configured to define a lateral boundary the potential resultant sleeve and a path along which the sleeve gastrectomy may be performed; and
filling the potential resultant sleeve with fluid or gas via the first medical device, the fluid or gas being configured to be trapped into the potential resultant sleeve by the distal, proximal, and lateral boundaries created by the first occlusion device, the second occlusion device, and the second medical device respectively;
measuring pressure associated with the fluid or gas; and
calculating the volume based on the pressure.
a first medical device comprising at least a first occlusion device at a distal end thereof, the first medical device being configured to be inserted into an interior of a stomach and the first occlusion device being configured to be positioned at a landmark thereof to occlude a portion of the stomach and define a distal boundary of a potential resultant sleeve;
a second occlusion device, the second occlusion device being configured to be inserted into the interior of the stomach or positioned on an exterior of the stomach, the second occlusion device being configured to be positioned at another landmark of the stomach to occlude another portion of the stomach and define a proximal boundary of the potential resultant sleeve; and
a second medical device being configured to be positioned on the exterior of the stomach relative to the first medical device, the second medical device being configured to define a lateral boundary and a path along which the sleeve gastrectomy may be performed, the lateral boundary along with the proximal and distal boundaries and occlusion thereof being configured to enable a measurement of a volume of the potential resultant sleeve, wherein the volume of the potential resultant sleeve may be configured to be determined by one or more of the following:
9. The device of claim 8, wherein the second medical device may be a clamp.
10. The device of claim 8, wherein the second medical device may be a stapler.
11. The device of claim 8, wherein the first occlusion device may be a balloon.
US15/267,414 2015-09-16 2016-09-16 Systems and methods for measuring volume of potential sleeve in a sleeve gastrectomy Active 2037-02-20 US10285837B1 (en)
US201562219564P true 2015-09-16 2015-09-16
US15/267,414 US10285837B1 (en) 2015-09-16 2016-09-16 Systems and methods for measuring volume of potential sleeve in a sleeve gastrectomy
US10285837B1 true US10285837B1 (en) 2019-05-14
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US15/267,414 Active 2037-02-20 US10285837B1 (en) 2015-09-16 2016-09-16 Systems and methods for measuring volume of potential sleeve in a sleeve gastrectomy
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