Flexible tube insertion device and methods for operation and manufacturing of same

Abstract

A flexible medical tube insertion device for use coupled to a flexible medical tube such as a nasogastric tube or other flexible medical tube is disclosed. The device comprises a head assembly, an engagement assembly configured to reversibly engage a medical tube, an inserter assembly, a handle assembly having on its distal end a head assembly configured in shape to enter a hollow anatomic structure and configured to change the angle of direction of the head assembly and on its proximal end a handle assembly. An inserter assembly courses from the distal end of the handle assembly and connects to the proximal end of the engagement assembly, the distal end thereof being connected to the head assembly. A method for operating the device includes securing a medical tube to the engagement assembly before insertion within an anatomic lumen. The engagement assembly can disengage the medical tube.

Description

[0001] Flexible Tube Insertion Device and Methods for Operation and Manufacturing of Same TECHNICAL FIELD

[0002] The present systems, apparatuses, and methods lie in the field of medical devices. Some embodiments of systems and devices, and methods of their use, are disclosed that assist medical personnel in obtaining access to body cavities, more particularly, by assisting the insertion and positioning of existing medical probes, tubes, and devices; including, but not limited to nasogastric tubes, Dobhoff tubes, Sengstaken-Blakemore tubes, endotracheal tubes, or other feeding tubes and diagnostic or therapeutic catheters.

[0003] BACKGROUND ART

[0004] Enteral access is an important aspect of daily medical management and is one example of the introduction of medical catheters into a body cavity, especially in patients admitted to the hospital. Generally, the most common method for obtaining enteral access is by passing a hollow tube through the nose and nasopharynx into the stomach or the proximal small bowel. The tube provides for easy exchange of materials from within the stomach and the environment outside of the body, especially when such exchange cannot occur naturally by swallowing due to disease or unconsciousness. Some general uses of enteral access include the provision of liquid nutrition directly to the stomach or intestines, administration of medications, therapeutic interventions such as aspiration of luminal contents, and insertion of therapeutic devices such as Sengstaken- Blakemore tubes for the emergency treatment of variceal bleeding.

[0005] Enteral access is commonly used for feeding or medication administration in patients who cannot swallow either due to weakness, neuromuscular diseases, esophageal or oropharyngeal surgery, critical illness requiring mechanical ventilation, or patients who are unable to tolerate oral intake due to nausea and vomiting. There exist nasogastric tubes of smaller diameter that are dedicated to tube-feeding such as Dobhoff tubes, however, other tubes can also be used, such as standard nasogastric tubes.

[0006] Nasogastric tubes may also need to be placed urgently for therapeutic purposes such as for decompression in the setting of bowel obstruction, aspiration of gastric contents, or placement of Sengstaken-Blakemore tubes for the treatment of variceal bleeding. In these cases, rapid insertion is important so that the appropriate therapeutic intervention can be delivered. Often these interventions are lifesaving without an alternative treatment available. For the rapid treatment of some types of variceal bleeding, a balloon tube, such as the Sengstaken-Blakemore tube, is used. It resembled a large nasogastric tube with two inflatable balloons. The Sengstaken-Blakemore tube is inserted like a nasogastric tube through the nose or mouth, through the nasopharynx or oropharynx, and into the esophagus. Once the Sengstaken-Blakemore tube is in position, its associated balloons are inflated to provide tamponade effect against enlarged and bleeding esophageal varices. Treatment success depends on the positioning and rapid insertion by the treating provider, often a team of intensivists, emergency medicine physicians, and / or gastroenterologists.

[0007] U.S. Pat. No. 7,699,818 to Gilbert discloses anasogastric tube insertion system comprising a nasogastric tube, a guide element, and an inserter element. The inserter element is inserted through the nasal passages up to the oropharynx, where, through the guide element, a weight attached to a string is deployed and swallowed by the patient, carry ing the string with the weight to form a guidewire. The nasogastric tube can then be inserted over the guiding string into the stomach. Disadvantageous^, this system relies on intact swallowing and successful travel of the weight to the stomach. The Gilbert system also requires use of a specific nasogastric tube and, therefore, the system is not applicable or adaptable to be used with a variety of existing medical tubes such as those mentioned above. Furthermore, pushing of a flexible tube (such as anasogastric tube), even if over a guiding element, still constitutes a pushing force imparted on that tube, which remains prone to coiling. In addition, the difficulties of inserting existing bulky catheters such as the Sengstaken-Blakemore tube (with large balloons) remain unsolved. Notably, if swallowing is not successful or if swallowing reflexes are not intact, this system does not permit reliable, rapid insertion of a life-saving instrument, such as the Sengstaken-Blakemore tube.

[0008] U.S. Pat. No. 5,690,620 to Knott disclosed a nasogastric tube provided with a normally curved or normally bent leading end to conform to the anatomy of the pharynx. Knott also discloses a method for using the device that involves rotation of the device to change a direction of the fixed curved end of that nasogastric tube. However, Knott’s device represents a modified tube that cannot be used to insert a variety of other existing tubes, such as those mentioned above. Furthermore, the distal tip of the tube cannot be controlled and that is one of the reasons why the tube is provided with fixed bent sections to bias the direction of insertion when the device is manipulated during insertion.

[0009] U.S. Pat. No. 10,881,588 to Gabriel discloses a method for inserting a tube through the nasopharynx of a patient and a kit for inserting a tube through the nasopharynx of a patient. The method for inserting a tube comprises manipulating a direction of a tip of the tube by pulling or holding a thread-like element that is attached to the distal tip of the tube. A kit for insertion of that tube can comprise a tube to be used with a provided thread-like member. However, the Gabriel disclosure does not allow easy generalized use of that system with existing medical tubes such as those mentioned above, as the tube to be inserted in the device by Gabriel is adapted to be coupled to that device and that kit by Gabriel. Furthermore, attaching thread-like elements to a tip of a flexible tube does not resolve the problem of coiling when inserted within a lumen, which is inherent to all flexible tubes. Further related to coiling of the Gabriel tube, attaching strings to a tip of a flexible device cannot, on its own. accurately control direction of the tip in relation to anatomy of the patient. This is especially true if the tube is bent or coiled in an unpredictable direction. The ability to detach such a thread-like element from an inserted tube after delivery’ is complete also presents a challenge.

[0010] DISCLOSURE OF INVENTION

[0011] The systems, apparatuses, and methods described provide a medical tube insertion device and methods for operation and manufacturing of same that overcome the hereinaf ore-mentioned disadvantages of the heretofore-known devices and methods of this general ty pe and that provide an improved mechanism that facilitates directed insertion of a flexible medical tube through an anatomical passage, such as the oropharynx, while preventing coiling of the medical tube. The medical tube insertion device is economically constructed and is compatible with existing medical tubes including but not limited to: nasogastric tubes, Dobhoff tubes, Sengstaken-Blakemore tubes, Linton tubes, Minnesota tubes, endotracheal tubes, or other feeding tubes and diagnostic or therapeutic catheters to immediately allow use in appropriate cases and to increase utilization across health systems without requiring equipment upgrades.

[0012] With the foregoing and other objects in view, there is provided, a catheter insertion device for assisting insertion of a flexible tube through a lumen, the catheter insertion device comprising an engagement assembly comprising a distal end and a proximal end, an engager configured to reversibly engage with the flexible tube to maintain the position of the flexible tube within the lumen of the housing when engaged, and a housing comprising a housing lumen, a handle assembly comprising a handle comprising at least one operator engagement actuator control, the at least one operator actuator control configured to cause the engagement assembly to reversibly engage the flexible tube when the at least one operator engagement actuator control is actuated, and after engagement to cause the engagement assembly to disengage from the flexible lumen when the at least one operator engagement actuator control is disengaged, an inserter assembly comprising an inserter wire comprising a distal end connected to the housing of the engagement assembly, and a proximal end connected to the handle, an engagement line comprising a distal end connected to the engager, and a proximal end operatively connected to at least one of the at least one operator engagement actuator control to activate and deactivate the engager upon actuation of the at least one operator engagement actuator control.

[0013] With the objects in view, there is also provided a catheter insertion device for assisting insertion of a flexible tube through a lumen, the catheter insertion device comprising an engagement assembly comprising a housing comprising a housing lumen and a line channel, a distal end comprising a pedicle, a proximal end, and an engager configured to reversibly engage with the flexible tube to maintain a position of the flexible tube within the housing lumen when engaged, a handle assembly comprising a handle comprising at least one operator engagement actuator control, the at least one operator actuator control configured to cause the engagement assembly to reversibly engage the flexible tube when the at least one operator engagement actuator control is actuated, and after engagement, to cause the engagement assembly to disengage from the flexible lumen when the at least one operator engagement actuator control is disengaged, at least one operator line control, an inserter assembly comprising an inserter wire comprising a distal end connected to the housing of the engagement assembly, and a proximal end connected to the handle, a hollow engagement line comprising a distal end connected to the engager, and a proximal end operatively connected to at least one of the at least one operator engagement actuator control to activate and deactivate the engager upon actuation of the at least one operator engagement actuator control, a line comprising a distal end, and a proximal end operatively connected to at least one of the at least one operator line control and the handle, the at least one operator line control being configured to increase tension on the line or ease tension on the line responsive to action of the at least one operator line control, and a head assembly comprising a distal end and a proximal end a bulb comprising a superior aspect, an inferior aspect, and a diameter, and configured to secure the distal end of the line w ithin the inferior aspect of the bulb, and a head shaft comprising a proximal end connected to the engagement assembly, comprising a distal end confluently connected to the bulb configured to have a diameter smaller than the diameter of the bulb, and comprising a proximal end connected to the engagement assembly.

[0014] In accordance with another feature, the lumen is an anatomic lumen.

[0015] In accordance with a further feature, the engager is configured to expand and, thereby, reversibly engage with the flexible tube to maintain the position within the housing lumen.

[0016] In accordance with an added feature, the engager is a balloon and is activated by expansion.

[0017] In accordance with an additional feature, the flexible tube has a length and the inserter wire is longer than the length of the flexible tube.

[0018] In accordance with yet another feature, the inserter wire is made of at least one of stainless steel, metal, plastic, and combinations thereof.

[0019] In accordance with yet a further feature, the inserter wire has a cross-section that is one of circular, rectangular, and ovoid.

[0020] In accordance with yet an added feature, the housing has an outer circumference, the rectangular or ovoid inserter wire has a flatter aspect that is placed radially to the center of the lumen of the housing, and the inserter wire is disposed adjacent the circumference of the housing.

[0021] In accordance with yet an additional feature, the engagement line is hollow.

[0022] In accordance with again another feature, the distal end of the engagement assembly forms an exit hiatus to allow passage of the flexible tube therethrough. In accordance with again a further feature, there is provided a head assembly comprising a flexible distal tip and a proximal head shaft proximally connected to the engagement assembly.

[0023] In accordance with again an added feature, the distal end of the engagement assembly comprises a pedicle.

[0024] In accordance with again an additional feature, the head assembly is made of silicone, soft plastic, and combinations thereof.

[0025] In accordance with still another feature, the head shaft has a cross-section that is one of circular and oval.

[0026] In accordance with still a further feature, the engagement assembly comprising a line channel within the housing, the inserter assembly comprises a line comprising a distal end, and a proximal end, the line passing through the line channel of the housing and being operatively connected to at least one operator line actuator control on the handle, the at least one operator line actuator control being configured to selectively increase tension on the line or ease tension on the line responsive to action of the at least one operator line actuator control, the head assembly comprises a bulb comprising a superior aspect, an inferior aspect, and a diameter, and configured to secure the distal end of the line within the inferior aspect of the bulb, the head shaft comprises a proximal end connected to the engagement assembly, and a distal end continently connected to the bulb and having a diameter smaller than the diameter of the bulb.

[0027] In accordance with still an added feature, the engager is configured to reversibly engage w ith the flexible tube to maintain a position of the flexible tube within the housing lumen, and is a balloon activated by expansion.

[0028] In accordance with still an additional feature, the inferior aspect of the bulb is disposed in a plane, the line channel is disposed in the plane, and the line passes through the plane.

[0029] In accordance with a concomitant feature, the flexible tube has a length, and the inserter wire is substantially of equal length or longer than the length of the flexible tube.

[0030] In accordance with a concomitant feature, the inserter wire is made of at least one of stainless steel, metal, plastic, and combinations thereof, and the inserter wire has a cross-section that is one of, circular, rectangular, and ovoid.

[0031] In accordance with a concomitant feature, the housing has an outer circumference, the rectangular or ovoid inserter wire has a flatter aspect that is placed radially to the center of the lumen of the housing, and the inserter wire is disposed adjacent the circumference of the housing.

[0032] In accordance with a concomitant feature, the head assembly is made of silicone, soft plastic, and combinations thereof.

[0033] In accordance with a concomitant feature, the head assembly further comprises a flexible distal tip distal to the bulb and of a tapering and increasing flexibility. In accordance with a concomitant feature, wherein the head shaft has a cross-section that is one of circular and oval.

[0034] In accordance with a concomitant feature, there is provided a cage internally lining the lumen of the housing.

[0035] Although the systems, apparatuses, and methods are illustrated and described herein as embodied in a flexible tube insertion device and methods for operation and manufacturing of same, they are, nevertheless, not intended to be limited to the details shown because various modifications and structural changes may be made therein without departing from the spirit of the disclosure and within the scope and range of equivalents of the claims. Additionally, well-known elements of exemplary embodiments will not be described in detail or will be omitted so as not to obscure the relevant details of the systems, apparatuses, and methods.

[0036] Additional advantages and other features characteristic of the systems, apparatuses, and methods will be set forth in the detailed description that follows and may be apparent from the detailed description or may be learned by practice of exemplary embodiments. Still other advantages of the systems, apparatuses, and methods may be realized by any of the instrumentalities, methods, or combinations particularly pointed out in the claims.

[0037] Other features that are considered as characteristic for the systems, apparatuses, and methods are set forth in the appended claims. As required, detailed embodiments of the systems, apparatuses, and methods are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the systems, apparatuses, and methods, which can be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one of ordinary skill in the art to variously employ the systems, apparatuses, and methods in virtually any appropriately detailed structure. Additionally, it is to be understood that the disclosed embodiments can be combined together in any way, in two or three or more intermixed configurations. Further, the terms and phrases used herein are not intended to be limiting; but rather, to provide an understandable description of the systems, apparatuses, and methods. While the specification concludes with claims defining the systems, apparatuses, and methods of the invention that are regarded as novel, it is believed that the systems, apparatuses, and methods will be better understood from a consideration of the following description in conjunction with the drawing figures, in which like reference numerals are carried forward.

[0038] BRIEF DESCRIPTION OF DRAWINGS

[0039] The accompanying figures, where like reference numerals refer to identical or functionally similar elements throughout the separate views, which are not true to scale, and which, together with the detailed description below, are incorporated in and form part of the specification, serve to illustrate further various embodiments and to explain various principles and advantages all in accordance with the systems, apparatuses, and methods. Advantages of embodiments of the systems, apparatuses, and methods will be apparent from the following detailed description of the exemplary embodiments thereof, which description should be considered in conjunction with the accompanying drawing in which:

[0040] FIG. la is a fragmentary, enlarged, left side perspective view of an exemplary embodiment of a distal end of a medical tube insertion device;

[0041] FIG. lb is an enlarged, partially radially cross-sectional, perspective view of an exemplary' embodiment of ahead assembly of the medical tube insertion device of FIG. la along section line I-I in FIG. la with a circular head shaft;

[0042] FIG. 1c is a fragmentary, enlarged, longitudinally cross-sectional view of an exemplary embodiment of the distal end of the medical tube insertion device of FIG. la with an engagement assembly having an engager in an inactive state and ahead assembly connected on a distal end of an engagement assembly;

[0043] FIG. Id is an enlarged, radially cross-sectional view of an exemplary embodiment of a head assembly of the medical tube insertion device of FIGS, la and 1c along section line II-II in FIG. 1c and with a line anchor;

[0044] FIG. le is a fragmentary’, enlarged, longitudinally cross-sectional view of an exemplary embodiment of a distal end of the medical tube insertion device of FIG. la with an engagement assembly7having an engager in an active state and a head assembly connected on a distal end of an engagement assembly;

[0045] FIG. 2a is an enlarged, partially radially cross-sectional and perspective view of an exemplary embodiment of a head assembly of the medical tube insertion device of FIG. la along section line I-I in FIG. la with a line knot and a circular head shaft;

[0046] FIG. 2b is an enlarged, partially radially cross-sectional and perspective view of an exemplary embodiment of a head assembly of the medical tube insertion device of FIG. la along section line I-I in FIG. la with a line knot and an oval head shaft;

[0047] FIG. 2c is an enlarged, radially cross-sectional view of an exemplary embodiment of a bulb of ahead assembly of the medical tube insertion device of FIGS, la, 1c, and le along section line II-II in FIG. 1c with a bulb channel and a line coursing through the bulb channel;

[0048] FIG. 3a is a fragmentary’, enlarged, longitudinally cross-sectional view of an exemplary- embodiment of an engagement assembly of the medical tube insertion device of FIGS, la, 1c, and le with an engager in an active state and a medical tube docked and held in the lumen of the engagement assembly by the engager in the active state; FIG. 3b is a fragmentary, enlarged, longitudinally cross-sectional view of an exemplary embodiment of an engagement assembly of the medical tube insertion device of FIGS, la, 1c, le, and 3a illustrating an exemplary embodiment of an engager in an active state with an engager connector, a connector hold, and a distal end of an engagement line, with a fragment of a medical tube;

[0049] FIG. 4a is an enlarged, cross-sectional view of an exemplary embodiment of an engagement assembly of the medical tube insertion device of FIGS, la, 1c, and le along section line III-III in FIG. le, wherein an engager is in an active state.

[0050] FIG. 4b is a fragmentary, partially radially cross-sectional and perspective view of an exemplary embodiment of an inserter assembly of the medical tube insertion device of FIG. la, 1c, and le along section line IV-IV in FIG. 1c with an engagement line;

[0051] FIG. 5a is a fragmentary, enlarged, sectional view of an exemplary embodiment of a medical tube insertion device with bars of a cage within the lumen of an engagement assembly with an engager in an inactive state;

[0052] FIG. 5b is an enlarged, radially cross-sectional view of an exemplary embodiment of an engagement assembly of the medical tube insertion device of FIG. 5a along section line V-V in FIG. 5a with a cage within the lumen of an engagement assembly with an engager in an inactive state;

[0053] FIG. 5c is an enlarged, radially cross-sectional view of an exemplary embodiment of an engagement assembly of the medical tube insertion device of FIG. 5a along section line V-V in FIG. 5a with a cage within the lumen of an engagement assembly with an engager in an active state illustrating a formed apex of an interior wall of the engager;

[0054] FIG. 6 is a fragmentary, top plan and partially hidden view of an exemplary embodiment of the medical tube insertion device of FIGS, la, 1c, and le with a head assembly, an engagement assembly, an inserter assembly, and a handle assembly;

[0055] FIG. 7 is a fragmentary', perspective view of an exemplary embodiment of a distal end of the medical tube insertion device of FIGS, la, 1c, and le illustrating a range of motion and alternate positions of a head assembly of the medical tube insertion device when the device is in operation;

[0056] FIG. 8 is a flow chart of an exemplary' method of operation of the insertion device of FIGS, la, 1c, le, 6, and 7;

[0057] FIG. 9 is a fragmentary, enlarged, longitudinally cross-sectional view of an exemplary embodiment of a distal end of a medical tube insertion device with a medical tube docked and held in a lumen of an engagement assembly by an engager in an active state, with a distal end of the engagement assembly in a closed state; FIG. 10 is a fragmentary, enlarged, longitudinally cross-sectional view of an exemplary embodiment of a distal end of a medical tube insertion device with a medical tube docked and held in a lumen of an engagement assembly by an engager in an active state, where the distal end of the engagement assembly is open;

[0058] FIG. 11 is a fragmentary, partially, cross-sectional view of human larynx and esophagus:

[0059] FIG. 12 is a fragmentary, enlarged cross-sectional view of an exemplary embodiment of a medical tube insertion device entering the oropharynx;

[0060] FIG. 13 is a fragmentary7, enlarged cross-sectional photographic view of an exemplary7embodiment of a medical tube insertion device contacting the posterior pharyngeal wall of the oropharynx;

[0061] FIG. 14 is a fragmentary7, enlarged, and partially hidden, superior plan view of an exemplary7embodiment of a distal end of a medical tube insertion device;

[0062] FIG. 15 is a fragmentary, enlarged, and partially hidden, side elevational view of the medical tube insertion device of FIG. 14;

[0063] FIG. 16 is an enlarged and partially hidden perspective view of a proximal end of the medical tube insertion device of FIG. 14;

[0064] FIG. 17 is a fragmentary, enlarged, and partially hidden, perspective view of the medical tube insertion device of FIG. 14;

[0065] FIG. 18 is a fragmentary, enlarged, and partially hidden, side elevational view of the medical tube insertion device of FIG. 14 with an engager in a disengaged state;

[0066] FIG. 19 is a fragmentary7, enlarged, and partially hidden, side elevational view of the medical tube insertion device of FIG. 14 with an engager in an engaged state;

[0067] FIG. 20 is a fragmentary, enlarged, and partially hidden, superior plan view of the medical tube insertion device of FIG. 14;

[0068] FIG. 21 is a fragmentary7, enlarged, and partially hidden, vertical cross-sectional view of the medical tube insertion device of FIG. 20 along section line A- A;

[0069] FIG. 22 is a fragmentary7, enlarged, and partially hidden, superior plan view of an exemplary embodiment of a distal end of a medical tube insertion device;

[0070] FIG. 23 is a fragmentary, enlarged, and partially hidden, side elevational view of the medical tube insertion device of FIG. 22;

[0071] FIG. 24 is an enlarged and partially hidden perspective view of a proximal end of the medical tube insertion device of FIG. 22;

[0072] FIG. 25 is a fragmentary7, enlarged, and partially hidden, perspective view of the medical tube insertion device of FIG. 22; FIG. 26 is a fragmentary, enlarged, and partially hidden, side elevational view of the medical tube insertion device of FIG. 22 with an engager in a disengaged state;

[0073] FIG. 27 is a fragmentary, enlarged, and partially hidden, side elevational view of the medical tube insertion device of FIG. 22 with an engager in a rolled back state;

[0074] FIG. 28 is a fragmentary, enlarged, and partially hidden, superior plan view of the medical tube insertion device of FIG. 22;

[0075] FIG. 29 is a fragmentary', enlarged, and partially hidden, vertical cross-sectional view of the medical tube insertion device of FIG. 28 along section line A- A;

[0076] FIG. 30 is a fragmentary’, enlarged, and partially hidden, superior plan view of an exemplary embodiment of a distal end of a medical tube insertion device;

[0077] FIG. 31 is a fragmentary, enlarged, and partially hidden, side elevational view of the medical tube insertion device of FIG. 30;

[0078] FIG. 33 is an enlarged and partially hidden perspective view of a proximal end of the medical tube insertion device of FIG. 30;

[0079] FIG. 33 is a fragmentary, enlarged, and partially hidden, perspective view of the medical tube insertion device of FIG. 30;

[0080] FIG. 34 is a fragmentary, enlarged, and partially hidden, side elevational view of the medical tube insertion device of FIG. 30 with an engager in a disengaged state;

[0081] FIG. 35 is a fragmentary, enlarged, and partially hidden, side elevational view of the medical tube insertion device of FIG. 30 with an engager in a rolled back state;

[0082] FIG. 36 is a fragmentary7, enlarged, and partially hidden, superior plan view of the medical tube insertion device of FIG. 30;

[0083] FIG. 37 is a fragmentary, enlarged, and partially hidden, vertical cross-sectional view of the medical tube insertion device of FIG. 36 along section line A- A;

[0084] FIG. 38 is a fragmentary7, enlarged, and partially hidden, superior plan view of an exemplary embodiment of a distal end of a medical tube insertion device;

[0085] FIG. 39 is a fragmentary, enlarged, and partially hidden, side elevational view of the medical tube insertion device of FIG. 38;

[0086] FIG. 40 is an enlarged and partially hidden perspective view of a proximal end of the medical tube insertion device of FIG. 38;

[0087] FIG. 41 is a fragmentary, enlarged, and partially hidden, perspective view of the medical tube insertion device of FIG. 38;

[0088] FIG. 42 is a fragmentary, enlarged, and partially hidden, side elevational view of the medical tube insertion device of FIG. 38 with an engager in a disengaged state; FIG. 43 is a fragmentary, enlarged, and partially hidden, side elevational view of the medical tube insertion device of FIG. 38 with an engager in a rolled back state;

[0089] FIG. 44 is a fragmentary, enlarged, and partially hidden, superior plan view of the medical tube insertion device of FIG. 38;

[0090] FIG. 45 is a fragmentary, enlarged, and partially hidden, vertical cross-sectional view of the medical tube insertion device of FIG. 44 along section line A- A;

[0091] FIG. 46 is a fragmentary, enlarged, and partially hidden, superior plan view of an exemplary7embodiment of a distal end of a medical tube insertion device;

[0092] FIG. 47 is a fragmentary, enlarged, and partially hidden, side elevational view of the medical tube insertion device of FIG. 46;

[0093] FIG. 48 is an enlarged and partially hidden perspective view of a proximal end of the medical tube insertion device of FIG. 46;

[0094] FIG. 49 is a fragmentary, enlarged, and partially hidden, perspective view of the medical tube insertion device of FIG. 46;

[0095] FIG. 50 is a fragmentary, enlarged, and partially hidden, side elevational view of the medical tube insertion device of FIG. 46 with an engager in a disengaged state;

[0096] FIG. 51 is a fragmentary, enlarged, and partially hidden, side elevational view of the medical tube insertion device of FIG. 46 with an engager in a rolled back state;

[0097] FIG. 52 is a fragmentary, enlarged, and partially hidden, perspective view of the medical tube insertion device of FIG. 46;

[0098] FIG. 53 is a fragmentary7, enlarged, and partially hidden, superior plan view of the medical tube insertion device of FIG. 46;

[0099] FIG. 54 is a fragmentary, enlarged, and partially hidden, vertical cross-sectional view of the medical tube insertion device of FIG. 53 along section line A- A;

[0100] FIG. 55 is a fragmentary7, enlarged, and partially hidden, superior plan view of an exemplary embodiment of a distal end of a medical tube insertion device;

[0101] FIG. 56 is a fragmentary, enlarged, and partially hidden, side elevational view of the medical tube insertion device of FIG. 55;

[0102] FIG. 57 is an enlarged and partially hidden perspective view of a proximal end of the medical tube insertion device of FIG. 55;

[0103] FIG. 58 is a fragmentary, enlarged, and partially hidden, perspective view of the medical tube insertion device of FIG. 55;

[0104] FIG. 59 is a fragmentary, enlarged, and partially hidden, side elevational view of the medical tube insertion device of FIG. 55 with an engager in a disengaged state; FIG. 60 is a fragmentary, enlarged, and partially hidden, side elevational view of the medical tube insertion device of FIG. 55 with an engager in a rolled back state;

[0105] FIG. 61 is a fragmentary, enlarged, and partially hidden, superior plan view of the medical tube insertion device of FIG. 55; and

[0106] FIG. 62 is a fragmentary, enlarged, and partially hidden, vertical cross-sectional view of the medical tube insertion device of FIG. 61 along section line A- A.

[0107] BEST MODE FOR CARRYING OUT THE INVENTION

[0108] As required, detailed embodiments of the systems, apparatuses, and methods are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the systems, apparatuses, and methods, which can be embodied in vanous forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the systems, apparatuses, and methods in virtually any appropriately detailed structure. Further, the terms and phrases used herein are not intended to be limiting; but rather, to provide an understandable description of the systems, apparatuses, and methods. While the specification concludes with claims defining the features of the systems, apparatuses, and methods that are regarded as novel, it is believed that the systems, apparatuses, and methods will be better understood from a consideration of the following description in conjunction with the drawing figures, in which like reference numerals are carried forward.

[0109] In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which are shown by w ay of illustration embodiments that may be practiced. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope. Therefore, the following detailed description is not to be taken in a limiting sense, and the scope of embodiments is defined by the appended claims and their equivalents.

[0110] Alternate embodiments may be devised without departing from the spirit or the scope of the invention. Additionally, well-known elements of exemplar)’ embodiments of the systems, apparatuses, and methods will not be described in detail or will be omitted so as not to obscure the relevant details of the systems, apparatuses, and methods.

[0111] Before the systems, apparatuses, and methods are disclosed and described, it is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. The terms ‘'comprises / ’ “comprising,” or any other variation thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by ‘"comprises ... a” does not, without more constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element. The terms “including” and / or “having,” as used herein, are defined as comprising (i.e., open language). The terms “a” or “an”, as used herein, are defined as one or more than one. The term “plurality,” as used herein, is defined as two or more than two. The term “another,” as used herein, is defined as at least a second or more. The description may use the terms “embodiment” or “embodiments,” which may each refer to one or more of the same or different embodiments.

[0112] The terms “coupled” and “connected,” along with their derivatives, may be used. It should be understood that these terms are not intended as synonyms for each other. Rather, in particular embodiments, “connected” may be used to indicate that two or more elements are in direct physical or electrical contact with each other. “Coupled” may mean that two or more elements are in direct physical or electrical contact (e.g., directly coupled). However, “coupled” may also mean that two or more elements are not in direct contact with each other, but yet still cooperate or interact with each other (e.g., indirectly coupled).

[0113] For the purposes of the description, a phrase in the form “A / B” or in the form “A and / or B” or in the form “at least one of A and B” means (A), (B), or (A and B), where A and B are variables indicating a particular object or attribute. When used, this phrase is intended to and is hereby defined as a choice of A or B or both A and B, which is similar to the phrase “and / or”. Where more than two variables are present in such a phrase, this phrase is hereby defined as including only one of the variables, any one of the variables, any combination of any of the variables, and all of the variables, for example, a phrase in the form “at least one of A, B, and C” means (A). (B), (C), (A and B), (A and C), (B and C). or (A, B and C).

[0114] Relational terms such as first and second, top and bottom, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. The description may use perspective-based descriptions such as up / down. back / front, top / bottom, and proximal / distal. Such descriptions are merely used to facilitate the discussion and are not intended to restrict the application of disclosed embodiments. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding embodiments; however, the order of description should not be construed to imply that these operations are order dependent.

[0115] As used herein, the term “about” or “approximately” applies to all numeric values, whether or not explicitly indicated. These terms generally refer to a range of numbers that one of skill in the art would consider equivalent to the recited values (i.e., having the same function or result). In many instances these terms may include numbers that are rounded to the nearest significant figure. As used herein, the terms “substantial” and “substantially” means, when comparing various parts to one another, that the parts being compared are equal to or are so close enough in dimension that one skill in the art would consider them as being the same. Substantial and substantially, as used herein, are not limited to a single dimension and specifically include a range of values for those parts being compared. The range of values, both above and below (e.g., “+ / -” or greater / lesser or larger / smaller), includes a variance that one skilled in the art would know to be a reasonable tolerance for the parts mentioned.

[0116] Herein various embodiments of the systems, apparatuses, and methods are described. In many of the different embodiments, features are similar. Therefore, to avoid redundancy, repetitive description of these similar features may not be made in some circumstances. It shall be understood, however, that description of a first-appearing feature applies to the later described similar feature and each respective description, therefore, is to be incorporated therein without such repetition.

[0117] Described now are exemplary embodiments. Referring now to the figures of the drawings in detail and first, particularly to FIG. la, there is show n a first exemplar}' embodiment of a distal end of a medical tube insertion device 50 to assist the insertion of medical tubes in anatomic lumens, for example, to assist the insertion of a nasogastric tube into the esophagus and advancing the nasogastric tube into the stomach.

[0118] The exemplar}' embodiments of the disclosure are intended to be used and / or coupled to flexible medical tubes needing insertion into an anatomic lumen. Various embodiments illustrate and describe the use of insertion device 50, 60, 70 coupled with a medical tube, or additionally also in tandem with an endoscopic instrument having optical capability, such as an endoscope, a bronchoscope, a laryngoscope, or another medical visualization device. Some examples of medical tubes that could be coupled with the insertion device 50, 60, 70 include, but are not limited to, nasogastric tubes, feeding tubes such as Dobhoff tubes, endotracheal tubes, and tubes for the treatment of variceal bleeding such Sengstaken-Blakemore tubes, Minnesota Tubes. Linton- Nachlas tubes. In addition to the use of the insertion device 50, 60, 70 for the placement of tubes in the anatomic lumens of human subjects, the various embodiments of the insertion device 50, 60, 70 can also be used in veterinary settings to insert medical tubes in animals, with or without coupling to either human medical examination instruments or dedicated veterinary-specific examination instruments. It should be apparent to others with ordinary skill in the art that the discussion and the drawing figures included are by way of example only, and that the device may be utilized with other instruments in other hollow' anatomic structures within a human subject and elsewhere. Furthermore, it should be apparent to others with ordinary skill in the art that the device may be utilized with other flexible instruments in other lumens or conduits, such as inserting flexible members within piping such as fluid-carrying pipes, such as water or sewage plumbing or natural or propane gas.

[0119] In discussing the insertion device 50, 60, 70, the terms proximal and distal are used with respect to the operator. For instance, when the insertion device 50, 60, 70 is coupled to a medical tube, the proximal and distal end of the insertion device 50, 60, 70 also are with respect to the position of the operator. When referring to a location within the gastrointestinal tract, the terms proximal and distal are used with respect to the anatomic relationship of that segment of bowel relative to the mouth. For instance, when the insertion device 50, 60, 70 is in use within the esophagus, proximal and distal to the device is relative to the location of the mouth and applies along the entire length of gastrointestinal tract from mouth to anus.

[0120] FIG. la illustrates a view of a distal end of the insertion device 50 constructed in accordance with an embodiment for use coupled to a medical tube such as a Sengstaken- Blakemore tube and for insertion into an esophagus. The exemplary embodiment of the distal end of the insertion device 50 of FIG. la includes a head assembly 100 comprising a distal tip 102, a flexible tip shaft 104, a bulb 120, and ahead shaft 150. The head assembly 100 includes a proximal end 109 and, proximally thereof, an engagement assembly 200. The proximal end 109 of the head assembly 100 is connected to the engagement assembly 200. The connection between the head assembly 100 and the engagement assembly 200 is achieved, for example, by injection molding but can also be achieved by male-female barbed fitting, with a press-fit, with screw threads, or with an adhesive or other chemical or heat bonding, to name a few. The connection between the head assembly 100 and the engagement assembly 200 is described in greater detail in the subsequent sectional view of FIG. 1c.

[0121] In an exemplary embodiment, the head assembly 100 is constructed with flexible medical silicone or, alternatively, with flexible plastic and can be molded in a single piece. In an exemplary embodiment, the head assembly 100 is constructed with one of or a combination of flexible biocompatible material such as silicone, thermoplastic polyurethane, medical PVC, polycarbonate-urethane, fluoropolymers, and / or hydrogels, and / or contain radiopaque marker bands such as with barium or tungsten. In an exemplary embodiment, the flexible distal tip 102 of the head assembly 100 is circular in lateral cross-section and is the smallest diameter of the head assembly 100. In an exemplary embodiment, the flexible distal tip 102 is ovoid, square, rectangular in lateral cross-section, or otherwise assumes another polygonal shape. In an exemplary embodiment, the distal tip 102 is tapered until its most distal end is a flat flexible lame, with a rounded distal end when seen in plan view to avoid sharp angles capable of damaging tissue as the distal tip 102 advances through anatomic lumens. The flexible distal tip 102 of the head assembly 100 is the distal-most portion of the flexible tip shaft 104. The flexible tip shaft 104 is tapered with an increasing diameter in a proximal direction away from the distal tip 102 as it forms into the bulb 120. In an exemplary embodiment, the length of the flexible tip shaft 104 is variable depending on the use of the insertion device 50, 60, 70 and can vary from approximately 0. 1 cm to approximately 5 cm. For example, a length of the flexible tip shaft 104 may be longer for an embodiment of the insertion device 50 for use in the esophagus compared to an embodiment of the insertion device 50 for use in an airway, to accommodate for the variation in anatomy and the variation in the anatomy of the inlet of each organ. In an exemplary' embodiment, the flexible tip shaft 104 is circular in lateral cross-section but can also be other shapes such as ovular, square, rectangular, or other polygonal shape in lateral cross-section and is tapered in diameter so that the flexible tip shaft 104 decreases in diameter as it progresses distally from the bulb 120 to the flexible distal tip 102 of the head assembly 100. Therefore, in an exemplary' embodiment with a flexible tip shaft 104 that is circular in lateral cross section, the flexible tip shaft 104 assumes a conical shape as it progresses proximally from the flexible distal tip 102. In an exemplary’ embodiment, the flexible tip shaft 104 is tapered by forming a flat surface on the inferior surface of the flexible tip shaft 104 when observed from the side elevational view, which, in lateral cross-section, the flexible tip shaft 104 would form a semi-circle. An oval or semi-circle lateral cross-section of the flexible tip shaft 104 assists in limiting flexibility and direction of the flexible tip shaft 104 to a single plane rather than in two planes as would occur with a square or rectangular cross-section, or infinite planes as would occur with a circular cross-section. A flat inferior surface tapering of the flexible tip shaft 104 that in lateral cross-section appears as a semi-circle enhances contact with the posterior oropharynx and hypopharynx when the device 50, 60, 70 is inserted, and facilitates sliding of the device into the esophageal inlet. In an exemplary embodiment, the flexibility of the flexible tip shaft 104 is progressively tapered so that the distal end is more flexible than the proximal end 109. In an alternative exemplary' embodiment, the flexibility7of the flexible tip shaft 104 has the same flexibility' as the proximal end 109. In an exemplary embodiment, the flexibility' of the flexible tip shaft 104 has approximately the consistency of a gummy bear at room temperature, and / or with surface friction approximating that of a wet gummy bear.

[0122] The flexible tip shaft 104 forms a curve 106 of the head assembly 100 when viewed from the side elevation, so that the flexible distal tip 102 is directed upwards and away from a longitudinal axis of the head assembly 100. In some exemplary embodiments, the angle of the curve 106 can vary from approximately 1 degree to 80 degrees away from the longitudinal axis 108 of the head assembly 100. In an exemplary embodiment, there is no curve 106. The curve 106 is included to favor a direction of entry' during insertion depending on a positioning of a target anatomic lumen. Thus, the approximate radius of the curve can vary depending on that target. In an exemplary embodiment, the material of the flexible tip shaft 104 and / or bulb 120 can be malleable to permit the user to manually adjust the shape of the head assembly 100 and / or the curve 106, for example, in the manner of clay or putty7sold under the trademark SILLY PUTTY®. In an exemplary embodiment, the flexible tip shaft 104 is comprised of components of Nitinol® that are thermally configured to change the radius of the curve 106 of the flexible tip shaft 104 upon contact of the head assembly 100 with the oropharynx at body temperature. For example, in an exemplary embodiment, the flexible tip shaft 104 comprises one or more of linear and / or longitudinally placed rods of Nitinol® that, at room temperature, are configured to maintain the curve 106 of the flexible tip shaft 104 but, at body temperature, are configured to straighten and eliminate the curve 106 or invert the direction of the curve 106 along its plane. This temperature- controlled configuration change assists the entry of the flexible tip shaft 104 into the target organ and, therefore, guiding the remainder of the device.

[0123] In an exemplary' embodiment, the bulb 120 of the head assembly 100 has a larger diameter than the distally located flexible tip shaft 104, and a head shaft 150 is proximal to the bulb 120. In an exemplary' embodiment, the bulb 120 is circular in a cross-section that is orthogonal to the longitudinal axis 108. In an exemplary' embodiment, the bulb 120 is oval, square, or otherwise of other polygonal shape in a cross-section that is orthogonal to the longitudinal axis 108. In an exemplary embodiment, the bulb 120 has, at a proximal side thereof, a foramen 122 of the bulb 120 allowing a line 500 to access internal structures of the bulb 120. The bulb 120 serves multiple purposes. In an exemplary7embodiment, there is no line 500 nor foramen 122. In an exemplary embodiment, the bulb 120 contributes to the tapering effect of the flexible tip shaft 104, as described above. In an exemplary embodiment, the bulb 120 has an inferior wall 128 that serv es to retain internal structures (described in subsequent figures) that connect to the line 500. In an exemplary embodiment, the inferior wall 128 of the bulb 120 also serves to favor a direction of transit of the head assembly 100 as the insertion device 50 is inserted into an anatomic lumen. For example, during passage of the insertion device 50 (of FIG. la) past the posterior phary nx by gliding on the posterior wall of the pharynx and into the esophagus (see, e.g., FIG. 12), the flexible distal tip 102 of the head assembly 100 firsts enter the esophagus, and the tapering diameter of the flexible tip shaft 104 and the bulb 120 assist to open the esophageal lumen and push away the opening of the airway located anterior to the esophagus (see, e.g., FIG. 13). In an exemplary7embodiment, the diameter of the bulb 120 is configured such that a diameter between a superior wall 121 of the bulb 120 and the inferior wall 128 of the bulb 120 approaches the diameter of the engagement assembly 200. Furthermore, in an exemplary embodiment, compared to the bulb 120, the head shaft 150 has a smaller, and tapering lateral cross-sectional diameter with the smallest diameter at the center of the longitudinal length of the head shaft 150, such that a diameter between a superior wall 151 of the head shaft 150 and an inferior wall 158 of the head shaft 150 is less than the diameter of the bulb 120, favoring flexion of the head shaft 150 at the point of smallest diameter in an exemplary embodiment, the heretofore described dimensions allow space for the line 500 to travel inferiorly to the device 50 and allow the head assembly 100 to reversibly flex at the head shaft 150. In an exemplary embodiment, the direction of flexion of the head shaft 150. and consequently the direction of movement of the flexible tip shaft 104 distal to it, is biased to favor one plane, achieved by an oval shape, or other uneven polygonal shape of the head shaft 150. In an exemplary embodiment, the head shaft 150 serves to reversibly flex in a biased direction in one plane (i.e., such as favoring up and down movement), and does not comprise a line 500. As used herein, the term reversibly flex describes an ability of the head shaft 150 to bend by a stretching or a laterally applied force and then to return to the original configuration thereof when that force is released. These details are described in further detail below.

[0124] The head shaft 150 courses confluently from the proximal end 109 of the head assembly 100 to the bulb 120. In an exemplary embodiment, the diameter of a distal end of the head shaft 150 near the bulb 120 approximates the diameter of the bulb 120 and the diameter of a proximal end of the head shaft 150 forming the proximal end 109 of the head assembly 100 approximates the diameter of the engagement assembly 200. The diameter of the engagement assembly 200 is, therefore, larger than the diameter of the Blakemore tube or other medical tube coupled to and transported within the engagement assembly 200. In an exemplary configuration, the diameter of the engagement assembly 200 is between approximately 0. 1 mm and approximately 3 mm larger than the diameter of the Blakemore tube or other medical tube as defined above to be coupled to the engagement assembly 200. In an exemplary’ configuration developed to transport a 6.7 mm (20F) Blakemore tube, for example, the diameter of the engagement assembly 200 is between approximately 6.75 mm and approximately 15 mm, more particularly, between approximately 6.8 mm and approximately 10 mm, in particular, between approximately 6.8 mm and approximately 8 mm.] In an exemplary configuration therefore, the diameter of the engagement assembly 200 is between approximately 2 mm and approximately 15 mm, depending on the diameter of the medical tube to be coupled thereto. In an exemplary embodiment, the diameter of the bulb 120 is less than the diameter of the head shaft 150. In an exemplary embodiment, the center of the head shaft 150 between the bulb 120 and the proximal end 109 of the head assembly 100 has a smaller diameter than the diameter of the bulb 120 and a smaller diameter than the diameter of the engagement assembly 200. In an exemplary' embodiment, a lateral cross-sectional shape of the head shaft 150 is circular. In an exemplary embodiment, the lateral cross-sectional shape of the head shaft 150 is oval or elliptical or other polygonal shape with a minor and major axis to favor bending of the head shaft 150 inferiorly in a linear direction of a minor axis of the oval shape. In an exemplary' embodiment, the flexible tip shaft 104, the bulb 120, and the head shaft 150 have the same cross- sectional polygonal shape with a minor and major axis to favor flexion on one plane along the minor axis. The oval shape of an exemplary embodiment of the head shaft 150 is further illustrated in FIG. 2b. In an exemplary embodiment, the head shaft 150 is comprised of corrugations 152 that bias flexion of the head shaft 150 in a particular direction and / or plane. See. for example, FIGS. 14 to 62. In an exemplary embodiment, the corrugations 152 or spring 162 are pronounced along the inferior wall 158 of the head shaft 150 (ipsilateral to the flat inferior surface tapering of the flexible tip shaft 104), while in another exemplary embodiment the corrugations 152 are pronounced along the superior wall 151 of the head shaft 150 (contralateral to the flat inferior surface tapering of the flexible tip shaft 104). In an exemplary embodiment, the head shaft 150 is comprised of a biasing element with spring mechanism that urges the head shaft 150 to return to a default position along the longitudinal axis thereof. Suitable biasing elements include, without limitation, metallic coil springs, corrugated plastic, rubber, or metal springs, planar springs, torsional springs, elastomeric components (e.g., O-rings, pads), flexural members formed in the head shaft 150, Belleville washers, or pneumatic or magnetic spring mechanisms providing an equivalent elastic response. See, for example, FIGS. 14 to 62. In an exemplary embodiment, an overall length of the head assembly 100 is between approximately 1 cm and approximately 10 cm, and this length can vary to accommodate for a target anatomic lumen and to which medical tube is coupled to the insertion device 50 for transport. For example, the length of the head assembly 100 is longer for an insertion device 50 used for intubation of the esophagus as compared to the length of the head assembly 100 for an insertion device 50 used for airway intubation.

[0125] Referring again to FIG. la, the proximal end 109 of the head assembly 100 is connected to the engagement assembly 200 and an exemplary embodiment of this connection is shown in FIG. 1c. FIG. la also illustrates an exterior wall of a housing 210 of the engagement assembly 200. In an exemplary embodiment, the housing 210 is made of plastic. In some exemplary embodiments, the housing 210 is made of metal, which can add weight to the engagement assembly 200, or is made of silicone. In an exemplary embodiment the housing 210 is made of hard plastic, wood, or metal, and is coated in silicone, latex, or another soft biocompatible polymer on the exterior surface that is to be in contact with an anatomic lumen. In an exemplary embodiment, the housing assembly 100 and the engagement assembly 200 are made of the same material and made in a single piece. Also seen in FIG. la is a fragmentary view of an exemplary- embodiment of a distal portion of an inserter assembly 300 connected to a proximal side 209 of the engagement assembly 200 (details of the connection thereof are disclosed in FIGS. 1c, 3a, 4a, 4b, 5a to 5c, and further in FIGS. 9, 10, 15 to 21, 29, 37, 45, 54, and 62). In an exemplary- embodiment, the line 500 courses through the engagement assembly 200 through an internal channel 263, 264 disclosed in FIGS. 1c and 3a). The line 500 is made of any flexible thin material that allows it to freely flow within the engagement assembly 200, an anatomic lumen, and throughout the insertion device 50 in general. In exemplary embodiments, the line 500 is made of polypropylene, nylon, PVC, polyurethane, and / or polyethylene, among others, or made of a metal or another low-friction material and / or biologically inert synthetic polymer.

[0126] In an exemplary embodiment, the head assembly 100 has metallic or plastic portions within the silicone or other polymeric structure thereof for the purpose of added weight, strength, structure, and / or magnetism. In an exemplar}' embodiment, the bulb 120 is internally made of metal, which may or may not be magnetic. For example, iron is used in an exemplary embodiment due to the high density and magnetic properties thereof. Other metals used in exemplary embodiments that fulfill at least one of these qualities are for example, platinum, silver, tungsten, and gold, among others. Similarly, in an exemplary' embodiment, the head shaft 150, the bulb 120, and / or portions of the flexible tip shaft 104 contain elements of metal, in particular, radio-opaque metals. The length of the head shaft 150. the bulb 120. and / or portions of the flexible tip shaft 104 can vary by up to several centimeters. In addition to functional advantages, the variation in length can also be used to accommodate for added metallic or plastic product within the silicone head assembly 100. In an exemplary embodiment, the flexible tip shaft 104 is made of soft material such as silicone, latex, or another material(s) comprising the head assembly 100 as described above (with one of or a combination of flexible biocompatible material such as silicone, latex, thermoplastic polyurethane, medical PVC, polycarbonate-urethane, fluoropolymers, and / or hydrogels), that internally contains a skeleton of harder material such as plastic or metal to assist in modulation of the strength and / or flexibility characteristics of the flexible tip shaft 104. In an exemplary method of insertion, the added weight and magnetism can be used to direct the head assembly in a particular direction during insertion of the insertion device 50. For example, during passage of the hypopharynx in a supine patient, added weight and magnetism of iron within the bulb 120 could be coupled to a magnet behind the neck of a patient, directing the head assembly 100 posteriorly with two forces: weight and magnetism; therefore, favoring esophageal intubation rather than airway entry.

[0127] FIG. lb illustrates a partially cross-sectional and perspective view of an exemplary embodiment of a distal end of the head assembly 100 along section line I-I of FIG. la. Seen in FIG. lb is the circular cross-section of an exemplary’ embodiment of the head shaft 150. In an exemplary embodiment, the head shaft 150 is solid, for example, made of solid silicone. In an exemplary embodiment, the head shaft 150 is made of the same material as the remainder of the head assembly 100 as described above (with one of or a combination of flexible biocompatible material such as silicone, latex, thermoplastic polyurethane, medical PVC, polycarbonate- urethane, fluoropolymers, and / or hydrogels). In an exemplary embodiment, the head shaft 150 is solid and made of hard plastic, metal, or wood. In an exemplary embodiment, the head shaft 150 is solid and comprised of multiple components, such as an internal skeleton of hard plastic, wood, or metal, and is coated with silicone or another soft plastic as the remainder of the head assembly 100 as described above. In an exemplary embodiment, the head shaft 150 is not solid (instead, for example, hollow, or spongy) to allow for variations in density that allows more granular modulation of strength, shape, flexibility, and / or firmness. Also depicted is the flexible distal tip 102 of the head assembly 100 rising above the longitudinal axis of the superior wall 151 of the head shaft 150. In some exemplary’ embodiments, the location of the flexible distal tip 102 varies in relation to the longitudinal axis of the superior wall 151 of the head shaft 150 (a function of the angle of the curve 106 of the head assembly 100), as described above. The bulb 120 is shown extending below the longitudinal plane of the inferior wall 158 of the head shaft 150. In this exemplary embodiment, the cross-section of the line 500 is depicted and the distal extent of the line 500 enters the bulb 120 through the foramen 122 (not shown in FIG. lb) of the bulb 120. Other exemplary embodiments of the head assembly 100 are disclosed in FIGS. 2a, 2b, 2c. In an exemplary embodiment there is no line 500 and therefore there is no need for the foramen 122.

[0128] FIG. 1c illustrates a longitudinal cross-sectional view of a distal end of an exemplary' embodiment of the insertion device 50. The line 500 enters the bulb 120 through the foramen 122 of the bulb 120. In an exemplary embodiment, the line 500 attaches at a line bulb attachment site 124 to a line anchor 125 located inside the bulb 120 (also seen in FIG. Id and described in more detail below’. In an exemplar}’ embodiment, the line anchor 125 is a roughly edged piece of metal or plastic of a size that is contained within the borders of the bulb 120. In an exemplary’ embodiment, the line anchor 125 provides a location of fixation of the line 500 within the bulb so that the line 500 and the anchor 125 do not exit or damage the bulb 120 wfien tension is applied to the line 500. Visible in FIG. Id is the interior of the housing 210 of the engagement assembly 200. In an exemplary' embodiment, the housing 210 is cylindrical in shape and partially hollow, forming a lumen 206 of the engagement assembly 200. In an exemplary embodiment, within the housing 210, a line channel 260 courses through the entire length of the housing 210 and allows transit of the line 500 through the housing 210 of the engagement assembly 200 and alloyvs reciprocation within the line channel 260. The diameter of the line channel 260 is slightly larger than the diameter of the line 500 to allow low contact transit of the line 500 therethrough. In an exemplary- embodiment, the housing 210 contains one or more line channels 260 in one or more directions to allow- the line 500 to course through the housing 210 in a selected path. For example, the line 500 is constructed to course adjacent to an inserter wire 310 and the line channel 260 is constructed to course through the housing 210 adjacent to the inserter wire 310 and to bend around a base 207 of the engagement assembly 200.

[0129] In an exemplary embodiment, a distal end 201 of the engagement assembly 200 provides a pedicle 202, which comprises a distal surface of pedicle 202. In an exemplary' embodiment, the pedicle 202 is confluently part of the housing 210 and constructed, e.g.. by a mold or by 3D printing, along with the housing 210. In an exemplary embodiment, the pedicle 202 is attached to the housing 210, for example, by adhesive (e.g., glue) and / or screw entering the housing 210. In an exemplary embodiment, the distal surface 203 of pedicle 202 is corrugated and / or comprises a granular surface to allow better adhesion to the head assembly 100. In an exemplary’ embodiment, the pedicle 202 also provides a pedicle flange 204, which prevents the head assembly 100 from sliding off the pedicle 202 and the engagement assembly 200 once the head assembly 100 is connected to the engagement assembly 200. In an exemplary' embodiment, the head assembly 100 is made of silicone that is molded onto the pedicle 202 of the engagement assembly 200 so that, when the silicone of the head assembly 100 hardens, the head assembly 100 is fastened to the engagement assembly 200.

[0130] In an exemplary embodiment, an engager 250 is provided yvithin the lumen 206 of the engagement assembly 200 or external to the engagement assembly 200. In an exemplary' embodiment, the engager 250 is a resistance producing element within the lumen 206 of the engagement assembly 200, such as a set of barbs, adherent rubber, and / or an expansive foam, gel, or sponge. In an exemplary embodiment, an engager 250 yvithin the lumen 206 such as a sponge or foam can accommodate medical tubes of different sizes within a single sized, larger diameter engagement assembly 200. In an exemplary embodiment, the engager 250 is circumferential and lines the interior side of the housing 210 defining the lumen 206. In some exemplary embodiments, the engager 250 comprises: a roll-on silicone or other polymeric hood (such as with one of or a combination of flexible biocompatible material such as thermoplastic polyurethane, latex, medical PVC, polycarbonate-urethane, fluoropolymers, and / or hydrogels), plastic or metal barbs, and / or a C clamp or zip-tie mechanism fastening clamp. In an exemplary embodiment, the engager 250 is a balloon. In FIG. 1c, the engager 250 is in an inactive or unactuated state. The lumen 206 defines an entry hiatus 205 on the proximal side of the engagement assembly 200. Therefore, the exterior environment is in direct fluid communication yvith the lumen 206 of the engagement assembly 200 through the entry hiatus 205. Subsequently, FIG. 3a will illustrate that a medical tube to be loaded into device 50 passes through the entry hiatus 205 into the lumen 206 and interacts with the engager 250. Details of an exemplary embodiment of the engager 250 are provided subsequently in FIGS. 3a, 3b, and 4a. Still referring to FIG 1c.. the distal end of the inserter assembly 300 illustrates the inserter wire 310 coursing into the housing 210 of the engagement assembly 200 on the superior aspect thereof. In an exemplary embodiment, a distal end 311 of the inserter wire 310 is fixed within the housing 210. In an exemplary' embodiment, the connection between the distal end 311 of the inserter wire 310 and the housing 210 can be configured by positioning the distal end 311 of the inserter wire 310 at the time of molding or manufacturing of the housing 210. In an exemplary embodiment, construction is achieved by perforation of the housing 210 and insertion and fixation of the distal end 311 of the inserter wire 310 into the housing 210. The base 207 of the engagement assembly 200 is provided at the distal end of the lumen 206 and is part of the housing 210. The base 207 forms the distal end of the lumen 206 so that, when the engagement assembly 200 is loaded with a medical tube (Arrow A in FIG. 1c), the medical tube is loaded so that the tip of the medical tube reaches the base 207. In an exemplary' embodiment, to increase strength, the inserter wire 310 courses within the housing 210 and continues to form a right angle and enters parallel to and through the base 207. (See, e.g.. FIGS. 21, 29, 37, 45, 54 62 .) In an exemplary embodiment, the inserter wire 310 continues further through the wall of the housing 210 opposite to where the inserter wire 310 entered, and the inserter wire 310 can also exit the housing 210 parallel to the point of entry of the inserter wire 310 into the housing 210. (See, e.g., FIGS. 14 to 21.)

[0131] FIG. Id illustrates a cross-sectional view along section line II-II of FIG. 1c of an exemplary embodiment of the head assembly 100. In FIG. Id, the line anchor 125 is placed within the bulb 120. In this exemplary embodiment, the bulb 120 is circular in diameter. The line 500 attaches to the line anchor 125. Some other exemplary' embodiments of the bulb 120 are seen in FIGS. 2a, 2b, 2c and are described in further detail below.

[0132] FIG. le illustrates a longitudinal cross-sectional view of the insertion device 50 of FIG. 1c. Here, however, the engager 250 in FIG. le is provided in an active or actuated state. In an exemplary embodiment, the engager 250 is a balloon and, in the active state, expands to occupy space in the lumen 206, hence reducing free space in the lumen 206. In an exemplary' embodiment, the engager 250 expands circumferentially inward. In an exemplary embodiment, when a nonillustrated medical tube is loaded into the lumen 206 of the engagement assembly 200 (Arrow A in FIG. 1c), the engager 250 is activated to circumferentially press inwards against the external walls of the medical tube inserted therein, temporarily fixing the medical tube within the lumen 206 of the engagement assembly 200 until the engager 250 is thereafter deactivated, thereby- releasing the load imparted upon the medical tube within the lumen 206.

[0133] FIGS. 2a, 2b, 2c disclose exemplary variations of the head assembly 100. FIG. 2a illustrates a partially' cross-sectional and perspective view' of an exemplary' embodiment of the head assembly 100 along section line I-I of FIG. la. In an exemplary embodiment, the head shaft 150 is circular and a bulb channel 127 (seen in FIG. 2c) is present and transverses the bulb 120 orthogonally with respect to the longitudinal axis 108 of the head assembly 100. The line 500 courses through the bulb channel 127, therefore, traversing the bulb 120 internally, and exits the bulb 120 on an opposite side thereof, turns around back toward an origin of the line 500 and the line 500 is knotted onto itself forming a line knot 502 and a loop in the line 500. FIG. 2b illustrates a partially cross-sectional and perspective view of an exemplary embodiment of the head assembly 100 along section line I-I of FIG. la w ith the head shaft 150 in an oval shape. An oval shape is configured to favor one-sided flexion of the head shaft 150 and, consequently, flexion of the flexible distal tip 102 downward and upward (vertical motion in this example) along a plane of the minor axis of the oval. At the same time, an oval shape limits side to side (horizontal motion along the major axis in this example) flexion of the flexible distal tip 102 along the plane of the greater diameter of the oval.

[0134] FIG. 2c illustrates a cross-section of an exemplary embodiment of the head assembly 100 along section line II-II of FIG. le. In an exemplary embodiment, the bulb channel 127 courses through the bulb 120 and the line 500 courses through the bulb channel 127.

[0135] FIG. 3a illustrates an enlarged, longitudinally cross-sectional view of an exemplary embodiment of the engagement assembly 200 with an exemplary' medical tube 999 loaded through the entry hiatus 205 of the engagement assembly 200. In an exemplary embodiment, the engagement assembly 200 comprises the distal end 201 thereof, the pedicle 202, the housing 210, the line channel 260, and the engager 250. The pedicle 202 of the engagement assembly7200 forms a part of the housing 210 and is provided with a pedicle flange 204 that extends laterally / radially with respect to the remainder of the pedicle 202. In an exemplary embodiment, the pedicle flange 204 is cylindrical or circular and extends laterally to the pedicle 202 in a circumferential manner. In an exemplary embodiment, the pedicle 202 is cylindrical or circular, but the pedicle 202 can also be of other polygonal shapes such as rectangular, cuboidal, or conical with the tapered tip of the cone facing the distal end 201 of the engagement assembly 200. In an exemplary' embodiment, the distal surface 203 of the pedicle 202 is roughened, e.g., with raised sections or corrugations, similar in configuration to the distal surface 201 of the engagement assembly 200 for better adhesion without slippage. In an exemplary' embodiment, the pedicle 202 extends into the head shaft 150 of the head assembly 100. In an exemplary' embodiment, parts of the engagement assembly 200, for example the pedicle 202. may extend through and beyond the head assembly 100 and into the flexible tip shaft 104. In an exemplary embodiment, the engagement assembly 200 is constructed with one of or a combination of biocompatible material such as plastic, metal, silicone, latex, thermoplastic polyurethane, medical PVC, polycarbonate-urethane, fluoropolymers, and / or hydrogels. In an exemplary embodiment, the head assembly 100 and the engagement assembly 200 are constructed as a single piece.

[0136] Still referring to FIG. 3a, in an exemplary embodiment of the engagement assembly 200, the housing 210 is cylindrical and partially hollow. Within the cylindrical housing 210, there is provided the circumferential engager 250 in an active (inflated or expanded) state, creating a lumen 256 of the engager 250. In an exemplary embodiment, the engager 250 is a balloon. The exterior wall 251 of the engager 250 abuts the internal side of the hollow cylindrical housing 210. In an exemplary7embodiment, the exterior wall 251 of the engager 250 is adhered to or fixed to the internal side of the housing 210, for example, by using glue or adhesive or bonding or welding. In an exemplary embodiment, the exterior wall 251 of the engager 250 is linked at separate fixation points to the internal side of the housing 210 to allow mobility on expansion of the lumen 256. In an exemplary embodiment, the lumen 256 is expanded by a force created by injection of a fluid into the lumen 256 of the engager 250, either in the form of a gas, such as air, or a liquid, such as saline. Accordingly, when fluid is referred to herein, this includes both gases and liquids. In an exemplary embodiment, the fluid can be delivered to the engager 250 through an engagement line 600. In an exemplary embodiment, the engagement line 600 is made of a hollow tube, e.g., of plastic or another poly mer, having a minimal diameter needed to deliver the inflation fluid and achieve pressure within the lumen 256 of the engager 250 sufficient to removably fix a distal end of the medical tube 999 therein.

[0137] The external diameter of the housing 210 governs an internal diameter of the lumen 206 of the engagement assembly 200 and, therefore, determines the size of the medical tube 999 that can be placed inside of the lumen 206. Therefore, different exemplary embodiments of the engagement assembly 200 and housing 210 are made of different sizes to accommodate different medical tubes 999 of varying sizes. In an exemplary embodiment, the diameter of the lumen 206 of the engagement assembly 200 is approximately 1 mm to approximately 5 mm larger than the diameter of the medical tube 999. Similarly, the diameter of the engagement assembly 200 is only approximately larger than the lumen 206, considering that a favorable total diameter of the engagement assembly 200 is the smallest diameter possible to contain the medical tube 999 in the lumen 206. In an exemplary embodiment, the engagement assembly 200 can be approximately 1 mm to approximately 6 mm larger in diameter than the medical tube 999 being transported. The internal diameter of the lumen 206 also accounts for the diameter of the engager 250 when sized to fit a target medical tube 999. In an exemplary embodiment designed to transport an 18 French (6 mm) Sengstaken-Blakemore tube in the lumen 206, for example, the internal diameter of the lumen 206 is between approximately 3 mm and approximately 8 mm, in particular, approximately 6.5 mm, and the overall diameter of the engagement assembly 200 is between approximately 4 mm and approximately 9 mm. in particular, approximately 8 mm. In an exemplary embodiment, the length of the housing 210 varies from approximately 0.5 cm to approximately 4 cm.

[0138] In an exemplary embodiment, the distal end 311 of the inserter wire 310 is placed within the housing 210 of the engagement assembly 200. In an exemplary embodiment, the distal end 311 of the inserter wire 310 is placed in a superior aspect of the housing 210. but, in other exemplary embodiments, the distal end 311 of the inserter wire 310 may be placed in the inferior aspect or to the side of the housing 210. Location of the distal end 311 of the inserter wire 310 can vary depending on the preference to the direction of insertion of the particular embodiment of the insertion device 50. For example, pushing an inserter wire 310 that is placed on the superior aspect of the housing 210 places a downward biased flexion force on the engagement assembly 200 and, subsequently, also the head assembly 100 distal to the engagement assembly 200. In an exemplary embodiment, the distal end 311 of the inserter wire 310 is the same diameter as the inserter wire 310 coursing external to the housing 210. In an exemplary embodiment, to increase strength, the inserter wire 310 courses within the housing 210 and continues to form a right angle and enters parallel to and through the base 207. In an exemplary embodiment, the inserter wire 310 continues further through the wall of the housing 210 opposite to where the inserter wire 310 entered, and the inserter wire 310 can also exit the housing 210 parallel to the point of entry of the inserter wire 310 into the housing 210.

[0139] In an exemplary embodiment, the entire inserter wire 310 and / or the distal end 311 thereof is made of stainless steel; alternatively, a rigid but flexible plastic may be used; further alternatives may include shape memory alloys, such as Nitinol®. In an exemplary' embodiment, the inserter wire 310 is made of a strong, flexible material without memory in bending. The inserter wire 310 may be biased to maintain or return to an original straight configuration thereof. Materials of the inserter wire 310 may be carbon or alloy metals such as steel, spring steel, stainless spring steel, copper alloys, titanium alloys, iron alloys, Nitinol®, nickel alloys, cobalt-chromium alloys, fiberglass springs, carbon fiber springs, nylon, PET, polycarbonate, PEEK, polypropylene, or fluoropolymers, or combinations thereof. In an exemplary embodiment, the inserter wire 310 is comprised of biocompatible spring steel and / or a spring made of steel. In an exemplary embodiment, a diameter of the inserter wire 310 is between approximately 0.2 mm and approximately 1.5 mm, more particularly, between approximately 0.6 mm and approximately 1.2 mm, in particular, approximately 0.9 mm. In an exemplary embodiment, the diameter of the inserter wire 310 is such that a force resulting in bending of the inserter wire 310 of a particular material is equal to the force that results in perforation of bowel wall, so that perforation is avoided by coiling of the inserter wire 310 with resulting loss of point force. In an exemplary' embodiment, the inserter wire 310 is equipped with distance markers. In an exemplary' embodiment, the inserter wire 310 is equipped with radiopaque markers, if the inserter wire 310 is not already radiopaque. In an exemplary embodiment, the distal end 311 of the inserter wire 310 has roughening 315 (e.g., bosses or corrugations) on a surface thereof that increases fixation of the distal end 311 of the inserter wire 310 into the housing 210 during assembly and use. In an exemplary' embodiment, the distal end 311 of the inserter wire 310 can be manufactured by molding the housing 210 around the inserter wire 310, among other similar securement methods. In an exemplary embodiment, manufacturing of this detail can be accomplished by providing the distal end 311 of the inserter wire 310 with a barbed surface so that the distal end 311 can be inserted into the housing 210 and be fixed into place. In exemplary embodiments, the total length of the inserter wire 310 varies depending on the length of the target anatomic lumen from the operator and the length of the medical tube 999 to be coupled to the insertion device 50. In an exemplary' embodiment, the length of the inserter wire 310 is at least approximately 10 cm longer than a length of the medical tube 999. In an exemplary embodiment, the length of the inserter wire 310 is between an approximately equal length to the medical tube 999 and approximately 20 cm longer than a length of the medical tube 999. For example, for the exemplary embodiment of insertion device 50 used to insert a 65 cm long nasogastric tube into a stomach, a length of the inserter wire 310 is between approximately 65 cm and approximately 85 cm, in particular, approximately 80 cm. In an exemplary' embodiment, the inserter wire 310 is round in lateral cross-section. In an exemplary embodiment, the inserter wire 310 is rectangular or oval or elliptical in lateral cross-section to favor flexion in one plane along a short axis.

[0140] In an exemplary' embodiment, the line channel 260 is lined by a line channel sheath 263. The line channel 260 also forms a line channel lumen 264. The line channel sheath 263 may assist the molding of the housing 210 without the need to drill a line channel 260 directly into the housing 210. In an exemplary embodiment, the line channel sheath 263 is omitted and the line channel 260 is directly drilled, formed, or otherwise in the housing 210, thereby creating the line channel lumen 264, for example, by physical drilling or laser drilling, among other methods. In an exemplary' embodiment, the line 500 enters the line channel lumen 264 through a line channel proximal foramen 262, the line 500 then courses the entire length of the line channel lumen 264 (which can be the entire length of the housing 210) and exits through the line channel distal foramen 261, before continuing toward the bulb 120. In an exemplary' embodiment, the position of the line channel distal foramen 261 approximates a vertical level of the inferior wall 128 of the bulb 120 or the foramen 122 of the bulb 120 on a longitudinal plane of the distal end of the device 50. In an exemplary embodiment, the housing 210 contains one or more line channels 260 in one or more directions to allow the line 500 or lines to course through the housing 210 in a user-selected path. For example, in an embodiment where the line 500 is constructed to course adjacent to an inserter wire 310. the line channel 260 may be constructed to course through the housing 210 adjacent the inserter wire 310 and to bend around a base 207 of the engagement assembly 200. In an exemplary embodiment, the diameter of the line 500 is between approximately 0.05 mm and approximately 0.5 mm, more particularly, between approximately 0.085 mm and approximately 0.2 mm, in particular, approximately 0. 1 mm and, therefore, the diameter of the line channel lumen 264 is larger than the diameter of the line 500. Therefore, an exemplary embodiment of the diameter of the line channel lumen 264 is between approximately 0.03 mm and approximately 0.6 mm, more particularly, between approximately 0.08 mm and approximately 0.4 mm, in particular, approximately 0.15 mm.

[0141] FIG. 3b is an enlarged, sectional view of a portion of FIG. 3a, illustrating an exemplary embodiment of a fragment of the engagement assembly 200 and the relation between the engager 250, an engager connector 255, and the engagement line 600. In an exemplary embodiment, the engager 250 is a balloon. In an exemplary embodiment, the engager 250 is circumferential within the lumen 206 of the engagement assembly 200. In an exemplary embodiment, the engager 250 is not circumferential. The engager 250 illustrated in FIG. 3b is an active (inflated / enlarged) state. The lumen 256 of the engager 250 is in fluid communication with the engager connector 255. In an exemplary' embodiment, the engager connector 255 is made of the same material as the remainder of the engager 250 and forms a hollow tube to allow fluidic connection with the engagement line 600. In an exemplary embodiment, the connection between the engager connector 255 and the engagement line 600 is facilitated by a connector hold 257 to form a watertight seal. In an exemplar}' embodiment, the connector hold 257 is made of plastic, rubber, metal, or is fused onto the connection. In an exemplary embodiment, the connector hold 257 is omitted and the engager connector 255 is partially fused to the engagement line 600 to form a watertight seal while allowing a fluidic connection between the engagement line 600, the engager connector 255, and the lumen 256 of the engager 250. In other exemplary' embodiments, the watertight connection between the engager connector 255 and the engagement line 600 is made through a male-female fitting, barbed fitting, adhesive, or a valve. In yet another exemplary embodiment, the engager 250 is clamp that is secured to the engagement assembly 200 and can be actuated to clamp onto the medical tube 999 and actuated to release the medical tube 999. In an exemplary embodiment the engager 250 in the configuration of a clamp can be released by manually actuating a line that is connected to the engager 250 (described in further embodiments below). In another exemplary- embodiment, the engager 250 is a sliding hood that slides over the housing 210 and over the medical tube 999 fitted into the lumen 206 of the engagement assembly 200, thereby increasing contact and friction between the engagement assembly 200 with the medical tube 999. In an another exemplary embodiment, the engager 250 is a tapered hood of silicone molded onto the housing 210 and is manually actuated to roll onto the medical tube 999 that is inserted into the lumen 206 of the engagement assembly 200. Accordingly, the engager 250 is reversibly fixable to the medical tube 999 within the lumen 206.

[0142] FIG. 4a is a cross-sectional view of an exemplary' embodiment of the engagement assembly 200 along section line III-III of FIG. le. Disclosed in FIG. 4a is an exemplary embodiment of the relations of the housing 210 with the exterior wall 251 and the interior wall 252 of the engager 250. In an exemplary' embodiment, a housing interface 270 exists between the exterior wall 251 of the engager 250 and the inner side of the housing 210. The housing interface 270 is a space found within the lumen 206 of the engagement assembly 200 that is partially partitioned from the lumen 206 when the circumferential engager 250 is placed within the lumen 206 of the engagement assembly 200. Without a circumferential engager 250, the housing interface 270 would be part of and indistinguishable from the lumen 206 of the engager 200. In an exemplary' embodiment, the housing interface 270 is fdled with adhesive to fix the exterior wall 251 of the engager 250 to the housing 210. In an exemplary embodiment, the housing interface 270 contains points of adhesive or other fixation points serving to fix the exterior wall 251 of the engager 250 to the housing 210. The engager 250 illustrated in cross-section in FIG. 4a is in an active (inflated / expanded) state, and therefore the interior wall 252 of the engager 250 is seen separated from the exterior wall 251 of the engager 250 resulting in the formation of the lumen 256 of the engager 250. In an exemplary embodiment, the lumen 256 of the engager 250 is filled with fluid, such as a liquid or a gas, as previously7described. The expansion of the lumen 256 of the engager 250 subsequently distends the interior wall 252 of the engager 250 toward the space in the lumen 206 of the engagement assembly 200 imparting a force on a medical tube (non-illustrated) placed in the lumen 206 of the engagement assembly 200. The force from the expanding interior wall 252 of the engager 250, therefore, reversibly squeezes against and fixes the medical tube placed within the lumen 206 of the engagement assembly until the engager 250 is inactivated, e.g., by removal of fluid from the lumen 206 of the engager 250.

[0143] The distal end 311 of the inserter wire 310 is seen placed within the housing 210. In an exemplary embodiment, edges 312 of the inserter wire 310 are rounded to avoid blunt angles. In an exemplary7embodiment, the line channel 260 courses through the housing 210, forming the line channel lumen 264. The line 500 courses within the line channel lumen 264.

[0144] FIG. 4b is a fragmentary, partially cross-sectional and perspective view of an exemplary- embodiment of the inserter assembly 300 and the engagement line 600 of the medical tube insertion device 50 of FIG. 1c along section line IV-IV of FIG. 1c. In an exemplary embodiment, the engagement line 600 courses adjacent to the inserter wire 310. In an exemplary7embodiment, the engagement line 600 is fixed to the inserter wire 310 by several straps along the length thereof, or a sheath surrounding the entire length of the inserter wire 310 in a way not to obstruct the lumen 601 of the engagement line 600. In an exemplary embodiment, the line 500 also courses adjacent the inserter wire 310 and the engagement line 600 and within a sheath, but the line 500 is free to run proximally and distally as tension to the line 500 is applied and released. In an exemplary' embodiment, the engagement line 600 is left free of any attachments. In an exemplary embodiment, the edges 312 of the inserter wire 310 are rounded to ease the efficiency of manufacturing and prevent tissue trauma as the inserter wire 310 contacts tissue of an anatomic lumen. In an exemplary' embodiment, the inserter wire 310 is elliptical in cross-section to favor one plane of flexion along the short axis. Alternatively, in other exemplary embodiments the inserter wire 310 is in lateral cross-section shape oval, elliptical, flattened, or rectangular, or other polygonal shape with a short and long axis. In another exemplary embodiment, the inserter wire 310 is round or of other polygonal shapes. In an exemplary' embodiment, the inserter assembly 300 comprises the inserter wire 310 but does not comprise a line 500 or an engagement line 600.

[0145] FIGS. 5a-c disclose an exemplary embodiment of insertion device 50 wherein the engagement assembly 200 is comprised of a cage 700. In FIG. 5a, in an exemplary embodiment, the cage 700 is placed within the lumen 206 of the engagement assembly 200. The engager 250 seen in FIG. 5a is in an inactive (deflated / contracted) state. In an exemplary embodiment, the engager 250 is a balloon. The cage 700 extends horizontally from the entry hiatus 205 to the base 207 of the engagement assembly 200. The cage 700 lines the interior of the housing 210 of the engagement assembly 200. In an exemplary embodiment, the proximal end of the cage 700 is open to allow loading of a medical tube w ithin the cage 700. In an exemplary embodiment, the cage 700 is constructed of metal, such as stainless steel, or rigid plastic. In an exemplary’ embodiment, the distal end of the cage 700 forms a base 701 thereof and the base 701 of the cage 700 is adhered to the base 207 of the engagement assembly 200 to keep the cage 700 fixed into place within the lumen 206 of the engagement assembly 200. The structure and relations of the cage 700 will be described in further detail below and w ith regard to subsequent figures.

[0146] FIG. 5b is a cross-section along section line V-V of FIG. 5a of an exemplary embodiment of the engagement assembly 200 with the cage 700 and engager 250 in an inactive (deflated) state. In an exemplary embodiment, the engager 250 is a balloon. In an exemplary embodiment, the cage 700 is comprised of metal bars 703 that line the inner side (the side tow ard the lumen 206 of the engagement assembly 200) of the interior wall 252 of the engager 250. In an exemplary- embodiment, the cage 700 is comprised of six bars 703. The number of the bars 703 that form the cage 700 can vary, for example, from three to eight. The cage 700 and the bars 703 provide a track for insertion of a medical tube 999 into the lumen 206 of the engagement assembly 200 w ithout friction or snagging onto the walls 251, 252 of the engager 250. In an exemplary embodiment, the bars 703 extend distally until the base 207 of the engagement assembly 200 where the bars 703 bend orthogonally toward the center of the lumen 206 and extend toward the center of the base 207 at an orthogonal angle and form the base 701 of the cage 700. The bars forming the base 701 of the cage 700 meet at the center of the base 207 of the engagement assembly 200 and form a confluence of bars 704. In an exemplary embodiment, the base 701 of the cage 700 and / or the confluence of the bars 704 are attached to the base 207 of the engagement assembly through adhesive or glue.

[0147] FIG. 5c is a cross-section along section line V-V of FIG. 5a of an exemplary7embodiment of the engagement assembly 200 with the cage 700, however with the engager 250 in an active state (inflated) and forming the lumen 256 of the engager 250. FIG. 5c illustrates an exemplary embodiment disclosing the relation of the cage 700 when the engager 250 is active and forms a lumen 256 of the engager 250. In an exemplary7embodiment, the engager 250 is a balloon. The cage 700 prevents complete distension of the interior wall 252 of the engager 250. An apex 252a of the interior wall 252 of the engager 250 is formed and protrudes toward the lumen 206 of the engagement assembly 200. In an exemplary embodiment, the apex 252a, therefore, contacts a nonillustrated medical tube loaded in the lumen 206 of the engager 250 previous to the activation (inflation) of the engagement ballon 250.

[0148] FIG. 6 is a top plan and partially hidden view of the insertion device 50 constructed in accordance with an exemplary- embodiment of the device comprised of the head assembly 100, engagement assembly 200, inserter assembly 300, and a handle assembly 400. In an exemplary embodiment, the inserter assembly 300 defines a distal end 311 and a proximal end 319 and comprises an inserter wire 310, the engagement line 600, and the line 500. In an exemplary embodiment, the inserter wire 310, the line 500. and the engagement line 600 course together distally to the engagement assembly 200 and proximally7to the handle assembly 400. In an exemplary7embodiment, the inserter assembly 300 is housed within a non-illustrated sheath and the line 500 is free to run proximally and distally within the sheath. In an exemplary7embodiment, a proximal end 319 of the inserter wire 310 enters a handle 409, which is diagrammatically depicted in FIG. 6.

[0149] In an exemplary7embodiment, the handle assembly 400 comprises a handle 409, an engagement actuator 401, and a line actuator 402. In an exemplary7embodiment, the proximal end of the inserter wire 310 is connected to the handle 409 by adhesive, socket, clamp, or direct fusion with the handle 409. In an exemplary embodiment, the handle 409 is constructed with plastic using a mold and is of a size to be held with a single, average-sized hand. In an exemplary embodiment, the engagement line 600 interacts with the engagement actuator 401. The engagement actuator 401 comprises one or more operator controls that allow the operator to interact with toggling the activation state of the engagement assembly 200. In an exemplary embodiment, the engagement actuator 401 is a port of access to the engagement line 600 for the injection of fluid to expand the engager 250 in the engagement assembly 200; the port can be, for example, a Tuohy Borst valve.

[0150] In an exemplary' embodiment, the handle 409 also provides the line actuator 402 used by the operator to create or release tension on the line 500. Tension applied to the line 500 is transferred to the bulb 120 of the head assembly 100 and results in flexion of the distal end of the head assembly 100. In an exemplary embodiment, the tension on the line 500 is created by pushing on the line actuator 402 by the operator. In an exemplary' embodiment, the line actuator 402 is connected to a rigid rod 403 and. therefore, pushing the line actuator 402 moves the rod 403 away from a pulley 405 located within the handle 409. The pulley 405 redirects the line 500 so that pushing the line actuator 402, and consequently of the rod 403, results in tension created on the line 500. Release of the line actuator 402 results in the release of tension from the line 500. In an exemplary embodiment, the proximal end of the line 500 is secured to a line handle attachment site 410 located on the rod 403. The line 500 can be attached to the line handle attachment site 410 using a knot or adhesive. In an exemplary embodiment, the orientation of the plane of the handle 409 approximates the orientation of the flat plane of the inserter wire 310 as depicted in FIG. 6.

[0151] FIG. 7 illustrates expected flexion motions in an exemplary embodiment of the head assembly 100 of the insertion device 50. Tension on the tine 500 is delivered to the bulb 120, resulting in flexion of the head assembly 100 approximately at the level of the head shaft 150, resulting in movement of the flexible distal tip 102 of the head assembly 100. The greater the tension on the line 500, the greater the flexion that is expected at the level of the superior wall 151 of the head shaft 150. Upon release of the tension on the tine 500 by the operator, the head assembly 100 returns to its neutral configuration due to the flexibility in the composition of the head assembly 100.

[0152] In an exemplary embodiment, the handle assembly 400 is omitted, such as for example in embodiments that lack a line 500 for active flexion control. In an exemplary embodiment, the handle assembly 400 comprises a soft ball, T-bar or other polygonal shape or structure at the proximal end of the inserter wire 310 to eliminate the otherwise free-standing sharp point thereof that has potential to harm the operators or surrounding individuals.

[0153] Also disclosed is a method for operating the insertion device 50 to advance a flexible medical tube, such as a Sengstaken-Blakemore tube, within a hollow anatomic lumen, such as the esophagus. However, the description of this exemplary method does not limit the method to use with medical tubes or use for the gastrointestinal tract.

[0154] In an exemplary' embodiment, the device 50 comprises a handle assembly 400, an inserter assembly 300, an engagement assembly 200, a head assembly 100, and a line 500. The tine 500 courses from the handle assembly 400 along the inserter assembly 300, through the engagement assembly 200, and into the bulb 120 of the head assembly 100.

[0155] FIG. 8 describes a method to use insertion device 50 in FIGS 1c, 3a, and 6 to insert a medical tube such as a nasogastric tube or Sengstaken-Blakemore tube into the esophagus or stomach. However, this process is applicable to insertion of other medical tubes in other anatomic lumens and is applicable to the use of other embodiments of the insertion device and / or the engagement assembly 200.

[0156] In step 1010, the tip of a medical tube 999 to be delivered to an anatomic lumen is inserted into the lumen 206 of the engagement assembly 200 as shown in FIG. 3a. The engager 250 is activated through the engagement actuator 401 (shown in FIG. 6), causing expansion of the lumen 256 of the engager 250 and temporary fixation of the medical tube 999 within the lumen 206 of the engagement assembly 200. The system of the medical tube coupled to insertion device 50 is ready to be inserted into an anatomic lumen to deliver the medical tube 999.

[0157] In step 1020. the insertion device 50, with the medical tube coupled thereto, is inserted through the mouth, into the oropharynx, until the posterior pharyngeal wall is reached. The insertion device 50 can be inserted either with the bulb 120 facing the tongue or facing the incisors. The insertion device 50 can be rotated during insertion. Small diameter embodiments of the insertion device 50 can also be inserted through the nose. In embodiments without the line 500, the insertion device 50 is inserted with the bulb 120 facing the incisors, and steps 1030, and 1040 below are skipped.

[0158] In step 1030, the flexible distal tip 102 is directed away from the posterior phary ngeal wall by inferior flexion of the head assembly 100 (if inserted with the bulb 120 facing the tongue) created by the application of tension to the line 500. Tension is applied to line 500 by control of the line actuator 402 by the operator, resulting in a pull force on the bulb 120 and, consequently, flexion of the head shaft 150. The device 50 is further inserted so that the flexible distal tip 102 approaches the hypopharynx. If the device is inserted with the bulb 120 facing the incisors, there is no need for manipulation of the line 500.

[0159] In step 1040, once the flexible distal tip 102 arrives in the hypopharynx near the opening of the esophagus and airway, tension on the line 500 is released (if inserted with the bulb 120 facing the tongue) by control of the line actuator 402 by the operator, and the head assembly 100 returns to a neutral, or steady-state, configuration. The curve 106 of the head assembly 100 then facilitates directing the head assembly 100 to enter the esophagus. If necessary, rotation of the inserter assembly 300, or additional control of tension on line 500, can be applied at this point to facilitate intubation of the esophagus. If the device is inserted with the bulb 120 facing the incisors, the tension on the line 500 would be increased to facilitate entry into the esophagus. In step 1050, the system of the medical tube coupled to the device 50 is inserted further to the desired location within the anatomic lumen.

[0160] In step 1060, the medical tube is uncoupled from the device 50 by inactivation / deactivation of the engager 250 so that the medical tube is no longer fixed within the engagement assembly 200

[0161] In step 1070, the device 50 is pushed further distally while the medical tube is held in position by the operator, causing the tip of the medical tube to exit the forward moving engagement assembly 200 of the insertion device 50.

[0162] In step 1080, the device 50 may be w ithdrawn from the anatomic lumen. The engagement assembly 200 can be used in other configurations to deliver a medical tube within an anatomic lumen as described in FIGS. 9 and 10 below.

[0163] FIG. 9 discloses an exemplary7embodiment of a distal end of a medical tube insertion device 60 with a medical tube 999 docked and held in the lumen of an engagement assembly 200 by an engager 250 in an active (e.g.. inflated / expanded) state, where the distal end of the engagement assembly 200 is closed and forms a base 207. In an exemplary embodiment, the engager 250 is a balloon, in particular, a cylindrical balloon. In an exemplary embodiment, the insertion device 60 comprises an engagement assembly 200 having the base 207, the housing 210, and the engager 250. In an exemplary7embodiment, the medical tube insertion device 60 comprises the inserter assembly 300 and the handle assembly 400. In an exemplary embodiment of the insertion device 60, the pedicle 202 and the line channel 260 are omitted. In an exemplary embodiment, a non-illustrated modified silicone or other soft flexible head assembly 100 can be attached to the distal end 201 of the engagement assembly 200 of the insertion device 60 to remove the blunt edge of the distal end 201 of the engagement assembly 200. In an exemplary embodiment, an inserter wire 310 is connected to the housing 210 of the engagement assembly 200. An engagement line 600 is provided to alloyv operator interaction with the engager 250 and to control inflation of the lumen 256 of the engager 250. In an exemplary embodiment, the insertion device 60 is coupled to a flexible medical instrument with optical image capability such as an endoscope, bronchoscope, laryngoscope, and other medical instruments. The insertion device 60 may be reversibly coupled to a flexible medical instrument by at least one strap, rubber ring, C-clamp, elastic band, or line and knot, yvhich can be placed, adjusted, and removed by the operator prior to use and after use of the insertion device 60.

[0164] A method for operating insertion device 60 includes coupling the insertion device 60 to a medical tube 999 to be delivered to an anatomic lumen by inserting a tip of the medical tube 999 into the engagement assembly 200 through the entry7hiatus 205. The engager 250 is inflated so that the interior wall 252 of the engager 250 presses against the inserted medical tube 999 and temporarily fixes the medical tube 999 to the engagement assembly 200. The insertion device 60 with a docked medical tube 999 is now coupled to an endoscope by the operator, e.g., by at least one strap, rubber ring, C-clamp, elastic band, or line and knot to form an endoscopy system. The endoscopy system is inserted into an anatomic lumen of interest. Directional pressure can be applied to the engagement assembly 200 through the inserter wire 310. which may assist with flexion, rotational, or sliding movements of the engagement assembly 200. Once the desired location is reached by the endoscopy system, the engager 250 is deactivated by at least one operator control and the medical tube 999 is slightly withdrawn to remove the tip thereof from the engagement assembly 200.

[0165] FIG. 10 is a fragmentary, enlarged, longitudinally cross-sectional view disclosing an exemplary embodiment of a distal end of a medical tube insertion device 70 with a medical tube 999 docked and held in the lumen 206 of an engagement assembly 200 by an engager 250 in an activated state, where the distal end 201 of the engagement assembly 200 is open and forms an exit hiatus 205b. In an exemplary embodiment, the engager 250 is a balloon. In an exemplary embodiment, the medical tube 999 can slide through the entire lumen 206 of the engagement assembly 200 and exit the engagement assembly 200 through the exit hiatus 205b when the engager 250 is not active. In an exemplary embodiment, the insertion device 70 is coupled to a flexible medical instrument with optical image capability, such as an endoscope, bronchoscope, laryngoscope, and other instruments. The insertion device 70 may be reversibly coupled to a flexible medical instrument by at least one strap, rubber ring, C-clamp, elastic band, or line and knot. In an exemplary' embodiment, the strap, ring, elastic, or C-clamp coupling the insertion device 70 to the endoscope allows sliding of the endoscope and / or insertion device 70 along the shaft of the endoscope and / or the insertion device 70. In an exemplary embodiment of the medical tube insertion device 70, the inserter wire 310 is omitted.

[0166] A method for operating insertion device 70 includes coupling the insertion device 70 to a medical tube 999 to be delivered to an anatomic lumen by inserting a tip of the medical tube 999 into the engagement assembly 200 through the entry hiatus 205. The engager 250 is inflated so that the interior wall 252 of the engager 250 is pressing against the inserted medical tube 999 and temporarily fixes the medical tube 999 to the engagement assembly 200. The insertion device 70 with the docked medical tube 999 is then coupled to an endoscope by at least one strap, rubber ring, C-clamp, elastic band, or line and knot to form an endoscopy system. The endoscopy system is inserted into an anatomic lumen of interest. Directional pressure can be applied to the engagement assembly through the inserter wire 310, which may assist with flexion, rotational, or sliding movements of the engagement assembly 200. Once the desired location is reached by the endoscopy system, the engager 250 is deactivated by at least one operator control and the medical tube 999 is slightly withdrawn to remove the tip thereof from the engagement assembly 200. Alternatively, the medical tube 999 can be pushed through the exit hiatus 205b, a feature that may assist the intubation of a select anatomic lumen by the medical tube 999 alone. In an exemplary embodiment, this process may be facilitated by applying force to the inserter wire 310.

[0167] The device 50, 60, 70, and other configurations of the engagement assembly 200 can be used coupled to an optical image assisted endoscope such as a gastroscope, laryngoscope, bronchoscope, and other instruments to assist visualization during insertion of the insertion device.

[0168] It can be seen that at least one embodiment of the medical tube insertion devices 50, 60, 70 and its components overcome the limitations of the prior art and provide economical yet effective measures of enhancing the placement of existing medical tubes into an anatomic lumen, such as nasogastric tubes, tubes for the treatment of variceal hemorrhage, and feeding tubes, among others. The insertion device 50, 60, 70 can be easily adapted to a plurality of existing tubes by simply altering the size of the engagement assembly 200 and / or the diameter of the inserter wire 310. The shape of the inserter wire 310 and the head assembly 100 allow for more predictable directional changes of the flexible distal tip 102 of the head assembly 100, which is crucial when targeting a specific anatomic lumen to enter. Furthermore, the shape of the inserter wire favors bending along a single plane, in this case, the curve 106 of the head assembly 100 is along the same flexion line as the inserter wire, providing for more accurate delivery of the inserter device 50, 60, 70 and the medical tube coupled to the inserter device 50, 60, 70. Therefore, the device 50, 60, 70 reduces complications in some situations associated with placing existing flexible medical tubes unassisted and blindly. Manufacture is completed with a variety of materials with relative simplicity, more easily allowing widespread adoption in different healthcare settings without requiring equipment upgrades. The limited complexity of the insertion device 50, 60, 70 also permits physicians, nurses, and mid-level providers of every skill level to use the insertion device 50, 60, 70 without significant additional training. Furthermore, easy implementation of the insertion device 50, 60, 70 by coupling to existing visual examination instruments provides immediate assistance during difficult cases of tube placement, or in emergent settings such as variceal hemorrhage. Described herein are only a few examples of additional gastrointestinal clinical scenarios which illustrate the advantages of the disclosed insertion devices.

[0169] The word “line” is used herein. This word is intended to embody and include all similar structures, such as rope, cord, string, rod. pole, strap, belt, band, shaft, wire, cable, thread, and strand, to name a few.

[0170] While the above description contains many specificities, these should not be construed as limitations on the scope, but rather as an exemplification of several embodiments thereof, including, but not limited to combinations of the various exemplary' embodiments described herein. Many other variations are possible, for example, in an exemplary embodiment, the head assembly can be an oval silicone piece attached to the distal end 201 of the engagement assembly 200. In another exemplary embodiment, the line 500 is omitted and therefore the head assembly 100 does not have a mechanism to command active flexion of the head assembly 100, aside from passive flexion. In another exemplary embodiment, the device 50, 60. 70 is provided with a strap, ring, elastic, or C-clamp to couple the device 50, 60, 70 to a flexible endoscope or other optical image capable medical device such as a laryngoscope. In an exemplary embodiment, the device 50, 60, 70 is provided with a strap, ring, elastic, or C-clamp to couple the device 50, 60, 70 to a flexible endoscope or other optical image capable medical device such as a laryngoscope, wherein the strap, ring, elastic, or C-clamp coupled to the endoscope allows sliding thereof along the shaft of the endoscope and / or the insertion device and, therefore, also allows the sliding of the coupled device 50, 60, 70 along the shaft of the endoscope. In an exemplary embodiment, the device 50, 60, 70 is coupled to an optical endoscope through the engagement assembly 200 and the inserter wire 310 is omitted. In an exemplary embodiment, the entry hiatus 205 is covered by a flap, which closes after removal of a medical tube to allow easier withdrawal of the insertion device 50, 60, 70. In an exemplary embodiment, the engager 250 is replaced with another grasping mechanism operated by an engagement line 600, such as a snare, a set of springs, a claw or a forceps. In an exemplary embodiment, the device 50,60,70 is equipped with a non-illustrated camera on the distal end of the flexible distal tip 102 of the head assembly 100. The power lines and the optical image cable of the camera course through the head assembly 100, the engagement assembly 200, and course along the inserter wire 310. In an exemplary’ embodiment, the camera is equipped with a wireless transmitter and a local battery’ power source that can be positioned within the head assembly 100, for example, within the bulb 120 or the head shaft 150.

[0171] FIGS. 14 to 62 illustrate various further exemplary embodiments of the device 50, 60, 70. Exemplary configurations of the devices in FIGS. 14 to 62 has a width W of approximately 8.5 mm, a length L of approximately 75.73 mm and a height H of approximately 10.69 mm. FIGS. 14 to 62 disclose an exemplary’ embodiment of the device 50 comprising the head assembly 100, the engagement assembly 200, and the inserter assembly 300. The head assembly 100 is further comprised of the flexible tip shaft 104, and a spring element 160. The head assembly 100 comprises, in an exemplary’ embodiment, a soft overmolded material, such as silicone with, for example, a Shore Hardness of approximately A60. The spring element 160 is configured to bias the flexible tip shaft 104 and the overall head assembly 100 toward a neutral state thereof when a bend or force is applied to the head assembly 100 and / or the flexible tip shaft 104. The neutral or steady state is illustrated, for example, in FIGS. 18, 26, 34, 42, 50, and 59. In an exemplary embodiment illustrated in FIGS. 14 to 21, the engagement assembly 200 is further comprised of an engager 250 that is a hollow cylinder situated in its default state (in FIGS. 14 to 18, 20, and 21) over a body 240 of the engagement assembly 200 and is actuated by sliding the engager 250 proximally into an actuated extended state (in FIG. 19), forming the lumen 256 of the engagement assembly 200. The engager 250 can therefore slide over the medical tube 999. In an non-illustrated exemplary embodiment, the engager 250 in the configuration of a hollow cylinder is provided on the internal surface of the proximal end thereof with resistance elements to engage with the medical tube 999. In an exemplary embodiment, the distal end of the inserter wire 310 can loop back into the lumen formed by the actuated engager 250 and therefore interact with the medical tube 999 placed within the lumen 256. In this embodiment, the distal tip of the inserter wire 310 may be coated and / or extended with soft flexible plastic or rubber material to provide both compression effect when pressed against the medical tube 999 as the engager 250 is actuated over the medical tube 999, and to prevent tissue injury on retraction of the device 50. In an exemplary embodiment, when the engager 250 is actuated into the extended state thereof, the engager 250 is no longer able to retract into the default state to prevent exposure of the wire during retraction of the device 50. In an exemplary' embodiment, the engager 250 is made of thermoplastic polyurethane and / or polycarbonate or other material listed herein.

[0172] An exemplary configuration of the devices in FIGS. 22 to 37 has a width W of approximately 8.5 mm, a length L of approximately 75.73 mm and a height H of approximately 10.69 mm. The head assembly 100 is further comprised of the flexible tip shaft 104, and a spring element 160. The head assembly 100 comprises, in an exemplary' embodiment, a soft overmolded material, such as silicone with, for example, a Shore Hardness of approximately A60. The spring element 160 is configured to bias the flexible tip shaft 104 and the overall head assembly 100 toward a neutral state thereof when a bend or force is applied to the head assembly 100 and / or the flexible tip shaft 104. The neutral or steady state is illustrated, for example, in FIGS. 26 and 34. In an exemplary embodiment, the spring element 160 is comprised of flexible plastic such as thermoplastic polyurethane. In an exemplary embodiment, the spring element 160 comprises a spring 162 to achieve the desired flexibility and spring effect for the spring element 160 to bias the head assembly 100 toward the neutral state thereof. In an exemplary embodiment, the spring element 160 is biased to flex in one axis or along plane. In an exemplary embodiment, the spring 162 comprises corrugations. In an exemplary embodiment, the depth and width of the corrugations vary to achieve the desired stiffness of the spring element 160. In other exemplary embodiments, the spring element 160 is comprised of slits, holes, altered filling density', and / or varying shapes to achieve the desired spring stiffness. In an exemplary' embodiment, the thermoplastic polyurethane has a Shore Hardness Scale durometer range of approximately Shore 00-10 to approximately Shore D70. In an exemplary embodiment, the spring element 160 is comprised of a spring 162 that further improves the desired stiffness of the spring element 160. A wide durometer range is possible because a consistent spring stiffness of the spring element 160 can be achieved when combining varying designs of the spring element 160 with material hardness thereof. For example, in an exemplary embodiment, the spring element 160 is comprised of TPU with a Shore Hardness of approximately A95 and the spring 162 in the shape of corrugations, with a depth of the trough of the corrugations of approximately 50% of the diameter of the spring element 160. In an exemplary embodiment, the spring 162 is V-shaped to allow bi-directional flexion. In an exemplary embodiment the spring 162 comprises linear slits and / or other breaks in the material continuity thereof. In an exemplary embodiment the spring element 160 comprises metal, plastic, or gels to form a coil or spring like element utilizing carbon or alloy metals such as steel, spring steel, stainless spring steel, copper alloys, titanium alloys, iron alloys, Nitinol®, nickel alloys, cobalt-chromium alloys, fiberglass springs, carbon fiber springs, nylon, PET, polycarbonate, PEEK, polypropylene, fluoropolymers, thermoplastic polyurethane, medical PVC, polycarbonate-urethane, fluoropolymers, hydrogels, and / or silicone. An exemplary embodiment of the inserter assembly 300 comprises a wire of spring tempered stainless steel.

[0173] In an exemplary embodiment, the spring element 160 comprises a spring extender 161, which extends the material of the spring element 160 into a portion of the flexible distal shaft 104. In another exemplary embodiment, the spring extender 161 is absent, and / or it functions as the pedicle 202 (seen in previous figures). In an exemplar}7embodiment, the spring extender 161 extends into between approximately 10% to approximately 75% of the length of the flexible distal shaft 104.

[0174] In an exemplary embodiment shown in FIG. 29 and FIG. 37, the spring element 160 extends proximally to comprise an inserter element coupler 164. In an exemplary embodiment, the inserter element coupler 164 is solid and made of the same material as the spring element 160. In an exemplary7embodiment, the inserter element coupler 164 is provided with a spring element channel 163. In an exemplary embodiment, the spring element channel 163 is comprised of peripheral and longitudinal cuts and / or perforation to allow entry and securing of the inserter wire 310. In an exemplary' embodiment, the inserter wire 310 is inserted parallel to the longitudinal axis of the spring element 160 and into the inserter element coupler 164, the inserter wire 310 and the spring element channel 163 then forming an orthogonal angle into a perforation that is orthogonal to the longitudinal axis of the spring element 160. This serves to more securely connect the inserter wire 310 to the spring element 160 compared to only longitudinal placement of the inserter wire 310. In an exemplary' embodiment, the angle formed by the inserter wire 310 once it is within the spring element 160 can vary, with an acute angle favored to increase the strength of the connection. In an exemplary embodiment, the inserter wire 310 is adhered to the spring element 160 by placing a securement 320, for example, an epoxy resin, within the spring element channel 163. In the exemplary embodiment, the inserter element coupler 164 can be partially hollow to at least partially accommodate the distal end of the medical tube 999 (not illustrated) and forming a port. In an exemplary embodiment, the inserter element coupler 164 with a hollow port is lined by one or more barbs 166, abrasive material, and / or material with a high coefficient of friction that, when in contact with the medical tube 999, assists to reversibly secure the medical tube 999 to the inserter element coupler 164.

[0175] In an exemplary embodiment illustrated in FIGS. 38 to 45, the lumen 206 of the engagement assembly 200 is equipped with one or more resistance elements 166, such as barbs, rings, adhesives, rubber cones, villi, or other friction generating material, that increase the friction between the engagement assembly 200 and the medical tube 999.

[0176] In an exemplar}' embodiment, the spring element 160 is overmolded with a soft biocompatible material, such as silicone or other material as listed above. In an exemplary embodiment, e.g., illustrated in FIGS. 22 to 62, the overmold also directly forms the flexible distal shaft 104. In an exemplary embodiment, the overmolded silicone also forms the engagement assembly 200. With the engagement assembly 200 being tubular and hollow and made of soft material such as silicone, the hollow silicone engagement assembly 200 defines a lumen that, in a neutral state, has a diameter less than a diameter of the medical tube 999 to be inserted therein. The hollow silicone engagement assembly 200 is stretchable so that it can be actuated to be rolled back distally onto the outer surface of the head assembly 100 and / or the spring element 160 thereof, exposing the lumen of the engagement assembly 200. In an exemplary embodiment as illustrated in FIG. 32. the engagement assembly 200 has a taper in a proximal direction so that the reduced diameter of the entry port for the medical tube 999 firmly grips and secures the medical tube 999 therein due to having an inner diameter smaller than an outer diameter of the medical tube 999. The rolled over state of the engagement assembly 200 is shown, for example, in FIGS. 25, 33, and 41. The rolled tubular engagement assembly 200 can then be actuated to be unrolled back onto the medical tube 999, thereby reversibly fastening the medical tube 999 to the engagement assembly with a force equal to a grip force of the tubular engagement assembly 200 surrounding the outer circumference of a distal end of the medical tube 999. The medical tube 999 can also be disengaged from the engagement assembly 200 by advancement of the inserter wire 310 while the medical tube 999 is held in place. In an exemplar}’ embodiment, the length of the engagement assembly 200 ranges from approximately 1 cm to approximately 10 cm, more particularly, between approximately 2 cm to approximately 6 cm, in particular, approximately 3 cm. In an exemplary embodiment illustrated with FIGS. 30 to 37, the head assembly 100 comprises the flexible distal shaft 104 and the spring element 160, and the engagement assembly 200 comprises the spring element coupler 170. In an exemplary embodiment, the spring element coupler 170 is manufactured separately from the spring element 160 to allow for a difference in material. For example, the spring element coupler 170 is made of polycarbonate. In an exemplary embodiment illustrated in FIG. 37, the spring element coupler 170 comprises a pedicle 172 that facilitates adhesion of the engagement assembly 200 to the spring element 160 of the head assembly 100. In an non-illustrated exemplary embodiment of FIG. 37, the spring element coupler 170 is partially hollow to form the housing 210 and to allow insertion of the medical tube 999 within the formed lumen 256 of the spring element coupler 170, in addition to the remainder of the lumen of the engagement assembly 200. Separating the manufacture of the engagement assembly 200 from the head assembly 100 allows for the engagement assembly 200 to comprise features that require different material structures to create the housing 210 thereof or the lumen 256 thereof.

[0177] In an exemplary embodiment illustrated with FIGS. 46 to 54, the engagement assembly 200 comprises a housing 210 forming the lumen 206 of the engagement assembly 200. The housing 210 is comprised of an engager 250. In an exemplary embodiment, the engager 250 is a reversible clamping mechanism that when actuated, allows manually commanded engagement with the medical tube 999 after the medical tube 999 is inserted into the lumen 206. In an exemplary embodiment, the engager 250 can be actuated by a housing clamp actuator 280. In an exemplary embodiment, the housing clamp actuator 280 is a line and / or wire and can be constructed with metal, plastic, string, cotton, other polymer or any other material used to construct the inserter wire 310. In an exemplary embodiment, the housing clamp actuator 280 can course alongside the inserter wire 310. In an exemplary embodiment, the housing clamp actuator 280 comprises a line and a reversible knot that can be actuated by release of the knot (for example, by pulling the line) to actuate the engager 250.

[0178] In an exemplary embodiment, the spring element 160 is confluent with, and comprised of the same material of the flexible distal shaft 104. In an exemplary embodiment, the entire head shaft 150 is made of a single material, for example, silicone or TPU. In an exemplary embodiment this material is also used for the overmold of the head assembly 100 and the engagement assembly 200. In an exemplary embodiment, the pedicle 202 of the engagement assembly 200 extends into the head shaft 150 and / or the spring element 160 up until or within the flexible tip shaft 104, contributing to the spring 162 of the spring element 160 and assisting in biasing the direction of flexion of the spring element 160 of the head assembly 100. In an exemplary embodiment, the pedicle 202 of the engagement assembly 200 behaves as a spring element 160 and comprises slits, holes, altered filling density, and / or varying shapes to achieve a desired spring stiffness (FIGS. 5a and 14 to 21). In an exemplary embodiment, the pedicle 202 of the engagement assembly 200 is oval, elliptical, rectangular or otherwise of any polygonal shape with a minor and major axis to favor flexion along the minor axis thereof. In an exemplary' embodiment, the pedicle 202 of the engagement assembly 200 is circular. In an exemplary embodiment, the engagement assembly 200 is overmolded with the same material forming the head assembly 100, for example, silicone. In an exemplary embodiment, the proximal end of the housing 210 is also overmolded with additional silicone to prevent injury' to tissues upon retraction of the device 50, 60, 70. In an exemplary' embodiment, the proximal end of the housing 210 is also overmolded with additional silicone to allow rolling of the silicone back distally over the engagement assembly 200, as shown in FIG. 51, for example, to allow easier access of the medical tube 999 to the lumen 206 of the engagement assembly 200. The rolled state allows the medical tube 999 to be inserted therein and then the rolled portion is unrolled back into the original state over the distal of the medical tube 999 once the medical tube 999 is in place, thereby temporarily securing the medical tube 999 therein.

[0179] In an exemplary embodiment illustrated in FIGS. 55 to 62, the entire head assembly 100 is comprised of a single flexible material, for example, such as silicone, and the spring 162 is comprised of alterations that are made to the head shaft 150 of the head assembly 100, such as corrugations 152, variation in density’, and / or variation in shape and / or diameter (seen in FIGS. 14 to 21)

[0180] In many of the illustrated embodiments, the entire head assembly' 100 and engagement assembly 200 is molded in one piece and with one material, such as silicone or other biocompatible flexible material listed above. In this embodiment, the engagement assembly 200 comprises silicone that can be rolled onto the medical tube 999 when the engagement assembly 200 is actuated. In an exemplary embodiment, the spring 162 of the head shaft 150 of the head assembly 100 is constructed for variations in the design of the head shaft 150 as described above, such as with corrugations and / or altered density and / or diameter of the head shaft 150. In an exemplary' embodiment, the device 50, 60, 70 is comprised of ahead assembly 100, an engagement assembly 200 with a lumen 256 thereof, and a rollable engager 250 all made of the same material and in a single mold. The inserter wire 310 is secured within the device 50 and the medical tube 999 is secured within the lumen 256 of the engagement assembly by actuating the rolling engager 250.

[0181] In a non-illustrated embodiment, the devices listed herein are provided in the form of a kit, wherein a device has a preloaded medical tube, such as with a preloaded Blakemore tube. In these kits, the operator will only need to open the package, insert the medical tube with the assistance of the attached device, and then release the medical tube into the desire anatomic lumen and extract the device from the anatomic lumen. It is noted that various individual features of the inventive processes and systems may be described only in one exemplary embodiment herein. The particular choice for description herein with regard to a single exemplary embodiment is not to be taken as a limitation that the particular feature is only applicable to the embodiment in which it is described. All features described herein are equally applicable to, additive, or interchangeable with any or all of the other exemplary embodiments described herein and in any combination or grouping or arrangement. In particular, use of a single reference numeral herein to illustrate, define, or describe a particular feature does not mean that the feature cannot be associated or equated to another feature in another drawing figure or description. Further, where two or more reference numerals are used in the figures or in the drawings, this should not be construed as being limited to only those embodiments or features, they are equally applicable to similar features or not a reference numeral is used or another reference numeral is omitted.

[0182] The foregoing description and accompanying drawings illustrate the principles, exemplary' embodiments, and modes of operation of the systems, apparatuses, and methods. However, the systems, apparatuses, and methods should not be construed as being limited to the particular embodiments discussed above. Additional variations of the embodiments discussed above will be appreciated by those skilled in the art and the above-described embodiments should be regarded as illustrative rather than restrictive. Accordingly, it should be appreciated that variations to those embodiments can be made by those skilled in the art without departing from the scope of the systems, apparatuses, and methods as defined by the following claims.

Claims

CLAIMSWhat is claimed is:

1. A catheter insertion device for assisting insertion of a flexible tube through a lumen, the catheter insertion device comprising: an engagement assembly comprising: a distal end and a proximal end; an engager configured to reversibly engage with the flexible tube to maintain the position of the flexible tube within the lumen of the housing when engaged; and a housing comprising a housing lumen; a handle assembly comprising: a handle comprising at least one operator engagement actuator control, the at least one operator actuator control configured: to cause the engagement assembly to reversibly engage the flexible tube when the at least one operator engagement actuator control is actuated; and after engagement, to cause the engagement assembly to disengage from the flexible lumen when the at least one operator engagement actuator control is disengaged; an inserter assembly comprising: an inserter wire comprising: a distal end connected to the housing of the engagement assembly; and a proximal end connected to the handle; an engagement line comprising: a distal end connected to the engager; and a proximal end operatively connected to at least one of the at least one operator engagement actuator control to activate and deactivate the engager upon actuation of the at least one operator engagement actuator control.

2. The catheter insertion device according to claim 1, wherein the lumen is an anatomic lumen.

3. The catheter insertion device according to claim 1, wherein the engager is configured to expand and thereby reversibly engage with the flexible tube to maintain position within the housing lumen.

4. The catheter insertion device according to claim 1, wherein the engager is a balloon and is activated by expansion.

5. The catheter insertion device according to claim 1. wherein the flexible tube has a length and the inserter wire is longer than the length of the flexible tube.

6. The catheter insertion device according to claim 1, wherein the inserter wire is made of at least one of stainless steel, metal, plastic, and combinations thereof.

7. The catheter insertion device according to claim 1, wherein the inserter wire has a cross-section that is one of circular, rectangular, and ovoid.

8. The catheter insertion device according to claim 7, wherein: the housing has an outer circumference; the rectangular or ovoid inserter wire has a flatter aspect that is placed radially to the center of the lumen of the housing; and the inserter wire is disposed adjacent the circumference of the housing.

9. The catheter insertion device according to claim 1, wherein the engagement line is hollow.

10. The catheter insertion device according to claim 1, wherein the distal end of the engagement assembly forms an exit hiatus to allow passage of the flexible tube therethrough.

11. The catheter insertion device according to claim 1, which further comprises a head assembly comprising a flexible distal tip and a proximal head shaft proximally connected to the engagement assembly.

12. The catheter insertion device according to claim 11. wherein the distal end of the engagement assembly comprises a pedicle.

13. The catheter insertion device according to claim 11, wherein the head assembly is made of silicone, soft plastic, and combinations thereof.

14. The catheter insertion device according to claim 13, wherein the head shaft has a cross-section that is one of circular and oval.

15. The catheter insertion device according to claim 1 1, wherein: the engagement assembly comprising a line channel within the housing; the inserter assembly comprises: a line comprising: a distal end; and a proximal end, the line passing through the line channel of the housing and being operatively connected to at least one operator line actuator control on the handle, the at least one operator line actuator control being configured to selectively increase tension on the line or ease tension on the line responsive to action of the at least one operator line actuator control; the head assembly comprises a bulb: comprising a superior aspect, an inferior aspect, and a diameter; and configured to secure the distal end of the line within the inferior aspect of the bulb; the head shaft comprises: a proximal end connected to the engagement assembly; anda distal end continently connected to the bulb and having a diameter smaller than the diameter of the bulb.

16. A catheter insertion device for assisting insertion of a flexible tube through a lumen, the catheter insertion device comprising: an engagement assembly comprising: a housing comprising a housing lumen and a line channel; a distal end comprising a pedicle; a proximal end; and an engager configured to reversibly engage with the flexible tube to maintain a position of the flexible tube within the housing lumen when engaged; a handle assembly comprising: a handle comprising at least one operator engagement actuator control, the at least one operator actuator control configured to cause the engagement assembly to reversibly engage the flexible tube when the at least one operator engagement actuator control is actuated; and after engagement, to cause the engagement assembly to disengage from the flexible lumen when the at least one operator engagement actuator control is disengaged; at least one operator line control; an inserter assembly comprising: an inserter wire comprising: a distal end connected to the housing of the engagement assembly; and a proximal end connected to the handle; a hollow engagement line comprising: a distal end connected to the engager; and a proximal end operatively connected to at least one of the at least one operator engagement actuator control to activate and deactivate the engager upon actuation of the at least one operator engagement actuator control; a line comprising: a distal end; and a proximal end operatively connected to at least one of the at least one operator line control and the handle, the at least one operator line control configured to increase tension or ease tension on the line responsive to action of the at least one operator line control; and a head assembly comprising: a distal end and a proximal end; a bulb:comprising a superior aspect, an inferior aspect, and a diameter; and configured to secure the distal end of the line within the inferior aspect of the bulb; and a head shaft: comprising a proximal end connected to the engagement assembly; comprising a distal end confluently connected to the bulb; configured to have a diameter smaller than the diameter of the bulb; and comprising a proximal end connected to the engagement assembly.

17. The catheter insertion device according to claim 16, wherein the engager: is configured to reversibly engage with the flexible tube to maintain a position of the flexible tube within the housing lumen; and is a balloon activated by expansion.

18. The catheter insertion device according to claim 16, wherein: the inferior aspect of the bulb is disposed in a plane; the line channel is disposed in the plane; and the line passes through the plane.

19. The catheter insertion device according to claim 16, wherein: the flexible tube has a length; and the inserter wire is substantially of equal length or longer than the length of the flexible tube.

20. The catheter insertion device according to claim 19, wherein the inserter wire is made of at least one of stainless steel, metal, plastic, and combinations thereof and the inserter wire has a cross-section that is one of, circular, rectangular, and ovoid.

21. The catheter insertion device according to claim 20, wherein: the housing has an outer circumference; the rectangular or ovoid inserter wire has a flatter aspect that is placed radially to the center of the lumen of the housing; and the inserter wire is disposed adjacent the circumference of the housing.

22. The catheter insertion device according to claim 16, wherein the head assembly is made of silicone, soft plastic, and combinations thereof.

23. The catheter insertion device according to claim 16, wherein the head assembly further comprises a flexible distal tip distal to the bulb and of a tapering and increasing flexibility .

24. The catheter insertion device according to claim 16, wherein the head shaft has a cross-section that is one of circular and oval.

25. The catheter insertion device according to claim 16, further comprising a cage internally lining the lumen of the housing.

26. A catheter insertion device for assisting insertion of a flexible tube through a lumen, the catheter insertion device comprising: an engagement assembly comprising: a distal end and a proximal end; an engager configured to reversibly engage with the flexible tube to maintain the position of the flexible tube within the lumen of the housing when engaged; and a lumen; an inserter assembly comprising: an inserter wire comprising a distal end connected to the engagement assembly and a free proximal end; a head assembly comprising: a distal end and a proximal end; a superior aspect, an inferior aspect, and a diameter; a proximal end connected to the engagement assembly;27. The catheter insertion device according to claim 26, wherein the lumen is an anatomic lumen.

28. The catheter insertion device according to claim 26, wherein the engager is configured to roll onto and engage with the flexible tube to maintain position within the housing lumen.

29. The catheter insertion device according to claim 26, wherein the flexible tube has a length and the inserter wire is longer than the length of the flexible tube.

30. The catheter insertion device according to claim 26, wherein the inserter wire is made of at least one of stainless steel, metal, plastic, and combinations thereof.

31. The catheter insertion device according to claim 30, wherein the inserter wire has a crosssection diameter of approximately 0.2 mm to 1.3 mm.

32. The catheter insertion device according to claim 26, wherein the inserter wire has a crosssection that is one of circular, rectangular, and ovoid.

33. The catheter insertion device according to claim 26. wherein the head assembly is comprised of silicone, soft plastic, TPU, and combinations thereof.

34. The catheter insertion device according to claim 26, wherein the head assembly is comprised of a spring element.

35. The catheter insertion device according to claim 34, wherein the spring element is comprised of a spring and a spring extender.

36. The catheter insertion device according to claim 26, wherein the head assembly has a crosssection that is one of oval, elliptical, or otherwise with a short axis and a long axis.

37. The catheter insertion device according to claim 36, wherein the head assembly has a tapered cross-section diameter that decreases from proximal to distal.

38. The catheter insertion device according to claim 26. wherein the head assembly comprises an inferior surface that is flattened and a distal tip that is rounded.

39. The catheter insertion device according to claim 26, wherein the head assembly comprises a inserter wire channel and inserter coupler.

40. The catheter insertion device according to claim 26, wherein: the head assembly comprises a bulb comprising a superior aspect, an inferior aspect, and a diameter; and further comprises a head shaft that comprises: a proximal end connected to the engagement assembly; and a distal end confluently connected to the bulb and having a diameter smaller than the diameter of the bulb.

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