ENDOSURGICAL DEVICE AND METHOD OF USE

Abstract

A method for treating or diagnosing cancer with and endosurgical device comprising at least two lengthwise extending channels (2,3,4,5; 2′,3′,4′,5′), two opposite jaws (9,10;9′,10′;9″,10″) with use of diathermy and flushing a tissue specimen to a proximal end of the endosurgical device. The method allows the surgeon to take several tissue specimens from an organ and to perform several functionalities when the device is inside the organ. The endosurgical device for use in the method is also disclosed.

Claims

1. A surgical method for treatment or diagnosing cancer of a human, comprising the steps: a) inserting the endosurgical device into the human, b) bringing a distal end of the endosurgical device to an area suspected of cancer, c) closing a pair of jaws of the endosurgical device by displacing an end effector inside an effector sleeve to enclose a tissue specimen and defining a biopsy cup inside the pair of jaws, d) activating diathermy by providing current via an electrical cord to the pair of jaws to set the tissue specimen free for accommodation inside the biopsy cup, e) flushing the tissue specimen out of the biopsy cup with a fluid, and f) collecting the tissue specimen at a proximal end fluidly connected to the distal end of the endosurgical device.

2. The surgical method as claimed in claim 1, further comprising the step of anesthetizing the area suspect of cancer with the endosurgical device before activating the diathermy in step d).

3. The surgical method as claimed in claim 2, wherein the step of anesthetizing the area suspect of cancer is carried out with a needle or a nozzle of the endosurgical device.

4. The surgical method as claimed in claim 1, further comprising the step of, before closing the pair of jaws in step c), displacing the end effector out of the effectors sleeve to open the pair of jaws.

5. The surgical method as claimed in claim 1, wherein steps b)-f) are repeated to take a plurality of tissue specimens without removing the endoscopic device out of the human between the tissue specimens.

6. The surgical method as claimed in claim 5, further comprising the step of destroying at least one remaining area of cancer by diathermy with the pair of jaws.

7. The surgical method as claimed in claim 1, further comprising the step of visualizing an area suspected of cancer with a visualizing means such as a fiber optic means.

8. The surgical method as claimed in claim 1, further comprising the step of expanding the area suspected of cancer with a liquid supplied through a lengthwise extending channel of the endosurgical device.

9. The surgical method as claimed in claim 1, wherein the step of flushing the tissue specimen out of the biopsy cup with a fluid is conduced with a high fluid pressure of at least 5 bar, preferably at least 10 bar, most preferably at least 20 bar.

10. The surgical method as claimed in claim 1, wherein the step of collecting the tissue specimen at a proximal tube end, is carried out by collecting the tissue specimen in a formalin-containing vial.

11. The surgical method as claimed in claim 1, wherein the step of closing the pair of jaws in step c) comprises holding the jaws tight together to close the biopsy cup around the tissue specimen in a substantially leak-proof manner.

12. The surgical method as claimed in claim 1, wherein the pair of jaws comprise exterior faces being electrically insulated by a coating.

13. An endosurgical device suitable for use in the method as described in claim 1, comprising: a flexible tube having a distal tube end, a proximal tube end, and at least two lengthwise extending channels, an end effector comprising two opposite jaws which end effector is provided at the distal tube end, an effector sleeve that surrounds the flexible tube at least at the distal tube end, and means for reciprocating the end effector axially in relation to the effector sleeve, or vice versa, to open and close the jaws, wherein the end effector of the endosurgical device comprises a main tubular body having a first end connected to the distal tube end to provide fluid communication to the at least two lengthwise extending channels, and an opposite second end having the opposite jaws, at least one of the jaws is arranged to diverge from a longitudinal axis of the end effector in a relaxed condition when the end effector is at least partly outside the effector sleeve, the end effector and the jaws are arranged so that the jaws are subjected to a compression force by the effector sleeve to keep the gap between the jaws closed to define a closed biopsy cup when the end effector is at least partly inside the effector sleeve, the exterior faces of the opposite jaws are electrically insulated, and an electrical cord for providing current to the end effector extends inside one of the lengthwise extending channels.

14. An endosurgical device according to claim 13, wherein an exterior diameter of the flexible tube is less than or equal to 2 mm.

15. An endosurgical device according to claim 13, wherein the closed biopsy cup is configured to withhold a flushing pressure of least 5 bar, preferably at least 10 bar, most preferably at least 20 bar.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0071] The invention will now be described with reference to the drawing by way of exemplary embodiments of endosurgical devices of the present invention.

[0072] FIG. 1 is a perspective view of a flexible 4-channel tube for use in an endosurgical device of the present invention,

[0073] FIG. 2 is a perspective view of an effector sleeve,

[0074] FIG. 3 is a perspective view of the front end part of a first embodiment of an endosurgical device seen from the side,

[0075] FIG. 4 is a lengthwise enlarged scale sectional view taken along line in FIG. 3,

[0076] FIG. 5 shows, in an enlarged scale view, the first embodiment of an endosurgical device with open jaws,

[0077] FIG. 6 shows the same with closed jaws and exposed needle,

[0078] FIG. 7 shows a first embodiment of an end effector made from two pipe piece blanks with tapered noses, and where the jaws are closed,

[0079] FIG. 8 is an exploded, enlarged scale view of the same with open jaws,

[0080] FIG. 9 shows the same in assembled state with the jaws in open position,

[0081] FIG. 10 is a perspective view seen from the front of a second embodiment of an end effector connected to a double-lumen tube,

[0082] FIG. 11 is a perspective, angled side view of an endosurgical device implementing the end effector seen in FIG. 10 with the jaws seen in closed condition and the needle exposed,

[0083] FIG. 12 is a sectional view of a third embodiment of an end effector having a tubular guide member for the nozzle,

[0084] FIG. 13 is a perspective view seen from the front of a fourth embodiment of an end effector mounted to an alternative embodiment of a tube and with open jaws and exposed needle, and

[0085] FIG. 14 shows the same in a front end view.

DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS

[0086] The flexible multi-channel tube 1 seen in FIG. 1 has four lengthwise extending channels 2,3,4,5. The first lengthwise extending channel 2 accommodates an effector wire (not shown), the second lengthwise extending channel 3 serves as a first flushing channel for supplying flushing liquid, such as water, under high pressure to the biopsy cup, the third lengthwise extending channel 4 serves as a second flushing channel for ejecting the tissue specimen by means of the flushing liquid arriving from the second lengthwise extending channel 3, and the fourth lengthwise extending channel 5 accommodates a lengthwise displaceable needle or nozzle (not shown).

[0087] The effector sleeve 6 seen in FIG. 2 has an internal diameter selected for the end effector to move tightly in and out of it to open and close the jaws. The effector sleeve 6 may be a metal pipe.

[0088] FIG. 3 is a perspective fragmentary view of the front end part of a first embodiment 7 of an endosurgical device seen from the side, and FIG. 4 is a lengthwise, enlarged scale, sectional view of the same taken along line in FIG. 3.

[0089] The endosurgical device 7 has a first embodiment of an end effector 8 accommodated inside the effector sleeve 6 with the opposite jaws 9,10 closed due to the 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 that includes the opposite first jaw 9 and second jaw 10 that together delimit a biopsy cup 13 in the closed condition of said opposite jaws 9,10.

[0090] An electrical cord 14 extends via the first lengthwise extending channel 2 of the tube 1 and is secured to the main tubular body 15 at securing aperture 29 between the first end 11 and the second end 12 of the end effector 8 to heat up the opposite jaws 9,10 when current is applied to the end effector to take the tissue specimen.

[0091] The flexible tube 1 is surrounded by a coiled member 16, as seen best in FIG. 4, to reinforce the flexible tube with sufficient flexible rigidity so that it can move inside a working channel of an endoscope (not shown). An exterior plastic tubing 17 is heat-shrunken around the length of the of the endosurgical device to seal joints and insulate the endosurgical device from the working channel, and combining the coiled reinforcing member 16 to the effector sleeve 6, e.g. heat fusion, to enable the effector sleeve to move lengthwise to open and close the jaws 9,10 when needed.

[0092] The first jaw 9 has an opening 18 for exposing a needle or nozzle 19, as seen best in FIG. 6, which needle or nozzle extends closely inside the fourth lengthwise extending channel 5 of the tube 1, so that when the needle 19 is retracted it sealingly plugs the opening 18.

[0093] FIG. 7 shows the 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 have been cut into two elongate pipe halves 19a,19b along a first cutting line 22, e.g. by laser cutting into a pattern that provides the respective pipe halves 19a,19b with opposite first coupling means 20a′20b′ and second coupling means 21a′,21b″ that, when the opposite pipe halves 19a,19b are subsequently joined to obtain the main tubular body 15 of the end effector 8, said coupling means mate so closely together that leakage along the first assembling line 22 is substantially prevented, and assembling can be done without even welding. Welding or other kinds of fusion of the appropriate parts of the main tubular body is not excluded.

[0094] As seen in FIGS. 7, 8 and 9 each jaw 9,10 is also sectioned out of the curved pipe walls 23a,23b of the opposite pipe halves 19a,19b, e.g. by laser cutting along second cutting lines 28a,28b. Each jaw 9,10 is thereby shaped with an elongate hinge member 25 emanating from the respective pipe wall 23a,23b and an opposite wider cup-shaped end 27a,27b inherently obtained due to the initially closed tapered nose 24 of the pipe piece 26.

[0095] After cutting the respective hinge members 25 are deflected to curve away from each other, as seen in FIGS. 8 and 9. The opposite first coupling means 20a′20b′ and second coupling means 21a′,21b″ have been mated together, as seen in FIG. 9, where the end effector 8 is in its relaxed state ready to pinch a tissue specimen. When the end effector 8 is retracted inside the effector sleeve 6, or the effector sleeve is displaced distally by displacing the reinforcing member with the effector sleeve in front of it, the opposite jaws 9,10 are forced together, and the end effector 8 reaches the tensioned configuration similar to the configuration seen in FIGS. 3, 4 and 7. The effector sleeve 6 provides further sealing effect along the cutting lines 22;28a,28b. A securing aperture 29 for the electrical cord 14 is provided at the main tubular body 15.

[0096] FIG. 10 is a perspective view seen from the front of a second embodiment 30 of an end effector connected to a double-lumen tube 31 via an effector sleeve 6. FIG. 11 shows a fragment of the front end part of an endosurgical device implementing the end effector seen in FIG. 10 with the jaws seen in closed condition and the anesthetic needle exposed, but where the effector sleeve 6 has been left out in FIG. 11 to better illustrate the end effector. To illustrate the two lumens of the double lumen tube 31 this tube is shown as transparent and no reinforcing member is shown either.

[0097] The second embodiment of an end effector 30 mainly differs from the first embodiment of an end effector 8 in that the nose 24′ is flat instead of tapered, as seen in FIG. 11. A flat nose requires less processing during manufacturing in that a pipe piece simply is closed by a flat end plate during molding or by welding. The end effector 30 is cut similarly as described for the first embodiment of an end effector, and the jaws 9′,10′ made by deflecting the cut hinge members away from each other as also described for the first embodiment of an end effector. A flat-nosed end effector can be made of two separate end-closed pipes cut lengthwise and subsequently joined, or be made from one end-closed pipe.

[0098] Using the terminology used for the first embodiment of an end effector and tube the double lumen tube 31 has a fourth lengthwise extending channel 5 for the needle 19 and a third lengthwise extending channel 4 for transporting the tissue specimen out of the tube 31 by flushing or suction. The insulated electric cord 14 extends alongside the wall of the third lengthwise extending channel 4, inside said third lengthwise extending channel 4 of the double lumen tube 31, which third lengthwise extending channel 4 then also serves the purpose of the first lengthwise extending channel 2. Optionally an exterior lengthwise extending recess in the exterior wall of said tube may serve as the first lengthwise extending channel 2. The fourth lengthwise extending channel 5 may also serve the purpose of the second lengthwise extending channel 3 to deliver the flushing fluid to the biopsy cup 13′ in the closed condition of the opposite jaws 9′,10′ where the needle 19 plugs the opening 18′ for exposing said needle 19.

[0099] For both the first and second embodiment of an endosurgical device the effector wire 33 may be the electrical cord 14 or be separate component.

[0100] FIG. 12 is a sectional view of a third embodiment 34 of an end effector having a tubular guide member 34 for controlling the displacing of the needle 19. The tubular guide member 35 guides the needle 19 out of the opening 18 and has a length sufficient to keep the needle tip inside the tubular guide member 35 during an injection stroke.

[0101] FIG. 13 is a perspective view seen from the front of a fourth end effector 36 with open jaws 9″,10′ and exposed needle 19 and mounted on an alternative embodiment of a tube 1′. FIG. 14 shows the same in a front end view. The fourth embodiment of an end effector 36 corresponds substantially to the second embodiment shown in FIGS. 10 and 11 and for like parts same reference numerals are used.

[0102] The fourth embodiment of an end effector 36 differs from the second embodiment of an end effector in that the flat nose 24′ has no opening 18 through which the needle 19 can be exposed when the jaws 9′,10″ are closed. Instead the needle 19 is confined within the closed biopsy cup defined by the closed jaws 9′,10″ of the end effector 36. Once the end effector 36 is set free of the effector sleeve 6, either by retracting the effector sleeve 6 or by pushing the end effector 36 forward out of the distal opening of the effector sleeve 6, the needle can be set free to assume an exposed active position wherein it can be manipulated to apply local anesthetic. To that aspect the active position may be triggered by the needle being spring-biased. To actually conduct a biopsy, the needle 19 may be retracted, the opposite jaws closed around the selected tissue, diathermy applied, and the cut tissue specimen flushed through the tube 1′ towards the handle of the endoscope used together with the endosurgical device with the end effector 36.

[0103] The alternative tube 1′ corresponds substantially to the first embodiment of a tube 1 and for like part same reference numerals are used. The alternative tube 1′ differs only slightly from the first embodiment of a tube 1 in that the diameters and cross-sections of the lengthwise extending channels 2′,3′,4′,5′ differ. In particular, the second lengthwise extending channel 3′ that serves as a first flushing channel for supplying flushing liquid, such as water, under high pressure to the closed biopsy cup, and the third lengthwise extending channel 4, that e.g. serves as a second flushing channel for ejecting the tissue specimen by means of the flushing liquid arriving from the second lengthwise extending channel 3, are larger or serves for application of suction.

[0104] As for the first embodiment of an endosurgical device 7, a second embodiment of an endosurgical device implementing any embodiment of an end effector 30;34;36, and any kind of multi-lumen tube 1,1′ can be reinforced by a coiled reinforcing member, the effector sleeve be end-to-end connected to a coiled reinforcing member, and a heat-shrink tubing 17 be applied exteriorly, as described above.

[0105] The endosurgical device of the present invention suggests a whole new way to take biopsies from a hollow organ. Completely new conditions are created for the treatment of these patients. The costs can be drastically reduced and the patient benefit is extremely high. It will be possible to diagnose and correct outpatients with cancers in a few minutes on a regular visit. Patients no longer need any catheter treatment after surgery, which means they eliminate the high risk of urinary tract infection that a catheter entails. All different categories of staff no longer need to be involved; it is enough with a doctor and nurse, which means a huge cost reduction, and patients can receive cancer treatment much faster, and surgical capacity for other purposes are released.