MXPA05013964A - Endoscopic attachment device - Google Patents

Abstract

A sheath device (1) suitable for endoscopic instruments (2) and comprising an elongated tubular member (4) having a proximal end (6), a distal open end (7), and at least one fluid channel (23). A flushing unit (5) is connected to the proximal end (6) of the tubular member (4) and comprises a proximal open end (8) suitable for receiving a first endoscopic instrument (2), a fluid inlet (16) in contact with said fluid channel (23), and a fluid outlet (17). The tubular member and the flushing unit together define a first interior guiding passage (10) for sheathing at least a part of said first endoscopic instrument (2). The connection between the tubular member (4) and the flushing unit (5) allows for axial rotation of the tubular member (4) in relation to the flushing unit (5).

Description

ENDOSCOPIC CONNECTION DEVICE FIELD OF THE INVENTION The present invention relates to a protection device or cover suitable for an endoscopic device, such as a catheter or cystoscope, which, when the cover is mounted on any optical device, allows the surgeon to examine or manipulate it inside. from a hole or through an incision, while easily manipulating the endoscopic device. The device allows administration through an agent to the target organ or tissue in variable positions while maintaining a fixed position of the optical device or fluid inlet / outlet device.

BACKGROUND OF THE INVENTION In medical practice, whether for purposes of examination or surgical procedures, the devices used in practice must allow the surgeon to interact easily with the organs and cavities of the patient. The devices that are annoying or difficult to handle or manipulate could cause unsatisfactory surgical procedures, erroneous diagnoses and, in particular, in the case where the patient is not anesthetized, a great discomfort for the patient.

Document UK 2 284 158 describes an injection catheter consisting of an outer cover and a needle means located and movable in axial direction relative to the outer cover. In this way, when multiple injections are made, retraction of the needle means and rotation of the outer cover is required. In addition, the device does not allow visualization during the medical procedure. WO 99/47069 describes an instrument that guides the administration of an injectable material for the treatment of urinary incontinence. The device does not allow variable injection positions, nor the visualization during the medical procedure. US 5,020,514 describes an endoscope for nasal surgery. The endoscope comprises an outer cover with a handle incorporating a switching or change valve for the connection / disconnection of the source of negative pressure and a source of cleaning fluid. A working insert, which is inserted into the outer shaft, comprises an axis for the reception of an optical system, connected in close manner with the working insert, an axis for the reception of an auxiliary instrument and two guides for wires and rods , which are movable through levers. US 5,287,845 discloses an endoscope for transurethral surgery, which has a main body that non-rotatably supports an optical device and a surgical instrument, an outer tube fixed in the main body and that encloses in a tubular form the optical devices and the surgical instrument. The outer tube is rotatable relative to the rest of the parts of the endoscope. DE 42 37 850 describes a device and method for the injection / application of a fluid carrier / medicament, such as polyacrylamide, for medical use. Additional devices representative of the state of the prior art are described in WO 94/28782, US 4,877,033, US 5,313,934 and US 5,320,091. There is a need in the art for a device that, when joined with an optical device, allows manipulation of the work element, namely, the elements that make contact with the patient, while allowing other elements, normally connected with units fixed in the operation scene, remain immovable. This allows the surgeon to easily manipulate the work element while visually accounting for the interaction between the element inserted in the patient with the patient and that is free of other annoying joints.

SUMMARY OF THE INVENTION A first aspect of the invention refers to a protection device or cover (1) suitable for endoscopic instruments (2), the device comprises: a) an elongated tubular member (4) comprising: - a proximal end (6), - a distal open end (7), - at least one fluid channel (23) extending longitudinally from the proximal end to a fluid outlet; and b) a cleaning or washing unit (5) connected to the proximal end (6) of the tubular member (4) and comprising: - a proximal open end (8) suitable for receiving a first endoscopic instrument (2) ), - a fluid inlet (16) which is in contact with the fluid channel (23), and - a fluid outlet (17), the tubular member and the washing unit together define a first interior guide passage (10) extending longitudinally from the proximal open end (8) of the washing unit (5) towards the distal open end (7) of the tubular member (4) for the protection or coating of at least a portion of the first instrument endoscopic (2), and wherein the connection between the tubular member (4) and the washing unit (5) allows the axial rotation of the tubular member (4) in relation to the washing unit (5). A further aspect of the invention relates to the use of the device of the invention for the examination or surgical treatment of the body of a mammal, such as a human. Similarly, the invention relates to a method of treating or examining an internal organ of the body of a mammal comprising the use of the device. A further aspect of the invention relates to a method of injecting a material into a human body comprising the use of the device of the invention. The invention further relates to a kit or necessary material comprising the device and a material suitable for injection into the human body, such as a polymeric hydrogel including polyacrylamide. A further aspect of the invention relates to a device for use in the examination or surgical treatment of a mammalian body, such as a human.

DESCRIPTION OF THE INVENTION An object of the present invention is to provide an endoscopic device that allows the surgeon to manipulate the work element during operation and / or diagnosis while not keeping the work elements immovable. Furthermore, an object of the present invention is to provide a cover of an endoscopic equipment that needs minimal sterilization and is disposable. According to the invention, the above objects are satisfied through a protective device or cover that is suitable for endoscopic instruments, the device comprises: a) an elongated tubular member comprising: a proximal end, a distal open end , and - at least one fluid channel extending longitudinally from the proximal end to the fluid outlet; and b) a washing unit connected to the proximal end of the tubular member and comprising: a proximal open end suitable for receiving a first endoscopic instrument, a fluid inlet that is in contact with the fluid channel, and a fluid outlet, the tubular member and the washing unit together define a first interior guide passage extending longitudinally from the proximal open end of the washing unit to the distal open end of the tubular member for the protection of at least one part of the first endoscopic instrument, and wherein the connection between the tubular member and the washing unit allows axial rotation of the tubular member relative to the washing unit. The term "internal organ" is intended to mean an organ, tissue or any cellular structure located within the body cavity. The term "endoscopic instrument" is intended to mean any type of surgical endoscope or diagnosis of internal cavities of a human body. In a preferred embodiment, each of the elongate tubular member and the washing unit comprises an interior guide passage, which together define the first interior passage, when the two elements are connected to each other. In this way, the first endoscopic instrument could be received through the proximal open end of the washing unit and is pushed into the guide passage. The first endoscopic instrument could be a lens for observing internal tissues or organs during operation or diagnosis, the instrument is coupled with a camera that could be connected to a television / screen. The tubular member encloses at least the part of the endoscopic instrument that will be located within the body, and while this part is wrapped, the open distal end of the tubular member is introduced, for example, through a cavity in the body within the tissue or organ.

The side wall of the tubular member could have a smooth outer surface to thereby expose the patient to as little pain as possible, when the tubular member is inserted into the cavity, for example, the urethra, vagina or rectum preferably, the The cross section perpendicular to the longitudinal direction of the tubular member is of a substantially circular shape, although it could be of a substantially oval shape. The entire tubular member or only the part, which will be introduced into the body, for example, 5-15 cm from the tubular member (measured from the distal end), could have an outer circular or oval cross section. The diameter of the tubular member could be different depending on the type of endoscopy, such as 3 mm and up to 15 mm. For the treatment of incontinence, the diameter of the part, which will be introduced through the urethra, is preferred to be 7-8 mm. Also, the length of the tubular member could vary depending on the type of endoscopy, so that the length can be, for example, 5-30 cm, such as 10-25 cm, or 15-20 cm. The washing unit is arranged for the administration of a flow of water (or other fluids) through the fluid outlet, which is preferably located adjacent the distal end or at the distal end. The water flow could be used for washing or cleaning, for example, of the removed tissue or bone parts outside the body during an operation or for washing, for example, of the bladder when operated due to incontinence. Preferably, the fluid channel is placed between the inner guide passage and the side wall of the tubular member, although it could be placed separately within the inner guide passage of the tubular member. The diameter of the outlet could be larger than the diameter of the inlet. In the event that the cover device, for example, is used for the treatment of anal incontinence, it is not necessary for it to wash with water inside the rectum and therefore, the washing unit could be removed. In this way, the cover device could in this case be connected in a rotating manner directly with the endoscopic instrument. Preferably, the fluid outlet is located at the distal open end, albeit alternately, it could comprise one or more holes provided in the side wall adjacent the distal open end of the tubular member, so that the water leaves the tubular member at an angle with respect to the longitudinal direction of the tubular member. Preferably, the tubular member and the washing unit are fixedly connected (although they are still rotatable) to each other, although they can be connected releasably, so that the two elements can be separated. In a preferred embodiment of the invention, the tubular member further comprises a second guide passage extending substantially longitudinally from a position adjacent the proximal end or from the proximal end to the distal end of the tubular member, the second passageway. it is suitable for receiving and guiding a second endoscopic instrument. As the second guide passage is located in the tubular member, it allows rotation of the second endoscopic instrument relative to the first endoscopic instrument and the washing unit. This is a major advantage during the operation, since in an endoscopic operation the movement and rotation of one or more of the instruments located inside the body during the operation are required, and which can be complicated to control. Since the second guide passage can be rotated separately, the surgeon only needs to move the tubular member with the second instrument and not the washing unit and the first endoscopic instrument, when the second instrument is moved, for example, from an area from tissue to another. This provides easier management of the equipment and a less painful operation for the patient. In particular, the second guide passage is useful when treating a patient due to incontinence. This treatment comprises, for example, the step of injecting a stabilizing agent into different areas of tissue of the urethra next to the neck of the bladder. In this case, the first instrument could comprise a lens and the second instrument could comprise a needle that will be introduced into the tissue, the needle is guided towards the second guide passage when the tubular member is introduced into the bladder through the urethra. The needle is introduced into the tissue area and the stabilizing agent is injected, and if the surgeon wanted to inject the agent into another area of tissue, he could only retract the needle from the tissue by rotating the tubular member without moving the lens and the unit. washing and introducing the needle into another area of tissue. Therefore, the surgeon can hold the lens in the same orientation while moving the needle (via the tubular member) within the body. The tubular member could be rotated within a range of angles from 0 ° to 360 ° relative to the washing unit, such as 45 ° or 90 °. The connection between the tubular member and the washing unit could comprise an indicating means indicating the axially angular rotation between the tubular member and the washing unit + the first instrument. Preferably, the second guide passage comprises an entrance at its end closest to the proximal end of the tubular member, the inlet being located on the outer surface of the tubular member. The input could be configured in a substantially conical fashion to thereby provide better guidance of the second instrument within the passage. The entry could comprise a pierceable seal that will be penetrated by the instrument. Preferably, the inlet could comprise an entrance of conical shape made of rubber. In order to improve the bending moment of the tubular member and therefore, to avoid breaking the member, it could comprise reinforcing bosses extending on the outer surface of the tubular member from its proximal end and along the less than one part of the tubular member toward the distal end. The entry of the second guide passage could be incorporated into one of the reinforcing bosses. The second endoscopic instrument could comprise a needle, such as a needle for injection of the stabilizing agent or other medical agent, the needle being flexible through a substantial portion of its length. The needle could be an ablation needle having a cutting edge (s) for tissue ablation and / or penetration. Alternatively, the second instrument could comprise a fiber optic probe for the operation of internal tissue.

Preferably, the cover device could be disposable (one-time use) in order to provide a surgical device that requires as little sterilization time as possible. Also, the washing unit could be disposable, in particular if the tubular member and the unit were connected to each other in a fixed manner. In order to avoid reuse of the disposable cover device and the washing unit, a rubber seal could be provided, for example, between the washing unit and the tubular member, the rubber seal is destroyed when the device is exposed. cover to a sterilization process, for example, in an autoclave. The washing unit is provided for the purpose of cleaning with water inside the internal organ of the body in order to externally wash the removed tissue or parts of the bone. The fluid inlet could be connected to a water reservoir through a flexible tube for the removal with clean water through the fluid channel and the extraction of the fluid outlet towards the organ. The outlet could also be connected through a flexible tube with another water tank for cleaning and extracting the dirty water out of the internal organ through the interior passage. The fluid outlet could be in contact with the open distal end of the tubular member by means of an interior passage extending longitudinally from the tubular member. Preferably, the interior passage is composed of the first inner guiding guide passage of the tubular member, the diameter of which is larger than the diameter of the endoscopic instrument inserted therein. In this way, dirty water could flow to the distal open end, along the outer surface of the endoscopic instrument and outwardly through the outlet. Alternatively, the outlet could be in contact with the distal open end by means of a separate passage / fluid channel provided in the tubular member. In a preferred embodiment, the washing unit comprises an inner tube and an outer tube that surrounds the inner tube with a space therebetween. The entrance is connected to the space created between the outer and inner tubes, and the outlet is connected to the space inside the inner tube. When the washing unit is assembled with the tubular member, the inner tube will be connected to the first guide passage, and the outer tube will be connected to the fluid channel (s). Therefore, when cleaning, for example, the bladder and / or the urethra, the fluid exiting the distal end of the tubular member will be returned to the first interior guide passage without applying a suction in the first passage. This is a substantially faster process than for the devices described in the prior art, where the cleaning and suction are changed separately. However, the suction could be provided in the first guide passage, so that the fluid is sucked out of the bladder and / or the urethra. The first interior guide passage of the washing unit could be located so as to co-extend within the inner tube, so that this passage is connected with the inner guide passage of the tubular member when the washing unit is connected with the same. In this manner, the first interior guide passage, extending longitudinally from the proximal open end of the washing unit to the distal open end of the tubular member to cover at least a portion of the first endoscopic instrument, is defined in accordance with claim 1. The proximal open end of the wash unit is suitable for receiving and guiding the first endoscopic instrument towards the interior guide passage. Sealing means may be provided at the proximal open end of the washing unit in order to obtain a tight connection in the endoscopic instrument. Preferably, the first and second guide passageways and the fluid channel extend substantially parallel to each other. When the tubular member is observed in cross section perpendicular to its longitudinal direction, this could have a cross section of honeycomb shape, wherein the first guide passage is provided in the middle (on the center line of the tubular member) and the fluid channel (s), the second guide passage or more guide passages are provided between the first guide passage and the side wall of the tubular member. Due to the ease of production of the cover device, the fluid channel and the guide passages could be provided through a removable wall member located inside the tubular member, and which is not molded simultaneously with the tubular member, but it is inserted into it. The removable wall member, together with the side wall of the tubular member, could define the fluid channel (s) and the passages. The tubular member could comprise two or three additional guideways extending longitudinally for endoscopic instruments. The distal end of the tubular member could comprise a protrusion extending inward in a circumferential direction for guiding the distal end of the second endoscopic instrument, in particular, the flexible needle mentioned above. The protrusion is useful in connection with the aforementioned incontinence treatment, because the distal end of the needle can be bent to thereby provide still better control of the needle tip. The protrusion could bend the distal end of the needle, so that it could emerge from the tubular member at an angle of 5 ° to 45 ° relative to the centerline of the tubular member. Depending on the type of operation / endoscopic diagnosis, the cover device could be suitable for different types of endoscopic instrument. The instruments that will be introduced into the first interior guide passage could comprise a cystoscope or a gastroscope or a ureteroscope or a resectoscope or an arthroscope or a telescope or a shutter. The first endoscopic instrument could also comprise a camera lens, for example, for the observation of tissue or internal organs. The lens is connected to a camera, so that the surgeon can observe the interior of the body on a screen. Due to the second guide passage, the surgeon only has to observe on the screen and not on the endoscopic equipment placed in the guide passage, for example, the needle. The lens could be disposable (for one-time use). One type of lens used for this purpose could be the type of lens used in "night vision goggles" in the military industry. The disposable lens could be incorporated in the tubular member, so that the surgeon only has to connect the cover device with the endoscopic instruments necessary for the operation and also connect the lens with the camera. After the operation, the cover device with the built-in lens is discarded, and the sterilization process is eliminated or dispensed with. Preferably, the distal end of the tubular member exceeds the distal end of the lens, so that the surgeon, when an instrument is inserted through the second guide passage, could observe the tip of the instrument on the screen before the instrument is introduced. in the tissue or organ. When incontinence treatment is performed, known methods and equipment require a visual inspection which means that the surgeon needs to observe the urine output flow before knowing the correct location to be treated in the neck of the bladder. Since the cover device according to the invention allows the use of both a camera lens and an injection needle at the same time, visual inspection is dispensed with, since the surgeon can find the correct location to be treated in the television / screen. The cover device could be made of a suitable plastic material or metal. A generally interesting aspect of the invention relates to a method of injecting a material into the human body comprising the use of the device of the invention. A very interesting aspect of the invention relates to a case comprising i) the device of the invention; ii) a material suitable for injection into the human body. The material is selected from the group consisting of silicone, hyaluronic acid, polyacrylamide hydrogel, soybean, alginates such as modified alginates, bacterial polysaccharides such as galana gum, plant polysaccharides such as carrageenans, hyaluronic acids, block copolymers, polyethylene-polypropylene glycol oxide, proteins such as fibrin, collagen and gelatin, mixtures of polyethylene oxide and polyacrylic acid, crosslinked elonace chitosan, ethylenically unsaturated groups photochemically crosslinked, macromers such as PEG-oligolactyl-acrylates, polyethylene imine, polylysine, poly (vinylamine) and poly (allyla ine). In a preferred embodiment, the material is polyacrylamide and derivatives thereof. Suitable material could be selected from Metacril, Dermagen, Evolution®, OutLine®, Formacryl®, Argiform®, Bioformacryl, DermaLive, DermaDeep®, Amazing Gel, Bioplastique®, Artecoll®, Arteplast®, Silicone Injections, Profill or Pofil, Aquamid®, Bio-Alcamid ™, Radiance (from Bioform) or derivatives thereof or materials essentially of the same chemical composition. As indicated in a preferred embodiment, the material is polyacrylamide and derivatives thereof, more preferably, wherein the crosslinked polyacrylamide was prepared from methylene bis acrylamide. A further aspect of the invention relates to a device for use in the examination or surgical treatment of a mammalian body, such as a human. A further aspect of the invention relates to the use of a device of the present invention for the surgical or diagnostic examination or treatment of a mammalian body, such as a human. The invention relates to a method of treatment or examination of an internal organ of a mammalian body comprising the use of the device of the invention. In a typical embodiment, the method of the invention relates to a method of treatment, examination or diagnosis of a urogenital organ comprising the use of the device of the present invention. In a typical aspect of the invention, the invention relates to a method of performing a gynealogy examination, usually on a woman, comprising the use of the device of the invention. In a particularly interesting aspect, the invention is directed to a method of treatment of incontinence, which comprises the use of the device of the invention, commonly urinary incontinence or anal incontinence. In a further aspect, the invention is directed to a method of treating an articular joint in a mammal comprising the use of the device of the invention. In a further aspect, the invention is directed to a vesicouretal reflux treatment method comprising the use of the device of the invention. In a further aspect, the invention is directed to a method of treating reflux esophagitis comprising the use of the device of the invention. In a further aspect, the invention is directed to an arthritis treatment method comprising the use of the invention. Similarly, in a further aspect, the invention is directed to a tendonitis treatment method comprising the use of the device of the invention. In a preferred embodiment, the hydrogel of the invention is for use in the treatment of urinary and anal incontinence, more preferably, of urinary incontinence. Urinary incontinence could be stress or reflex urinary incontinence or urge urinary incontinence. Normally, the hydrogel of the invention is suitable for the treatment of stress or reflex urinary incontinence.

In a further aspect of the invention, the present hydrogel is used in the preparation of a stent. Thus, a further object of the invention is the use of a hydrogel, as described above, comprising about 0.5 to 25% by weight of polyacrylamide, based on the total weight of the hydrogel, for the preparation of a stent for the treatment and prevention of incontinence and vesicouretal reflux. The stent is suitably formulated as an injectable suspension. The suspension comprises a homogenized formulation of the hydrogel. Normally, a syringe is filled with the suspension. A further object of the invention relates to a method of treatment or prevention of vesicouretal incontinence or reflux comprising the administration of a hydrogel to a mammal, the hydrogel comprising 0.5 to 25% by weight of polyacrylamide, based on the total weight of the hydrogel The hydrogel, in any of the embodiments described above, is suitable for the method of the invention. Based on the administration of the hydrogel, a thin layer of connective tissue surrounds the stent, allowing the stent to become a stable part of the connective tissue. Due to the stability of the hydrogel and the thin layer of the connective tissue, the stent could be removed from the patient. This advantage is at least in part due to the stability of the hydrogel, which in turn is at least in part due to the cleaning process. Several factors affect the rheological properties of the hydrogel, such as the relative amount of monomer used, the relative amount of the initiator, the temperature and other parameters of the polymerization process and the cleaning or washing process. In this way, the polymerization process could provide a hydrogel with a series of viscosities. The invention is directed to a stent normally for the urethra, the rectum or the colon (or canalis analis), or the ureter and thus could be adapted for the requirements of the conduit. An important object of the invention is to provide a prosthetic device for increasing the resistance of the conduits selected from the group consisting of the urethra; the rectum or colon (or canalis analis); and the ureter for the treatment of urinary incontinence, anal incontinence and vesicouretal reflux, respectively; wherein the device is injectable and comprises the hydrogel as described herein. Preferably, the method of the invention includes the administration of the hydrogel by means of injecting the hydrogel into the suitable conduit. In the treatment of urinary incontinence, the hydrogel is commonly injected into the urethra, specifically, below the submucosal membrane of the urethra. The injection is by means of the external surface of the urethra and towards the submucosal membrane. The present investigators have found that typically 2 to 5 mL of the hydrogel is adequate to provide adequate resistance in the urethra by stabilizing the urethra. Commonly, 3 mL of hydrogel is injected and preferably, 2-5 mL are distributed by deposition of the gel in more than one position in cross section along a single longitudinal position of the urethra. In a particularly suitable embodiment, 3 or more reservoirs are effected along a single longitudinal position of the urethra. The present investigators have found that deposits of 0.5 cm distance from the neck of the bladder are particularly suitable. The present investigators have found that submucosal injections in positions 10, 2 and 6 of the cross-sectional axis of the urethra clock are particularly suitable for the treatment of urinary incontinence. The deposits are usually made through a syringe or through the use of a cystoscope or catheter. Suitably, a needle of 21 to 27G is used for the injection.

For the treatment of anal incontinence, the hydrogel is commonly injected into the colon or rectum. { canalis analis) specifically, below the submucosal membrane of the colon or rectum. Injections of 2 to 6 mL are adequate. Preferably, the hydrogel is distributed in more than one cross-sectional position along a single longitudinal position of the colon or rectum. In a particularly suitable embodiment, 3 or more deposits are made along a single longitudinal position of the colon or rectum, preferably at positions 10, 2 and 6 of the axis clock in cross section of the colon or rectum. For the treatment of vesicourethral reflux, submucosal injections into the patient's ureter are required. Injections of 2 to 5 mL are adequate. Preferably, the hydrogel is distributed in more than one cross-sectional position along a single longitudinal position of the ureter. In a particularly suitable embodiment, 3 or more deposits are made along a single longitudinal position of the ureter, preferably at positions 10, 2 and 6 of the axis clock in cross section of the ureter. In an alternative embodiment of the invention, the method comprises the use of a prosthetic device comprising cells, such as germ cells. Polyacrylamide provides an excellent template and matrix and a matrix for cell growth. The use of cells in combination with the hydrogel of the invention for the preparation of the device would allow cell grafting into the surrounding tissue in the ureter, urethra or analis canalis. A method comprising the hydrogel of the invention and suitable cells allows for greater strength and efficiency to provide strength. In a further embodiment of the invention, the prosthetic device comprises cells, such as germ cells or fat cells. Polyacrylamide provides an excellent template and matrix for cell growth. The use of cells with the hydrogel of the invention for the preparation of the device would allow cell grafting into the surrounding tissue in the ureter, urethra or analis canalis. The device comprising the hydrogel of the invention and the suitable cells allows a greater resistance and efficiency to provide resistance.

BRIEF DESCRIPTION OF THE FIGURES Next, a preferred embodiment of the invention will be described with reference to the accompanying figures, in which Figure 1 shows the cover device connected to an endoscope, Figure 2 shows a cross-sectional view of the cover device connected to an endoscope, Figure 3 shows a cross-sectional view of the proximal end of the cover device, Figures 4-6 show a cross-sectional view of the cover device, Figure 7 shows a washing unit of According to the invention, Figures 8-9 show a cross-sectional view of the washing unit, Figure 10 shows an elongated tubular member according to the invention, and Figure 11 shows a removable wall member providing a channel. of fluid and guide passages. Figure 1 shows a cover device 1 connected to an endoscope 2 and an injection needle 3 is also inserted. The cover device comprises a tubular member 4 and a washing unit 5, which are connected to each other detachably in a way that allows the rotation of the tubular member relative to the washing unit and the endoscope. Figure 2 shows a cross-sectional view of the cover device 1 connected to an endoscope 2. The tubular member has a proximal end 6 and a distal open end 7, the washing unit 5 is connected to the proximal end 6. The unit washing comprises a proximal open end 8 and a distal end 9 (see for example, Figures 7-8), the end proximal 8 is adapted to receive the endoscope. The tubular member 4 and the washing unit 5 together define a first interior guide passage 10 extending in the longitudinal direction from the proximal open end 8 of the washing unit to the distal open end 7 of the tubular member for the tubular wrapping. a portion of the endoscopic instrument 2. The tubular member further comprises a second guide passage 11 extending substantially longitudinally from a position 12 adjacent the proximal end or from the proximal end 6 to the distal end 7 of the tubular member, the second passage is suitable for receiving and guiding a second endoscopic instrument 3 (needle). Figure 3 shows the detail X of Figure 2, wherein the needle 3 is located in the second guide passage 11, and the endoscope is located in the first guide passage. The second guide passage 11 comprises an inlet 14 at its end closest to the proximal end 6 of the tubular member 4, the inlet being located on the outer surface of the tubular member. The inlet 14 has a substantially conical shape, so as to guide the treatment instrument 3 within the passage. The inlet comprises a pierceable seal 15 which will be penetrated by the instrument 3. Preferably, the inlet could comprise an entrance of conical shape made of rubber. The washing unit 5 comprises a fluid inlet 16 and a fluid outlet 17, the fluid inlet is in contact with the first guide passage 10 which can also be used as a fluid channel, and which comprises a fluid outlet 13 at the distal open end of the tubular member, see Figure 2. Figure 4 shows a cross section CC of Figure 2, which is a cross section of the tubular member 4. The tubular member comprises the reinforcing ribs 18 which extend on its outer surface. The first guide passage 10 is located, so that its center line coincides with the centerline of the tubular member. The inlet 14 of the second guide passage 11 is located in the rubber release element 19 which is slid over the shoulder 20. A removable wall member 21 is located inside the tubular member 4, and which is not molded in shape. simultaneous with the tubular member, although it is inserted later. The removable wall member 21, together with the side wall 22 of the tubular member, defines the channels / passages 23.

Figure 5 shows a cross-section B-B of Figure 2, wherein the wall detachable member 21 defines the channels 23 for fluid and / or instruments. The second guide passage 11 is shown. Figure 6 shows a cross section A of the Figure 2, comprising the endoscope 2, the needle 3 and the tubular member 4. Figure 7 shows the washing unit 5 with the fluid inlet 16 and the fluid outlet 17, the inlet is in contact with the channel fluid 24 and the outlet is in contact with the fluid channel 25. Figure 8 shows a cross section of the washing unit comprising the inlet 16, the outlet 17 and the guide passage 10. Figure 9 is a section cross section of the washing unit taken perpendicular to the cross section of Figure 8. Figure 10 shows the tubular member 4 of the cover device. Figure 11 shows the wall detachable member 21 which provides the fluid channels and / or guide passages within the tubular member 4, see the description of the previous Figure 4.

Claims (52)

1. CLAIMS 1.
2. A cover device (1) suitable for endoscopic instruments (2), characterized in that it comprises: a) an elongated tubular member (4) comprising: - a proximal end (6), - a distal open end (7) , - at least one fluid channel (23) extending longitudinally from the proximal end to the fluid outlet; and b) a washing unit (5) connected to the proximal end (6) of the tubular member (4) and comprising: - a proximal open end (8) suitable for receiving a first endoscopic instrument (2), - a fluid inlet (16) which is in contact with the fluid channel (23), and - a fluid outlet (17), the tubular member and the washing unit together define a first interior guide passage (10) which extends longitudinally from the proximal open end (8) of the washing unit (5) to the distal open end (7) of the tubular member (4) for the wrapping of at least a portion of the first endoscopic instrument (2), in where the connection between the tubular member (4) and the washing unit (5) allows the axial rotation of the tubular member (4) relative to the washing unit (5), and wherein the tubular member (4) further comprises a second guide passage (11) extending substantially longitudinally from a position (12) next to the proximal end (6) or from the proximal end (6) to the distal end (7) of the tubular member (4), the second passage (11) is suitable for receiving and guiding a second instrument endoscopic (3) The device according to claim 1, characterized in that the second guide passage (11) comprises an entrance (14) at its end closest to the proximal end (6) of the tubular member (4), the inlet (14) it is located on the outer surface of the tubular member.
3. The device according to claim 2, characterized in that the inlet (14) has a substantially conical shape in order to guide the instrument (3) within the passage.
4. The device according to any of claims 1-3, characterized in that the tubular member (4) is disposable (ie, one-time use).
5. The device according to any of claims 1-4, characterized in that the washing unit (5) is disposable.
6. The device according to any of claims 1-5, characterized in that the tubular member (4) and the washing unit (5) are connected to each other in a fixed manner.
7. The device according to any of claims 1-5, characterized in that the tubular member (4) and the washing unit (5) are connected to each other in releasable form.
8. The device according to any of claims 1-7, characterized in that the fluid outlet (13) is located adjacent the distal end (7).
9. The device according to any of claims 1-8, characterized in that the fluid outlet (13) is located at the distal end (7).
10. The device according to any of claims 1-9, characterized in that the fluid outlet (17) is in contact with the open distal end (7) of the tubular member (4) by means of an interior passage that is extends longitudinally in the tubular member (4).
11. The device according to claim 10, characterized in that the interior passage is a part of the first interior guide passage (10).
12. The device according to any of the preceding claims, characterized in that the guide passages (10, 11) and the fluid channel (23) extend in a direction substantially parallel to each other.
13. The device according to any of the preceding claims, characterized in that the center line of the first interior guide passage (10) is coincident with the center line of the tubular member (4).
14. 14. The device according to any of claims 2-13, characterized in that the second endoscopic instrument comprises a needle (3).
15. The device according to any of claims 2-14, characterized in that the first endoscopic instrument comprises a fiber optic probe.
16. The device according to any of the preceding claims, characterized in that the tubular member (4) is capable of being rotated within a range of angles from 0 ° to 360 ° relative to the washing unit (5), such as 45 ° or 90 °.
17. 17. The device according to any of the preceding claims, characterized in that the fluid inlet (16) is connected to a water tank for washing with clean water through the fluid channel (23) and leaving through the fluid outlet (13).
18. 18. The device according to any of the preceding claims, characterized in that the fluid outlet (17) is connected to a water tank for the extraction of waste water from the internal organ by means of the internal passage (10).
19. The device according to any of the preceding claims, characterized in that the tubular member (4) comprises two or three additional longitudinal extension guide passages for additional endoscopic instruments.
20. The device according to any of the preceding claims, characterized in that the outer diameter next to the distal end (7) of the tubular member (4) is between 5-20 mm, such as between 10-15 mm, such as between 7-8 mm.
21. The device according to any of the preceding claims, characterized in that the cross section perpendicular to the longitudinal direction of the tubular member (4) has a substantially oval shape or a substantially circular shape.
22. 22. The device according to any of the preceding claims, characterized in that the length of the tubular member (4) is 5-40 cm, such as 10-35 cm, such as 15-30 cm.
23. 23. The device according to any of claims 2-22, characterized in that one or more of the fluid channel (23) and the guide passages (10, 11) is supplied through a removable wall member located in the interior of the tubular member.
24. 24. The device according to any of claims 2-23, characterized in that the distal end (7) of the tubular member (4) comprises a protrusion extending in an inwardly circumferential direction for the guidance of the distal end of the second endoscopic instrument. .
25. 25. The device according to any of the preceding claims, characterized in that the first endoscopic instrument (2) comprises a cystoscope or a gastroscope or a ureteroscope or a resectoscope or an arthroscope or a telescope or a shutter.
26. 26. The device according to any of claims 1-24, characterized in that the first endoscopic instrument (2) comprises a camera lens, for example, for the observation of the internal tissue or organs.
27. 27. The device according to claim 26, characterized in that the lens is disposable (for one-time use).
28. The device according to claim 26 or 27, characterized in that the distal end (7) of the tubular member (4) exceeds the distal end of the lens.
29. 29. The device according to any of the preceding claims, characterized in that the washing unit comprises cover (s) located next to the entrance and / or exit for the change / turn of the off / on of the washing unit. .
30. 30. The device according to any of claims 1-29, characterized in that it is used in the examination of a mammalian body, such as a human.
31. 31. The device according to any of claims 1-29, characterized in that it is used in the surgical treatment of a mammalian body., just like a human.
32. 32. The use of a device according to any of claims 1-29, for the examination of a mammalian body, such as a human.
33. 33. The use of a device according to any of claims 1-29, for the surgical treatment of a mammalian body, such as a human.
34. 34. A method of treating an internal organ of a mammalian body, characterized in that it comprises the use of the device according to any of claims 1-29.
35. 35. A method of examining an internal organ of a mammalian body, characterized in that it comprises the use of the device according to any of claims 1-29.
36. 36. A method of treating a urogenital organ, characterized in that it comprises the use of the device according to any of claims 1-29.
37. 37. A method of examining a urogenital organ, characterized in that it comprises the use of the device according to any of claims 1-29.
38. 38. A method of treating an articular joint in a mammal, characterized in that it comprises the use of the device according to any of claims 1-29.
39. 39. A method of treating a urinary incontinence, characterized in that it comprises the use of the device according to any of claims 1-29.
40. 40. A method of treating an anal incontinence, characterized in that it comprises the use of the device according to any of claims 1-29.
41. 41. A method of treating an anal incontinence, characterized in that it comprises the use of the device according to any of claims 1-29.
42. 42. A vesicouretal reflux treatment method, characterized in that it comprises the use of the device according to any of claims 1-29.
43. 43. A method of treating reflux esophagitis, characterized in that it comprises the use of the device according to any of claims 1-29.
44. 44. An arthritis treatment method, characterized in that it comprises the use of the device according to any of claims 1-29.
45. 45. A method of treatment of tendonitis, characterized in that it comprises the use of the device according to any of claims 1-29.
46. 46. A method of conducting a genealogical examination, characterized in that it comprises the use of the device according to any of claims 1-29.
47. 47. A method of injecting a material into the human body, characterized in that it comprises the use of the device according to any of claims 1-29.
48. 48. A case, characterized in that it comprises i) the device according to any of claims 1-29; ii) a material suitable for injection into the human body.
49. 49. A kit according to claim 48, characterized in that the material is selected from the group consisting of silicone, hyaluronic acid, polyacrylamide hydrogel, soybean, alginates such as modified alginates, bacterial polysaccharides such as gallana gum, polysaccharides plant such as carrageenans, hyaluronic acids, polyethylene oxide-polypropylene glycol block copolymers, proteins such as fibrin, collagen and gelatin, mixtures of polyethylene oxide and polyacrylic acid, cross-linked chitosan, photochemically cross-linked ethylenically unsaturated groups, macromers such as PEG -oligolactyl-acrylates, polyethyleneimine, poly-lysine, poly (vinylamine) and poly (allylamine).
50. 50. A kit according to claim 48, characterized in that the material is polyacrylamide and derivatives thereof.
51. 51. A kit according to claim 50, characterized in that the polyacrylamide is a crosslinked polyacrylamide.
52. 52. A kit according to claim 51, characterized in that the crosslinked polyacrylamide was prepared from methylene-bis-acrylamide.