System and method for endoscopic vacuum treatment

Abstract

Medical systems and methods for applying negative pressure within a lumen are provided. The medical systems include one or more inflatable bodies having a delivery state in which it is adapted to be delivered into the lumen, and an inflated state. The inflatable bodies are coupled to an inflating-fluid delivery channel for transitioning the inflatable bodies from the delivery state to the inflated state. The inflatable bodies are coupled to a negative-pressure delivery channel, for delivery of negative pressure to the interior of the lumen, outside of the inflatable bodies. In one implementation, the inflatable body is longitudinal, and the negative pressure is applied along a longitudinal axis of the inflatable body. In another implementation, multiple inflatable bodies extend out of a longitudinal shaft, and the negative pressure if applied via orifices in the shaft in a radial direction relative to the longitudinal axis of the shaft.

Description

[0001] SYSTEM AND METHOD FOR ENDOSCOPIC VACUUM TREATMENT

[0002] REFERENCE TO RELATED APPLICATIONS

[0003] The present application claims the benefit of US provisional application serial number 63 / 433,031, filed December 16, 2022, which is incorporated herein by reference in its entirety. The present application additionally claims the benefit of US provisional application serial number 63 / 433,032, filed December 16, 2022, which is incorporated herein by reference in its entirety.

[0004] BACKGROUND

[0005] Wounds along the gastrointestinal tract such as perforations and post-surgical leaks, are common in endoscopic and open surgical procedures. The endoluminal locations of these wounds, as well as the naturally wet and bacteria-rich environment surrounding the wound, make these wounds particularly difficult to treat. Limited treatment options exist for these wounds, which have significant morbidity and mortality rates and involve extensive hospital stay.

[0006] Vacuum assisted closure (VAC) therapy can increase the rate of wound closure. Negative pressure wound therapy (NPWT) or VAC therapy is the application of sub-atmospheric pressure to acute or chronic wounds to promote the healing of a wound. In theory, creating a negativepressure in the local wound environment draws away bacteria, exudate, fluid, and debris tissue from the wound site, increases the rate of healing by promoting blood flow, and facilitates localized cell migration and proliferation.

[0007] There is thus a need for improved techniques and devices for assisting in healing of wounds in the GI tract, by removal of liquid from the environment of the wounds.

[0008] SUMMARY

[0009] Various applications herein relate to medical systems and methods for removal of liquid from a target area in the GI tract, as well as for introduction of fluids into the target area, for example as prophylactic treatment to prevent infection or to assist in healing of an endoluminal wound in the target area.

[0010] A medical system for applying negative pressure within a gastrointestinal tract of a subject is disclosed herein. In a first embodiment, the system includes:

[0011] (i) a longitudinal shaft disposed along a longitudinal axis, the longitudinal shaft including: (a) a longitudinally extending negative-pressure delivery channel; and

[0012] (b) a plurality of negative-pressure delivery orifices, longitudinally distributed along the longitudinal shaft, the plurality of negative -pressure delivery orifices being in fluid communication with the negative-pressure delivery channel; and

[0013] (ii) a plurality of expandable portions including at least three expandable portions, disposed periodically along the shaft and extending outwardly therefrom, such that a gap is formed between each pair of adjacent ones of the plurality of expandable portions, each of the plurality of expandable portions having: a delivery operative state in which the plurality of expandable portions have a first dimension, or a first diameter, perpendicular to the longitudinal axis of the shaft; and an expanded operative state in which the plurality of expandable portions have a second dimension, or a second diameter, about the longitudinal axis, the second dimension or diameter being greater than the first dimension or diameter, wherein the longitudinally extending negative-pressure delivery channel is adapted to couple to a source of negative pressure and to deliver negative pressure, along the longitudinally extending negative -pressure delivery channel and via the plurality of negative -pressure delivery orifices, to the gaps between the expandable portions, in a radial direction relative to the longitudinal axis.

[0014] In a second embodiment, the medical system includes:

[0015] (i) a sleeve extending along a longitudinal axis, the sleeve including:

[0016] (a) a plurality of tubular portions having a first diameter about the longitudinal axis of the sleeve, each of the plurality of tubular portions including at least one sleeve orifice; and

[0017] (b) a plurality of expandable portions including at least three expandable portions, each pair of adjacent ones of the plurality of expandable portions being separated by one of the plurality of tubular portions, each of the plurality of expandable portions having: a delivery operative state; and an expanded operative state in which the plurality of expandable portions have a second diameter about the longitudinal axis of the sleeve, the second diameter being greater than the first diameter, such that gaps are formed between the expandable portions along the longitudinal axis of the sleeve; and

[0018] (ii) a longitudinal shaft, disposed within the sleeve, and including:

[0019] (a) a longitudinally extending negative-pressure delivery channel; and (b) a plurality of negative-pressure delivery orifices, longitudinally distributed along the longitudinal shaft, the plurality of negative -pressure delivery orifices being in fluid communication with the negative-pressure delivery channel and being aligned with the sleeve orifices, wherein the longitudinally extending negative-pressure delivery channel is adapted to couple to a source of negative pressure and to deliver negative pressure, along the longitudinally extending negative-pressure delivery channel and via the plurality of negativepressure delivery orifices and the sleeve orifices, to the gaps between the expandable portions, in a radial direction relative to the longitudinal axis of the sleeve.

[0020] In another embodiment, the medical system includes:

[0021] (i) a sleeve extending along a longitudinal axis, the sleeve including:

[0022] (a) a plurality of tubular portions having a first diameter about the longitudinal axis of the sleeve, each of the plurality of tubular portions including at least one sleeve orifice; and

[0023] (b) a plurality of inflatable portions including at least three expandable portions, each pair of adjacent ones of the plurality of inflatable portions being separated by one of the plurality of tubular portions, each of the plurality of inflatable portions having: a delivery operative state; and an inflated operative state when inflated by an inflating fluid, wherein, in the inflated operative state, the plurality of inflatable portions have a second diameter about the longitudinal axis of the sleeve, the second diameter being greater than the first diameter, such that gaps are formed between the inflatable portions along the longitudinal axis of the sleeve; and

[0024] (ii) a longitudinal shaft, disposed within the sleeve along the longitudinal axis, and including:

[0025] (a) at least one longitudinally extending inflating-fluid delivery channel;

[0026] (b) a longitudinally extending negative-pressure delivery channel;

[0027] (c) a plurality of inflating-fluid delivery orifices, longitudinally distributed along the longitudinal shaft, each the plurality of inflating-fluid orifices being in fluid communication with one of the at least one longitudinally extending inflating-fluid delivery channel and with one of the plurality of inflatable portions; and

[0028] (d) a plurality of negative-pressure delivery orifices, longitudinally distributed along the longitudinal shaft, the plurality of negative -pressure delivery orifices being in fluid communication with the negative-pressure delivery channel and being aligned with the sleeve orifices, wherein the at least one longitudinally extending inflating-fluid delivery channel is adapted to couple to a source of the inflating fluid for delivery of the inflating fluid to the plurality of inflatable portions, via the plurality of inflating-fluid delivery orifices, and wherein the longitudinally extending negative-pressure delivery channel is adapted to couple to a source of negative pressure and to deliver negative pressure, along the negativepressure delivery channel and via the plurality of negative-pressure delivery orifices and the sleeve orifices, to the gaps between the inflatable portions, in a radial direction relative to the longitudinal axis.

[0029] In another embodiment, a method for applying negative pressure within a gastrointestinal tract of a subject is disclosed herein. In some embodiments, the method includes:

[0030] (a) advancing to the target location a longitudinal shaft having at least three expandable portions disposed therearound, the plurality of expandable portions being separated by gaps along the longitudinal shaft and being in a delivery operative state;

[0031] (b) transitioning the expandable or inflatable portions from the delivery operative state to an expanded operative state;

[0032] (c) delivering negative pressure, from a negative pressure source coupled to the longitudinal shaft, to the gaps between the expandable portions, via a negative-pressure delivery channel in the shaft and via negative-pressure delivery orifices in the shaft which are in fluid communication with the gaps and with the negative-pressure delivery channel.

[0033] A medical system for applying negative pressure within a gastrointestinal tract of a subject is disclosed herein. In another embodiment, the system includes: i. an inflating-fluid delivery channel having a distal end; and ii. a longitudinal inflatable body disposed at the distal end of the inflating-fluid delivery channel, the longitudinal inflatable body having a delivery operative state and an inflated operative state, the longitudinal inflatable body comprising: a. a tissue-engaging portion having a plurality of longitudinally arranged lobes and a plurality of longitudinally arranged troughs formed therein when the longitudinal inflatable body is in the inflated operative state; and b. a bridging portion disposed between the inflating-fluid delivery channel and the tissueengaging portion, wherein, in the inflated operative state, a plurality of inlet troughs extend along an exterior surface of the bridging portion, from the distal end of the inflating-fluid delivery channel to a proximal end of each of the plurality of troughs.

[0034] In another embodiment, the system includes: i. an inflating-fluid delivery channel having a distal end; ii. a longitudinal inflatable body disposed at the distal end of the inflating-fluid delivery channel, the longitudinal inflatable body having a delivery operative state and an inflated operative state, the longitudinal inflatable body comprising: a. a tissue-engaging portion having a plurality of longitudinally arranged lobes and a plurality of longitudinally arranged troughs formed therein when the longitudinal inflatable body is in the inflated operative state; and b. a bridging portion disposed between the inflating-fluid delivery channel and the tissue-engaging portion, wherein, in the inflated operative state, a plurality of inlet troughs extend along an exterior surface of the bridging portion, from the distal end of the inflating-fluid delivery channel to a proximal end of each of the plurality of troughs; and iii. a fluid tight lumen including at least one channel, the fluid tight lumen adapted to couple to a source of negative pressure and to deliver negative pressure, along the at least one channel, to the proximal end of the longitudinal inflatable body, and to apply the negative pressure along the longitudinally arranged troughs via the inlet troughs.

[0035] In another embodiment, the medical system the medical system includes: i. a longitudinal body having a delivery operative state and an inflated operative state, wherein, in the inflated operative state, the longitudinal body includes: a. a plurality of longitudinally arranged lobes, each of the plurality of longitudinally arranged lobes adapted to be coupled, via an inflating fluid delivery channel, to at least one source of an inflating fluid; and b . a plurality of longitudinally arranged troughs, wherein each pair of adjacent longitudinally arranged lobes is separated by one of the plurality of longitudinally arranged troughs; and ii . a fluid tight lumen including at least one channel, the fluid tight lumen adapted to couple to a source of negative pressure and to deliver negative pressure, along the at least one channel, to a proximal end of the longitudinal body, and to apply the negative pressure along the longitudinally arranged troughs.

[0036] In another embodiment, the medical system the medical system includes: a longitudinal inflatable body having a delivery operative state and an inflated operative state; an inflating-fluid delivery channel terminating in, and in fluid communication with, the longitudinal inflatable body, such that the longitudinal inflatable body is at a distal end of the inflating-fluid delivery channel, the inflating-fluid delivery channel adapted for delivery of an inflating fluid to the inflatable body, wherein, in the inflated operative state, the longitudinal inflatable body includes: a plurality of longitudinally arranged lobes; and a plurality of longitudinally arranged troughs, wherein each pair of adjacent longitudinally arranged lobes is separated by one of the plurality of longitudinally arranged troughs; and a fluid tight lumen including at least one negative pressure delivery channel adapted to couple to a source of negative pressure and to deliver negative pressure to a proximal end of the inflatable body, and to apply the negative pressure along the longitudinally arranged troughs.

[0037] In another embodiment, there is provided a method of applying negative pressure to a target location of a gastrointestinal tract of a subject. In this aspect, the method includes:

[0038] (a) advancing to the target location an inflatable body, the inflatable body being in a delivery operative state and being coupled to an inflating-fluid delivery channel;

[0039] (b) transitioning the inflatable body from the delivery operative state to an inflated operative state, by delivering to the inflatable body, via the inflating-fluid delivery channel, an inflating fluid, wherein, in the inflated operative state, the inflatable body includes a plurality of longitudinally arranged lobes and a plurality of longitudinally arranged troughs, wherein each pair of adjacent longitudinally arranged lobes is separated by one of the plurality of longitudinally arranged troughs;

[0040] (c) advancing a fluid tight lumen to the target location, such that a distal end of the fluid tight lumen is adjacent a proximal end of the inflatable body and at least one channel of the fluid tight lumen is in fluid communication with each of the plurality of troughs;

[0041] (d) delivering negative pressure, from a negative pressure source coupled to the at least one channel, via the at least one channel, to the proximal end of the inflatable body and along the longitudinally arranged troughs.

[0042] BRIEF DESCRIPTION OF THE FIGURES

[0043] The foregoing discussion will be understood more readily from the following detailed description when taken in conjunction with the accompanying Figures, in which: Figs. 1A and IB are, respectively, a perspective illustration and a side view illustration of a sleeve forming part of a medical system according to embodiments of the disclosed technology;

[0044] Fig. 2 is a perspective view illustration of a sleeve, similar to that of Figs. 1A and IB, suitable for use in a lumen having a wound in a wall thereof, the sleeve forming part of a medical system according to embodiments of the disclosed technology;

[0045] Figs. 3A and 3B are, respectively, a perspective illustration and an end view illustration of a sleeve forming part of a medical system according to embodiments of the disclosed technology;

[0046] Figs. 4A and 4B are, respectively, a perspective illustration and an end view illustration of another sleeve forming part of a medical system according to embodiments of the disclosed technology;

[0047] Figs. 5A, 5B, and 5C are, respectively, two perspective view illustrations and an end view illustration of a sleeve forming part of a medical system according to embodiments of the disclosed technology;

[0048] Fig. 6 is a perspective view illustration of a sleeve forming part of a medical system according to embodiments of the disclosed technology;

[0049] Figs. 7A and 7B are end view illustrations of a sleeve forming part of a medical system according to embodiments of the disclosed technology, in a pleated operative state and in a delivery operative state, respectively;

[0050] Fig. 8 is sectional perspective view illustration of a longitudinal shaft, forming part of a medical system according to embodiments of the disclosed technology;

[0051] Figs. 9A, 9B, 9C, and 9D are, respectively, a perspective view illustration, an end view illustration, and two sectional illustrations of a medical system according to embodiments of the disclosed technology, the medical system including the sleeve of Figs. 1A and IB;

[0052] Figs. 10A and 10B are, respectively, an end view illustration and a sectional view illustration of a medical system including a sleeve according to additional embodiments of the disclosed technology, the sleeve being in a delivery operative state;

[0053] Figs. 11A and 11B are, respectively, an end view illustration and a sectional view illustration of the medical system of Figs. 10A and 10B, the sleeve being in an expanded operative state;

[0054] Figs. 12A and 12B are, respectively, an end view illustration and a side view illustration of a medical system according to further embodiments of the disclosed technology; Fig. 13 is a flow chart of a method of treating the gastrointestinal tract of a subject using a medical system according to embodiments of the disclosed technology;

[0055] Fig. 14 is a perspective view illustration of an inflatable body according to embodiments of the disclosed technology;

[0056] Figs. 15A and 15B are, respectively, a schematic side view illustration and a schematic front view illustration of an inflating-fluid delivery channel connected to the inflatable body of Fig. 14 according to embodiments of the disclosed technology;

[0057] Fig. 16 is a perspective view illustration of an inflatable body according to embodiments of the disclosed technology;

[0058] Figs. 17A and 17B are, respectively, a schematic side view illustration and a schematic front view illustration of an inflating-fluid delivery channel connected to the inflatable body of Fig. 16 according to embodiments of the disclosed technology;

[0059] Fig. 18 is a perspective cross sectional illustration of the inflatable body of Figs. 16- 17B, taken along section lines XVIII-XVIII in Fig. 17A;

[0060] Figs. 19A, 19B, and 19C are, respectively, a schematic side view illustration, a schematic front view illustration, and a partially cut away illustration of a medical system according to embodiments of the disclosed technology, including the inflating-fluid delivery channel and the inflatable body of Figs. 17 and 17B;

[0061] Fig. 20 is a flow chart of a method of treating the gastrointestinal tract of a subject using a medical system according to embodiments of the disclosed technology;

[0062] Figs. 21A, 21B, and 21C are schematic illustrations of mechanisms for deploying a portion of a medical system according to embodiments of the disclosed technology into the body of a subject;

[0063] Figs. 22A and 22B are schematic illustrations of a procedure of deploying a medical system according to embodiments of the disclosed technology into the body of a subject; and

[0064] Figs. 23A, 23B, 23C, 23D, and 23E are schematic illustrations of steps of a procedure for maintaining a medical system according to embodiments of the disclosed technology in the body of the subject via a nasal wire or tube.

[0065] DETAILED DESCRIPTION

[0066] The principles of the medical systems and methods may be better understood with reference to the drawings and the following description. In the following description, various aspects of the disclosure will be described. For the purpose of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the different aspects of the disclosure. However, it will also be apparent to one skilled in the art that the disclosure may be practiced without specific details being presented herein. Furthermore, well-known features can be omitted or simplified in order not to obscure the disclosure. Additionally, in order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some elements may not be explicitly identified in every drawing that contains that element.

[0067] It is to be understood that the scope of the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other implementations or of being practiced or carried out in various ways. Furthermore, it is to be understood that the phraseology and terminology employed in the disclosure is for the purpose of description and should not be regarded as limiting.

[0068] For the purposes of this application, the term “subject” relates to any mammal, particularly humans.

[0069] In the context of the present description and claims, the terms “proximal” and “distal” are defined relative to a direction in which the system is deployed into the body of the subject. As such, an element is said to be “proximal” if it is closer to the point at which the system enters the body of the subject than other elements, and is said to be “distal” if it is further from the point at which the system enters the body of the subject than other elements.

[0070] In the context of the present description and claims, the term “wound” relates to any form of damage to the tissue, including, but not limited to, a leak, a perforation, a rupture, a tear, a cut, or a fistula in the tissue, for example in the wall of the GI tract.

[0071] In the context of the present description and claims, the term “negative pressure” relates to sub-atmospheric pressure, which may be applied, for example, to help reduce inflammatory exudate and promote granulation tissue.

[0072] In the context of the present description and claims, the terms “expanded state” and “inflated state” of an element include any state that is more expanded, or more inflated, relative to a longitudinal axis of the element, than a delivery state of the element. As such, these terms include a state of partial expansion or inflation, as well as a state of complete expansion or inflation.

[0073] Referring now to the drawings, Figs. 1A and IB are, respectively, a perspective illustration and a side view illustration of a sleeve 100 forming part of a medical system according to embodiments of the disclosed technology. The sleeve is typically biocompatible or biodegradable and may be formed from a compliant, semi -compliant or non-compliant material.

[0074] As seen, sleeve 100 extends along a longitudinal axis 102, and includes a plurality of tubular portions 104. Each of tubular portions 104 has a first diameter DI, in a direction perpendicular to longitudinal axis 102. Each of tubular portions 104 includes at least one sleeve orifice 106.

[0075] In some embodiments, the length of sleeve 100 is in the range of 6mm to 200mm. In some embodiments, the length of sleeve 100 is at least 10mm.

[0076] In some embodiments, first diameter DI is in the range of 1.5 to 10 mm. In some embodiments, a length of each tubular portion 104, indicated by LI, is in the range of 2 to 40mm, 2 to 20mm, 2 to 15mm or 0.5 to 40mm. In some embodiments, each of sleeve orifices 106 has a diameter or longest dimension in the range of 0.5 to 5mm or 0.5 to 10mm.

[0077] Sleeve 100 further includes a plurality of inflatable portions 108, for example at least three, at least four, or at least five such inflatable portions. Each pair of adjacent inflatable portions 108 is separated by a tubular portion 104. Each of inflatable portions 108 has a delivery operative state, in which it is typically deflated and pleated or compressed, and an inflated operative state. In the inflated operative state, inflatable portion 108 have a second diameter D2, which is greater than diameter DI of tubular portions 104, such that gaps 110 are formed between inflatable portions 108, along longitudinal axis 102.

[0078] The inflated state results from passage of an inflating fluid through the inflating-fluid delivery channel and via the plurality of inflating-fluid delivery orifices. The expanded state may result from unfolding, unrolling, unfurling, unwinding, or spreading outwards of the delivery-state expandable portions

[0079] In some embodiments, an external diameter of inflatable portions 108, in the delivery 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.

[0080] In some embodiments, external diameter D2 of inflatable portions 108, in the inflated state, is in the range of

[0081] 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.

[0082] In some embodiments, diameter D2 is equal to all inflatable portions 108. However, in some embodiments, diameter D2Pof a proximal-most inflatable portion 108a, and diameter D2a of a distal-most inflatable portion 108b, in the inflated state, are greater than diameters D2 of other inflatable portions, disposed between inflatable portions 108a and 108b. As explained herein below, in use, such distinction in diameters enabling sealing of the sleeve against a target location within the gastrointestinal tract.

[0083] In some embodiments, diameter D2Pof a proximal-most inflatable portion 108a, and diameter D2a of a distal-most inflatable portion 108b, in the inflated state, are smaller than diameters D2 of other inflatable portions, disposed between inflatable portions 108a and 108b.

[0084] In some embodiments, sleeve 100 includes at least two inflatable portions 108. However, in other embodiments, sleeve 100 may include three inflatable portions (as shown), or more than three inflatable portions, such as four, five, or more inflatable portions.

[0085] In the embodiment illustrated in Figs. 1A and IB, inflatable portions 108 are ring shaped, and have a circular or annular cross section. However, in some other embodiments, inflatable portions 108 may be substantially spherical having a tubular center. Reference is now made to Fig. 2, which is a perspective view illustration of a sleeve 100’, similar to sleeve 100 of Figs. 1A and IB, suitable for use in a lumen having a wound in a wall thereof, sleeve 100’ forming part of a medical system according to embodiments of the disclosed technology.

[0086] As seen in Fig. 2, sleeve 100’ includes a first group 112a of inflatable portions 108, and a second group 112b of inflatable portion 108, the inflatable portions being similar to those described hereinabove with respect to Figs. 1A and IB. Inflatable portions 108 within each group are separated by tubular portions 104 substantially as described hereinabove with respect to Figs. 1A and IB, the tubular portions including sleeve orifices 106. The two groups 112a and 112b are separated by a tubular portion 114, which is typically longer than tubular portions 104, and may be bent, as shown in Fig. 2. In some embodiments, and as shown, tubular portion 114 may be devoid of sleeve orifices. In other embodiments, tubular portion 114 may include sleeve orifices, similar to sleeve orifices 106 described hereinabove.

[0087] Sleeve 100’ may be particularly useful for drainage or treatment of a wound in the wall of the gastrointestinal lumen, such as in the wall of the esophagus. For example, inflatable portions in second group 112b may be anchored within the wound (i.e. within the wall of the esophagus), for drainage thereof, while inflatable portions in first group 112a may be anchored within the lumen of the esophagus, to position the sleeve such that it applies negative pressure within the wound itself as well as in its immediate vicinity.

[0088] Reference is now made to Figs. 3A and 3B, which are, respectively, a perspective illustration and an end view illustration of a sleeve 120 forming part of a medical system according to embodiments of the disclosed technology, and to Figs. 4A and 4B, which are, respectively, a perspective illustration and an end view illustration of another sleeve 120’ forming part of a medical system according to embodiments of the disclosed technology.

[0089] Sleeves 120 and 120’ are substantially similar to sleeve 100, with dimensions of tubular portions 104 and sleeve orifices 106 being similar to those described hereinabove with respect to Figs. 1A and IB. Sleeves 120 and 120’ differ from sleeve 100 in the shape of respective inflatable portions 128 and 128’ thereof.

[0090] As seen in Figs. 3A to 4B, inflatable portions 128 and 128’ are substantially spherical structures, each including a plurality of longitudinally arranged lobes 140. Each pair of adjacent lobes 140 is separated by a longitudinally arranged trough 142. As such, each inflatable portion 128 and 128’ includes an equal number of lobes 140 and troughs 142.

[0091] In some embodiments, troughs 142 extend along a significant portion of the longitudinal length of the sleeve, for example because of the substantially spherical structure of inflatable portions 128 and 128’.

[0092] In some embodiments, each inflatable portion 128 and 128’ includes at least 3, at least 4, at least 5, or at least 6 lobes 140. In some embodiments, lobes 140 are distributed circumferentially about the inflatable portion, typically equidistantly, as shown in Figs. 3B and 4B.

[0093] In sleeve 120, the lobes 140 of all inflatable portions 128 are aligned with one another, and consequently also the troughs 142 are aligned with one another, as seen clearly in Fig. 3B.

[0094] By contrast, in sleeve 120’, the inflatable portions 128’ are rotationally offset from one another by half the angular distance between two lobes, which, in the illustrated embodiment, is approximately 30 degrees. As seen clearly in Fig. 4B, lobes 140a of one inflatable portion 128a’ are aligned with troughs 142b of another inflatable portion 128b’. Similarly, troughs 142a of inflatable portion 128a’ are aligned with lobes 140b of inflatable portion 128b’.

[0095] In some embodiments, and as shown in Fig. 4A, the rotational offset arrangement of the inflatable portions 128’ may alternate, such that inflatable portion 128c’ is rotationally aligned with inflatable portion 128a’, and if there was an additional inflatable portion it would be rotationally aligned with inflatable portion 128b’.

[0096] In other embodiments (not explicitly shown) each inflatable portion 128’ may have a distinct rotational offset relative to the distal-most inflatable portion (e.g. inflatable portion 128a’).

[0097] As mentioned above, the rotational offset between inflatable portions 128’ results in troughs 142 not being aligned with one another. This may be advantageous because when the sleeve is disposed within a body lumen and negative pressure is applied via sleeve orifices 126, as explained hereinbelow, the wall of the lumen cannot collapse into a trough along an entire longitudinal length of the sleeve. Rather, the troughs 142 are available for collapsing of the lumen wall thereinto only in unaligned places, resulting in the formation of “vacuum regions” which provide for more effective application of negative pressure to the vicinity of the sleeve.

[0098] Prevent collapsing along a whole longitudinal length when vacuum is applied. Track is spiral

[0099] Reference is additionally made to Figs. 5A, 5B, and 5C, which are, respectively, two perspective view illustrations and an end view illustration of a sleeve 130 forming part of a medical system according to embodiments of the disclosed technology.

[0100] Sleeve 130 is substantially similar to sleeve 120, and differs therefrom in the shape of respective inflatable portions 138. Inflatable portions 138 include lobes 140 and troughs 142 similar to those of inflatable portions 128. However, inflatable portions 138 are longitudinally narrower than their diameter, in a direction perpendicular to longitudinal axis 102, than inflatable portions 128, and are shaped similarly to a gear. Stated differently, if one were to “fill in” troughs 142, inflatable portions 138 would be substantially ring shaped. In sleeve 130, inflatable portions 138 are narrower, and more annular, than in sleeve 120, such that troughs 142 extend along a smaller fraction of the longitudinal length of the sleeve than in sleeve 120.

[0101] Sleeve 130 is shown in Figs. 5A to 5C as being similar to sleeve 120, with troughs 142 being rotationally aligned with one another. However, it is to be appreciated that sleeve 130 may be similar to sleeve 120’, and may have troughs 142 of inflatable portions 138 be rotationally offset from one another, substantially as shown in Figs. 4A and 4B.

[0102] Relating now to Fig. 5C and to the structure and the dimensions of lobes 140 and troughs 142, it is to be appreciated that though described only with respect to inflatable portions 138, the following discussion pertains equally to inflatable portions 128 of Figs. 3A and 3B and to inflatable portions 128’ of Figs. 4A and 4B.

[0103] In some embodiments, in the inflated operative state of inflatable portions 138, a height differential between one, or each, of lobes 140, and an adjacent trough 142, indicated by Hl in Fig. 5C, is at least 0.5mm. In some embodiments, Hl is in the range of 1 to 7mm, 1mm to 5mm, 1mm to 4mm, or 1mm to 3mm. For clarity, it will be appreciated that the height differential Hl is measured from a point of lobe 140 which is farthest, in a radial direction, from longitudinal axis 102, to a point of trough 142 which is closest, in a radial direction, to longitudinal axis 102.

[0104] In order to discuss proportions of the lobes 140 and the troughs 142 when an inflatable portion 138 is in the inflated operative state, we imagine a cylinder 146 (seen in Figs. 5B and 5C) circumscribing sleeve 130, such that the lobes 140 engage the imaginary cylinder. The imaginary cylinder includes portions that engage inflatable portions 138, indicated by A in Fig. 5C, and portions that are spaced from the inflatable portions, indicated by B.

[0105] In some embodiments, a ratio between arcs A and arcs B, in a cross section or end view of inflatable portions 138 (as shown in Fig. 5C), taken at a region of the inflatable portions having a maximal diameter D2 (see Fig. IB), 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.

[0106] In some embodiments, a portion (A) of the internal wall of imaginary cylinder 146 which engages inflatable portions 138, is less than 60%, 50%, 40%, 30% or 20% of the circumference, or cross-section, of imaginary cylinder 146.

[0107] A second imaginary cylinder 148, shown in Fig. 5C, is disposed at half the height Hl. The second imaginary cylinder 148 includes arcs, or portions, AA which cut through lobes 140, and arcs, or portions, BA which cut through troughs 142. In some embodiments, a ratio between arcs AA and arcs BA, in a cross section or end view of inflatable portions 138 (as shown in Fig. 5C), 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.

[0108] In some embodiments, at least one of lobes 140 may be textured, or wavy. In some embodiments, lobes 140 may include one or more lobe-troughs, disposed longitudinally along the lobe 140.

[0109] In some embodiments, when negative pressure is applied to troughs 142 (as explained herein below), the presence of lobe-troughs enables the negative pressure to be applied from multiple different direction to each location along troughs 142, thus reducing the chance of blockage in troughs 142. Additionally, in use, texturing of lobes 140 may function as a tissuegrowth enhancing therapy, for example by mildly massaging a target location at which the sleeve is located.

[0110] Reference is now made to Fig. 6, which is a perspective view illustration of a sleeve 149 forming part of a medical system according to embodiments of the disclosed technology.

[0111] As seen, sleeve 149 is substantially similar to sleeves 100 and 130, with dimensions of tubular portions 104 and sleeve orifices 106 being similar to those described hereinabove with respect to Figs. 1A and IB. However, sleeve 149 includes two inflatable portions 108 having a ring-shaped cross section (as shown in Figs. 1 A and IB) and three inflatable portions 138 having lobes and troughs, and having a flower-shaped cross section (as shown in Figs. 5A to 5C).

[0112] In the illustrated embodiment, inflatable portions 108 are disposed at ends of sleeve 149, and inflatable portions 138 are disposed between inflatable portions 108. In use, when the inflatable portions are in their inflated operative state within a bodily lumen, inflatable portions 108 may form a seal against the lumen of the body, thereby creating a sealed region in which are disposed inflatable portions 138, and in which vacuum can be applied to the lumen. This may be advantageous in preventing debris or additional fluid entering the vicinity of inflatable portions 138, and blocking orifices thereof.

[0113] Other arrangements of inflatable portions 108 and 138 are considered within the scope of the disclosed technology. Similarly, sleeves including any combination of inflatable portions 108, 128, and 138, in any order, are considered within the scope of the disclosed technology.

[0114] Reference is now made to Figs. 7A and 7B, which are end view illustrations of a sleeve forming part of a medical system according to embodiments of the disclosed technology, in a pleated operative state and in a delivery operative state, respectively. Figs. 7A and 7B are applicable to any one of sleeves 100, 120, 120’, 130, or 149 described hereinabove, and, for brevity, are described herein using the reference numerals of sleeve 100 of Figs. 1A and IB.

[0115] The states shown in Figs. 7A and 7B illustrate stages of manufacture of sleeve 100, which lead the sleeve to be in the delivery operative state used for delivery into a bodily lumen, as described in further detail hereinbelow.

[0116] As seen in Fig. 7A, at a first stage, the sleeve, which is a form of air-filled balloon, is pleated. Specifically, each inflatable portion 108 is compressed to form a plurality of double layer pleats 109. This may be accomplished, for example, by pushing a plurality of paddles toward the longitudinal axis of the sleeve, which pleat portion 108 along the paddle lines to form the star shape shown in Fig. 7A. In the operative state shown in Fig. 7A, tubular portions 104 remain in their standard state, and form the center of the star shape of Fig. 7A.

[0117] As seen in Fig. 7B, the pleats 109 are rotated about tubular portions 104 in the direction of arrow 111, resulting in a substantially cylindrical structure suitable for delivery into a bodily lumen, which structure represents the delivery operative state of the sleeve 100. It is to be appreciated that any form of compression of pleats 109 about tubular portions 104 would be suitable for delivery into the bodily lumen, but rotation of the pleats as shown in Fig. 7B is the most organized and compact mechanism of achieving this goal.

[0118] The pleating and compressing shown in Figs. 7A and 7B may be accomplished using balloon pleating devices known in the art, such as a VC wrapping machine commercially available from Blockwise Engineering LLC of Tempe, Arizona, USA.

[0119] Reference is now made to Fig. 8, which is sectional perspective view illustration of a longitudinal shaft 150, forming part of a medical system according to embodiments of the disclosed technology. As explained in further detail herein below, shaft 150 is adapted to be disposed within sleeve 100, 120, 120’, 130, or 149.

[0120] In the context of the present description and claims, the longitudinal shaft disposed along a longitudinal axis may be flexible but capable of configuration along a longitudinal axis.

[0121] As seen, longitudinal shaft 150 includes a first longitudinally extending channel 152, also termed an inflating-fluid delivery channel. Inflating-fluid delivery channel 152 is in fluid communication with a first plurality of orifices 154, also termed inflating-fluid delivery orifices, which are longitudinally distributed along the longitudinal shaft. Inflating-fluid delivery channel 152 is adapted to couple to a source 156 of an inflating fluid 158. In some embodiments, source 156 and / or inflating fluid 158 form part of the medical system of the disclosed technology. In some embodiments, inflating fluid 158 comprises saline. In some embodiments, inflating fluid 158 comprises air. In some embodiments, inflating fluid 158 comprises carbon dioxide.

[0122] In some embodiments, inflating-fluid delivery channel 152 has an inner diameter in the range of 0.15mml5mm to 4mm, 0.2mm to 4mm, 0.3mm to 4mm, 0.15mm to 3mm, 0.2mm to 3mm, 0.3mm to 3 mm, 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.

[0123] In some embodiments, each orifice 154 has a diameter (if the orifice is generally circular) or longest dimension (if the orifice is not circular, such as a rectangular orifice or elliptical orifice) 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. In some embodiments, the diameter or longest dimension of orifices 154 depends on the specific fluid used as the inflating fluid, and on the viscosity thereof. For example a more viscous fluid would require larger orifices.

[0124] In some embodiments, a distance D3 along longitudinal shaft 150, between pairs of adjacent inflating-fluid delivery orifices 154, should be greater than the length of the tubular portions 104, such that the inflating-fluid delivery orifices would be aligned with inflatable portions 108 when sleeve 100 is disposed about shaft 150. As such, in a shaft 150 to be used with sleeve 120 or 120’ (which have spherical inflatable portions and a greater distance between each pair of tubular portions), the distance D3 may be greater than in a shaft 150 to be used with sleeve 100, 130, or 149 (which have annular and / or gear shaped inflatable portions).

[0125] Longitudinal shaft 150 further includes a second longitudinally extending channel 162, also termed a negative-pressure delivery channel. Negative-pressure delivery channel 162 is in fluid communication with a second plurality of orifices 164, also termed negative-pressure delivery orifices, which are longitudinally distributed along the longitudinal shaft. Negativepressure delivery channel 162 is adapted to couple to a source of negative pressure 166. In some embodiments, source of negative pressure 166 forms part of the medical system of the disclosed technology.

[0126] In some embodiments, negative-pressure delivery channel 162 has a cross sectional area in the range of 1 mm2to 85 mm2.

[0127] In some embodiments, each orifice 164 has a diameter (e.g. if the orifice is circular) or longest dimension (e.g. if the orifice is not circular, such as rectangular or elliptical) 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.

[0128] In some embodiments, each of orifices 164 has substantially the same diameter or longest dimension. In some other embodiments, orifices 164 in a first subset of the orifices have a first diameter or longest dimension, and orifices 164 in a second subset of the orifices have a second diameter or longest dimension, the second diameter or longest dimension being different from the first diameter or longest dimension.

[0129] In some embodiments, the cross-sectional area of the orifices 164 increases along the length of shaft 150, from the proximal end towards the distal end. In some such embodiments, the cross-sectional area of the distal-most orifice is at least 50% greater than the cross-sectional area of the proximal -most orifice.

[0130] In the illustrated embodiment, orifices 164 are equidistantly distributed along shaft 150. In some embodiments, a distance D4 along longitudinal shaft 150, between pairs of adjacent orifices 164, is in the range of 2mm to 40mm, 2mm to 30mm, 2mm to 20mm, 2mm to 15mm, 2mm to 10mm. Specifically, the distance D4 must be sufficient that orifices 164 are aligned with gaps between inflatable portions 108, and are not blocked by the inflatable portions.

[0131] In some other embodiments, orifices 164 may be heterogeneously distributed along shaft 150. For example, a first pair of adjacent orifices 164 may have a first longitudinal distance therebetween, and a second pair of adjacent orifices 164 may have a second longitudinal distance therebetween, the second longitudinal distance being different from the first longitudinal distance.

[0132] In some embodiments, distance D4 between pairs of adjacent orifices 164, is greater than the width of the inflatable portions, such that when sleeve 100 is disposed about shaft 150, orifices 164, which are negative-pressure delivery orifices, would be aligned with tubular portions 104 of the sleeve and with sleeve orifices 106 thereon, and not with the inflatable portions 108. As such, in a shaft 150 to be used with sleeve 120 or 120’ (which have spherical inflatable portions), the distance D4 may be greater than in a shaft 150 to be used with sleeve 100, 130, or 149 (which have annular and / or gear shaped inflatable portions).

[0133] Reference is now made to Figs. 9A, 9B, 9C, and 8D, which are, respectively, a perspective view illustration, an end view illustration, and two sectional illustrations of a medical system 200 according to embodiments of the disclosed technology. The sectional illustration of Fig. 9C is taken along section lines IXC-IXC in Fig. 9B, and the sectional illustration of Fig. 9D is taken along section lines IXD-IXD in Fig. 9B. The following is described with respect to sleeve 100 of Figs. 1A and IB, although it is similarly applicable to sleeves 120, 120’, 130, and 149.

[0134] As seen, in medical system 200, longitudinal shaft 150 extends longitudinally through sleeve 100. Negative-pressure delivery orifices 164 are aligned such that gaps 110 are in fluid communication with vacuum delivery channel 162. For example, the negative-pressure delivery orifices 164 may be aligned with sleeve orifices 106, such that gaps 110 are in fluid communication with vacuum delivery channel 162 via negative-pressure delivery orifices 164 and sleeve orifices 106, as seen clearly in Fig. 9D.

[0135] Additionally, inflating-fluid delivery orifices 154 are longitudinally aligned with inflatable portions 108, such that inflatable portions 108 are in fluid communication with inflating-fluid delivery channel 152, via inflating-fluid delivery orifices 154, as seen clearly in Fig. 9C.

[0136] In use, inflatable portions 108 may be transitioned from the delivery state (shown for example in Fig. 7B) to the inflated state (shown for example in Fig. IB) by introduction of inflating fluid 158 from source 156 (Fig. 8) into the inflatable portions, via inflating-fluid delivery channel 152 and inflating-fluid delivery orifices 154.

[0137] Additionally, negative pressure is applied from the source 166 of negative pressure to gaps 110, via negative-pressure delivery channel 162, negative -pressure delivery orifices 164, and sleeve orifices 106. As such, the negative is applied to the gaps in a radial direction relative to longitudinal axis 102 of sleeve 100 (Fig. 1A). In some embodiments, the source of negative pressure 166 is configure to apply a negative pressure in the range of 50-350mmHg. In some embodiments, the inflatable portions 108 retain their shape when negative pressure is applied thereto, even for complex shapes such as those of inflatable portions 128, 128’, and 138.

[0138] It is a particular feature of the disclosed technology that shaft 150 and sleeve 100 are sealingly bonded to each other, for example by soldering. This is critical to ensure that negative pressure delivery channel 162 is not in fluid communication with inflating-fluid delivery channel 152, to avoid drainage of the inflating fluid via the negative pressure delivery channel. Additionally, it is important that the inflatable portions 108 be sealed relative to negativepressure delivery channel 162 and relative to gaps 110.

[0139] It is a particular feature of the present technology that inflatable portions 108 are fluid tight, other than fluid communication with inflating-fluid delivery channel 152. In some embodiments, sleeve 100 may be sealed, at proximal and distal ends thereof, as well as around sleeve orifices 106, to shaft 150, so that the inflatable portions, as a group, are fluid tight other than fluid communication with channel 152. In some embodiments, each inflatable portion 108 can be sealed to shaft 150 on either side thereof. In some embodiments, each inflatable portion 108 is sealingly attached to circumference of its corresponding inflating fluid orifice 154.

[0140] It is to be appreciated that, in some embodiments, sleeve 100 may be replaced by multiple individual inflatable portions 108, each individually sealed to shaft 150. The individual inflatable portions 108 are separated by gaps 110 along shaft 150, such that negative-pressure delivery orifices 164 are in fluid communication directly with the gaps. In such embodiments, circumferential portions 104 of the sleeve, and sleeve orifices 106, are obviated.

[0141] In some embodiments, negative-pressure delivery channel 162 may be coupled to a source of a fluid, such as a flushing fluid or a medicament fluid (not explicitly shown). This may occur, for example, when the negative -pressure delivery channel 162 is not coupled to source 166 of negative pressure. When the negative-pressure delivery channel 162 is coupled to the source of fluid, the fluid may be delivered to gaps 110, in a similar manner to the application of negative pressure thereto.

[0142] In some embodiments, the fluid may be a flushing fluid. In some embodiments, the fluid may be a medicament fluid, such as an antimicrobial fluid or a tissue-growth promoting fluid. In some embodiments, the fluid may be a contrast fluid. In some embodiments, the fluid may be ionized gas. In some embodiments, the fluid may be carbon dioxide.

[0143] As will be explained in further detail hereinbelow, longitudinal shaft 150 and sleeve 100 disposed thereon are delivered into the gastrointestinal tract of the subject for use therein. Various methods of delivery of the longitudinal shaft 150 and sleeve 100 into the gastrointestinal tract of the user are described hereinbelow, for example with respect to Figs. 21 to 23D. As explained further hereinbelow, longitudinal shaft 150 and / or sleeve 100 may be delivered into the gastrointestinal tract using a delivery device, which may also form part of system 200.

[0144] In some embodiments, sleeve 100, or inflatable portions 108, may be enclosed within a textured layer (not explicitly shown) such as a layer of mesh, and the like. In some embodiments, distal end of shaft 150 may include a supporting element or device (not explicitly shown). For example, the distal end of shaft 150 may include a valve, such as a duckbill valve. As another example, the distal end of shaft 150 may have mounted thereon an illumination device and / or an imaging device for illuminating and / or imaging the gastrointestinal tract during advancement of shaft 150 to its intended location within the gastrointestinal tract.

[0145] It is to be appreciated that inflatable portions 108 (as well as inflatable portions 128, 128’, 138, and 149) may be inflated using fluid from any source, not necessarily fluid introduced through shaft 150.

[0146] For example, in some embodiments, inflatable portions 108 may have disposed therein, in the delivery operative state, precursors or reactants of a gas-releasing chemical reaction. When the shaft 150 and sleeve 100 are advanced to the target area within the GI tract, the chemical reaction between the gas-releasing chemical reaction is triggered, causing the release of gas into inflatable portions 108 for transition thereof from the delivery operative state to the inflated operative state. In some such embodiments, inflating-fluid delivery channel 152 and inflating-fluid delivery orifices 154 may be obviated from shaft 150. In some embodiments, a triggering mechanism for triggering the chemical reaction may be introduced into, or form part of, shaft 150.

[0147] Reference is now made to Figs. 10A and 10B, which are, respectively, an end view illustration and a sectional view illustration of a medical system 300 including a sleeve 302 according to additional embodiments of the disclosed technology, the sleeve 302 being in a delivery operative state, and to Figs. 11A and 11B, which are, respectively, an end view illustration and a sectional view illustration of medical system 300, the sleeve 302 being in an expanded operative state.

[0148] System 300 includes sleeve 302, mounted onto a shaft 350, similar to shaft 150 described hereinabove with respect to Fig. 8. System 300 may further include a source of negative pressure as shown in Fig. 8.

[0149] Sleeve 302 of system 300 is similar to sleeve 100 described hereinabove with respect to Figs. 1 A and IB, and includes tubular portions 304, sleeve orifices 306, and expandable portions 308 forming gaps 310 therebetween. As discussed hereinabove, sleeve 302 may include at least three, at least four, or at least five expandable portions.

[0150] Sleeve 302 differs from sleeve 100 in the mechanism of expansion of its expandable portions 308. Each expandable portion 308 in sleeve 302 houses a shape memory scaffold, or skeleton, 309, which may be held in a compressed state, and when released, is adapted to form an expanded position. Shape memory scaffold 309 may comprise, for example nickel-titanium alloy otherwise known as nitinol or NiTiCu (copper zinc nickel), or any other super-elastic alloy or shape-memory polymer or alloy. Other suitable materials may include other biocompatible metals, such as stainless steel. The scaffold may further be coated or textured to increase the biocompatibility thereof.

[0151] It is to be appreciated that in the context of the present application the term “scaffold” is defined as any compressible and expandable structure which is capable of retaining its expanded shape independently of additional supports, and may have various configurations such as a porous compressible material, a stent-shape, and the like.

[0152] In the delivery operative state of system 300, illustrated in Figs. 10A and 10B, shape memory scaffold 309 is held in a compressed state. As such, an external diameter D5 of expandable portions 308 is significantly smaller than diameter D2 shown in Fig. IB. In this state, an external diameter of the portion of system 300 which is advanced into a bodily lumen is approximately equal to external diameter D5. It is desireable that D5 be as close as possible to the diameter of shaft 350, or to the diameter of tubular portions 304 indicated by DI in Fig. IB.

[0153] When shaft 350 and sleeve 302 are advanced into the target area in the gastrointestinal tract, the shape memory scaffold 309 is released, and expands to its “remembered” expanded state. This results in expansion of expandable portions 308 to their expanded operative state, as shown in Figs. 11A and 1 IB. The expanded operative state of expandable portions 308, shown in Figs. 11A and 1 IB is very similar to the inflated state of inflatable portions 108, shown in Fig. IB, and functions in a similar manner.

[0154] Shaft 350 differs from shaft 150 of Fig. 8 in that it is devoid of an inflation-fluid delivery channel and of inflation-fluid delivery orifices, and only includes negative-pressure delivery channel 362 and negative-pressure delivery orifices 364. This is made possible because expansion of expandable portions 308 is based on shape memory scaffold 309 resuming its “remembered” shape, and not on introduction of an inflation fluid into the expandable portions.

[0155] In some embodiments, the shape memory scaffold 309 may be replaced by any material or substance that has a compressed state and can expand from the compressed state to an expanded state, such as a porous compressible material or a foaming agent. In some embodiments, the expansion of the material or substance may be triggered by a change in the environment thereof or activation of a triggering mechanism, such as introduction of a foaming agent to a liquid environment. It is to be appreciated that the material replacing shape memory scaffold 309 must be strong enough to resist compression when negative pressure is applied to a lumen in which the scaffold is placed or deployed, such as within a body lumen.

[0156] In some embodiments, shape memory scaffold 309 may be attached to, or extend directly from, shaft 350. In some such embodiments, sleeve 302 surrounding shape memory scaffold 309 may be obviated, such that expandable portions 308 only include the scaffold 309, the scaffold being exposed to the vicinity surrounding shaft 350. In some embodiments, shape memory scaffold 309 may be integrally formed with shaft 350. In some embodiments, the sleeve may be obviated in some of expandable portions 308, and retained in other expandable portions.

[0157] In the most general terms, the expandable portions 308 extend periodically outwardly from the longitudinal shaft 350, forming gaps 310 between the expandable portions, such that the negative-pressure delivery channel 362 is in fluid communication with the gaps, via negative-pressure delivery orifices 364 formed in shaft 350.

[0158] Reference is now made to Figs. 12A and 12B, which are, respectively, an end view illustration and a side view illustration of a medical system 400 according to further embodiments of the disclosed technology.

[0159] Medical system 400 includes sleeve 402, mounted onto a shaft 450, similar to shaft 450 described hereinabove with respect to Fig. 8. System 400 may further include a source of negative pressure as shown in Fig. 8.

[0160] Sleeve 402 of system 400 is similar to sleeve 100 described hereinabove with respect to Figs. 1A and IB, and includes tubular portions 404, sleeve orifices 406, and inflatable portions 408 forming gaps 410 therebetween. However, sleeve 402 further includes a second plurality of sleeve orifices 407, disposed in tubular portions 404. In some embodiments, each orifice of the second plurality of sleeve orifices is longitudinally aligned with one of sleeve orifices 406.

[0161] Shaft 450 differs from shaft 150 of Fig. 8 in that, in addition to inflation-fluid delivery channel 452 and negative-pressure delivery channel 462, the shaft includes a third channel 472, in fluid communication with a third plurality of orifices.

[0162] Each orifice 407 in the second plurality of sleeve orifices is aligned with a corresponding orifice of the third plurality of orifices, such that third channel 472 is in fluid communication with gaps 410 between inflatable portions 408 via sleeve orifices 407 and orifices in the third plurality of orifices.

[0163] In some embodiments, third channel 472 may be a flushing-fluid delivery channel, and the third plurality of orifices may be flushing-fluid delivery orifices. In some such embodiments, flushing-fluid delivery channel 472 may be coupled to a source of a fluid, such as a flushing fluid or a medicament fluid (not explicitly shown). When the flushing-fluid delivery channel 472 is coupled to the source of fluid, the fluid may be delivered to gaps 410, in a similar manner to the application of negative pressure to the gaps, described hereinabove with respect to Fig. 8 and negative-pressure delivery channel 162.

[0164] In some embodiments, the fluid may be a flushing fluid. In some embodiments, the fluid may be a medicament fluid, such as an antimicrobial fluid or a tissue-growth promoting fluid. In some embodiments, the fluid may be a contrast fluid. In some embodiments, the fluid may be ionized gas. In some embodiments, the fluid may be carbon dioxide.

[0165] In some embodiments, third channel 472 may be a second negative-pressure delivery channel, adapted to function as a back-up if negative-pressure delivery channel 462 fails for some reason, or to be used simultaneously with application of negative pressure via negativepressure delivery channel 462 to further reduce the pressure in gaps 410. In some such embodiments, third channel 472 may be coupled to a source of negative pressure, which may be source 166 described hereinabove with respect to Fig. 8, or a second source of negative pressure.

[0166] It is to be appreciated that channel 472, and the corresponding orifices, may be used in a shaft devoid of an inflating-fluid delivery channel, such as shaft 350 described hereinabove with respect to Figs. lOA to 11B.

[0167] Reference is now made to Fig. 13, which is a flow chart of a method of treating the gastrointestinal tract of a subject using any one of medical systems 200, 300, or 400 according to embodiments of the disclosed technology. For brevity, Fig. 13 is described with respect to medical system 200 and sleeve 100. However, the description is similarly applicable to medical system 200 with sleeves 120, 120’, 130, and 149, to medical system 300 with sleeve 302, and to medical system 400 with sleeve 402. It is to be appreciated that the description below uses the terms “expandable portions” and “expanded state” interchangeably with the terms “inflatable portions” and “inflated state”. As such, expandable portions 108 are equivalent to inflatable portions 108, and the expanded state of these portions is equivalent to their inflated state.

[0168] At step S502, shaft 150 and sleeve 100, together, are advanced to a target location in the gastrointestinal tract of the subject, while inflatable (expandable) portions 108 are in the delivery state. For example, the target location may be in the vicinity of a wound in the gastrointestinal tract, which may be an endoluminal or an extraluminal wound. For example, the target location may be in the esophagus, or in the colon, of the subject.

[0169] The advancement of shaft 150 and sleeve 100 to the target location may be carried out using a variety of methods, some of which are described hereinbelow with respect to Figs. 21 to 23D. However, any other suitable method is considered within the scope of the disclosed technology.

[0170] At step S504, inflatable (expandable) portions 108 are expanded, to transition them from their delivery state to their inflated (expanded) state. For inflatable portions 108, this is accomplished by delivery inflating fluid to the inflatable portions via inflating-fluid delivery channel 152 and orifices 154 of shaft 150. However, for expandable portions of other types, such as expandable portions 308, the expanding of the expandable portions may be carried out using another mechanism, such as release of the compressed state of scaffold 309.

[0171] In some embodiments, such as when using sleeve 100 and inflatable portions 108, step S506 may further include coupling shaft 150 to source 156 of inflating fluid 158, prior to inflation of the inflatable portions.

[0172] At step S508 source 166 of negative pressure is activated to apply negative pressure to gaps 110, via negative-pressure delivery channel 162, orifices 164, and sleeve orifices 106. In some embodiments, the negative pressure is activated to apply negative pressure by a control system which may additionally involve input of information involving treatment and management of pressure parameter or time period. The negative pressure is delivered in a radial direction relative to a longitudinal axis of the sleeve.

[0173] In some embodiments, an optional step S506, in which shaft 150, and specifically negative-pressure delivery channel 162, is coupled to the source of negative pressure, may occur prior to step S508.

[0174] Application of negative pressure to gaps 110 at step S508 causes the negative pressure to drain fluid from the target location in the gastrointestinal tract, via orifices 164 and 106. Such draining reduces the amount of contaminating fluids in the target location, and thus can enhance the healing of a wound in the target region. It is a particular feature of the disclosed technology that, application of negative pressure to gaps 110 also causes the gastrointestinal tract, at the target location, to collapse inward, onto the inflatable (expandable) portions 108. However, the distance between the inflatable portions is selected such that the tissue does not collapse into gaps 110, or into troughs of the inflatable portions (where relevant). As a result, gaps 110 and / or troughs of the inflatable portions form enclosed negative pressure regions or pockets, each enclosed by the lumen wall, and by the inflatable portions. In each such pocket, negative pressure can be applied to a surface of the lumen wall, and not just to a single point (e.g. the location of the orifice), while at least some of the lumen wall is exposed and not in contact with the medical device. Stated differently, using a relatively small number of orifices, or “exit points” for negative pressure, the negative pressure is applied to extensive surfaces or regions of the lumen, because the structure of the inflatable portions and the gaps therebetween prevents collapse of the lumen onto the negative pressure orifices and ensures the formation of negative pressure pockets.

[0175] On the other hand, collapsing of the tissue of the lumen onto the inflatable portions assists in maintaining sleeve 100 correctly placed within the target location.

[0176] In some embodiments, sleeve 100 may be retained at the target location for an extended duration, such as days or weeks.

[0177] Following completion of treatment of the target location of the gastrointestinal tract, all sleeve 100 and shaft 150, as well as any other components of the medical system disposed within the body, are removed from the target location at step S510.

[0178] Such removal typically includes decoupling of shaft 150 from source 166 of negative pressure, and in some embodiments may also include decoupling of shaft 150 from source 156 of inflating fluid or from any other fluid or pressure source to which the shaft is connected.

[0179] In some embodiments, such removal further includes compressing of expandable portions or deflating of inflatable portions.

[0180] In some embodiments, the sleeve and shaft are removed from the body of the user together, for example in an inverse process to that by which they were advanced into the body at step S502.

[0181] In some other embodiments, sleeve 100, or a portion thereof, may be detached for shaft 150, and may be removed from the body in a different manner than removal of shaft 150. For example, sleeve 100 or the portion thereof may continue down the gastrointestinal tract and may be removed from the body together with fecal matter. As another example, sleeve 100 or the portion thereof may be biodegradable and may degrade in the body, or may be bioabsorbable and be resorbed by the cells of the intestinal wall. In some embodiments, such detachment of sleeve 100 may be time dependent or tool dependent, to ensure that sleeve 100 remains properly attached to shaft 150 during use thereof, which is significantly important to the functionality of medical system 200, as explained hereinabove.

[0182] In some embodiments, the method may include an optional initial step S500, at which shaft 150 is connected to the interior of sleeve 100, with the required alignment of orifices 154, 164, and 106. For example, step S500 may include soldering or adhering of sleeve 100 to shaft 150 in the required orientation. Reference is now made to Fig. 14, which is perspective view illustration of an inflatable body 102 according to embodiments of the disclosed technology, and to Figs. 15A and 15B which are, respectively, a schematic side view illustration and a schematic front view illustration of an inflating-fluid delivery channel 600 connected to inflatable body 602 of Fig. 14 according to embodiments of the disclosed technology.

[0183] Inflating-fluid delivery channel 600 terminates in, and is in fluid communication with, inflatable body 602. Channel 600 and inflatable body 602 are both arranged along a central longitudinal axis 604. In some embodiments, inflating-fluid delivery channel 600 and inflatable body 602 are integrally formed. In some other embodiments, inflating-fluid delivery channel 600 is reversibly attachable to, and separable from, inflatable body 602.

[0184] Inflatable body 602 has a delivery operative state, in which it is typically deflated, and an inflated operative state. Inflating-fluid delivery channel 600 is adapted for delivery of an inflating fluid 606 from an inflating-fluid source 608 to inflatable body 602, for inflation thereof. In some embodiments, inflating fluid 606 may be saline. Introduction of inflating fluid 606 into inflatable body 602 results in transition of the inflatable body from the delivery state to the inflated state.

[0185] As seen in Figs. 14 to 15B, in the inflated operative state, inflatable body 602 includes a plurality of longitudinally arranged lobes 610 and a plurality of longitudinally arranged troughs 612. Each pair of adjacent lobes 610 is separated by one of troughs 612. As such, inflatable body 602 includes an equal number of lobes 610 and troughs 612.

[0186] In some embodiments, inflatable body 602 includes at least 3, at least 4, at least 5, or about least 6 lobes 610. In some embodiments, inflatable body 602 includes between 3 and 10 lobes, 4 and 9 lobes, or 5 and 8 lobes 610. In some embodiments, lobes 610 are distributed circumferentially about inflatable body 602, typically equidistantly, as shown in Fig. 15B.

[0187] Inflatable body 602 include a bridging portion 614 and a tissue-engaging portion 616. Bridging portion 614 is disposed between inflating-fluid delivery channel 600 and tissueengaging portion 616. As seen, in the inflated state, lobes 610 and troughs 612 are formed in tissue-engaging portion 616. Additionally, as seen in Fig. 14, in the inflated state, inlet troughs 618 extend along an exterior surface of bridging portion 614, from a distal end of the inflating- fluid delivery channel 600 (e.g. a joining point between the inflating-fluid delivery channel and the inflatable body) to the proximal end of each of troughs 612. Similarly, in the inflated state, inlet lobes 619 extend along an exterior surface of bridging portion 614, from the distal end of the inflating-fluid delivery channel 600 to the proximal end of each of lobes 610. An angle a is defined between a longitudinal axis of one of inlet troughs 618, and longitudinal axis 604, when inflatable portion 602 is inflated, as seen in Fig. 14A. In some embodiments, angle a is in the range of 100 to 160 degrees, 105 to 155 degrees, or 105 to 150 degrees.

[0188] An angle P is formed in the longitudinal cross section of bridging portion 614, where the bridging portion connects to channel 600, as seen in Fig. 14A. In some embodiments, angle is in the range of 60 to 160 degrees, 60 to 155 degrees, or 60 to 150 degrees, or 70 to 150 degrees.

[0189] In some embodiments, in the inflated operative state of inflatable body 602, a height differential between one, or each, of lobes 610, and an adjacent trough 612, indicated by H2 in Fig. 15B, is in the range of 1mm to 7mm, 1mm to 5mm, 1mm to 4mm, 1mm to 3mm, or 1mm to 2mm. For clarity, it will be appreciated that the distance H2 is measured from a point of lobe 610 which is farthest, in a radial direction, from longitudinal axis 604, to a point of trough 612 which is closest, in a radial direction, to longitudinal axis 604.

[0190] In order to discuss proportions of the lobes 610 and the troughs 612 when inflatable body 602 is in the inflated operative state, we imagine a cylinder 620 (seen in Figs. 15A and 15B) circumscribing tissue-engaging portion 616 of inflatable body 602, such that the lobes 610 engage the imaginary cylinder. The imaginary cylinder includes portions that engage inflatable body 602, indicated in Fig. 15B by A, and portions that are spaced from the inflatable body, indicated by B.

[0191] In some embodiments, a ratio between arcs A and arcs B, in a cross section of inflatable body 602 (as shown in Fig. 15B), 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

[0192] A second imaginary cylinder 621, shown in Fig. 15B, is disposed at half the height H2. The second imaginary cylinder 621 includes arcs, or portions, A'A which cut through lobes 610, and arcs, or portions, B 'A which cut through troughs 612. In some embodiments, a ratio between arcs A14 and arcs B'A, in a cross section or end view of inflatable body 602 (as shown in Fig. 15B), 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.

[0193] In some embodiments, a portion (A) of the internal wall of imaginary cylinder 620 which engages inflatable body 602, is less than 60%, 50%, 40%, 30% or 20% of the circumference, or cross-section, of imaginary cylinder 620. In some embodiments, inflating-fluid delivery channel 600 has an external diameter smaller than 8mm, smaller than 7mm, smaller than 6mm, smaller than 5mm, smaller than 4mm, smaller than 3.7mm, or smaller than 3.5mm. In some embodiments, the external diameter of inflating-fluid delivery channel 600 is in the range of 1mm to 6mm.

[0194] In some embodiments, inflating-fluid delivery channel 600 has an internal diameter 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, 1.5mm to 3mm.

[0195] In some embodiments, inflatable body 602, in the delivery state, has an external diameter smaller than 8mm, smaller than 7mm, smaller than 6mm, smaller than 5mm, smaller than 4mm, smaller than 3.7mm, or smaller than 3.5mm.

[0196] In some embodiments, inflatable body 602, in the inflated operative state, has an external diameter 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.. .

[0197] In some embodiments, a distal end 622 of inflatable body 602 is blunt or soft, to prevent injury to surrounding tissue during delivery of the inflatable body into the gastrointestinal tract, as explained herein below.

[0198] In some embodiments, lobes 610 and troughs 612 terminate before distal end 622 of inflatable body 602. As such, in the inflated operative state, the distal-most end of inflatable body 602 is cylindrical or spherical, and can seal against a lumen.

[0199] Reference is now additionally made Fig. 16, which is a perspective view illustration of an inflatable body 602’ according to embodiments of the disclosed technology, and to Figs. 17A and 17B, which are, respectively, a schematic side view illustration and a schematic front view illustration of inflating-fluid delivery channel 600 connected to inflatable body 602’ according to embodiments of the disclosed technology.

[0200] As seen in Figs. 16 and 17A, inflatable body 602’ includes troughs 612 substantially as shown in Figs. 14 and 15A. However, lobes 610’ of inflatable body 602’ have a longitudinal curvature or are textured. More specifically, each of lobes 610’ includes a plurality of subtroughs 632, disposed longitudinally along the lobe 610.

[0201] In some embodiments, when negative pressure is applied to troughs 612 (as explained herein below), the presence of sub-troughs 632 enables the negative pressure to be applied from multiple different direction to each location along troughs 612, thus reducing the chance of blockage in troughs 612, relative to the structure of inflatable body 602. Additionally, in use of inflatable body 602’ within the gastrointestinal tract, the texturing of lobes 610’ may function to apply a degree of physical pressure to a tissue while enabling exposure to negative pressure in the area of the GI tract at which the inflatable body 602’ is located.

[0202] Reference is now made to Fig. 18, which is a perspective cross sectional illustration of the inflatable body of Fig. 17A, taken along section lines XVIII-XVIII in Fig. 17A. the cross- sectional view of Fig. 18 is obtained at a distance of 2mm from the distal end of inflating-fluid delivery channel 600, along longitudinal axis 604. As seen in Fig. 18, at a distance of 2mm from channel 600, a height differential between an inlet trough 618 and an adjacent inlet lobe 619 of bridging portion 614 is indicated by H3. In some embodiments, D3 is at least 0.4mm or at least 0.5mm.

[0203] Reference is now made to Figs. 19A, 19B, and 19C which are, respectively, a schematic side view illustration, a schematic front view illustration, and a partially cut away illustration of a medical system 650 according to embodiments of the disclosed technology. Medical system 650 includes inflating-fluid delivery channel 600 and inflatable body 602’ (as shown) or may include inflatable body 602 of Figs. 14 to 15B. For brevity, the following description will relate to inflatable body 602’. System 650 may further include source 608 and the inflating fluid 606 contained therein (see Fig. 15A).

[0204] As seen in Figs. 19A to 19C, in addition to channel 600 and inflatable 602’, system 650 includes a fluid tight lumen 652. Fluid tight lumen 652 includes a first channel 654, disposed around inflating-fluid delivery channel 600, as shown clearly in Fig. 19C. Fluid tight lumen 652 further includes at least one second channel 656, also termed a negative-pressure delivery channel, shown in Fig. 19B as three channels 656 and in Fig. 19C as two such channels. In some such embodiments, the negative-pressure delivery channels may be disposed radially outwardly of, or around, the inflating-fluid delivery channel. Fluid tight lumen 652, and specifically negative-pressure delivery channel(s) 656, is adapted to couple to a source of negative pressure 658. Fluid tight lumen 652 delivers negative pressure, along negative-pressure delivery channel(s) 656, to a proximal end of the inflatable body 602’. The negative pressure is then applied along troughs 612, longitudinally along inflatable body 602’.

[0205] In some embodiments, the source of negative pressure 658 is configure to apply a negative pressure in the range of 50 to 350mmHg. As seen in Fig. 19A, when in the inflated state, inflatable body 602’ maintains its structure, including lobes 610’, troughs 612, and inlet troughs 618, when the negative pressure is applied thereto. Negative pressure applied to troughs 612 results in a general flow of the material in the vicinity in the direction of arrow 660, shown in Fig. 19A. As seen in Fig. 19B, when negative pressure is via negative -pressure delivery channel(s) 656, the negative pressure is applied to troughs 612 via inlet troughs 618. For this purpose, at least a portion of at least one negative-pressure delivery channel 656 is longitudinally aligned with each of inlet troughs 618 and troughs 612.

[0206] In some embodiments, and as shown in Figs. 19A to 19C, fluid tight lumen 652 is centered relative to, and is coaxial with, inflating-fluid delivery channel 600 and inflatable body 602’.

[0207] In some embodiments, the at least one negative-pressure delivery channel 656 comprises a single, annular channel. In some such embodiments, the annular channel may be supported by struts 662, shown in Fig. 19C. Struts 662 connect an interior surface of negativepressure delivery channel 656 to an exterior surface of first channel 654, to retain the coaxial relationship between the two channels.

[0208] In some embodiments, and as shown, multiple second channels 656 are formed in fluid tight lumen 652. Typically, the negative-pressure delivery channels 656 are distributed circumferentially about first channel 654. In some embodiments, a total surface area of all negative-pressure delivery channels 656, in a direction perpendicular to the longitudinal axis of fluid tight lumen 652, is at least 5mm2.

[0209] In some embodiments, fluid tight lumen 652 has an external diameter D6 (shown in Fig. 19A) smaller than 8mm, smaller than 5mm, smaller than 4mm, smaller than 3.7mm, or smaller than 3.5mm.

[0210] In some embodiments, the external diameter D6 is smaller than a greatest external diameter of inflatable body 602’ when the inflatable body is in its inflated state. In such embodiments, diameter D6, as well as the cross section of negative pressure delivery channels 656, are sufficient to ensure that negative pressure is applied to each of troughs 612 via inlet troughs 618.

[0211] In other embodiments, the external diameter D6 is at least equal to a greatest diameter of inflatable body portion 602’, such that negative pressure can be applied from negative pressure delivery channels 656 directly to troughs 612. In some such embodiments, bridging portion 614 may be obviated, or may have a different angular relationship with the longitudinal axis than that described above.

[0212] In some embodiments, a distal end 664 of fluid tight lumen 652 is disposed at a fixed position relative to inflatable body 602’. In some such embodiments, system 650 may further include an anchoring mechanism (not explicitly shown) adapted to anchor fluid tight lumen 652 to a fixed longitudinal location relative to inflatable body 602’. In some embodiments, in the inflated state of inflatable body 602’, a distance D7 (shown in Fig. 19A) between distal end 664 of the fluid tight lumen 652 and a proximal end of one of troughs 612, along the longitudinal axis 604 of inflatable body 602’ (see Fig. 15A), is at most 6mm, at most 4mm, at most 2mm, or at most 1mm.

[0213] In some embodiments, fluid tight lumen 652 may be coupled to a source of a fluid, such as a flushing fluid or a medicament fluid (not explicitly shown). This may occur, for example, when the fluid tight lumen is not coupled to source 658 of negative pressure. When the fluid tight lumen 652 is coupled to the source of fluid, the fluid may be delivered, via second channel(s) 656, to troughs 612, in a similar manner to the application of negative pressure thereto. Alternatively, fluid tight lumen 652 may include an additional fluid-delivery channel for this purpose, adapted to deliver to troughs 612, in a similar manner to the application of negative pressure thereto. For example, such a fluid delivery channel may be concentric about, or within, negative-pressure delivery channel(s) 656.

[0214] In some embodiments, the fluid may be a flushing fluid. In some embodiments, the fluid may be a medicament fluid, such as an antimicrobial fluid or a tissue-growth improving fluid. In some embodiments, the fluid may be a contrast fluid. In some embodiments, the fluid may be ionized gas. In some embodiments, the fluid may be carbon dioxide.

[0215] Inflating -fluid delivery channel 600, inflatable body 602’, and / or fluid tight lumen 652, may be delivered into the gastrointestinal tract of a subject using various delivery techniques, some of which are described hereinbelow with respect to Figs. 21A to 23D. For example, they may be delivered directly, via the mouth or via the anus.

[0216] As another example, inflating-fluid delivery channel 600, inflatable body 602’, and / or fluid tight lumen 652, may be delivered into the gastrointestinal tract of the subject via a working channel of a delivery device, such as an endoscope (not explicitly shown). The endoscope may also form part of system 650.

[0217] In some embodiments, during the delivery, inflating-fluid delivery channel 600, inflatable body 602’, and / or fluid tight lumen 652, may be disposed within a catheter or delivery sheath 670, shown clearly in Fig. 19C. In some such embodiments, sheath 670 assists in maintaining the diameter of inflatable body 602’ suitably small during delivery of the inflatable body. Sheath 670 may be used in direct delivery, or in delivery via a working channel of a delivery device.

[0218] It is to be appreciated that a sheath, similar to sheath 670, may similarly be used for advancement of the medical systems of Figs. 1A to 12B, described hereinabove, into the body of a subject. In some embodiments, inflatable body 602’ may be enclosed within a textured layer (not explicitly shown) such as a layer of mesh, netting and the like. This may be designed to contact the wound and apply a pressure. The textured layer may also prevent ingress of contacting tissue into the gaps.

[0219] Reference is now made to Fig. 20, which is a flow chart of a method of treating the gastrointestinal tract of a subject using medical system 650 according to embodiments of the disclosed technology. For brevity, Fig. 20 is described with respect to inflatable portion 602’. However, the description is similarly applicable to inflatable portion 602.

[0220] At step S700, inflatable body 602’ is advanced, in its delivery state, to a target location in the gastrointestinal tract of the subject. For example, the target location may be in the vicinity of a wound in the gastrointestinal tract, which may be an endoluminal or an extraluminal wound. For example, the target location may be in the esophagus, or in the colon, of the subject.

[0221] Various mechanisms for advancing the inflatable body to the target location are described hereinbelow with respect to Figs. 21A to 23D.

[0222] At step S702, inflatable body 602’ is transitioned from its delivery state, in which it was advanced at step S700, to its inflated state, by delivery of inflating fluid to the inflatable body via channel 600. In some embodiments, the inflating fluid delivery channel 600 may be connected to inflatable body 602’ at an initial step S701, which occurs prior to step S702 and in some embodiments also prior to step S700. In some embodiments, attachment of the inflatable body 602’ to channel 600 may be part of the manufacturing process of the inflatable body.

[0223] At step S704, fluid tight lumen 652 is advanced over inflating-fluid delivery channel 600, until distal end 662 of the lumen is adjacent inflatable portion 602’, at step S206. In some embodiments, S704 may be an initial step of the method. In such embodiments, inflatable portion 602’ is advanced to the target location together with channel 600 enclosed within fluid tight lumen 652. However, in other embodiments, the fluid tight lumen 652 is advanced to the target location only after placement, and inflating, of inflatable portion 602’.

[0224] Once the fluid tight lumen 652 is properly positioned relative to inflatable body 602’, at step S706 source 658 of negative pressure is activated to apply negative pressure to troughs 612, via second channel(s) 656 and inlet troughs 626. In some embodiments, step S206 further includes coupling fluid tight lumen 652, and specifically second channel(s) 656, to the source of negative pressure.

[0225] In use, when negative pressure is applied to troughs 612, the negative pressure is adapted to drain fluid from the target location in the gastrointestinal tract, via troughs 612. Such draining reduces the amount of contaminating fluids in the target location, and thus can enhance the healing of a wound in the target region.

[0226] It is a particular feature of the disclosed technology that application of negative pressure to troughs 612 also causes the gastrointestinal tract, at the target location, to collapse inward, onto the inflatable body 602’. However, the width of the troughs 612 is selected such that the tissue does not collapse into the troughs.

[0227] As a result, troughs 612 of the inflatable portions form enclosed negative pressure regions or pockets. In each such pocket, negative pressure can be applied to a surface of the lumen wall, and not just to a single point, while at least some of the lumen wall is exposed and not in contact with the medical device.

[0228] Stated differently, using a “exit point” for negative pressure at the proximal end of the inflatable body, the negative pressure is applied to extensive surfaces or regions of the lumen, because the structure of the inflatable body and of the troughs prevents collapse of the lumen into the troughs and ensures the formation of negative pressure pockets.

[0229] On the other hand, collapsing of the lumen onto lobes 610 also assists in maintaining inflatable body 602’ correctly placed within the target location.

[0230] In some embodiments, inflatable body 602’ may be retained at the target location for an extended duration, such as days or weeks.

[0231] Following completion of treatment, at step S708 the components of medical system 650 are removed from the target location. The removal step typically includes deflating of inflatable body 602, for example by puncturing a hole in the inflatable body or by applying negative pressure to inflating -fluid delivery channel 600 so as to drain the inflating-fluid from the interior of the inflatable body.

[0232] In some embodiments, the removal at step S708 may include removal of fluid tight lumen 652 from inflating-fluid delivery channel 600 prior to removal of the channel, and of inflatable body 602’, from the target location. In other embodiments, step S708 may include removal of fluid tight lumen 652 from the target location together with inflating fluid delivery channel 600.

[0233] In embodiments in which inflatable body 602’ and inflating-fluid delivery channel 600 are separable, or separate, the removal at step S708 may include disconnection of inflating-fluid delivery channel 600 from inflatable body 602’ and subsequent removal of channel 600 from the target location. In some such embodiments, inflatable body 602’ may be removed from the target location by the inflatable body continuing down the gastrointestinal tract and being naturally evacuated from the body, or by the inflatable body being biodegradable and / or bioabsorbable within the body.

[0234] However, in embodiments in which inflatable body 602’ is integrally formed with inflating-fluid delivery channel 600, removing the inflatable body inherently includes removing of the inflating-fluid delivery channel as well.

[0235] Reference is now made to Fig. 21A, 21B, and 21C, which are schematic illustration of various mechanisms for deploying portions of a medical system, such as any one of medical systems 200, 300, 400, or 650 into the gastrointestinal tract using a delivery device, according to an embodiment of the disclosed technology.

[0236] In some embodiments, and as illustrated in Fig. 21 A, an elongate portion 722 of the medical system, such as shaft 150 together with sleeve 100, or channel 600 together with inflatable body 602’, may be delivered into the gastrointestinal tract within a working channel 724 of a delivery device 720. In such embodiments, the elongate portion of the medical system is sized and configured to pass through working channel 724 of delivery device 720.

[0237] In some embodiments, delivery device 720 may be a catheter or an endoscope.

[0238] In some embodiments, delivery device 720 may include an image capturing element 726, adapted to provide images of the elongate portion 722 during its delivery into the gastrointestinal tract. For example, image capturing element 726 may be a video camera adapted to capture images of the interior of the gastrointestinal tract during placement of the elongate portion therein.

[0239] In some embodiments, the medical system may include a handle portion, mechanically couplable to a distal end of the elongate portion 722. Manipulation of the handle portion, for example by pushing or turning thereof, results in distal motion of elongate portion 722. In some embodiments, the handle portion is adapted to be detached from the elongate portion following delivery of the elongate portion into the gastrointestinal tract.

[0240] In some embodiments, and as illustrated in Fig. 2 IB, elongate portion 722 of the medical system may be disposed within an over-tube 727 during delivery thereof. For example, overtube 727 may be delivered into the gastrointestinal tract within working channel 724, as shown in Figure 21 A.

[0241] In some embodiments, and as seen in Fig. 21C, elongate portion 722 of the medical system may delivered into the gastrointestinal tract of the user over a guide-wire 728. In some such embodiments, a valve 729, such as a duck-bill valve, may be disposed at a distal end of elongate portion 722, such that guide-wire 728 extends through the valve. Reference is now made to Figs. 22A and 22B, which are schematic illustrations of a procedure of deploying portions of a medical system 730, such as any one of medical systems 200, 300, 400, or 650 into the body of a subject, according to embodiments of the disclosed technology.

[0242] As seen in Fig. 22A, system 730, and specifically an elongate portion thereof, may be fed into the gastrointestinal tract of the subject, via the subject’s mouth. For example, in the illustrated embodiment, an endoscope is used to deliver the elongate tube into the esophagus of the subject, via the subject’s mouth.

[0243] In Fig. 22B, the elongate portion of medical system 730 is delivered into the esophagus surgically. Specifically, a hole is punctured in the abdominal wall of the subject, and the elongate portion is delivered to the gastrointestinal tract, and specifically to the esophagus, of the subject via the stomach. Alternatively, a hole is punctured in the submental triangle (not shown) of the subject, and the elongate portion is delivered to the gastrointestinal tract and specifically to the esophagus of the subject via the punctured hole. In some such applications, a distal end of elongate the elongate portion may be sharp, or may include a needle, suitable for puncturing the required hole in the abdominal wall. In some other embodiments, the process may be similar to that of placing a percutaneous endoscopic gastronomy (PEG) device, with the distinction that the elongate portion could be delivered further than the stomach, into the esophagus.

[0244] Reference is now made to Figs. 23A, 23B, 23C, 23D, and 23E, which are schematic illustrations of steps of a procedure for maintaining a portions of medical system 730, such as any one of medical systems 200, 300, 400, or 650 in the body of the subject via a nasal wire or tube, following its introduction as shown in Fig. 22A. For brevity, the elongate portion of medical system 730 is considered to be shaft 150 and sleeve 100 of medical system 200, as illustrated in Fig. 8 hereinabove.

[0245] As seen, in Fig. 23A delivery device 720 is deployed into the esophagus of the subject, via the subject’s mouth 740. In Fig. 23B, the elongate portion of medical system 730 is delivered to the esophagus of the user using the delivery device 720 (not shown). Subsequently, the delivery device 720 is removed from the mouth of the subject, leaving the elongate portion (i.e. shaft 150 and sleeve 100) of medical system 730 in place. Following placement of medical system 730 within the esophagus of the subject, delivery device 720 is removed from the body, as seen in Fig. 23C.

[0246] In Fig. 23D, a wire 750 is inserted into the nose of the subject, and through the sinuses of the subject into, and out of, the subject’s mouth. A proximal end of shaft 150 (i.e. of the elongate portion of the medical system) is then associated with end 752 of wire 750 extending out of the subject’s mouth. In Fig. 23E, the wire 750 is pulled out of the subject’s nose. As wire 750 is pulled out of the subject’s nose, end 752 of the wire, together with the proximal end shaft 150 (i.e. of the elongate portion), are pulled into the subject’s nose. When wire 750 is fully removed from the subject’s nose, the proximal end of shaft 150 (or the proximal portion of the elongate portion) continues to extend through the subject’s nose and to the exterior of the subj ect’ s body, for connection to the source of negative pressure or to a source of inflating fluid, as relevant. The proximal portion of the elongate portion can additionally be associated with a nasal retaining element which is configured to maintain the longitudinal position of elongate portion within the subject.

[0247] The disclosed technology may be better understood with respect to the following exemplary embodiments:

[0248] 1. A medical system for applying negative pressure within a gastrointestinal tract of a subject, the system comprising:

[0249] (i) a longitudinal shaft disposed along a longitudinal axis, the longitudinal shaft including:

[0250] (a) a longitudinally extending negative-pressure delivery channel; and

[0251] (b) a plurality of negative-pressure delivery orifices, longitudinally distributed along the longitudinal shaft, the plurality of negative -pressure delivery orifices being in fluid communication with the negative-pressure delivery channel; and

[0252] (ii) a plurality of expandable portions including at least three expandable portions, disposed periodically along the shaft and extending outwardly therefrom, such that a gap is formed between each pair of adjacent ones of the plurality of expandable portions, each of the plurality of expandable portions having: a delivery operative state in which the plurality of expandable portions have a first dimension, or a first diameter, perpendicular to the longitudinal axis of the shaft; and an expanded operative state in which the plurality of expandable portions have a second dimension, or a second diameter, about the longitudinal axis, the second dimension or diameter being greater than the first dimension or diameter, wherein the longitudinally extending negative-pressure delivery channel is adapted to couple to a source of negative pressure and to deliver negative pressure, along the longitudinally extending negative -pressure delivery channel and via the plurality of negative-pressure delivery orifices, to the gaps between the expandable portions, in a radial direction relative to the longitudinal axis. 2. A medical system for applying negative pressure within a gastrointestinal tract of a subject, the system comprising:

[0253] (i) a sleeve extending along a longitudinal axis, the sleeve including:

[0254] (a) a plurality of tubular portions having a first diameter about the longitudinal axis of the sleeve, each of the plurality of tubular portions including at least one sleeve orifice; and

[0255] (b) a plurality of expandable portions including at least three expandable portions, each pair of adjacent ones of the plurality of expandable portions being separated by one of the plurality of tubular portions, each of the plurality of expandable portions having: a delivery operative state; and an expanded operative state in which the plurality of expandable portions have a second diameter about the longitudinal axis of the sleeve, the second diameter being greater than the first diameter, such that gaps are formed between the expandable portions along the longitudinal axis of the sleeve; and

[0256] (ii) a longitudinal shaft, disposed within the sleeve, and including:

[0257] (a) a longitudinally extending negative-pressure delivery channel; and

[0258] (b) a plurality of negative-pressure delivery orifices, longitudinally distributed along the longitudinal shaft, the plurality of negative -pressure delivery orifices being in fluid communication with the negative-pressure delivery channel and being aligned with the sleeve orifices, wherein the longitudinally extending negative-pressure delivery channel is adapted to couple to a source of negative pressure and to deliver negative pressure, along the longitudinally extending negative-pressure delivery channel and via the plurality of negativepressure delivery orifices and the sleeve orifices, to the gaps between the expandable portions, in a radial direction relative to the longitudinal axis of the sleeve.

[0259] 3. A medical system for applying negative pressure within a gastrointestinal tract of a subject, the system comprising:

[0260] (i) a sleeve extending along a longitudinal axis, the sleeve including:

[0261] (a) a plurality of tubular portions having a first diameter about the longitudinal axis of the sleeve, each of the plurality of tubular portions including at least one sleeve orifice; and

[0262] (b) a plurality of inflatable portions including at least three expandable portions, each pair of adjacent ones of the plurality of inflatable portions being separated by one of the plurality of tubular portions, each of the plurality of inflatable portions having: a delivery operative state; and an inflated operative state when inflated by an inflating fluid, wherein, in the inflated operative state, the plurality of inflatable portions have a second diameter about the longitudinal axis of the sleeve, the second diameter being greater than the first diameter, such that gaps are formed between the inflatable portions along the longitudinal axis of the sleeve; and

[0263] (ii) a longitudinal shaft, disposed within the sleeve along the longitudinal axis, and including:

[0264] (a) at least one longitudinally extending inflating-fluid delivery channel;

[0265] (b) a longitudinally extending negative-pressure delivery channel;

[0266] (c) a plurality of inflating-fluid delivery orifices, longitudinally distributed along the longitudinal shaft, each the plurality of inflating-fluid orifices being in fluid communication with one of the at least one longitudinally extending inflating-fluid delivery channel and with one of the plurality of inflatable portions; and

[0267] (d) a plurality of negative-pressure delivery orifices, longitudinally distributed along the longitudinal shaft, the plurality of negative -pressure delivery orifices being in fluid communication with the negative-pressure delivery channel and being aligned with the sleeve orifices, wherein the at least one longitudinally extending inflating-fluid delivery channel is adapted to couple to a source of the inflating fluid for delivery of the inflating fluid to the plurality of inflatable portions, via the plurality of inflating-fluid delivery orifices, and wherein the longitudinally extending negative-pressure delivery channel is adapted to couple to a source of negative pressure and to deliver negative pressure, along the negativepressure delivery channel and via the plurality of negative-pressure delivery orifices and the sleeve orifices, to the gaps between the inflatable portions, in a radial direction relative to the longitudinal axis.

[0268] 4. The medical system of embodiment 1, wherein the plurality of expandable portions are integrally formed with the longitudinal shaft.

[0269] 5. The medical system of any one of embodiments 1, 2, or 4, wherein each of the plurality of expandable portions comprises a shape memory scaffold, the shape memory scaffold being held in a compressed state when the expandable portions are in the delivery operative state, and wherein release of the shape memory scaffold from the compressed state and expansion of the shape memory scaffold causes the expandable portions to transition from the delivery operative state to the expanded operative state. 6. The medical system of any one of embodiments 1, 2, or 4, wherein each of the plurality of expandable portions comprises a porous compressible material, the porous compressible material being held in a compressed state when the expandable portions are in the delivery operative state, and wherein release of the porous compressible material from the compressed state and expansion of the shape memory scaffold causes the expandable portions to transition from the delivery operative state to the expanded operative state.

[0270] 7. The medical system of any one of embodiments 1, 2, or 4, wherein each of the plurality of expandable portions has precursors or reactants of a chemical reaction disposed therein, and wherein triggering of the chemical reaction between the precursors or reactants causes the release of a gas or material expansion which causes the expandable portions to transition from the delivery operative state to the expanded operative state.

[0271] 8. The medical system of embodiment 1 or of any one of embodiments 4 to 7, wherein each of the expandable portions comprises an expandable sleeve portion disposed externally to each of the expandable portions, the expandable sleeve portion sealingly engaging the longitudinal shaft.

[0272] 9. The medical system of embodiment 8, wherein the plurality of expandable portions comprises a plurality of inflatable portions, adapted to be transitioned from the delivery operative state to the expanded operative state by introduction of an inflating fluid thereinto.

[0273] 10. The medical system of embodiment 9, wherein the longitudinal shaft further includes:

[0274] (c) at least one longitudinally extending inflating-fluid delivery channel; and

[0275] (d) a plurality of inflating-fluid delivery orifices, longitudinally distributed along the longitudinal shaft, each of the plurality of inflating-fluid delivery orifices being in fluid communication with one of the at least one longitudinally extending inflating-fluid delivery channel and with one of the plurality of inflatable portions, wherein the at least one longitudinally extending inflating-fluid delivery channel is adapted to couple to a source of the inflating fluid for delivery of the inflating fluid to the plurality of inflatable portions, via the plurality of inflating-fluid delivery orifices.

[0276] 11. The medical system of embodiment 3 or embodiment 10, wherein the at least one longitudinally extending inflating-fluid delivery channel comprises a plurality of longitudinally extending inflating-fluid delivery channels, each in fluid communication with a corresponding one of the plurality of inflatable portions and adapted to couple to the source of the inflating fluid for delivery of the inflating fluid to the corresponding inflatable portion. 12. The medical system of embodiment 11, wherein each of the plurality of longitudinally extending inflating-fluid delivery channels is adapted to couple to a different source of the inflating fluid.

[0277] 13. The medical system of embodiment 11, wherein the plurality of longitudinally extending inflating-fluid delivery channels are adapted to couple to the source of the inflating fluid at different times.

[0278] 14. The medical system of embodiment 3 or any one of embodiments 10 to 13, wherein, introduction of the inflating fluid into the plurality of inflatable portions, via the at least one inflating-fluid delivery channel and the inflating-fluid delivery orifices, transitions the inflatable portions from the delivery operative state to the expanded operative state.

[0279] 15. The medical system of embodiment 3 or any one of embodiments 9 to 14, wherein the inflating fluid comprises saline.

[0280] 16. The medical system of embodiment 3 or any one of embodiments 10 to 15, further comprising the source of the inflating fluid.

[0281] 17. The medical system of any one of embodiments 8 to 16, further comprising the sleeve extending along the longitudinal axis, the sleeve including: the plurality of expandable portions; a plurality of tubular portions, such that each pair of adjacent expandable portions is separated by one of the plurality of tubular portions; and a plurality of sleeve orifices, disposed in the plurality of tubular portions, wherein the longitudinally extending negative-pressure delivery channel is adapted to deliver the negative pressure to the gaps between the expandable portions via the negative pressure delivery orifices and via the sleeve orifices.

[0282] 18. The medical system of embodiment 3 or of any one of embodiments 10 to 17, wherein the at least one longitudinally extending inflating-fluid delivery channel has an inner diameter 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 3 mm, 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..

[0283] 19. The medical system of embodiment 3 or any one of embodiments 10 to 18, wherein each orifice in the plurality of inflating-fluid delivery orifices has a diameter 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. 20. The medical system of embodiment 3 or any one of embodiments 17 to 19, wherein a length of the sleeve is 6 to 200mm.

[0284] 21. The medical system of embodiment 3 or any one of embodiments 17 to 20, wherein the length of the sleeve is at least 10mm.

[0285] 22. The medical system of embodiment 3 or any one of embodiments 17 to 21, wherein, the length of each of the tubular portions of the sleeve is in the range of 2 to 40mm, 2mm to 20mm, 2mm to 15mm, or 0.5mm to 40mm.

[0286] 23. The medical system of embodiment 3 or any one of embodiments 17 to 21, wherein, the length of each of the tubular portions of the sleeve is at most 40mm.

[0287] 24. The medical system of embodiment 3 or any one of embodiments 17 to 23, wherein an external diameter of each tubular portion of the sleeve is in the range of 1.5 to 10mm.

[0288] 25. The medical system of embodiment 3 or any one of embodiments 17 to 24, wherein a longest dimension of each sleeve orifice is in the range of 0.5mm to 10mm or 0.5mm to 5mm.

[0289] 26. The medical system of any one of embodiments 1 to 25, wherein the plurality of expandable or inflatable portions includes at least 4 or at least 5 expandable or inflatable portions.

[0290] 27. The medical system of any one of embodiments 1 to 26, wherein an external diameter of the expandable or inflatable portions, in the delivery operative 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.

[0291] 28. The medical system of any one of embodiments 1 to 27, wherein an external diameter of the expandable or inflatable portions, in the expanded operative 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.

[0292] 29. The medical system of any one of embodiments 1 to 28, wherein in the expanded operative state, a proximal-most expandable or inflatable portion and a distal-most expandable or inflatable portion have a greater external diameter than the rest of the plurality of expandable or inflatable portions disposed between the proximal most expandable or inflatable portion and the distal most expandable or inflatable portion.

[0293] 30. The medical system of any one of embodiments 1 to 28, wherein in the expanded operative state, a proximal-most expandable or inflatable portion and a distal-most expandable or inflatable portion have a smaller external diameter than the rest of the plurality of expandable or inflatable portions disposed between the proximal most expandable or inflatable portion and the distal most expandable or inflatable portion. 31. The medical system of any one of embodiments 1 to 30, wherein, in the expanded operative state, a cross section of at least one of the expandable or inflatable portions is annular.

[0294] 32. The medical system of any one of embodiments 1 to 31, wherein, in the expanded operative state, the cross section of each of the expandable or inflatable portions is annular.

[0295] 33. The medical system of any one of embodiments 1 to 32, wherein, in the expanded operative state, at least one of the expandable or inflatable portions is ring-shaped.

[0296] 34. The medical system of any one of embodiments 1 to 33, wherein, in the expanded operative state, each of the expandable or inflatable portions is ring-shaped.

[0297] 35. The medical system of any one of embodiments 1 to 32, wherein, in the expanded operative state, at least one of the expandable or inflatable portions is spherical with a tubular center.

[0298] 36. The medical system of any one of embodiments 1 to 32, wherein, in the expanded operative state, each of the expandable or inflatable portions is spherical with a tubular center.

[0299] 37. The medical system of any one of embodiments 1 to 30, wherein, in the expanded operative state, a cross section of at least one of the expandable or inflatable portions includes a plurality of lobes, each pair of adjacent lobes separated by a trough.

[0300] 38. The medical system of embodiment 37, wherein, in the expanded operative state, a cross section of a first of the expandable or inflatable portions and of a second of the expandable or inflatable portions includes the plurality of lobes, each pair of adjacent lobes separated by the trough.

[0301] 39. The medical system of embodiment 38, wherein, in the expanded operative state, the troughs of the first of the expandable or inflatable portions are longitudinally aligned with the troughs of the second of the expandable or inflatable portions.

[0302] 40. The medical system of embodiment 38, wherein, in the expanded operative state, the troughs of the first of the expandable or inflatable portions are rotationally offset with respect to the troughs of the second of the expandable or inflatable portions, such that the troughs of the first expandable or inflatable portion are not longitudinally aligned with the troughs of the second expandable or inflatable portion.

[0303] 41. The medical system of any one of embodiments 1 to 30 or 37, wherein, in the expanded operative state, at least one of the expandable or inflatable portions includes a plurality of longitudinally arranged lobes and a plurality of longitudinally arranged troughs, wherein each pair of adjacent longitudinally arranged lobes is separated by one of the plurality of longitudinally arranged troughs. 42. The medical system of any one of embodiments 37 to 41, wherein, in the expanded operative state of the expandable or inflatable portions, a height differential between one of said plurality of lobes, and an adjacent one of said plurality of troughs, is at least 0.5mm.

[0304] 43. The medical system of any one of embodiments 37 to 42, wherein, in the expanded operative state of the expandable or inflatable portions, the height differential between one of said plurality of lobes, and an adjacent one of said plurality of troughs, is in the range of 1mm to 7mm, 1mm to 5mm, 1mm to 4mm, or 1mm to 3mm.

[0305] 44. The medical system of 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.

[0306] 45. The medical system of any one of embodiments 37 to 44, wherein the lobes are equidistantly arranged circumferentially about the at least one expandable or inflatable portion.

[0307] 46. The medical system of any one of embodiments 1 to 45, wherein a radially outward surface of at least one of the expandable or inflatable portions is textured.

[0308] 47. The medical system of any one of embodiments 1 to 46, wherein, in the expanded operative state, a first of the plurality of expandable or inflatable portions has a first cross section in a direction perpendicular to the longitudinal axis, and a second of the plurality of expandable or inflatable portions has a second cross section in the direction perpendicular to the longitudinal axis, the second cross section being distinct from the first cross section.

[0309] 48. The medical system of any one of embodiments 1 to 47, wherein the longitudinally extending negative pressure delivery channel has a cross sectional area in the range of 1mm2to 85 mm2.

[0310] 49. The medical system of any one of embodiments 1 to 48, wherein each of the plurality of negative pressure delivery orifices has a longest dimension 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.

[0311] 50. The medical system of any one of embodiments 1 to 49, wherein the plurality of negative pressure delivery orifices includes a first subset and a second subset, wherein negative pressure delivery orifices in the first subset have a first longest dimension and negative pressure delivery orifices in the second subset have a second longest dimension, the second longest dimension being different from the first longest dimension.

[0312] 51. The medical system of any one of embodiments 1 to 50, wherein a cross-sectional area of a distal -most one of the plurality of negative pressure delivery orifices is greater than a cross- sectional area of a proximal-most one of the plurality of negative pressure delivery orifices. 52. The medical system of any one of embodiments 1 to 51, wherein, a distance along the longitudinal shaft, between pairs of adjacent ones of the plurality of negative pressure orifices, is in the range of 2mm to 40mm, 2mm to 30mm, 2mm to 20mm, 2mm to 10mm.

[0313] 53. The medical system of any one of embodiments 1 to 52, further comprising the source of negative pressure.

[0314] 54. The medical system of any one of embodiments 1 to 53, wherein the longitudinal shaft further includes: a second longitudinally extending negative-pressure delivery channel; and a second plurality of negative-pressure delivery orifices, longitudinally distributed along the longitudinal shaft, the second plurality of negative-pressure delivery orifices being in fluid communication with the second longitudinally extending negative-pressure delivery channel, wherein the second longitudinally extending negative-pressure delivery channel is adapted to couple to the source of negative pressure or to an additional source of negative pressure and to deliver negative pressure, along the second longitudinally extending negativepressure delivery channel and via the second plurality of negative -pressure delivery orifices, to the gaps between the expandable or inflatable portions, in a radial direction relative to the longitudinal axis.

[0315] 55. The medical system of any one of embodiments 1 to 53, wherein, when not coupled to a source of negative pressure, the longitudinally extending negative-pressure delivery channel is adapted to be coupled to a source of a flushing-fluid, for delivery of the flushing-fluid to the gaps via the plurality of negative-pressure delivery orifices.

[0316] 56. The medical system of any one of embodiments 1 to 53, wherein the longitudinal shaft further includes: a longitudinally extending flushing-fluid delivery channel; and at least one flushing-fluid delivery orifice, the at least one flushing-fluid delivery orifice being in fluid communication with the longitudinally extending flushing-fluid delivery channel, wherein the longitudinally extending flushing-fluid delivery channel is adapted to couple to the source of the flushing fluid for delivery of the flushing fluid to the gaps via the at least one fluid-flushing delivery orifice.

[0317] 57. The medical system of embodiment 55 or embodiment 56, wherein the flushing fluid is a medicament fluid.

[0318] 58. The medical system of embodiment 55 or embodiment 56, wherein the flushing fluid is a contrast material. 59. The medical system of embodiment 55 or embodiment 56, wherein the flushing fluid is ionized gas.

[0319] 60. The medical system of embodiment 55 or embodiment 56, wherein the flushing fluid is carbon dioxide.

[0320] 61. The medical system of any one of embodiments 55 to 60, further comprising the source of the flushing fluid.

[0321] 62. The medical system of any one of embodiments 1 to 61, wherein, in the delivery state, the shaft is sized and configured to be disposed over a guidewire during delivery into the gastrointestinal tract of the subject.

[0322] 63. The medical system of any one of embodiments 1 to 61, wherein, in the delivery state, the shaft and expandable or inflatable portions are sized and configured to be delivered into the gastrointestinal tract of the subject via a working channel of a delivery device.

[0323] 64. The medical system of any one of embodiments 1 to 63, further comprising a delivery sheath having a diameter suitable to be delivered into the gastrointestinal tract of the subject via a working channel of a delivery device and adapted to house the expandable or inflatable portions in the delivery operative state, and the longitudinal shaft.

[0324] 65. The medical system of any one of embodiments 1 to 64, further comprising a textured layer covering an exterior of at least some of the expandable or inflatable portions.

[0325] 66. The medical system of embodiment 65, wherein the textured layer comprises a netted or mesh layer.

[0326] 67. The medical system of embodiment 65, wherein the textured layer is adapted to contact the wound for mechanical stimulation thereof.

[0327] 68. A method of applying negative pressure to a target location of a gastrointestinal tract of a subject, the method comprising:

[0328] (a) advancing to the target location a longitudinal shaft having at least three expandable portions disposed therearound, the plurality of expandable portions being separated by gaps along the longitudinal shaft and being in a delivery operative state;

[0329] (b) transitioning the expandable or inflatable portions from the delivery operative state to an expanded operative state;

[0330] (c) delivering negative pressure, from a negative pressure source coupled to the longitudinal shaft, to the gaps between the expandable portions, via a negative-pressure delivery channel in the shaft and via negative-pressure delivery orifices in the shaft which are in fluid communication with the gaps and with the negative-pressure delivery channel. 69. The method of embodiment 68, further comprising, prior to (c), coupling the source of negative pressure to the longitudinal shaft.

[0331] 70. The method of embodiment 68 or of embodiment 69, further comprising, following (c), removing the longitudinal shaft and the expandable portions from the target location.

[0332] 71. The method of embodiment 70, further comprising, prior to the removing, transitioning the expandable or inflatable portions from the expanded operative state to the delivery operative state.

[0333] 72. The method of any one of embodiments 68 to 71, wherein: the plurality of expandable portions comprises a plurality of inflatable portions; the shaft comprises a longitudinally extending inflating-fluid delivery channel and a plurality of longitudinally distributed inflating-fluid delivery orifices; and the expanding at step (b) comprises, from a source of an inflating fluid coupled to the shaft, delivering the inflating fluid to the inflatable portions, via the inflating-fluid delivery channel and the inflating-fluid delivery orifices to expand the inflatable portions.

[0334] 73. The method of embodiment 72, further comprising, prior to (b), coupling the source of the inflating fluid to the longitudinal shaft.

[0335] 74. The method of any one of embodiments 68 to 71, wherein the expandable portions comprise a shape memory scaffold, and wherein: during the advancing at step (a), the shape memory scaffold is held in a compressed state; and the expanding at step (b) comprises releasing the shape memory scaffold from the compressed state, such that expansion of the shape memory scaffold causes the expanding of the expandable portions.

[0336] 75. The method of any one of embodiments 68 to 71, wherein the expandable portions comprise a porous compressible material, and wherein: during the advancing at step (a), the porous compressible material is held in a compressed state; and the expanding at step (b) comprises releasing the porous compressible material from the compressed state, such that expansion of the porous compressible material causes the expanding of the expandable portions.

[0337] 76. The method of any one of embodiments 68 to 71, wherein the expandable portions have reactants of a gas-releasing chemical reaction disposed therein, and wherein the expanding at step (b) comprises triggering the gas-releasing chemical reaction, such that gas release by the chemical reaction causes the expanding of the expandable portions. 77. The method of any one of embodiments 68 to 76, further comprising: coupling the shaft to a source of a flushing fluid; and delivering the flushing fluid to the gaps between the expandable portions for flushing thereof.

[0338] 78. The method of embodiment 77, wherein the delivering of the flushing fluid is carried out when the negative-pressure delivery channel is detached from the source of the negative pressure, via the negative-pressure delivery channel and the negative-pressure delivery orifices.

[0339] 79. The method of embodiment 78, further comprising, prior to coupling of the shaft to the source of flushing fluid, decoupling of the shaft from the source of the negative pressure.

[0340] 80. The method of embodiment 77, wherein the longitudinal shaft further includes a flushing-fluid delivery channel and at least one flushing-fluid delivery orifice in fluid communication with the flushing-fluid delivery channel, and wherein the delivering of the flushing fluid to the gaps between the expandable portions is via the flushing-fluid delivery channel and flushing-fluid delivery orifice.

[0341] 81. The method of any one of embodiments 68 to 80, wherein the advancing comprises disposing the longitudinal shaft about a guidewire, and advancing the guidewire, with the longitudinal shaft disposed therearound, to the target location.

[0342] 82. The method of any one of embodiments 68 to 80, wherein the advancing comprises advancing the longitudinal shaft and the expandable portions, in their delivery operative state, to a target location via a working channel of a delivery device.

[0343] 83. The method of any embodiment 82, wherein the delivery device includes an image capturing element, and wherein the advancing further comprising capturing images of the target treatment site during advancing thereof to the target location.

[0344] 84. The method of any one of embodiments 81 to 83, further comprising, prior to the expanding, removing the guidewire or the delivery device from the target location.

[0345] 85. A medical system for applying negative pressure within a gastrointestinal tract of a subject, the medical system comprising: i. an inflating-fluid delivery channel having a distal end; and ii. a longitudinal inflatable body disposed at the distal end of the inflating-fluid delivery channel, the longitudinal inflatable body having a delivery operative state and an inflated operative state, the longitudinal inflatable body comprising: a. a tissue-engaging portion having a plurality of longitudinally arranged lobes and a plurality of longitudinally arranged troughs formed therein when the longitudinal inflatable body is in the inflated operative state; and b. a bridging portion disposed between the inflating-fluid delivery channel and the tissueengaging portion, wherein, in the inflated operative state, a plurality of inlet troughs extend along an exterior surface of the bridging portion, from the distal end of the inflating-fluid delivery channel to a proximal end of each of the plurality of troughs.

[0346] 86. The medical system for applying negative pressure within a gastrointestinal tract of a subject, the medical system comprising: i. an inflating-fluid delivery channel having a distal end; ii. a longitudinal inflatable body disposed at the distal end of the inflating-fluid delivery channel, the longitudinal inflatable body having a delivery operative state and an inflated operative state, the longitudinal inflatable body comprising: a. a tissue-engaging portion having a plurality of longitudinally arranged lobes and a plurality of longitudinally arranged troughs formed therein when the longitudinal inflatable body is in the inflated operative state; and b. a bridging portion disposed between the inflating-fluid delivery channel and the tissue-engaging portion, wherein, in the inflated operative state, a plurality of inlet troughs extend along an exterior surface of the bridging portion, from the distal end of the inflating-fluid delivery channel to a proximal end of each of the plurality of troughs; and iii. a fluid tight lumen including at least one channel, the fluid tight lumen adapted to couple to a source of negative pressure and to deliver negative pressure, along the at least one channel, to the proximal end of the longitudinal inflatable body, and to apply the negative pressure along the longitudinally arranged troughs via the inlet troughs.

[0347] 87. A medical system for applying negative pressure within a gastrointestinal tract of a subject, the medical system comprising: i. a longitudinal body having a delivery operative state and an inflated operative state, wherein, in the inflated operative state, the longitudinal body includes: a. a plurality of longitudinally arranged lobes, each of the plurality of longitudinally arranged lobes adapted to be coupled, via an inflating fluid delivery channel, to at least one source of an inflating fluid; and b . a plurality of longitudinally arranged troughs, wherein each pair of adjacent longitudinally arranged lobes is separated by one of the plurality of longitudinally arranged troughs; and ii . a fluid tight lumen including at least one channel, the fluid tight lumen adapted to couple to a source of negative pressure and to deliver negative pressure, along the at least one channel, to a proximal end of the longitudinal body, and to apply the negative pressure along the longitudinally arranged troughs.

[0348] 88. The medical system of embodiment 87, wherein the longitudinal body comprises multiple inflatable longitudinal bodies attached to each other, each including at least one of the plurality of longitudinally arranged lobes, such that at least some of said plurality of longitudinally arranged troughs are formed between two adjacent ones of the multiple inflatable longitudinal bodies; and the medical system further comprises multiple inflating fluid delivery channels, each in fluid communication with a corresponding one of the multiple inflatable longitudinal bodies and coupled to the at least one source of the inflating fluid for delivery of inflating fluid to the corresponding inflatable longitudinal body.

[0349] 89. The medical system of embodiment 88, wherein each of the multiple inflating fluid delivery channels is adapted to be coupled to a dedicated source of inflating fluid.

[0350] 90. A medical system for applying negative pressure within a gastrointestinal tract of a subject, the system comprising: a longitudinal inflatable body having a delivery operative state and an inflated operative state; an inflating-fluid delivery channel terminating in, and in fluid communication with, the longitudinal inflatable body, such that the longitudinal inflatable body is at a distal end of the inflating-fluid delivery channel, the inflating-fluid delivery channel adapted for delivery of an inflating fluid to the inflatable body, wherein, in the inflated operative state, the longitudinal inflatable body includes: a plurality of longitudinally arranged lobes; and a plurality of longitudinally arranged troughs, wherein each pair of adjacent longitudinally arranged lobes is separated by one of the plurality of longitudinally arranged troughs; and a fluid tight lumen including at least one negative pressure delivery channel adapted to couple to a source of negative pressure and to deliver negative pressure to a proximal end of the inflatable body, and to apply the negative pressure along the longitudinally arranged troughs.

[0351] 91. The medical system of any one of embodiments 88 to 90, wherein: the inflatable body includes a bridging portion and a tissue-engaging portion, the bridging portion adapted to be disposed between the inflating-fluid delivery channel and the tissue-engaging portion; in the inflated operative state, the plurality of lobes and the plurality of troughs are formed in the tissue-engaging portion; and in the inflated operative state, a plurality of inlet troughs extend along an exterior surface of the bridging portion, from a distal end of the inflating-fluid delivery channel to the proximal end of each of the plurality of troughs.

[0352] 92. The medical system of any one of embodiments 85, 86, or 91, wherein, in the inflated operative state, an angle a between a longitudinal axis of one of the plurality of inlet troughs and a longitudinal axis of the inflating-fluid delivery channel is in the range of 100 to 160 degrees, 105 to 155 degrees, or 105 to 150 degrees.

[0353] 93. The medical system of any one of embodiments 85, 86, 91, or 92, wherein, in the inflated operative state, an angle formed by the bridging portion at a connection between the bridging portion and the inflating-fluid delivery channel is in the range of 60 to 160 degrees, 60 to 155 degrees, or 60 to 150 degrees, or 70 to 150 degrees.

[0354] 94. The medical system of any one of embodiments 85 to 86 or 91 to 93, wherein, at a distance of 2mm from the distal end of the inflating-fluid delivery channel along the longitudinal axis of the inflatable body, a height differential between one of the plurality of inlet troughs and an adjacent lobe of the bridging portion is at least 0.4mm or at least 0.5mm.

[0355] 95. The medical system of any one of embodiments 85 to 86 or 91 to 94, wherein, in the inflated operative state, a longitudinal length of at least one of the plurality of inlet troughs is in a range of 10 to 80mm.

[0356] 96. The medical system of any one of embodiments 86 or 88 to 95, wherein the fluid tight lumen further includes an additional channel adapted to be disposed around the inflating-fluid delivery channel.

[0357] 97. The medical system of any one of embodiments 85 to 96, wherein the inflatable body includes the plurality of lobes and the plurality of troughs when negative pressure in the range of 50 to 350 mmHg is applied at the proximal end of the inflatable body in the inflated operative state.

[0358] 98. The medical system of any one of embodiments 85 to 96, wherein the an outer contour of the inflatable body is maintained, having less that 20%, less than 15%, less than 10%, or less than 5% change, when negative pressure in the range of 50 to 350 mmHg is applied at the proximal end of the inflatable body in the inflated operative state.

[0359] 99. The medical system of any one of embodiments 85 to 98, wherein, in the inflated operative state of the inflatable body, a height differential between one of said plurality of lobes, and an adjacent one of said plurality of troughs, is at least 2mm. 100. The medical system of any one of embodiments 85 to 98, wherein, in the inflated operative state of the inflatable body, a height differential between one of said plurality of lobes, and an adjacent one of said plurality of troughs, is in the range of at least 2mm. or in a range of 1mm to 7mm, 1mm to 6mm, 1mm to 5mm, 1mm to 4mm, 1mm to 3mm, or 1mm to 2mm.

[0360] 101. The medical system of any one of embodiments 85 to 100, wherein the number of lobes in the plurality of lobes is at least 3, at least 4, at least 5, or at least 6.

[0361] 102. The medical system of any one of embodiments 85 to 101, wherein the lobes are distributed circumferentially about the inflatable body.

[0362] 103. The medical system of any one of embodiments 85 to 102, wherein the lobes are equidistantly arranged circumferentially about the inflatable body.

[0363] 104. The medical system of any one of embodiments 85 to 103, wherein a radially outward surface of at least one of the lobes is textured.

[0364] 105. The medical system of any one of embodiments 85 to 103, wherein a radially outward surface of at least one lobe of the plurality of lobes includes a second plurality of troughs, separated by a plurality of ridges extending along the longitudinal length of the at least one lobe.

[0365] 106. The medical system of any one of embodiments 86 or 88 to 105, wherein the inflatable body is integrally formed with the inflating-fluid delivery channel.

[0366] 107. The medical system of any one of embodiments 86 or 88 to 105, wherein the inflatable body is separable from the inflating-fluid delivery channel.

[0367] 108. The medical system of any one of embodiments 85 to 107, wherein, in the delivery operative state, the inflatable body is deflated.

[0368] 109. The medical system of any one of embodiments 86 to 108, wherein the fluid tight lumen has an external diameter smaller than 8mm, smaller than 6mm, smaller than 5mm, smaller than 4mm, smaller than 3.7mm, or smaller than 3.5mm.

[0369] 110. The medical system of any one of embodiments 86 or 88 to 109, wherein the inflating- fluid delivery channel has an external diameter smaller than 8mm, smaller than 6mm, smaller than 5mm, smaller than 4mm, smaller than 3.7mm, or smaller than 3.5mm.

[0370] 111. The medical system of any one of embodiments 86 or 88 to 110, wherein the inflating- fluid delivery channel has an external diameter in the range of 1mm to 6mm.

[0371] 112. The medical system of any one of embodiments 86 or 88 to 111, wherein the inflating- fluid delivery channel has an internal diameter 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, 1.5mm to 3mm.

[0372] 113. The medical system of any one of embodiments 85 to 112, wherein the inflatable body, in the delivery operative state, has an external diameter smaller than 8mm, smaller than 6mm, smaller than 5mm, smaller than 4mm, smaller than 3.7 mm, or smaller than 3.5mm.

[0373] 114. The medical system of any one of embodiments 85 to 113, wherein the inflatable body, in the inflated operative state, has an external diameter 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.

[0374] 115. The medical system of any one of embodiments 85 to 86 or 88 to 114, wherein, introduction of the inflating fluid into the inflatable body, via the inflating-fluid delivery channel, transitions the inflatable body from the delivery operative state to the inflated operative state.

[0375] 116. The medical system of any one of embodiments 85 to 86 or 88 to 115, wherein the inflating fluid comprises saline.

[0376] 117. The medical system of any one of embodiments 85 to 86 or 88 to 116, further comprising a source of the inflating fluid.

[0377] 118. The medical system of any one of embodiments 85 to 86 or 88 to 117, wherein the fluid tight lumen is centered relative to, and is coaxial with, the inflating-fluid delivery channel and the inflatable body.

[0378] 119. The medical system of any one of embodiments 86 to 118, wherein the at least one channel comprises an annular channel.

[0379] 120. The medical system of embodiment 119, wherein the at least one channel comprises an annular channel disposed around, and coaxially with, the additional channel.

[0380] 121. The medical system of embodiment 120, wherein a plurality of struts connect an interior surface of the at least one channel to an exterior surface of the additional channel, to retain the coaxial relationship of the at least one channel and the additional channel.

[0381] 122. The medical system of any one of embodiments 97, 120, or 121, wherein the at least one channel comprises a plurality of channels, distributed circumferentially about the additional channel.

[0382] 123. The medical system of embodiment 122, wherein at least a portion of each of the plurality of second channels is longitudinally aligned with each of the plurality of troughs. 124. The medical system of any one of embodiments 86 to 123, wherein a surface area of the at least one channel, in a direction perpendicular to the longitudinal axis thereof, is at least 5mm2.

[0383] 125. The medical system of any one of embodiments 86 to 124, wherein the external diameter of the fluid tight lumen is smaller than a greatest external diameter of the inflatable body, in the inflated operative state.

[0384] 126. The medical system of any one of embodiments 86 to 125, wherein the fluid tight lumen is adapted to be disposed at a fixed position relative to the inflatable body.

[0385] 127. The medical system of any one of embodiments 86 to 126, further comprising an anchoring mechanism, adapted to anchor the fluid tight lumen to a fixed longitudinal location relative to the inflatable body.

[0386] 128. The medical system of any one of embodiments 86 to 127, wherein, in the inflated operative state, a distance between a distal end of the fluid tight lumen, a proximal end of one of said plurality of troughs, along the longitudinal axis of the inflating-fluid delivery channel and of the inflatable body, is in at most 6mm, at most 4mm, at most 2mm, or at most 1mm.

[0387] 129. The medical system of any one of embodiments 86 to 128, further comprising a source of negative pressure coupled to the fluid tight lumen, the source of negative pressure configured to apply negative pressure in the range of 50 to 350 mmHg.

[0388] 130. The medical system of any one of embodiments 86 to 129, wherein, when not coupled to the source of negative pressure, the at least one channel of the fluid tight lumen can be coupled to a source of a fluid, for delivery of the fluid to the plurality of troughs via the at least one channel.

[0389] 131. The medical system of embodiment 130, further comprising the source of the fluid.

[0390] 132. The medical system of embodiment 130 or embodiment 131, wherein the fluid is a medicament fluid.

[0391] 133. The medical system of embodiment 130 or embodiment 131, wherein the fluid is a contrast material.

[0392] 134. The medical system of embodiment 130 or embodiment 131, wherein the fluid is ionized gas.

[0393] 135. The medical system of embodiment 130 or embodiment 131, wherein the fluid is carbon dioxide.

[0394] 136. The medical system of any one of embodiments 85 to 135, wherein the inflatable body, in the delivery operative state, is sized and configured to be delivered into the gastrointestinal tract of the subject via a working channel of a delivery device. 137. The medical system of any one of embodiments 86 to 136, wherein the fluid tight lumen is sized and configured to be delivered into the gastrointestinal tract of the subject via a working channel of a delivery device.

[0395] 138. The medical system of any one of embodiments 85 to 137, wherein the plurality of lobes and the plurality of troughs do not extend to a distal-most end of the inflatable body, such that, in the inflated operative state, the distal-most end of the inflatable body is cylindrical or spherical.

[0396] 139. The medical system of any one of embodiments 86 to 138, further comprising a delivery sheath adapted to house the inflatable body, in the delivery operative state, or the fluid tight lumen during delivery thereof into the gastrointestinal tract of the subject.

[0397] 140. The medical system of any one of embodiments 85 to 139, further comprising a textured layer covering an exterior of the inflatable body.

[0398] 141. A method of applying negative pressure to a target location of a gastrointestinal tract of a subject, the method comprising:

[0399] (a) advancing to the target location an inflatable body, the inflatable body being in a delivery operative state and being coupled to an inflating-fluid delivery channel;

[0400] (b) transitioning the inflatable body from the delivery operative state to an inflated operative state, by delivering to the inflatable body, via the inflating-fluid delivery channel, an inflating fluid, wherein, in the inflated operative state, the inflatable body includes a plurality of longitudinally arranged lobes and a plurality of longitudinally arranged troughs, wherein each pair of adjacent longitudinally arranged lobes is separated by one of the plurality of longitudinally arranged troughs;

[0401] (c) advancing a fluid tight lumen to the target location, such that a distal end of the fluid tight lumen is adjacent a proximal end of the inflatable body and at least one channel of the fluid tight lumen is in fluid communication with each of the plurality of troughs;

[0402] (d) delivering negative pressure, from a negative pressure source coupled to the at least one channel, via the at least one channel, to the proximal end of the inflatable body and along the longitudinally arranged troughs.

[0403] 142. The method of embodiment 141, further comprising, prior to (d), coupling the negative pressure source to the fluid tight lumen.

[0404] 143. The method of any one of embodiments 141 to 142, further comprising, following (d), removing the fluid tight lumen and the inflating-fluid delivery channel from the target location.

[0405] 144. The method of embodiment 143, further comprising, prior to the removing, transitioning the inflatable body from the inflated operative state to the delivery operative state. 145. The method of embodiment 143 or embodiment 144, wherein the removing comprises detaching the fluid tight lumen from the inflatable body, and removing the fluid tight lumen from the target location separately from removal of the inflatable body from the target location.

[0406] 146. The method of any one of embodiments 141 to 143, wherein the removing comprises removing the inflating-fluid delivery channel and the inflatable body, together, from the target location.

[0407] 147. The method of any one of embodiments 141 to 143, wherein the removing comprises separating the inflating-fluid delivery channel from the inflatable body, and subsequently removing the inflating-fluid delivery channel from the target location.

[0408] 148. The method of any one of embodiments 141 to 147, further comprising, prior to (b), coupling a source of the inflating fluid to the inflating-fluid delivery channel.

[0409] 149. The method of any one of embodiments 141 to 148, further comprising: coupling the fluid tight lumen to a source of a fluid; and delivering the fluid, from the source of the fluid to the proximal end of the inflatable body and along the longitudinally arranged troughs, via the at least one channel of the fluid tight lumen.

[0410] 150. The method of embodiment 149, wherein the delivering of the fluid is carried out when the at least one channel of the fluid tight lumen is detached from the negative pressure source.

[0411] 151. The method of embodiment 150, further comprising, prior to coupling of the fluid tight lumen to the source of fluid, decoupling of the fluid tight lumen from the negative pressure source.

[0412] 152. The method of any one of embodiments 141 to 151, wherein the advancing comprises placing the inflating-fluid delivery channel and the inflatable body in a working channel of a delivery device, and advancing the delivery device, with the inflating-fluid delivery channel and the inflatable body disposed therein, to the target location.

[0413] 153. The method of embodiment 152, further comprising, prior to the transitioning, removing the inflating-fluid delivery channel and the inflatable portion from the working channel of the delivery device.

[0414] 154. The method of embodiment 152 or embodiment 153, wherein the delivery device includes an image capturing element, and wherein the advancing further comprising capturing images of the inflatable body during advancing thereof to the target location.

[0415] It should be understood that the use of “and / or” is defined inclusively such that the term “a and / or b” should be read to include the sets: “a and b,” “a or b,” “a,” “b ” The various systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise such sterilization of the associated system, device, apparatus, etc. Furthermore, the scope of the present disclosure includes, for some applications, sterilizing one or more of any of the various systems, devices, apparatuses, etc. in this disclosure.

[0416] Any of the techniques, methods, operations, steps, etc. described or suggested herein can be performed on a living animal (e.g., human, other mammal, etc.) or on a non-living simulation, such as a cadaver, an ex-vivo organ, and / or a simulator device (which may include computerized and / or physical representations of body parts, tissue, etc.).

[0417] The present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description. Further, the techniques, methods, operations, steps, etc. described or suggested herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver gastrointestinal tract, simulator (e.g., with the body parts, tissue, etc. being simulated), etc.

[0418] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth above. For example, operations or steps described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms can vary depending on the particular implementation and are discernible by one of ordinary skill in the art.

Claims

CLAIMS1. A medical system for applying negative pressure within a gastrointestinal tract of a subject, the system comprising:(i) a longitudinal shaft disposed along a longitudinal axis and having a first diameter about the longitudinal axis, the longitudinal shaft including:(a) a longitudinally extending negative-pressure delivery channel;(b) a plurality of negative -pressure delivery orifices, longitudinally distributed along the longitudinal shaft, the plurality of negative -pressure delivery orifices being in fluid communication with the negative-pressure delivery channel;(c) at least one longitudinally extending inflating-fluid delivery channel; and(d) at least three inflating-fluid delivery orifices, longitudinally distributed along the longitudinal shaft and in fluid communication with the at least one longitudinally extending inflating-fluid delivery channel; and(ii) at least three inflatable portions, disposed periodically along the shaft and extending outwardly therefrom, such that a gap is formed between each pair of adjacent ones of the inflatable portions, each of the inflatable portions having: a delivery operative state sized for passage through the working channel of a delivery device, in which the inflatable portion has a first dimension perpendicular to the longitudinal axis of the shaft ; and an inflated operative state in which the inflatable portion has a second dimension about the longitudinal axis, the second dimension being greater than the first dimension, such that in the inflated operative state gaps are formed between the inflatable portions along the longitudinal axis, each the inflatable portions being in fluid communication with one of the at least one longitudinally extending inflating-fluid delivery channel via at least one of the inflating-fluid delivery orifices, wherein the longitudinally extending negative-pressure delivery channel is adapted to couple to a source of negative pressure and to deliver negative pressure, along the longitudinally extending negative-pressure delivery channel and via theplurality of negative-pressure delivery orifices, to the gaps between the expandable portions, in a radial direction relative to a longitudinal axis, and wherein the at least one longitudinally extending inflating-fluid delivery channel is adapted to couple to a source of an inflating fluid for delivery of the inflating fluid to the plurality of inflatable portions, via the plurality of inflating-fluid delivery orifices.

2. The medical system of claim 1, further comprising a sleeve extending along the longitudinal axis, the sleeve including: the at least three inflatable portions; a plurality of tubular portions, such that each pair of adjacent inflatable portions is separated by one of the plurality of tubular portions; and a plurality of sleeve orifices, disposed in the plurality of tubular portions, wherein the longitudinally extending negative-pressure delivery channel is adapted to deliver the negative pressure to the gaps between the inflatable portions via the negative pressure delivery orifices and via the sleeve orifices.

3. The medical system of claim 1 or claim 2, wherein a length of each gap between each pair of adjacent inflatable portions is not greater than 40mm.

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

5. The medical system of any one of claims 1 to 4, wherein the at least three inflatable portions includes at least 5 inflatable portions.

6. The medical system of any one of claims 1 to 5, wherein an external diameter of the inflatable portions, in the inflated operative 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.

7. The medical system of any one of claims 1 to 6, wherein in the inflated operative state, a proximal-most inflatable portion and a distal-most inflatable portion have agreater external diameter than the rest of the inflatable portions disposed between the proximal-most inflatable portion and the distal-most inflatable portion.

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

9. The medical system of any one of claims 1 to 8, wherein, in the inflated operative state, at least one of the inflatable portions is spherical with a tubular center.

10. The medical system of any one of claims 1 to 7, wherein, in the inflated operative state, a cross section of at least one of the inflatable portions includes a plurality of lobes, each pair of adjacent lobes separated by a trough.

11. The medical system of claim 10, wherein, in the inflated operative state, the troughs of a first of the inflatable portions are longitudinally aligned with the troughs of a second of the inflatable portions.

12. The medical system of claim 10, wherein, in the inflated operative state, the troughs of a first of the inflatable portions are rotationally offset with respect to the troughs of a second of the inflatable portions, such that the troughs of the first inflatable portion are not longitudinally aligned with the troughs of the second inflatable portion.

13. The medical system of any one of claims 1 to 7 or 10 to 12, wherein, in the inflated operative state, at least one of the inflatable portions includes a plurality of longitudinally arranged lobes and a plurality of longitudinally arranged troughs, wherein each pair of adjacent longitudinally arranged lobes is separated by one of the plurality of longitudinally arranged troughs.

14. The medical system of any one of claims 10 to 13, wherein, in the inflated operative state of the inflatable portions, a height differential between one of said plurality of lobes, and an adjacent one of said plurality of troughs, is at least 0.5mm.

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

16. The medical system of any one of claims 1 to 15, wherein the plurality of negative pressure delivery orifices includes a first subset and a second subset, wherein negative pressure delivery orifices in the first subset have a first longest dimension and negative pressure delivery orifices in the second subset have a second longest dimension, the second longest dimension being different from the first longest dimension.

17. The medical system of any one of claims 1 to 16, wherein the longitudinal shaft further includes: a longitudinally extending flushing-fluid delivery channel; and at least one flushing-fluid delivery orifice, the at least one flushing-fluid delivery orifice being in fluid communication with the longitudinally extending flushing-fluid delivery channel, wherein the longitudinally extending flushing-fluid delivery channel is adapted to couple to a source of the flushing fluid for delivery of the flushing fluid to the gaps via the at least one fluid-flushing delivery orifice.

18. The medical system of any one of claims 1 to 17, further comprising a delivery sheath having a diameter suitable to be delivered into the gastrointestinal tract of the subject via a working channel of a delivery device and adapted to house the inflatable portions in the delivery operative state, and the longitudinal shaft.

19. The medical system of any one of claims 1 to 18, further comprising a textured layer covering an exterior of at least some of the inflatable portions.

20. A method of applying negative pressure to a target location of a gastrointestinal tract of a subject, the method comprising:(a) advancing to the target location a longitudinal shaft having at least three expandable portions disposed therearound, the plurality of expandable portions being separated by gaps along the longitudinal shaft and being in a delivery operative state;(b) transitioning the expandable portions from the delivery operative state to an expanded operative state;(c) delivering negative pressure, from a negative pressure source coupled to the longitudinal shaft, to the gaps between the expandable portions, via a negative-pressure delivery channel in the shaft and via negative-pressure delivery orifices in the shaft which are in fluid communication with the gaps and with the negative-pressure delivery channel.

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

22. The method of claim 20 or of claim 21, further comprising, following (c), removing the longitudinal shaft and the expandable portions from the target location.

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

24. A medical system for applying negative pressure within a gastrointestinal tract of a subject, the medical system comprising: i. an inflating -fluid delivery channel having a distal end; ii. a longitudinal inflatable body disposed at the distal end of the inflating -fluid delivery channel, the longitudinal inflatable body having a delivery operative state and an inflated operative state, the longitudinal inflatable body comprising: a. a tissue-engaging portion having a plurality of longitudinally arranged lobes and a plurality of longitudinally arranged troughs formed therein when the longitudinal inflatable body is in the inflated operative state; and b. a bridging portion disposed between the inflating-fluid delivery channel and the tissue-engaging portion, wherein, in the inflated operative state, a plurality of inlet troughs extend along an exterior surface of the bridging portion, from a distal end of the inflating-fluid delivery channel to the proximal end of each of the plurality of troughs; and iii. a fluid tight lumen including at least one channel, the fluid tight lumen adapted to couple to a source of negative pressure and to deliver negative pressure, along the at least one channel, to a proximal end of the longitudinal inflatable body, and to apply the negative pressure along the longitudinally arranged troughs via the inlet troughs.

25. The medical system of claim 24, wherein, in the inflated operative state, an angle a between a longitudinal axis of one of the plurality of inlet troughs and a longitudinal axis of the inflating -fluid delivery channel is in the range of 100 to 160 degrees, 105 to 155 degrees, or 105 to 150 degrees.

26. The medical system of any one of claims 24 to 25, wherein, in the inflated operative state, an angle formed by the bridging portion at the connection between the bridging portion and the inflating-fluid delivery channel is in the range of 60 to 160 degrees, 60 to 155 degrees, or 60 to 150 degrees, or 70 to 150 degrees.

27. The medical system of any one of claims 24 to 26, wherein, at a distance of 2mm from the distal end of the inflating-fluid delivery channel along the longitudinal axis of the inflatable body, a height differential between one of the plurality of inlet troughs and an adjacent lobe of the bridging portion is at least 0.4mm or at least 0.5mm.

28. The medical system of any one of claims 24 to 27, wherein the fluid tight lumen further includes an additional channel adapted to be disposed around the inflating-fluid delivery channel.

29. The medical system of any one of claims 24 to 28, wherein the inflatable body retains the plurality of lobes and the plurality of troughs when a negative pressure in the range of 50 to 350 mmHg is applied at a proximal end of the inflatable body in the inflated operative state.

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

31. The medical system of any one of claims 24 to 30, wherein a radially outward surface of at least one lobe of the plurality of lobes includes a second plurality of troughs, separated by a plurality of ridges extending along the longitudinal length of the at least one lobe.

32. The medical system of any one of claims 24 to 31, wherein the inflatable body is integrally formed with the inflating-fluid delivery channel.

33. The medical system of any one of claims 24 to 31, wherein the inflatable body is separable from the inflating-fluid delivery channel.

34. The medical system of any one of claims 24 to 33, wherein the fluid tight lumen has an external diameter smaller than 8mm, smaller than 6mm, smaller than 5mm, smaller than 4mm, smaller than 3.7mm, or smaller than 3.5mm.

35. The medical system of any one of claims 24 to 34, wherein the inflatable body, in the inflated operative state, has an external diameter 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.

36. A method of applying negative pressure to a target location of a gastrointestinal tract of a subject, the method comprising:(a) advancing to the target location an inflatable body, the inflatable body being in a delivery operative state and being coupled to an inflating-fluid delivery channel;(b) transitioning the inflatable body from the delivery operative state to an inflated operative state, by delivering to the inflatable body, via the inflating-fluid delivery channel, an inflating fluid, wherein, in the inflated operative state, the inflatable body includes a plurality of longitudinally arranged lobes and a plurality of longitudinally arranged troughs, wherein each pair of adjacent longitudinally arranged lobes is separated by one of the plurality of longitudinally arranged troughs;(c) advancing a fluid tight lumen to the target location, such that a distal end of the fluid tight lumen is adjacent a proximal end of the inflatable body and at least one channel of the fluid tight lumen is in fluid communication with each of the plurality of troughs;(d) delivering negative pressure, from a negative pressure source coupled to the at least one channel, via the at least one channel, to the proximal end of the inflatable body and along the longitudinally arranged troughs.

Images