WO2016182463A1

WO2016182463A1 - Videoendoscope having disposable functional tubing

Info

Publication number: WO2016182463A1
Application number: PCT/PL2016/000052
Authority: WO
Inventors: Szymon MANKOWSKI
Original assignee: Mankowski Szymon
Priority date: 2015-05-12
Filing date: 2016-05-11
Publication date: 2016-11-17
Also published as: PL410915A1; PL226750B1

Abstract

The invention relates to a videoendoscope having disposable functional tubing (14a) and equipped with a handle (2), a peripheral device (3), an insertion tube (1) ending with a distal tip (la) and divided into a deflective distal tube (lb) with bendable element (Id) and a flexible proximal tube (1c). According to the invention, the sealed detachable vision- lighting module (16) terminated with a distal end (16a) is detachably fixed with half clamps (1a1, 1a2). The clamping rings (1a1, 1a2) comprise outflows (1a1a, 1a1b, 1a1C, 1a2a) of functional tubing (14a) that form the distal tip (1a),wherein a proximal end (1d2) of the bendable element (1d) is connected with the flexible proximal tube (1c) and a distal end (1d1) of the bendable element (Id) is fastened with the half clamps (1a1, 1a2). A conical culvert (4) is mounted to the flexible proximal tube (1c) that is detachably connected with the handle (2) and a connector bundle (14) extends comprising bundle of functional tubing (14a), transmission wires bundle (14b) and multifilament optical fibre (14c). The connectors bundle (14 ) is detachably connected with the peripheral device (3) by mechanical or electrical connectors.

Description

Videoendoscope having disposable functional tubing

The invention relates to a video endoscope device with disposable functional tubing designed for diagnostic and medical procedures performed via natural body orifices, especially hollow organs.

The known videoendoscopes with a flexible tube are used on a permanent basis.

The insertion tubes of the known videoendoscope comprises distal tip, a passive flexible part forming flexible proximal tube and an active flexible part forming deflective distal tube, which is strengthened with a metal spiral belt and metal net and covered with hermetic polymer sheath.

The active flexible part has a bendable articulated element composed of half rings, equipped with holes for operation lines. The flexible tube of the insertion tube is connected by a conical culvert with a handle. The handle is connected via a bundle of function tubing with channels, a transmission wires bundle and an optical fibre to the peripheral devices by electric and optical connectors.

After medical procedures performed using videoendoscope, the whole video endoscope with the handle is washed and is subject to high-level disinfection in a very expensive, specially designed equipment.

The design and construction of the known videoendoscope does not allow to disassemble the elements of the insertion tube because the insertion tube is a completely inseparable, non-removable device. In line with this, such a whole device must be washed and disinfected between medical procedures.

The most dangerous part of videoendoscope in terms of the risk of diseases transmission between the medical procedures are long functional tubing with channels having approximately 1500 mm in length which have very small diameters, not exceed approximately 2,5 mm. Moreover, they are made of a type of polymer which temperature strength is relatively low amounting above 393° K. In line with this, the functional tubing required special wash and disinfection procedures.

Therefore, the use of non-disposable videoendoscopes with an insertion tube that is used permanently do not guarantee the protection against transmission of diseases between medical procedures, despite high-level disinfection and careful wash.

Furthermore, the price of purchasing and service of videoendoscopes as well as the price of its washing and disinfecting devices are very high. In addition there are special requirements for storage unites or endoscopes must be periodically disinfected to prevent recontamination.

Taking the above into account, it is no surprise that non-disposable videoendoscopes are used only in high budget health care units. Consequently, there is a limited patient accessibility to this kind of procedure.

Therefore there is a need to find a solution to achieve completely effective disinfection of video endoscopes tubes and channels.

The patent specification USA 5483951 describes an insertion tube consists of an air tube made of polyethylene, water tube made of polyethylene and a biopsy- suction tube made of polyvinyl chloride.

The insertion tube is divided into two semi-circular segments in cross-section. The above-mentioned tubes are placed in one segment and a bundle of optical fibres is placed in the other segment. They have semi-circular sleeve sheath in cross-section. Both segments of insertion tube adhere through flat surface and they are covered with semi-circular sheathes. Such a construction of insertion tube does not meet requirements of flexibility in the video endoscopy procedures.

The patent application USA 5483951 and the patent publication US2007/022555611 disclose solution of the problem of flexibility of bendable elements by constructing a polymer cylindrical tube with openwork cuts of a special pattern. On the other hand, the openwork cuts are difficult and expensive to be made. Furthermore, the elements are difficult to operate and in same directions are not possible to move.

Based on foregoing, there is therefore need to overcome the above problems. The object of the present invention and technical issue which needs to be solved is to construct an ergonomic video endoscope device with the simple structure, low-cost production and use, and most of all it has to eliminate the risk of disease transmission.

In order to achieve the objective mentioned above, the present invention provides videoendoscope having disposable functional tubing that allows to separate and re-use particular elements fixed inside tubing as well as use functional tubing in disposable way.

According to the invention, the sealed and detachable vision- lighting module terminated with a distal end is detachably fixed with half clamps. The clamping rings comprise outflows of functional tubing that form the distal tip of the endoscope. A proximal end of the bendable element within the deflective distal tube is connected with the flexible proximal tube and a distal end of the bendable element is fastened with the half clamps. A conical culvert is mounted to the flexible proximal tube that is detachably connected with the handle. Connector bundle extends from the culvert comprising bundle of functional tubing, transmission wires bundle and multifilament optical fibre. The connectors bundle are detachably connected with the peripheral device by mechanical or electrical connectors.

In preferred embodiment of the invention, the distal end of a vision-lighting module comprises a optical section for recording of image and a light section.

In preferred embodiment of the invention, at least the distal tip of the device, the deflective distal tube are coated with a protector that is adjusted to shape and size of the coated elements. The protector is preferably made of polytetrafluorethylene, and has a hole for the vision-lighting module and holes for functional tubing in the front part of the protector.

In preferred embodiment of the invention, the functional tubing comprises biopsy - suction tube, an air tube, a tubes for flushing that allows examined body organs flushing ( body cavity, especial hollow organs) and lens flushing.

In preferred embodiment of the inventionin order to bend the distal tip of the insertion tube in all directions using the same force the bendable element in the form of bellows is applied which has cylindrical ends and longitudinal pattern of holes placed in four planes of deflective distal tube. The bellows is made of polymer.

In preferred embodiment of the invention, the handle is equipped with functional valves, an input for operation tools of the suction-biopsy tube which is sealed with a hole plug, a steering mechanism for vertical bending - upper-lower of the distal tip of the insertion tube, steering mechanism for horizontal bending - left- right of the distal tip of the insertion tube, vertical and horizontal knobs and vertical and horizontal locks.

In preferred embodiment of the invention, the housing of the handle comprisesa supporting protrusion, first and second covers detachably connected with each other. The supporting protrusion supports a hand carrying the weight of the insertion tube with the handle and connectors bundle. Γη preferred embodiment of the invention, within peripheral device an imaging device, a lighting control device, an air pumping device and a suction device are located.

In preferred embodiment of the invention, the flexible proximal tube of the insertion tube is equipped with mounting elements keeping all parts of the flexible insertion tube in the same position to each other. Mounting elements have an axial hole for positioning the vision-lighting module, and have plural open from one side recesses in shape of partially open circular for placing functional tubes, vertical operational lines and horizontal operational lines. The recesses are located circumferentially in respect with the axial hole. On its perimeter conical shaped protrusion are placed.

The essential advantage of presentinvention is a significant limitation of the contamination risk during the endoscopic procedure. It is achievable through the new insertion tube design which allows to easy disassemble of the expensive vision- lighting module which is reusable from the rest parts which are disposable including the handle and connectors bundle. Simple design of the vision-lighting module makes it fully sterilizable using ordinary medical equipment.

Sterile vision-lighting module is easy to install into newly fabricated and sterile elements of the insertion tube, the handle and connectors which are free of necessity of periodic sterilizations. The device according to the invention significantly facilitates an usage and reduces the time to prepare a endoscopy procedure. An advantage of this invention is a substantial cost reduction of service and exploitation.

Detachable half clamps of the distal tip of the insertion tube stabilize the fixing of the vision-lighting module, easy assembling and disassembling and also stable fixing of the deflective distal tube. Applying bellows as a bendable elements significantly reduces the cost and of the insertion tube fabrication and positively influences on precise movements of the insertion tube during the medical procedures. Detachable mounts of covers of the handle housing facilitates assembling and disassembling of the vision-lighting module, functional valves, the flexible functional tubing and the deflective distal tube. Mounting elements of the flexible proximal tube gives the same position of the functional tubing one to each other, the deflective distal tube, operational lines and metal reinforcement of the polymer cover as well.

The videoendoscopic device has been illustrated by the detailed description of the invention, which describes an exemplary embodiment of the invention taken in conjunction with the accompanying drawings with appropriate reference to it, in which:

fig. lis a perspective view of the videoendoscopic device with partial protection cover, peripheral devices and its connectors,

fig.2is a view of the distal tip after disassemble the half clamp with partial covers, fig.3isa frontal view of the distal tip

fig.4isa view of the vision-lighting module,

fig.Sisa cross-section of the bendable element,

fig.6is a cross-section of the protector,

fig.7isa frontal view of the protector,

fig.8isa view of the mounting element,

fig.9isa isometric projection of the flexible element of the insertion tube after partial uncover the polymer cover.

Reference is made to Fig.l, the videoendoscopic device is assembled of the insertion tube 1, the handle 2, peripheral devices 3. The insertion tube 1 contains the distal tip la, the deflective distal tube lb and the flexible proximal tube lc. The distal tip la detachably connected to the distal end ldl of the bendable element which is in form of bellows Id. The proximal end of the bendable element ld2 of the bendable element -bellows Id is permanently connected to the metal reinforcement of the insertion tube lcl. The flexible proximal tube lc of the insertion tube 1 is coated with the polymer cover lc2. On the flexible proximal tube lc is fastened conical culvert 4 detachably connected to the with the handle 2, The handle 2 is assembled of following functional valves 5: suction-biopsy valve 5a, the air valve 5b, the valve for body cavity flushing 5c, the valve for lens flushing 5d, the input for operation tools 6 of the biopsy-suction tube 14al sealed at the end with the hole plug 7. The handle 2 is equipped also with a tilt control mechanisms (up-down and left-right) of the distal tip la and these are coupled with vertical and horizontal knobs 8,9 and vertical and horizontal locks 10,11. On the handle 2 is supporting protrusion 2a, left and right cover 2b, 2c connected by self-tapping screws 12. The handle 2 is detachably connected to the culvert 13 which fixes the connectors bundle 14 covered with the polymer coating 15.

Connectors bundle 14 have the functional tubing 14a which contains the biopsy-suction tube 14al, the air tube 14a2, the tube for body cavity flushing 14a3, the tube for lens flushing 14a4, the transmission wires bundle 14b, the multifilament optical fiber 14c. The functional tubing 14a is a system of polyethylene tubes with appropriate inner dimensions. The transmission wires bundle 14b and the multifilament optical fiber 14c are placed in a polyethylene tubes 14bl, 14cl. Connectors bundle 14 is detachably connected to the proper peripheral devices 3 with a mechanical or electrical connectors. Peripheral devices usually are the imaging device 3a, the lighting control device 3b, the air pumping device 3c, the suction device 3d.

Reference is made to Fig.2, the distal tip la of the insertion tube 1 contains the distal tip 16a of the vision-lighting module 16 detachably fixed in half clamps lal and la2 detachably connected to each other by pin connections 17. The distal tip of the vision-lighting module 16a contains the optical section 16al and the light section 16a2 fastened in module housing 16a3 and fixed with epoxy resin 18. The optical section 16al consist of lens 16ala, focusing lens 16alb and CCD matrix 16alc. The light section 16a2 contains dissipative lenses 16a2a. The half clamp la2 has the outflow for lens flushing la2a of the tube for lens flushing 14a4 which is equipped with the nozzle la2b for water flushing. Half clamps lal and la2 contain holes laid and la2c for left-right operational lines assembling. To assemble up-down operational lines cylindrical protrusions la2e and la2d are used also for detachably connection of half clamps lal and la2.

Half clamps lal and la2 have circular protrusions lale, la2f used for assembly the distal end of the bendable element ldl of the bendable element in form of bellows Id.

Reference is made to Fig.3, half clamp lal has a suction biopsy outflow lala of the biopsy-suction tube Hal, air outflow lalb and outflow laic of the tube for body cavity flushing 14a3. The half clamp la2 has the outflow la2a of the tube for lens flushing 14a4 which ends comes with a nozzle la2b. The distal tip of vision- lighting module 16a is fastened with eccentricity in half clamps lal and la2. Lens 16ala are placed in a center of the housing module 16a3 and around it also coaxially dissipative lens 16a2a of the light section 16a2.

Reference is made to Fig.4, the vision-lighting module 16 has a distal end 16a which is permanently connected with the flexible part 16b and it contains the transmission wires bundle 14b set in the polyethylene tubes 14bl and multifilament optical fiber 14c also set in the polyethylene tube 14cl. Omitting frontal surface the distal tip of the vision-lighting module 16a and its flexible part 16b are sealed with polymer coating 16c.

Reference is made to Fig.5 and fig.2_} bendable element - bellows Id made of polymer is equipped with the distal end ldl and the proximal end ld2 which have a cylinders shape. The flexible part of bellows ld3 have longitudinal pattern of holes ld3a drilled in perpendicular planes one to another. The distal end of bendable element ldl contains holes for operational lines assembly Id I a and ldlb and appropriate fitting cylindrical protrusion.

Reference is made to Fig.6, the protector 19 made of TPFE is suited with shape and dimensions to the distal tip la of the deflective distal tube lb and the flexible proximal tube lc. Its cylindrical part 19a is ended from inner surface with circular protrusion and in cross-section with a half circular protrusion 19al .

Reference is made to Fig.7, the frontal part 19b of the protector 19 has the vision-lighting hole 19bl and the biopsy-suction tube hole 19b2_; the air tube hole 19b3, the body cavity hole 19b4, the flushing lenses hole 19b5 of the functional tubing 14a with suitable diameters to match the proper holes in the distal tip la of the insertion tube 1.

Reference is made to Fig.8, mounting elements 20 contains the axial longitudinal hole 20a placing the vision-lighting module 16 and located on the perimeter around it angled(open from the side circular recesses)recesses 20b, 20c, 20d, 20e fastening as follows: the biopsy-suction tube 14al, the air tube 14a2, the tube for body cavity flushing 14a3, the tube for lens flushing 14a4 and also angled (open from the side circular recesses) recesses 20f, 20g, 20h, 20i for placing up-down operational lines and left right operational lines. On the perimeter of the mounting element 20, conical protrusions are stationary fixed preventing from rotating around the metal reinforcement of the insertion tube lcl and the polymer cover lc2.

Reference is made to Fig. 8 and Fig.9, the flexible part 16b of the vision- lighting module 16 fastened in the axial longitudinal holes 20a of the mounting elements 20. Around the flexible part 16b of the vision-lighting module 16 the functional tubing (14a) are located as follows: 14al, 14a2, 14a3, 14a4 and they are fastened in open from one side circular recesses in shape of partially open circular 20b, 20c, 20d, 20e. Up-down operational lines 21, 22 and left-right operational lines23, 24 are placed in open from one side recesses in shape of partially open circular 20f,20g,20h,20i and located around the vision-lighting module 16. Mounting elements 20 are fixed in a distance experimentally evaluated in accordance to the required stiffness of the flexible proximal tube lc of the insertion tube 1. Mounting elements 20 are shielded by metal reinforcement of the insertion tube lcl and connected with it and with the polymer cover lc2 by conical protrusions 20k.

The end of the flexible proximal tube lc is equipped with metal reinforcement of the insertion tube lcl which stretches up to polymer cover boundary lcla. With that reinforcement the proximal end of flexible element is permanently connected to the bendable element - bellows Id.

The videoendoscopic device according to invention may find wide application in every medical fields and hospital units.

REFERENCES to the figures

1. Insertion tube.

la. Distal tip.

lal . Half clamp.

lala. Suction biopsy outflow.

lalb. Air outflow.

laic. Outflow for body cavity flushing. laid. Hole for operational lines assembly. lale.Cylindrical protrusion.

Ia2. Half clamp.

Ia2a. Outflow for lens flushing.

Ia2b. Nozzle .

Ia2c. .Hole for operational lines assembly.

Ia2d. Cylindrical protrusion.

Ia2e. Cylindrical protrusion

la2f. Cylindrical protrusion.

lb. Deflective distal tube.

lc.Flexible proximal tube.

Icl. Metal reinforcement of insertion tube. lcla. Polymer cover boundary.

Ic2. Polymer cover.

Id. Bendable element - bellows.

ldl. Distal end of bendable element.

ldla. Hole for operational lines assembly ldlb. Hole for operational lines assembly ld2.Proximal end of bendable element.

Id3.Flexible part of bellows.

Id3a. Longitudinal pattern of holes. . Handle.

a. Supporting protrusion.

b. Left cover.

c. Right cover.

. Peripheral devices.

a. Imaging device.

b. Lighting control device.

c. Air pumping device.

d. Suction device.

. Conical culvert.

. Functional valves.

a. Suction-biopsy valve.

b. Air valve.

c. Valve for body cavity flushing. d. Valve for lens flushing.

. Input for operation tools .

. Hole plug.

. Vertical knob.

. Horizontal knob.

10. Vertical lock.

11. Horizontal lock.

12. Self-tapping screws.

13. Culvert.

14. Connectors bundle.

14a. Functional tubing .

Hal. Biopsy-suction tube.

14a2. Air tube.

14a3.Tube for body cavity flushing. a4. Tube for lens flushing.

b. Transmission wires bundle.

bl. Polyethylene tube.

c. Multifilament optical fiber.

cl. Polyethylene tube.

. Polymer coating.

. Vision-lighting module.

a. Distal end of the vision-lighting module.al. Optical section.

ala. Lens.

alb.Focusing lens.

alc. CCD matrix.

a2. Light section.

a2a. Dissipative lenses.

a3. Module housing.

b. Flexible part.

c. Polymer coating.

. Pin connections.

. Epoxy resin.

. Protector.

a.Cylindrical part.

al. Circular protrusion.

b. Frontal part.

bl. Vision-lighting hole.

b2. Biopsy-suction tube hole.

b3.Air tube hole .

b4. Hole for body cavity flushing.

b5. Flushing lenses hole. . Mounting element.

a.Axial hole.

b. Recess for biopsy-suction tube.

c. Recess for air tube.

d. Recess for hole for body cavity flushing.e. Recess for hole for flushing lenses.f. Recess for upper operational line.

g. Recess for lower operational line.

h. Recess for right operational line.

i. Recess for left operational line.

k. Conical protrusion.

. Upper operational line.

. Lower operational line.

. Right operational line.

Xeft operational line.

Claims

1. Videoendoscope having disposable functional tubing and equipped with a handle, a peripheral device, an insertion tube ending with a distal tip and divided into a deflective distal tube with bendable element, a flexible proximal tube, characterized in that the sealed detachable vision- lighting module (16) terminated with a distal end (16a) is detachably fixed with half clamps (lal, la2), wherein the clamping rings (lal, la2) comprise outflows (lala, lalb, laic, la2a) of functional tubing (14a) that form the distal tip (la), wherein a proximal end (ld2) of the bendable element (Id) is connected with the flexible proximal tube (lc) and a distal end (ldl) of the bendable element (Id) is fastened with the half clamps (lal, la2), wherein a conical culvert (4) is mounted to the flexible proximal tube (lc) that is detachably connected with the handle (2) and a connector bundle (14) extends comprising bundle of functional tubing (14a), transmission wires bundle (14b) and multifilament optical fibre (14c), wherein the connectors bundle (14 )is detachably connected with the peripheral device (3) by mechanical or electrical connectors.

2. Videondoscope according to the claim 1, wherein the distal end (16a) of a vision-lighting module (16) comprises an optical section (16al) for recording of image and a light sectk (16a2).

3. Videondoscope according to the claim 1, wherein at least the distal tip (la), the deflective distal tube (lb) are coated with a protector (19)that is adjusted to its shape and size, that is preferably made of polytetrafluorethylene, and having a hole (19bl) for the vision-lighting module (16) and holes (19b2, 19b3, 19b4, 19b5) for functional tubing (14a) in the front part (19b) of the protector (19).

4. Videondoscope according to the claim 1, wherein the functional tubing (14a) comprises a biopsy-suction tube (Hal), an air tube (14a2), a tube for body cavity flushing (14a3) and a tube for lens flushing {14a4}.

5. Videondoscope according to the claim I, wherein the bendable element (Id) has a structure of bellows, preferably made of polymer.

6. Videondoscope according to the claim 1 , wherein the handle (2) is equipped with functional valves (5), an input (6) for operation tools (6) of suction- biopsy tube (Hal) that is closed by a hole plug (7), a steering mechanism for vertical - bending of the distal tip (la) with a vertical knob (8) and a vertical lock (10), a steering mechanism for horizontal - bending of the distal tip (la) with a horizontal knob (9) and a horizontal lock (11).

7. Videondoscope according to the claim 1 or the claim 6, wherein the handle (2) comprises supporting protrusion (2a), a first cover (2b) being detachably connected with a second cover (2 c).

8. Videondoscope according to the claim 1, wherein within peripheral device (3) an imaging device (3a), a lighting control device (3b),an air pumping device (3c) and a suction device (3d) are located.

9. Videondoscope according to the claim 1, wherein the flexible proximal tube (lc) of the insertion tube (l)is equipped with a mounting elements (20) having an axial hole(20a) for the vision-lighting module (16), open from the side circular recesses (20b, 20c, 20d, 20e) for functional tubing (14a), open from the side circular recesses (20f, 20g, 20h, 20i) for vertical operational lines (21, 22) and for horizontal operational lines (23, 24), wherein the recesses are located circumferentially, and having protrusions (20k), that are preferably conical-shaped.