Endosurgical devices and methods of use

Abstract

To provide an endosurgical device and a method of use.SOLUTION: An endosurgical device comprises a flexible tube having at least two lengthwise extending channels, an end effector comprising two opposite jaws having opposite cutting edges, an effector sleeve that surrounds the tube at least at a distal tube end, and means for reciprocating the end effector in relation to the effector sleeve when the effector sleeve is moved forward and backward to close and open the jaws. Exterior faces of the opposite jaws are electrically insulated, and an electrical cord for providing a current to the end effector extends inside one of the lengthwise extending channels of the tube. The endosurgical device may allow a surgeon to take several tissue specimens from an organ and to perform several functions when the device is inside the organ.SELECTED DRAWING: Figure 5

Description

[Technical Field]

[0001] The present invention provides - a flexible tube having a distal tube end, a proximal tube end, and at least two lengthwise extending channels; - an end effector including two opposing jaws with opposing cutting edges, the end effector being provided at the distal tube end; - an effector sleeve surrounding the tube at least at the distal tube end; - means for axially reciprocating the end effector relative to the effector sleeve or for axially reciprocating the effector sleeve relative to the end effector to open and close the jaws; The present invention relates to an endosurgical device comprising: [Background technology]

[0002] Bladder cancer is one of the most costly forms of cancer in Sweden and internationally. In the United States, the estimated cost is approximately $140,000 per newly diagnosed person. In Sweden, approximately 2,400 new cases of bladder cancer are diagnosed each year. Over the past 20 years, the number of cases has increased by a total of 35 percent, and urinary cancers affect men three times more frequently than women. Cancer of the bladder and urinary tract is the third most common form of cancer in Swedish men.

[0003] Approximately 70% of patients have a form of superficial bladder cancer that is limited to the mucosa. This means that although these patients can be treated, unfortunately, there is a risk of recurrence and residual tumor. Approximately two-thirds of patients require a new surgery. It is not uncommon for the same patient to undergo several surgeries, sometimes just a few months after the first. This will likely result in multiple regular visits to a urologist to detect recurrence early so the cancer does not grow.

[0004] Cystoscopy is the primary diagnostic method for diagnosing bladder cancer. Conventional cystoscopes typically have two ports: an optical port that allows viewing the inside of the bladder, and ports for the insertion of various devices.

[0005] If cancer or a suspicious area is found during cystoscopy, the patient is usually scheduled for surgery in the operating room and then stays overnight in the urology ward. In Sweden, patients must wait approximately two weeks for this procedure, and they usually receive spinal or general anesthesia before any procedures that may be performed in the surgery. During surgery, a biopsy specimen is taken using a rigid metal instrument, or a transurethral resection is performed using a rigid metal instrument. In some hospitals, biopsies can be performed as an outpatient procedure using a flexible cystoscope, but the quality of the tissue specimen is not sufficient with flexible biopsy instruments, so a rigid instrument with a larger diameter must be used to obtain a good tissue specimen and to be able to remove the cancer.

[0006] During a cystoscopy, if bladder cancer is suspected, the urologist will typically obtain multiple bladder tissue specimens from various locations within the bladder, typically using punch biopsy forceps, to help establish a diagnosis and determine the extent of the potential tumor. Generally, tissue specimens are taken from any area of ​​abnormal-looking urothelium and from suspicious tumor areas, but are typically taken from the trigone, bladder dome, and the right, left, anterior, and posterior bladder walls. During the procedure, the bladder is irrigated with fluid. Prior to tissue acquisition, during transurethral bladder biopsy using a flexible cystoscope, local anesthesia is administered at the specimen collection site, or anesthesia is obtained locally by instilling an anesthetic into the bladder. After tissue acquisition, the biopsy site is cauterized for hemostasis, and the procedure is repeated. Conventional cystoscopes have only one working channel for the various devices needed during the surgical procedure, and each device must be inserted and removed from the working channel each time a tissue sample is taken from the bladder. Today, it is impossible to administer anesthesia, obtain one or more biopsies, stop bleeding, and destroy small cancers within the bladder using only one instrument. Furthermore, due to their small size, the quality of the biopsy is poor because it does not include important layers within the bladder wall that need to be seen under a microscope. Currently, biopsies are taken by withdrawing the instrument when the jaws become trapped within the tissue, destroying the edges of the tissue sample, reducing the quality of the tissue sample, and making it unusable for accurately diagnosing cancer.

[0007] Treating patients with superficial bladder cancer involves staff from many different departments and is expensive. Today, the cost of obtaining a tissue sample from a bladder cancer in a surgical operating room ranges from 24,000 to 32,000 SEK per patient. Patients are scheduled for surgery, fast, and are anesthetized, and the procedure is performed using a rigid metal device. A urinary catheter is inserted to drain blood, and the patient is monitored 24 hours a day in the ward.

[0008] If instead tissue samples could be taken in a gentle biopsy procedure in the office as an outpatient procedure, without general anesthesia and without the need for a subsequent urinary catheter, the cost of the procedure would be only 3,600 SEK per patient, plus the cost of the device. Therefore, if the biopsy procedure could be optimized, significant costs could be saved.

[0009] (2003) describes a novel system of flexible endoscopic biopsy forceps that takes larger and less traumatic biopsies than existing single biopsy forceps. The device utilizes a central wire with a barbed spike at one end to which sliding, spring-loaded steel jaws are attached. An outer plastic sleeve surrounds the central wire, and a conventional handle actuates the jaws.

[0010] This known device is advanced along the biopsy channel of a fiber-optic endoscope, visualizing the tissue to be biopsied. The forceps open and close when an outer sleeve slides over an inner wire, which allows the spring-loaded steel jaws to open and close. The jaws open, forcing the barbs into the tissue to be biopsied. The fishhook-like barbs pull the tissue back into the jaws, allowing the jaws to bite at an optimal angle, thus obtaining a cleaner, larger tissue specimen. For the second biopsy, the jaws are simply reopened, and the barbed spikes once again penetrate the tissue, pushing the first specimen along the central wire. In this way, up to six biopsies should be obtained with a single pass of the biopsy forceps through the endoscope. All tissue specimens are retracted along with the device when it is withdrawn from the fiber-optic endoscope. However, the fishhook-like barbs injure the tissue specimen, so either the barbs must be scraped off using additional forceps, or the barb tips are pushed into a piece of cork to excise the specimen. Both methods reduce the size of each tissue specimen, thus affecting the specimen's integrity and casting doubt on its exact origin. Because the tissue specimen must be handled without the barbs, the specimen's origin can be difficult to maintain under control. Furthermore, barb-type biopsy devices are quite harsh on both the patient and the tissue specimen, lack a means for local anesthesia or for stopping local bleeding at the specimen collection site, and require a fairly large front end because six tissue specimens are simultaneously deposited along the barbs.

[0011] (2003) describes a monopolar technique for obtaining a biopsy, requiring an active electrical cord fitted to the biopsy forceps and a standard electrocautery device. A grounding pad is placed on the patient's thigh. To obtain the biopsy, the forceps are advanced through the working channel of the cystoscope. The target area is engaged by the toothed jaws of the forceps under direct vision, and a coagulating current is applied while retracting to cause blanching of the surrounding urethelium. The cystoscope and tissue specimen are removed as a unit, and the cystoscope is reinserted to inspect the biopsy site and obtain additional tissue specimens.

[0012] Patent Document 1 proposes a biopsy forceps including a sheath and a rigid inner stainless steel shaft slidably disposed within the sheath and having an end configured with multiple gripping members. The gripping members are movable between open and closed configurations when the shaft and sheath are moved. The gripping members have a curvilinear profile and are biased outward from the longitudinal axis when in the open configuration. The gripping members are unconstrained by the sheath when in the open configuration and are constrained by the sheath when in the closed configuration. The end of the shaft can be laser-cut to form multiple gripping members with proximal edges suitable for shearing, grasping, tearing, or cutting tissue, such that when in the closed configuration, the gripping members form a receptacle for holding one or more tissue specimens. The shaft can be connected to an electrocautery device to apply a voltage to the shaft to electrosurgically cut tissue. This known biopsy forceps device can also be operably connected to an injection or suction source. A suction source in the form of a vacuum pump or syringe has been proposed to be connected to the shaft to assist in tissue removal around the biopsy site or general fluid removal, or to pull tissue samples back into the shaft for removal or to take multiple biopsy samples. Alternative lumens have been proposed in addition to single-lumen shafts that must be used alternately. U.S. Patent No. 5,999,523 is silent on how the gripping members achieve holding several tissue samples at a time, and therefore how the gripping members can be opened without re-dropping the samples inside the closed gripping members.

[0013] Therefore, it is known that tissue specimens can be excised or extracted using various types of effector tools, the most common of which is forceps.1 To reduce the risk of complications and produce better tissue specimens for pathologists, monopolar electrocautery systems have been introduced into cystoscopy.2 To date, however, these monopolar electrocautery systems tend to apply excessive heat to the tissue specimen, thereby destroying cancer cells and rendering the tissue specimen unsuitable for use in cancer diagnosis. [Prior art documents] [Patent documents]

[0014] [Patent Document 1] European Patent No. 1838229 [Non-patent literature]

[0015] [Non-Patent Document 1] “A system of multiple biopsy forceps”, by Thomas V. Taylor, Curr. Surg. 2004 Nov-Dec; 61(6): pages 594-596 [Non-patent document 2] “Flexible cystoscopic bladder biopsies: a technique for outpatient evaluation of the lower urinary tract urothelium” by Marc Beaghler and Michael Grasso in Urology. 1994 Nov; 44(5):756-9 Summary of the Invention [Problem to be solved by the invention]

[0016] There is a need in the art for improved intra-operative devices for obtaining tissue specimens from hollow organs, body cavities, or tissue surfaces via an access channel. [Means for solving the problem]

[0017] In a main aspect of the present invention, there is provided an endo-surgical device of the kind mentioned in the introduction, which has multiple functions that can be activated while the device is still inserted into the endoscope, so that the device does not have to be moved in and out of the endoscope multiple times to complete the required number of biopsies in a non-destructive and safe manner.

[0018] In a further aspect of the present invention, an endo-surgical device in the form of an endoscopic biopsy forceps is provided which is simple, inexpensive to produce, and disposable.

[0019] In a further aspect of the present invention, a multi-functional endo-surgical device is provided for taking several tissue samples, particularly for taking tissue samples from the bladder.

[0020] The novel and unique features by which the above and other aspects are achieved according to the present invention are as follows: - an end effector of an endo-surgical device comprising a main tubular body having a first end connected to a distal tube end to provide fluid communication to at least two longitudinally extending channels, and an opposite second end having opposing jaws; at least one of the jaws is positioned to deflect from a longitudinal axis of the end effector in a relaxed state when the end effector is at least partially outside the effector sleeve; - the end effector and jaws are positioned such that when the end effector is at least partially within the effector sleeve, the jaws are subjected to a compressive force by the effector sleeve to maintain a gap between the closed jaws and define a closed biopsy cup; - The outer surfaces of the opposing jaws are electrically insulated, An electrical cord for providing electrical current to the end effector extends inside one of the longitudinally extending channels.

[0021] The endosurgical device can advantageously be used without general anesthesia for the patient on an outpatient basis or in the receiving ward. The endosurgical device allows the surgeon to obtain several tissue samples directly from the suspected target area without having to repeatedly insert a series of different tools into the working channel of the endoscope each time a tissue sample is obtained. Cancer cells can be destroyed in the same surgical procedure while the endosurgical device is still inside the patient's body. The patient can go home immediately afterwards; no catheter is required, and no fasting is required before the surgical biopsy procedure.

[0022] The outer surfaces of the opposing jaws are electrically insulated from the outside to form a diathermy device that allows the tissue specimen to be released from the organ.

[0023] The use of the term "diathermy" in the context of the present invention means that the jaws of an endo-surgical device are adapted to generate heat in organ tissue by high frequency electromagnetic currents that pass through the tissue to create precise surgical incisions, much like a scalpel blade, thereby providing a fine, precise incision and tissue specimen along with hemostasis.

[0024] The jaws clamp the tissue specimen, and in a diathermy step, the jaws gently sever the tissue specimen from the organ and sear and / or cauterize the wound left at the biopsy site to stop bleeding. In this way, the tissue specimen is free from the organ and does not stick to the jaws. The tissue specimen is freely contained and protected between the jaws inside the biopsy cup defined by the closed jaws when the end effector is positioned inside the effector sleeve. The effector sleeve holds the jaws together in a firm compression to close the biopsy cup around the tissue specimen in a substantially leak-tight manner.

[0025] Electrical insulation of the outer surfaces of the jaws may preferably be obtained by providing a coating on said outer surfaces. Such a coating is preferably a low-friction coating, e.g., a tungsten carbide coating, which can be easily applied onto conductive surfaces of the jaws, such as metallic surfaces, e.g., nitinol, aluminum, or stainless steel. BaP The coating may be a Parylene® coating or a diamond-like carbon (DLC) coating. The trade name Parylene® is a chemical vapor deposited poly(p-oxygen) often used as a moisture barrier and dielectric barrier. R Other types of insulating coatings may also be used within the scope of the present invention.

[0026] The tube may be a non-conductive flexible tube, such as a plastic tube, and said thin flexible tube may be surrounded by a reinforcing member to provide the endo-surgical device with sufficient structure to be guided along the working channel of an endoscope.

[0027] The effector sleeve may be reciprocated to open and close the jaws. Alternatively, the end effector may be reciprocated in and out of the effector sleeve to open and close the jaws. In the jaw closed position, with the end effector located completely inside the effector sleeve, the effector sleeve effectively seals any gap between the opposing jaws, seals the gap where the jaws and hinge member are free from the main tubular body, and seals as much as possible any gap between the opposing cutting edges of the jaws. The effector sleeve may be a steel sleeve or may be resilient to enhance sealing ability. A firm fit around the tube may be sufficient to provide an adequate seal.

[0028] In an advantageous embodiment, both jaws are positioned to deflect from the longitudinal axis of the end effector in a relaxed state when the end effector is at least partially outside the effector sleeve, allowing the jaws to straddle large tissue specimens. The opposing jaws can be spaced apart by, for example, about 5 mm.

[0029] In a preferred embodiment, the tube may have at least a first longitudinally extending channel for an effector wire that functions to hold the jaws in place as the effector sleeve is reciprocated. Alternatively, the effector wire may function to pull the end effector inside the effector sleeve. The effector wire may be an electrical cord for supplying electrical current to the end effector. Alternatively, the electrical cord may be provided in a separate, second longitudinally extending channel in the tube. Alternatively, the effector sleeve may be reciprocated by a reinforcing member that surrounds the tube and is joined end-to-end to the effector sleeve.

[0030] A third longitudinally extending channel may be provided for flushing the closed biopsy cup, for example, to return the tissue specimen to an outlet located at the proximal end of the third longitudinally extending channel at the proximal tube end, so that the tissue specimen is collected directly into a tissue vial marked with patient identification information and its location on a bladder map. Thus, collection of the tissue specimen occurs without the need for further human intervention, without the tissue specimen being touched by a human, or any other type of manipulation of the sample. While further human intervention during biopsy is not excluded within the scope of the present invention, it is preferably omitted in this surgical procedure to make it easier to perform and less invasive to the patient, as well as to make the surgical procedure safer with respect to contamination and preservation of the tissue specimen, and to reduce patient discomfort. The tissue specimen does not become frayed at the edges, does not need to be removed from the endo-surgical device, and can be released from the barbs, cut into smaller pieces, or in any other way exposed to the surrounding environment. The endosurgical device allows for a completely closed procedure once the end effector is positioned within the patient. The vial may be removably coupled in fluid communication with the third longitudinally extending channel of the tubing, for example, via a suitably configured adapter or manifold, or the proximal end of the tubing may separate into individual tubes. In the case of a tubing that separates into individual tubes, they are removable by the surgeon from outside the patient, for example, at the handle. Therefore, the requirement that the maximum outer diameter of the effector sleeve and / or the maximum outer diameter of the reinforcing member around the tube must not exceed the inner diameter of the working channel of the endoscope need not be observed for the individual tubes outside the patient.

[0031] Known commercially available forceps devices that use diathermy thermally destroy the tissue specimen and trap the tissue specimen between the opposing cutting edges of the opposing jaws, requiring the tissue specimen to be manually removed from the forceps. With the endo-surgical device of the present invention, the diathermy does not damage the tissue specimen because the tissue specimen is easily released from the organ and from the externally insulated jaws, and because of the instantaneous cooling of the jaws, optionally initiated by flushing fluid.

[0032] One of the opposing jaws may have an opening configured to expose a needle or nozzle for application of local anesthesia at one or more target sites or localized areas from which tissue specimens are to be excised. When the biopsy cup is closed, the needle or nozzle may reciprocate inside the fourth longitudinally extending channel of the tube to allow the needle or nozzle to be retracted into the opening and sealingly close it.

[0033] Advantageously, the needle or nozzle is arranged so that it is exposed along an axis that is offset from the central axis of the flexible tube.

[0034] In a preferred embodiment, the opening configured to expose the needle or nozzle may comprise a tubular guide member that protrudes inside the biopsy cup when the jaws are closed, which can keep the tip of the needle or the end of the nozzle out of contact with the tissue specimen and can prevent the needle or nozzle from bending so that exposure of the needle or nozzle can be achieved and ensured at all times.

[0035] The third longitudinally extending channel may be advantageously used to flush the closed biopsy cup as described above. In that regard, the third longitudinally extending channel may be in fluid communication with another of the longitudinally extending channels through the biopsy cup defined by the closed opposing jaws. The other longitudinally extending channel may be configured to be connected to a source of flushing fluid, such as water, saline, or a non-conductive liquid like glycine, to supply the flushing fluid, and the third longitudinal channel may be configured to allow the tissue specimen contained inside the biopsy cup to be flushed out of the device by the flushing fluid reaching the biopsy cup from the other longitudinally extending channel and entering the third longitudinally extending channel. The other longitudinally extending channel may advantageously be an empty second longitudinally extending channel. If the first longitudinally extending channel carrying the electrical cord is also used as a delivery channel for the flushing fluid, the electrical cord must be insulated. Suction may be used instead of flushing.

[0036] The third longitudinally extending channel may have a larger cross-section than any of the first, second, and / or fourth longitudinally extending channels to facilitate flushing of the tissue specimen. Preferably, the third longitudinally extending channel may have the largest cross-section possible given the dimensions of the other longitudinally extending channels and the overall diameter of the tube.

[0037] The tissue specimen should be thick enough to include both the lamina propria and the muscularis mucosae, i.e., 3-5 mm. Because the third longitudinally extending channel is the only channel that allows the tissue specimen to be entrained in the flushing fluid and exit the outlet of the third longitudinally extending channel together with the flushing fluid, the tissue specimen is automatically pushed toward the larger cross-section of the third longitudinally extending channel by the pressure of the flushing fluid, and is forced into and along the third longitudinally extending channel. When the tissue specimen is exposed to the pressure or suction of the flushing fluid, the tissue specimen slightly conforms to the lumen in terms of shape, allowing it to easily pass through the third longitudinally extending channel.

[0038] In a preferred embodiment, the jaws of the end effector may be obtained from a piece of conductive pipe having a closed nose portion at its second end. The jaws may then be obtained by cutting, e.g., laser cutting, the pipe piece and deflecting the jaws away from the central axis of the pipe piece. The opposing jaws may then comprise opposing spring members hinged integral with the main tubular body of the pipe piece, and the opposing free ends may comprise biopsy cup ends that together define a biopsy cup in the form of a temporary container for a tissue specimen when the jaws are closed by the effector sleeve.

[0039] Each of the jaws of the end effector may be obtained from a respective piece of conductive pipe with a closed nose portion to make two end effector halves that are assembled into the end effector.

[0040] For example, two end effector halves may be made by cutting two separate pieces of pipe including the hinge member and cup-shaped jaws and welding the main tubular body together. The main tubular body may also include male and / or female coupling means that may fit snugly together after cutting of the appropriate pipe pieces even without welding of the main tubular body, such that the biopsy cup may be hermetically closed by the effector sleeve to prevent flushing fluid from being injected into the organ through gaps and / or crevices as the tissue specimen is flushed out.

[0041] The outer diameter of the tubing can be as little as 2 mm or less to allow the endo-surgical device to fit movably inside the cystoscope, although other types of endoscopes may have larger working channels, in which case the outer diameter of the tubing can be about 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, or even about 5 mm or larger, with any diameter of the longitudinally extending channel being smaller than the diameter of the tubing.

[0042] A reinforcing member or tubing, such as a coiled or helical member, may be used around the tubing to make it sufficiently stiff for movement in and out of the working channel of the endoscope. When using a reinforcing helical or coiled member, for example, to add support to the tubing, the member may advantageously be encapsulated by an outer heat-shrink tubing or sheath. The heat-shrink tubing advantageously seals and insulates the endo-surgical device along its length, preventing it from escaping flushing fluid, while also providing low friction to facilitate threading of the endo-surgical device through the working channel. The distal end of the reinforcing member may be coupled to the proximal end of the effector sleeve to mate the reinforcing member with the effector sleeve, allowing the reinforcing member to move the effector sleeve along the tubing to open and close the jaws. The outer heat-shrink tubing or sheath may be used to mate the effector sleeve and reinforcing member end-to-end.

[0043] The flushing pressure of the flushing fluid, or the applied suction force, can be set taking into account the diameter of the tubing's flushing channel and the size of the tissue specimen to prevent the tissue specimen from getting stuck inside the third longitudinal channel, thus avoiding and preventing clogging of the aforementioned third longitudinal channel. For an endosurgical device incorporating a tubing with an overall outer diameter of, for example, 2 mm for all functions and intended for use with a cystoscope, a fairly high flushing fluid delivery pressure of at least 5 bar may be required through the delivery channel, which is preferably an empty second longitudinally extending channel. However, the fluid delivery pressure can be as high as 10 bar, 20 bar, or even higher. A fluid delivery pressure of, for example, 26 bar has been shown to be sufficient and efficient.

[0044] The opposing free edges of the cup-shaped second ends of the jaws form a conductive pinch surface to diathermally contact tissue when the jaws are moved toward each other by pulling the effector wire or moving the effector sleeve so that the end effector is positioned inside the effector sleeve. Diathermy reduces the need for the surgeon to repeatedly pull the end effector to excise a tissue specimen. The surgeon only needs to wait a few seconds for the applied heat to release the tissue specimen, with negligible discomfort for the patient and minimal steps for the surgeon. Once the tissue specimen is released, force from the effector sleeve forces the biopsy cup jaws to fully close, allowing flushing fluid to pass through without causing the biopsy cup to significantly leak.

[0045] The steps of a surgical procedure using the endo-surgical device of the present invention to obtain a tissue sample include: a) inserting an endoscope, preferably having means such as fiber optic means for visualizing the organ internally; b) optionally distending the organ from which the tissue sample is to be removed with a liquid delivered through the working channel or other channel of the endoscope; c) inserting an endo-surgical device of the present invention into a working channel of an endoscope, and optionally, if not done in step b), distending the organ from which the tissue specimen is to be excised with a liquid delivered through the longitudinally extending channel of the endo-surgical device; d) using the needle or nozzle of the endo-surgical device to anesthetize the entire suspected cancer area or to anesthetize locally at the sampling site, optionally including inflation to facilitate collection of the tissue sample; e) closing the jaws by displacing the end effector inside the effector sleeve to clamp the tissue specimen; f) activating the diathermy by providing an electrical current to the end effector via the electrical cord to release the tissue specimen for placement inside the biopsy cup; g) flushing the tissue specimen out of the biopsy cup under high fluid pressure to collect the tissue specimen at the proximal tube end, preferably in a vial containing formalin; h) displacing the end effector out of the effector sleeve to open the jaws; i) repeating steps e) to h) if all areas suspected of cancer are anesthetized, or repeating steps d) to h) if local anesthesia is used, until the relevant number of tissue samples have been taken; j) optionally destroying any remaining areas of cancer with a burning function by moving the jaws to the tissue to be destroyed; k) withdrawing the endo-surgical device; l) withdrawing the endoscope; may include:

[0046] Preferably the organ is the bladder, but other organs may be amenable to the same principles and biopsy procedures, for example the organ may be the digestive tract, such as the intestine, stomach or esophagus, or the respiratory tract, such as the lungs.

[0047] In the event of excessive bleeding, step j) may be performed at any stage of the surgical procedure, as well as repeated local diathermy, which may advantageously be monopolar.

[0048] The needle or nozzle associated with the fourth longitudinally extending channel may be utilized for purposes other than anesthesia, such as delivering a distending fluid to the organ in step c), injecting a drug or fluid, such as local anesthetic or adrenaline, to stop bleeding, etc. Other options include, but are not limited to, the use of a surgical laser or clamping tool through the fourth longitudinally extending channel.

[0049] The present invention will now be described with reference to the drawings, which illustrate exemplary embodiments of the endo-surgical device of the present invention. [Brief explanation of the drawings]

[0050] [Figure 1] FIG. 1 is a perspective view of a flexible four-channel tube for use in the endo-surgical device of the present invention. [Figure 2] FIG. 10 is a perspective view of the effector sleeve. [Figure 3] FIG. 1 is a side perspective view of the front end of a first embodiment of an endo-surgical device. [Figure 4] 3. FIG. 4 is a longitudinal cross-sectional view taken along line III-III in FIG. [Figure 5] FIG. 1 is a close-up view of a first embodiment of an endo-surgical device with the jaws open. [Figure 6] FIG. 1 is a view of a first embodiment of an endo-surgical device with the jaws closed and the needle exposed. [Figure 7] FIG. 1 is a view of a first embodiment of an end effector made from two pipe blanks including a tapered nose, with the jaws in a closed position. [Figure 8] FIG. 8 is an exploded view of the first embodiment of the end effector of FIG. 7 with the jaws open. [Figure 9]FIG. 8 is an assembled view of the first embodiment of the end effector of FIG. 7, with the jaws in the open position. [Figure 10] FIG. 10 is a front perspective view of a second embodiment of an end effector connected to a dual lumen tube. [Figure 11] FIG. 11 is a perspective side view of an endo-surgical device implementing the end effector seen in FIG. 10, with the jaws seen in a closed position and the needle exposed. [Figure 12] FIG. 10 is a cross-sectional view of a third embodiment of an end effector having a tubular guide member for a nozzle. [Figure 13] FIG. 10 is a front perspective view of a fourth embodiment of an end effector attached to an alternative embodiment of a tube, with the jaws open and the needle exposed. [Figure 14] FIG. 10 is a front end view of a fourth embodiment of an end effector. DETAILED DESCRIPTION OF THE INVENTION

[0051] 1 has four longitudinally extending channels 2, 3, 4, and 5. The first longitudinally extending channel 2 accommodates an effector wire (not shown), the second longitudinally extending channel 3 functions as a first flushing channel for supplying a flushing fluid, such as water, to the biopsy cup under high pressure, the third longitudinally extending channel 4 functions as a second flushing channel for evacuating the tissue specimen with the flushing fluid arriving from the second longitudinally extending channel 3, and the fourth longitudinally extending channel 5 accommodates a longitudinally displaceable needle or nozzle (not shown).

[0052] The effector sleeve 6 seen in Figure 2 has an inner diameter selected to allow the end effector to fit tightly into and out of the effector sleeve 6 to open and close the jaws. The effector sleeve 6 can be a metal pipe.

[0053] FIG. 3 is a partial side perspective view of the front end of a first embodiment 7 of an endo-surgical device, and FIG. 4 is an enlarged longitudinal cross-sectional view of the first embodiment 7 along line III-III in FIG. 3.

[0054] The endo-surgical device 7 includes a first embodiment of an end effector 8 housed within an effector sleeve 6, with opposing jaws 9, 10 closed by a force applied to the jaws 9, 10 by said effector sleeve 6. The end effector 8 has a first end 11 in fluid communication with the multi-lumen tube 1 and an opposite second end 12 including opposing first and second jaws 9, 10, which, in their closed state, define a biopsy cup 13.

[0055] An electrical cord 14 extends through the first longitudinally extending channel 2 of the tube 1 and is secured to the main tubular body 15 at a securing opening 29 between the first end 11 and the second end 12 of the end effector 8 to heat the opposing jaws 9, 10 when an electrical current is applied to the end effector to obtain a tissue specimen.

[0056] 4, the flexible tube 1 is surrounded by a coiled member 16 that reinforces the flexible tube with sufficient bending stiffness to allow it to move inside the working channel of an endoscope (not shown). An outer plastic tubing 17 is heat shrunk around the length of the endo-surgical device to seal the seam and insulate the endo-surgical device from the working channel, and to combine the coiled reinforcement member 16 with the effector sleeve 6, e.g., by heat fusing, to allow the effector sleeve to move longitudinally to open and close the jaws 9, 10 as needed.

[0057] As best seen in FIG. 6, the first jaw 9 has an opening 18 for exposing a needle or nozzle 19 that extends closely inside the fourth longitudinally extending channel 5 of the tube 1 such that the needle 19 sealingly blocks the opening 18 when the needle 19 is retracted.

[0058] FIG. 7 shows a first embodiment of an end effector 8 made from two pipe pieces 26, each having a tapered nose 24. Each of the pipe pieces 26 has been cut into two elongated pipe halves 19a, 19b along a first cutting line 22, for example by laser cutting a pattern that provides opposing first connecting means 20a', 20b' and second connecting means 21a', 21b" on each pipe half 19a, 19b; when the opposing pipe halves 19a, 19b are then joined to obtain the main tubular body 15 of the end effector 8, said connecting means fit closely together such that leakage along the first assembly line 22 is substantially prevented and such that assembly can be performed without welding. Welding or other types of fusing of appropriate parts of the main tubular body is not excluded.

[0059] 7, 8, and 9, each jaw 9, 10 is also separated from the curved pipe wall 23a, 23b of the opposing pipe half 19a, 19b, for example by laser cutting along second cut lines 28a, 28b. Each jaw 9, 10 is thus formed with an elongated hinge member 25 arising from the respective pipe wall 23a, 23b, and an opposite wider cup-shaped end 27a, 27b, essentially provided by the initially closed tapered nose 24 of the pipe section 26.

[0060] After cutting, the respective hinge members 25 are biased to bend away from each other, as can be seen in Figures 8 and 9. The opposing first and second coupling means 20a', 20b' and 21a', 21b" are mated together, as can be seen in Figure 9, with the end effector 8 in its relaxed state, ready to clamp a tissue specimen. When the end effector 8 is retracted inside the effector sleeve 6, or when the effector sleeve is displaced distally by displacing the stiffening member carrying the effector sleeve in front of it, the opposing jaws 9, 10 are urged together and the end effector 8 reaches a tensioned configuration similar to that seen in Figures 3, 4, and 7. The effector sleeve 6 provides an additional seal along the cutting line 22; 28a, 28b. A fixed opening 29 for the electrical cord 14 is provided in the main tubular body 15.

[0061] Figure 10 is a front perspective view of a second embodiment of an end effector 30 connected to a dual lumen tube 31 via an effector sleeve 6. Figure 11 shows a portion of the front end of an endo-surgical device incorporating the end effector seen in Figure 10, with the jaws shown in a closed position and the anesthesia needle exposed, although the effector sleeve 6 has been omitted from Figure 11 to better show the end effector. The dual lumen tube 31 is shown as transparent to show its two lumens, and the stiffening members are not shown.

[0062] The second embodiment of the end effector 30 differs from the first embodiment of the end effector 8 primarily in that the nose 24' is flat instead of tapered, as seen in FIG. 11 . The flat nose requires less machining during manufacturing, in that the pipe pieces are simply closed with flat end plates or by welding during forming. The end effector 30 is similarly cut as described for the first embodiment of the end effector, and the jaws 9', 10' are created by deflecting cut hinge members away from each other, also as described for the first embodiment of the end effector. A flat-nose end effector can be made from two separate pieces of closed-end pipe that are cut lengthwise and then joined, or from a single closed-end pipe.

[0063] Using the terminology used for the first embodiment of the end effector and tube, the dual lumen tube 31 has a fourth longitudinally extending channel 5 for the needle 19 and a third longitudinally extending channel 4 for conveying the tissue specimen out of the tube 31 by flushing or aspiration. An insulated electrical cord 14 extends inside the third longitudinally extending channel 4 of the dual lumen tube 31, parallel to the wall of said third longitudinally extending channel 4, which also serves the purpose of the first longitudinally extending channel 2. Optionally, an outer longitudinally extending recess in the outer wall of said tube may function as the first longitudinally extending channel 2. The fourth longitudinally extending channel 5 can also serve the purpose of the second longitudinally extending channel 3 for delivering flushing fluid to the biopsy cup 13' in the closed state of the opposing jaws 9', 10', in which the needle 19 blocks the opening 18' for exposing said needle 19.

[0064] In the case of the first and second embodiments of the endo-surgical device, the effector wire 33 may be the electrical cord 14 or may be a separate component.

[0065] 12 is a cross-sectional view of a third embodiment of an end effector having a tubular guide member 34 for controlling the displacement of the needle 19. The tubular guide member 35 has a length sufficient to guide the needle 19 out of the opening 18 and to retain the needle tip inside the tubular guide member 35 during the injection stroke.

[0066] FIG. 13 is a front perspective view of the fourth end effector 36 with jaws 9", 10' open and needle 19 exposed, attached to an alternative embodiment of tubing 1'. FIG. 14 shows the fourth end effector 36 in a front end view. The fourth embodiment of the end effector 36 substantially corresponds to the second embodiment shown in FIGS. 10 and 11, and like reference numerals are used for like parts.

[0067] The fourth embodiment of the end effector 36 differs from the second embodiment of the end effector in that the flat nose 24' does not have an opening 18 through which the needle 19 can be exposed when the jaws 9', 10" are closed. Instead, the needle 19 is trapped within a closed biopsy cup defined by the closed jaws 9', 10" of the end effector 36. When the end effector 36 is released from the effector sleeve 6 by retracting the effector sleeve 6 or by pushing the end effector 36 forward and out of the distal opening of the effector sleeve 6, the needle may be released to assume an exposed, active position from which it may be manipulated to apply local anesthetic. In that regard, the active position may be caused by the needle being spring-loaded. To actually perform the biopsy, the needle 19 is retracted, the opposing jaws are closed around the selected tissue, diathermy is applied, and the severed tissue specimen can be flushed through the tube 1' toward the handle of an endoscope used in conjunction with an endosurgical device including an end effector 36.

[0068] The alternative tube 1' substantially corresponds to the first embodiment of the tube 1, and like parts are designated by the same reference numerals. The alternative tube 1' differs only slightly from the first embodiment of the tube 1 in that the longitudinally extending channels 2', 3', 4', 5' have different diameters and cross-sectional areas. Specifically, the second longitudinally extending channel 3', which functions as a first flushing channel for supplying a flushing fluid, such as water, to the closed biopsy cup under high pressure, and the third longitudinally extending channel 4, which functions as a second flushing channel for evacuating a tissue specimen, for example, with the flushing fluid arriving from the second longitudinally extending channel 3, are larger or useful for applying suction.

[0069] As in the case of the first embodiment of the endosurgical device 7, any embodiment of the end effector 30; 34; 36 and the second embodiment of the endosurgical device implementing any type of multi-lumen tube 1, 1' may be reinforced by a coiled reinforcing member as described above, and the effector sleeve may be connected end-to-end to the coiled reinforcing member and heat-shrink tubing 17 may be applied to the outside.

[0070] The endosurgical device of the present invention suggests an entirely new way of obtaining biological tissue from hollow organs. Completely new conditions are created for the treatment of these patients. Costs can be significantly reduced and the benefits to patients enormous. It will be possible to diagnose and repair cancer in outpatients in a matter of minutes during a routine visit. Patients will no longer require post-operative catheterization, which means the high risk of catheter-induced urinary tract infections is eliminated. The involvement of staff from various departments is no longer required; only doctors and nurses are required, which means huge cost savings and allows patients to receive cancer treatment much more quickly, freeing up surgical capacity for other purposes.

Claims

1. a flexible tube (1; 31; 1') having a distal tube end (1a), a proximal tube end (1b) and at least two longitudinally extending channels (2, 3, 4, 5; 2', 3', 4', 5'); an end effector (8; 30; 34; 36) comprising two opposing jaws (9, 10; 9', 10'; 9", 10") with opposing cutting edges, the end effector (8; 30; 34; 36) being provided at said distal tube end (1a) and defining a closed biopsy cup when said opposing jaws are in a closed position; 1. An endo-surgical device comprising: - the opposing cutting edges are configured to cut a tissue specimen by diathermy when an electrical current is applied to the opposing jaws; one of said longitudinally extending channels is configured to provide a fluid for fluidically flushing said closed biopsy cup; an endo-surgical device, wherein a second of said longitudinally extending channels is configured to convey a tissue specimen from said closed biopsy cup by said flushing fluid to an outlet at said proximal tube end.

2. The endo-surgical device of claim 1 , wherein the outer surfaces of the opposing jaws are electrically insulating.

3. 3. The endo-surgical device according to claim 1 or 2, wherein the flexible tube (1; 31; 1') comprises at least three longitudinally extending channels (2, 3, 4, 5; 2', 3', 4', 5).

4. The endo-surgical device of claim 3, wherein one of the longitudinally extending channels houses an electrical cord for providing electrical current to the end effector (8; 30; 34; 36).

5. 5. The endo-surgical device of claim 1, wherein the longitudinally extending channel configured to convey the tissue sample from the closed biopsy cup has a larger cross-section than at least the longitudinally extending channel configured to provide fluid for fluidically flushing the closed biopsy cup.

6. The endo-surgical device of claim 1 , wherein the endo-surgical device is configured to collect the tissue specimen directly into a tissue vial marked with patient identifying information.

7. 7. The endo-surgical device of claim 6, wherein the tissue vial is further marked with the location from which the tissue sample was taken, such as a location on a bladder map.

8. 8. The endo-surgical device of claim 1, further comprising an effector sleeve (6) surrounding the flexible tube at least at the distal tube end, and means for axially reciprocating the end effector (8; 30; 34; 36) relative to the effector sleeve (6) or for axially reciprocating the effector sleeve (6) relative to the end effector (8; 30; 34; 36) to open and close the jaws (9, 10; 9', 10'; 9", 10").

9. 9. The endo-surgical device of claim 8, wherein at least one of the jaws is positioned to deflect from a longitudinal axis of the end effector in a relaxed state when the end effector is at least partially outside the effector sleeve.

10. 10. The endo-surgical device of claim 8 or 9, wherein the end effector and the jaws are arranged such that when the end effector is at least partially located inside the effector sleeve, the jaws are subjected to a compressive force by the effector sleeve to maintain a closed gap between the jaws and define a closed biopsy cup.

11. 11. The endo-surgical device of claim 1, wherein the longitudinally extending channel configured to convey the tissue sample from the closed biopsy cup is in fluid communication with the longitudinally extending channel configured to provide a fluid for fluidly flushing the closed biopsy cup through the biopsy cup (13) defined by the closed opposing jaws.

12. The endo-surgical device according to any one of claims 1 to 11, wherein the flexible tube (1; 31; 1') has an outer diameter of less than or equal to 2 mm.

13. 13. The endo-surgical device of any one of claims 1 to 12, wherein the flushing pressure across the closed biopsy cup (13) is at least 5 bar, at least 10 bar, or at least 20 bar.

14. 11. The endo-surgical device according to any one of claims 8 to 10, wherein the effector sleeve is connected end to end to a stiffening member (16) surrounding the flexible tube (1; 31; 1').

15. 15. The endo-surgical device of claim 1, wherein the jaws are made of an electrically conductive material such as a metal.

16. The endo-surgical device of claim 2 , wherein the electrical insulation on the outer surface of the jaw comprises a coating.

17. The endo-surgical device of claim 16, wherein the coating is a low friction coating such as a chemical vapor deposited poly(p-xylylene) polymer.

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