Patent Application
20240252027
This application claims priority from and the benefit of Danish Patent Applications Nos. PA 2021 70265, filed May 21, 2021, and PA 2021 70266, filed May 21, 2021; the contents of the aforementioned applications are incorporated herein by reference in their entirety.
The disclosure relates to endoscopes and, in particular, to endoscopes with irrigation channels.
Generally, an endoscope includes a handle and a shaft which is inserted into the body to a target site. A working channel may be provided through which various tools may be inserted to reach the target site. A ureteroscope is a type of endoscope used to examine a patient's kidneys. In a typical procedure, laser lithotripsy is performed to break stones into multiple smaller fragments which are collected within the calyx. Each fragment is then individually removed using a device inserted through the working channel of the ureteroscope. In another procedure, a vacuum system is used in which the stone fragments are sucked out through the working channel. During this procedure, irrigation fluid is pumped into the kidney through an irrigation channel or the working channel and is expirated out, with the fragmented stones, through the working channel.
U.S. Patent Application No. 2020/0196843 discloses a ureteroscope including a first port and a second port and a shaft including a shaft lumen open at the distal end of the shaft. The first port is in communication with a handle channel which is in communication with the shaft lumen and the second port is in communication with the working channel extending through the handle and the shaft lumen to the distal end of the shaft. Hubs are connected to the shaft lumen and the working channel to seal them so that no fluid can enter into the handle cavity through the hubs. An end cap at the distal end of the shaft includes a plurality of irrigation holes fluidly coupled to the shaft lumen and provided to irrigate the target site.
U.S. Pat. No. 8,784,298 discloses an endoscope instrument including an insertion tube with a distal portion presenting an outlet section and housing an appliance (a tubular duct) for occupying a retracted position inside the tube and a working position in which the appliance occupies at least a portion of the outlet section. The distal portion of the insertion tube includes at least one radially deformable wall over a portion of its length extending from the outlet section, enabling the outlet section of the distal portion of the tube to be increased on the appliance passing from its retracted position (Abstract). Irrigation may be fed through the appliance (col. 5, I. 12-17).
U.S. Pat. No. 10,492,662 discloses integrated endoscope irrigation in the form of an endoscopic device in which the empty spaces between the plurality of tubes, wires, and cables are utilized as a channel that enables liquid or gas to flow from a handle section to a distal tip. The distal tip comprises a pattern of alternating grooves and lands on its outer surface and a cap that fits tightly over the lands extends to and slightly beyond the far end of the distal tip. The tight fitting cap changes the grooves into closed channels through which liquid or gas can flow to an annular nozzle provided by a gap between the front face of the distal tip and a bottom surface of an annular curved portion of the cap
U.S. Patent Publication No. 2017/0215965 discloses a medical device, a ureteroscope, providing for use of a laser to break kidney stones into smaller fragments or dust for removal from a patient. The ureteroscope comprises a tube with two or, in an embodiment shown, three lumens. At the distal end the ureteroscope comprises a distal portion or cap with three openings at the far end corresponding to the three lumens. A first lumen/opening provides for introduction of a laser fiber and/or flow of irrigation fluid, a second lumen/opening provides for suction, and a third lumen provides for wires/fibers/etc. necessary for controlling and communication with an imaging and/or illumination device(s) located at a distal end of the medical device. In some examples, a fourth and/or fifth lumen may be included for, e.g., a separate lumen exclusively for the introduction of the laser fiber or an additional lumen for the introduction of fluid through side ports. The lumens included in the tube may be any size, shape, and/or in any configuration. The first lumen may fork and/or include a plurality of small branches at multiple locations to place first lumen in fluid communication with a plurality of side ports to allow the flow of irrigation fluid within first lumen to exit into the kidney at a plurality of locations along an exterior circumference of distal portion. It is further suggested to position side ports on the sides of tube, whereby more surface area will be available on the distal face of tube (e.g., by minimizing the volume of fluid through the distal end of first lumen and thus cross-sectional area of first lumen at the distal end). The cap may be integral with a sheath which fits along a portion of the tube or a sheath that extends substantially the entire length of the endoscope.
Commonly-owned International Application No. PCT/US2020/030605, published as WO2020/0223429A1, discloses a ureteroscope with a fluid port at the handle for introducing irrigation fluid into a space between the outer wall of the shaft and the working channel within the shaft, denoted as the interstitial space. A fluid seal is provided at the handle, between the fluid port and the outer diameter of the working channel. Pull wires and other wires can pass through the fluid seal, which prevents fluid in the interstitial space in the shaft from flowing into the handle. Some elements passing through fluid seal, such a camera wire, may not need to translate and thus are glued/sealed into place. At a tip at the distal end of the shaft is an opening configured to discharge the irrigation fluid to help clear away debris from the field of view of the camera.
Improvements are desirable to further reduce the size of endoscopes, including ureteroscopes, while simultaneously increasing their functionality.
It is an object of the present disclosure to provide solutions which overcome or reduce at least some of the limitations of the prior art visualization devices. One solution is a visualization device with a reduced distal end cross-section, said reduction being relative to prior art devices performing the same functions. Another solution is a method of making said visualization device, said method being lower-cost relative to prior art devices performing the same functions. Another solution is a system including a video processing apparatus and said visualization device.
The disclosure also relates to small diameter endoscopes where both water irrigation and suction is needed.
It is an object of the present disclosure to provide a construction of an insertion cord for an endoscope that facilitates construction with a small diameter of the insertion cord and especially of a distal end thereof.
In accordance with the aforementioned object and solutions, the present disclosure provides a visualisation device, such as an endoscope, more particularly a ureteroscope, with an interstitial lumen provided to irrigate a distal end of the device. The present disclosure further provides a visualization device with an outer sleeve, or tubular sheath, disposed over a bending section of an insertion cord of the visualization device, which provides at least one bending section fluid opening to permit irrigation of the space surrounding the distal end of insertion cord. The bending section fluid opening may be supplied irrigation fluid via the interstitial lumen or via any other lumen or channel. The interstitial lumen may provide irrigation liquid to the bending section fluid opening or to any other opening at the distal end of the device.
In a first aspect of the present disclosure, an interstitial lumen is provided in an insertion cord of a visualization device, such as an endoscope, the interstitial lumen flowing irrigation liquid to the distal end of the insertion cord. Some embodiments of visualization devices according to the first aspect are described immediately below.
In some embodiments, said endoscope includes a seal between the interstitial lumen and an internal space of a position interface. In some examples, the position interface is a handle comprising a handle housing having an internal space. The seal may be positioned, at least partly, in the internal space.
In some embodiments, said endoscope is provided with an outer sleeve, or tubular sheath, disposed over a bending section of the insertion cord. The outer sleeve provides at least one fluid opening to permit irrigation of the space surrounding the distal end of insertion cord.
In some variations of the present embodiment, the at least one fluid opening is closed in a relaxed condition of the outer tubular sheath and opens when the outer tubular sheath is subject to a pressure of fluid introduced through the proximal end of the insertion cord. Hereby a valve function is obtained that prevents or limits back reflux of fluid into the interstitial lumen.
In some variations of the present embodiment, the outer tubular sheath is of a stretchable material adapted to be stretched when subject to a pressure of fluid introduced through the proximal end of the insertion cord. Hereby is obtained that stretching the material of the tubular sheath may allow the at least one opening to open and relaxation of said pressure may result in the stretchable material returning to its pre-stretched condition closing the at least one opening.
In some variations of the present embodiment, a distal portion of the outer tubular sheath is externally surrounding a part of the elongated body part and is preferably attached to the circumferential body surface thereof at separate positions circumferentially spaced around said circumferential body surface, thus leaving the outer tubular sheath unattached to the circumferential body surface at at least one position between spaced positions of attachment. Hereby may e.g. be obtained that irrigation fluid may leak out along the surface of the elongated body part in a direction towards the area in front of the distal end of the insertion cord. At the same time the attachments prevent displacement of the tubular sheath during insertion of the endoscope insertion cord.
In some variations of the present embodiment, the outer tubular sheath, at least in a relaxed condition, surrounds the circumferential body surface with a tight fit. Hereby a valve function as mentioned above may be obtained.
In some variations of the present embodiment, the elongated body part comprises at least one groove in the circumferential body surface, said at least one groove extending from a proximal end thereof to a distal end thereof, and said groove extending between positions of attachment of the outer tubular sheath to the circumferential body surface. Hereby the flow of irrigation fluid out of the interstitial lumen along the circumferential surface may e.g. be facilitated and focussed by an at least one channel provided by the at least one groove.
In some variations of the present embodiment, the at least one fluid opening is provided by a slit through the material of the outer tubular sheath. Such slit may provide an opening that is closed when the material of the outer tubular sheath is in a relaxed condition and that opens when subject to an internal pressure of fluid.
In some embodiments, said endoscope includes the aforementioned interstitial lumen, and the at least one fluid opening is fluidly coupled to the interstitial lumen to permit irrigation through the at least one fluid opening.
In some embodiments, said sealing body comprises at least one integral part moulded in one piece, said integral part comprising a first portion with at least a first part extending snugly along at least a part of a circumference of at least one of any second tubular body; wire; and wire pipe and a second portion abutting snugly towards the first tubular body, and wherein a fluid passage for communicating a fluid with the interstitial lumen is attached to the sealing body. In an embodiment a construction is obtained that facilitates production, e.g. when the endoscope is produced as a single use, disposable object.
By the expression the “second portion abutting snugly towards the first tubular body” should be understood that the second portion provides for sealing relative to the first tubular body, either directly by contact with the first tubular body, possibly with an intermediate layer of sealant, such as glue, or indirectly through another element.
The endoscope provides for application of different tools through the working channel. In case of use as a ureteroscope the tool may comprise an optic fiber for applying laser pulses e.g. to a kidney stone inside a patient to break or dissolve the kidney stone for subsequent removal by suction through the insertion cord, e.g. through the working channel.
In an embodiment the second portion comprises a second part extending snugly along at least a part of a circumference of the first tubular body. Hereby a need for further sealing between the first tubular body and the internal space of the handle housing may be avoided.
In some embodiments the sealing body comprises a number of two or more of said integral parts, and the first parts of the first portions of said integral parts jointly extend snugly around the entire circumferences of the at least one of any second tubular body; wire; and wire pipe. In other embodiments the sealing body comprises a number of two or more of said integral parts, whereby the first parts of the first portions of said integral parts jointly extend snugly around the entire circumferences of the at least one of any second tubular body; wire; and wire pipe, and whereby the second parts of the second portions of said integral parts jointly extend snugly around the entire circumferences of the first tubular body. Such embodiments facilitate production of the sealing body as moulded parts ready for subsequent assembly.
In a further embodiment the sealing body comprises a first sealing body portion comprising the joint first portions of the integral parts and a second sealing body portion comprising the joint second portions of the integral parts, a first direction is extending from the first sealing body portion towards the second sealing body portion, and the first sealing body portion is extended to have a larger extent relative to an extent the second sealing body portion in a second direction perpendicular to the first direction along a dividing line between said integral parts, the at least one of any second tubular body; wire; wire pipe; and fluid passage being positioned on said dividing line.
In a further embodiment more of said at least one of any second tubular body; wire; wire pipe; and fluid passage are positioned on said dividing line and are mutually spaced whereby the integral parts on either side of the dividing line meet on the dividing line between any pair of said at least one of any second tubular body; wire; wire pipe; and fluid passage for the first parts of said integral parts jointly to extend snugly around each of said at least one of any second tubular body; wire; wire pipe; and fluid passage individually.
Further, in a such embodiment the first sealing body portion is extended to have a larger extent in the second direction relative to the extent of the first sealing body portion in a third direction perpendicular to the first and the second direction.
In some embodiments the fluid passage comprises a tubular element, and third parts of the first portions of said integral parts jointly extend snugly around an entire circumferences of the tubular element. Hereby is facilitated use of an internal tube or hose inside the handle housing for connecting a source of irrigation liquid.
In an embodiment the sealing body is constituted by a single moulded body. In a further embodiment the single moulded body is moulded in situ to seal in relation to first tubular body; and the at least one of any second tubular body; wires; wire pipes; and the fluid passage. Hereby is provided for moulding in situ of the sealing body, e.g. during assembly of the endoscope.
In an embodiment at least one wire is constituted by a Bowden cable comprising an inner cable, typically called a steering wire or pull wire housed in a hollow outer cable housing, typically called a wire pipe, whereby the hollow outer cable housing comprises a pipe sealing extending from the first part and a distance in at least one of a distal direction and a proximal direction of the Bowden cable. The hollow outer cable housing of a Bowden cable is often made from a coiled metal wire. However, such a coiled metal wire will not be watertight, and therefor water in the interior space of the insertion cord may leak through the wire pipes and into the interior space of the handle. By this embodiment sealing of the Bowden cable may be provided.
In an embodiment an inner space is defined inside the sealing body, said inner space being in fluid connection with the interstitial lumen and sealed relative to the internal space of the handle housing.
In a further embodiment a sealing glue is present in the hollow outer cable housing at the place where the hollow outer cable housing is passing the first part and a distance in at least one of the distal direction and the proximal direction of the Bowden cable, and wherein a slip means, such as oil is present between the sealing glue and the inner cable. Hereby is obtained sealing of the Bowden cable in case the pipe sealing does not extent a sufficient distance from the first portion of the sealing body to ensure proper sealing of the Bowden cable while it is still possible to pull the inner cable back and forth.
In a further embodiment the pipe sealing is constituted by the sealing glue. Thus the glue will in this embodiment basically penetrate the hollow outer cable housing to seal the same thereby making a separate pipe sealing superfluous.
In an embodiment the handle housing comprises a connector for connecting a fluid connection, especially a liquid connection, such as a hose, the handle housing further comprising two housing parts interconnected i.a. along respective channel interfaces extending from the connector to the sealing body at a point of attachment of the insertion cord to the handle housing, said channel interfaces providing between them a tubular channel extending along a part of the handle housing. Thus the need for an internal tube or hose inside the handle housing may be reduced or avoided. It should be understood, that the two housing parts may be interconnected along connection interfaces of the two housing parts wherein the channel interfaces constitute parts of said connection interfaces.
In general, the fluid passage for communicating a fluid with the interstitial lumen may be an irrigation liquid inlet for inlet of irrigation fluid to the interstitial lumen. As an alternative, the fluid passage may be used to applying suction to the interstitial lumen.
In some embodiments the endoscope comprises a handle housing and an insertion cord, the insertion cord comprising a first tubular body and having a proximal end and a distal end, the first tubular body housing at least one of: a working channel, constituted by a second tubular body; a wire; and a wire pipe, the first tubular body comprising an interstitial lumen between any present second tubular body; wire; and wire pipe, said interstitial lumen providing a channel for flowing a fluid through the insertion cord, the handle housing comprising an internal space, wherein the proximal end of the insertion cord is attached to the handle housing, and the interstitial lumen of the first tubular body is sealed relative to the internal space of the handle housing by a sealing body, wherein said sealing body comprises at least one integral part moulded in one piece, said integral part comprising a first portion with at least a first part extending snugly along at least a part of a circumference of at least one of any second tubular body; wire; and wire pipe and a second portion abutting snugly towards the first tubular body, and wherein a fluid passage for communicating a fluid with the interstitial lumen is attached to the sealing body.
In some embodiments the endoscope comprises a handle housing and an insertion cord, the insertion cord comprising a first tubular body and having a proximal end and a distal end, the first tubular body housing at least one of: a working channel, constituted by a second tubular body; a wire; and a wire pipe, the first tubular body comprising an interstitial lumen between any present second tubular body; wire; and wire pipe, said interstitial lumen providing a channel for flowing a fluid through the insertion cord, the handle housing comprising an internal space, wherein the proximal end of the insertion cord is attached to the handle housing, and the interstitial lumen of the first tubular body is sealed relative to the internal space of the handle housing by a sealing body, wherein said sealing body comprising a first body part and a second body part, each of said body parts comprising a first portion with at least a first part extending along at least a part of a circumference of at least one of any second tubular body; wire; and wire pipe and a second portion for sealing connection towards the first tubular body, and wherein a fluid passage for communicating a fluid with the interstitial lumen is attached to the sealing body. In an embodiment the first and the second body parts each comprises an assembly face for connection with other of the second and the first body part, and the first parts of the first portions of the first and second body part provide together in an assembled condition of the sealing body, a channel for the at least one of: a working channel, constituted by a second tubular body; a wire; and a wire pipe to extend into the sealing body.
In a variation of the present embodiment, the second portions of the first and second body part provide together in an assembled condition of the sealing body, a second channel for the first tubular body to extend into the sealing body. In an embodiment portions of the first and second body part provide together in an assembled condition of the sealing body, a third channel for the fluid passage to extend into the sealing body. In an embodiment, the assembly faces are provided with mutually corresponding ridges and valleys for securing mutual positioning in the assembled condition.
In an example of the present embodiment, at least one of the first, second, and third channel comprises an intermediate branch channel extending to an outer surface of the sealing body.
In some embodiments an endoscope, such as a ureteroscope, comprises a handle housing and an insertion cord, the insertion cord comprising a first tubular body and having a proximal end and a distal end, the first tubular body housing at least one of: a working channel, constituted by a second tubular body; a wire; and a wire pipe, the first tubular body comprising an interstitial lumen between any present second tubular body; wire; and wire pipe, said interstitial lumen providing a channel for flowing a fluid through the insertion cord, the handle housing comprising an internal space, wherein the proximal end of the insertion cord is attached to the handle housing, and the interstitial lumen of the first tubular body is sealed relative to the internal space of the handle housing by a sealing body.
In a second aspect, the present disclosure provides a visualization system comprising a visualization device according to the first aspect, and a video processing device, such as a monitor.
In a third aspect, a method of irrigating a space within a patient is provided, the method comprising: inserting the insertion cord of the endoscope according to the first aspect into the patient; supplying irrigation fluid to the irrigation channel of the endoscope, the irrigation fluid flowing through the interstitial space and discharging through an opening to the environment. The opening may be an interstitial flow opening according to the fifth aspect of the disclosure.
In a fourth aspect, the present disclosure provides an endoscope in which the insertion cord comprises a bending section and an outer tubular sheath providing an external surface of at least a portion of the bending section. Said outer tubular sheath provides at least one fluid opening for fluid to pass from the bending section to a surrounding of the insertion cord. Some embodiments of endoscopes according to the third aspect are described immediately below.
Providing irrigation fluid through the at least one fluid opening provided by the outer tubular sheath voids the need to provide an irrigation through the distal tip of the insertion cord, thus the overall diameter of the distal tip, and of at least the bending section, may be reduced.
In some embodiments, the insertion cord includes an interstitial lumen provided to flow irrigation liquid to the at least one fluid opening.
In some embodiments, an endoscope comprises a first tubular body and having a proximal end and a distal end, the first tubular body housing at least one of: a second tubular body; a wire; and a wire pipe, the first tubular body comprising an interstitial lumen between any present second tubular body; wire; and wire pipe, said interstitial lumen providing a fluid channel for flowing a fluid through the insertion cord, the insertion cord further comprising a distal tip provided by an elongated body part comprising a circumferential body surface and a distal end tip adjacent the circumferential body surface, an outer tubular sheath providing an external surface of at least a distal part of the insertion cord adjacent the distal end tip of the elon-gated body part, said outer tubular sheath being at least in part exposed to the interstitial lumen, wherein said outer tubular sheath provides at least one fluid opening for fluid to pass between the interstitial lumen and a surrounding of the insertion cord.
In an embodiment the at least one fluid opening is closed in a relaxed condition of the outer tubular sheath and opens when the outer tubular sheath is subject to a pressure of fluid introduced through the proximal end of the insertion cord. Hereby a valve function is obtained that prevents or limits back reflux of fluid into the interstitial lumen.
In an embodiment the outer tubular sheath is of a stretchable material adapted to be stretched when subject to a pressure of fluid introduced through the proximal end of the insertion cord. Hereby is obtained that stretching the material of the tubular sheath may allow the at least one opening to open and relaxation of said pressure may result in the stretchable material returning to its pre-stretched condition closing the at least one opening.
In an embodiment a distal portion of the outer tubular sheath is externally surrounding a part of the elongated body part and is preferably attached to the circumferential body surface thereof at separate positions circumferentially spaced around said circumferential body surface, thus leaving the outer tubular sheath unattached to the circumferential body surface at at least one position between spaced positions of attachment. Hereby may e.g. be obtained that irrigation fluid may leak out along the surface of the elongated body part in a direction towards the area in front of the distal end of the insertion cord. At the same time the attachments prevent displacement of the tubular sheath during insertion of the endoscope insertion cord.
In a further embodiment the outer tubular sheath, at least in a relaxed condition, surrounds the circumferential body surface with a tight fit. Hereby a valve function as mentioned above may be obtained.
In yet a further embodiment the elongated body part comprises at least one groove in the circumferential body surface, said at least one groove extending from a proximal end thereof to a distal end thereof, and said groove extending between positions of attachment of the outer tubular sheath to the circumferential body surface. Hereby the flow of irrigation fluid out of the interstitial lumen along the circumferential surface may e.g. be facilitated and focussed by an at least one channel provided by the at least one groove.
In an embodiment the at least one fluid opening is provided by a slit through the material of the outer tubular sheath. Such slit may provide an opening that is closed when the material of the outer tubular sheath is in a relaxed condition and that opens when subject to an internal pressure of fluid.
In an embodiment the distal part comprises a bending section. In such case the outer tubular sheath may be a cover of the bending section, and the material of the outer tubular sheath may be different from the material of the first tubular body.
In an embodiment the bending section extends distally beyond a distal end of the first tubular body, and in an embodiment the at least one opening is positioned distally of the distal end of the first tubular body.
In an embodiment the bending section comprises a row of segments, where adjacent segments are connected by hinges, preferably made integrally from the same material as the segments, the hinges being arranged for allowing the connected segments to bend in a bending plane, wherein the interstitial lumen extends through at least a number of the segments at a proximal end of the row of segments and the outer tubular sheath is exposed to the interstitial volume between adjacent segments. In a further embodiment the outer tubular sheath is attached to the most proximal segment through the entire circumference thereof to provide openings for the passage, e.g. exit, of fluid, e.g. irrigation liquid, only at one or more positions more distal than the position of the most proximal segment, possibly only at the distal end of the outer tubular sheath.
In a further embodiment the elongated body part comprises a distal segment of the row of segments.
In an embodiment the elongated body part includes a tip housing attached to the distal segment of the row of segments.
In an embodiment the outer tubular sheath is more flexible than the first tubular body. Thus the outer tubular sheath may be made of a different material than the first tubular body and/or the material of the outer tubular sheath may be thinner than the material of the first tubular body.
In some embodiments, the endoscope comprises a handle with an internal space, and an insertion cord, wherein the proximal end of the insertion cord is attached to the handle.
In some variations of the present embodiment, an interstitial lumen is provided in the insertion cord of the endoscope, the interstitial lumen flowing irrigation liquid to the distal end of the insertion cord.
In some variations of the present embodiment, the interstitial lumen of the first tubular body is sealed relative to the internal space of the housing.
In some variations of the present embodiment, said endoscope includes a seal between the interstitial lumen and an internal space of the handle. The seal may be positioned, at least partly, in the internal space. The seal may be as described with reference to embodiments according to the first aspect.
In some embodiments, an endoscope is provided that comprises a handle including a handle housing, an irrigation inlet port adapted to receive irrigation fluid, and an irrigation channel; and an insertion cord extending distally from the handle. The insertion cord includes an insertion tube; a bending section extending from the insertion tube; a distal tip extending from the bending section and including a tip housing; a camera at least partially enclosed in the tip housing; interstitial space within the insertion tube in fluid communication with the irrigation channel; and at least one interstitial flow opening in fluid communication with the interstitial space and adapted to discharge the irrigation fluid.
In a fifth aspect, the present disclosure provides a visualization system comprising an endoscope according to the fourth aspect, and a video processing device, such as a monitor.
In a sixth aspect, a method of irrigating a space within a patient is provided, the method comprising: inserting the insertion cord of the endoscope according to the first aspect into the patient; supplying irrigation fluid to the irrigation channel of the endoscope, the irrigation fluid flowing through the interstitial space and discharging through the at least one interstitial flow opening to irrigate the space.
The disclosure will be explained in further detail by means of examples of embodiments having reference to the accompanying schematic drawings, in which:
The present disclosure may be further understood with reference to the following description and appended drawings, wherein like elements are referred to with the same reference numerals.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In case of conflict, the present document, including definitions, will control. Preferred methods and materials are illustrated below, although apparatuses, methods, and materials similar or equivalent to those illustrated herein may be used in practice or testing. All publications, patent applications, patents and other references mentioned herein are incorporated by reference in their entirety. The materials, methods, and examples disclosed herein are illustrative only and not intended to be limiting.
The terms “comprise(s),” “include(s),” “having,” “has,” “can,” “contain(s),” and variants thereof, as used herein, are intended to be open-ended transitional terms that do not preclude the possibility of additional acts or structures. By contrast, the term “consists,” as used herein, is intended to be a closed-ended transitional term that precludes the possibility of additional acts or structures.
The term “distal,” as used herein, refers to a direction or position that is generally towards a target site, and the term “proximal,” as used herein, refers to a direction or position that is generally away from the target site.
It is noted that the “hollow outer cable housing” may also be denoted “wire pipe” or “wire tube”. Henceforward the term “wire pipe” will be used in this disclosure as a synonym to “hollow outer cable housing”.
As used herein the term “interstitial lumen” refers to the part of the inner lumen of first tubular body not occupied by any second tubular body; wires; or wire pipes, etc.
As used herein the term “snugly” refers to a situation wherein a surface of an element is close to a surface of another element either to be in direct contact or to leave a play between the two surfaces to provide for addition of a liquid or viscous pre-set sealing glue for said glue to provide for sealing in a set condition between the two surfaces. Especially in case of a cylindrical element, such as a tubular element, “snugly” refers to a situation where a surface of an element extends at least partially around the cylindrical element substantially following the contour of the surface of the cylindrical element.
As mentioned above, existing endoscopes and other visualization devices rely on dedicated channels, or lumens, for either irrigation or suction of fluid. Dedicated channel, as used herein, means a channel that is provided by structure that isolates the fluid flowing through the structure such that the fluid only contacts an internal surface of the structure, thereby the structure is dedicated, at least temporaly, exclusively to the passage of the irrigation fluid. For example, the channel may be defined by the internal surface of a tube or the internal surface of a tubular passage.
There is a need to minimize the outer diameter of the insertion cord to reduce trauma to the patient when the device is inserted, for example into the ureter. Ureteroscopes typically have outer diameters of approximately between 7-10 (e.g., 8-10) French (Fr). The smaller the outer diameter becomes, the less room there is to fit multiple dedicated working channels, e.g. one for irrigation and one for suction. Furthermore, as the tip end becomes smaller, it becomes more difficult to fit the camera, light source, and distal ends of various channels. One way to reduce the outer diameter is to eliminate a dedicated irrigation channel and use, instead, an interstitial lumen.
An interstitial channel or lumen, as used herein, means a channel formed in the internal space of a structure that also includes other components of the device, therefore the internal space is not dedicated to the passage of the irrigation liquid, which flows around, and contacts, the other components. See for example
While the present disclosure may be exemplified with an ureteroscope and methods of using the ureteroscope for treating kidney stones, the apparatus and methods described herein find use with any visualization device benefitting from a reduced cross-section or additional functionality, said visualization devices including, but not being limited to, endoscopes. Accordingly, references to the kidney and kidney stones can be generalized to tissue of the patient and objects, including kidney stones, debris and tissue.
Provided herein in some embodiments is a device that utilizes the interstitial space, e.g. interstitial lumen, inside the insertion cord to deliver irrigation fluid at or near the distal end of the device while simultaneously using the working channel for fluid suction and/or other device components. This greatly improves visualization for the procedure while enabling a smaller device outer diameter. In practice, irrigation fluid can be pressurized and flow from an irrigation inlet port 46 in the handle, as described with reference to
A position interface functions to control the position of the insertion cord. A handle is an example of a position interface and, unless stated otherwise, the terms are used interchangeably. The handle also functions to provide manual control actuators, e.g. knobs, levers, buttons, and the like, to steer the tip part and control instruments guided through the insertion cord. Alternatively, a different position interface can be provided that is connected to the insertion cord and is detachably connected to a robotic arm. The insertion cord thus extends from the robotic arm, and the visualization device is detachable from the robotic arm. The tip part (described below) is the same regardless of the position interface used. The robotic arm responds to signals, including voice commands from an operator, to rotate, translate, and otherwise position the proximal end of the insertion cord, as an operator would do manually. The position interface can include control actuators, including manual control actuators. Alternatively or additionally, control actuators can be provided in or on the robotic arm or by the robotic system including the robotic arm, thereby potentially reducing the cost of the visualization device. Example control actuators include single axis actuators, including linear motion actuators. A linear motion actuator may comprise a threaded rod coupled to a threaded nut portion, in which a motor rotates the rod to translate the nut portion.
A visualization system 15 comprises a visualization device and a video processing apparatus, for example the endoscope 1 and a monitor 16 or VPA 16a (shown in
Another embodiment of a video processing apparatus (VPA), i.e. VPA 16b, is shown in
One or more electrical conductors 24 provide power to the camera and light source at the distal tip and transfer data comprising, for example, camera configuration parameters and images obtained by the camera. The electrical conductors 24 may also be utilized to control the light sources at the tip part, such as to illuminate an area in front of the camera. In alternative examples, optical fibres are provided to substitute light sources at the distal tip and, to the extent used, respective power wires.
An interstitial lumen 26 is shown. The interstitial lumen 26 comprises the spacing within the inner surface of the insertion tube 11 that is not occupied by components of the insertion cord 10, for example the working channel 20, the pull cable sheaths 22, and the electrical conductors 24. The electrical conductors 24 comprise power wires and signal wires to provide communication capabilities via, for example, a serial communications protocol.
Pull or steering wires 29, 30 extend through the pull cable sheaths 22 in the insertion tube 11 from a bending actuator at the position interface, e.g. control lever 3, to the distal tip, whereby rotation of the bending actuator translates the steering wires 29, 30 causing the bending section to bend. Additional steering wires may be added for two dimensional steering. The pull wires 29, 30 may be solid wire, such as a monofilament steel wire, or a multifilament cable.
Having described, generally, the visualization device and VPA, attention is now directed to
An irrigation tube 40 defining within it a portion of an irrigation channel 42 is provided in the handle 2, 2′. The irrigation tube 40 extends to a fluid junction body 44 (described with reference to
The interstitial flow openings 64 are formed in the bending section sleeve 63 and may comprise holes 64h, slits 64s, or any other shapes, as depicted in
The irrigation tube 40 may, in an alternative embodiment shown in
The internal walls 74, 76 may connect with each other by interlocking to ensure a fluid seal for the irrigation channel 42. In some variations, the interlocking may be provided by two wall portions of one of the housing parts forming a channel for a wall portion of the other of the housing parts. An example of such an interlocking is provided by wall portions 76b and 76c of the internal wall 76 providing a channel or groove 76d for a wall portion 74b, or tongue, of the internal wall 74, which extends from a wall portion 74a connecting the peripheral wall 70c with the tongue 74b. The channel interlocking, known as a “tongue and groove” joint, may also be formed on the peripheral walls 70c, 70d. A wall portion 76a is also shown, from which the wall portions 76b and 76c extend to form the channel 76d.
In some variations, the interlocking may be provided by a wall portion of one of the housing parts mating, without forming a channel, with a wall portion of the other of the housing parts. An example of such a channelless interlocking is provided by wall portions 70e and 70f of the peripheral walls 70c, 70d, where each of the wall portions 70e and 70f overlaps the other. Each of the wall portions 70e, 70f abuts the opposite peripheral wall portion 70e, 70f. Their thickensses in the overlapping portion may be less than the thickness of the peripheral wall, preferably both thicknesses adding up to the thickness of the peripheral wall. The channelless interlocking, also known as a “half lap” joint, may also be formed on the internal walls 74, 76 instead of the tongue and groove joint.
As shown, the tongue and groove joint provides a more secure seal, protecting the internal components of the handle 2, 2′ from irrigation fluid leaks while the half lap joint keeps the irrigation fluid from leaking to the outside space. However, the stresses provide by the tongue and groove joint on the internal walls can also press the portions of the half lap joint against each other to improve the external seal. Of course an adhesive may be applied along the half lap and/or tongue and groove joints to further seal the irrigation channel 42′.
Having discussed the handle attention is now directed to the bending section and the distal tip of the insertion cord 10.
Referring to
Still referring to
The interstitial fluid openings of the preceding embodiments may be closed in a relaxed condition of the bending section sleeve and open when the bending section sleeve is subject to a pressure of irrigation fluid introduced through the proximal end of the insertion cord 10 through the interstitial space. The bending section sleeve may comprise a stretchable/resilient material adapted to be stretched by the fluid pressure to open the interstitial fluid openings, which may be referred to as pressure-dependent interstitial fluid openings. The length of the slits and the thickness and tensile strength of the material can be selected for a desired irrigation pressure.
The interstitial fluid openings, especially when the openings are provided at positions of non-attachment, as described above, and the outer tubular cover in a relaxed condition surrounds the circumferential surface of the housing 120 with a tight fit, the interstitial fluid openings may close when the the internal or irrigation pressure is below a threshold, which may be a no-pressure threshold. Further, when the interstitial fluid openings are provided by slits, and especially when such slits extend in a longitudinal direction of the insertion cord, the slits 43 may close in the relaxed condition of the outer tubular cover and open when subject to an internal pressure of irrigation liquid in the interstitial space of the bending section.
The cross-section of the distal tip can have several configurations, some of which are more advantageous for creating larger interstitial space in the distal tip. Referring to
In the present embodiment, the passage 92 in the wall 90 accommodates the tube 34. Some space 93 may remain between the circumference of the passage 92 and the tube 34. The space 93 may increase the flexibility of the bending section and also add volume to the interstitial space. The interstitial volume also may include the space between the components 97, 98 and the passages 95, 96 and between the pull wires 29a, 29b and the pull cable passages 84. A wall portion 94 separates the tube 34 and the passages 95, 96.
Referring now to
In some embodiments, the fluid junction body 44 is constituted by a single molded body that may be molded in situ around the insertion tube 11, the pull cable sheaths 22, the working channel tube 34, and the components 97, 98 to seal them with the fluid junction body 44. Alternatively, the two parts 44c and 44d can be molded in a two-shot injection molding step after placing the pull cable sheaths 22, the working channel tube 34, and the components 97, 98.
The first and the second body parts 180a, 180b each comprises a first portion and a second portion and in the assembled condition shown in
The second sealing body portion 187 is intended for sealing connection towards the insertion tube 11 and comprises a second channel 184 provided by second body parts of the second portions. The second channel 184 provides for the insertion tube 11 to extend into the fluid joint body 180.
The fluid joint body 180 provides for a fluid passage for communicating a fluid with the interstitial space of the insertion cord 10. The first and second body part provide together in the assembled condition of the fluid joint body 180 a third channel 182d for the fluid passage to extend into the fluid joint body 180. Such fluid passage may be provided by the irrigation tube 46.
As shown, optionally, the first, second, and third channel 182a, 184, 182d each comprises an intermediate branch channel 192 extending from an intermediate position in the respective channel to an outer surface 193 of the second body part 180b.
In use of the fluid joint body 180 for assembling an endoscope, prior to assembling the first and second body parts 180a, 180b, glue may be applied to the assembly faces 190a, 190b, especially to the valleys 191a and to the parts to provide the first, second, and third channels 182a, 184, 182d. The at least one of a working channel tube 34, a pull cable 170 or a component 97, 98, the insertion tube 11, and the irrigation tube 46 may be positioned on the second body part 180b. The first body part 180a may be assembled with the second body part 180b thereby finishing the first, second, and third channels 182a, 184, 182d with at least one of a working channel tube 34, a pull cable 170 or a component 97, 98, the insertion tube 11, and the irrigation tube 46 positioned and sealed by glue. If the amount of glue provided in the respective first, second, and third channel 182a, 184, and 182d are not sufficient to effectively seal between the surface of the respective channel and the elements positioned therein, additional glue may be injected into the channels through the intermediate branch channels 192.
The fluid joint body 180 comprises an inner space 48 defined inside the fluid joint body. The inner space 48 is in fluid connection with the interstitial space of the insertion tube 11 and sealed relative to the internal space 2b of the handle housing 2a (see
For the glue and/or sealant as described herein a UV setting glue may be used, such as MD® Medical Adhesive 1187-M of the company, DYMAX, but the person skilled in the art will easily realise that many alternatives are useable.
The valleys 191a and ridges 191b provide a tongue-in-groove joint between the first body part 180a and the second body part 180b. In alternative embodiments the tonge-in-groove joint is substituted by a half-lap joint. In further alternative embodiments the joint is substituted by using adhesive to secure the first body part 180a and the second body part 180b to each other.
The insertion tube 11 is connected to the handle 2 at the transition part 202. A sleeve 214 connects the insertion tube 11 with the bending section 12 and the bending section sleeve 63. The pull cables 170 extend from the bending section 12 to the inside of the handle 2. The two pull wires 29a and 29b are attached to a control mechanism with the control lever 216. Thus, an operator may activate the bending section 12 using the control knob 3 which is mechanically attached ot the control lever 216.
The working channel 20 is provided by a first tube segment 220, located in the bending section, connected by a short length of rigid tubing 222 to a second tube segment 224. A flexible hose 226 is also shown. A T-joint 228 attached, in the assembled condition, to the connector 5. A conduit 240 is, optionally, provided surrounding the signal cables or wires 163 to extend through inside the insertion cord 10.
The following items are examples of various embodiments disclosed above:
| Number | Date | Country | Kind |
|---|---|---|---|
| PA 2021 70265 | May 2021 | DK | national |
| PA 2021 70266 | May 2021 | DK | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/063812 | 5/20/2022 | WO |
