Pressure-propelled devices

Abstract

The present disclosure relates to pressure-propelled devices that can be navigated through one or more lumens of a patient's body. In an example, a pressure-propelled device includes a tube and a head portion at the distal end of the tube. The head portion defines a head cavity which is in fluid communication with a primary lumen of the tube, and includes an inner movable membrane extending from an inner surface of the head portion and at least one outer movable membrane extending from an outer surface of the head portion, each of the movable membranes configured to transition between flattened states and extended states thereof, so as to prevent or allow fluid flow through opening aligned with the respective membranes.

Description

PRESSURE-PROPELLED DEVICESFIELD

[0001] The present invention relates to pressure-propelled devices configured to allow advancement and navigation through one or more lumens in a patient's body.BACKGROUND

[0002] Medical patients who suffer from acute or chronic diseases are often unable to ingest food through the mouth. Hampering of the patient’s eating capabilities can lead to malnourishment, which may have severe adverse effects on the treatment of the disease, as well as leading to additional complications. Maintaining of proper nutrition in these conditions is therefore crucial. Enteral nutrition, i.e., delivery of nutrition directly to the stomach or small intestine, is typically preferred over parenteral nutrition, i.e., intravenous nutrition, due to its simplicity, safety, and lower costs. In particular, gastric feeding through a tube, such as a nasogastric tube, is the most common method for patients who cannot maintain adequate oral nutrition. While gastric feeding has advantages, such as corresponding to the physiological digestion route and the ability to tolerate larger volumes and higher osmotic loads, it is not always possible and may be associated with adverse events.

[0003] Post pyloric feeding is a potential alternative for patients with a history of regurgitation, aspiration, or delayed gastric emptying. It has also been shown to benefit patients who suffer from severe illness, overcoming the limitations of poor gastric motility as well as reducing the risk of pneumonia and other complications. Post pyloric feeding involves extending of a feeding tube past the stomach into the first portions of the small intestine, such as the duodenum or the jejunum. However, placing the tube in this relatively advanced location and maintaining it in the proper position is challenging, with less than 50% success rate in unassisted placing thereof. Several methods have been developed to improve post pyloric positioning, such as weighted tubes, gastric insufflation, and medications such as erythromycin or metoclopramide, but these have demonstrated none or limited efficacy. Electromagnetic guidance and radiological monitoring during placement are more successful, and endoscopic placement is the most reliable method. However, these methods are costly, and require experienced personnel.SUMMARY

[0004] At present, navigation of a feeding tube through the gastrointestinal tract, particularly in cases of post pyloric feeding, is challenging due to the need to precisely navigate the tubefrom a large lumen or cavity, such as that of the stomach, towards and through a significantly narrower gate or passage, such as the pylorus. Accordingly, there is a need for an improved mechanism and method for positioning and maintaining feeding tubes in a post pyloric location, for effective nutrition of patients suffering from acute or chronic diseases.

[0005] According to some aspects of the disclosure, there is provided a pressure-propelled device comprising a tube defining a lumen, and a head portion at a distal end of the tube. The head portion comprises a head cavity around a central axis of the head portion, a head inner surface facing the central axis, a head outer surface facing away from the central axis, one or more proximal openings, one or more groups of distal openings, an inner movable membrane, and at least one outer movable membrane distal to the inner movable membrane. The head cavity is in fluid communication with the lumen of the tube.

[0006] The inner movable membrane extends from an inner membrane attachment end at the head inner surface, to an inner membrane free end radially inwards to the head inner surface. The at least one outer movable membrane extends from an outer membrane attachment end at the head outer surface, to an outer membrane free end radially outwards to the head outer surface. The one or more groups of distal openings each comprises one or more distal openings. The inner movable membrane is aligned with the one or more proximal openings. The outer movable membrane is aligned with a correspond group of the one or more groups of distal openings.

[0007] In some examples, the inner movable membrane is configured to transition between a flattened state and an extended state thereof.

[0008] In some examples, the at least one outer movable membrane is configured to transition between a flattened state and an extended state thereof.

[0009] In some examples, the head portion is configured to transition between an outflow configuration and an inflow configuration by alternating between positive and negative flow pressures through the primary lumen and the head cavity.

[0010] In some examples, the inner movable membrane is in its flattened state and the at least one outer movable membrane is in its extended state in the outflow configuration.

[0011] In some examples, the inner movable membrane is in its extended state and the at least one outer movable membrane is in its flattened state in the inflow configuration.

[0012] The aspects of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scopeof the claimed subject matter. The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.BRIEF DESCRIPTION OF THE FIGURES

[0013] Some examples of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some examples may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an example in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.In the Figures:

[0014] Fig. 1 schematically illustrates an exemplary pressure-propelled device inserted into a patient's body.

[0015] Fig. 2A is a side view of a distal portion of an exemplary pressure-propelled device, showing a head portion thereof in an outflow configuration.

[0016] Fig. 2B is a side view in perspective of the distal portion of the device of Fig. 2A, with some components thereof shown with partial transparency.

[0017] Figs. 2C and 2D are a cross-sectional side view and a sectional view in perspective, respectively, of the distal portion of the device of Figs. 2A-2B.

[0018] Fig. 3 A is a perspective view of the distal portion of the device of Figs. 2A-2D, showing the head portion in an inflow configuration.

[0019] Fig. 3B is a perspective view of the distal portion of the device of Fig. 3A, with some components thereof shown with partial transparency.

[0020] Figs. 3C and 3D are a cross-sectional side view and a sectional view in perspective, respectively, of the distal portion of the device of Figs. 3A-3B.

[0021] Fig. 4 shows a proximal portion of the pressure-propelled device comprising a hub attached to the tube.

[0022] Fig. 5A is a perspective view of a distal portion of an exemplary pressure-propelled device comprising two outer movable membranes, showing its head portion in an inflow configuration.

[0023] Figs. 5B and 5C are a cross-sectional side view and a sectional view in perspective, respectively, of the distal portion of the device of Fig. 5A.

[0024] Fig. 6A is a perspective view of the distal portion of the device of Figs. 5A-5C, showing the head portion in an outflow configuration.

[0025] Figs. 6B and 6C are a cross-sectional side view and a sectional view in perspective, respectively, of the distal portion of the device of Fig. 6A.

[0026] Fig. 7 schematically shows a distal portion of an exemplary pressure-propelled device navigated through the stomach.

[0027] Fig. 8A is a perspective view of the distal portion of an exemplary pressure-propelled device that includes a series of optical sensors proximal to the outer stationary membrane.

[0028] Fig. 8B is a perspective view of the distal portion of an exemplary pressure-propelled device that includes a series of optical sensors disposed between the outer stationary membrane and the outer movable membrane.

[0029] Fig. 8C is a perspective view of the distal portion of an exemplary pressure-propelled device that includes optical sensors located at the head distal tip portion.

[0030] Fig. 9 is a cross-sectional view taken along line 9-9 of Fig. 8A.

[0031] Fig. 10 is a perspective view of the distal portion of an exemplary pressure-propelled device that includes a series of irrigation openings.

[0032] Fig. 11 is a cross-sectional view taken along line 11-11 of Fig. 10.

[0033] Fig. 12A is a perspective view of an exemplary pressure-propelled device and a medical device separate to the pressure-propelled device.

[0034] Fig. 12B a cross-sectional view taken along line 12B-12B of Fig. 12A.

[0035] Fig. 13 A is a perspective view of an exemplary pressure-propelled device and a medical device mounted within pressure-propelled device.

[0036] Fig. 13B a cross-sectional view taken along line 13B-13B of Fig. 13A.DETAILED DESCRIPTION

[0037] For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present, or problems be solved. The technologies from any example can be combined with the technologies described in any one or more of the other examples. In view of the many possibleexamples to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope of the disclosed technology.

[0038] 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 below. For example, operations described sequentially may 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 may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0039] All features described herein are independent of one another and, except where structurally impossible, can be used in combination with any other feature described herein.

[0040] As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the terms "have" or "includes" means "comprises". Further, the terms "coupled", "connected", and "attached", as used herein, are interchangeable and generally mean physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. As used herein, "and / or" means "and" or "or", as well as "and" and "or".

[0041] Directions and other relative references may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as "inner", "outer", "upper", "lower", "inside", "outside", "top", "bottom", "interior", "exterior", "left", right", and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated examples. Such terms are not, however, intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an "upper" part can become a "lower" part simply by turning the object over, such as prior to insertion of the device into a patient. Nevertheless, it is still the same part and the object remains the same.

[0042] The term "plurality" or "plural" when used together with an element means two or more of the element. Directions and other relative references (e.g., inner and outer, upper and lower,above and below, left and right, and proximal and distal) may be used to facilitate discussion of the drawings and principles herein but are not intended to be limiting.

[0043] As used herein, the term "substantially" means the listed value and / or property and any value and / or property that is at least 75% of the listed value and / or property. Equivalently, the term "substantially" means the listed value and / or property and any value and / or property that differs from the listed value and / or property by at most 25%. For example, "at least substantially parallel" refers to directions that are fully parallel, and to directions that diverge by up to 22.5 degrees.

[0044] In the present disclosure, a reference numeral that includes an alphabetic label (for example, "a," "b," "c," etc.) is to be understood as labeling a particular example of the structure or component corresponding to the reference numeral. Accordingly, it is to be understood that components sharing like names and / or like reference numerals (for example, with different alphabetic labels or without alphabetic labels) may share any properties and / or characteristics as disclosed herein even when certain such components are not specifically described and / or addressed herein.

[0045] Throughout the figures of the drawings, different superscripts for the same reference numerals are used to denote different examples of the same elements. Examples of the disclosed devices and assemblies may include any combination of different examples of the same elements. Specifically, any reference to an element without a superscript may refer to any alternative example of the same element denoted with a superscript. In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some components will be introduced via one or more drawings and not explicitly identified in every subsequent drawing that contains that component.

[0046] Fig. 1 schematically illustrates an exemplary pressure-propelled device 100 inserted into a patient's body. The pressure-propelled device 100 comprises a tube 102 defining a primary lumen 104 (lumen 104 shown, for example, in Fig. 2C), and a head portion 110 at a distal end of the tube 102. A pressure-propelled device 100 can be, in some examples, a feeding tube that can be passed through the gastrointestinal tract, for administration of enteral nutrition or other substances. In the example illustrated in Fig. 1, the pressure-propelled device 100 is shown to be inserted through the patient's mouth 12, passing through the esophagus 14 to the lower esophageal sphincter 16 and into the stomach 18. In some cases, as in the illustrated example, the pressure-propelled device 100 is further steered towards and through the pylorus 20. Exemplary head portion 110 described herein are configured to facilitate advancement along the gastrointestinal tract, including towards and through the pylorus 20. While thepressure-propelled device 100 is illustrated in Fig. 1 to enter through a patient's mouth 12, for example when implemented to serve as a transoral feeding tube, it is to be understood that other entry regions are contemplated, including entry through a patient's nose when implemented, for example, to serve as a transnasal feeding tube.

[0047] As used herein, the terms “proximal” and “distal” refer to the direction closer to and away from, respectively, a practitioner who would implant or insert the pressure-propelled device 100. Thus, for example, the end of the pressure-propelled device 100 including the head portion 110 would be the distal end, while the opposite end would be the proximal end. The terms "device 100" and "pressure-propelled device 100", as used herein, are interchangeable.

[0048] A head portion 110 of any pressure-propelled device 100 disclosed herein is configured to transition between an outflow configuration and an inflow configuration. Figs. 2A-2D and 3A-3D show a distal portion of an exemplary pressure -propelled device 100 in an outflow configuration and an inflow configuration, respectively, of its head portion 110. Fig. 2A is a side view of a distal portion of a pressure-propelled device 100, showing the head portion 110 in an outflow configuration. Fig. 2B is a side view in perspective of the distal portion of the device 100 of Fig. 2A, with some components thereof shown with partial transparency to expose various structural components of the device 100. Figs. 2C and 2D are a cross-sectional side view and a sectional view in perspective, respectively, of the distal portion of the device 100 of Figs. 2A-2B. Fig. 3A is a perspective view of the distal portion of the device 100 of Figs. 2A-2D, showing the head portion 110 in an inflow configuration. Fig. 3B is a perspective view of the distal portion of the device 100 of Fig. 3A, with some components thereof shown with partial transparency to expose various structural components of the device 100. Figs. 3C and 3D are a cross-sectional side view and a sectional view in perspective, respectively, of the distal portion of the device 100 of Figs. 3A-3B. Figs. 2A-3D are described herein together.

[0049] The device 100 defines a central axis CA (indicated, for example, in Fig. 2C) extending along the tube 102 and head portion 110. The tube 102 extends from a tube proximal end 106 (indicated, for example, in Fig. 4) to a tube distal end 108, and the head portion 110 extends from a head proximal end 112 to a head distal tip portion 114, and defines a head cavity 160 which is in fluid communication with, and is continuous with, the primary lumen 104 of the tube 102. The head distal tip portion 114 is close-ended, such that fluid flowing through the primary lumen 104 into head cavity 160 cannot maintain the same distally-oriented direction, due to the closed distal end. In some examples, the head distal tip portion 114 can be conical or frustoconical in shape, tapering in the distal direction. In some examples, the head distal tipportion 114 can be atraumatic, such as by being rounded at its tip or otherwise formed so as not to include a sharp tip at its distal terminal end.

[0050] In some examples, the head portion 110 and the tube 102 are integrally formed, provided as a unitary component of the device 100, such that the tube distal end 108 is also the head proximal end 112. In some examples, the head portion is a separate component which is affixed, such as by gluing, welding, and the like, to the tube distal end 108, in which case the attachment is a sealed attachment to prevent leakage at the region of attachment.

[0051] The head portion 110 comprises an inner movable membrane 150 distally extending from an outer surface 118 of the head portion 110, optionally adjacent head proximal end 112, and at least one outer movable membrane 120 extending from the outer surface 118 of the head portion 110, optionally in a proximally oriented direction, wherein the at least one outer movable membrane 120 is distal to the inner movable membrane 150.

[0052] Various exemplary implementations for pressure-propelled device 100, and / or components thereof, such as head portion 110, can be referred to, throughout the specification, with superscripts, for ease of explanation of features that refer to such exemplary implementations. It is to be understood, however, that any reference to structural or functional features of any device or component, without a superscript, refers to these features being commonly shared by all specific exemplary implementations that can be also indicated by superscripts. In contrast, features emphasized with respect to an exemplary implementation of any device or component, referred to with a superscript, may be optionally shared by some but not necessarily all other exemplary implementations. For example, pressure-propelled device 100aillustrated in Figs. 2A-3D is an exemplary implementation of pressure-propelled device 100, and thus includes all of the features described for pressure-propelled device 100 throughout the current disclosure, except that while a head portion 110 of a pressure-propelled device 100 can include any number of outer movable membranes 120, the head portion 110aof pressure-propelled device 100ais shown to include a single outer movable membrane 120. Any reference to an outer movable membrane in a singular form, may similarly refer to any one of a plurality of outer movable membrane 120, unless stated otherwise.

[0053] The inner movable membrane 150 extends from an inner membrane attachment end 152 at the inner surface 116 of the head portion 110, and an inner membrane free end 154, which is positioned radially inward to the head inner surface 116. The outer movable membrane 120 extends from an outer membrane attachment end 122 at the outer surface 118 of the head portion 110, and an outer membrane free end 124, which is positioned radially outward to the head outer surface 118. Any movable membrane of the head portion 110, including the innermovable membrane 150 and the outer movable membrane 120, is configured to move between a flattened state and an extended state. The term "radially inwards" and "radially outwards", as used herein, refer to a radial position relative to the central axis CA.

[0054] In the outflow configuration of the head portion 110, the inner movable membrane 150 is in a flattened state, while the outer movable membrane 120 in an extended state, as shown for example in Figs. 2A-2D. In the inflow configuration of the head portion 110, the inner movable membrane 150 is in an extended state, while the outer movable membrane 120 in a flattened state, as shown for example in Figs. 3A-3D.

[0055] In some examples, the inner movable membrane 150 is integrally formed with the section of the head portion 110 it extends from, such that the inner membrane attachment end 152 constitutes an integral part of the head portion 110, from which the inner movable membrane 150 extends. In some examples, the inner movable membrane 150 is provided as a separate component which is attached, such as by gluing, welding and the like, to the head portion 110, at the inner membrane attachment end 152. In some examples, the inner movable membrane 150 is pivotably movable about the inner membrane attachment end 152, to transition between the flattened and extended states thereof.

[0056] In some examples, the outer movable membrane 120 is integrally formed with the section of the head portion 110 it extends from, such that the outer membrane attachment end 122 constitutes an integral part of the head portion 110, from which the outer movable membrane 120 extends. In some examples, the outer movable membrane 120 is provided as a separate component which is attached, such as by gluing, welding and the like, to the head portion 110, at the outer membrane attachment end 122. In some examples, the outer movable membrane 120 is pivotably movable about the outer membrane attachment end 122, to transition between the flattened and extended states thereof.

[0057] The head portion 110 further comprises one or more proximal openings 164 in fluid communication with the head cavity 160, extending between the head inner surface 116 and the head outer surface 118. The one or more proximal openings 164 are aligned with the inner movable membrane 150, meaning that the one or more proximal openings 164 do not extend proximally past the inner membrane attachment end 152 and do not extend distally past the inner membrane free end 154, in the flattened state of the inner movable membrane 150. In some examples, the one or more proximal openings 164 comprise a single proximal opening 164. In some examples, the one or more proximal openings 164 comprise a plurality of proximal openings 164 that can be distributed around the circumference of the head portion 110, equally or unequally spaced from each other. Any reference to proximal openings 164 ina plural form throughout the specification and the claims, may similarly refer to a single proximal opening 164, unless stated otherwise.

[0058] The head portion 110 further comprises one or more distal openings 162 in fluid communication with the head cavity 160, extending between the head inner surface 116 and the head outer surface 118. One or more groups of distal opening 162 can be provided, the number of groups of distal openings 162 matching the number of outer movable membranes 120, as each group includes one or more distal openings 162 aligned with the corresponding outer movable membrane 120. This means that the one or more distal openings 162 in each group of distal openings, do not extend distally past the outer membrane attachment end 122 and do not extend proximally past the outer membrane free end 124, in the flattened state of the outer movable membrane 120. In some examples, the one or more distal openings 162 in each respective group of distal openings, comprise a single distal opening 162. In some examples, the one or more distal openings 162 in each respective group of distal openings, comprise a plurality of distal openings 162 that can be distributed around the circumference of the head portion 110, equally or unequally spaced from each other. Any reference to distal openings 162 in a plural form throughout the specification and the claims, may similarly refer to a single distal opening 162, unless stated otherwise.

[0059] The head portion 110 can further comprise, in some examples, an outer stationary membrane 130 angularly extending in a distal direction from the head outer surface 118. The outer stationary membrane 130 extends from a stationary membrane proximal end 132 at the outer surface 118 of the head portion 110, and a stationary membrane distal end 134, which is positioned radially outward to the head outer surface 118.

[0060] In some examples, the outer stationary membrane 130 is integrally formed with the section of the head portion 110 it extends from, such that the stationary membrane proximal end 132 constitutes an integral part of the head portion 110, from which the outer stationary membrane 130 extends. In some examples, the outer stationary membrane 130 is provided as a separate component which is attached, such as by gluing, welding and the like, to the head portion 110, at the stationary membrane proximal end 132.

[0061] The outer stationary membrane 130 is aligned with the proximal openings 164 and / or the inner movable membrane 150, such that the stationary membrane proximal end 132 is proximal to the proximal openings 164. In some examples, the stationary membrane proximal end 132 is axially aligned with the inner membrane attachment end 152. In some examples, the stationary membrane distal end 134 is distal to the proximal openings 164.

[0062] In some examples, any of the movable membranes disclosed herein, such as the inner movable membrane 150 and / or the outer movable membrane 120, can be made of a flexible material, such as a flexible polymeric material that can facilitate transitioning of the respective movable membrane between flattened and extended states thereof. In contrast to the movable membranes, the outer stationary membrane 130 is not configured to be movable about an end thereof, but rather retains a fixed orientation with respect to the central axis CA and the head outer surface 118.

[0063] The outer stationary membrane 130 extends in an angular orientation relative to the head outer surface 118, defining a surface that tapers from a greater diameter at the stationary membrane distal end 134, to a narrower diameter which is similar to the outer diameter of the head portion 110 at the stationary membrane proximal end 132. In some examples, the outer stationary membrane 130 distally extends from the stationary membrane proximal end 132 at an acute angle relative to the head outer surface 118.

[0064] In some examples, the head portion 110 further comprises one or more membrane supports 136 extending between the head outer surface 118 and the outer stationary membrane 130, such as between the head outer surface 118 and the stationary membrane distal end 134. In some examples, the one or more membrane supports 136 comprise a single membrane support 136. In some examples, the one or more membrane supports 136 comprise a plurality of membrane supports 136 that can be distributed around the circumference of the head portion 110, equally or unequally spaced from each other. Any reference to membrane supports 136 in a plural form throughout the specification and the claims, may similarly refer to a single membrane support 136, unless stated otherwise.

[0065] The membrane supports 136 are configured to retain the outer stationary membrane 130 in a fixed angular orientation relative to the head outer surface 118. The membrane supports 136 can extend angularly from the head outer surface 118, such that a distal end 140 of each membrane support 136 is attached to the head portion 110, such as to the head outer surface 118, while the proximal end 138 of each membrane support 136 is attached to the outer stationary membrane 130, such as to the stationary membrane distal end 134. Thus, each membrane support 136 can define a surface that tapers from a greater diameter at the support proximal end 138, optionally similar to the diameter defined by the stationary membrane distal end 134, to a narrower diameter which is similar to the outer diameter of the head portion 110 at the support distal end 140. In some examples, the membrane support 136 can be made of a relatively rigid or non-bendable material.

[0066] In some examples, the outer stationary membrane 130 can be made of a relatively rigid or non-flexible material. In some examples, the outer stationary membrane 130 is made of a material that is configured to retain the angular orientation of the membrane 130 relative to the head outer surface 118, in which case the head portion 110 can be devoid of membrane support 136, or can optionally still include the membrane support 136 for the sake of redundancy.

[0067] In a flattened state of the inner movable membrane 150, shown for example in Figs. 2A-2D, the inner movable membrane 150 is flattened against the head inner surface 116, such that the inner movable membrane 150 extends substantially parallel to the central axis CA and the head inner surface 116 between the inner membrane attachment end 152 and the inner membrane free end 154. The inner membrane free end 154 is distal to the inner membrane attachment end 152 in this state, and can be in contact with the head inner surface 116, causing the inner movable membrane 150 to cover the proximal openings 164 in a manner that seals them.

[0068] In an extended state of the inner movable membrane 150, shown for example in Figs. 3A-3D, the inner movable membrane 150 is angularly oriented relative to the central axis CA and the head inner surface 116, such that the inner membrane free end 154 is distanced away from the head inner surface 116 and is radially closer to the central axis CA relative to its position in the flattened state. In this state, fluid communication is maintained between the proximal openings 164 and the head cavity 160 via the gap formed between the inner membrane free end 154 and the head inner surface 116.

[0069] In a flattened state of the outer movable membrane 120, shown for example in Figs. 3A-3D, the outer movable membrane 120 is flattened against the head outer surface 118, such that the outer movable membrane 120 extends substantially parallel to the central axis CA and the head outer surface 118 between the outer membrane attachment end 122 and the outer membrane free end 124. The outer membrane free end 124 is proximal to the outer membrane attachment end 122 in the flattened state, and can be in contact in this state with the head outer surface 118, causing the outer movable membrane 120 to cover the distal openings 162 aligned therewith in a manner that seals them.

[0070] In an extended state of the outer movable membrane 120, shown for example in Figs. 2A-2D, the outer movable membrane 120 extends away from the central axis CA and the head outer surface 118, such that the outer membrane free end 124 is distanced away from the head outer surface 118 and is radially farther from the central axis CA relative to its position in the flattened state. In this state, fluid communication is maintained between the distal openings162 and the head cavity 160, flowing through the gap formed between the outer membrane free end 124 and the head outer surface 118.

[0071] The head portion 110 is configured to facilitate axial advancement of the pressure propelled device 100 through one or more lumens in a patient's body, such as along the gastrointestinal tract, while it transitions between the outflow and inflow configurations. In an outflow configuration of the head portion 110, shown in Figs. 2A-2D, the inner movable membrane 150 is in the flattened configuration, while the outer movable membrane 120 is in the extended configuration. In an inflow configuration of the head portion 110, shown in Figs. 3A-3D, the outer movable membrane 120 is in the flattened configuration, while the inner movable membrane 150 is in the extended configuration.

[0072] Pressurized fluid, such as a saline solution (or any other suitable fluid), can be injected into the primary lumen 104 of tube 102 and towards the head cavity 160. Suction can be also applied to the primary lumen 104 to cause proximally-directed suction of fluid through the head cavity 160 and primary lumen 104, out of the tube 102. Advancement of the pressure- propelled device 100 in the distal direction 50 (indicated, for example, in Fig. 2C) can be achieved by alternating between positive and negative flow pressures through the primary lumen 104 of the tube 102.

[0073] As shown in Figs. 2A-2D, when pressurized fluid is admitted into the primary lumen 104 of the tube 102, it propagates into the head cavity 160 and forces the inner movable membrane 150 to assume its flattened state, pressed radially outwards to close the proximal openings 164 and prevent the fluid from passing therethrough. As indicated by arrow 60 in Fig. 2C for example, the fluid propagates distally inside the head cavity 160 towards the distal openings 162, and exits through the distal openings 162 while pressing against the outer movable membrane 120, forcing it to deflect radially outward and assume its extended state.

[0074] When a single outer movable membrane 120 is provided, as shown for exemplary pressure-propelled device 100a, it can assume an angled orientation in its extended state, such as by defining a surface that tapers from the outer membrane free end 124 to the outer membrane attachment end 122, optionally defining an acute angle relative to the head outer surface 118. When a plurality of outer movable membranes 120 are provided, as will be described below with respect to an exemplary pressure -propelled device 100billustrated in Figs. 5A-6C, at least one of the outer movable membranes 120, such as at least a proximal- most one of the plurality of outer movable membranes 120, can be configured to assume a similar angled orientation in its extended state.

[0075] When the pressurized fluid exits through the distal openings 162 aligned with an angularly oriented outer movable membrane 120, the fluid impinges against the outer movable membrane 120 and its flow is redirected in a "reverse" proximal direction out of the head portion 110, as further indicated by arrow 60 in Fig. 2C for example, thereby propelling the head portion 110, and the tube 102 attached thereto or extending proximally therefrom, in a distal direction. The size and arrangement of the distal openings 162, and the angle of the angularly-oriented outer movable membrane 120 relative to the central axis CA in the extended state, can be designed so that the exiting fluid will create jets which are sufficient to propel the pressure-propelled device 100 in the distal direction 50.

[0076] As shown in Figs. 3A-3D, when negative pressure or vacuum is applied to the primary lumen 104 of the tube 102, the outer movable membrane 120 is pulled radially inward to its flattened state, pressed against the head outer surface 118 so as to close the distal openings 162 and prevent fluid from passing therethrough, and the inner movable membrane 150 is also pulled radially inward to its extended state, exposing the proximal openings 164 to allow fluid flow therethrough. As indicated by arrow 62 in Fig. 3C for example, the fluid surrounding the head portion 110 is sucked towards the proximal openings 164, at which point the outer stationary membrane 130 redirects the fluid from a proximal flow direction 52 radially inwards, towards and through the proximal openings 164.

[0077] As the fluid enters through the proximal openings 164, the angularly-oriented inner movable membrane 150 redirects the flow to the distal direction 50 inside of the head cavity 160, such that the fluid can impinge against the inner wall of the head distal tip portion 114 and then continue to be suctioned in the proximal direction 52 towards and through the primary lumen 104 of tube 102. This flow path, along which the fluid flows in a rearward direction 52 inside the head cavity 160 and can apply a distally-oriented force against the head distal tip portion 114, also serves to urge the head portion 110 in the distal direction 50, thus further propagating the pressure-propelled device 100 as a whole.

[0078] As mentioned above, in some examples, a plurality of membrane supports 136 can be provided, in which case, fluid may pass through the spaces formed between the circumferentially arranged membrane support 136 towards the outer stationary membrane 130 and the proximal openings 164. As further mentioned, in some examples, the one or more membrane supports 136 can have an angled orientation, tapering from the support proximal ends 138 to the support distal ends 140. Such a tapering shape of the membrane supports 136 can facilitate easier advancement of the head portion 110 through relatively narrow and / or tortuous path of advancement through one or more lumens in a patient's body.

[0079] When suction is applied through the primary lumen 104, head cavity 160 and proximal openings 164, in the absence of an outer stationary membrane 130, tissues disposed around the head portion 110 can be accidentally pulled in a manner that can clog some or all of the proximal opening 164. Thus, the inclusion of an outer stationary membrane 130 circumferentially disposed around the openings 164 can advantageously mitigate the risk of proximal openings 164 being clogged by surrounding tissues.

[0080] The size and arrangement of the proximal openings 164, the arrangement and circumferential spacings between membrane supports 136, the angle of the outer stationary membrane 130 relative to the central axis CA, and the angle of the inner movable membrane 150 relative to the central axis CA the extended state, can be designed so that the entering fluid will create jets which are sufficient to propel the pressure-propelled device 100 in the distal direction 50.

[0081] When pressurized fluid is supplied into the pressure-propelled device 100 and exits through the distal openings 162, it can cause excessive fluid accumulating along the bodily lumen through which the head portion 110 is distally propelled. Applying a negative pressure to suction fluid surrounding the head portion 110 can alleviate such fluid buildup by removing at least a portion of the injected fluid from the patient. The proposed arrangement of membranes in the head portion 110 is designed to allow for continued forward or distally-oriented movement of the head portion 110 both when pressurized fluid is admitted into the head cavity 160, and when fluid surrounding the head portion 110 is suctioned back into the head cavity 160 and primary lumen 104. In some examples, controlled advancement of the pressure- propelled device 100 is achieved by alternating between positive and negative flow pressures applied to the primary lumen 104 of the tube 102 and the head cavity 160.

[0082] In some examples, the pressure-propelled device 100 further comprises a flow control hub 170, as schematically illustrated in Fig. 4. The flow control hub 170 include a tube port 172 to which the tube 102 is coupled, a fluid inlet port 174, and a fluid outlet port 176. The flow control hub 170 can define an internal hub chamber 178 which is in fluid communication with the tube port 172 and the primary lumen 104 of the tube 102 attached thereto, and can be selectively transitioned between being in fluid communication with the fluid inlet port 174 and the fluid outlet port 176. The fluid inlet port 174 can be coupled to, and in fluid communication with, a fluid source (not shown) configured to admit fluid therethrough into the hub chamber 178, such as a syringe, a pump, and the like. The fluid outlet port 176 can be coupled to, and in fluid communication with, a suction pump (not shown) such as a pump present in a hospital or other medical facility.

[0083] The flow control hub 170 can further include a switch 180 configured to switch between fluid injection and suction modes. The switch 180 can be operated either manually of electrically, such as by being operably coupled to a control circuitry (not shown) configured to control the state of the switch. In a fluid injection mode, the switch can close the fluid outlet port 176 and open the fluid inlet port 174, such that when pressurized fluid is provided, it flows in a distal direction 50 from the fluid inlet port 174, through the hub chamber 178 and tube port 172, into the primary lumen 104 of tube 102 and head cavity 160. In a suction mode, the switch can close the fluid inlet port 174 and open the fluid outlet port 176, such that when negative pressure or vacuum is applied to the fluid outlet port 176, is facilitates suction of the fluid surround the head portion 110 into the head cavity 160 and primary lumen 104 of tube 102, via the tube port 172 and hub chamber 178, toward the fluid outlet port 176.

[0084] In some examples, the device 100 comprises a flex sensor 190, an output of the flex sensor 190 in communication with the control hub 170. The term "flex sensor", as used herein, means a sensor that measures how much it is bent, as known to those skilled in the art. The flex sensor 190 extends along a portion of tube 102. In some examples, the flex sensor 190 extends proximally from tube distal end 108, along tube 102. The output of the flex sensor 190 is received at the control hub 170, and, based at least in part of the output of the flex sensor 190, the control hub 170 determines whether the degree of bend of tube 102 is within one or more predetermined parameters. In some examples, the control hub 170 compares the degree of bend of tube 102 to a predetermined threshold value. In some examples, if the control hub 170 determines that the degree of bend of tube 102 is outside the one or more predetermined parameters (e.g., the degree of bend is greater than the predetermined threshold value), the control hub 170 generates an alert signal. In some examples, the generated alert signal emits a warning indication at a user indicator unit (e.g., a display, a speaker and / or a light-emitting indicator). Thus, if the tube 102 bends too much, the user can stop advancing it to avoid having the tube 102 getting tangled or stuck.

[0085] Figs. 5A-6C show a distal portion of an exemplary pressure-propelled device 100b, in an inflow configuration and an outflow configuration, respectively, of its head portion 110b. Pressure-propelled device 100bis an exemplary implementation of pressure-propelled device 100, and thus includes the features described for pressure -propelled device 100 throughout the current disclosure, except that the head portion 110bof pressure-propelled device 100bcomprises two outer movable membranes 120, indicated as a first outer movable membrane 120a and a second outer movable membrane 120b, wherein the first outer movable membrane 120a is proximal to the second outer movable membrane 120b.

[0086] Fig. 5A is a perspective view of the distal portion of the pressure-propelled device 100b, showing the head portion 110bin an inflow configuration. Figs. 5B and 5C are a cross-section side view and a sectional view in perspective, respectively, of the distal portion of the device 100bof Fig. 5A. Fig. 6A is a perspective side-view of the distal portion of the device 100bof Figs. 5A-5C, showing the head portion 110bin an outflow configuration. Figs. 6B and 6C are a cross-section side view and a sectional view in perspective, respectively, of the distal portion of the device 100bof Fig. 6A. Figs. 5A-6C are described herein together.

[0087] As further illustrated, the head portion 110bincludes two groups of distal openings 162, such as a first group that includes one or more distal openings 162a, aligned with the first outer movable membrane 120a, and a second group that includes one or more distal openings 162b, aligned with the second outer movable membrane 120b.

[0088] In the inflow configuration of the head portion 110bshown in Figs. 5A-5C, the inner movable membrane 150 is in its extended state, while both outer movable membranes 120a and 120b are in their flattened states, closing the respective distal openings 164a and 164b. In the outflow configuration of the head portion 110bshown in Figs. 6A-6C, the inner movable membrane 150 is in its flattened state, while both outer movable membranes 120a and 120b are in their extended states, exposing the respective distal openings 164a and 164b.

[0089] The lengths of the outer movable membranes 120, defined between their attachment 122 and free 124 ends, can be similar or different from each other. The material properties and / or thickness of the outer movable membranes 120 can be similar or different from each other. The size and arrangement of distal openings 162 in different groups can be similar or different from each other.

[0090] In some examples, at least one of a plurality of outer movable membranes 120 is configured to define an angle a, relative to the central axis CA, in the extended state, which is different than the angled a defined by a different one of the plurality of outer movable membranes 120. In the example illustrated in Figs. 6A-6C, the first outer movable membrane 120a defines an angle aa, and the second outer movable membrane 120b defines an angle ab, relative to the central axis CA in their extended state, wherein the angle ab is greater than the angle aa. Stated otherwise, the angle defined by the more proximal outer movable membrane 120a in its extended state is more acute than the angle defined by the more distal outer movable membrane 120b.

[0091] The angle aa defined by the outer movable membrane 120a, which can be also referred to as a proximal-most outer movable membrane 120, is an acute angle, while the angle ab defined by the outer movable membrane 120b, which can be also referred to as a distal-mostouter movable membrane 120, can be either acute or a right angle, relative to the central axis CA. In some examples, the angle ab defined by a distal-most of a plurality of outer movable membranes 120 is in the range of 70°-90°, inclusive. In some examples, the angle aa defined by a proximal-most of a plurality of outer movable membranes 120 is less than 70°.

[0092] While two outer movable membranes 120 are illustrated in Figs. 5A-6C, it is to be understood that any other number of outer movable membranes 120 is contemplated. For example, three or more outer movable membranes 120 can be provided, axially spaced from each other, each aligned with a separate group of distal openings 162, wherein all outer movable membranes 120 can define similar angles a, each can have a different angle a, or two or more of the outer movable membranes 120 can have a similar angle a which is different from the angle a of at least one other outer movable membrane 120.

[0093] Fig. 7 schematically shows a distal portion of a pressure-propelled device 100, such as device 100b, navigated through the stomach 18. When pressurized fluid is supplied, flow jets 70a are created by an angularly-oriented outer movable membrane 120 in its extended state, such as the proximal most or first outer movable membrane 120a of head portion 110a, streamed in a radially-outward and proximally-oriented direction, so as to facilitate pressure- propelled advancement of the device 100 through the esophagus, via the lower esophageal sphincter 16, and into the stomach 18.

[0094] At the same time, flow jets 70b can be also created by distal most or second outer movable membrane 120b of head portion 110b, streamed in a radially-outward direction generally defined by the greater angle of the second outer movable membrane 120b, such that the jets 70b can form an "umbrella" like configuration either at a right angle to the central axis CA of the head portion 110b, or also proximally directed to some extent, but less than the jets 70a. The umbrella-like formation of distal jets 70b extends to a diameter that is relatively greater than that of the umbrella-like configuration of the distal jets 70b, which can be also referred to as the distal jets 70b applying a greater radially-oriented force in the radial direction than the distal jets 70a at the same radial distance from the head outer surface 118.

[0095] Depending on the pressure of the injected fluid, the size of distal openings 162b, and the angle a of the second outer movable membrane 120b, the distal jets 70b can be configured to apply, at a radial distance of between 5 to 10 cm (centimeters) from the central axis CA, or between 7 to 9 cm from the central axis CA, a force sufficient to encounter an upper wall of the stomach cavity 18 when the head portion 110benters through the lower esophageal sphincter 16, so as to reorient the head portion 110 in a downwardly-oriented direction, such as toward the pylorus 20. The distal jets 70b can advantageously further serve to centralize the headportion 110 within the bodily lumen it is advanced through, such as during its downwards advancement along the stomach 18, by simultaneously impinging against the surrounding walls of the stomach 18 to prevent the head portion from being biased toward one side or region of the stomach 18. This centralization can facilitate steering or better controlled navigation of the head portion 110 towards and eventually through the pylorus 20.

[0096] Upon reaching the desired target site, which can be past pylorus 20, enteral nutrition, as well as other substances, can be administered through the tube 102 and head portion 110. This can be achieved by administering enteral nutrition into the primary lumen 104 of tube 102, and via head cavity 160, in a positive pressure that can be lower than that of the pressurized fluid used for distal advancement of the device 100. During administration of enteral food or other substances, the head portion 110 is maintained in its outflow configuration, to allow passage of the substances from the head cavity 160 through the distal openings 162. The pressure of the administered enteral nutrition is positive to allow it to distally advance through the primary lumen 104 and head cavity 160 and exit via distal opening 162, yet not high enough such that during such administration, the head portion 110 will be kept in the same position without being axially advanced any further.

[0097] In some examples, the lower pressure of the administered enteral nutrition (or other substances) is high enough to keep the inner movable membrane 150 in its flattened configuration, and the outer movable membrane 120 in its extended configuration. In some examples, the inner movable membrane 150 can be biased, in a free state thereof, radially outward to the flattened state, and the outer movable membrane 120 can be biased, in a free state thereof, radially outwards to its extended state, such that as long as no active suction force is applied, the inner movable membrane 150 and / or the outer movable membrane 120 will be biased radially outward to achieve an outflow configuration of the head portion.

[0098] In some examples, the tube 102 can be disconnected from the flow control hub 170 after advancement to the target site, and connected to a feeding source (not shown). In some examples, a tube connected to the fluid inlet port 174 to provide pressurized fluid for propagating the device 100 is removed from the fluid inlet port 174 after advancement to the target site, and a different tube from a feeding source is connected into the fluid inlet port 174 instead. In some examples, the flow control hub 170 can include another inlet port, such as a feeding port (not shown) coupled to a feeding source, and the switch 180 can be controlled to close both the fluid inlet port 174 and fluid outlet port 176, and open the feeding port, after advancement to the target site.

[0099] Fig. 8A show a distal portion of an exemplary pressure-propelled device 100c. Fig. 9 is a cross-sectional view taken along line 9-9 of Fig. 8A. Pressure-propelled device 100cis an exemplary implementation of pressure-propelled device 100, and thus includes the features described for pressure-propelled device 100 throughout the current disclosure, except that the head portion further comprises one or more optical sensors 192 such as a camera or any other type of imaging device. The one or more optical sensors 192 can be configured to obtain images from inside the lumen or body cavity through which the head portion 110 is passed. In some examples, the one or more optical sensors 192 can include one or more in-vivo video cameras which may capture and transmit images of portions of the gastrointestinal tract while the head portion 110 passes through a lumen or cavity of the gastrointestinal system. Nevertheless, it is to be understood that any other bodily lumen or cavity can be imaged.

[0100] While not illustrated, it is to be understood that in some examples, the head portion 110 can further include one or more illumination devices such as optic fibers, LED, and the like. The one or more illumination devices are configured to illuminate a slice or region of the bodily lumen or cavity imaged by the one or more optical sensors 192. In some examples, an illumination device can be embedded as part of the optical sensor 192.

[0101] The one or more optical sensors 192 can be connected to an external power source (not shown) and / or a control device (e.g., a processor) via one or more connectors, such as wire(s) 194 that can extend through a communication channel 144 (see Fig. 9) along a length of the tube 102.

[0102] In some examples, the one or more optical sensors 192 comprises a plurality of optical sensors 192. A plurality of optical sensors 192 can be optionally arranged around a perimeter of the head portion 110, equally or unequally spaced from each other.

[0103] In some examples, any of the one or more optical sensor 192 can have a broad field of view. In some examples, the one or more optical sensor 192 may view and / or capture images of body areas transverse or substantially transverse to the general direction of movement of head portion 110. For example, portions of bodily lumens or cavities directly adjacent to head portion 110, as opposed to in front of the head portion 110, may be imaged. In some examples, the one or more optical sensor 192 may view and / or capture panoramic images with a broad field-of-view, e.g., up to 360 degrees, and / or with a substantially circular or radial field-of- view.

[0104] In some examples, the head portion 110, such as exemplary head portion 110cshown in Fig. 8A, can include an areas, such as a transparent ring 146, which are transparent and which allow the one or more optical sensors 192 aligned therewith, to have an un-obstructedfield-of-view of the environment external to head portion 110. In some examples, transparent ring 146 is configured such that a 360 degree field of view is enabled. Other shaped transparent areas may be used.

[0105] As further illustrated in Figs. 8A and 9, the pressure-propelled device 100 can optionally further include a working channel 142 extending along the length of the tube 104, and open ended at a working channel opening 158 exposed to the outer environment surrounding the pressure-propelled device 100. The working channel 142 is fluidly sealed from the primary lumen 104 and can be in communication with a port (not shown) of a handle or a hub of the pressure-propelled device 100, allowing insertion and / or retrieval of various devices and / or components therethrough and along the working channel 142, such as tools configured to acquire a biopsy sample of a tissue and the like.

[0106] In some examples, the working channel opening 158 can be defined at a proximal part of the head portion 110, such as proximally to the outer stationary membrane 130 as shown in the example illustrated in Fig. 8A. In some examples, the working channel 142 can extend farther so as to define the working channel opening 158 at the head outer surface 118 at a position that can be distal to the outer stationary membrane 130. In some examples, the working channel 142 does not necessarily reach the head portion 110, such that the working channel opening 158 can be formed proximally to the head portion 110.

[0107] It is to be understood that an exemplary pressure-propelled device 100cis shown in Figs. 8A and 9 to include both a working channel 142 and a series of optical sensors 192 by way of illustration and not limitation, and that such components can be either both included in a pressure-propelled device 100, or one can appear without the other. Thus, any exemplary pressure-propelled device 100 disclosed herein can include a working channel 142 without including optical sensor(s) 192, can include optical sensor(s) 192 without including a working channel 142, can include both a working channel 142 and one or more optical sensors 192, or can be devoid of both.

[0108] Optical sensor(s) 192 can be arranged in any suitable circumferential arrangement and can be axially positioned at any suitable axial position along the head portion 110. In the example illustrated for pressure-propelled device 100c, the optical sensors 192 are shown to be positioned proximal to the outer stationary membrane 130. Fig. 8B shows an exemplary pressure-propelled device 100dwhich can be similar in structure and function to any example described herein with respect to pressure-propelled device 100d, except that the one or more optical sensors 192 are shown to be positioned between the outer stationary membrane 130 and the outer movable membrane 120. If the head portion 110 includes more than one outermovable membrane 120, the optical sensor(s) 192 can be positioned between any pair of membranes.

[0109] Fig. 8B shows an exemplary pressure-propelled device 100dwhich can be similar in structure and function to any example described herein with respect to pressure-propelled device 100d, except that the one or more optical sensors 192 are shown to be positioned distal to the outer movable membrane 120, or distal to a distal-most outer movable membrane 120 in the case of a head portion 110 that includes a plurality of outer movable membranes 120. For example, the one or more optical sensors 192 can be located at the head distal tip portion 114. In some examples, an optical sensor 192 located at the head distal tip portion 114 can be configured to image a portion of a bodily lumen or cavity in front of the head portion 110. It is to be understood that any combination of locations for optical sensors 192 is similarly contemplated. For example, a plurality of optical sensors 192 can be arranged at more than one axial position along a length of the head portion 110.

[0110] In some cases, irrigation of the visualized region may be required to provide a clear view for the one or more optical sensors 192. For example, acquired images can be analyzed in real time to detect local turbidity, in which case irrigation may be either manually or automatically applied to the corresponding view region.

[0111] In some examples, the extended state described herein above for the at least one outer movable membrane 120 is a first extended state, and the outer movable membrane 120 is further configured to move between a first extended state and a second extended state, wherein, in the second extended state, the angle a defined between the corresponding outer movable membrane 120 and the central axis CA is larger than the angle a defined in the first extended state. Fluid ejected from the distal openings 162 at a first flow rate or flow velocity is configured to impinge against the outer movable membrane 120 at a force sufficient to move it towards, or maintain it in, the first extended state, but not the second extended state, while fluid ejected from the distal openings 162 at a second greater flow rate or flow velocity is configured to impinge against the outer movable membrane 120 at a greater force which is sufficient to move it towards, or maintain it in, the second extended state.

[0112] The outer movable membrane 120 can be optionally extended at a right angle, or substantially at a right angle, relative to the central axis CA, in the second extended state, thereby allowing the fluid ejected from the distal openings 162 at the second flow rate to serve as irrigation fluid directed radially towards the region surrounding the head portion 110. In some examples, the angle a defines by the at least one outer movable membrane 120 in the second extended state is in a range of 70°-90°.

[0113] Irrigation fluid ejected at the second flow rate from the distal openings 162 can both clear the region of view around the head portion 110, while also causing axial advancement of the head portion 110 according to the advancement mechanisms described above. However, in some cases, it may be desired to allow for irrigation of the region surrounding the head portion 110 while maintaining axial position of the head portion 110, so as to allow the optical sensor 192 to focus on the region of interest without axial movement thereof.

[0114] Fig. 10 show a distal portion of an exemplary pressure-propelled device 100f. Fig. 11 is a cross-sectional view taken along line 11-11 of Fig. 10. Pressure-propelled device 100fis an exemplary implementation of pressure-propelled device 100, and thus includes the features described for pressure-propelled device 100 throughout the current disclosure, except that the head portion further comprises an irrigation lumen 168 in fluid communication with one or more irrigation openings 166, wherein the irrigation lumen 168 is fluidly sealed from the primary lumen 104. In some examples, the irrigation opening(s) 166 can be positioned in close proximity to the one or more optical sensors 192. The irrigation openings can be uncovered and axially misaligned with any of the membranes of the head portion 110f, and can be configured to direct fluid ejected therefrom in a radial direction (i.e., perpendicularly to the central axis CA).

[0115] When irrigation is required, irrigation fluid can be supplied to the irrigation lumen 168 and ejected through the irrigation opening(s) 166, while no fluid is either supplied to or drained from the primary lumen 104, so as to provide a clear view for the one or more optical sensors 192 without advancing the head portion 110. While the irrigation openings 166 are shown in Fig. 10 to be positioned next to optical sensors 192 at a position proximal to the outer stationary membrane, it is to be understood that both the optical sensors 192 and the irrigation openings 166 can be positioned at any other axial positions, and that in some examples, the irrigation openings 166 can be father distanced in the axial direction from the optical sensors 192.

[0116] While the primary lumen 104 and the irrigation lumen 168 are shown in Fig. 11 to be similarly shaped and sized, it is to be understood that any of the primary lumen 104, irrigation lumen 168, working channel 142 and / or communication channel 144 can be differently shaped and differently sized.

[0117] In some examples, the optical sensors 192 take images of the surrounding body cavity, responsive to a respective user input and / or at predetermined intervals. In some examples, the images are transmitted to the control device, which is configured to analyze the images to identify pathological conditions. In some examples, the control device comprises one or more processors, and a memory, the memory having stored therein a plurality of instructions thatwhen run by the one or more processors cause the one or more processors to identify pathological conditions within the images. In some examples, the images are analyzed by a neural network trained and / or fine-tuned to identify pathological conditions within images of the body cavity.

[0118] Fig. 12A shows a perspective view of an exemplary pressure propelled device 100gand a medical device 200, wherein the devices are separated from each other. Medical device 200 is shown to comprise an elongated delivery shaft 208 and a distal tip 210. In some examples, the medical device 200 can be an endoscope (e.g. colonoscope), although it is understood that medical device 200 can be any suitable medical device having an elongated shaft configured for insertion into a bodily lumen. Pressure propelled device 100gcan be functionally and structurally similar to any example of pressure propelled device 100 disclosed herein, except that a proximal portion of tube 102gof pressure propelled device 100gcomprises a generally C-shaped cross-sectional profile, as shown in Fig. 12B. Fig. 12B shows a cross-sectional side view of pressure propelled device 100g, taken along line 12B-12B, illustrating the C-shaped cross-sectional profile.

[0119] Fig. 13A shows a perspective view of an exemplary pressure propelled device 100g, along with medical device 200 mounted therein. Fig. 13B shows a cross-sectional side view of pressure propelled device 100gand medical device 200 mounted therein, taken along line 13B- 13B. In some examples, medical device 200 can comprise a working channel 220 extending along a length of shaft 208. Medical device 200 can further comprise two illumination devices 214, and a visualization device 212, positioned at a distal tip 210, as shown in Figs. 13A and 13B. It is understood that these components are optional and other components or combinations of components can be included in medical device 200.

[0120] As shown in Fig. 13B, the generally C-shaped cross-sectional profile of tube 102gis configured to be positioned around delivery shaft 208 of medical device 200 in a clamping manner. In some examples, tube 102gcan transition from having a generally C-shaped cross- sectional profile to having a generally circular cross-sectional profile at a distal portion thereof. In some examples, a generally circular cross-sectional profile can be provided at a further proximal portion thereof, so long as there is a sufficient length of tube 102ghaving a generally C-shaped cross-sectional profile for medical device 200 to be mounted therein.

[0121] As shown in Figs. 12A-13B, the C-shaped cross-sectional profile of tube 102gdefines a gap configured to receive delivery shaft 208. The gap, in a free-state thereof, has a width sufficiently smaller than an outer diameter of delivery shaft 208 that a clamping force can be exerted by tube 102garound delivery shaft 208. The clamping force exerted by tube 102gondelivery shaft 208 can be sufficient that any motion of tube 102gwill be equally experienced by the medical device 200, such that medical device 200 can be held in place during a medical procedure. However, the clamping force can also permit enough flexibility for delivery shaft 208 to be moved along tube 102gby an operator or by any other means. Tube 102gis configured to circumferentially extend around more than 180 degrees of the delivery shaft 208, thereby providing tube 102gwith sufficient flexibility for delivery shaft 208 to be clamped into and advanced along tube 102g.

[0122] As shown in Fig. 13B, tube 102gdefines a primary lumen 104g. Lumen 104gis shown to have a similarly generally C-shaped cross-sectional profile to tube 102gwhere tube 102ghas such a cross-sectional profile, although it is understood that this is optional and other suitable cross-sectional profiles can be provided for lumen 104g. Likewise, in some examples, lumen 104gcan have a generally circular cross-sectional profile where tube 102ghas such a cross- sectional profile. Lumen 104gis in fluid communication with the head cavity 160 of head portion 110g, positioned at a distal end of tube 102g. Head portion 110gcan be implemented as any example of head portion 110 disclosed herein.

[0123] Various structural features common to all examples of head portion 110 disclosed herein, such as distal openings 162 and proximal openings 164, are omitted from Fig. 13 A for simplicity. However, it is understood that all relevant features of head portion 110 can be present and may be provided.Some Examples of the Disclosed Implementations

[0124] Some examples of above-described implementations are enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more examples below are examples also falling within the disclosure of this application.

[0125] Example 1. A pressure-propelled device for navigating through a lumen in a patient's body, comprising: a tube defining a primary lumen; and a head portion at a distal end of the tube, comprising: a head cavity around a central axis of the head portion, wherein the head cavity is in fluid communication with the primary lumen of the tube; a head inner surface facing the central axis; a head outer surface facing away from the central axis; one or more proximal openings;one or more groups of distal openings, each group comprising one or more distal openings; an inner movable membrane extending from an inner membrane attachment end at the head inner surface, to an inner membrane free end radially inwards to the head inner surface; and at least one outer movable membrane distal to the inner movable membrane, the at least one outer movable membrane extending from an outer membrane attachment end at the head outer surface, to an outer membrane free end radially outwards to the head outer surface; wherein the inner movable membrane is aligned with the one or more proximal openings; wherein the outer movable membrane is aligned with a correspond group of the one or more groups of distal openings; wherein the inner movable membrane is configured to transition between a flattened state and an extended state thereof; wherein the at least one outer movable membrane is configured to transition between a flattened state and an extended state thereof; wherein the head portion is configured to transition between an outflow configuration and an inflow configuration by alternating between positive and negative flow pressures through the primary lumen and the head cavity, wherein the inner movable membrane is in its flattened state and the at least one outer movable membrane is in its extended state in the outflow configuration, and wherein the inner movable membrane is in its extended state and the at least one outer movable membrane is in its flattened state in the inflow configuration.

[0126] Example 2. The device of any example herein, particularly example 1, wherein the inner movable membrane is parallel to the central axis in its flattened state.

[0127] Example 3. The device of any example herein, particularly example 1 or 2, wherein the inner membrane free end is in contact with the head inner surface in the flattened state of the inner movable membrane.

[0128] Example 4. The device of any example herein, particularly any one of examples 1 to3, wherein the inner membrane free end is closer to the central axis in the extended state of the inner movable membrane than in its flattened state.

[0129] Example 5. The device of any example herein, particularly any one of examples 1 to4, wherein the inner membrane free end is distal to the one or more proximal openings in the flattened state of the inner movable membrane.

[0130] Example 6. The device of any example herein, particularly any one of examples 1 to5, wherein the inner movable membrane covers the one or more proximal openings in its flattened state.

[0131] Example 7. The device of any example herein, particularly any one of examples 1 to6, wherein the inner movable membrane is angularly oriented relative to the central axis in its extended state.

[0132] Example 8. The device of any example herein, particularly any one of examples 1 to7, wherein the at least one outer movable membrane is parallel to the central axis in its flattened state.

[0133] Example 9. The device of any example herein, particularly any one of examples 1 to8, wherein the outer membrane free end of the at least one outer movable membrane is in contact with the head outer surface in the flattened state of the at least one outer movable membrane.

[0134] Example 10. The device of any example herein, particularly any one of examples 1 to9, wherein the outer membrane free end of the at least one outer movable membrane is farther from the central axis in the extended state of the at least one outer movable membrane than in its flattened state.

[0135] Example 11. The device of any example herein, particularly any one of examples 1 to10, wherein the outer membrane free end of the at least one outer movable membrane is proximal to the corresponding group of proximal openings aligned therewith, in the flattened state of the at least one outer movable membrane.

[0136] Example 12. The device of any example herein, particularly any one of examples 1 to11, wherein the at least one outer movable membrane covers the one or more distal openings aligned therewith in its flattened state.

[0137] Example 13. The device of any example herein, particularly any one of examples 1 to 12, wherein the head portion further comprises a stationary membrane, extending from a stationary membrane proximal end at the head outer surface, to a stationary membrane distal end radially outward to the head outer surface.

[0138] Example 14. The device of any example herein, particularly example 13, wherein the stationary membrane is angled relative to the central axis.

[0139] Example 15. The device of any example herein, particularly example 13 or 14, wherein the stationary membrane is aligned with the one or more proximal openings.

[0140] Example 16. The device of any example herein, particularly any one of examples 13 to 15, wherein the stationary membrane distal end is distal to the one or more proximal openings.

[0141] Example 17. The device of any example herein, particularly any one of examples 13 to 16, wherein the head portion further comprises at least one membrane support extending from a support distal end at the head outer surface to a support proximal end at the stationary membrane distal end.

[0142] Example 18. The device of any example herein, particularly example 17, wherein the at least one membrane support is angled relative to the central axis.

[0143] Example 19. The device of any example herein, particularly example 17 or 18, wherein the at least one membrane support comprises a plurality of membrane supports circumferentially disposed around the central axis.

[0144] Example 20. The device of any example herein, particularly any one of examples 1 to19, wherein the one or more proximal openings comprises a plurality of proximal openings circumferentially disposed around the central axis.

[0145] Example 21. The device of any example herein, particularly any one of examples 1 to20, wherein the one or more distal openings of any group of the one or more groups of distal openings, comprises a plurality of distal openings circumferentially disposed around the central axis.

[0146] Example 22. The device of any example herein, particularly any one of examples 1 to21, wherein the at least one outer movable membrane comprises a single outer movable membrane.

[0147] Example 23. The device of any example herein, particularly example 22, wherein the single outer movable membrane defines an acute angle relative to the central axis, in its extended state.

[0148] Example 24. The device of any example herein, particularly any one of examples 1 to 21, wherein the at least one outer movable membrane comprises a first outer movable membrane and a second outer movable membrane which is distal to the first outer movable membrane.

[0149] Example 25. The device of any example herein, particularly example 24, wherein the one or more groups of distal openings comprises a first group that comprises one or more distal openings aligned with the first outer movable membrane, and a second group that comprises one or more distal openings aligned with the second outer movable membrane.

[0150] Example 26. The device of any example herein, particularly example 24 or 25, wherein the second outer movable membrane defines, in its extended state, an angle relative to the central axis, which is greater than an angle defined by the first outer movable membrane defines, in its extended state, relative to the central axis.

[0151] Example 27. The device of any example herein, particularly example 26, wherein the angle defined between the central axis and the second outer movable membrane, in its extended state, is in a range of 70°-90°.

[0152] Example 28. The device of any example herein, particularly any one of examples 1 to 27, further comprising a flow control hub, the flow control hub comprising: a hub chamber; a tube port attached to a proximal end of the tube, wherein the tube port is in fluid communication with the hub chamber and the primary lumen of the tube; a fluid inlet port; a fluid outlet port; and a switch configured to controllably close and open fluid communication between any of the fluid inlet port and fluid outlet port, with the hub chamber.

[0153] Example 29. The device of any example herein, particularly example 28, wherein the switch is configured to open the fluid inlet port while closing the fluid outlet port, and to open the fluid outlet port while closing the fluid inlet port.

[0154] Example 30. The device of any example herein, particularly example 28 or 29, further comprising a flex sensor extending along the tube, the flow control hub in communication with an output of the flex sensor.

[0155] Example 31. The device of any example herein, particularly example 30, wherein, based at least in part on the output of the flex sensor, the flow control hub is configured todetermine whether a degree of bend of the tube is within one or more predetermined parameters.

[0156] Example 32. The device of any example herein, particularly example 31, wherein in the event that the flow control hub determines that the degree of bend of the tube is outside of the one or more predetermined parameters, the flow control hub is configured to generate an alert signal.

[0157] Example 33. The device of any example herein, particularly example 31 or 32, wherein the one or more predetermined parameters comprises a predetermined threshold value, and wherein the degree of bend of the tube is within the one or more predetermined parameters if the degree of bend of the tube is not greater than the predetermined threshold value.

[0158] Example 34. The device of any example herein, particularly any one of examples 1 to33, further comprising a working channel extending along a length of the tube and terminating at a working channel opening, wherein the working channel is fluidly sealed from the primary lumen.

[0159] Example 35. The device of any example herein, particularly any one of examples 1 to34, further comprising one or more optical sensors configured to obtain images from inside a lumen or body cavity through which the head portion is passed.

[0160] Example 36. The device of any example herein, particularly example 35, wherein the one or more optical sensors comprise one or more in-vivo video cameras.

[0161] Example 37. The device of any example herein, particularly example 35 or 36, wherein the one or more optical sensors comprise a plurality of optical sensors.

[0162] Example 38. The device of any example herein, particularly example 37, wherein the plurality of optical sensors are arranged around a perimeter of the head portion.

[0163] Example 39. The device of any example herein, particularly example 37 or 38, wherein the plurality of optical sensors are configured to capture panoramic images spanning 360 degrees around the head portion.

[0164] Example 40. The device of any example herein, particularly any one of examples 35 to 39, wherein the extended state of the at least one outer movable membrane is a first extended state, and wherein the at least one outer movable membrane is further configured to move between the first extended state and a second extended state, wherein an angle defined by the at least one outer movable membrane relative to the central axis in the second extended state is greater than an angle defined by the at least one outer movable membrane relative to the central axis in the first extended state.

[0165] Example 41. The device of any example herein, particularly example 40, wherein the central axis and the at least one second outer movable membrane, in the second extended state, is in a range of 70°-90°.

[0166] Example 42. The device of any example herein, particularly any one of examples 35 to 41, wherein the head portions further comprises one or more irrigation openings in fluid communication with an irrigation lumen extending along a length of the tube, wherein the irrigation lumen is fluidly sealed from the primary lumen.

[0167] Example 43. The device of any example herein, particularly example 42, wherein the one or more irrigation openings are oriented perpendicularly to the central axis.

[0168] Example 44. The device of any example herein, particularly any one of examples 35 to 41, wherein a proximal portion of the tube comprises a generally C-shaped cross-sectional profile defining a gap.

[0169] Example 45. The device of any example herein, particularly example 44, wherein the gap is configured for a shaft of a medical device to be mounted therein.

[0170] Example 46. The device of any example herein, particularly any one of examples 44 or 45, wherein the tube transitions from having a generally C-shaped cross-sectional profile at a proximal portion thereof to having a generally circular cross-sectional profile at a distal portion thereof.

[0171] Example 47. An assembly comprising: the device of any example herein, particularly of examples 44 to 46; and a medical device comprising an elongated delivery shaft; wherein the elongated delivery shaft of the medical device is mounted within the gap; and wherein the gap, in a free state thereof, has a width smaller than an outer diameter of the delivery shaft, such that when the delivery shaft is mounted within the gap, a clamping force is exerted by the tube around the delivery shaft.

[0172] Example 48. The assembly of any example herein, particularly of example 47, wherein the clamping force exerted by the tube around the delivery shaft is sufficient that motion of the tube is experienced equally by the medical device.

[0173] Example 49. The assembly of any example herein, particularly of example 47 or example 48, wherein the tube circumferentially extends around more than 180 degrees of the elongated delivery shaft.

[0174] Example 50. The assembly of any example herein, particularly of any one of example 47 to example 49, wherein the clamping force exerted by the tube around the delivery shaft permits enough flexibility that the delivery shaft can be moved along the tube.

[0175] It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate examples, may also be provided in combination in a single example. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single example, may also be provided separately or in any suitable sub-combination or as suitable in any other described example of the disclosure. No feature described in the context of an example is to be considered an essential feature of that example, unless explicitly specified as such.

[0176] In view of the many possible examples to which the principles of the disclosure may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope. Rather, the scope is defined by the following claims. We therefore claim all that comes within the scope and spirit of these claims.

Claims

CLAIMS1. A pressure-propelled device for navigating through a lumen in a patient's body, comprising: a tube defining a primary lumen; and a head portion at a distal end of the tube, comprising: a head cavity around a central axis of the head portion, wherein the head cavity is in fluid communication with the primary lumen of the tube; a head inner surface facing the central axis; a head outer surface facing away from the central axis; one or more proximal openings; one or more groups of distal openings, each group comprising one or more distal openings; an inner movable membrane extending from an inner membrane attachment end at the head inner surface, to an inner membrane free end radially inwards to the head inner surface; and at least one outer movable membrane distal to the inner movable membrane, the at least one outer movable membrane extending from an outer membrane attachment end at the head outer surface, to an outer membrane free end radially outwards to the head outer surface; wherein the inner movable membrane is aligned with the one or more proximal openings; wherein the outer movable membrane is aligned with a correspond group of the one or more groups of distal openings; wherein the inner movable membrane is configured to transition between a flattened state and an extended state thereof; wherein the at least one outer movable membrane is configured to transition between a flattened state and an extended state thereof; wherein the head portion is configured to transition between an outflow configuration and an inflow configuration by alternating between positive and negative flow pressures through the primary lumen and the head cavity, wherein the inner movable membrane is inits flattened state and the at least one outer movable membrane is in its extended state in the outflow configuration, and wherein the inner movable membrane is in its extended state and the at least one outer movable membrane is in its flattened state in the inflow configuration.

2. The device of claim 1, wherein the inner movable membrane is parallel to the central axis in its flattened state.

3. The device of claim 1 or 2, wherein the inner membrane free end is in contact with the head inner surface in the flattened state of the inner movable membrane.

4. The device of any one of claims 1 to 3, wherein the inner membrane free end is closer to the central axis in the extended state of the inner movable membrane than in its flattened state.

5. The device of any one of claims 1 to 4, wherein the inner membrane free end is distal to the one or more proximal openings in the flattened state of the inner movable membrane.

6. The device of any one of claims 1 to 5, wherein the inner movable membrane covers the one or more proximal openings in its flattened state.

7. The device of any one of claims 1 to 6, wherein the inner movable membrane is angularly oriented relative to the central axis in its extended state.

8. The device of any one of claims 1 to 7, wherein the at least one outer movable membrane is parallel to the central axis in its flattened state.

9. The device of any one of claims 1 to 8, wherein the outer membrane free end of the at least one outer movable membrane is in contact with the head outer surface in the flattened state of the at least one outer movable membrane.

10. The device of any one of claims 1 to 9, wherein the outer membrane free end of the at least one outer movable membrane is farther from the central axis in the extended state of the at least one outer movable membrane than in its flattened state.

11. The device of any one of claims 1 to 10, wherein the outer membrane free end of the at least one outer movable membrane is proximal to the corresponding group of proximal openings aligned therewith, in the flattened state of the at least one outer movable membrane.

12. The device of any one of claims 1 to 11, wherein the at least one outer movable membrane covers the one or more distal openings aligned therewith in its flattened state.

13. The device of any one of claims 1 to 12, wherein the head portion further comprises a stationary membrane, extending from a stationary membrane proximal end at the head outer surface, to a stationary membrane distal end radially outward to the head outer surface.

14. The device of claim 13, wherein the stationary membrane is angled relative to the central axis.

15. The device of claim 13 or 14, wherein the stationary membrane is aligned with the one or more proximal openings.

16. The device of any one of claims 13 to 15, wherein the stationary membrane distal end is distal to the one or more proximal openings.

17. The device of any one of claims 13 to 16, wherein the head portion further comprises at least one membrane support extending from a support distal end at the head outer surface to a support proximal end at the stationary membrane distal end.

18. The device of claim 17, wherein the at least one membrane support is angled relative to the central axis.

19. The device of claim 17 or 18, wherein the at least one membrane support comprises a plurality of membrane supports circumferentially disposed around the central axis.

20. The device of any one of claims 1 to 19, wherein the one or more proximal openings comprises a plurality of proximal openings circumferentially disposed around the central axis.

21. The device of any one of claims 1 to 20, wherein the one or more distal openings of any group of the one or more groups of distal openings, comprises a plurality of distal openings circumferentially disposed around the central axis.

22. The device of any one of claims 1 to 21, wherein the at least one outer movable membrane comprises a single outer movable membrane.

23. The device of claim 22, wherein the single outer movable membrane defines an acute angle relative to the central axis, in its extended state.

24. The device of any one of claims 1 to 21, wherein the at least one outer movable membrane comprises a first outer movable membrane and a second outer movable membrane which is distal to the first outer movable membrane.

25. The device of claim 24, wherein the one or more groups of distal openings comprises a first group that comprises one or more distal openings aligned with the first outer movable membrane, and a second group that comprises one or more distal openings aligned with the second outer movable membrane.

26. The device of claim 24 or 25, wherein the second outer movable membrane defines, in its extended state, an angle relative to the central axis, which is greater than an angle defined by the first outer movable membrane defines, in its extended state, relative to the central axis.

27. The device of claim 26, wherein the angle defined between the central axis and the second outer movable membrane, in its extended state, is in a range of 70°- 90°.

28. The device of any one of claims 1 to 27, further comprising a flow control hub, the flow control hub comprising: a hub chamber; a tube port attached to a proximal end of the tube, wherein the tube port is in fluid communication with the hub chamber and the primary lumen of the tube; a fluid inlet port; a fluid outlet port; and a switch configured to controllably close and open fluid communication between any of the fluid inlet port and fluid outlet port, with the hub chamber.

29. The device of claim 28, wherein the switch is configured to open the fluid inlet port while closing the fluid outlet port, and to open the fluid outlet port while closing the fluid inlet port.

30. The device of claim 28 or 29, further comprising a flex sensor extending along the tube, the flow control hub in communication with an output of the flex sensor.

31. The device of claim 30, wherein, based at least in part on the output of the flex sensor, the flow control hub is configured to determine whether a degree of bend of the tube is within one or more predetermined parameters.

32. The device of claim 31, wherein in the event that the flow control hub determines that the degree of bend of the tube is outside of the one or more predetermined parameters, the flow control hub is configured to generate an alert signal.

33. The device of claim 31 or 32, wherein the one or more predetermined parameters comprises a predetermined threshold value, and wherein the degree of bend of the tube is within the one or more predetermined parameters if the degree of bend of the tube is not greater than the predetermined threshold value.

34. The device of any one of claims 1 to 33, further comprising a working channel extending along a length of the tube and terminating at a working channel opening, wherein the working channel is fluidly sealed from the primary lumen.

35. The device of any one of claims 1 to 34, further comprising one or more optical sensors configured to obtain images from inside a lumen or body cavity through which the head portion is passed.

36. The device of claim 35, wherein the one or more optical sensors comprise one or more in-vivo video cameras.

37. The device of claim 35 or 36, wherein the one or more optical sensors comprise a plurality of optical sensors.

38. The device of claim 37, wherein the plurality of optical sensors are arranged around a perimeter of the head portion.

39. The device of claim 37 or 38, wherein the plurality of optical sensors are configured to capture panoramic images spanning 360 degrees around the head portion.

40. The device of any one of claims 35 to 39, wherein the extended state of the at least one outer movable membrane is a first extended state, and wherein the at least one outer movable membrane is further configured to move between the first extended state and a second extended state, wherein an angle defined by the at least one outer movable membrane relative to the central axis in the second extended state is greater than an angle defined by the at least one outer movable membrane relative to the central axis in the first extended state.

41. The device of claim 40, wherein the central axis and the at least one second outer movable membrane, in the second extended state, is in a range of 70°-90°.

42. The device of any one of claims 35 to 41, wherein the head portions further comprises one or more irrigation openings in fluid communication with anirrigation lumen extending along a length of the tube, wherein the irrigation lumen is fluidly sealed from the primary lumen.

43. The device of claim 42, wherein the one or more irrigation openings are oriented perpendicularly to the central axis.

44. The device of any one of claims 1 to 43, wherein a proximal portion of the tube comprises a generally C-shaped cross-sectional profile defining a gap.

45. The device of claim 44, wherein the gap is configured for a shaft of a medical device to be mounted therein.

46. The device of any one of claims 44 or 45, wherein the tube transitions from having a generally C-shaped cross-sectional profile at a proximal portion thereof to having a generally circular cross-sectional profile at a distal portion thereof.

47. An assembly comprising: the device of any one of claims 44 to 46; and a medical device comprising an elongated delivery shaft; wherein the elongated delivery shaft of the medical device is mounted within the gap; and wherein the gap, in a free state thereof, has a width smaller than an outer diameter of the delivery shaft, such that when the delivery shaft is mounted within the gap, a clamping force is exerted by the tube around the delivery shaft.

48. The assembly of claim 47, wherein the clamping force exerted by the tube around the delivery shaft is sufficient that motion of the tube is experienced equally by the medical device.

49. The assembly of claim 47 or claim 48, wherein the tube circumferentially extends around more than 180 degrees of the elongated delivery shaft.

50. The assembly of any one of claims 47 to claim 49, wherein the clamping force exerted by the tube around the delivery shaft permits enough flexibility that the delivery shaft can be moved along the tube.

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