Endoscopic vacuum therapy system and method

Abstract

A medical system and method for applying negative pressure within a lumen is provided. The medical system includes one or more inflatable bodies having a delivery state configured for delivery into the lumen and an inflated state. The inflatable bodies are connected to an inflation fluid supply channel, thereby transitioning the inflatable bodies from the delivery state to the inflated state. The inflatable bodies are connected to a negative pressure supply channel, and negative pressure is supplied to the interior of the lumen outside the inflatable bodies. In one embodiment, the inflatable bodies are elongated, and negative pressure is applied along the longitudinal axis of the inflatable bodies. In another embodiment, multiple inflatable bodies extend from a longitudinal shaft, and negative pressure is applied through openings in the shaft in a direction radial to the longitudinal axis of the shaft.

Description

[Technical Field]

[0001] Related Applications This application claims the benefit of U.S. Provisional Application No. 63 / 433,031, filed December 16, 2022, which is incorporated herein by reference in its entirety. This application also claims the benefit of U.S. Provisional Application No. 63 / 433,032, filed December 16, 2022, which is incorporated herein by reference in its entirety. [Background technology]

[0002] Gastrointestinal wounds, such as perforations and postoperative leaks, are common in endoscopic and open surgery. These wounds are particularly challenging to treat due to their intraluminal location and the naturally moist surrounding wound area, which favors bacterial growth. Treatment options for these wounds are limited, resulting in high morbidity and mortality and prolonged hospital stays.

[0003] Vacuum wound closure (VAC) therapy can improve the rate of wound closure. Negative pressure wound therapy (NPWT), or VAC therapy, is a treatment that applies subatmospheric pressure to acute or chronic wounds to promote wound healing. Theoretically, applying negative pressure to the wound site removes bacteria, exudate, fluids, and debris from the wound site, promotes blood flow, and promotes local cell migration and proliferation, thereby increasing the rate of healing.

[0004] Therefore, there is a need for improved techniques and devices to aid in the healing of gastrointestinal wounds by removing fluid from around the wound. Summary of the Invention

[0005] Various applications herein relate to medical systems and methods for removing liquid from a target area within the digestive tract, as well as medical systems and methods for introducing fluid to a target area, for example, as a prophylactic treatment to prevent infection or to aid in the healing of intraluminal wounds in the target area.

[0006] Disclosed herein is a medical system for applying negative pressure within the gastrointestinal tract of a subject. In a first embodiment, the system includes: (i) a longitudinal shaft disposed along a longitudinal axis, (a) a longitudinally extending negative pressure supply channel; (b) a plurality of negative pressure supply ports longitudinally disposed along the longitudinal shaft and in fluid communication with the negative pressure supply channel; A longitudinal shaft having (ii) at least three expandable sections, periodically arranged along the shaft and extending outward from the shaft, with a gap between each pair of adjacent expandable sections, each expandable section comprising: a delivery actuation state in which the plurality of expandable portions have a first dimension, or first diameter, perpendicular to the longitudinal direction of the shaft; an expanded actuated state in which the plurality of expandable portions have a second dimension or diameter about the longitudinal axis, the second dimension or diameter being greater than the first dimension or diameter; The longitudinally extending negative pressure supply channel is connected to a negative pressure source and is configured to supply negative pressure along the longitudinally extending negative pressure supply channel and through the plurality of negative pressure supply ports to gaps between the expandable portions in a radial direction relative to the longitudinal axis.

[0007] In a second embodiment, a medical system includes: (i) a medical device; (i) a sleeve extending along a longitudinal axis, (a) a plurality of tubular sections having a first diameter about the longitudinal axis of the sleeve, each of the plurality of tubular sections including at least one sleeve opening; (b) a plurality of expandable portions including at least three expandable portions, each pair of adjacent expandable portions being separated by one of the plurality of tubular portions, each of the plurality of expandable portions being: a delivery operating state; an expanded operating state, wherein the plurality of expandable sections have a second diameter about the longitudinal axis of the sleeve, the second diameter being greater than the first diameter, thereby forming gaps between the expandable sections along the longitudinal axis of the sleeve; and and an expandable portion having a sleeve. (ii) a longitudinal shaft disposed within the sleeve, (a) a longitudinally extending negative pressure supply channel; (b) a plurality of negative pressure supply ports longitudinally disposed along the longitudinal shaft, the plurality of negative pressure supply ports in fluid communication with the negative pressure supply channel and aligned with the sleeve ports; The longitudinal shaft, wherein the longitudinally extending negative pressure supply channel is connected to a negative pressure source and is configured to supply negative pressure along the longitudinally extending negative pressure supply channel, via the plurality of negative pressure supply ports and the sleeve port, to the gap between the expandable portions in a radial direction relative to the longitudinal axis of the sleeve.

[0008] In another embodiment, the medical system includes: (i) a medical device; (i) a sleeve extending along a longitudinal axis, (a) a plurality of tubular sections having a first diameter about the longitudinal axis of the sleeve, each of the plurality of tubular sections including at least one sleeve opening; (b) a plurality of inflatable sections including at least three expandable sections, each adjacent pair of the plurality of inflatable sections being separated by one of the plurality of tubular sections, each of the plurality of inflatable sections comprising: a delivery operating state; a plurality of expandable sections in an inflated operating state when inflated with an inflation fluid, wherein in the inflated operating state, the plurality of expandable sections have second diameters about the longitudinal axis of the sleeve, the second diameter being greater than the first diameter, thereby forming gaps between the expandable sections along the longitudinal axis of the sleeve; Including sleeve. (ii) a longitudinal shaft disposed within the sleeve along the longitudinal axis, (a) at least one longitudinally extending inflation fluid supply channel; (b) a longitudinally extending negative pressure supply channel; (c) a plurality of inflation fluid supply ports longitudinally disposed along the longitudinal shaft, each of the inflation fluid supply ports in fluid communication with one of the at least one longitudinally extending inflation fluid supply channel and one of the plurality of inflatable portions; (d) a plurality of negative pressure supply ports longitudinally disposed along the longitudinal shaft, the plurality of negative pressure supply ports in fluid communication with the negative pressure supply channel and aligned with the sleeve ports; the at least one longitudinally extending inflation fluid supply channel is connected to a supply of inflation fluid and is configured to supply the inflation fluid to the plurality of inflatable portions through the plurality of inflation fluid supply ports; the longitudinally extending negative pressure supply channel is connected to a negative pressure source and configured to supply negative pressure along the negative pressure supply channel and through the plurality of negative pressure supply ports and the sleeve port to the gap between the inflatable portions in a radial direction relative to the longitudinal axis; and a longitudinal shaft.

[0009] In another embodiment, disclosed herein is a method of applying negative pressure within the gastrointestinal tract of a subject. In some embodiments, the method includes: (a) advancing a longitudinal shaft in a delivery actuation state having at least three expandable sections disposed thereabout, the expandable sections separated by gaps along the longitudinal shaft, to a target site; (b) transitioning the expandable or inflatable portion from a delivery operating state to an expansion operating state; (c) supplying negative pressure from a negative pressure source connected to the longitudinal shaft to the gap between the expandable portions via a negative pressure supply channel in the shaft and a negative pressure supply port in the shaft that is in fluid communication with the gap between the expandable portions and the negative pressure supply channel.

[0010] Disclosed herein is a medical system for applying negative pressure within the gastrointestinal tract of a subject. In another embodiment, the system includes: i. An inflation fluid supply channel having a distal end. ii. a longitudinal inflation body disposed at a distal end of the inflation fluid supply channel, the longitudinal inflation body having a delivery actuation state and an inflation actuation state; a. a tissue engaging portion having a plurality of longitudinally disposed lobes and a plurality of recesses disposed between said lobes when the longitudinal expansion body is in an expanded operating state; b. A longitudinal expansion body having a bridge portion disposed between the inflation fluid supply channel and the tissue engagement portion, wherein, in an inflation operating state, a plurality of inlet recesses extend along the outer surface of the bridge portion from the distal end of the inflation fluid supply channel to the proximal end of each of the plurality of recesses.

[0011] In another embodiment, the system includes: i. An inflation fluid supply channel having a distal end. ii. a longitudinal inflation body disposed at a distal end of the inflation fluid supply channel, the longitudinal inflation body having a delivery actuation state and an inflation actuation state; a tissue engaging portion having a plurality of longitudinally disposed lobes and a plurality of longitudinally disposed recesses when the longitudinal expansion body is in an expanded activated state; b. a bridge portion disposed between the inflation fluid supply channel and the tissue engaging portion, wherein, in an inflation actuation state, a plurality of inlet recesses extend along an outer surface of the bridge portion from a distal end of the inflation fluid supply channel to a proximal end of each of the plurality of recesses; A longitudinal expansion body comprising: iii. A fluid-tight lumen including at least one channel, the fluid-tight lumen being connected to a negative pressure source and configured to supply negative pressure along the at least one channel to a proximal end of the longitudinal expansion body and to apply negative pressure along the longitudinally disposed recesses via the inlet recesses.

[0012] In another embodiment, the medical system includes the following i and ii: i. a longitudinal body having a delivery operating state and an expansion operating state, wherein in the expansion operating state: a. a plurality of longitudinally disposed lobes, each of the plurality of longitudinally disposed lobes configured to be connected to at least one inflation fluid source via an inflation fluid supply channel; b. a plurality of longitudinally disposed recesses, each pair of adjacent longitudinally disposed lobes being separated by one of the plurality of longitudinally disposed recesses; A longitudinal body including: ii. A fluid-tight lumen including at least one channel, the fluid-tight lumen being connected to a negative pressure source and configured to supply negative pressure along the at least one channel to the proximal end of the longitudinal body and to apply negative pressure along the longitudinally disposed recess.

[0013] In another embodiment, the medical system comprises: a longitudinal expansion body having a delivery operating state and an expansion operating state; an inflation fluid supply channel terminating in and in fluid communication with the longitudinal expansion body, the longitudinal expansion body being located at a distal end of the inflation fluid supply channel, the inflation fluid supply channel being configured to supply inflation fluid to the expansion body; In the expansion operating state, the longitudinal expansion body a plurality of longitudinally arranged lobes; a plurality of longitudinally arranged recesses; each pair of adjacent longitudinally disposed lobes is separated by one of a plurality of longitudinally disposed recesses; and The fluid-tight lumen, including at least one negative pressure supply channel, is connected to a negative pressure source and is configured to supply negative pressure to the proximal end of the inflatable body and apply negative pressure along the longitudinally disposed recess.

[0014] In another embodiment, there is provided a method of applying negative pressure to a target site in the gastrointestinal tract of a subject, comprising: (a) Advancing an inflation body (the inflation body is in a delivery activated state and connected to an inflation fluid supply channel) to a target site. (b) transitioning the inflatable body from the delivery operating state to the expansion operating state by supplying inflation fluid to the inflatable body through the inflation fluid supply channel, wherein in the expansion operating state the inflatable body includes a plurality of longitudinally disposed lobes and a plurality of longitudinally disposed recesses, each pair of adjacent longitudinally disposed lobes being separated by one of the longitudinally disposed recesses. (c) advancing the fluid-tight lumen to the target site, whereby a distal end of the fluid-tight lumen is adjacent to a proximal end of the expansion body and at least one channel of the fluid-tight lumen is in fluid communication with each of the plurality of recesses. (d) providing negative pressure from a negative pressure source connected to the at least one channel, through the at least one channel, to the proximal end of the inflatable body and along the longitudinally disposed recess. [Brief explanation of the drawings]

[0015] The above discussion will be more readily understood with reference to the accompanying drawings and the following detailed description. [Figure 1] 1A and 1B are perspective and side views, respectively, of a sleeve that constitutes a part of a medical system according to an embodiment of the disclosed technology. [Figure 2] FIG. 2 is a perspective view of a sleeve similar to FIGS. 1A and 1B, suitable for use in a lumen having an injury in its wall, and forming part of a medical system according to an embodiment of the disclosed technology. [Figure 3]3A and 3B are perspective and end views, respectively, of a sleeve that forms part of a medical system according to an embodiment of the disclosed technology. [Figure 4] 4A and 4B are perspective and end views, respectively, of another sleeve that may be part of a medical system in accordance with an embodiment of the disclosed technology. [Figure 5] 5A, 5B, and 5C are two perspective views and an end view, respectively, of a sleeve that forms part of a medical system according to an embodiment of the disclosed technology. [Figure 6] FIG. 6 shows perspective and end views of a sleeve that constitutes part of a medical system according to an embodiment of the disclosed technology. [Figure 7] 7A and 7B are end views of another sleeve forming part of a medical system in a pleated and delivery actuation state, respectively, in accordance with an embodiment of the disclosed technology. [Figure 8] FIG. 8 is a cross-sectional perspective view of a longitudinal shaft forming part of a medical system according to an embodiment of the disclosed technology. [Figure 9A-D] 9A, 9B, 9C, and 9D are a perspective view, an end view, and two cross-sectional views, respectively, of a medical system (including the sleeve of FIGS. 1A and 1B) according to an embodiment of the disclosed technology. [Figure 10] 10A and 10B are cross-sectional and end views, respectively, of a medical system including a sleeve in an actuated delivery state in accordance with an embodiment of the disclosed technology. [Figure 11] 11A and 11B are cross-sectional and end views, respectively, of the medical system shown in FIGS. 10A and 10B, with the sleeve in an expanded, actuated state. [Figure 12] 12A and 12B are end and side views, respectively, of a medical system according to a further embodiment of the disclosed technology. [Figure 13] FIG. 13 is a flowchart diagram of a method for treating the digestive tract of a subject using a medical system according to an embodiment of the disclosed technology. [Figure 14] FIG. 14 is a perspective view of an inflatable body according to an embodiment of the disclosed technique. [Figure 15A-B] 15A and 15B are schematic side and front views, respectively, of an inflation fluid supply channel connected to the inflatable body shown in FIG. 14 according to an embodiment of the disclosed technology. [Figure 16] FIG. 16 is a perspective view of an inflatable body according to an embodiment of the disclosed technique. [Figure 17] 17A and 17B are schematic side and front views, respectively, of an inflation fluid supply channel connected to the inflation body shown in FIG. 16, in accordance with an embodiment of the disclosed technology. [Figure 18] FIG. 18 is a perspective cross-sectional view of the inflatable body shown in FIGS. 16-17B taken along section line XVIII-XVIII in FIG. 17A. [Figure 19A-C] 19A, 19B, and 19C are schematic side, front, and partial cutaway views, respectively, of a medical system according to an embodiment of the disclosed technology, including the inflation fluid supply channel and inflation body shown in FIGS. 17 and 17B. [Figure 20] FIG. 20 is a flowchart of a method for treating the digestive tract of a subject using a medical system according to an embodiment of the disclosed technology. [Figure 21] 21A, 21B, and 21C are schematic diagrams of a mechanism for deploying a portion of a medical system within a subject's body according to an embodiment of the disclosed technology. [Figure 22] 22A and 22B are schematic illustrations of a procedure for deploying a medical system according to an embodiment of the disclosed technology within a subject's body. [Figures 23A-E] 23A, 23B, 23C, 23D, and 23E are schematic diagrams illustrating steps in a procedure for maintaining a medical system according to an embodiment of the disclosed technology within a subject's body via a nose wire or tube. Detailed Description of the Invention

[0016] The principles of the present medical system and method may be better understood with reference to the drawings and the following description.

[0017] In the following description, various aspects of the present disclosure are described. For convenience of explanation, specific configurations and details are set forth to provide a thorough understanding of various aspects of the present disclosure. However, it will be apparent to those skilled in the art that the present disclosure can be practiced without the specific details. Furthermore, well-known features may be omitted or simplified so as not to obscure the present disclosure. In addition, to avoid over-cluttering a particular drawing with too many reference numbers or leads, some elements may not be explicitly identified in all drawings in which they appear.

[0018] It is to be understood that the scope of the invention is not limited to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Moreover, it is to be understood that the phraseology and terminology employed in this disclosure are for the purpose of description and should not be construed as limiting.

[0019] For the purposes of this application, the term "subject" relates to any mammal, particularly humans.

[0020] In the context of this specification and claims, the terms "proximal" and "distal" are defined relative to the direction in which the system is deployed within the subject's body. Thus, an element is said to be "proximal" if it is closer than other elements to the point at which the system enters the subject's body, and "distal" if it is farther than other elements from the point at which the system enters the subject's body.

[0021] In the context of this specification and claims, the term "wound" relates to any form of damage to tissue, including, but not limited to, leakage, perforation, rupture, laceration, cut, fistula, etc. of tissue (e.g., the wall of the digestive tract).

[0022] In the context of this specification and claims, the term "negative pressure" refers to a pressure below atmospheric pressure, which may be applied, for example, to help reduce inflammatory exudate and promote the formation of granulation tissue.

[0023] In the context of this specification and claims, the terms "expanded state" and "inflated state" of an element include any state of expansion or inflation relative to the longitudinal axis of the element relative to the delivery state, and thus include a fully expanded or inflated state as well as a partially expanded or inflated state.

[0024] Referring now to the drawings, Figures 1A and 1B are perspective and side views, respectively, of a sleeve 100 that forms part of a medical system in accordance with an embodiment of the disclosed technology. Sleeves are typically biocompatible or biodegradable and can be made from compliant, semi-compliant, or non-compliant materials.

[0025] As shown, the sleeve 100 extends along a longitudinal axis 102 and includes a plurality of tubular portions 104. Each tubular portion 104 has a first diameter D1 in a direction perpendicular to the longitudinal axis 102. Each tubular portion 104 includes at least one sleeve opening 106.

[0026] In some embodiments, the length of sleeve 100 ranges from 6 mm to 200 mm. In some embodiments, the length of sleeve 100 is at least 10 mm.

[0027] In some embodiments, first diameter D1 is in the range of 1.5 to 10 mm. In some embodiments, the length of each tubular portion 104, designated L1, is in the range of 2 to 40 mm, 2 to 20 mm, 2 to 15 mm, or 0.5 to 40 mm. In some embodiments, the diameter or longest dimension of each sleeve opening 106 is in the range of 0.5 to 5 mm, or 0.5 to 10 mm.

[0028] The sleeve 100 further includes a plurality of expandable portions 108, e.g., at least three, at least four, or at least five expandable portions. Each pair of adjacent expandable portions 108 is separated by the tubular portion 104. Each expandable portion 108 has a delivery operating state in which it is normally contracted and pleated or compressed, and an expansion operating state. In the expansion operating state, the expandable portions 108 have a second diameter D2 that is larger than the diameter D1 of the tubular portion 104, thereby forming gaps 110 between the expandable portions 108 along the longitudinal axis 102.

[0029] The inflated state is achieved by passing inflation fluid through the inflation fluid supply channel via the plurality of inflation fluid supply ports. The expanded state can be achieved by unfolding, unwinding, unwinding, or unrolling the expandable portion in the delivery state.

[0030] In some embodiments, the outer diameter of the expandable portion 108 in the delivery state is in the range of 2 mm to 8 mm, 2 mm to 7 mm, 2 mm to 6 mm, 2 mm to 5 mm, 2 mm to 4 mm, 2 mm to 3.5 mm, 3.0 mm to 8 mm, 3 mm to 7 mm, 3 mm to 6 mm, 3 mm to 5 mm, 3 mm to 4 mm, or 3 mm to 3.5 mm.

[0031] In some embodiments, the outer diameter D2 of the expandable portion 108 in the expanded state is in the range of 7 mm to 30 mm, 10 mm to 30 mm, 10 mm to 25 mm, 10 mm to 22 mm, 10 mm to 20 mm, 10 mm to 20 mm, 7 mm to 20 mm, or 5 mm to 20 mm.

[0032] In some embodiments, the diameter D2 is equal to the diameter D2 of all of the expandable portions 108. However, in some embodiments, the diameter D2 of the most proximal expandable portion 108a is equal to the diameter D2 of the most proximal expandable portion 108a. p and the diameter D2 of the most distal inflatable portion 108b d In the expanded state, diameter D1 of expandable portion 108a is greater than diameter D2 of the other expandable portion disposed between expandable portions 108a and 108b. In use, as described below, this difference in diameter allows the sleeve to fit snugly against a target site within the gastrointestinal tract.

[0033] In some embodiments, the diameter D2 of the most proximal expandable portion 108a p and the diameter D2 of the most distal inflatable portion 108b d is smaller than the diameter D2 of the other expandable portion disposed between expandable portions 108a and 108b in the expanded state.

[0034] In some embodiments, sleeve 100 has at least two inflatable sections 108. However, in other embodiments, sleeve 100 may have three inflatable sections as shown, or may have more than three inflatable sections, such as four, five, or more inflatable sections.

[0035] In the embodiment shown in Figures 1A and 1B, the expandable portion 108 is ring-shaped and has a circular or annular cross-section. However, in other embodiments, the expandable portion 108 may be substantially spherical with a tubular center. Reference is now made to Figure 2, which is a perspective view of a sleeve 100' similar to the sleeve 100 of Figures 1A and 1B. The sleeve 100' is suitable for use in a lumen having an injury in its wall and forms part of a medical system in accordance with an embodiment of the disclosed technology.

[0036] As shown in FIG. 2, the sleeve 100′ includes a first group 112a of inflatable portions 108 and a second group 112b of inflatable portions 108, which are similar to those described above with respect to FIGS. 1A and 1B. The inflatable portions 108 within each group are separated by a tubular portion 104, which is substantially similar to that described above with respect to FIGS. 1A and 1B, and which includes a sleeve opening 106. The two groups 112a and 112b are separated by a tubular portion 114, which is generally longer than the tubular portion 104 and may be curved as shown in FIG. 2. In some embodiments, the tubular portion 114 may not include a sleeve opening, as shown. In other embodiments, the tubular portion 114 may include a sleeve opening similar to the sleeve opening 106 described above.

[0037] Sleeve 100' is particularly useful for draining or treating wounds in the wall of a digestive lumen, such as the wall of the esophagus. For example, the sleeve may be positioned so that the inflatable portions of second group 112b are anchored within the wound (i.e., the wall of the esophagus) to provide drainage, while the inflatable portions of first group 112a are anchored within the esophageal lumen to apply negative pressure within and adjacent to the wound.

[0038] Reference is now made to Figures 3A and 3B, which are perspective and end views, respectively, of a sleeve 120 that forms part of a medical system in accordance with an embodiment of the disclosed technology. Reference is also made to Figures 4A and 4B, which are perspective and end views, respectively, of another sleeve 120' that forms part of a medical system in accordance with an embodiment of the disclosed technology.

[0039] Sleeves 120 and 120' are substantially similar to sleeve 100, with the dimensions of tubular portion 104 and sleeve opening 106 being similar to those described above with respect to Figures 1A and 1B. Sleeves 120 and 120' differ from sleeve 100 in the shape of their respective inflatable portions 128 and 128'.

[0040] 3A-4B, expandable portions 128 and 128' are substantially spherical structures each having a plurality of longitudinally disposed rounded projections (hereinafter referred to as lobes) 140. Each pair of adjacent lobes 140 is separated by a longitudinally disposed recess 142. Thus, each of expandable portions 128 and 128' includes an equal number of lobes 140 and recesses 142.

[0041] In some embodiments, for example, because the expandable portions 128 and 128' are substantially spherical in structure, the recess 142 extends along most of the longitudinal length of the sleeve.

[0042] In some embodiments, inflatable portions 128 and 128' each include at least three, at least four, at least five, or at least six lobes 140. In some embodiments, lobes 140 are generally evenly spaced and circumferentially disposed around the inflatable portion, as shown in Figures 3B and 4B.

[0043] In the sleeve 120, the lobes 140 of all of the inflatable sections 128 are aligned with one another, and as a result, the recesses 142 are also aligned with one another, as best seen in FIG. 3B.

[0044] In contrast, in sleeve 120', inflatable portions 128' are rotationally offset from one another by half the angular distance between the two lobes, which in the illustrated embodiment is approximately 30 degrees. As best seen in FIG. 4B, lobe 140a of one inflatable portion 128a' is aligned with recess 142b of the other inflatable portion 128b'. Similarly, recess 142a of inflatable portion 128a' is aligned with lobe 140b of inflatable portion 128b'.

[0045] In some embodiments, as shown in FIG. 4A, the rotational offset arrangement of inflatable portions 128′ may alternate, such that inflatable portion 128c′ may be rotationally aligned with inflatable portion 128a′, and if there is an additional inflatable portion, it may be rotationally aligned with inflatable portion 128b′.

[0046] In other embodiments (not shown), each inflatable portion 128' may have a different rotational offset relative to the most distal inflatable portion (eg, inflatable portion 128a').

[0047] As mentioned above, due to the rotational offset between inflatable sections 128', recesses 142 are not aligned with one another. This has the advantage that when the sleeve is placed within a body cavity and negative pressure is applied through sleeve ports 106, as described below, the lumen wall will not collapse into the recesses along the entire longitudinal length of the sleeve. Rather, recesses 142 will only collapse the lumen wall where they are not aligned, resulting in a "vacuum zone" that allows for more effective application of negative pressure adjacent to the sleeve.

[0048] The track is spiral, preventing collapse along the entire length when vacuuming.

[0049] Reference is further made to Figures 5A, 5B, and 5C, which are two perspective views and an end view, respectively, of a sleeve 130 that forms part of a medical system in accordance with an embodiment of the disclosed technology.

[0050] Sleeve 130 is substantially similar to sleeve 120, except for the shape of each expandable portion 138. Expandable portion 138 includes lobes 140 and recesses 142 similar to expandable portion 128. However, expandable portion 138 has a longitudinal width narrower than its diameter in a direction perpendicular to longitudinal axis 102 than expandable portion 128, giving it a gear-like shape. In other words, if the recesses 142 were to be "filled," expandable portion 138 would be substantially ring-shaped. In sleeve 130, expandable portion 138 is narrower and more annular than sleeve 120, and therefore recesses 142 extend along a shorter portion of the sleeve's longitudinal length than sleeve 120.

[0051] 5A-5C, sleeve 130 has recesses 142 that are rotationally aligned with one another, similar to sleeve 120. However, it will be appreciated that sleeve 130, similar to sleeve 120', may have recesses 142 in expandable portion 138 that are rotationally offset from one another, as substantially shown in FIGS. 4A and 4B.

[0052] While the following description of FIG. 5C and the structure and dimensions of lobes 140 and recesses 142 will be limited to the inflatable portion 138, it will be understood that the following description applies equally to inflatable portion 128 of FIGS. 3A and 3B and inflatable portion 128' of FIGS. 4A and 4B.

[0053] In some embodiments, in the expanded, actuated state of the inflatable portion 138, the height difference between one or each lobe 140 and an adjacent recess 142, indicated as H1 in FIG. 5C , is at least 0.5 mm. In some embodiments, H1 is in the range of 1 to 7 mm, 1 to 5 mm, 1 to 4 mm, or 1 to 3 mm. For clarity, it should be understood that the height difference H1 is measured from the point on the lobe 140 that is radially farthest from the longitudinal axis 102 to the point on the recess 142 that is radially closest to the longitudinal axis 102.

[0054] To discuss the ratio of lobes 140 to recesses 142 when expandable portion 138 is in an inflated, actuated state, imagine a cylinder 146 (shown in FIGS. 5B and 5C) surrounding sleeve 130. This imaginary cylinder is engaged by lobes 140. The imaginary cylinder includes a portion that engages expandable portion 138, designated A in FIG. 5C, and a portion that is spaced apart from the expandable portion, designated B.

[0055] In some embodiments, the ratio of arc A to arc B in a cross-sectional or end view (see FIG. 5C) of the expandable portion 138 taken in the region of the expandable portion having the maximum diameter D2 (see FIG. 1B) is at least 5:1, at least 4:1, at least 3:1, at least 2:1, at least 1:1, at least 1:2, at least 1:3, at least 1:4, at least 1:5, at least 1:7, at least 1:10, at least 1:15, at least 1:20, or at least 1:30.

[0056] In some embodiments, the portion (A) of the inner wall of the imaginary cylinder 146 that engages with the expandable portion 138 is less than 60%, less than 50%, less than 40%, less than 30%, or less than 20% of the circumference or cross-sectional area of ​​the imaginary cylinder 146.

[0057] 5C is positioned at half the height H1. The second imaginary cylinder 148 is an arc or segment A that cuts the lobe 140. 1 / 2 and B, which is an arc or portion cutting the recess 142. 1 / 2 In some embodiments, arc A in a cross-sectional or end view of inflatable portion 138 (shown in FIG. 5C) 1 / 2 and arc B 1 / 2 is at least 5:1, at least 4:1, at least 3:1, at least 2:1, at least 1:1, at least 1:2, at least 1:3, at least 1:4, at least 1:5, at least 1:7, at least 1:10, at least 1:15, at least 1:20, or at least 1:30.

[0058] In some embodiments, at least one lobe 140 may be textured or corrugated. In some embodiments, the lobe 140 may include one or more combinations of lobes and recesses along the length of the lobe 140.

[0059] In some embodiments, when negative pressure is applied to recesses 142 (as described below), the presence of lobe grooves allows negative pressure to be applied from multiple different directions to locations along recesses 142, reducing the likelihood of clogging of recesses 142. Additionally, in use, the texturing of lobes 140 can act as a tissue growth promoting therapy, for example, by gently massaging the target site where the sleeve is placed.

[0060] Reference is now made to Figure 6. Figure 6 is a perspective view of a sleeve 149 that forms part of a medical system in accordance with an embodiment of the disclosed technology.

[0061] As shown, sleeve 149 is substantially similar to sleeves 100 and 130, with the dimensions of tubular portion 104 and sleeve opening 106 being similar to those described above with respect to Figures 1A and 1B, except that sleeve 149 includes two expandable portions 108 having ring-shaped cross sections (see Figures 1A and 1B) and three expandable portions 138 having lobes and recesses and flower-shaped cross sections (see Figures 5A-5C).

[0062] In the illustrated embodiment, the expandable portions 108 are disposed at opposite ends of the sleeve 149, with the expandable portions 138 disposed between the expandable portions 108. In use, when the expandable portions are in an inflated, activated state within a body cavity, the expandable portions 108 seal against the body cavity, thereby forming a sealed area within which the expandable portions 138 can be positioned and a vacuum applied within the lumen. This is advantageous in preventing debris or excess fluid from entering the vicinity of the expandable portions 138 and blocking the opening therein.

[0063] Other arrangements of inflatable portions 108 and 138 are also considered within the scope of the disclosed technology. Similarly, sleeves including inflatable portions 108, 128, and 138 in any order and combination are also considered within the scope of the disclosed technology.

[0064] Reference is now made to Figures 7A and 7B, which are end views of a sleeve forming part of a medical system in accordance with an embodiment of the disclosed technology, in a pleated and delivery actuation state. Figures 7A and 7B are applicable to any of sleeves 100, 120, 120', 130, or 149 described above, but for simplicity, will be described herein using the reference numerals of sleeve 100 of Figures 1A and 1B.

[0065] 7A and 7B illustrate stages in the manufacture of sleeve 100 that result in the sleeve being in an operative delivery state for delivery into a body cavity, as described in more detail below.

[0066] As shown in Figure 7A, in the first stage, pleats are formed in the air-filled balloon-like sleeve. Specifically, each inflatable portion 108 is compressed to form multiple double-layer pleats 109. This can be achieved, for example, by compressing multiple paddles toward the longitudinal axis of the sleeve, causing the inflatable portions 108 to fold along the lines of the paddles, forming the star shape shown in Figure 7A. In the actuated state shown in Figure 7A, the tubular portion 104 remains in its normal state, forming the center of the star shape shown in Figure 7A.

[0067] As shown in Figure 7B, pleats 109 are rotated around tubular portion 104 in the direction of arrow 111 to form a substantially cylindrical configuration suitable for delivery into a body cavity. This configuration represents the delivery activation state of sleeve 100. While any compact configuration of pleats 109 around tubular portion 104 can be used for delivery into a body cavity, it will be appreciated that rotating the pleats as shown in Figure 7B is the most organized and compact mechanism to achieve this goal.

[0068] The pleating and compression shown in Figures 7A and 7B can be performed using balloon pleating equipment known in the art, such as a VC wrapping machine commercially available from Blockwise Engineering LLC of Tempe, Arizona, USA.

[0069] Reference is now made to Figure 8, which is a cross-sectional perspective view of a longitudinal shaft 150 that forms part of a medical system in accordance with an embodiment of the disclosed technology. As will be described in more detail below, shaft 150 is configured to be disposed within sleeve 100, 120, 120', 130, or 149.

[0070] In the context of this specification and claims, a longitudinal shaft disposed along the longitudinal axis may be flexible and configured along the longitudinal axis.

[0071] As shown, longitudinal shaft 150 includes a first channel 152 (also referred to as an inflation fluid supply channel) extending longitudinally. Inflation fluid supply channel 152 is in fluid communication with a first plurality of openings 154 (also referred to as inflation fluid inlets) distributed longitudinally along the longitudinal shaft. Inflation fluid supply channel 152 is configured to connect to a source 156 of inflation fluid 158. In some embodiments, source 156 and / or inflation fluid 158 comprise part of a medical system of the disclosed technology. In some embodiments, inflation fluid 158 includes saline. In some embodiments, inflation fluid 158 includes air. In some embodiments, inflation fluid 158 includes carbon dioxide.

[0072] In some embodiments, the inner diameter of the inflation fluid supply channel 152 is in the range of 0.15mm to 4mm, 0.2mm to 4mm, 0.3mm to 4mm, 0.15mm to 3mm, 0.2mm to 3mm, 0.3mm to 3mm, 0.5mm to 3mm, 0.15mm to 2mm, 0.2mm to 2mm, 0.3mm to 2mm, 0.5mm to 2mm, or 0.5mm to 1.2mm.

[0073] In some embodiments, the diameter (if the openings are generally circular) or longest dimension (if the openings are non-circular, e.g., rectangular or oval) of each opening 154 is in the range of 0.05 mm to 10 mm, 0.05 mm to 7 mm, 0.05 mm to 5 mm, 0.05 mm to 2 mm, 0.1 mm to 5 mm, 0.1 mm to 2 mm, 0.2 mm to 2 mm, 0.3 mm to 2 mm, 0.5 mm to 2 mm, or 0.5 mm to 1.0 mm. In some embodiments, the diameter or longest dimension of openings 154 depends on the particular fluid used as the inflation fluid and its viscosity. For example, more viscous fluids require larger openings.

[0074] In some embodiments, the distance D3 between adjacent pairs of inflation fluid supply ports 154 along the longitudinal shaft 150 should be greater than the length of the tubular portion 104 so that the inflation fluid supply ports are aligned with the inflatable portions 108 when the sleeve 100 is placed around the shaft 150. Thus, for a shaft 150 used with sleeve 120 or 120′ (which has spherical inflatable portions and a greater distance between each tubular portion), the distance D3 may be greater than for a shaft 150 used with sleeve 100, 130, or 149 (which has annular and / or gear-shaped inflatable portions).

[0075] The longitudinal shaft 150 further includes a second longitudinally extending channel 162 (also referred to as a negative pressure supply channel). The negative pressure supply channel 162 is in fluid communication with a second plurality of openings 164 (also referred to as negative pressure supply ports) distributed longitudinally along the longitudinal shaft. The negative pressure supply channel 162 is configured to connect to a negative pressure source 166. In some embodiments, the negative pressure source 166 constitutes part of the medical system of the disclosed technology.

[0076] In some embodiments, the cross-sectional area of ​​the negative pressure supply channel 162 is 1 mm 2 ~85mm 2 The range is.

[0077] In some embodiments, the diameter (e.g., if the opening is circular) or longest dimension (e.g., if the opening is non-circular, such as rectangular or oval) of each opening 164 is in the range of 0.5 mm to 15 mm, 0.5 mm to 12 mm, 0.5 mm to 10 mm, 0.5 mm to 7 mm, 0.5 mm to 5 mm, 0.5 mm to 3 mm, or 1 mm to 2 mm.

[0078] In some embodiments, each opening 164 has substantially the same diameter or longest dimension. In other embodiments, the openings 164 in a first group of openings have a first diameter or longest dimension and the openings 164 in a second group of openings have a second diameter or longest dimension that is different from the first diameter or longest dimension.

[0079] In some embodiments, the cross-sectional area of ​​the openings 164 increases from the proximal end to the distal end along the length of the shaft 150. In some such embodiments, the cross-sectional area of ​​the most distal opening is at least 50% greater than the cross-sectional area of ​​the most proximal opening.

[0080] In the illustrated embodiment, the openings 164 are evenly spaced along the shaft 150. In some embodiments, the distance D4 along the shaft 150 between adjacent openings 164 ranges from 2 mm to 40 mm, 2 mm to 30 mm, 2 mm to 20 mm, 2 mm to 15 mm, or 2 mm to 10 mm. Specifically, the distance D4 should be long enough so that the openings 164 are aligned with the gaps between the inflatable portions 108 and are not blocked by the inflatable portions.

[0081] In other embodiments, the openings 164 may be unevenly spaced along the shaft 150. For example, a first pair of adjacent openings 164 may have a first longitudinal distance therebetween, and a second pair of adjacent openings 164 may have a second longitudinal distance therebetween, where the second longitudinal distance is different from the first longitudinal distance.

[0082] In some embodiments, the distance D4 between adjacent openings 164 is greater than the width of the inflatable portion so that when sleeve 100 is placed around shaft 150, the openings 164, which are negative pressure supply ports, are aligned with the sleeve's tubular portion 104 and the sleeve openings 106 thereon, rather than with the inflatable portion 108. Thus, for shaft 150 used with sleeve 120 or 120′ (which have spherical inflatable portions), distance D4 may be greater than for shaft 150 used with sleeve 100, 130, or 149 (which have annular and / or gear-shaped inflatable portions).

[0083] Reference is now made to Figures 9A, 9B, 9C, and 9D, which are a perspective view, an end view, and two cross-sectional views, respectively, of medical system 200 in accordance with an embodiment of the disclosed technology. The cross-sectional view of Figure 9C is taken along section line IXC-IXC in Figure 9B, and the cross-sectional view of Figure 9D is taken along section line IXD-IXD in Figure 9B. The following describes sleeve 100 of Figures 1A and 1B, but is equally applicable to sleeves 120, 120', 130, and 149.

[0084] As shown, in medical system 200, longitudinal shaft 150 extends longitudinally through sleeve 100. Negative pressure supply port 164 is aligned such that gap 110 is in fluid communication with negative pressure supply channel 162. For example, as best seen in FIG. 9D , negative pressure supply port 164 may be aligned with sleeve port 106, in which case gap 110 is in fluid communication with negative pressure supply channel 162 via negative pressure supply port 164 and sleeve port 106.

[0085] Additionally, the inflation fluid supply port 154 is longitudinally aligned with the inflatable portion 108, thereby placing the inflatable portion 108 in fluid communication with the inflation fluid supply channel 152 via the inflation fluid supply port 154, as shown clearly in FIG. 9C.

[0086] In use, the inflatable portion 108 can be transitioned from a delivery state (illustrated in FIG. 7B) to an inflated state (illustrated in FIG. 1B) by introducing inflation fluid 158 from a source 156 (FIG. 8) into the inflatable portion via inflation fluid supply channel 152 and inflation fluid supply port 154.

[0087] Additionally, negative pressure is applied to gap 110 from negative pressure source 166 via negative pressure supply channel 162, negative pressure supply inlet 164, and sleeve inlet 106. This applies negative pressure to the gap in a direction radial to longitudinal axis 102 (FIG. 1A) of sleeve 100. In some embodiments, negative pressure source 166 is configured to apply a negative pressure in the range of 50-350 mmHg. In some embodiments, inflatable portion 108 maintains its shape when negative pressure is applied, even if the inflatable portion has a complex shape, such as inflatable portions 128, 128', and 138.

[0088] A feature of the disclosed technology is that the shaft 150 and sleeve 100 are tightly joined to one another, for example, by soldering. This is important to prevent the negative pressure supply channel 162 from being in fluid communication with the inflation fluid supply channel 152, preventing the inflation fluid from escaping through the negative pressure supply channel. It is also important that the inflatable portion 108 is sealed against the negative pressure supply channel 162 and the gap 110.

[0089] A feature of the present technology is that the inflatable portions 108 are fluid-tight except in fluid communication with the inflation fluid supply channels 152. In some embodiments, the sleeve 100 may be sealed to the shaft 150 at its proximal and distal ends and around the sleeve ports 106, such that the entire inflatable portion is fluid-tight except in fluid communication with the channels 152. In some embodiments, each inflatable portion 108 may be sealed on both sides of the shaft 150. In some embodiments, each inflatable portion 108 is tightly bonded around a corresponding inflation fluid port 154.

[0090] It will be appreciated that in some embodiments, sleeve 100 may be replaced with a plurality of individual inflatable sections 108, each individually sealed to shaft 150. Individual inflatable sections 108 are separated along shaft 150 by gaps 110, with vacuum supply ports 164 in direct fluid communication with the gaps. In such an embodiment, sleeve circumference 104 and sleeve ports 106 are not required.

[0091] In some embodiments, the negative pressure supply channel 162 may be connected to a fluid source, such as a flushing fluid or a chemical fluid (not shown). This may occur, for example, when the negative pressure supply channel 162 is not connected to a negative pressure source 166. When the negative pressure supply channel 162 is connected to a fluid source, fluid is supplied to the gap 110, similar to when negative pressure is applied.

[0092] In some embodiments, the fluid may be a flushing fluid. In some embodiments, the fluid may be a medicinal fluid, such as an antibacterial fluid or a tissue growth promoting fluid. In some embodiments, the fluid may be a contrast fluid. In some embodiments, the fluid may be an ionized gas. In some embodiments, the fluid may be carbon dioxide.

[0093] As described in further detail below, the longitudinal shaft 150 and the sleeve 100 disposed thereon are delivered to and used within the gastrointestinal tract of a subject. Various methods for delivering the longitudinal shaft 150 and sleeve 100 within the gastrointestinal tract of a user are described below, for example, with reference to Figures 21-23D. As described further below, the longitudinal shaft 150 and / or sleeve 100 may be delivered within the gastrointestinal tract using a delivery device that may form part of the system 200.

[0094] In some embodiments, the sleeve 100 or inflatable portion 108 may be enclosed within a textured layer (not explicitly shown), such as a mesh layer.

[0095] In some embodiments, a support element or device (not shown) may be provided at the distal end of shaft 150. For example, a valve, such as a duckbill valve, may be provided at the distal end of shaft 150. As another example, an illumination device and / or an imaging device may be attached to the distal end of shaft 150 for illuminating and / or imaging the digestive tract as shaft 150 is advanced to a desired location within the digestive tract.

[0096] It will be understood that inflatable portion 108 (and inflatable portions 128, 128', 138, and 149) may be inflated using fluid from any source, not necessarily fluid introduced through shaft 150.

[0097] For example, in some embodiments, inflatable portion 108 may have a precursor or reactant for a gas-releasing chemical reaction therein in the delivery actuation state. When shaft 150 and sleeve 100 are advanced to a target region in the GI tract, the gas-releasing chemical reaction is triggered, releasing gas within inflatable portion 108 and transitioning from the delivery actuation state to the inflation actuation state. In some such embodiments, inflation fluid supply channel 152 and inflation fluid supply port 154 may be omitted from shaft 150. In some embodiments, a triggering mechanism for triggering the chemical reaction may be incorporated into or form part of shaft 150.

[0098] Reference is now made to Figures 10A and 10B, which are cross-sectional and end views, respectively, of a medical system 300 including a sleeve 302 in a delivery actuation state in accordance with a further embodiment of the disclosed technology. Reference is also made to Figures 11A and 11B, which are cross-sectional and end views, respectively, of the medical system 300, with the sleeve 302 in an expanded actuation state.

[0099] System 300 includes a sleeve 302. Sleeve 302 is attached to a shaft 350 similar to shaft 150 described above with respect to Figure 8. System 300 may further include a negative pressure source as shown in Figure 8.

[0100] 1A and 1B, includes a tubular portion 304, a sleeve opening 306, an expandable portion 308, and a gap 310 formed between the expandable portions. As described above, the sleeve 302 can include at least three, at least four, or at least five expandable portions.

[0101] Sleeve 302 differs from sleeve 100 in the expansion mechanism of expandable portions 308. Each expandable portion 308 of sleeve 302 houses a shape memory scaffold 309. Shape memory scaffold 309 is configured to be held in a compressed state and to form an expanded state upon release. Shape memory scaffold 309 may include, for example, a nickel-titanium alloy known as Nitinol, or NiTiCu (copper-zinc-nickel), or other superelastic alloys, shape memory polymers, or alloys. Other suitable materials include biocompatible metals such as stainless steel. The scaffold may be further coated or textured to enhance biocompatibility.

[0102] It is understood that in the context of this application, the term "scaffold" is defined as any compressible and expandable structure that can retain its expanded shape without relying on other support and that may have a variety of configurations, such as a porous compressible material or a stent shape.

[0103] 10A and 10B, the shape-memory scaffolding 309 is held in a compressed state. As a result, the outer diameter D5 of the expandable portion 308 is significantly smaller than the diameter D2 shown in FIG. 1B. In this state, the outer diameter of the portion of the system 300 that is inserted into the body cavity is approximately equal to the outer diameter D5. It is desirable that D5 be as close as possible to the diameter of the shaft 350 or the diameter of the tubular portion 304, shown as D1 in FIG. 1B.

[0104] Once the shaft 350 and sleeve 302 are advanced to the target site within the GI tract, the shape memory scaffold 309 is released and expands to its "memorized" expanded state. This causes the expandable portion 308 to expand to its expanded actuated state, as shown in Figures 11A and 11B. The expanded actuated state of the expandable portion 308 shown in Figures 11A and 11B is very similar to and functions similarly to the expanded state of the inflatable portion 108 shown in Figure 1B.

[0105] Shaft 350 differs from shaft 150 of Figure 8 in that it lacks inflation fluid supply channels and inlets, and only includes negative pressure supply channels 362 and inlets 364. This is because expansion of expandable portion 308 is based on shape memory scaffold 309 regaining a "memorized" shape rather than on the introduction of inflation fluid into the expandable portion.

[0106] In some embodiments, the shape memory scaffold 309 may be replaced with any material or substance that has a compressed state and is capable of expanding from the compressed state to an expanded state, such as a porous compressible material, a foam, etc. In some embodiments, the expansion of the material or substance may be caused by a change in its environment or activation of a triggering mechanism, such as the introduction of a foam into a liquid environment. It should be understood that the material replacing the shape memory scaffold 309 must be strong enough to withstand compression when negative pressure is applied within a lumen, such as a body cavity, in which the scaffold is placed or deployed.

[0107] In some embodiments, the shape memory scaffold 309 may be attached to or extend directly from the shaft 350. In some such embodiments, the sleeve 302 surrounding the shape memory scaffold 309 is omitted and the expandable portion 308 includes only the scaffold 309, with the scaffold exposed in the vicinity surrounding the shaft 350. In some embodiments, the shape memory scaffold 309 may be integrally formed with the shaft 350. In some embodiments, the sleeve may be omitted in some of the expandable portion 308 and retained in others.

[0108] In the most general terms, the expandable sections 308 extend periodically outward from the longitudinal shaft 350, forming gaps 310 between the expandable sections. As a result, the negative pressure supply channels 362 are in fluid communication with the gaps via negative pressure supply ports 364 formed in the shaft 350.

[0109] 12A and 12B, which are end and side views, respectively, of a medical system 400 in accordance with a further embodiment of the disclosed technology.

[0110] The medical system 400 includes a sleeve 402. The sleeve 402 is attached to a shaft 450 similar to the shaft 150 described above with respect to Figure 8. The system 400 may further include a negative pressure source as shown in Figure 8.

[0111] 1A and 1B, includes a tubular portion 404, a sleeve aperture 406, an inflatable portion 408, and a gap 410 formed between the inflatable portions. However, sleeve 402 further includes a plurality of second sleeve apertures 407 disposed within tubular portion 404. In some embodiments, each opening of the plurality of second sleeve apertures is longitudinally aligned with one of sleeve apertures 406.

[0112] Shaft 450 differs from shaft 150 of FIG. 8 in that, in addition to inflation fluid supply channel 452 and negative pressure supply channel 462, shaft 450 includes a third channel 472 in fluid communication with a third plurality of openings.

[0113] Each of the openings 407 of the second plurality of sleeve openings is aligned with a corresponding opening of the third plurality of openings, such that the third channel 472 is in fluid communication with the gap 410 between the inflatable portion 408 via the sleeve openings 407 and the openings in the third plurality of openings.

[0114] In some embodiments, the third channel 472 is a flushing fluid supply channel, and the third plurality of openings are flushing fluid supply ports. In some such embodiments, the flushing fluid supply channel 472 can be connected to a fluid source, such as a flushing fluid or a medical fluid (not explicitly shown). When the flushing fluid supply channel 472 is connected to a fluid source, fluid is supplied to the gap 410, similar to applying negative pressure to the gap, as described above with respect to FIG. 8 and the negative pressure supply channel 162.

[0115] In some embodiments, the fluid may be a flushing fluid. In some embodiments, the fluid may be a medicinal fluid, such as an antibacterial fluid or a tissue growth promoting fluid. In some embodiments, the fluid may be a contrast fluid. In some embodiments, the fluid may be an ionized gas. In some embodiments, the fluid may be carbon dioxide.

[0116] In some embodiments, third channel 472 may be a second negative pressure supply channel configured to act as a backup if negative pressure supply channel 462 fails for any reason, or may be configured to be used in conjunction with the application of negative pressure via negative pressure supply channel 462 to further reduce pressure within gap 410. In some such embodiments, third channel 472 may be connected to a negative pressure source, such as negative pressure source 166 described above with respect to FIG.

[0117] It should be understood that the channel 472 and corresponding openings may also be used in shafts without inflation fluid supply channels, such as the shaft 350 described above with respect to Figures 10A-11B.

[0118] Reference is now made to FIG. 13 , which illustrates a flowchart of a method for treating a subject's digestive tract using any of medical systems 200, 300, or 400 according to embodiments of the disclosed technology. For simplicity, FIG. 13 is described with respect to medical system 200 and sleeve 100. However, this description equally applies to medical system 200 including sleeves 120, 120′, 130, and 149, medical system 300 including sleeve 302, and medical system 400 including sleeve 402. Note that in the following description, the terms “expandable portion” and “expanded state” are used interchangeably with the terms “inflatable portion” and “inflated state.” Thus, expandable portion 108 is equivalent to inflatable portion 108, and the expanded states of these portions are equivalent to these inflated states.

[0119] In step S502, with the inflatable portion 108 in the delivery state, the shaft 150 and sleeve 100 are advanced together to a target site within the subject's gastrointestinal tract. For example, the target site may be near a wound in the gastrointestinal tract, and the wound may be an intraluminal or extraluminal wound. For example, the target site may be within the esophagus or colon of the subject.

[0120] A variety of methods can be used to advance shaft 150 and sleeve 100 to the target site, some of which are described below with reference to Figures 21-23D, although any other suitable method is contemplated within the scope of the disclosed technology.

[0121] In step S504, the inflatable portion 108 is expanded, transitioning from a delivery state to an expanded state. For the inflatable portion 108, this transition is achieved by supplying inflation fluid to the inflatable portion via the inflation fluid supply channel 152 and openings 154 in the shaft 150. However, for other types of expandable portions, such as the expandable portion 308, expansion of the expandable portion may be achieved using other mechanisms, such as releasing the scaffold 309 from a compressed state.

[0122] In some embodiments, such as when using a sleeve 100 and an inflatable portion 108, step S506 may further include connecting the shaft 150 to a source 156 of inflation fluid 158 before inflating the inflatable portion.

[0123] In step S508, the negative pressure source 166 is activated to apply negative pressure to the gap 110 via the negative pressure supply channel 162, the opening 164, and the sleeve port 106. In some embodiments, the negative pressure source is activated to apply negative pressure by a control system, which may also include input information for processing and managing pressure parameters or time intervals. The negative pressure is applied radially relative to the longitudinal axis of the sleeve.

[0124] In some embodiments, the optional step S506 of connecting the shaft 150, and in particular the negative pressure supply channel 162, to a negative pressure source may be performed before step S508.

[0125] Applying negative pressure to gap 110 in step S508 causes fluid to drain from the target region of the gastrointestinal tract through openings 164 and 106. This drainage reduces the amount of contaminated fluid at the target region and promotes wound healing in the target area. A feature of the disclosed technology is that applying negative pressure to gap 110 causes the gastrointestinal tract at the target region to collapse inward, i.e., toward inflatable (expandable) portion 108. However, the distance between the inflatable portions is selected so that tissue does not collapse into gap 110 or into the recesses (if applicable) in the inflatable portion. As a result, gap 110 and / or the recesses in the inflatable portion form enclosed negative pressure regions or pockets bounded by the lumen wall and the inflatable portion, respectively. In each such pocket, negative pressure can be applied to the surface of the lumen wall, rather than just a single point (e.g., the location of an opening), with at least a portion of the lumen wall exposed and not in contact with a medical device.

[0126] In other words, by using a relatively small number of openings, i.e., "exit points" for negative pressure, the structure of the inflatable portions and the gaps between them prevents the lumen from collapsing over the negative pressure openings, ensuring the formation of negative pressure pockets, so that negative pressure is applied to a large surface or area of ​​the lumen.

[0127] Meanwhile, collapsing the lumen tissue over the expandable portion helps to maintain proper placement of sleeve 100 within the target site.

[0128] In some embodiments, the sleeve 100 may be retained at the target site for an extended period of time, such as days or weeks.

[0129] After treatment of the target site in the digestive tract is complete, all sleeves 100 and shafts 150, as well as all other components of the medical system disposed within the body, are removed from the target site in step S510.

[0130] Such removal typically involves isolating the shaft 150 from the negative pressure source 166, and in some embodiments may involve isolating the shaft 150 from the inflation fluid source 156 or from any other fluid or pressure source to which the shaft is connected.

[0131] In some embodiments, such removal further comprises compressing the expandable portion or deflating the inflatable portion.

[0132] In some embodiments, the sleeve and shaft are removed together from the user's body, for example, in the reverse process by which they were inserted into the body in step S502.

[0133] In some other embodiments, sleeve 100, or a portion thereof, may be detached from shaft 150 and removed from the body in a manner different from the removal of shaft 150. For example, sleeve 100, or a portion thereof, may travel intact through the digestive tract and be removed from the body along with waste products. As another example, sleeve 100, or a portion thereof, may be biodegradable and broken down within the body, or bioabsorbable and reabsorbed by cells in the intestinal wall. In some embodiments, such detachment of sleeve 100 may be time-dependent or tool-dependent, ensuring that sleeve 100 remains properly attached to shaft 150 during use, which is critical to the functionality of medical system 200 as described above.

[0134] In some embodiments, the method may include an optional initial step S500 in which shaft 150 is connected to the interior of sleeve 100 with the required alignment of openings 154, 164, 106. For example, step S500 may include soldering or gluing sleeve 100 to shaft 150 in the required orientation.

[0135] Reference is now made to Figure 14, which is a perspective view of an inflatable body 102 in accordance with an embodiment of the disclosed technology. Reference is also made to Figures 15A and 15B, which are schematic side and front views, respectively, of an inflation fluid supply channel 600 connected to the inflatable body 602 of Figure 14 in accordance with an embodiment of the disclosed technology.

[0136] Inflation fluid supply channel 600 terminates in and is in fluid communication with inflation body 602. Both channel 600 and inflation body 602 are aligned along a central longitudinal axis 604. In some embodiments, inflation fluid supply channel 600 and inflation body 602 are integrally formed. In other embodiments, inflation fluid supply channel 600 is reversibly attachable to and detachable from inflation body 602.

[0137] The inflatable body 602 has a delivery operating state, which is normally deflated, and an inflation operating state. The inflation fluid supply channel 600 is configured to supply inflation fluid 606 from an inflation fluid source 608 to the inflatable body 602 to inflate the body. In some embodiments, the inflation fluid 606 can be saline. Introducing the inflation fluid 606 into the inflatable body 602 transitions the body from the delivery state to the inflation state.

[0138] 14-15B, in an inflated operating state, the inflatable body 602 includes a plurality of longitudinally arranged lobes 610 and a plurality of longitudinally arranged recesses 612. Each pair of adjacent lobes 610 is separated by one of the recesses 612. Thus, the inflatable body 602 has an equal number of lobes 610 and recesses 612.

[0139] In some embodiments, the inflatable body 602 includes at least three, at least four, at least five, or at least six lobes 610. In some embodiments, the inflatable body 602 includes three to ten, four to nine, or five to eight lobes 610. In some embodiments, the lobes 610 are generally evenly spaced circumferentially around the inflatable body 602, as shown in FIG.

[0140] The inflation body 602 includes a bridge portion 614 and a tissue-engaging portion 616. The bridge portion 614 is disposed between the inflation fluid supply channel 600 and the tissue-engaging portion 616. As shown, in the inflated state, the tissue-engaging portion 616 defines lobes 610 and recesses 612. Additionally, as shown in FIG. 14 , in the inflated state, inlet recesses 618 extend along the outer surface of the bridge portion 614 from the distal end of the inflation fluid supply channel 600 (e.g., the junction of the inflation fluid supply channel and the inflation body) to the proximal end of each recess 612. Similarly, in the inflated state, inlet lobes 619 extend along the outer surface of the bridge portion 614 from the distal end of the inflation fluid supply channel 600 to the proximal end of each lobe 610.

[0141] 15A, when inflatable portion 602 is in an inflated state, an angle α is defined between the longitudinal axis of one inlet recess 618 and longitudinal axis 604. In some embodiments, angle α is in the range of 100-160°, 105-155°, or 105-150°.

[0142] 15A, a longitudinal cross section of bridge portion 614 defines an angle β where it connects to channel 600. In some embodiments, angle β is in the range of 60-160°, 60-155°, 60-150°, or 70-150°.

[0143] In some embodiments, in the expanded actuation state of the expandable body 602, the height difference between one or each of the lobes 610 and the adjacent recess 612, indicated as H2 in FIG. 15B, ranges from 1 mm to 7 mm, 1 mm to 5 mm, 1 mm to 4 mm, 1 mm to 3 mm, or 1 mm to 2 mm. For clarity, it should be understood that the distance H2 is measured from the point on the lobe 610 that is radially farthest from the longitudinal axis 604 to the point on the recess 612 that is radially closest to the longitudinal axis 604.

[0144] For purposes of discussing the ratio of lobes 610 to recesses 612 when the expandable body 602 is in an activated expanded state, imagine a cylinder 620 (shown in FIGS. 15A and 15B) surrounding the tissue-engaging portion 616 of the expandable body 602, with the lobes 610 engaging this imaginary cylinder. This imaginary cylinder includes a portion that engages the expandable body 602, shown as A in FIG. 15B, and a portion that is spaced apart from the expandable body, shown as B.

[0145] In some embodiments, the ratio of arc A to arc B in the cross section of the expandable body 602 (as shown in FIG. 15B) is 5:1, at least 4:1, at least 3:1, at least 2:1, at least 1:1, at least 1:2, at least 1:3, at least 1:4, at least 1:5, at least 1:7, at least 1:10, at least 1:15, at least 1:20, or at least 1:30.

[0146] The second imaginary cylinder 621 shown in FIG. 15B is positioned at half the height H2. The second imaginary cylinder 621 is an arc or portion A that cuts the lobe 610. 1 / 2 and an arc or portion B cutting the recess 612 1 / 2 In some embodiments, arc A in a cross-sectional or end view of the inflatable body 602 (shown in FIG. 15B) 1 / 2 and arc B 1 / 2 is at least 5:1, at least 4:1, at least 3:1, at least 2:1, at least 1:1, at least 1:2, at least 1:3, at least 1:4, at least 1:5, at least 1:7, at least 1:10, at least 1:15, at least 1:20, or at least 1:30.

[0147] In some embodiments, the portion (A) of the inner wall of the imaginary cylinder 620 that engages the expandable body 602 is less than 60%, 50%, 40%, 30%, or 20% of the circumference or cross-sectional area of ​​the imaginary cylinder 620.

[0148] In some embodiments, the outer diameter of the inflation fluid supply channel 600 is less than 8 mm, less than 7 mm, less than 6 mm, less than 5 mm, less than 4 mm, less than 3.7 mm, or less than 3.5 mm, hi some embodiments, the outer diameter of the inflation fluid supply channel 600 ranges from 1 mm to 6 mm.

[0149] In some embodiments, the inner diameter of the inflation fluid supply channel 600 ranges from 0.5 mm to 5 mm, 0.5 mm to 4 mm, 0.5 mm to 3 mm, 0.5 mm to 2 mm, 0.5 mm to 1.5 mm, 0.5 mm to 1 mm, 1 mm to 3 mm, 1.5 mm to 3 mm.

[0150] In some embodiments, the expandable body 602 has an outer diameter of less than 8 mm, less than 7 mm, less than 6 mm, less than 5 mm, less than 4 mm, less than 3.7 mm, or less than 3.5 mm in the delivery state.

[0151] In some embodiments, the expandable body 602 has an outer diameter in the expanded working state ranging from 5 mm to 30 mm, 7 mm to 30 mm, 10 mm to 30 mm, 10 mm to 25 mm, 10 mm to 22 mm, 10 mm to 20 mm, 10 mm to 20 mm, 7 mm to 20 mm, or 5 mm to 20 mm.

[0152] In some embodiments, the distal end 622 of the expandable body 602 is blunt or soft to avoid trauma to surrounding tissue when delivering the expandable body into the gastrointestinal tract, as described below.

[0153] In some embodiments, the lobes 610 and recesses 612 terminate before the distal end 622 of the expandable body 602. Thus, in the expanded actuation state, the distal-most end of the expandable body 602 is cylindrical or spherical and can fit tightly against the lumen.

[0154] Reference is now made to Figure 16, which is a perspective view of an inflatable body 602' in accordance with an embodiment of the disclosed technology. Reference is also made to Figures 17A and 17B, which are schematic side and front views, respectively, of an inflation fluid supply channel 600 connected to an inflatable body 602' in accordance with an embodiment of the disclosed technology.

[0155] As shown in Figures 16 and 17A, the expandable body 602' includes recesses 612 substantially as shown in Figures 14 and 15A, except that the lobes 610' of the expandable body 602' are longitudinally curved or textured. More specifically, each lobe 610' includes a plurality of minor recesses 632 disposed longitudinally along the lobe 610.

[0156] In some embodiments, when negative pressure is applied to recess 612 (as described below), the presence of sub-recess 632 allows negative pressure to be applied to locations along recess 612 from multiple different directions, thus reducing the likelihood of blockage of recess 612 compared to the configuration of expandable body 602. Additionally, when expandable body 602' is used within the digestive tract, the texture of lobe 610' can function to apply consistent physical pressure to tissue while exposing the region of the digestive tract in which expandable body 602' is located to negative pressure.

[0157] Reference is now made to Figure 18, which is a cross-sectional perspective view of the inflatable body of Figure 17A taken along section line XVIII-XVIII of Figure 17A. The cross-sectional view of Figure 18 was taken along longitudinal axis 604 at a distance of 2 mm from the distal end of inflation fluid supply channel 600. As shown in Figure 18, at a distance of 2 mm from channel 600, the height difference between inlet recess 618 and the adjacent inlet lobe 619 in bridge portion 614 is designated H3. In some embodiments, H3 is at least 0.4 mm, or at least 0.5 mm.

[0158] Reference is now made to Figures 19A, 19B, and 19C, which are schematic side, front, and partial cutaway views, respectively, of a medical system 650 in accordance with an embodiment of the disclosed technology. Medical system 650 includes an inflation fluid supply channel 600 and an inflation body 602' (as shown), or may include the inflation body 602 of Figures 14-15B. For brevity, the following description will be provided with reference to inflation body 602'. System 650 may further include an inflation fluid source 608 and inflation fluid 606 contained therein (see Figure 15A).

[0159] As shown in FIGS. 19A-19C , in addition to the channel 600 and the inflatable portion 602′, the system 650 includes a fluid-tight lumen 652. The fluid-tight lumen 652 includes a first channel 654 disposed around the inflation fluid supply channel 600, as best seen in FIG. 19C . The fluid-tight lumen 652 further includes at least one second channel 656, also referred to as a negative pressure supply channel, shown as three channels 656 in FIG. 19B and two channels 656 in FIG. 19C . In some such embodiments, the negative pressure supply channel may be disposed radially outward of or around the inflation fluid supply channel. The fluid-tight lumen 652, specifically the negative pressure supply channel 656, is configured to connect to a negative pressure source 658. The fluid-tight lumen 652 supplies negative pressure along the negative pressure supply channel 656 to the proximal end of the inflatable body 602′. This negative pressure is then applied along the recess 612 and along the longitudinal direction of the expandable body 602'.

[0160] In some embodiments, the negative pressure source 658 is configured to apply a negative pressure in the range of 50-350 mmHg. As shown in Figure 19A, in an expanded state, the expandable body 602' maintains a structure including the lobes 610', recesses 612, and inlet recesses 618 when negative pressure is applied. Application of negative pressure to recesses 612 causes the general flow of adjacent material in the direction of arrow 660 shown in Figure 19A.

[0161] 19B, when negative pressure is applied via negative pressure supply channels 656, it is applied to recesses 612 via inlet recesses 618. To this end, at least a portion of at least one negative pressure supply channel 656 is longitudinally aligned with each of inlet recesses 618 and recesses 612.

[0162] In some embodiments, as shown in Figures 19A-19C, the fluid-tight lumen 652 is centered and coaxial with respect to the inflation fluid supply channel 600 and the inflation body 602'.

[0163] In some embodiments, at least one negative pressure supply channel 656 comprises a single annular channel. In some such embodiments, the annular channel may be supported by struts 662, as shown in Figure 19C. The struts 662 connect the inner surface of the negative pressure supply channel 656 to the outer surface of the first channel 654, maintaining a coaxial relationship between the two channels.

[0164] In some embodiments, as shown, a plurality of second channels 656 are formed within the fluid-tight lumen 652. Typically, the negative pressure supply channels 656 are circumferentially arranged around the first channel 654. In some embodiments, the total surface area of ​​all of the negative pressure supply channels 656 in a direction perpendicular to the longitudinal axis of the fluid-tight lumen 652 is at least 5 mm 2 is.

[0165] In some embodiments, the outer diameter D6 (shown in FIG. 19A) of the fluid-tight lumen 652 is less than 8 mm, less than 5 mm, less than 4 mm, less than 3.7 mm, or less than 3.5 mm.

[0166] In some embodiments, the outer diameter D6 is less than the maximum outer diameter of the expandable body 602' when the expandable body 602' is in an expanded state. In such embodiments, the diameter D6 and the cross-sectional area of ​​the negative pressure supply channel 656 are large enough to ensure that negative pressure is applied to each recess 612 via the inlet recess 618.

[0167] In other embodiments, the outer diameter D6 is at least equal to the maximum diameter of the expandable body 602′, thereby allowing negative pressure to be applied directly to the recess 612 from the negative pressure supply channel 656. In some such embodiments, the bridge portion 614 may be omitted or may have a different angular relationship to the longitudinal axis than described above.

[0168] In some embodiments, the distal end 664 of the fluid-tight lumen 652 is disposed in a fixed position relative to the inflation body 602'. In some such embodiments, the system 650 may further include an anchoring mechanism (not shown) configured to secure the fluid-tight lumen 652 in a fixed longitudinal position relative to the inflation body 602'.

[0169] In some embodiments, when the expandable body 602' is in an expanded state, the distance D7 (shown in FIG. 19A) between the distal end 664 of the fluid-tight lumen 652 and the proximal end of one recess 612 along the longitudinal axis 604 (see FIG. 15A) of the expandable body 602' is at most 6 mm, at most 4 mm, at most 2 mm, or at most 1 mm.

[0170] In some embodiments, the fluid-tight lumen 652 may be connected to a fluid source, such as a flushing fluid or a medicinal fluid (not shown). This may occur, for example, when the fluid-tight lumen 652 is not connected to a negative pressure source 658. When the fluid-tight lumen 652 is connected to a fluid source, fluid may be supplied to the recess 612 via the second channel 656, similar to when a negative pressure is applied. Alternatively, the fluid-tight lumen 652 may include an additional fluid supply channel for this purpose, configured to supply the recess 612, similar to when a negative pressure is applied. For example, such a fluid supply channel may be provided concentrically around the negative pressure supply channel 656 or internal to the negative pressure supply channel.

[0171] In some embodiments, the fluid may be a flushing fluid. In some embodiments, the fluid may be a medicinal fluid, such as an antibacterial fluid or a tissue growth promoting fluid. In some embodiments, the fluid may be a contrast fluid. In some embodiments, the fluid may be an ionized gas. In some embodiments, the fluid may be carbon dioxide.

[0172] The inflation fluid supply channel 600, inflation body 602′, and / or fluid-tight lumen 652 can be delivered into the subject's digestive tract using a variety of delivery techniques, some of which are described below with reference to Figures 21A-23D. For example, delivery may be direct, oral, or anal.

[0173] As another example, inflation fluid supply channel 600, inflation body 602′, and / or fluid-tight lumen 652 may be delivered into the subject's digestive tract through a working channel of a delivery device, such as an endoscope (not shown), which may also form part of system 650.

[0174] In some embodiments, during delivery, the inflation fluid supply channel 600, inflation body 602′, and / or fluid-tight lumen 652 may be disposed within a catheter or delivery sheath 670, as best seen in FIG. 19C. In some such embodiments, the sheath 670 helps maintain an appropriately small diameter of the inflation body 602′ during delivery of the inflation body 602′. The sheath 670 may be used for direct delivery or for delivery via a working channel of a delivery device.

[0175] It should be understood that a sheath similar to sheath 670 may similarly be used to advance the medical system of Figures 1A-12B described above into the body of a subject.

[0176] In some embodiments, the expandable body 602' may be surrounded by a textured layer (not shown), such as a layer of mesh, netting, etc. This textured layer may be designed to contact and apply pressure to the wound. The textured layer may also prevent contacting tissue from creeping into the gaps.

[0177] Reference is now made to Figure 20, which illustrates a flowchart of a method for treating the digestive tract of a subject using a medical system 650 in accordance with an embodiment of the disclosed technology. For simplicity, Figure 20 describes inflatable portion 602', although the description applies equally to inflatable portion 602.

[0178] In step S700, the inflatable body 602' is advanced in a delivery state to a target site within the subject's gastrointestinal tract. For example, the target site may be near a wound in the gastrointestinal tract, and the wound may be an intraluminal or extraluminal wound. For example, the target site may be within the esophagus or colon of the subject.

[0179] Various mechanisms for advancing the expandable body to the target site are described below with reference to Figures 21A-23D.

[0180] In step S702, the inflatable body 602' is transitioned from the delivery state advanced in step S700 to an inflated state by supplying inflation fluid to the inflatable body 602' via the channel 600. In some embodiments, the inflation fluid supply channel 600 may be connected to the inflatable body 602' in an initial step S701, which may occur before step S702, or in some embodiments, may even occur before step S700. In some embodiments, the attachment of the inflatable body 602' to the channel 600 may be part of the manufacturing process for the inflatable body.

[0181] In step S704, the fluid-tight lumen 652 is advanced over the inflation fluid supply channel 600 until the distal end 662 of the lumen is adjacent the inflatable portion 602'. In some embodiments, S704 may be the initial step of the method. In such embodiments, the inflatable portion 602' is advanced to the target site with the channel 600 contained within the fluid-tight lumen 652. However, in other embodiments, the fluid-tight lumen 652 is advanced to the target site only after the inflatable portion 602' has been positioned and inflated.

[0182] Once the fluid-tight lumen 652 is properly positioned relative to the inflatable body 602′, the negative pressure source 658 is activated in step S706 to apply negative pressure to the recess 612 via the second channel 656 and the inlet recess 626. In some embodiments, step S706 further includes connecting the fluid-tight lumen 652, and specifically the second channel 656, to the negative pressure source.

[0183] In use, when negative pressure is applied to recess 612, the negative pressure is configured to drain fluid from a target site within the digestive tract through recess 612. Such drainage reduces the amount of contaminated fluid at the target site and can promote wound healing in the target area.

[0184] A feature of the disclosed technology is that the gastrointestinal tract at the target site collapses inward, i.e., toward the expandable body 602′, by applying negative pressure to the recess 612. However, the width of the recess 612 is selected so that the tissue does not collapse into the recess.

[0185] As a result, the recesses 612 of the inflatable portion form enclosed negative pressure areas or pockets, where at least a portion of the lumen wall is exposed and not in contact with the medical device, allowing negative pressure to be applied to a surface, rather than a single point, of the lumen wall.

[0186] In other words, by using a negative pressure "exit point" at the proximal end of the inflatable body, negative pressure is applied to a large surface or area of ​​the lumen because the structure of the inflatable body and recess prevents the lumen from collapsing into the recess and ensures the formation of a negative pressure pocket.

[0187] Meanwhile, collapsing the lumen over the lobes 610 also helps to keep the expandable body 602' properly positioned within the target site.

[0188] In some embodiments, the expander 602' may be retained at the target site for an extended period of time, such as days or weeks.

[0189] After treatment is complete, the components of the medical system 650 are removed from the target site in step S708. The removal step typically involves deflating the inflatable body 602. Deflation can be accomplished, for example, by puncturing the inflatable body or by applying negative pressure to the inflation fluid supply channel 600 to expel the inflation fluid from within the inflatable body.

[0190] In some embodiments, removing in step S708 may include removing the fluid-tight lumen 652 from the inflation fluid supply channel 600 before removing the channel, and removing the inflation body 602' from the target site before removing the channel. In other embodiments, step S708 may include removing the fluid-tight lumen 652 along with the inflation fluid supply channel 600 from the target site.

[0191] In embodiments in which the inflation body 602' and the inflation fluid supply channel 600 are separable or separate, removing in step S708 may include separating the inflation fluid supply channel 600 from the inflation body 602' and then removing the channel 600 from the target site. In some such embodiments, the inflation body 602' may be removed from the target site by the inflation body 602' progressing further through the digestive tract and naturally passing from the body, or by the inflation body being biodegradable and / or bioabsorbable within the body.

[0192] However, in embodiments where the inflation body 602' is integrally formed with the inflation fluid supply channel 600, removing the inflation body essentially removes the inflation fluid supply channel as well.

[0193] Reference is now made to Figures 21A, 21B, and 21C, which are schematic illustrations of various mechanisms for deploying a portion of a medical system, such as any one of medical systems 200, 300, 400, and 650, within the gastrointestinal tract using a delivery device, in accordance with embodiments of the disclosed technology.

[0194] 21A, an elongated portion 722 of the medical system (e.g., shaft 150 and sleeve 100, or channel 600 and inflation body 602′) may be delivered to the gastrointestinal tract within a working channel 724 of a delivery device 720. In such embodiments, the elongated portion of the medical system is sized and configured to pass through the working channel 724 of the delivery device 720.

[0195] In some embodiments, the delivery device 720 may be a catheter or an endoscope.

[0196] In some embodiments, delivery device 720 may include an imaging element 726 configured to provide images of elongated portion 722 as it is delivered within the gastrointestinal tract. For example, imaging element 726 may be a video camera configured to capture images of the interior of the gastrointestinal tract as the elongated portion is positioned within the gastrointestinal tract.

[0197] In some embodiments, the medical system may include a handle portion that is mechanically connectable to the distal end of the elongated portion 722. Manipulating the handle portion, for example, by pushing or turning, moves the elongated portion 722 in a distal direction. In some embodiments, the handle portion is configured to be detachable from the elongated portion after the elongated portion has been delivered to the gastrointestinal tract.

[0198] In some embodiments, as shown in Figure 21B, the elongated portion 722 of the medical system may be disposed within an overtube 727 during delivery. For example, as shown in Figure 21A, the overtube 727 may be delivered into the gastrointestinal tract through a working channel 724.

[0199] 21C, the elongated portion 722 of the medical system may be delivered into the user's gastrointestinal tract over a guidewire 728. In some such embodiments, a valve 729, such as a duckbill valve, may be positioned at the distal end of the elongated portion 722, with the guidewire 728 extending through the valve.

[0200] Reference is now made to Figures 22A and 22B, which are schematic illustrations of a procedure for placing a portion of a medical system 730, such as one of medical systems 200, 300, 400, or 650, within a subject's body, in accordance with an embodiment of the disclosed technology.

[0201] 22A, system 730, and in particular its elongated portion, may be inserted through the subject's mouth and into the digestive tract. For example, in the illustrated embodiment, an endoscope is used to insert an elongated tube through the subject's mouth and into the esophagus.

[0202] In FIG. 22B , an elongated portion of the medical system 730 is surgically delivered to the esophagus. Specifically, a hole is drilled in the subject's abdominal wall, and the elongated portion is delivered via the stomach into the subject's digestive tract, specifically the esophagus. Alternatively, a hole is drilled in the subject's submental triangle (not shown), and the elongated portion is delivered via the punctured hole into the subject's digestive tract, specifically the esophagus. In some such applications, the distal end of the elongated portion may be sharp or may include a needle suitable for drilling the necessary hole in the abdominal wall. In other embodiments, the process is similar to the process for placing a percutaneous endoscopic gastrostomy (PEG) device, except that the elongated portion is delivered further into the esophagus than the stomach.

[0203] Reference is now made to Figures 23A, 23B, 23C, 23D, and 23E, which are schematic diagrams illustrating steps in a procedure for maintaining a portion of medical system 730, such as maintaining any one of medical systems 200, 300, 400, or 650 within a subject's body via a nose wire or tube after introduction therein as shown in Figure 22A. For simplicity, the elongated portion of medical system 730 will be considered to be the shaft 150 and sleeve 100 of medical system 200, as shown in Figure 8 above.

[0204] As shown in Figure 23A, delivery device 720 is placed into the subject's esophagus through mouth 740. In Figure 23B, an elongated portion of medical system 730 is delivered into the user's esophagus using delivery device 720 (not shown). Delivery device 720 is then removed from the subject's mouth, leaving the elongated portion of medical system 730 (i.e., shaft 150 and sleeve 100) in place. After medical system 730 is placed in the subject's esophagus, delivery device 720 is removed from the body, as shown in Figure 23C.

[0205] In FIG. 23D, the wire 750 is inserted into the subject's nose, passed through the subject's sinuses, into the oral cavity, and then exited outside the oral cavity. Next, the proximal end of the shaft 150 (i.e., the elongated portion of the medical system) is connected to the end 752 of the wire 750 protruding from the subject's oral cavity. In FIG. 23E, the wire 750 is withdrawn from the subject's nose. As the wire 750 is withdrawn from the subject's nose, the end 752 of the wire is withdrawn into the subject's nose together with the proximal end of the shaft 150 (i.e., the elongated portion). After the wire 750 is completely withdrawn from the subject's nose, the proximal end of the shaft 150 (or the proximal portion of the elongated portion) continues to extend through the subject's nose and outside the subject's body, and is connected to a negative pressure source or inflation fluid source as needed. The proximal portion of the elongated portion may further be provided with a nasal retention member configured to maintain the longitudinal position of the elongated portion within the subject's body.

[0206] The present disclosure may be better understood with respect to the following exemplary embodiments.

[0207] <Embodiment 1> 1. A medical system for applying negative pressure within a gastrointestinal tract of a subject, the medical system comprising: (i) a gastrointestinal tract; (i) a longitudinal shaft disposed along a longitudinal axis, (a) a longitudinally extending negative pressure supply channel; (b) a plurality of negative pressure supply ports longitudinally disposed along the longitudinal shaft and in fluid communication with the negative pressure supply channel; A longitudinal shaft having (ii) at least three expandable sections, periodically arranged along the shaft and extending outward from the shaft, with a gap between each pair of adjacent expandable sections, each expandable section comprising: a delivery actuation state in which the plurality of expandable sections have a first dimension or first diameter perpendicular to a longitudinal axis of the shaft; an expanded actuated state in which the plurality of expandable portions have a second dimension or diameter about the longitudinal axis, the second dimension or diameter being greater than the first dimension or diameter; The longitudinally extending negative pressure supply channel is connected to a negative pressure source and configured to supply negative pressure along the longitudinally extending negative pressure supply channel and through a plurality of negative pressure supply ports to gaps between the expandable portions in a radial direction relative to the longitudinal axis.

[0208] <Embodiment 2> 1. A medical system for applying negative pressure within a subject's gastrointestinal tract, the medical system comprising: (i) a gastrointestinal tract; (i) a sleeve extending along a longitudinal axis, (a) a plurality of tubular sections having a first diameter about the longitudinal axis of the sleeve, each of the plurality of tubular sections including at least one sleeve opening; (b) a plurality of expandable portions including at least three expandable portions, each pair of adjacent expandable portions being separated by one of the plurality of tubular portions, each of the plurality of expandable portions being: a delivery operating state; an expanded operating state, wherein the plurality of expandable sections have a second diameter about the longitudinal axis of the sleeve, the second diameter being greater than the first diameter, thereby forming gaps between the expandable sections along the longitudinal axis of the sleeve; and and an expandable portion having a sleeve. (ii) a longitudinal shaft disposed within the sleeve, (a) a longitudinally extending negative pressure supply channel; (b) a plurality of negative pressure supply ports longitudinally disposed along the longitudinal shaft, the plurality of negative pressure supply ports in fluid communication with the negative pressure supply channel and aligned with the sleeve ports; The longitudinal shaft, wherein the longitudinally extending negative pressure supply channel is connected to a negative pressure source and is configured to supply negative pressure along the longitudinally extending negative pressure supply channel, via the plurality of negative pressure supply ports and the sleeve port, to the gap between the expandable portions in a radial direction relative to the longitudinal axis of the sleeve.

[0209] <Embodiment 3> 1. A medical system for applying negative pressure within a subject's gastrointestinal tract, the medical system comprising: (i) a gastrointestinal tract; (i) a sleeve extending along a longitudinal axis, (a) a plurality of tubular sections having a first diameter about the longitudinal axis of the sleeve, each of the plurality of tubular sections including at least one sleeve opening; (b) a plurality of inflatable sections including at least three expandable sections, each adjacent pair of the plurality of inflatable sections being separated by one of the plurality of tubular sections, each of the plurality of inflatable sections comprising: a delivery operating state; a plurality of expandable sections in an inflated operating state when inflated with an inflation fluid, wherein in the inflated operating state, the plurality of expandable sections have second diameters about the longitudinal axis of the sleeve, the second diameter being greater than the first diameter, thereby forming gaps between the expandable sections along the longitudinal axis of the sleeve; Including sleeve. (ii) a longitudinal shaft disposed within the sleeve along the longitudinal axis, (a) at least one longitudinally extending inflation fluid supply channel; (b) a longitudinally extending negative pressure supply channel; (c) a plurality of inflation fluid supply ports longitudinally disposed along the longitudinal shaft, each of the inflation fluid supply ports in fluid communication with one of the at least one longitudinally extending inflation fluid supply channel and one of the plurality of inflatable portions; (d) a plurality of negative pressure supply ports longitudinally disposed along the longitudinal shaft, the plurality of negative pressure supply ports in fluid communication with the negative pressure supply channel and aligned with the sleeve ports; the at least one longitudinally extending inflation fluid supply channel is connected to a supply of inflation fluid and is configured to supply the inflation fluid to the plurality of inflatable portions through the plurality of inflation fluid supply ports; the longitudinally extending negative pressure supply channel is connected to a negative pressure source and configured to supply negative pressure along the negative pressure supply channel and through the plurality of negative pressure supply ports and the sleeve port to the gap between the inflatable portions in a radial direction relative to the longitudinal axis; and a longitudinal shaft.

[0210] <Embodiment 4> A medical system as described in embodiment 1, wherein the multiple expandable portions are integrally formed with the longitudinal shaft.

[0211] <Embodiment 5> A medical system according to any one of embodiment 1, embodiment 2, and embodiment 4, wherein each of the plurality of expandable sections comprises a shape memory scaffold, the shape memory scaffold is held in a compressed state when the expandable section is in the delivery actuation state, and the expandable section transitions from the delivery actuation state to the expanded actuation state upon release of the shape memory scaffold from the compressed state and expansion of the shape memory scaffold.

[0212] <Embodiment 6> A medical system described in any one of embodiment 1, embodiment 2, and embodiment 4, wherein each of the plurality of expandable sections comprises a porous compressible material, the porous compressible material is held in a compressed state when the expandable section is in the delivery operating state, and the expandable section transitions from the delivery operating state to the expanded operating state upon release of the porous compressible material from the compressed state and expansion of the shape memory scaffold.

[0213] <Embodiment 7> A medical system described in any one of embodiment 1, embodiment 2, and embodiment 4, wherein each of the multiple expandable portions has a precursor or reactant for a chemical reaction disposed therein, and inducing the chemical reaction between the precursors or reactants results in the release of gas or expansion of material, thereby transitioning the expandable portion from the delivery operating state to the expansion operating state.

[0214] <Embodiment 8> A medical system described in any one of embodiment 1 or embodiments 4 to 7, wherein each of the expandable portions comprises an expansion sleeve portion disposed outside the expandable portion, and the expansion sleeve portion tightly engages with the longitudinal shaft.

[0215] <Embodiment 9> A medical system as described in embodiment 8, wherein the plurality of expandable portions comprises a plurality of inflatable portions, and the plurality of inflatable portions are configured to transition from the delivery operating state to the expansion operating state by introducing an inflation fluid therein.

[0216] <Embodiment 10> 10. The medical system of embodiment 9, wherein the longitudinal shaft further comprises: (c) at least one longitudinally extending inflation fluid supply channel; (d) a plurality of inflation fluid supply ports longitudinally disposed along the longitudinal shaft; each of the plurality of inflation fluid supply ports in fluid communication with one of the at least one longitudinally extending inflation fluid supply channel and one of the plurality of inflatable portions; The at least one longitudinally extending inflation fluid supply channel is configured to connect to an inflation fluid source for supplying inflation fluid to the plurality of inflatable portions via the plurality of inflation fluid supply ports.

[0217] <Embodiment 11> A medical system as described in embodiment 3 or embodiment 10, wherein the at least one longitudinally extending inflation fluid supply channel comprises a plurality of longitudinally extending inflation fluid supply channels, each channel being in fluid communication with a corresponding one of the plurality of inflatable portions and configured to be connected to the inflation fluid source and to supply the inflation fluid to the corresponding inflatable portion.

[0218] <Embodiment 12> A medical system as described in embodiment 11, wherein each of the plurality of longitudinally extending inflation fluid supply channels is configured to connect to a different source of the inflation fluid.

[0219] <Embodiment 13> A medical system as described in embodiment 11, wherein the multiple longitudinally extending inflation fluid supply channels are configured to connect to the inflation fluid source at different times.

[0220] <Embodiment 14> A medical system described in any one of embodiment 3 or embodiments 10 to 13, wherein the inflatable portions transition from the delivery operating state to the expansion operating state by introducing the inflation fluid into the plurality of inflatable portions through the at least one inflation fluid supply channel and the inflation fluid supply port.

[0221] <Embodiment 15> The medical system according to any one of embodiment 3 or embodiments 9 to 14, wherein the inflation fluid includes saline.

[0222] <Embodiment 16> The medical system according to any one of the third embodiment and the tenth to fifteenth embodiments, further comprising the inflation fluid source.

[0223] <Embodiment 17> The medical system according to any one of embodiments 8 to 16, further comprising a sleeve extending along the longitudinal axis, wherein the sleeve: the plurality of expandable portions; each pair of adjacent expandable portions being separated by one of the plurality of tubular portions; a plurality of sleeve ports disposed on the plurality of tubular portions; The medical system, wherein the longitudinally extending negative pressure supply channel is configured to supply the negative pressure to the gap between the expandable portions via the negative pressure supply port and the sleeve port.

[0224] <Embodiment 18> A medical system according to any one of embodiment 3 or embodiments 10 to 17, wherein the inner diameter of the at least one longitudinally extending inflation fluid supply channel is in the range of 0.15mm to 4mm, 0.2mm to 4mm, 0.3mm to 4mm, 0.15mm to 3mm, 0.2mm to 3mm, 0.3mm to 3mm, 0.5mm to 3mm, 0.15mm to 2mm, 0.2mm to 2mm, 0.3mm to 2mm, 0.5mm to 2mm, or 0.5mm to 1.2mm.

[0225] <Embodiment 19> A medical system described in any one of embodiment 3 or embodiments 10 to 18, wherein the diameter of each opening in the multiple inflation fluid supply ports is in the range of 0.05mm to 10mm, 0.05mm to 7mm, 0.05mm to 5mm, 0.05mm to 2mm, 0.1mm to 5mm, 0.1mm to 2mm, 0.2mm to 2mm, 0.3mm to 2mm, 0.5mm to 2mm, or 0.5mm to 1.0mm.

[0226] <Embodiment 20> The medical system according to any one of the third embodiment and seventeenth to nineteenth embodiments, wherein the length of the sleeve is 6 to 200 mm.

[0227] <Embodiment 21> The medical system according to any one of embodiment 3 or embodiments 17 to 20, wherein the length of the sleeve is at least 10 mm.

[0228] <Embodiment 22> A medical system described in any one of embodiment 3 or embodiments 17 to 21, wherein the length of each of the tubular portions of the sleeve is in the range of 2 to 40 mm, 2 mm to 20 mm, 2 mm to 15 mm, or 0.5 mm to 40 mm.

[0229] <Embodiment 23> A medical system according to any one of embodiment 3 or embodiments 17 to 21, wherein the length of each of the tubular portions of the sleeve is a maximum of 40 mm.

[0230] <Embodiment 24> The medical system according to any one of the third embodiment and seventeenth to twenty-third embodiments, wherein the outer diameter of each tubular portion of the sleeve is in the range of 1.5 to 10 mm.

[0231] <Embodiment 25> The medical system according to any one of the third embodiment or the seventeenth to twenty-fourth embodiments, wherein the longest dimension of each sleeve opening is in the range of 0.5 mm to 10 mm or 0.5 mm to 5 mm.

[0232] <Embodiment 26> A medical system described in any one of embodiments 1 to 25, wherein the plurality of expandable or inflatable parts include at least four or at least five expandable or inflatable parts.

[0233] <Embodiment 27> A medical system described in any one of embodiments 1 to 26, wherein the outer diameter of the expandable portion or the inflatable portion in the delivery operating state is in the range of 2mm to 8mm, 2mm to 7mm, 2mm to 6mm, 2mm to 5mm, 2mm to 4mm, 2mm to 3.5mm, 3.0mm to 8mm, 3mm to 7mm, 3mm to 6mm, 3mm to 5mm, 3mm to 4mm, or 3mm to 3.5mm.

[0234] <Embodiment 28> A medical system described in any one of embodiments 1 to 27, wherein the outer diameter of the expandable portion or the inflatable portion in the expanded operating state is in the range of 5mm to 30mm, 7mm to 30mm, 10mm to 30mm, 10mm to 25mm, 10mm to 22mm, 10mm to 20mm, 10mm to 20mm, 7mm to 20mm, or 5mm to 20mm.

[0235] <Embodiment 29> A medical system described in any one of embodiments 1 to 28, wherein in the expanded operating state, the most proximal expandable or inflatable portion and the most distal expandable or inflatable portion have a larger outer diameter than the remaining multiple expandable or inflatable portions arranged between the most proximal expandable or inflatable portion and the most distal expandable or inflatable portion.

[0236] <Embodiment 30> A medical system described in any one of embodiments 1 to 28, wherein in the expanded operating state, the most proximal expandable or inflatable portion and the most distal expandable or inflatable portion have an outer diameter smaller than that of the remaining expandable or inflatable portions arranged between the most proximal expandable or inflatable portion and the most distal expandable or inflatable portion.

[0237] <Embodiment 31> A medical system according to any one of embodiments 1 to 30, wherein in the expanded operating state, the cross section of at least one of the expandable portion or the inflatable portion is annular.

[0238] <Embodiment 32> A medical system according to any one of embodiments 1 to 31, wherein in the expanded operating state, the cross section of each of the expandable portion or the inflatable portion is annular.

[0239] <Embodiment 33> The medical system according to any one of the first to thirty-second embodiments, wherein in the expanded operating state, at least one of the expandable portion or the inflatable portion is ring-shaped.

[0240] <Embodiment 34> A medical system according to any one of embodiments 1 to 33, wherein in the expanded operating state, each of the expandable portion or the inflatable portion is ring-shaped.

[0241] <Embodiment 35> A medical system described in any one of embodiments 1 to 32, wherein in the expanded operating state, at least one of the expandable portion or the inflatable portion is spherical with a tubular center.

[0242] <Embodiment 36> A medical system described in any one of embodiments 1 to 32, wherein in the expanded operating state, each of the expandable portion or the inflatable portion is spherical with a tubular center.

[0243] <Embodiment 37> A medical system described in any one of embodiments 1 to 30, wherein in the expanded operating state, at least one cross section of the expandable portion or the inflatable portion includes multiple lobes, and each pair of adjacent lobes is separated by a recess.

[0244] <Embodiment 38> A medical system as described in embodiment 37, wherein in the expanded operating state, the cross-section of the first expandable portion or inflatable portion and the cross-section of the second expandable portion or inflatable portion include the multiple lobes, and each pair of adjacent lobes is separated by the recess.

[0245] <Embodiment 39> A medical system as described in embodiment 38, wherein in the expanded operating state, the recess of the first expandable portion or inflatable portion is longitudinally aligned with the recess of the second expandable portion or inflatable portion.

[0246] <Embodiment 40> A medical system as described in embodiment 38, wherein in the expanded operating state, the recess of the first expandable portion or inflatable portion is rotationally offset relative to the recess of the second expandable portion or inflatable portion, such that the recess of the first expandable portion or inflatable portion is not longitudinally aligned with the recess of the second expandable portion or inflatable portion.

[0247] <Embodiment 41> A medical system described in any one of embodiments 1 to 30 or embodiment 37, wherein in the expanded operating state, at least one of the expandable portion or the inflatable portion includes a plurality of longitudinally arranged lobes and a plurality of longitudinally arranged recesses, and each pair of adjacent longitudinally arranged lobes is separated by one of the longitudinally arranged recesses.

[0248] <Embodiment 42> A medical system described in any one of embodiments 37 to 41, wherein in the expanded operating state of the expandable portion or the inflatable portion, the height difference between one of the plurality of lobes and one of the adjacent plurality of recesses is at least 0.5 mm.

[0249] <Embodiment 43> A medical system described in any one of embodiments 37 to 42, wherein in the expanded operating state of the expandable portion or the inflatable portion, the height difference between one of the plurality of lobes and one of the adjacent plurality of recesses is in the range of 1 mm to 7 mm, 1 mm to 5 mm, 1 mm to 4 mm, or 1 mm to 3 mm.

[0250] <Embodiment 44> A medical system according to any one of embodiments 37 to 43, wherein the number of lobes in the plurality of lobes is at least 3, at least 4, at least 5, or at least 6.

[0251] <Embodiment 45> A medical system described in any one of embodiments 37 to 44, wherein the lobes are arranged circumferentially at equal intervals around the at least one expandable or inflatable portion.

[0252] <Embodiment 46> A medical system described in any one of embodiments 1 to 45, wherein the radially outer surface of at least one of the expandable portion or the inflatable portion is textured.

[0253] <Embodiment 47> A medical system described in any one of embodiments 1 to 46, wherein, in the expanded operating state, the first of the plurality of expandable sections or the inflatable section has a first cross-section in a direction perpendicular to the longitudinal axis, and the second of the plurality of expandable sections or the inflatable section has a second cross-section in a direction perpendicular to the longitudinal axis, the second cross-section being different from the first cross-section.

[0254] <Embodiment 48> In the medical system according to any one of the first to fourth embodiments, the cross-sectional area of ​​the negative pressure supply channel extending in the longitudinal direction is 1 mm 2 ~85mm 2 range, healthcare systems.

[0255] <Embodiment 49> A medical system described in any one of embodiments 1 to 48, wherein the longest dimension of each of the multiple negative pressure supply ports is in the range of 0.5mm to 15mm, 0.5mm to 12mm, 0.5mm to 10mm, 0.5mm to 7mm, 0.5mm to 5mm, 0.5mm to 3mm, or 1mm to 2mm.

[0256] <Embodiment 50> A medical system described in any one of embodiments 1 to 49, wherein the plurality of negative pressure supply ports include a first group and a second group, the negative pressure supply ports of the first group have a first longest dimension, and the negative pressure supply ports of the second group have a second longest dimension, and the second longest dimension is different from the first longest dimension.

[0257] <Embodiment 51> A medical system described in any one of embodiments 1 to 50, wherein the cross-sectional area of ​​the most distal of the plurality of negative pressure supply ports is larger than the cross-sectional area of ​​the most proximal of the plurality of negative pressure supply ports.

[0258] <Embodiment 52> A medical system described in any one of embodiments 1 to 51, wherein the distance along the longitudinal shaft between adjacent pairs of the plurality of negative pressure supply ports is in the range of 2 mm to 40 mm, 2 mm to 30 mm, 2 mm to 20 mm, or 2 mm to 10 mm.

[0259] <Embodiment 53> A medical system according to any one of embodiments 1 to 52, further comprising the negative pressure source.

[0260] <Embodiment 54> The medical system according to any one of the first to fifth embodiments, wherein the longitudinal shaft is a second, longitudinally extending negative pressure supply channel; a second plurality of negative pressure supply ports; the second plurality of negative pressure supply ports are longitudinally disposed along the longitudinal shaft and are in fluid communication with the second longitudinally extending negative pressure supply channel; The second longitudinally extending negative pressure supply channel is connected to a negative pressure source or an additional negative pressure source and is configured to supply negative pressure along the second longitudinally extending negative pressure supply channel and through the second plurality of negative pressure supply ports to the gap between the expandable portions or the inflatable portions in a radial direction relative to the longitudinal axis.

[0261] <Embodiment 55> A medical system described in any one of embodiments 1 to 53, wherein when not connected to a negative pressure source, the longitudinally extending negative pressure supply channel is configured to connect to a flushing fluid source and supply the flushing fluid to the gap via the multiple negative pressure supply ports.

[0262] <Embodiment 56> The medical system according to any one of the first to fifth embodiments, wherein the longitudinal shaft is a longitudinally extending flushing fluid supply channel; at least one flushing fluid supply port; the at least one flushing fluid supply inlet is in fluid communication with the longitudinally extending flushing fluid supply channel; The longitudinally extending flushing fluid supply channel is connected to the flushing fluid source and configured to supply the flushing fluid to the gap via the at least one flushing fluid supply port.

[0263] <Embodiment 57> A medical system according to embodiment 55 or embodiment 56, wherein the flushing fluid is a medicinal liquid.

[0264] <Embodiment 58> A medical system according to embodiment 55 or embodiment 56, wherein the flushing fluid is a contrast agent.

[0265] <Embodiment 59> A medical system according to embodiment 55 or embodiment 56, wherein the flushing fluid is an ionized gas.

[0266] <Embodiment 60> 57. The medical system of embodiment 55 or embodiment 56, wherein the flushing fluid is carbon dioxide.

[0267] <Embodiment 61> A medical system according to any one of embodiments 55 to 60, further comprising the flushing fluid source.

[0268] <Embodiment 62> A medical system described in any one of embodiments 1 to 61, wherein in the delivery state, the shaft is sized and configured to be positioned over a guidewire when delivered into the digestive tract of a subject.

[0269] <Embodiment 63> A medical system described in any one of embodiments 1 to 61, wherein in the delivery state, the shaft and expandable or inflatable portion are sized and configured to be delivered into the digestive tract of the subject through a working channel of a delivery device.

[0270] <Embodiment 64> A medical system described in any one of embodiments 1 to 63, further comprising a delivery sheath and the longitudinal shaft, wherein the delivery sheath has a diameter suitable for delivery into the subject's digestive tract through the working channel of a delivery device and is configured to accommodate the expandable portion or the inflatable portion in the delivery operating state.

[0271] <Embodiment 65> A medical system according to any one of embodiments 1 to 64, further comprising a textured layer covering the outside of at least a portion of the expandable portion or the inflatable portion.

[0272] <Embodiment 66> A medical system as described in embodiment 65, wherein the textured layer comprises a net layer or a mesh layer.

[0273] <Embodiment 67> A medical system as described in embodiment 65, wherein the textured layer is configured to contact the wound and provide mechanical stimulation.

[0274] <Embodiment 68> 1. A method of applying negative pressure to a target site in the gastrointestinal tract of a subject, comprising: (a) advancing a longitudinal shaft having at least three expandable sections disposed thereabout, the expandable sections being separated by gaps along the longitudinal shaft, the longitudinal shaft in a delivery actuation state to the target site; (b) transitioning the expandable or inflatable portion from the delivery operating state to an expansion operating state; (c) supplying negative pressure from a negative pressure source connected to the longitudinal shaft to the gap between the expandable portions via a negative pressure supply channel in the shaft and a negative pressure supply port in the shaft that is in fluid communication with the gap between the expandable portions and the negative pressure supply channel.

[0275] <Embodiment 69> The method of embodiment 68, further comprising, before (c), connecting the negative pressure source to the longitudinal shaft.

[0276] <Embodiment 70> The method of embodiment 68 or embodiment 69, further comprising, after (c), removing the longitudinal shaft and the expandable portion from the target site.

[0277] <Embodiment 71> The method of embodiment 70, further comprising the step of transitioning the expandable portion or the inflatable portion from the expanded operating state to the delivery operating state before the removing step.

[0278] <Embodiment 72> The method according to any one of embodiments 68 to 71, the plurality of expandable portions comprises a plurality of inflatable portions; the shaft includes a longitudinally extending inflation fluid supply channel and a plurality of longitudinally disposed inflation fluid supply ports; The method, wherein the expanding step (b) comprises supplying the inflation fluid from an inflation fluid source connected to the shaft to the inflatable portion through the inflation fluid supply channel and the inflation fluid supply port, thereby expanding the inflatable portion.

[0279] <Embodiment 73> 73. The method of embodiment 72, further comprising, before (b), connecting the inflation fluid source to the longitudinal shaft.

[0280] <Embodiment 74> 72. The method according to any one of claims 68 to 71, wherein the expandable portion comprises a shape-memory scaffold; While proceeding with step (a), the shape memory scaffold is held in a compressed state; The method, wherein expanding in step (b) comprises releasing the shape memory scaffold from the compressed state, whereby expansion of the shape memory scaffold results in expansion of the expandable portion.

[0281] <Embodiment 75> 72. The method according to any one of claims 68 to 71, wherein the expandable portion comprises a porous compressible material; A method wherein the porous compressible material is held in a compressed state while proceeding in step (a), and expanding in step (b) comprises releasing the porous compressible material from the compressed state, whereby expansion of the porous compressible material results in expansion of the expandable portion.

[0282] <Embodiment 76> A method according to any one of embodiments 68 to 71, wherein a reactant for a gas-releasing chemical reaction is disposed in the expandable portion, and the expansion in step (b) includes a step of inducing the gas-releasing chemical reaction, whereby gas release by the chemical reaction results in expansion of the expandable portion.

[0283] <Embodiment 77> The method according to any one of embodiments 68 to 76, connecting the shaft to a source of flushing fluid; The method further comprising supplying the flushing fluid to the gap between the expandable portions to effect flushing therein.

[0284] <Embodiment 78> A method as described in embodiment 77, wherein the flushing fluid is supplied through the negative pressure supply channel and the negative pressure supply port when the negative pressure supply channel is separated from the negative pressure source.

[0285] <Embodiment 79> 79. The method of embodiment 78, further comprising the step of disconnecting the shaft from the negative pressure source before connecting the shaft to the flushing fluid source.

[0286] <Embodiment 80> A method according to embodiment 77, wherein the longitudinal shaft further comprises a flushing fluid supply channel and at least one flushing fluid supply port fluidically connected to the flushing fluid supply channel, and the supply of the flushing fluid to the gap between the expandable portions is carried out via the flushing fluid supply channel and the flushing fluid supply port.

[0287] <Embodiment 81> A method according to any one of embodiments 68 to 80, wherein the advancing step comprises the steps of positioning the longitudinal shaft around a guidewire and advancing the guidewire around which the longitudinal shaft is positioned to the target site.

[0288] <Embodiment 82> A method according to any one of embodiments 68 to 80, wherein the advancing step comprises advancing the longitudinal shaft and the expandable portion in a delivery operating state through a working channel of a delivery device to a target site.

[0289] <Embodiment 83> 83. The method of embodiment 82, wherein the delivery device includes an imaging element, and the advancing step further comprises taking an image of the target treatment site while advancing to the target site.

[0290] <Embodiment 84> A method according to any one of embodiments 81 to 83, further comprising the step of removing the guidewire or delivery device from the target site prior to the expansion.

[0291] <Embodiment 85> 1. A medical system for applying negative pressure within a gastrointestinal tract of a subject, comprising: i. an inflation fluid supply channel having a distal end; ii. a longitudinal inflation body disposed at the distal end of the inflation fluid supply channel, the longitudinal inflation body having a delivery operative state and an inflation operative state; a. a tissue engaging portion having longitudinally disposed lobes and a plurality of recesses formed between the lobes when the longitudinal expansion body is in the expanded operating state; b. a bridge portion disposed between the inflation fluid supply channel and the tissue engaging portion, wherein in the inflation operating condition, a plurality of inlet recesses extend along an outer surface of the bridge portion from the distal end of the inflation fluid supply channel to the proximal end of each of the plurality of recesses; and a longitudinal expansion body comprising:

[0292] <Embodiment 86> 1. A medical system for applying negative pressure within a gastrointestinal tract of a subject, comprising: i. an inflation fluid supply channel having a distal end; ii. a longitudinal inflation body disposed at the distal end of the inflation fluid supply channel, the longitudinal inflation body having a delivery operative state and an inflation operative state; a. a tissue engaging portion having longitudinally disposed lobes and a plurality of recesses formed between the lobes when the longitudinal expansion body is in the expanded operating state; b. a bridge portion disposed between the inflation fluid supply channel and the tissue engaging portion, wherein in the inflation operating condition, a plurality of inlet recesses extend along an outer surface of the bridge portion from the distal end of the inflation fluid supply channel to the proximal end of each of the plurality of recesses; a longitudinal expansion body comprising: iii. a fluid-tight lumen including at least one channel, the fluid-tight lumen being connected to a negative pressure source and configured to provide negative pressure along the at least one channel to a proximal end of the longitudinal expansion body and to apply negative pressure along the longitudinally disposed recesses via the inlet recess; A medical system that includes:

[0293] <Embodiment 87> A medical system for applying negative pressure within a subject's digestive tract, comprising: i) a first end of a first tube; i. a longitudinal body having a delivery operating state and an expansion operating state, wherein in said expansion operating state: a. a plurality of longitudinally arranged lobes, each of the plurality of longitudinally arranged lobes configured to be connected to at least one inflation fluid source via an inflation fluid supply channel; b. a plurality of longitudinally disposed recesses, each pair of adjacent longitudinally disposed lobes being separated by one of the plurality of longitudinally disposed recesses; A longitudinal body including: ii. A fluid-tight lumen including at least one channel, the fluid-tight lumen being connected to a negative pressure source and configured to supply negative pressure along the at least one channel to the proximal end of the longitudinal body and to apply negative pressure along the longitudinally disposed recess.

[0294] <Embodiment 88> A medical system as described in embodiment 87, wherein the longitudinal body comprises a plurality of expandable longitudinal bodies joined to one another, each of the expandable longitudinal bodies including at least one of the plurality of longitudinally arranged lobes, whereby at least some of the plurality of longitudinally arranged recesses are formed between adjacent two of the plurality of expandable longitudinal bodies, and further comprising: The medical system further comprises a plurality of inflation fluid supply channels, each of which is in fluid communication with a corresponding one of the plurality of inflatable longitudinal bodies, connected to the at least one inflation fluid source, and supplies inflation fluid to the corresponding inflatable longitudinal body.

[0295] <Embodiment 89> A medical system as described in embodiment 88, wherein each of the multiple inflation fluid supply channels is configured to be connected to a dedicated inflation fluid source.

[0296] <Embodiment 90> 1. A medical system for applying negative pressure within a gastrointestinal tract of a subject, comprising: a longitudinal expansion body having a delivery operating state and an expansion operating state; an inflation fluid supply channel terminating in and in fluid communication with the longitudinal expansion body, the longitudinal expansion body being located at a distal end of the inflation fluid supply channel, the inflation fluid supply channel being configured to supply inflation fluid to the expansion body; In the expansion operating state, the longitudinal expansion body a plurality of longitudinally arranged lobes; a plurality of longitudinally arranged recesses; each pair of adjacent longitudinally disposed lobes being separated by one of the longitudinally disposed recesses; and A medical system, wherein the fluid-tight lumen including at least one negative pressure supply channel is connected to a negative pressure source and configured to supply negative pressure to the proximal end of the inflatable body and apply negative pressure along the longitudinally arranged recess.

[0297] <Embodiment 91> A medical system according to any one of embodiments 88 to 90, the inflation body includes a bridge portion and a tissue engaging portion, the bridge portion configured to be disposed between the inflation fluid supply channel and the tissue engaging portion; In the expanded operating state, the plurality of lobes and the plurality of recesses are formed in the tissue engaging portion; In the inflation operating condition, a plurality of inlet recesses extend along an outer surface of the bridge portion from a distal end of the inflation fluid supply channel to a proximal end of each of the plurality of recesses.

[0298] <Embodiment 92> A medical system described in any one of embodiments 85, 86, and 91, wherein, in the inflation operating state, the angle α between the longitudinal axis of one of the plurality of inlet recesses and the longitudinal axis of the inflation fluid supply channel is in the range of 100 to 160°, 105 to 155°, or 105 to 150°.

[0299] <Embodiment 93> A medical system described in any one of embodiments 85, 86, 91, and 92, wherein, in the inflation operating state, the angle β formed by the bridge portion at the connection between the bridge portion and the inflation fluid supply channel is in the range of 60 to 160°, 60 to 155°, 60 to 150°, or 70 to 150°.

[0300] <Embodiment 94> A medical system described in any one of embodiments 85 to 86 or embodiments 91 to 93, wherein at a distance of 2 mm from the distal end of the inflation fluid supply channel along the longitudinal axis of the inflation body, the height difference between one of the multiple inlet recesses and an adjacent lobe of the bridge portion is at least 0.4 mm or at least 0.5 mm.

[0301] <Embodiment 95> A medical system described in any one of embodiments 85 to 86 or embodiments 91 to 94, wherein, in the expansion operating state, the longitudinal length of at least one of the multiple inlet recesses is in the range of 10 to 80 mm.

[0302] <Embodiment 96> A medical system described in any one of embodiment 86 or embodiments 88 to 95, wherein the liquid-tight lumen further includes an additional channel configured to be arranged around the inflation fluid supply channel.

[0303] <Embodiment 97> A medical system described in any one of embodiments 85 to 96, wherein in the expansion operating state, when a negative pressure in the range of 50 to 350 mmHg is applied to the proximal end of the expansion body, the expansion body includes the multiple lobes and the multiple recesses.

[0304] <Embodiment 98> A medical system described in any one of embodiments 85 to 96, wherein, in the expansion operating state, when a negative pressure in the range of 50 to 350 mmHg is applied to the proximal end of the expansion body, the outer contour of the expansion body is maintained and the change in the outer contour is less than 20%, less than 15%, less than 10%, or less than 5%.

[0305] <Embodiment 99> A medical system described in any one of embodiments 85 to 98, wherein, in the expanded operating state of the expansion body, the height difference between one of the plurality of lobes and one of the adjacent plurality of recesses is at least 2 mm.

[0306] <Embodiment 100> A medical system described in any one of embodiments 85 to 98, wherein, in the expanded operating state of the expansion body, the height difference between one of the plurality of lobes and one of the adjacent plurality of recesses is at least 2 mm, or in the range of 1 mm to 7 mm, 1 mm to 6 mm, 1 mm to 5 mm, 1 mm to 4 mm, 1 mm to 3 mm, or 1 mm to 2 mm.

[0307] <Embodiment 101> A medical system according to any one of embodiments 85 to 100, wherein the number of lobes in the plurality of lobes is at least three, at least four, at least five, or at least six.

[0308] <Embodiment 102> A medical system according to any one of embodiments 85 to 101, wherein the lobes are circumferentially arranged around the inflatable body.

[0309] <Embodiment 103> A medical system according to any one of embodiments 85 to 102, wherein the lobes are arranged at equal intervals circumferentially around the expandable body.

[0310] <Embodiment 104> A medical system according to any one of embodiments 85 to 103, wherein the radially outer surface of at least one of the lobes is textured.

[0311] <Embodiment 105> A medical system described in any one of embodiments 85 to 103, wherein the radially outer surface of at least one of the plurality of lobes includes a second plurality of recesses separated by a plurality of ridges extending along the longitudinal length of the at least one lobe.

[0312] <Embodiment 106> A medical system according to any one of embodiment 86 or embodiments 88 to 105, wherein the expansion body is integrally formed with the expansion fluid supply channel.

[0313] <Embodiment 107> A medical system according to any one of embodiment 86 or embodiments 88 to 105, wherein the expansion body is separable from the expansion fluid supply channel.

[0314] <Embodiment 108> A medical system according to any one of embodiments 85 to 107, wherein the expansion body is contracted in the delivery operating state.

[0315] <Embodiment 109> A medical system described in any one of embodiments 86 to 108, wherein the outer diameter of the liquid-tight lumen is less than 8 mm, less than 6 mm, less than 5 mm, less than 4 mm, less than 3.7 mm, or less than 3.5 mm.

[0316] <Embodiment 110> A medical system described in any one of embodiment 86 or embodiments 88 to 109, wherein the outer diameter of the inflation fluid supply channel is less than 8 mm, less than 6 mm, less than 5 mm, less than 4 mm, less than 3.7 mm, or less than 3.5 mm.

[0317] <Embodiment 111> A medical system according to any one of embodiment 86 or embodiments 88 to 110, wherein the outer diameter of the inflation fluid supply channel is in the range of 1 mm to 6 mm.

[0318] <Embodiment 112> A medical system described in any one of embodiment 86 or embodiments 88 to 111, wherein the inner diameter of the inflation fluid supply channel is in the range of 0.5mm to 5mm, 0.5mm to 4mm, 0.5mm to 3mm, 0.5mm to 2mm, 0.5mm to 1.5mm, 0.5mm to 1mm, 1mm to 3mm, or 1.5mm to 3mm.

[0319] <Embodiment 113> A medical system described in any one of embodiments 85 to 112, wherein in the delivery operating state, the outer diameter of the expansion body is less than 8 mm, less than 6 mm, less than 5 mm, less than 4 mm, less than 3.7 mm, or less than 3.5 mm.

[0320] <Embodiment 114> A medical system described in any one of embodiments 85 to 113, wherein in the expansion operating state, the outer diameter of the expansion body is in the range of 5mm to 30mm, 7mm to 30mm, 10mm to 30mm, 10mm to 25mm, 10mm to 22mm, 10mm to 20mm, 10mm to 20mm, 7mm to 20mm, or 5mm to 20mm.

[0321] <Embodiment 115> A medical system described in any one of embodiments 85 to 86 or embodiments 88 to 114, wherein the expansion body transitions from the delivery operating state to the inflation operating state by introducing the expansion fluid into the expansion body through the expansion fluid supply channel.

[0322] <Embodiment 116> A medical system described in any one of embodiments 85 to 86 or embodiments 88 to 115, wherein the inflation fluid includes saline.

[0323] <Embodiment 117> A medical system described in any one of embodiments 85 to 86 or embodiments 88 to 116, further comprising the inflation fluid source.

[0324] <Embodiment 118> A medical system described in any one of embodiments 85 to 86 or embodiments 88 to 117, wherein the liquid-tight lumen is centrally positioned relative to and coaxial with the inflation fluid supply channel and the inflation body.

[0325] <Embodiment 119> A medical system according to any one of embodiments 86 to 118, wherein the at least one channel comprises an annular channel.

[0326] <Embodiment 120> A medical system as described in embodiment 119, wherein the at least one channel comprises an annular channel arranged around the additional channel and coaxially with the additional channel.

[0327] <Embodiment 121> A medical system as described in embodiment 120, wherein a plurality of struts connect the inner surface of the at least one channel to the outer surface of the additional channel, maintaining a coaxial relationship between the at least one channel and the additional channel.

[0328] <Embodiment 122> A medical system described in any one of embodiments 97, 120, and 121, wherein the at least one channel comprises a plurality of channels arranged circumferentially around the additional channel.

[0329] <Embodiment 123> A medical system as described in embodiment 122, wherein at least a portion of each of the plurality of second channels is longitudinally aligned with each of the plurality of recesses.

[0330] <Embodiment 124> The medical system according to any one of the embodiments 86 to 123, wherein the surface area of ​​the at least one channel is at least 5 mm in a direction perpendicular to the longitudinal axis thereof. 2 That is, the medical system.

[0331] <Embodiment 125> A medical system according to any one of embodiments 86 to 124, wherein in the expansion operating state, the outer diameter of the liquid-tight lumen is smaller than the maximum outer diameter of the expansion body.

[0332] <Embodiment 126> A medical system described in any one of embodiments 86 to 125, wherein the liquid-tight lumen is configured to be positioned in a fixed position relative to the expansion body.

[0333] <Embodiment 127> A medical system described in any one of embodiments 86 to 126, further comprising a fixing mechanism configured to fix the fluid-tight lumen in a fixed longitudinal position relative to the expansion body.

[0334] <Embodiment 128> A medical system described in any one of embodiments 86 to 127, wherein in the inflation operating state, the distance between the distal end of the fluid-tight lumen and the proximal end of one of the multiple recesses along the longitudinal axis of the inflation fluid supply channel and the inflation body is up to 6 mm, up to 4 mm, up to 2 mm, or up to 1 mm.

[0335] <Embodiment 129> A medical system described in any one of embodiments 86 to 128, further comprising a negative pressure source connected to the liquid-tight lumen, the negative pressure source configured to apply negative pressure in the range of 50 to 350 mmHg.

[0336] <Embodiment 130> A medical system described in any one of embodiments 86 to 129, wherein when not connected to the negative pressure source, at least one channel of the liquid-tight lumen is connected to a fluid source, and the fluid can be supplied to the multiple recesses through the at least one channel.

[0337] <Embodiment 131> A medical system as described in embodiment 130, further comprising the fluid source.

[0338] <Embodiment 132> A medical system according to embodiment 130 or embodiment 131, wherein the fluid is a medicinal liquid.

[0339] <Embodiment 133> The medical system of embodiment 130 or embodiment 131, wherein the fluid is a contrast agent.

[0340] <Embodiment 134> The medical system of embodiment 130 or embodiment 131, wherein the fluid is an ionized gas.

[0341] <Embodiment 135> The medical system of embodiment 130 or embodiment 131, wherein the fluid is carbon dioxide.

[0342] <Embodiment 136> A medical system described in any one of embodiments 85 to 135, wherein the expansion body in the delivery operating state is sized and configured to be delivered into the subject's digestive tract through the working channel of a delivery device.

[0343] <Embodiment 137> A medical system described in any one of embodiments 86 to 136, wherein the fluid-tight lumen is sized and configured to be delivered into the subject's digestive tract through the working channel of a delivery device.

[0344] <Embodiment 138> A medical system described in any one of embodiments 85 to 137, wherein the multiple lobes and the multiple recesses do not extend to the distal end of the expandable body, thereby causing the distal end of the expandable body to be cylindrical or spherical in the expansion operating state.

[0345] <Embodiment 139> A medical system described in any one of embodiments 86 to 138, further comprising a delivery sheath, the delivery sheath configured to accommodate the expansion body in the delivery operating state or the fluid-tight lumen during delivery into the subject's digestive tract.

[0346] <Embodiment 140> A medical system according to any one of embodiments 85 to 139, further comprising a textured layer covering the outside of the inflatable body.

[0347] <Embodiment 141> 1. A method of applying negative pressure to a target site in the gastrointestinal tract of a subject, comprising: (a) advancing an inflation body in a delivery activated state and connected to an inflation fluid supply channel to the target site; (b) transitioning the inflatable body from the delivery operating state to an expansion operating state by supplying inflation fluid to the inflatable body through the inflation fluid supply channel, wherein in the expansion operating state the inflatable body includes a plurality of longitudinally disposed lobes and a plurality of longitudinally disposed recesses, each pair of adjacent longitudinally disposed lobes being separated by one of the longitudinally disposed recesses; (c) advancing the fluid-tight lumen to the target site such that a distal end of the fluid-tight lumen is adjacent to a proximal end of the inflation body and at least one channel of the fluid-tight lumen is in fluid communication with each of the plurality of recesses; (d) supplying negative pressure from a negative pressure source connected to the at least one channel, through the at least one channel, to the proximal end of the inflatable body and along the longitudinally disposed recess.

[0348] <Embodiment 142> The method of embodiment 141, further comprising, before (d), a step of connecting the negative pressure source to the fluid-tight lumen.

[0349] <Embodiment 143> A method according to any one of embodiments 141 to 142, further comprising, after (d), a step of removing the fluid-tight lumen and the inflation fluid supply channel from the target site.

[0350] <Embodiment 144> The method of embodiment 143, further comprising the step of transitioning the expandable body from the expansion operating state to the delivery operating state prior to the removing step.

[0351] <Embodiment 145> A method as described in embodiment 143 or embodiment 144, wherein the removing step further comprises the steps of separating the fluid-tight lumen from the expansion body and removing the fluid-tight lumen from the target site separately from removing the expansion body from the target site.

[0352] <Embodiment 146> A method according to any one of embodiments 141 to 143, wherein the removal step comprises removing both the inflation fluid supply channel and the inflation body from the target site.

[0353] <Embodiment 147> A method according to any one of embodiments 141 to 143, wherein the removal step comprises separating the inflation fluid supply channel from the inflation body and then removing the inflation fluid supply channel from the target site.

[0354] <Embodiment 148> A method according to any one of embodiments 141 to 147, further comprising, before (b), a step of connecting an inflation fluid source to the inflation fluid supply channel.

[0355] <Embodiment 149> The method according to any one of embodiments 141 to 148, further comprising: connecting the fluid-tight lumen to a fluid source; supplying the fluid from the fluid source to the proximal end of the inflatable body along the longitudinally disposed recesses through the at least one channel of the fluid-tight lumen.

[0356] <Embodiment 150> A method according to embodiment 149, wherein the step of supplying the fluid is performed when the at least one channel of the fluid-tight lumen is isolated from the negative pressure source.

[0357] <Embodiment 151> The method of embodiment 150, further comprising the step of isolating the fluid-tight lumen from the negative pressure source before connecting the fluid-tight lumen to the fluid source.

[0358] <Embodiment 152> A method according to any one of embodiments 141 to 151, wherein the advancing step comprises placing the inflation fluid supply channel and the inflation body within a working channel of a delivery device, and advancing the delivery device with the inflation fluid supply channel and the inflation body positioned therein to the target site.

[0359] <Embodiment 153> The method of embodiment 152, further comprising removing the inflation fluid supply channel and the inflation body from the working channel of the delivery device prior to the transferring step.

[0360] <Embodiment 154> A method as described in embodiment 152 or embodiment 153, wherein the delivery device includes an imaging element, and the advancing step further comprises taking an image of the expanding body while the expanding body advances to the target site.

[0361] It should be understood that the use of "and / or" is defined inclusively, and the term "a and / or b" is to be interpreted as including the sets "a and b," "a or b," "a," and "b."

[0362] The various systems, devices, apparatus, etc. of the present disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure their safety for patient use, and the methods herein can include steps of so sterilizing the relevant systems, devices, apparatus, etc. Additionally, the scope of the present disclosure includes sterilizing one or more of the various systems, devices, apparatus, etc. of the present disclosure in some applications.

[0363] Any of the techniques, methods, operations, processes, etc. described or suggested herein may be performed on live animals (e.g., humans, other mammals, etc.) or on non-living simulations such as cadavers, ex vivo organs, and / or simulator devices (which may include electronic and / or physical representations of body parts, tissues, etc.).

[0364] The present invention is not limited to what has been particularly shown and described above. Rather, the scope of the present invention includes combinations and subcombinations of the various features described above, as well as variations and modifications thereof that would occur to one skilled in the art upon reading the above description and that are not present in the prior art. Furthermore, the techniques, methods, operations, steps, etc. described or suggested herein may be performed on live animals or non-living simulations, such as cadavers, cadaver digestive tracts, simulators (e.g., computerized versions of body parts, tissues, etc.).

[0365] Although some operations in the disclosed examples are described in a particular order for convenience, it should be understood that this method of description encompasses rearrangements unless a particular order is required by specific terminology above. For example, operations or steps described in a sequence may be rearranged or performed simultaneously in some cases. Moreover, for the sake of brevity, the accompanying figures may not show the various ways in which the disclosed methods can be used in combination with other methods. In addition, terms such as "provide" and "achieve" may be used herein to describe the disclosed methods. These terms are high-level abstractions of operations that are actually performed, and the actual acts corresponding to these terms may vary depending on the particular embodiment and are discernible to those skilled in the art.

Claims

1. 1. A medical system for applying negative pressure within a gastrointestinal tract of a subject, comprising: (i) a longitudinal shaft disposed along a longitudinal axis and having a first diameter about the longitudinal axis; The longitudinal shaft (a) a longitudinally extending negative pressure supply channel; (b) a plurality of negative pressure supply ports longitudinally disposed along the longitudinal shaft and in fluid communication with the negative pressure supply channel; (c) at least one longitudinally extending inflation fluid supply channel; (d) at least three inflation fluid supply ports longitudinally disposed along the longitudinal shaft and in fluid communication with the at least one longitudinally extending inflation fluid supply channel; The medical system further comprises: (ii) comprising at least three inflatable sections; The expandable portions are periodically arranged along the shaft and extend outwardly from the shaft, with a gap between each pair of adjacent expandable portions, and each expandable portion comprises: a delivery activation state in which the expandable portion has a first dimension perpendicular to a longitudinal axis of the shaft that is sized to pass through a working channel of a delivery device; and an expanded operating state in which the expandable portions have a second dimension about the longitudinal axis, the second dimension being greater than the first dimension, and gaps are formed between the expandable portions along the longitudinal axis; each of the inflatable portions is in fluid communication with one of the at least one longitudinally extending inflation fluid supply channel via at least one longitudinally extending inflation fluid supply port; the longitudinally extending negative pressure supply channel is connected to a negative pressure source and configured to supply negative pressure along the longitudinally extending negative pressure supply channel and through the plurality of negative pressure supply ports to gaps between the inflatable portions in a radial direction relative to the longitudinal axis; The at least one longitudinally extending inflation fluid supply channel is connected to an inflation fluid source and The medical system is configured to supply inflation fluid to the plurality of inflatable portions via the plurality of inflation fluid supply ports.

2. 10. The medical system of claim 1, further comprising a sleeve extending along the longitudinal axis; The sleeve has at least three of the inflatable portions; a plurality of tubular portions, each pair of adjacent inflatable portions being separated by one of the plurality of tubular portions; a plurality of sleeve ports disposed on the plurality of tubular portions; A medical system, wherein the longitudinally extending negative pressure supply channel is configured to supply the negative pressure to the gap between the inflatable portions via the negative pressure supply port and the sleeve port.

3. 3. The medical system according to claim 1 or claim 2, wherein the length of each gap between each pair of adjacent inflatable portions is 40 mm or less.

4. 3. The medical system according to claim 1 or claim 2, wherein the length of each gap between each pair of adjacent inflatable portions is in the range of 2 mm to 40 mm.

5. The medical system according to any one of claims 1 to 4, wherein the at least three inflatable sections comprises at least five inflatable sections.

6. 6. The medical system according to claim 1, wherein the outer diameter of the inflatable portion in the inflated operating state is in the range of 5 mm to 30 mm, 7 mm to 30 mm, 10 mm to 30 mm, 10 mm to 25 mm, 10 mm to 22 mm, 10 mm to 20 mm, 10 mm to 20 mm, 7 mm to 20 mm, or 5 mm to 20 mm.

7. A medical system as described in any one of claims 1 to 6, wherein in the inflation operating state, the most proximal and most distal expandable sections have larger outer diameters than the remaining expandable sections disposed between the most proximal and most distal expandable sections.

8. The medical system according to any one of claims 1 to 7, wherein in the inflated operating state, at least one cross section of the inflatable portion is annular.

9. 9. The medical system according to claim 1, wherein in the inflated operating state, at least one of the inflatable portions is spherical with a tubular center.

10. A medical system as described in any one of claims 1 to 7, wherein in the inflated operating state, at least one cross section of the inflatable portion includes a plurality of rounded protrusions (lobes), and each pair of adjacent lobes is separated by a recess.

11. 11. The medical system of claim 10, wherein in the inflated operating state, the recess in a first inflatable portion is longitudinally aligned with the recess in a second inflatable portion.

12. 11. The medical system of claim 10, wherein in the inflation operating state, the recess of a first inflatable portion is rotationally offset relative to the recess of a second inflatable portion such that the recess of the first inflatable portion is not longitudinally aligned with the recess of the second inflatable portion.

13. 13. A medical system as claimed in any one of claims 1 to 7 or claims 10 to 12, wherein in the inflated operating state, at least one of the inflatable portions comprises a plurality of longitudinally disposed lobes and a plurality of longitudinally disposed recesses, each pair of adjacent longitudinally disposed lobes being separated by one of the longitudinally disposed recesses.

14. 14. A medical system as claimed in any one of claims 10 to 13, wherein in the inflated operating state of the inflatable section, a height difference between one of the plurality of lobes and an adjacent one of the plurality of recesses is at least 0.5 mm.

15. The medical system of any one of claims 1 to 14, wherein the radially outer surface of at least one of the expandable portions is textured.

16. A medical system as described in any one of claims 1 to 15, wherein the plurality of negative pressure supply ports includes a first group and a second group, the negative pressure supply ports of the first group having a first longest dimension and the negative pressure supply ports of the second group having a second longest dimension, the second longest dimension being different from the first longest dimension.

17. 17. The medical system according to claim 1, wherein the longitudinal shaft further comprises: a longitudinally extending flushing fluid supply channel; at least one flushing fluid supply inlet, the at least one flushing fluid supply inlet being in fluid communication with the longitudinally extending flushing fluid supply channel; The longitudinally extending flushing fluid supply channel is configured to connect to a flushing fluid source to supply the flushing fluid to the gap via the at least one flushing fluid supply port.

18. 18. The medical system of claim 1, comprising a delivery sheath and the longitudinal shaft, The delivery sheath has a diameter suitable for delivery through a working channel of a delivery device into the gastrointestinal tract of a subject, and is configured to accommodate the expandable portion in the delivery actuation state.

19. The medical system according to any one of claims 1 to 18, further comprising a textured layer covering the outside of at least a portion of the inflatable portion.

20. 1. A method of applying negative pressure to a target site in the gastrointestinal tract of a subject, comprising: (a) advancing a longitudinal shaft having at least three expandable sections disposed thereabout, the expandable sections being separated by gaps along the longitudinal shaft, the longitudinal shaft in a delivery actuation state to the target site; (b) transitioning the expandable portion from the delivery operating state to an expanded operating state; (c) supplying negative pressure from a negative pressure source connected to the longitudinal shaft to the gap between the expandable portions via a negative pressure supply channel in the shaft and a negative pressure supply port in the shaft that is in fluid communication with the gap between the expandable portions and the negative pressure supply channel.

21. 21. The method of claim 20, further comprising, prior to (c), connecting the negative pressure source to the longitudinal shaft.

22. 22. The method of claim 20 or claim 21, further comprising, after (c), removing the longitudinal shaft and the expandable portion from the target site.

23. 23. The method of claim 22, further comprising transitioning the expandable or inflatable portion from the expanded operating state to the delivery operating state prior to the removing step.

24. 1. A medical system for applying negative pressure within a gastrointestinal tract of a subject, comprising: i. an inflation fluid supply channel having a distal end; ii. a longitudinal inflation body disposed at the distal end of the inflation fluid supply channel, the longitudinal inflation body having a delivery operative state and an inflation operative state; a tissue engaging portion having a plurality of longitudinally disposed lobes and a plurality of recesses formed between the lobes when the longitudinal expansion body is in the expanded operating state; b. a bridge portion disposed between the inflation fluid supply channel and the tissue engaging portion, wherein in the inflation operating condition, a plurality of inlet recesses extend along an outer surface of the bridge portion from a distal end of the inflation fluid supply channel to the proximal end of each of the plurality of recesses; a longitudinal expansion body comprising: iii. a fluid-tight lumen including at least one channel, the fluid-tight lumen being connected to a negative pressure source and configured to provide negative pressure along the at least one channel to a proximal end of the longitudinal expansion body and along the longitudinally disposed recesses via the inlet recesses; A medical system that includes:

25. 25. The medical system of claim 24, wherein in the inflated operating state, an angle α between a longitudinal axis of one of the plurality of inlet recesses and a longitudinal axis of the inflation fluid supply channel is in a range of 100 to 160 degrees, 105 to 155 degrees, or 105 to 150 degrees.

26. 26. The medical system of claim 24 or claim 25, wherein in the inflated operating state, the angle β formed by the bridge portion at the connection between the bridge portion and the inflation fluid supply channel is in the range of 60 to 160°, 60 to 155°, 60 to 150°, or 70 to 150°.

27. 27. A medical system as described in any one of claims 24 to 26, wherein at a distance of 2 mm from the distal end of the inflation fluid supply channel along the longitudinal axis of the inflation body, the height difference between one of the plurality of inlet recesses and an adjacent lobe of the bridge portion is at least 0.4 mm or at least 0.5 mm.

28. 28. The medical system according to claim 24, wherein the fluid-tight lumen further comprises an additional channel configured to be disposed around the inflation fluid supply channel.

29. A medical system as described in any one of claims 24 to 28, wherein in the expansion operating state, the expansion body retains the plurality of lobes and the plurality of recesses when a negative pressure in the range of 50 to 350 mmHg is applied to the proximal end of the expansion body.

30. 30. The medical system of any one of claims 24 to 29, wherein a radially outer surface of at least one of the lobes is textured.

31. 31. A medical system as described in any one of claims 24 to 30, wherein a radially outer surface of at least one of the plurality of lobes includes a second plurality of recesses separated by a plurality of ridges extending along the longitudinal length of the at least one lobe.

32. 32. The medical system according to claim 24, wherein the expansion body is integrally formed with the expansion fluid supply channel.

33. 32. The medical system according to claim 24, wherein the inflatable body is separable from the inflation fluid supply channel.

34. A medical system according to any one of claims 24 to 33, wherein the outer diameter of the fluid-tight lumen is less than 8 mm, less than 6 mm, less than 5 mm, less than 4 mm, less than 3.7 mm, or less than 3.5 mm.

35. 35. A medical system according to any one of claims 24 to 34, wherein the outer diameter of the expansion body in the expansion operating state is in the range of 5 mm to 30 mm, 7 mm to 30 mm, 10 mm to 30 mm, 10 mm to 25 mm, 10 mm to 22 mm, 10 mm to 20 mm, 10 mm to 20 mm, 7 mm to 20 mm, or 5 mm to 20 mm.

36. 1. A method of applying negative pressure to a target site in the gastrointestinal tract of a subject, comprising: (a) advancing an inflation body in a delivery actuation state and connected to an inflation fluid supply channel to the target site; (b) transitioning the inflatable body from the delivery operating state to an inflation operating state by supplying inflation fluid to the inflatable body through the inflation fluid supply channel, wherein in the inflation operating state the inflatable body includes a plurality of longitudinally disposed lobes and a plurality of longitudinally disposed recesses, each pair of adjacent longitudinally disposed lobes being separated by one of the longitudinally disposed recesses; (c) advancing the fluid-tight lumen to the target site whereby a distal end of the fluid-tight lumen is adjacent to a proximal end of the inflation body and at least one channel of the fluid-tight lumen is in fluid communication with each of the plurality of recesses; (d) supplying negative pressure from a negative pressure source connected to the at least one channel, through the at least one channel, to the proximal end of the inflatable body and along the longitudinally disposed recess.

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