US-20260123822-A1 - STERILE SHEATH FOR PERFORMING NOTES PROCEDURE

US20260123822A1US 20260123822 A1US20260123822 A1US 20260123822A1US-20260123822-A1

Abstract

A device creates a sterile passage to perform natural orifice transluminal endoscopic surgery (NOTES). A balloon tube is connected with a fluid-impervious shroud to define an interior passage that is continuous and that can exclude pathogens. Two torus-shape balloons are arranged axially along the outside surface of the balloon tube and define a circumferential gap. In an exemplary use, an endoscope/laparoscope is inserted through the shroud and through the balloon tube. The endoscope/laparoscope, surrounded by the shroud, is inserted through a patient's mouth and advanced to a position in the stomach adjacent where a procedure will be performed in the peritoneum. The ballon tube is positioned through an incision in the stomach wall so that the wall is positioned in the gap between the balloons. The balloons are inflated to seal the balloon tube with the stomach wall to create a sterile pathway for surgical instruments.

Inventors

Larry S. Miller

Assignees

THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH

Dates

Publication Date: 20260507
Application Date: 20251031

Claims (10)

1 . A device for facilitating a surgical procedure, comprising: a fluid-impervious shroud comprising a continuous interior passage; a balloon tube, wherein the balloon tube comprises an interior passage, an outside surface, a proximal portion and a distal portion; and a torus-shape proximal balloon and a torus-shaped distal balloon, wherein the proximal and distal balloons are arranged axially along the outside surface, wherein a distal portion of the shroud is connected with the outside surface along a circumference of the outside surface, and wherein the connection is fluid-impervious.
2 . The device according to claim 1 , wherein the balloon tube is adapted to engage with a distal end of an endoscope.
3 . The device according to claim 1 , further comprising a gasket disposed across the interior passage.
4 . The device according to claim 1 , further comprising a distal cover connected with the balloon tube at the circumference and extending in a distal direction, wherein the distal cover encloses the distal portion of the balloon tube.
5 . The device according to claim 4 , wherein the distal cover includes a weakened portion adapted to be ruptured by a surgical instrument.
6 . The device according to claim 1 , wherein the surgical procedure comprises a NOTES procedure.
7 . A method for surgically accessing a body cavity through a natural orifice using the device according to claim 1 , comprising the steps of: extending an endoscope through the inner passage of the shroud, wherein a distal end of the endoscopeextends at least partly within the inner passage of the balloon tube; inserting the endoscope surrounded by the shroud though the natural orifice and along a body channel to a surgical site, wherein pathogens in the body channel are excluded from the inner passage; positioning the balloon tube through an incision in a tissue wall, wherein the distal balloon is positioned distal of the wall and the proximal balloon is positioned proximal of the wall; and inflating the proximal and distal balloons, wherein the balloons contact respective proximal and distal sides of the wall and create a fluid-impervious seal between the balloon tube and the wall.
8 . The method of claim 7 , wherein the endoscope comprises an instrument passage, further comprising performing a surgical procedure at a location distal of the wall by moving one or more surgical instruments through the instrument passage.
9 . The method of claim 7 , wherein the endoscope comprises a source of germicidal radiation, wherein the step of extending the endoscope through the inner passage comprises illuminating the shroud with the germicidal radiation, wherein pathogens on within the inner passage are reduced or eliminated.
10 . The method of claim 9 , wherein the tissue wall is a stomach wall between a stomach and a peritoneum, further comprising the steps of: forming a bleb below a mucosa of the stomach; creating an opening through the mucosa into the bleb; extending an instrument through the opening to form a tunnel; inserting the balloon tube and the distal portion of the endoscope along the tunnel; and forming the incision, wherein the incision extends through a muscle layer and a serosa into the peritoneum.

Description

This application claims priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 63/715,007 , filed on Nov. 1, 2024. The disclosure of that application is incorporated herein by reference. BACKGROUND Field This disclosure relates to a sheath for a surgical instrument used to facilitate performance of natural orifice transluminal endoscopic surgery (NOTES). In particular, the disclosure relates to a sheath that provides a sterile path to deploy instruments via a patient's natural bodily opening and through an anatomical wall into a body cavity. According to one embodiment, such a sheath is used to facilitate access to a patient's peritoneal cavity via the patient's mouth while preventing pathogens and contaminants that may be present in the patient's gastrointestinal tract from flowing into the peritoneum. According to other embodiments, a sheath is provided to facilitate NOTES procedures via other natural orifices such as the rectum, vagina, anus or nose. According to other embodiments two or more sheaths could be used at the same or different anatomical location to perform procedures that are similar to standard laparoscopic procures using multiple ports and laparoscopes. NOTES procedures allow surgeons to access body cavities and perform minimally invasive surgical (“MIS”) procedures without the need for an incision through the patient's skin. Such procedures may reduce surgical pain and trauma to the patient, reduce the chance of infection through an external surgical wound, and reduce complexity of certain procedures. Such procedures may access body cavities via a natural opening such as the mouth, the vagina, the anus, the rectum, or other opening. In NOTES procedures, an endoscope or laparoscope is inserted through the natural orifice, for example, the patient's mouth. The endoscope/laparoscope is advanced to the part of the stomach, duodenum, or intestine adjacent to the part of the abdominal cavity selected for the surgical procedure. According to known techniques, an incision is made into the peritoneal cavity through the stomach, esophageal, colon, small intestine, vagina or rectal wall and endoscopic or laparoscopic instruments are manipulated through the incision to perform the procedure in the abdominal cavity. Known NOTES procedures may allow pathogens or other contaminants to move through the incision from an unsterilized part of the patient's body, e.g., the stomach, esophagus, vagina, or rectum, into an internal body cavity, e.g., the peritoneal cavity, leading to potential infection. This risk of infection may limit the use of NOTES techniques. Thus, there is a need for a device and a method that can provide a sterile pathway to access a body cavity via a natural orifice. SUMMARY According to one aspect of the disclosure, a sheath is provided that can be deployed to create a sterile pathway for endoscopic or laparoscopic instruments to access internal body cavities, such as the peritoneal cavity via a natural orifice such as the mouth. According to one embodiment, the sheath includes a shroud that will form a sterile passageway for instruments performing a NOTES procedure. A balloon tube is connected with a distal portion of the shroud and a seal is formed between the shroud and the outside surface of the balloon tube. The balloon tube defines a central passage sized to permit endoscopic or laparoscopic instruments to pass through. On the outer surface of the balloon tube are two balloons separated by a circumferential gap and extending around the circumference of the tube. According to one embodiment, the shroud is connected with, and sealed to, the circumference of the balloon tube at a location proximal of the proximal-most balloon. A distal end portion of the sheath extends distally from the point where it is connected with the balloon tube and encloses the distal end of the balloon tube. According to one embodiment, the shroud extends proximally a sufficient length that, when deployed, the shroud reaches from the selected site of the NOTES procedure, through the GI tract and out of the patient's body through a natural orifice, e.g., the patient's mouth. According to one embodiment, the balloon tube includes a gasket to reduce the flow of gases through the tube to facilitate insufflation once the device has been deployed, as will be discussed below. According to one embodiment, the internal surfaces of the sheath including the shroud and balloon tube are sterilized and stored to maintain sterility, using techniques known to those of skill in the field of the disclosure. According to another embodiment, the sheath and balloon tube may not be maintained in a sterile condition and may be sterilized just prior to or during a surgical procedure Such a device may be used to perform a NOTES procedure, for example, in the stomach to perform a procedure in the peritoneum. According to one embodiment a surgical procedure is performed on tissues in the peritoneum through the wall