The invention relates generally to the delivery and/or suction of matter to desired anatomical locations and more particularly, in some respects, to medical devices (e.g., surgical apparatuses) that include an elongated device having at least one passageway (e.g., a tube) attachable via a coupling structure to an endoscope and useful for suctioning and/or inserting material during a procedure (e.g., a surgical procedure).
Endoscopes are typically used by physicians to inspect the interior of a body of a patient. An endoscope may include one or more channels to allow entry of medical instruments or manipulators, and for removal and introduction of contents. The rate at which contents can be removed from or introduced to a patient's interior is limited by the diameter of the relevant channel. Additionally, some contents, such as stomach or colon contents, may be too large to pass through a normal endoscope internal channel.
Disclosed are surgical apparatuses for coupling an elongated member, like surgical tubing, to an endoscope. Some embodiments of the present surgical apparatuses include an elongated member, such as a flexible tube, and a coupling structure configured to couple the elongated structure to an endoscope. The elongated structure has a channel that extends between first and second openings in the elongated structure, which openings may, in some embodiments, be located at the distal and proximal ends of the elongated structure. The coupling structure may be attached to the elongated structure, such as with an adhesive, or may be formed integrally with the elongated structure. The coupling structure may, in some embodiments, comprise a cap configured to fit over a distal end of an endoscope. The coupling structure may, in some embodiments, include curved portions that extend toward but do not touch each other. The coupling structure may, in some embodiments, be configured to not completely surround a tubular structure (such as an endoscope) when coupled to the tubular structure. The elongated structure may, in other embodiments, comprise a flexible sleeve configured to fit over both an endoscope and the elongated member, and may be configured to be unrolled following placement over both structures; the flexible sleeve may be provided in a rolled-up form. The elongated member may have an inner surface that defines its channel, and the channel may have any suitable cross-sectional profile at any location along its length (which profile may be defined at a given location by the intersection of the inner surface and a plane oriented perpendicular to an axis centered in and running within the channel), such profile having a cross sectional area of at least 0.12 centimeters squared (cm2) in some embodiments, and, in more specific embodiments, a cross sectional area of at least 0.28 cm2; such profile may exist at a location along (or at several spaced-apart locations along) the length of the channel, or may exist along the length of the channel. In some embodiments, the surgical apparatus also includes another coupling structure, such as at least one plastic tie (and, in some embodiments, multiple plastic ties), that can be used to couple the elongated member to an endoscope at a more proximal location than the above-mentioned coupling structure. In some embodiments, the surgical apparatus also includes a hub, that can have a male end over which the proximal end of the elongated member may be positioned to couple the elongated member to the hub, the hub being equipped with a valve; additionally or alternative, the surgical apparatus includes a clamp that can be positioned at a location along the elongated member and used to inhibit flow through the elongated member as desired.
Some embodiments of the present surgical apparatuses include an elongated member coupling structure (such as a cap or a sleeve) configured to be coupled to and surround an exterior portion of an elongated member; and a coupling structure attached to or integral with the elongated member coupling structure and configured to couple the elongated member coupling structure to an endoscope.
The surgical apparatus may comprise a kit that includes a container (such as a flexible pouch), one or more of the components disclosed, and instructions for use (which may be included on the outside of the container (e.g., via a label) or on material (e.g., a card or other insert) disposed inside the container).
Also disclosed are methods of using a surgical apparatus, including methods of using the apparatus during a medical procedure, and methods of instructing another or others (e.g., through a demonstration that is live and in person, live and remote, or pre-recorded, and which may be a mock demonstration) on using the apparatus. Some embodiments of the present methods, which may be characterized as a medical procedure-related methods, comprise coupling an elongated member having a distal end to an endoscope having a distal end so that the distal ends of the elongated member and of the endoscope are aligned. Some embodiments of the present methods comprise coupling an elongated member having a length and a channel to an endoscope having a length so that: the elongated member is positioned beside the endoscope for a portion of their respective lengths, no portion of the elongated member is coaxial with any portion of the endoscope, and no portion of the channel of the elongated member is in communication with any channel of the endoscope. The elongated member of any of these embodiments may be any of the disclosed elongated members, including any of those discussed above in this Summary section. In some embodiments, the coupling may be accomplished with at least a coupling structure, such as a cap configured to fit over the end of the endoscope, that is attached to or integral with the elongated member. In other embodiments, the coupling may be accomplished with at least a coupling structure comprising a flexible sleeve that is positioned around both the endoscope and the elongated member. In still other embodiments, the coupling may be accomplished using at least a coupling structure to which the elongated member is coupled (e.g., via an elongated member coupling structure) and to which the endoscope is coupled. In some embodiments, the method may include using at least another coupling structure to further couple the elongated member to the endoscope at a location proximal of the first coupling structure; the other coupling structure may comprise at least one plastic tie, and the use of the plastic tie to achieve the further coupling may include wrapping the tie around both the endoscope and the elongated member. In some embodiments, the method may also include coupling the elongated member (e.g., its proximal end) to a suction (or vacuum) source (such as a suction canister) or to a fluid-advancing source (such as a syringe or a pump), inserting the endoscope and the elongated member into an animal (e.g., a human), and using the channel of the elongated member to introduce material into or remove material from the animal, which use may involve the suction source or the fluid-advancing source. Some embodiments of the present methods may also include inserting an endoscope coupled, in one of the manners set forth herein, to an elongated member into any location (e.g., a lumen, like a body cavity, or extra-lumen, like the pleural cavity or the peritoneum) of a subject (e.g., a human patient), including a stomach, colon, intestine, bladder, bronchus, ear, nose, throat, or the like.
The term “coupled” is defined as connected, although not necessarily directly, and not necessarily mechanically. The terms “a” and “an” are defined as one or more unless this disclosure explicitly requires otherwise. The term “substantially” is defined as largely but not necessarily wholly what is specified (and includes what is specified), as understood by a person of ordinary skill in the art. In any disclosed embodiment, the terms “substantially,” “approximately,” and “about” may be substituted with “within [a percentage] of” what is specified, where the percentage includes 0.1, 1, 5, and 10 percent.
Further, an apparatus or a component of an apparatus that is configured in a certain way is configured in at least that way, but it can also be configured in other ways than those specifically described.
The terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), “include” (and any form of include, such as “includes” and “including”), and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, an apparatus that “comprises,” “has,” “includes,” or “contains” one or more elements possesses those one or more elements, but is not limited to possessing only those elements. Likewise, a method that “comprises,” “has,” “includes,” or “contains” one or more steps possesses those one or more steps, but is not limited to possessing only those one or more steps. Additionally, terms such as “first” and “second” are used only to differentiate steps, structures, features, or the like, and not to limit the different structures or features to a particular order.
Any embodiment of any of the apparatuses and methods can consist of or consist essentially of—rather than comprise/include/contain/have—any of the described elements, features, and/or steps. Thus, in any of the claims, the term “consisting of” or “consisting essentially of” can be substituted for any of the open-ended linking verbs recited above, in order to change the scope of a given claim from what it would otherwise be using the open-ended linking verb.
The feature or features of one embodiment may be applied to other embodiments, even though not described or illustrated, unless expressly prohibited by this disclosure or the nature of the embodiments.
Details associated with the embodiments described above and others are described below.
The following drawings illustrate by way of example and not limitation. For the sake of brevity and clarity, every feature of a given structure is not always labeled in every figure in which that structure appears. Identical reference numbers do not necessarily indicate an identical structure. Rather, the same reference number may be used to indicate a similar feature or a feature with similar functionality, as may non-identical reference numbers.
Referring to
In most embodiments, elongated member 130 will have a consistent cross-sectional profile, and may comprise surgical tubing. The size of it may be suited to the application. The material from which elongated member 130 is made should be thin and soft enough to not cause excessive trauma on insertion into the body, yet strong enough that it does not collapse under suction. In some embodiments, at least one location along the length elongated member 130 will have an inner cross sectional area of at least 0.12 centimeters squared (cm2) (including at least 0.20 cm2, at least 0.28 cm2, at least 0.38 cm2, at least 0.50 cm2, at least 0.64 cm 2, at least 0.79 cm2, at least 0.95 cm2, at least 1.13 cm2, at least 1.33 cm2, at least 1.54 cm2, at least 1.77 cm2, or more); in some embodiments, that inner cross-sectional area (which may be at least 0.28 cm2) will exist at every location that is completely bounded by the elongated member perpendicular to axis 135 at a given location along the axis (or length) of the elongated member (in contrast, such an area will not exist at locations bounded by the angled distal end of the elongated member). In other words, that inner cross-sectional area may exist at each location along the channel at which a plane (not shown) intersecting axis 135 also intersects inner surface 136 in a closed perimeter. For example, elongated member 130 may have a tubular shape and channel 138 may have an inner diameter of at least 4 millimeters (including 5 and 5.5 mm). As another example, elongated member 130 may have a tubular shape and channel 138 may have an inner diameter of at least 6 mm (including 6.5, 7, 7.5, 8, 8.5, 9, 9.5, and 10 mm or more). Such channel sizes may be used to be used to remove or introduce material at a greater rate and/or of a larger size than is possible by some channels located within some endoscopes.
Coupling structure 150 is configured to couple elongated member 130 to an endoscope (not shown). In the embodiment shown in
Some embodiments of coupling structure 150 can be attached to elongated member 130 in any suitable fashion, including through the use of an adhesive or through sonic welding. Alternatively, coupling structure 150 may be formed integrally with elongated member 130. For example, coupling structure 150 and elongated member 130 may be formed of rigid plastic, metal, or other suitable material, and molded or forged as one piece, such as through injection molding or the like. The attachment between or integration of coupling structure 150 and elongated member 130 may create a fixed relationship between coupling structure 150 and elongated member 130 such that a fixed position and orientation of distal end 132 of elongated member 130 with respect to the distal end of an endoscope may be predetermined.
Versions of coupling structure 150 other than caps may be used. For example, coupling structure 150 may comprise a clip structure having back-to-back openings for receiving an endoscope in one clip-shaped opening and an elongated member in the other clip-shaped opening, or a clamping structure, such as one that includes back-to-back clamps, one sized for an endoscope and another for an elongated member.
In an alternative embodiment to surgical apparatus 100, surgical apparatus 100′ shown in
Coupling structure 250 may have any suitable length. In some embodiments, the length of coupling structure 250 may be 50 percent or less of the length of elongated member 130 (including 50, 49, 48, 47, 46, 45, 44, 43, 42, 41, 40, 39, 38, 37, 36, 35, 34, 33, 32, 31, 30, 29, 28, 27, 26, 25, 24, 23, 22, 21, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 percent or less, but greater than 0 percent of the length of elongated member 130). In other embodiments, the length of coupling structure 250 may be less than 100 percent but greater than 50 percent of the length of elongated member 130 (including less than 100, 99, 98, 97, 96, 95, 94, 93, 92, 91, 90, 89, 88, 87, 86, 85, 84, 83, 82, 81, 80, 79, 78, 77, 76, 75, 74, 73, 72, 71, 70, 69, 68, 67, 66, 65, 64, 63, 62, 61, 60, 59, 58, 57, 56, 55, 54, 53, 52, 51 but greater than 50 percent of the length of elongated member 130).
Surgical apparatus 200 may include multiple coupling structures 250 that can be positioned at multiple locations along the respective lengths of elongated member 130 and endoscope 170. Coupling structure 250 may be configured so that, when positioned around both endoscope 170 and elongated member 130, coupling structure 250 does not overly compress channel 138 of elongated member 130. With coupling structure 250, distal end 132 of elongated member 130 may be positioned in any desired location with respect to the distal end of the endoscope to which the elongated member is coupled. Thus, the first opening of channel 138 may be positioned distal or proximal of the distal end of the endoscope. In addition, the use of coupling structure 250 may afford the surgeon with the option of cutting distal end 132 (and, in some embodiments, therefore, first opening 134) of elongated member 130 to any desired angle, curve, or shape that may be desired to address the needs of a particular patient or procedure.
For embodiments of coupling structure 250 that possess a sufficient degree of elasticity, it may be possible to use one size of coupling structure 250 to function with most or all available endoscopes. Coupling structure 150, when configured as a cap, may require more size varieties to function with the same range of endoscopes.
Embodiments of the present surgical apparatuses (e.g., surgical apparatuses 100, 100′, and 200) may also include one or more additional coupling structures, for further coupling elongated member 130 to an endoscope at locations proximal to the location at which coupling structure 150 or 250 is used (in some embodiments, coupling structures 150 and 250 can be part of the same embodiment and, thus, both used to couple elongated member 130 to an endoscope, and multiple coupling structures 250 may be included in some embodiments of the present surgical apparatuses).
For example,
Embodiments of the present surgical apparatuses (e.g., surgical apparatuses 100, 100′, and 200) may also include a valve member, such as clamp 180 shown in
Embodiments of the present surgical apparatuses may take the form of kits that include a container (e.g., a tray (e.g., a sealed tray), a box, or a pouch (e.g., a sealed, flexible pouch)) in which the components of one of the present surgical apparatuses (e.g., surgical apparatus 100, 100′, or 200) are disposed and that also includes instructions for use (e.g., on the outside of the container (e.g., on a sticker) or on material disposed inside the container (e.g., a written insert) with the surgical apparatus components). One or more of the components of the surgical apparatus included in the container may be sterile.
This disclosure also includes methods, which may be characterized as medical procedure-related methods. Some embodiments of the present methods comprise a method of instructing one or more persons about how to use one of the present surgical apparatuses. The instruction may occur in person live, in person via video, or pre-recorded. The method may include inserting an endoscope coupled to an elongated member (in any manner disclosed herein) into any location (e.g., a lumen, like a body cavity, or extra-lumen, like the pleural cavity or the peritoneum) of a subject (e.g., a human patient), including a stomach, colon, intestine, bladder, bronchus, ear, nose, throat, or the like. For example, the method may include coupling an elongated member having a distal end to an endoscope having a distal end so that the distal ends of the elongated member and of the endoscope are aligned. In other embodiments, the method may include coupling an elongated member having a length and a channel to an endoscope having a length so that: the elongated member is positioned beside the endoscope for a portion of their respective lengths, no portion of the elongated member is coaxial with any portion of the endoscope, and no portion of the channel of the elongated member is in communication with any channel of the endoscope. With any of these embodiments, the elongated member has a channel that extends between a first opening in the elongated member and a second opening in the elongated member, and the channel has an inner cross sectional area of at least 0.12 cm2 at at least one location taken perpendicular to an axis centered in and running within the channel. The endoscope that is used may be suited and sized for any one of more of a variety of applications, including, but not limited to, urology (cystoscopy); pulmonary applications (bronchoscopy); ear, nose and throat applications; SILS (single incision laparoscopic surgery), NOTES (natural orifice transluminal endoscopic surgery), or even “extra-lumen” (pleura, peritoneum).
The coupling may be accomplished using at least a coupling structure, like coupling structure 150, to which the elongated member is coupled (e.g., via elongated member coupling structure 130′) and to which the endoscope is coupled. Alternatively, the coupling may be accomplished using at least a coupling structure (e.g., coupling structure 150) to which the elongated member is attached or with which the elongated member is integral. Still further, the coupling may be accomplished using at least a flexible sleeve.
Embodiments of the present methods may also include using at least another coupling structure to further couple the elongated member to the endoscope at a location proximal of the first coupling structure, such as coupling structure 160. One or more such coupling structures may be used for this purpose.
Embodiments of the present methods may also include locating a valve member at a location distal of the proximal end of the elongated member, such as clamp 180. Embodiments of the present methods may also include regulating the flow of material through the elongated member by actuating the valve member.
Embodiments of the present methods may also include coupling the elongated member to a suction canister and, following introduction of the elongated member and endoscope into an animal (e.g., a human, such as a human patient), removing material from at least one of a stomach, an intestine, and a colon of the animal. In such a circumstance, a valve member like clamp 180 may be actuated to allow flow through the channel, and thus effect removal of contents from the stomach or colon of the body of the patient or subject via suction. For example, blood clots and/or partially digested food may be removed in this fashion.
Embodiments of the present methods may also include coupling the elongated member to at least one of a syringe and a pump and, following introduction of the elongated member and endoscope into an animal (e.g., a human, such as a human patient), introducing material into the animal. In such a circumstance, a valve member like clamp 180 may be actuated to allow flow of contents through the channel, and the syringe or pump may be operated to introduce the contents to the stomach, an intestine, or colon of the body of the patient or subject. The contents may include, but are not limited to, fecal microbiota transplant.
Embodiments of the present methods may also include inserting the endoscope and the elongated member into an animal, such as into the stomach or colon of a human patient. During such insertion, flow may be restricted through the elongated member, such as using a valve member like clamp 180.
The above specification and examples provide a complete description of the structure and use of illustrative embodiments. Although certain embodiments have been described above with a certain degree of particularity, or with reference to one or more individual embodiments, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the scope of this invention. As such, the various illustrative embodiments of the devices are not intended to be limited to the particular foci s disclosed. Rather, they include all modifications and alternatives falling within the scope of the claims, and embodiments other than the one shown may include some or all of the features of the depicted embodiments. For example, while coupling structure 250 is shown as having only one lumen in which both an endoscope and an elongated member may be positioned, in other embodiments (not shown), coupling structure 250 may have an inner divider that creates two lumens, one for the endoscope and one for the elongated member, and those separate lumens may be configured to fit snugly around those respective structures in a non-sliding fashion when used. Where appropriate, aspects of any of the examples described above may be combined with aspects of any of the other examples described to form further examples having comparable or different properties and addressing the same or different problems. Similarly, it will be understood that the benefits and advantages described above may relate to one embodiment or may relate to several embodiments.
The claims are not intended to include, and should not be interpreted to include, means-plus- or step-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase(s) “means for” or “step for,” respectively.
This application claims the benefit of priority to U.S. Provisional Patent Application Ser. No. 61/868,003, filed August 2013, hereby incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2014/051910 | 8/20/2014 | WO | 00 |
Number | Date | Country | |
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61868003 | Aug 2013 | US |