DEVICE AND METHOD FOR PERFORMING AN ENDOSCOPIC EXAMINATION FREE FROM CONTAMINATION
20210030261 · 2021-02-04
Inventors
Cpc classification
A61B1/31
HUMAN NECESSITIES
A61B1/00142
HUMAN NECESSITIES
International classification
A61B1/00
HUMAN NECESSITIES
Abstract
Endoscope with contamination protection device comprising a rigid or flexible shaft, at a distal end of which optics and a lighting device are disposed, a handle adjoining the shaft, an inner sheath, which is closed at its one distal end and is optically transparent at least on the end face and which is unrolled along the shaft in the manner of a condom, at least one air tube and water tube, which terminate openly at the distal end of the inner sleeve and are connected thereto and are positioned between the shaft and inner sleeve, and a handle attachment, which is plugged onto the handle with an air and a water valve, to which the air and water tubes are connected, an outer sleeve envelops the inner sleeve and, at a proximal end of the inner sleeve, is connected in an air, water and germ-tight manner to the same.
Claims
1. Endoscope with contamination protection device comprising: a rigid or flexible shaft (1), at the tip of which optics (11), a lighting device (12) and a nozzle (13) are disposed, a handle (2) adjoining the shaft (1), an inner sheath (3) which is closed at its one distal end and is optically transparent at least on the end face and which is unrolled along the shaft (1) in the manner of a condom, at least one air tube (4a) and a water tube (4b), which terminate openly at the distal end of the inner sleeve (3) and are connected thereto and are positioned between the shaft (1) and inner sleeve (3), and characterised in that an outer sleeve (6) envelops the inner sleeve (3) and, at a proximal end of the inner sleeve (3), is connected in an airtight, watertight and germ-tight manner to the same.
2. Endoscope according to claim 1, characterised in that, at one distal end of the outer sleeve (6), a first connecting piece (61a) is integrally formed, and diaper pants (7a) for a patient to be coloscopically examined are provided, which have an opening with a first receiving part (71a), to which the first connecting piece (61a) of the outer sleeve (6) is connected in an airtight, watertight and germ-tight manner, and/or a second connecting piece (61b) is integrally formed, and a bite ring (7b) for a patient to be gastroscopically examined is provided, which has an opening with a second receiving part (71b), to which the second connecting piece (61b) of the outer sleeve (6) is connected in an airtight, watertight and germ-tight manner, and/or a third connecting piece (61c) is integrally formed, and separating wall (7c) or cabin for a patient to be examined behind it is provided, which has an opening with a third receiving part (71c), to which the third connecting piece of the outer sleeve (6) is connected in an airtight, watertight and germ-tight manner.
3. Endoscope according to claim 1, characterised in that a film with an opening is welded onto a distal end of the outer sleeve (6) in an airtight, watertight and germ-tight manner, and, by means of a holding device, is spanned in front of a patient to be examined.
4. Endoscope according to claim 1, characterised in that the inner sleeve (3) and outer sleeve (6) consist of airtight and watertight material that is impervious to pathogens, and/or of flexibly compressible material, that is to say can in particular be rolled up or folded in the manner of a bellows.
5. Endoscope according to claim 1, characterised in that in the shaft (1), there runs at least one instrument channel (10), which opens at the shaft tip into a distal instrument channel opening (101) in each case and, at the handle (2), in a proximal instrument channel opening (102), the inner sleeve (3) has at its end face an operating tube opening (30c) that is congruent with the distal instrument channel opening (101), and the operating tube opening (30c) has an adjoining operating tube (4c), which is positioned in the instrument channel (10) and projects out of the instrument channel opening (102).
6. Endoscope according to claim 5, characterised in that the operating tube (4c) has, in its section that projects out of the proximal instrument channel opening (102), a predetermined breaking point (4c0), and in that a protective tube (4c1), made of a polymeric material, which has a higher elongation at break than a material of the operating tube (4c), is fastened on an outer or inner side of the operating tube (4c) such that the protection tube (4c1) is connected upstream as well as downstream of the predetermined breaking point (4c0) in a manner that is airtight, watertight and germ-tight (4c).
7. Endoscope according to claim 1, characterised by valve holders (22a, 22b) in the handle (2), into which an air valve (5a) and a water valve (5b) or a combined air/water valve (5ab) integrated in a valve block (5ab), as well as a suction valve (5d) can be plugged, and a two-way tube manifold (24), which is plugged at a distal, in particular conically designed end (241) into a proximal end of the operating tube (4c), the tube distributor (24) having, in particular, an instrument opening (242) and a ring nut (243), which is movable axially relative to the tube (4c) and by means of which a proximal instrument channel opening (102) of the endoscope can be fastened.
8. Endoscope according to claim 1, characterised by a handle (21) that is plugged onto the handle attachment (2), in which the following are retained: an air valve (5a) and a water valve (5b) in a valve holder (22), an instrument holder (23) with, inserted therein, a 2-way tube manifold (24), on the distal end of which the operating tube (4c) is connected, a suction valve (5d) and a suction tube (4d), which is connected on a first proximal end of the tube manifold (24) and on the suction valve (5d).
9. Endoscope according to claim 8, characterised in that, at a second proximal end of the tube manifold (24), an instrument protector (8) is connected, which consists of an instrument tube (81), which can be gathered together in the manner of a bellows, and, on each end, has an instrument protection cap (82) with an opening at its end, and has a length that is larger than one length of the operating tube (4c).
10. Endoscope according to claim 1, characterised in that the inner sleeve (3) and/or the outer sleeve (6) on a proximal end of the shaft (1) is fastened on an outer surface of the shaft (1), in particular in that it is pressed, by means of a clip (91) or a rubber ring, on a proximal clamping bracket (93), which is disposed on the outer surface of the shaft (1) and has a proximal seal (92) placed below it, and has passages for the air tube (4a) and water tube (4b).
11. Endoscope according to claim 1, characterised in that the distal end of the inner sleeve (3) is designed as an essentially hollow cylindrical cap (31) with an open end face, which, at an end face opposite the open end face, has an air tube opening (30a) and a water tube opening (30b), on which the air tube (4a) and water tube (4b) are integrally formed, a yoke-like gripper (33) with a click-closure (331, 331) being integrally formed on the cap (31) and the fastening of the cap (31) on the distal end of the shaft (1) being ensured in that it is mounted on a distal clamping bracket (96) that is disposed on an outer surface of the shaft (1) and is underlaid by a distal gasket (95) and has passages for the air tube (4a) and water tube (4b), or for clamping on the distal end of the shaft, axially running elastic branches are integrally formed on an open end face of the cap (31).
12. Endoscope according to claim 1, characterised in that the inner sleeve (3) and outer sleeve (6) are made in one piece, that is to say that the airtight, watertight and germ-tight connection of the outer sleeve (6) to the proximal end of the inner sleeve (3) are already provided during manufacturing, for example by welding and/or the inner sleeve (3) is underlaid by a fabric tubing and/or the outer sleeve (6) encloses the handle (2) and the handle attachment (21).
13. Endoscope according to claim 12, characterised in that, the two-way tube manifold (24) is integrated into that section of the outer sleeve (6) that envelops the handle (2) and the handle attachment (21).
14. Method for mounting a contamination protection device for an endoscope according to claim 1, characterised by the steps: application to the optically transparent region at the distal end of the inner sleeve (3) of a substance that produces optical contact with the optics (11) of the endoscope, plugging the handle attachment (21) onto the handle (2), introducing the distal end of the endoscope shaft (1) into the rolled-up inner sleeve (3), condom-like unrolling of the inner sleeve (3) with inclusion of the shaft (1) and of the air tube (4a) and water tube (4b) positioned thereon, connecting the proximal ends of air tube (4a) and water tube (4b) with air valve (5a) and water valve (5b) on the handle attachment (21), pushing the rolled-up outer sleeve (6) over the inner sleeve (3) and fastening, in an airtight, watertight and germ-tight manner, on the proximal end of the inner sleeve (3), and condom-like unrolling the outer sleeve (6) beyond the tip of the endoscope shaft (1).
15. Method for mounting a contamination protection device for an endoscope according to claim 14, characterised in that, subsequently a first or second or third connection piece (61a,b,c) of the exterior sleeve (6) is connected to thea first or second or third connection part (71a,b,c), respectively.
16. Method for mounting a contamination protection device for an endoscope according to claim 14, characterised in that, for fastening and connecting the inner sleeve (3) and outer sleeve (6), the following steps are performed: bonding of a proximal gasket (92) onto the outer surface of a proximal end of the shaft (1), application of a proximal clamping bracket (93) on the proximal gasket (92), bonding of a distal gasket (95) onto an outer surface of a distal end of the shaft (1), mounting a distal clamping bracket (96) on the distal gasket (95) using a positioning aid (960), positioning the air tube (4a) and water tube (4b) in passages on the distal clamping bracket (96), plugging a cap (31) onto the distal clamping bracket (96), positioning the air tube (4a) and water tube (4b) in passages on the distal clamping bracket (93), positioning proximal ends of the inner sleeve (3) and outer sleeve (6) over the proximal clamping bracket (93), and clamping the inner sleeve (3) and outer sleeve (6) between the proximal clamping bracket (93) and a clip (91) or rubber ring.
17. Method for mounting a contamination protection device for an endoscope according to claim 16, characterised in that, before introduction of the distal end of the shaft (1) into the rolled up inner sleeve (3), the proximal end of ab operating tube (4c) is introduced into a distal instrument channel opening (101) to the extent that it projects out of a proximal instrument channel opening (102) and in that subsequently the proximal end of the operating tube (4c) is connected to a distal end of a 2-way tube manifold (24, 24), a first proximal end of the tube manifold (24, 24) is connected to a suction valve (5d) by means of a suction tube (4d) and a second proximal end of the tube manifold (24, 24) is connected to an instrument protector (8), which is folded in the manner of a bellows.
18. Method according to claim 17, characterised in that the tube manifold (24) is fastened by means of a ring nut (243) directly on the proximal instrument channel opening (102).
19. Method according to claim 16 for preparing an endoscope for a second, contamination-protected endoscopic examination after the contamination-protected performing of a first endoscopic examination of which the last step consists in the pulling out of the endoscope shaft from the examined body orifice, characterised by the steps: separating the outer sleeve (6) in the region of its distal end as well as from the air tube (4a) and water tube (4b) in the region of the handle (2), in each case with a torch cutter, and removal and disposal of the contamination protection device, clamping brackets (93, 96), which may be fastened on the outer surface of the shaft, being left on the endoscope, provision of a further contamination protection, comprising inner sleeve (3), outer sleeve (6) and water, air and operating tubes (4a, 4b, 4c) and assembly of the further contamination protection according to the steps defined in claim 16, wherein the mounting of the proximal clamping bracket (93) and distal clamping bracket (96) possibly are omitted as redundant.
Description
[0069]
[0070]
[0071] With reference to
[0072]
[0073] The clamping bracket 96 and positioning aid 960 are advantageously embodied in two parts in each case and the connection between the two is produced by means of a clamp-like engagement.
[0074]
[0075]
[0076]
[0077] In
[0078]
[0079] Neither the proximal clamping bracket 93 nor the distal clamping bracket 96 has to be removed between two contamination-protected examinations. That is to say the time required until preparation of the endoscope for a further examination is advantageously reduced in that after the dismounting of the contamination protection the clamping brackets, together with the gaskets located blow remain on the shaft and are used for fastening a further contamination protection.
[0080]
[0081] Opposite this, in
[0082]
[0083]
[0084]
[0085]
[0086] For gastroscopies the bite ring 7b according to the invention is used, on the opening of which is provided the connection part 71b. This serves in turn for patient-side connection of the outer sleeve 6 via the connection piece 61b. During the examination, to avoid or minimise the leaking of saliva from the patient's mouth corners and resulting contamination of the outer side of the outer sleeve 6, the bite ring 7b can be further extended with sections that enclose the patient's face or at least jaw part.
[0087] Alternatively to the diaper pants 7a or bite ring 7b, a partition wall 7c with opening and connection part 71c can be used, behind which the patient is positioned during the endoscopic examination. The treating doctor acts from the front side of the partition wall and is thus protected against direct contamination. In a further advantageous embodiment, the partition wall 7c may take the form of a cabin that is closed except for the passage opening, in which all the contamination removed from the patient during the examination can remain enclosed.
[0088]
[0089]
[0090]
[0091]
[0092]
[0093] The polymeric material used for the protection tube 4c1 should have a significantly higher elongation at break than the material of the operating tube 4c, so that the torn-apart end sections, as shown in
[0094] Instead of the embodiment shown here with protection tube 4c1 fastened on the outer side of the operating tube 4c, thus could also be mounted analogously in the interior of the operating tube.
[0095]
[0096] Instead of using a handle attachment for fastening the two-way tube manifold and the valves, the tube manifold 24 is connected directly to the proximal instrument channel opening 102. The air and water valves are combined in a single valve 5ab, which is used together with the suction valve 5d in holders which are provided in the handle 2 for this purpose.
[0097] To the two-way tube manifold 24, first, the proximal end led out of the proximal instrument channel opening 102 of the operating tube 4c and, further, the suction tube 4d leading to the suction valve 5d are connected. The tubes for the compressed air 4a and the water supply 4b are wound around the shaft 1 for security and led to the combined air/water valves 5ab, and connected there.
[0098]
[0099] The Y-shaped two-way tube manifold 24 has three ends or connections. With the distal end 241, which may in particular be conically formed, it can be plugged into the proximal end 242 of the operating tube 4c led out of the instrument channel opening 102. At one of the two proximal ends, the suction tube 4d is connected. The other end 242 is open and serves as instrument access.
[0100] For fastening to the proximal instrument channel opening, the tube manifold 24 is equipped with a ring nut 243, which is seated on the tube manifold 24 so as to be axially displaceable. A collar 244, which is radially prominent and is integrally formed on the distal end 241 interacts with a stop on the ring nut 243, in order after fixing of the ring nut on a corresponding connection means of the proximal instrument channel opening 102, to fasten the tube manifold thereon. The instrument channel opening 102 may for this purpose have a widespread Luer lock connection.
[0101] The (partial)
[0102] First, as shown in partial Figure A, the operating tube 4c is pushed a sufficient distance out of the proximal instrument channel opening 102. Then the two-way tube manifold 24 is connected to the distal end 41 thereof by plugging in the operating tube, partial Figure B. The operating tube 4c is designed here such that, due to the compressive forces exerted by plugging in the two-way tube manifold 24, the proximal operating tube end is compressed in the manner of a bellows and the bellows section 4c is formed in this manner. Partial figure C shows the step in which the ring nut 243 of the tube manifold 24 is connected with the aid of a connection means, in this case a Luer lock connection, to the proximal instrument channel opening. The endoscope is now ready for an examination or an operation. After its end, as indicated in partial figure D, the two-way tube manifold 24 is released again and, together with the operating channel of the proximal instrument channel openings 102, pulled off, whereby the bellows section 4c of the operating channel 4c unfolds again. By means of a torch cutter, the operating tube can be cut in one step and sealed and thus drawn, in a contamination free condition, distally out of the instrument channel.
[0103]
[0104] The distal end of the shaft 1, shown in the left-hand partial figure, has two distal instrument channel openings 101, into which, within the scope of the contamination protection according to the invention, an operating tube 4c in each case is to be pushed. The two instrument channels of the endoscope shown here open proximally into two corresponding instrument channel openings 102, partial figure top right. This partial figure also shows the valve holders with valves 5ab for air and water, as well as 5d for suction. The partial figure below right shows the instrument channel openings 102 sealed with protective caps.
LIST OF REFERENCE CHARACTERS
[0105] 1 Shaft [0106] 10 Instrument channel [0107] 101 Instrument channel opening, distal [0108] 102 Instrument channel opening, proximal [0109] 11 Optics [0110] 12 Lighting device [0111] 13 Nozzle [0112] 2 handle [0113] 20 Operating element Shaft tip angling [0114] 21 Handle attachment [0115] 22 Valve holder [0116] 23 Instrument holder [0117] 24, 24 2-way tube manifold [0118] 241 Distal end of 24 and 24 [0119] 242 Instrument opening of 24 [0120] 243 Ring nut [0121] 3 Inner sleeve [0122] 30 Inner sleeve end face [0123] 30a Air-tube opening [0124] 30b Water-tube opening [0125] 30c Operating tube opening [0126] 31 Cap [0127] 32 Fabric tube [0128] 33 Gripper [0129] 331, 331 Click-closure [0130] 332 Bridge [0131] 4a Air tube [0132] 4b Water tube [0133] 4c Operating tube [0134] 4c Bellows section [0135] 4c0 Predetermined breaking point [0136] 4c1 Protective tube [0137] 4d Suction tube [0138] 5a Air valve [0139] 5b Water valve [0140] 5ab Combined air and water valve [0141] 5d Suction valve [0142] 6 Outer sleeve [0143] 61a,b,c Connection pieces [0144] 7a Diaper pants [0145] 7b Bite ring [0146] 7c Partition wall [0147] 71a,b,c Connection pieces [0148] 8 Instrument protection [0149] 81 Instrument tube [0150] 82 Instrument tube cap [0151] 80 Instrument [0152] 80a Micro unit [0153] 80b Instrument Bowden cable [0154] 80c Operating element instrument [0155] 91 Clip [0156] 92 Gasket, proximal [0157] 93 Clamping bracket, proximal [0158] 94 Clamp [0159] 95 Gasket, proximal [0160] 96 Clamping bracket, proximal [0161] 960 Positioning aid