US-12616594-B2 - Gastrointestinal bypass devices and related methods of use

US12616594B2US 12616594 B2US12616594 B2US 12616594B2US-12616594-B2

Abstract

A bypass device may include an elongate member extending from a proximal end toward a distal end, and a proximal opening and a distal opening coupled to one another by a lumen disposed through the elongate member. The bypass device also may include at least one port extending through a side surface of the elongate tubular member, wherein at least a portion of the bypass device may be bioabsorbable.

Inventors

John Allen Hingston
Niklas Andersson
Moises Rivera-Bermudez
John B. Golden
Andrew Calabrese
Leah McElhaney

Assignees

BOSTON SCIENTIFIC SCIMED, INC.

Dates

Publication Date: 20260505
Application Date: 20210831

Claims (13)

1 . A stent, comprising: a tubular frame having a proximal end opposite a distal end, wherein a lumen extends between the proximal and distal ends, the tubular frame comprising: a flared section at the proximal end, wherein the flared section includes a sloped portion; a plurality of anchoring features extending radially outward from an outer surface of the proximal end, wherein the plurality of anchoring features are located adjacent to the sloped portion of the flared section, wherein each of the plurality of anchoring features are both longitudinally and radially staggered from adjacent anchoring features; an intermediate section extending from the flared section and positioned between the proximal and distal ends, wherein a diameter of the flared section is greater than a diameter of the intermediate section, wherein the intermediate section includes a plurality of ports extending through the intermediate section, and wherein the intermediate section includes a plurality of radiopaque markers corresponding to a position of each of the plurality of ports; and a coating extending partially along a surface of the tubular frame, and configured to inhibit tissue in-growth into the stent, wherein the coating is spaced apart from the plurality of anchoring features of the flared section to promote tissue ingrowth at the flared section.
2 . The stent of claim 1 , wherein the coating is spaced apart from a second plurality of anchoring features to promote tissue ingrowth with the intermediate section.
3 . The stent of claim 2 , wherein the second plurality of anchoring features are provided on the distal end, and wherein the distal end has a diameter greater than the diameter of the intermediate section.
4 . The stent of claim 3 , wherein the coating is spaced from the distal end to promote tissue ingrowth with the distal end.
5 . The stent of claim 1 , wherein the sloped portion extends away from a central longitudinal axis extending through the lumen and the intermediate section.
6 . The stent of claim 1 , wherein the intermediate section has a substantially uniform diameter.
7 . The stent of claim 1 , wherein the tubular frame is formed by a plurality of filaments interwoven with one another to form one or more of the proximal end, the intermediate section, and the distal end.
8 . The stent of claim 1 , wherein the plurality of ports are positioned such that a longitudinal position and a circumferential position of each of the plurality of ports are offset from longitudinal positions and circumferential positions of adjacent ports.
9 . The stent of claim 1 , wherein each of the plurality of radiopaque markers are positioned in longitudinal alignment with at least one of the plurality of ports.
10 . A method, comprising: deploying a system within a gastrointestinal (GI) tract of a patient, the system comprising: a stent comprising: a tubular frame having a first end opposite a second end, wherein a lumen extends between the first and second ends, and wherein the tubular frame comprises: a flared section at one of the first or second ends; an intermediate section extending from the flared section, wherein a diameter of the flared section is greater than a diameter of the intermediate section; a plurality of ports extending through the intermediate section, each of the plurality of ports having a radiopaque marker corresponding to a position of each respective port; and a coating extending partially along a surface of the tubular frame, wherein the coating is configured to inhibit tissue in-growth into the stent and spaced from an anchoring feature on the flared section, and wherein the anchoring feature is exposed to the GI tract to promote attachment to tissue along the GI tract; and positioning the flared section along one side of a GI tract target site, positioning the intermediate section directly adjacent the GI tract target site, and introducing fluid or therapeutic material through the ports during treatment.
11 . The method of claim 10 , further comprising determining a location of the GI tract target site, wherein the GI tract target site corresponds to a leak of the GI tract.
12 . The method of claim 10 , further comprising bypassing a portion of the GI tract using the intermediate section; and positioning the second end at a location distal to the GI tract target site.
13 . The method of claim 12 , further comprising securing the second end within the GI tract, such that fluid received at the first end is allowed to travel to the second end through the intermediate section.

Description

CROSS-REFERENCE TO RELATED APPLICATION(S) This patent application is a continuation of U.S. patent application Ser. No. 15/611,925, filed on Jun. 2, 2017, which claims the benefit under 35 U.S.C. § 119 to U.S. Provisional Patent Application No. 62/345,254, filed on Jun. 3, 2016, the entireties of which are incorporated herein by reference. TECHNICAL FIELD Examples of the present disclosure relate to gastrointestinal bypass devices and related methods of use. BACKGROUND Obesity is a medical condition in which excess body fat has accumulated to the extent that it may have an adverse effect on health, leading to reduced life expectancy and/or increased health problems. Body mass index (BMI), a measurement which compares weight and height, defines people as overweight (pre-obese) when their BMI is between 25 kg/m2 and 30 kg/m2, and obese when it is greater than 30 kg/m2. Obesity is most commonly caused by a combination of excessive dietary calories, lack of physical activity, and genetic susceptibility. On average, obesity may reduce life expectancy by six to seven years. Obesity also increases the likelihood of various diseases, particularly heart disease, type 2 diabetes, breathing difficulties during sleep, certain types of cancer, and osteoarthritis. Obesity is a leading preventable cause of death worldwide, with increasing prevalence in adults and children. Bariatric (or weight loss) surgeries are surgical treatments for treating severe obesity, and may involve removal of a portion of the stomach or a reduction in the size of the stomach (e.g., in a sleeve gastrectomy). These procedures can be effective but also have associated risks. After such procedures, patients may be at risk for developing a post-surgical leak. On their own, leaks can complicate recovery, but they are more severe for patients who have compromised immune systems or multiple co-morbidities. Leaks can even cause sepsis and death. Furthermore, leaks are costly to treat, and some patients cannot safely withstand another surgery. Esophageal stents have been used to treat leaks after sleeve gastrectomy. Esophageal stents, however, are prone to migration because their shapes are not adapted to the modified stomach geometry after sleeve gastrectomy. Two esophageal stents are often employed because existing stents are too short for a successful treatment. Thus, a need exists for a minimally-invasive, endoscopic approach for reducing risks associated with post-surgical leaks. SUMMARY In one aspect, the present disclosure is directed to a bypass device, which may include an elongate member extending from a proximal end toward a distal end, and a proximal opening and a distal opening coupled to one another by a lumen disposed through the elongate member. The bypass device also may include at least one port extending through a side surface of the elongate tubular member, wherein at least a portion of the bypass device may be bioabsorbable. The elongate member may be a stent defining proximalmost and distalmost portions of the bypass device. The bypass device may include a coating disposed over an outer surface of the stent, wherein the coating may be impermeable to liquid. The coating may include a bioadhesive. An outer surface of the elongate member may include one or more anchoring features configured to pierce or grab tissue. The one or more anchoring features may be bioabsorbable. The elongate member may be biologically-stable. An entirety of the bypass device may be bioabsorbable. The proximal end and the distal end of the elongate member each may have a larger cross-sectional dimension than an intermediate portion of the elongate member. In another aspect, the present disclosure is directed to a bypass device, which may include a proximal anchor having an opening, a distal anchor having an opening, and a membrane sleeve disposed between the proximal anchor and the distal anchor, wherein the opening of the proximal anchor and the opening of the distal anchor may be fluidly coupled to one another via the membrane sleeve, wherein at least one of the proximal anchor, the distal anchor, and the membrane sleeve may be bioabsorbable. Each of the proximal anchor, the distal anchor, and the membrane sleeve may be bioabsorbable. The membrane sleeve may be bioabsorbable, and the proximal anchor and the distal anchor may be biologically-stable. A interior of the proximal anchor and the distal anchor each may include a material configured to inhibit tissue in-growth. The proximal anchor and the distal anchor may be self-expanding, and each may be configured to exert a radially outward force when compressed. One or more of the proximal anchor and the distal anchor may include one or more anchoring features on a respective outer surface, wherein the one or more anchoring features may configured to pierce or grab tissue. In yet another aspect, the present disclosure is directed to a method of treating a surgically-modified stomach of a patient. The method m