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US-20260124015-A1 - SURGICAL DEVICES AND METHODS FOR BARIATRIC AND GASTROESOPHAGEAL SURGERY

US20260124015A1US 20260124015 A1US20260124015 A1US 20260124015A1US-20260124015-A1

Abstract

Disclosed are various embodiments for improved surgical devices and methods of using the same in connection with bariatric and gastroesophageal surgery. The present disclosure includes a lighted bougie device that can include an elongate member and a light source. The light source can be configured to emit near infrared light. The light source can also be positioned about the bougie such that light emitted from the light source illuminates along a portion of the bougie.

Inventors

  • Nova Szoka

Assignees

  • West Virginia University Board of Governors on behalf of West Virginia University

Dates

Publication Date
20260507
Application Date
20260105

Claims (20)

  1. 1 - 50 . (canceled)
  2. 51 . A lighted device for use in a surgical procedure, the lighted device comprising: an elongated member having a distal end for inserting into an operative field of a patient and having a proximal end; a handle coupled to the proximal end of the elongated member; and a plurality of light sources disposed along the elongated member and configured to emit light in a first wavelength range and a second wavelength range different from the first wavelength range, wherein: a first light source closest to the distal end of the elongated member among the plurality of light sources is disposed at a first location of the elongated member, a second light source closest to the proximal end of the elongated member among the plurality of light sources is disposed at a second location of the elongated member, a length of the elongated member between the first location and the second location is at least 50% of a length of the operative field of the patient, and light sources in at least a subset of the plurality of light sources are spaced apart along a length direction of the elongated member at a predetermined interval of between 0.5 cm and 5 cm, thereby allowing use of the elongated member and the light sources as a ruler for one or more intraoperative measurements.
  3. 52 . The lighted device of claim 51 , wherein the first wavelength range is a white light range and the second wavelength range is a near-infrared light range.
  4. 53 . The light device of claim 52 , wherein the plurality of light sources comprises at least one light source that emits light in the white light range and comprises at least one light source that emits light in the near-infrared light range.
  5. 54 . The lighted device of claim 52 , wherein the first wavelength range is about 400 nm to about 650 nm.
  6. 55 . The lighted device of claim 52 , wherein the second wavelength range is about 700 nm to about 1300 nm, or about 700 nm to about 850 nm.
  7. 56 . The lighted device of claim 51 , wherein the length of the elongated member between the first location and the second location is at least 60%, at least 70%, at least 80% or at least 90% of the length of the operative field of the patient.
  8. 57 . The lighted device of claim 51 , wherein the plurality of light sources comprises at least one LED light, at least one optic fiber, a polymer containing a near infrared fluorescent material, or any combination thereof.
  9. 58 . The lighted device of claim 51 , wherein the plurality of light sources comprises at least 10 individual light sources.
  10. 59 . The lighted device of claim 51 , wherein adjacent light sources in at least the subset of the plurality of light sources are spaced apart evenly along the length direction of the elongated member.
  11. 60 . The lighted device of claim 51 , wherein at least one light source among the plurality of light sources is disposed at or adjacent to the distal end of the elongated member.
  12. 61 . The lighted device of claim 51 , wherein the plurality of light sources is operated to alternately emit the light in the first wavelength range and in the second wavelength range.
  13. 62 . The lighted device of claim 51 , wherein the elongated member comprises a suction channel, and one or more apertures extending from an exterior surface of the elongated member into the suction channel.
  14. 63 . The lighted device of claim 51 , wherein the operative field is a gastrointestinal tract of the patient and the light emitted from the plurality of light sources is detectable by a camera positioned outside of the gastrointestinal tract.
  15. 64 . The lighted device of claim 51 , wherein the elongated member is a bougie configured to be inserted into a stomach of the patient, and the light emitted by the plurality of light sources allows visualization of an outside of the stomach and the bougie in the stomach of the patient.
  16. 65 . The lighted device of claim 51 , wherein the lighted device is configured to be used as a guide during the surgical procedure.
  17. 66 . The lighted device of claim 51 , wherein the lighted device is configured to be used for a laparoscopic or robotic surgery.
  18. 67 . The lighted device of claim 51 , wherein the elongated member has a diameter of 34 French, 36 French, 38 French, or 40 French.
  19. 68 . The lighted device of claim 51 , wherein the elongated member has a length of about 32 inches.
  20. 69 . A lighted device for use in a surgical procedure, the lighted device comprising: an elongated member having a distal end for inserting into an operative field of a patient and having a proximal end; a handle coupled to the proximal end of the elongated member; and a plurality of light sources disposed along the elongated member and configured to emit light in a first wavelength range and a second wavelength range different from the first wavelength range, wherein the plurality of light sources comprises at least 8 individual light sources that are spaced apart along a length direction of the elongated member at a predetermined interval of between 0.5 cm and 5 cm, thereby allowing use of the elongated member and the light sources as a ruler for one or more intraoperative measurements.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 16/836,396, filed Mar. 31, 2020, which claims the benefit of and priority to U.S. Provisional Patent Application No. 62/827,359, filed on Apr. 1, 2019, entitled “USE OF NEAR-INFRARED CAMERA AND LIGHTED BOUGIE TO IMPROVE SLEEVE GASTRECTOMY TECHNIQUE,” the contents of which is incorporated by reference herein in its entirety. BACKGROUND Obesity and its associated costs represent a significant healthcare issue in the United States and worldwide. Treatments for obesity vary from dietary and behavioral changes and increasing healthy exercise/activity, to prescription medications, and weight-loss surgery. Bariatric surgery has become the standard of care for treatment of severe obesity and obesity related health problems, due to its proven ability to achieve sustained weight reduction, as well as reduction of the comorbidities related to obesity. Scientific studies cite benefits such as weight loss, as well as high rates of improvement or resolution of diabetes, hyperlipidemia, hypertension, and obstructive sleep apnea after a bariatric procedure. Laparoscopic sleeve gastrectomy (LSG) has overtaken Roux en Y gastric bypass (RNY) as the most widely performed procedure in both community and academic practices. The most common complications of sleeve gastrectomy and gastric bypass operations include leak (1%), bleeding, and venous thromboembolism. However, another complication of these operations is bougie-related injury. Bougie-related injury is defined as an injury to the patient that occurs as a result of bougie placement or use. Within the bariatric literature the incidence of bougie-related injury is 0.1-1.2%. Reported injuries most commonly occur in bariatric operations while stapling the gastric sleeve or gastric pouch. Comparatively, within the foregut surgical literature, the incidence of bougie-related injury is 0.8-1.6%, with most common injuries occurring while passing the bougie down the esophagus into the stomach which can cause either esophageal or gastric perforation. Based on the lower rate of bougie-related injury in the bariatric literature, there is concern that these injuries may currently be under-reported. A bougie-related injury can occur during many different surgical procedures. Iatrogenic instrument-related injuries can include accidental stapling of tube, probe, or bougie during gastric sleeve or gastric pouch formation, as well as esophageal or gastric perforation from insertion of a bougie. For example, a bougie related injury can occur in a bariatric surgery while advancing the bougie down the esophagus into the stomach, while creating a gastric sleeve during laparoscopic sleeve gastrectomy, or while creating the gastric pouch during laparoscopic gastric bypass. Typical bougie-related injuries can include, proximal, mid, or distal esophageal perforation; proximal, mid or distal gastric perforation, as well as stapling the bougie into the stomach, necessitating immediate revision/reconstruction, or stapling across the bougie and leaving a foreign body behind inside or outside the patient. Furthermore, minimally invasive surgery, and especially robotic surgery, provides decreased tactile feedback to the surgeon, which is associated with increased risk of iatrogenic esophageal and gastric injury during bougie insertion, gastric sleeve formation, or gastric pouch formation. These types of injuries can result in serious morbidity and even mortality if they go undetected until after the procedure, and even when detected immediately, they can require lengthy and costly procedural modifications that result in increased morbidity and longer hospital stay. Therefore, laparoscopic visualization is necessary to ensure proper performance of the procedure. However, as a minimally invasive approach has become the gold standard in bariatric surgery, this has led to decreased tactile feedback and greater reliance on laparoscopic two-dimensional white light visualization. Furthermore, with the growing use of robotic bariatric surgery, where the surgeon is remote from the patient with even more limited tactile sensation, the need for additional safety techniques/tools to evaluate and perform minimally invasive surgical procedures is necessary. Despite the large number of laparoscopic sleeve gastrectomies performed in the worldwide annually, there is no fully standardized technique for this operation. A consensus of experts agrees on the basic steps of the operation, namely to mobilize the stomach by dividing the short gastric arteries along the greater curvature, and to divide the stomach starting 6 cm from the pylorus, taking care not to narrow the stomach at the incisura or the angle of His. A bougie is passed to help maintain uniform sleeve size. However, within the bariatric community, there are still wide variations in terms of port placement, bougie size, when to pass a bougie, stapler len