Device to control a flexible section at the distal end of the elongated instrument, managed guidewire and method of controlling a wire leader
(57) Abstract:Elongated driven tool can be either managed with a wire leader or catheter in relation to coronary angioplasty. Free managed the tip on the managed area of the distal end of the tool and control device at the proximal end is connected with a large number of moving in the axial direction of the deflecting wires passing through the instrument. Manipulation control for the deviation of the controlled area 360oaround the instrument axis without axial rotation of the tool itself. 3 S. and 12 C.p. f-crystals, 11 ill. The invention relates to managed devices that can be used with catheters, cannulae, wire napraviteley, etc. In particular, the invention relates to catheters and wire napravila, which are managed through the cavity in the housing or cavity and is positioned inside or directed to narrowing (neprokhodimoy), organs, or tissues in the body from a position outside of the body.Recently, various attempts have been made to create catheters, which would be managed proximally with the er-cylinder which is controlled from the proximal end. The catheter is provided with a deflecting wire passing through the entire length of the catheter, which can be moved in the axial direction to reject the distal end. However, the tip of the catheter is curved in only one direction, and the entire catheter with a view to its direction should rotate or spin. In addition, the design requires the use of a deflecting wire of relatively large diameter, which prevents the use of catheters a very small diameter, such as those that are preferred for use in laser or balloon angioplasty.Known catheter device having a Central cavity, passing through it, and four of the stretch cord running along the inner wall of the catheter in which the catheter can be manufactured in accordance with the design Barcelona having diameters from 3,18 to 50.8 mm, and is suitable for applications such as introduction to the bulb of the duodenum or in the ascending shell intestine. These diameters are not suitable for use as a wire leader when coronary angioplasty, which usually requires diameters of the order of 0,356 to 0,457 mmthe second manageability and large outer diameters. The limited controllability of the catheter tip leads to more time spent in the body, as well as significantly greater risk of injury as the inner lining of blood vessels, so the patient as a whole. Repeated administration of the wire napravila or catheters can lead to thrombus formation as a result of coagulation, which began along the surface of the wire leader. In addition, it is extremely important for laser angioplasty is accurate directional control to ensure accurate targeting of the laser beam to remove plaque. However, the only known catheters with multilateral control, normally much higher than the diameters almost catheters for angioplasty.In addition to the limited controllability of the famous wire napraviti rely on the spring tension of the spiral wire of the sender (and the elasticity of the distal end of the deflection wire in the construction of Buchbinder) to return the wire to the sender in a straight neitherthe position. However, equally important is how the deviation of the wire to enter into the branch artery and straightening of the wire after passing this atatlanticcity at the distal end of the wire, also jeopardize the desired degree of freedom of the tip of the wire leader.Thus, there is a need in the managed device is of small diameter, which can easily be adapted for use in a wire napravila and catheters, and which, in particular, suitable for operations such as ballyroan and laser angioplasty. Preferably, the controlled device is performed in such a way as to enable the use of diameter less than that available from existing catheters-cylinder or wire napravila used in angioplasty, and also capable of full deflection movement 360owithout axial rotation.In accordance with the purpose of the invention provides an improved controlled guidewire or catheter instrument of this type which is suitable for percutaneous transportnogo introduction to the cardiovascular system. The invention provides a controlled passage of the forks and turns to the direction of the catheter or wire napravila for angioplasty for arterial stenosis or damaged is the tool. The distal tip on the managed tools made in accordance with the invention, may be manageable radially displaced in either direction, thereby providing full moving 360owithout rotation of the housing of the controlled instrument.In one variant embodiment of the invention provides guidewire having an elongated flexible shaft with a Central cavity, passing through it, and free elastic tip at the distal end. Running in the axial direction of the driven rack is located inside the controlled area at the distal part of the flexible shaft. Managed strut pivotally attached to its proximal end to the radial bearing, mounted on the axis inside the flexible shaft at the proximal end of the controlled section, to prevent axial displacement of the managed stand, while providing a lateral deviation of the managed stands, bringing it from a position parallel to the axis of the flexible shaft.At least one, preferably four, deflecting wire installed with the possibility of axial movement within the cavity of the flexible shaft and are approximately the distal attachment point on UPrev wire passes through the slot or hole on the radial bearing.In another variant embodiment of the controllable strut provided with a plot of attaching wire located on its distal end, and the plot, guide wire at its proximal end. Preferably, the cross-sectional area of the rack to a point located midway between the area of mounting and guiding the plot was less than the cross-sectional area of the rack on at least one of the sections, fastening or guide, and even more preferably, it was less than the cross-sectional area at both sites: the guiding and fastening.In another variant embodiment of the fastening of the deflection wire is located on the managed area of the flexible shaft, the remote in the distal direction from the deflecting guide wire. Preferably, the other pair of deflection wires are formed using a continuous section of wire that forms a loop at its mid-point across the distal end of the bar and both ends of which pass through the flexible shaft in the proximal direction.The axial displacement of any one of the deflecting wires in the proximal direction causes displacement of the axis of the driven rack is participating wires driven hour deviates to the side and rotates a full 360oaround the axis of the flexible shaft.Thus, managed care device of the invention can overcome tortuous and branched arterial system without the need for output and multiple-input, with the aim of clinching the tip, and without axial rotation of the catheter. Managed medical device can easily be manufactured with known technologies and low-cost.These and other features and advantages of the invention will become apparent from the subsequent detailed description of its preferred designs, which is accompanied by reference to the accompanying drawings.In Fig. 1 shows a view in partial section of a managed wire guiding equipment, which cleared the outer tubular casing; Fig. 2 is a view in cross section of the wire guiding equipment, showing first rejected the position of Fig. 3, showing the second rejected the position of Fig. 4 is a view in partial section of the driven laser angioplastika of the catheter of Fig. 5 is another variant design managed wire guiding equipment of Fig. 6 is a schematic depiction of the wire guiding equipment, showing overcoming designated arterial branching is on the device; in Fig. 8 the same; Fig. 9 section a-a in Fig. 8; Fig. 10 is a simplified front view of the device shown in Fig. 8 after installation of the mounting cover; Fig. 11 is a simplified front view of the device shown in Fig. 7 after you install the mounting cover.In Fig. 1 shows an elongated flexible instrument 1 having a tubular body 2 with 3 and the proximal distal 4 ends. The distal end 4 contains the managed area 5, and the proximal end 3 provided with a management body 6 to control the instrument 1, which may be, for example, managed a wire leader or catheter. Although the managed device will be mainly described with reference to a wire leader for angioplasty, but for professionals it will be obvious that the managed device can be easily adapted for other medical and non-medical applications.Case 2 managed tool 1 may be of any desired length from a few inches to many feet, depending on the intended application. In the design used as the wire of the sender or catheter for angioplasty, the case 2 is usually several feet in length, and preferably its length Solanki any desired length.The housing 2 may be produced by any of the many existing in this area of ways, for example by tight winding (navipane) spiral of metal wire or by extrusion of a relatively flexible biocompatible polymer, such as polyethylene. Wound guidewire provides high tensile strength wire of resilient non-corrosive metal, such as stainless steel or platinum, and may have a circular shape in cross section with a diameter of the order of from 0.025 to 0.51 mm, Or the wire may have a rectangular shape in cross section and size of from 0.025 to 0.51 from 0.025 mm to 1.02 mm or other ways known in this field.Coronary angioplasticheskih wire napraviti of the wound wire, including the proposed controlled device, preferably wound so as to have an outer diameter in the range from 0,356 to 0.46 mm in Relation to the managed catheter diameter may vary to optimize the diameter of the Central working channel as required, while still maintaining a sufficiently small outer diameter for the intended use. Managed angioplasticheskih is the location of the affected area.The outer surface of the wire guiding equipment type spiral wound preferably provided with an elastic biocompatible coating or sheath for the formation of a smooth outer surface. Appropriate coatings may be performed by dipping, spraying or wrapping and heat treatment, as is well known in this field. Or compressible when heated tube can form the necessary outer shell. The coating material should be selected from among those which provide enough flexibility to the housing 2 without the formation of cracks, minimizing friction during sliding of the tool 1 when its input and output, in addition, it should be inert in the vascular environment. There are a large variety of materials, including, for example, polytetrafluoroethylene, urethane or polyethylene.Case 2 flexible tool 1 usually ends at its distal end 4, a closed tip 7. In this area there are several designs of lugs wire napravila and catheters, and so there is no need to go into great detail. In General, the tip 7 is preferably curved lid made of elastic polymer material is about to specialists in this field. As a sign of security to facilitate complete removal of the fragments of the broken wire guiding equipment safety wire is attached to one end against the inner side of the tip 7 and the other end to the rack 8 or pedestal 9.Immediately next to the tip 7 and the housing 2 flexible tool 7 in accordance with the present invention is free, but controlled controlled section 5. The latter is made in a way that facilitates lateral displacement of the tip 7 relative to the axis of the housing 2 due to the physical design and/or selection of flexible structural materials.For example, in a typical angioplasticheskih wire the sender or the catheter, which has a flexible body 2 contains a metal wire spiral number of turns of wire per unit axial distance along the body decreases on the managed area 5 relative to the housing 2 to form a more free spiral wound with gaps 10 between adjacent coils of wire, as shown in Fig. 1 6. Thus, as shown in Fig. 2, the lateral deviation of the controlled area 5 to the left may include both axial compression of adjacent turns of wire on tx2">Other structures and materials may be used provided that the catheter will have sufficient lateral flexibility. In General, the managed area 5 can be made of various suitable metal or plastic spirals or flexible sleeves, material impervious to x-rays, as platinum, gold, tungsten, tantalum, or etc., can be successfully used to act as fluoroscopies marker to facilitate accurate installation of the balloon section of the catheter.In accordance with the proposed control mechanism has managed 8 hour running essentially in the axial direction inside the controlled area 5 of the flexible body 2. Managed 8 hour preferably located coaxially within the Central cavity of the controlled section 5, when a managed area 5 and the housing 2 are linearly aligned, for example, while in the rest or inoperative (see Fig. 1).Managed rack 8 is mounted on the managed section 5 in a way that essentially prevents its axial displacement, while permitting lateral deviation of the axis of the driven 8 hours away from the axis of the housing 2.Hour 8 preferably contains the Alov, such as nylon, and may have a size in cross section from 0,051 to 0,305 mm for use in a typical design managed wire leader. Or you can use a variety of elastic or springy metals in the form of wire to run 8 hours, for example, phosphor bronze or other resilient metal.Length managed 8 hours will depend on the length of the controlled area 5. In a typical managed a wire leader for angioplasty entire managed area 5 will have a length of from 1,02 to 25.4 mm and preferably from 3,05 up 3,81 mm, and the length of the driven rack 8 can be from 1/4 to 2/3 the length of the plot. Although managed hour 8 may extend in the distal direction through the distal tip 7 a managed tool 1, however, it is desirable to limit its length is about 1/2 or 1/3 of the axial length of the controlled section 5, for the purpose of bringing to a minimum stiffness of the controlled section 5, while ensuring adequate handling.For example, a typical wire guiding equipment for angioplasty of the distal end 11 of the driven rack 22 is removed from the inner surface of the tip at a distance of the order's leadership is required. However, in the structure in which the distal portion of the bundle of fiber optics or flexible tube for the formation of a working channel additionally serves as a managed rack 8, the latter extends to the distal tip 7 and exits through the existing hole (see, for example, Fig. 4).In the preferred construction managed hour 8 have also enlarged part 12 to optimize the transmission of lateral forces from the driven rack 8 on the wall of the managed area 5. To this end, the part 12 is most effective placed on/or near the distal end of the driven rack 8. Part 12 can be manufactured by the methods of dipping or coating, or may be pre-fabricated element having an aperture for sliding on the end managed 8 hours. Or hour 8 may be formed or reservats to get made in one piece with the part 12. The latter has preferably a circular shape in cross section perpendicular to the axis of the rack 8, and the outer diameter portion or bead 12 is only slightly less than the inner diameter of the managed section 5, resulting in maximum lateral movement managed rack 8 is passed to a managed the The proximal end 13 of the managed rack 8 is attached to/or roller in contact with the radial support 9 so as to provide the rotation of the driven rack 8 360oaround the axis of the housing 2. Hour can be molded or obtained by milling in one piece with the support 9. The last are any means by which the deflection of the wire 14 are displaced radially outward from the axis of the tubular body 2 with respect to the points of their attachment to the managed rack 5, as will be described.As shown in Fig. 1, the support 9 contains the disk 15 mounted in a tubular housing 2 managed tool 1, preferably near its distal end. The disk 15 is axially fixed in the tubular casing 2 for the formation of a radial bearing at least one deflection wire 14 and the hinge support for the managed 8 hours. The disk can be mounted, for example, using the friction of the landing between adjacent coils of the spiral spring wire. Managed 8 hour preferably attached to/or in contact with the disc 15 by the way, providing her turn from the 90oto almost 0orelative to the transverse plane of the disk 15.The disc 15 may be made of stainless steel or lecheval sufficient axial rigidity of the proximal end 13 of the managed 8 hours. The disc 15 may be manufactured by stamping from sheet stock and drilling, injection molding or other known methods. In the center of the disc is preferably a notch or a hole for axial placement managed 8 hours. The diameter of the disk 15 may vary, but normally it should not exceed, and may be closer to the outside diameter controlled tool 1. The diameters of the order of 3,556 to 1.27 mm may preferably be used when creating cardiology angioplasties catheters.Lateral deviation managed 8 hours away from the axis of the housing 2 is achieved through the proximal axial displacement of any of the numerous deflecting wires 14, reaching proximally through the entire length of the flexible body 2. Although used only one or two deflecting wire 14, however, it is desirable to use three or four deflecting wire to allow full range of motion 360omanaged area 5 around the axis of the housing 2, as will be obvious. More detail will be described only one deflection wire 14.The distal end of the deflection wire 14 is attached by, for example, glue to a managed rack 8 at its distal end, is linoma the end of 13 hours 8 increases to the limit component of the lateral force, created by the axial displacement of the deflecting wire 14, and for this reason, deflecting the wire is preferably attached to the rack 8 is approximately within half or one-third of the axial length of the rack 8, reaching distal from the support 9. At the end of the deflection wire may be run loop, covering the rack 8 and resting on the ledge formed by the milled flange or gluing, or other means of fastening.Deflecting the wire 14 preferably passes radially outward from the attachment point to the managed rack 8 to the support 9. With this purpose, the bearing 9 is preferably provided with a groove or hole 16 for each deflection wire 14 passing through it, the opening 16 is removed radially outward from the axis of the tubular body 2 at the first distance. The distal end of each deflection wire attached to the control rack 8 at a point radially offset from the axis of the rack 8 to the second distance and the first distance is preferably greater than the second distance, with the objective of increasing to the limit of the lateral component of force. The second distance is preferably approaches zero, but essentially it will include the radius of the driven rack 8, where otklanyalsya design of the invention uses four deflecting wire 14, each of which passes through its opening 16 in the support 9, which is located at an angle of 90oto one another in the plane of the support 9. In a design with three deflecting wires, as shown in Fig. 1, each hole 16 located at an angle of about 120o.Deflecting the wire can be made of stainless steel, nylon or any other suitable material that provides sufficient tensile strength and flexibility. The diameter of the wires may vary from 0.025 to 0.127 mm or more, and the suitability of a particular size or material can be easily determined experimentally.In Fig. 1 to 3 schematically shows a control device 6 for controlling the catheter. In the Central control unit 6 preferably is hinged support 17, which allows him to tilt 360o. In the presented design, the control device 6 includes a round plate 18 attached to the proximal end 3 of the flexible tool 1 using the pivot bearing 17. Deflecting the wire 14 is uniformly removed radially outward from the center of rotation of the control device and at equal angular distance around the plate 18. Last, Atlantas 14, component which is decomposed into lateral force, deflecting the catheter tip to the/and away from the longitudinal axis of the catheter. Selective inclination of the deflecting plate 18 results in rotation of the catheter tip in any desired direction.Managed tool of the invention may be used various other control devices. For example, can be used with the device type of the control stick containing a single lever that can be moved to any position on almost hemispherical trajectory. As another alternative, the area of the proximal end 3 of the tubular body 2 is enlarged in cross section of 1/2 inch or more to facilitate capture. The enlarged portion is equipped with a large number of sliding in the axial direction of the switches, i.e., one for each deflection wire 14. Manipulation switches with large or forefinger achieved the desired deviation of the controlled area 5. As will be obvious to the expert, any control device is preferably provided with a stopper for preventing the bending of the rack 8 or the control section 5 for their limit of elasticity.Various facto the maximum displacement of any of the deflecting wires 14. For example, because the hole 16 is removed farther in a radial outer direction, the component of the lateral force will increase. However, lateral displacement of the holes 16 is limited to a maximum diameter that can be controlled instrument for the intended application.Conversely, the shorter the distance from the support 9 to the attachment point 19 deflecting wire to the managed rack 8 increases the angle between the axis of the rack 8 and the deflecting wire 14, thereby increasing the lateral component of the force.Another alternative design is shown in Fig. 5. In this construction, the hinge 21 is installed at a point midway between the radial support 9 and the fastening point 19 to maintain the deflection of the wire 14, a concave in a radially inner direction. The hinge 21 can contain essentially radially symmetric element, for example a sphere or toroid, which also serves to limit the proximal axial movement managed 8 hours through the Central hole in the support 9. In this construction the point of attachment of the deflecting wires 14 may be a hinge 21 instead of direct mounting to a managed rack 8.In accordance with another goal and the laser angioplasty. In Fig. 4 shows an elongated flexible tool 22 that contains at its distal end free the managed area 23. As discussed in relation to previous designs, increased flexibility may be communicated to the managed area 23 through a clearance 24 between adjacent turns of the wound wire 25.Radial support means 26 are located at the proximal end of the controlled area 23, which may contain circular plate 27 or other design to offset deflection wire 28 radially outward from the axis of the tool 22.The waveguide, for example harness 29 fiber optics located along the length of the tool 22 for directing a laser beam from a source (not shown) located at the proximal end of the tool 22, to the point of its application in the coronary artery at the distal tip 30 of the tool 22. With this purpose, the optical path passes through the entire length of the controlled area 23, and passes through the tip 30, leaving holes 31 made in it.Each of the deflection wire 28 is attached to its distal end to the bundle of fiber optics 29 to a point located midway between the radial support 26 and the distal n which is at a distance of 1/2 and preferably 1/3 of the distance between the radial support 26 and the distal tip 30 to optimize the lateral component of efforts.Thus, using the control unit, a laser catheter for angioplasty provides controlled the direction of the beam of light transmitted through the fiber tow at any desired point within a full circle 360oon the plane perpendicular to the axis of the tool 22.As is known in the field of fiber optics, the number of features can be achieved by using a waveguide, for example by using a fiber bundle. For example, essentially parallel but discrete bundles of fiber optics can be placed one near the other inside of the fiber bundle 29 to create multiple, discrete light-absorbing channels. Or it can be created a large number of concentric optical paths, which is well known in this field.A large number of discrete optical paths can be successfully used to implement various functions. For example, the first optical path can be used for visual inspection of the stenotic area or another subject to the treatment surface. A separate optical path can be used to transmit light to cover the affected area. The third optical path m is about radiation is well known to the specialists in fiber optics.Various additional functions can be performed through the use of positive internal space in the housing of the controlled tool 22. For example, in the preferred construction may be provided in the suction channel located near the distal end of the tool 22 for sucking foreign substances or gases, resulting from the action of the laser. Or instead of the waveguide in the managed device may be integrated flexible tube, which creates a working channel for receiving through him additional tools.In Fig. 7 shows another design of the control device. This device can be built into the guidewire or catheter, such as catheter-balloon, or other elongated instrument for which it is desirable handling.The control device 32 is preferably integrated in the managed guidewire of this type, which is made of an elongated flexible tubular spiral spring 33, having a Central cavity running through it. Spring coil 33 may also have an outer shell or coating, as is well known in this field, or spring itself was stolen maximally the end of the spiral spring 33 is composed of a larger number of neighboring loops or coils of wire. This flexibility spiral spring 33 at the distal managed area can be enhanced through the creation of an interval between adjacent loops of a spiral spring. Or adjacent loops of wire of the controlled area may come into contact with each other, i.e., to be without axial clearance when the controlled area is in line with the axis of the adjacent wire leader.In the axial direction inside the controlled area spiral spring 33 is located in the Central strut 34. The latter preferably is made of flexible polymer by the method of extrusion, although any of a wide variety of materials may be included in the rack 34. Most preferably the rack 34 includes a nylon rod having essentially circular shape in cross section and a diameter of the order is 0.102 mmThe distal end 35 of the rack 34 is preferably located on/or near the distal end of the spiral spring 33. For example, the distal end 35 in one design ends proximally from the tip of the wire guiding equipment (not shown), similar to the design shown in Fig. 1. Or the distal end 35 is in contact with the tip of the wire guiding equipment, which is a known biocompatible glue. In any structure, the distal end of the spiral spring 33 is supplied by any known automatic tip, which is the standard in the field of angioplasty, such as that produced by molding or dipping.Most preferably, the rack 34 were located in the distal direction beyond the distal ends of the guide wire 36 and the specified length to the distal end of the wire leader. The presence of such length between the effective point of attachment of the wire napravila and their tip leads to the fact that the managed land in the process forms the "knee" of the curve, which is clinically considered to be desirable. In addition, the rack 34 is located between the end of the guide wire and the tip of the wire guiding equipment, can serve as a safety wire to secure the tip of the wire guiding equipment from disconnecting.Cut free tip for tighter controlled area of the wire guiding equipment may vary depending on a number of considerations that will be clear to the person skilled in the art, including subject research vessels. In this design (Fig. 7 or 11), nab, the ka of 0.25 mm. The axial distance between the guide 37 and the bracket 36 is about 0,151 mm, the distance between the end of the bar 36 and the distal tip of the wire leader is of the order of 3.56 mm Diameter control rack 34 order is 0.102 mm Diameter spring wire housing wire leader 0,051 mm, an Outer diameter of the wire guiding equipment Assembly 0,356 mmHour 34 passes in the proximal direction through the spiral spring 33, so far as it is required for this application that will be obvious to a person skilled in this field. For example, the Central strut 34 may be located proximally to the extent that stretches guide wire 37, or farther in the proximal direction to impart greater rigidity of the spiral spring 33, than if it had otherwise.Hour 34 at some point of its length shall be secured against axial displacement in the proximal direction relative to the spiral spring 33. From the point of view of manufacture, it was found convenient for this purpose to secure the proximal wire guides as to the rack 34 and the inner surface of the spiral spring 33. However, the strut 34 may also be attached to the treno also a large number of proximal guides 37 for guiding each of a large number of deflecting wires 38. Preferably there are four proximal guides 37, evenly spaced about the periphery of the center pole 34. As will be clear to the specialist, three guides 37, evenly spaced around the periphery of the Central rack 34 will also provide full controllability of the wire guiding equipment in the range of 360o. However, the application of the four deflection wires 38 is preferred. Similarly, the guidewire can be performed with only two or even one proximal guide 37 with a corresponding decrease in range of movement in which the guidewire is manageable.A large number of deflection wire 38 is held in the axial direction along the length of the spiral spring 33, with each of them passes through unusual designs proximal guide 37 to the distal end 35 of the rack 34 is also provided a large number of distal guide corresponding to each of the deflecting wires 38.In accordance with the preferred design incorporates four deflection wire 38, each of which has proximal and distal guides. Each of adoneus the Udut obvious, for example, using mechanical fasteners, adhesives or thermal or chemical welding.However, it is found that the mechanical fixing or soldering the distal end of the deflection wire 38 is difficult to implement, although it provides sufficient strength, which allows repeated managed maneuvers by the control device 32 without causing separation of the distal end of the deflection wire 38 from the distal end 35 of the rack 34. Thus, although the preferred construction is equipped with four deflection wires 38, but in reality only two continuous deflection wire to form a loop around the distal end 35 of the rack 34. The first deflection wire 38 is held in the distal direction through the distal guide 36, and then around or through the distal end 35 of the Central rack 34 and back in the proximal direction through the proximal guide 36 and further towards the proximal end of the tool. Thus, all four ends of the two continuous wires end at the proximal end of the wire leader, where they are connected with the control unit, carrying out selective axial reciprocating movement.Deflection wire 38 is located distal the proximal end Napravi wire diameter, sufficient to ensure sufficient tensile strength to provide control wire leader without his break, but small enough that allows you to create a guidewire suitable for angioplasty. The wire is preferably used in stainless steel with a diameter of the order of 0.038 mm But can be used with various metals or polymers, and the minimum diameter for any selected material can easily be determined by a specialist.The distal guide 36 in a preferred variant embodiment has a construction similar to the proximal guide 37. Thus, the distal guides 36 are made of a large number of elongated tubular rails that are attached to the center pillar 34, for receiving through them the corresponding deflection wire 38. Or distal guide 36 may just be the groove going on the distal end 35 of the rack 34, or a hole passing transversely through the center of the Central rack 34.Proximal 37 and distal 36 guides when they are used, preferably attached to the center pillar 34 by applying adhesive, for example by finishing provenio through the corresponding proximal guide 37, through the distal guide 36, and then back in the proximal direction through the distal guide 36, and then back in the proximal direction through the appropriate on the opposite side of the rack 34 and passes through the proximal end of the tool. This Assembly process is repeated for the second deflecting wire. When installed in the position of the deflecting wires 38, the entire distal end 35 of the rack 34 is immersed in or covered with epoxy resin or other biocompatible material for formation of the cover 40 in order to consolidate each deflection wire 38 against axial displacement relative to the driven rack 34 (see Fig. 11).Then the whole Assembly from the rack 34 for guiding and deflecting the wire is inserted into the first distal end to the proximal end of the standard spiral spring 33 and moves up until the proximal guide 37 will not be around in the axial direction near the beginning of the distal flexible managed area on the spiral spring 33. Then epoxy or other biocompatible adhesive 39 is applied between adjacent loops of a spiral spring 33 to secure the proximal guide 37 to the spiral 33, those who midna tube can be glued with epoxy resin to the adjacent spiral spring 33, using wire 0,051 mm or other applicator tip under a microscope. However, care should be taken so that the epoxy resin has not got into contact with the deflection wire 38, as otherwise deflection wire 38 will not slide axially within the proximal guide 37.In Fig. 8 to 10 show another construction of the control device. The device 41 includes a main body 42 having a proximal guide wire 43, the fastener 44 to the wire and the hinge section 45. Preferably, the guide 43, the hinge 45 and fasteners 44 made in one piece from a single extruded or molded workpiece. In accordance with the preferred fabrication of the main body 42 has a maximum diameter of less than 0,227 mm or less and has an essentially circular shape in cross section, with the exception of a large number running in the axial direction of the channels 46 for admission wire napravila 47. Each of the channels 46 preferably has a depth of about 0,051 mm, resulting in a stainless steel wire with a diameter of 0.038 mm can be placed in it with the possibility of sliding. The channels 46 may conveniently be performed in the process of pressing in the form of Adelino outward flanges, situated along the axis for education between channels 46. The hinge 45 may be performed by any method that is well obvious to the expert and which will depend on the used materials. For example, in the case of thermoplastic polymer wypracowania hinge section 45 preferably contains the running radially inside the annular cavity, which can be obtained by the application of heat and pressure or by extrusion after extrusion process. Or the hinged section can be obtained by creating an annular depression with other operations, such as using physical milling or cutting away from the spray, or guide 20 and the bracket 44 can be fastened to cut metal or polymer wire, remote in the axial direction, to form between them a flexible section of the wire.Preferably, the control unit 41 provided with a deflecting wire 47 in each of the four 90othe current provisions around its periphery (see Fig. 9). As noted earlier, this can be achieved by providing four separate wire napravila that zakreplena when assembling the control device 41 with two continuous deflection wires 47, which form a loop around the distal end of the fastener 44 and go back in the proximal direction.A tubular sleeve 49, for example a segment of the compressible when heated tube, is attached to the distal end of the fastener 44 and moves proximally in aligned position with the proximal guide 20 so that each wire 47 were in the corresponding channel 46. When exposed to the heat annular sleeve 49 is reduced in diameter and tightly attached to the proximal guide 20. The use of the channels 50, having a depth of about 0,051 mm provides sufficient clearance after heat shrinkage of the sleeve 49, resulting in a stainless steel wire having a diameter of about 0.038 mm, are free to slide in the axial direction.After that, the control node is inserted in a standard spiral wire leader and pushed up until the proximal guide 20 will not be approximately aligned with the distal end of the flexible control sections of the spiral 51. The radial outer surface of the annular sleeve 49 may then be fastened to the adjacent loops or coils of the spiral 51, for example, using epoxy or other adhesive 52, Kinam direction causes the wire 47 to slide through the channel 50 in the proximal direction, and because the wire 47 still attached to the fastener 44, the hinge portion will be bent to provide lateral displacement of the fastener 44 in the direction of the wire 47, which is proximally moved. Thus, the control unit 41 provides selective lateral displacement of the distal tip in any direction and position of the distal end of the control device back axially aligned with the axis of the adjacent portion of the wire of the sender or of the catheter.In a modified embodiment of the device shown in Fig. 8 to 10, the hinge section 45 is missing, resulting in the assembled device has a fastening section 44 and the guide 20, the remote in the axial direction and attached to the spiral casing of the wire leader. Thus, in this design there is no hour. In addition, in this construction, the deflection of the wire are located distal from the guide 20 in the direction of the fastener 44, as before, but the passage is essentially parallel to the axis of the control device 41 each deflection wire crosses the axis control device toward the opposite side. Thus, for example, one deflecting Provo what about the device in position 180othe fastener 44. After that, the wire 38 in the preferred design forms a loop around the distal end of the fastener 44 and passes proximally through the channel 46 in the 90o-ing position. Then wire 38 passes diagonally across the axis of the control device through the guide 20 in a position 180oand proximally to the control device.As another alternative, the distal ends of the deflecting wires (which may be a mid-length double rear wire) is soldered directly to the wire spirals housing wire leader. The entire connection is conveniently achieved on the outer surface of the casing of the wire guiding equipment, and deflecting the wire is preferably arranged radially outward between adjacent coils of a housing of the wire leader. When two deflecting wire is made of one piece of wire, make a loop around the control area of the wire guiding equipment, its deflecting wire conveniently makes a loop around the outside of the body of the sender to provide a place for soldering. When you apply the solder connection, the distal fastener 44 may be missing. 1. The device is connected to it with an offset in the axial direction at least one deflection wire located inside the controlled area of an elongated tool, characterized in that the guiding and deflecting the wire is movably arranged in the axial direction.2. The device according to p. 1, wherein the elongated instrument includes a flexible catheter or flexible guidewire.3. The device under item 1, characterized in that it has four deflection wires and the means of their variances.4. The device according to p. 3, characterized in that the management tool deflection wire contains executed in the axial direction on the surface of the guide channel or passing through the guide hole.5. The device under item 1, characterized in that it has at least three deflecting wire, placed symmetrically in the radial direction.6. Managed guidewire for percutaneous transportnogo introduction in the coronary vascular system, containing elongated in the axial direction of the flexible hollow body having a capability of bending in the middle part, deflecting the wire from vehicle control, characterized in that it has at least three deflecting wire, evenly spaced radially around the body and along the axis.7. The leader on p. 6, Otley is its axial displacement relative to the catheter.8. The sender under item 6, characterized in that it has an inside cavity deflecting means.9. The sender under item 8, characterized in that it has a support for deflecting means, pivotally connected to the support.10. The sender under item 9, wherein the deflecting means is made in the form of deflecting hours.11. The sender under item 10, characterized in that the deflecting hour has the possibility of axial tilt.12. The sender under item 10, characterized in that the cross-sectional area of deflecting the rack in its middle part is less than the cross-sectional area of other portions of the deflecting hours.13. The sender under item 6, characterized in that it has a resilient tip on the end of the housing.14. The method of controlling a wire leader, having at least one deflection wire and an elongated flexible body with a tip engaged in the introduction of the wire leader in the coronary vascular system, its promotion to branching, the management tip of the wire to the sender due to an axial displacement of the deflecting wires, promotion of the wire leader through the turn, straighten and further promotion, otoh more than one.15. The method according to p. 14, characterized in that in the presence of at least three deflecting wires axial displacement of any of them carries out the lateral deviation of the tip and turnover 360oaround the axis of the flexible body.
FIELD: medical equipment; catheters.
SUBSTANCE: rectal catheter has cylinder, head made for close distal department of cylinder, and two tubes mounted at proximal end of cylinder at acute angle to cylinder. Elastic tube provided with scale passes through one tube and it is connected with head. Second tube is connected with manometer. Sealing contrivance is put onto cylinder, which sealing contrivance provides air-tightness of connection with tissues; the contrivance prevents catheter from dropping out by means of holders. Elastic tube is made for movement. Head is provided with cavity connected with several channels, which channels go out of cavity at acute angle to central axis of head.
EFFECT: ability of application of fluid to specific part of thick abdominal; improved precision of measurement; reliability of fixation of catheter.
3 cl, 2 dwg
SUBSTANCE: method involves carrying out cerebral trephination in hematoma position projection. Then, catheter is set into hematoma cavity. Additional catheter of lesser diameter is set through opening in the main catheter. Fibrinolytic agent is introduced via the additional catheter. Main mass of the hematoma being lysed and lysed blood being sucked off, the additional catheter is removed. Catheter of larger diameter is left in subgaleal space until hematoma is completely eliminated.
EFFECT: enhanced effectiveness of brain decompression; reduced risk of infectious complications.
SUBSTANCE: group of inventions refers to medicine. A device for prove movement comprises an elongated flexible tube limiting a central cavity adequately sized to be placed into a biological or construction tract, and having a proximal end and a distal end; a drive mechanism coupled with the proximal end; a fluid column extending in the central cavity from the proximal to distal end; and a displacement unit at the distal end and promoting a proximal movement of the fluid column in response to a distal movement of the fluid column. The drive mechanism is provided to make the fluid column reciprocate in the tube to supply a forward pulse to the tube and thereby to promote the movement of at least the distal end of the tube in the tract, when at least the distal end is found within the tract. What is disclosed is the method for the probe movement implemented by the above device.
EFFECT: providing the distant control of the probe movement.
15 cl, 44 dwg
SUBSTANCE: invention refers to medical equipment, namely to devices for the small intestinal drainage in acute abdominal surgical pathology. A device for the small intestinal intubation in the technically complex environment consists of an outer elastic tube of 12 mm in diameter, 280-300 cm long and having holes at a caudal end. A supplementary tube of 3 mm in diameter is inserted into a lumen of the outer tube along the entire length; a longitudinal rubber bag is attached to the caudal end of the supplementary tube brought out through the caudal end of the outer tube; at the end of the caudal end, there is an olive movable in relation to the outer tube. Progressive motion of the olive in the intestinal lumen is ensured by the inflation and elongation of the bag. The device is movable by fixing the olive in the intestinal lumen by the elastic contraction of the bag after de-aeration.
EFFECT: invention provides reducing injuries that might accompany the intestinal intubation manipulations in the technically complex environment.
SUBSTANCE: method involves the endoscopically controlled introduction of Coletex-D gel into a fistulous passage from the oesophagus until filled completely. The following exposure to a laser light at wavelength 0.66 mcm, output power 15-45 mWt/cm2 covers a fistulous passage mouth for 5-7 minutes to be repeated in the same mode every second day. The course of the laser light exposure makes 8-10 procedures.
EFFECT: method provides the adequate therapy requiring no abdominal surgeries and the lower risk of chest and abdominal injuries, the shorter rehabilitation period by improved sealing of the fistulous passage, fistula healing, reduced inflammatory process.
SUBSTANCE: group of inventions relats to medicine, namely to vascular surgery, and can be used in performing endovascular surgery, such as embolisation of blood vessels, treatment of arteriovenous defects or small aneurisms, and arterial laminations. For this purpose two versions of device for introduction of surgical glue on operation site of patient's body are used. In one version device, containing duct, which has input opening and output opening for surgical glue, is used. Device is made with possibility of travel in biological medium in patient's body from opening in patient's skin plane to operation site in such a way that immediately after duct reaches operation site, output opening is on operation site, with output opening remaining outside of said opening in skin plane. In the process of device application input opening is hydraulically connected with source of surgical glue and with pumping means, made with possibility of their control by operator. Device contains means for preventing contact between liquids, connected with duct and made with possibility of preventing penetration of blood or other biological material on operation site into duct and interaction with surgical glue. Second version of device contains duct and sliding connecting means, adjusted for connection of duct with needle-catheter. Duct has output opening and is adjusted for delivering dose of surgical glue and introduction of said dose through output opening on operation site at specified distance from skin plane hear operation site. Device also contains blocking means for blocking movement of duct relative to needle-catheter, made as one piece with duct and located at distance from output opening in such a way that output opening is located at said specified distance from skin plane, when blocking means rest against skin plane.
EFFECT: group of inventions provides occlusion of place of needle-catheter introduction, preventing haemorrhage, as well as provide possibility of realisation of endovascular surgery without changing properties of fast hardening of liquid due to prevention of contact of glue with biological fluids in the course of surgery.
22 cl, 49 dwg
SUBSTANCE: group of inventions relates to medical equipment, namely to control handle for medical devices, in particular to control handle with multiple mechanisms for managing plurality of extending wires, as well as to catheter with such handle. Control handle for medical device with at least first structural element controlled by user and at least first extraction element for control of first structural element comprises housing and first drive unit. First drive unit comprises: first actuating element, shaft, roller lever and clutch gear. Shaft length determines first rotation axis, first actuating element is installed on shaft and it is made with possibility of displacement in plane, in fact perpendicular to shaft. Roller lever is installed on shaft and is connected to it with possibility of rotation, wherein roller lever has possibility of activation of first traction element during shaft rotation. Coupling mechanism is made with possibility of engagement and disengagement. Clutch gear has friction disk and friction creating surface. Friction disk is installed on shaft and is connected to it with possibility of rotation. Friction disk is in contact with friction creating surface in engaged state and does not contact friction creating surface in disengaged state of clutch mechanism. Shaft is made with possibility of translational movement along its length under action of first actuating element, when first actuating element is removed from plane for disengagement of clutch mechanism, as well as with possibility of rotary movement under action of first actuating element, when clutch gear is in disengaged state. Catheter is configured with possibility of mapping and/or ablation, catheter comprises elongated body; intermediate flexible section located distally to catheter body; said control lever located proximally to catheter body; and at least first extraction element passing between control handle and intermediate flexible section.
EFFECT: invention enables more accurate control of position and direction of catheter.
20 cl, 20 dwg
SUBSTANCE: medical device control lever with an elongated body, a distal assembly that located distally relative to the elongated body and having an adjustable configuration. At that, the medical device comprises a pull-out element extending through the elongated body and the distal assembly. The control handle comprises a housing and an actuator assembly. The housing has an outer surface with a groove formed thereon. The actuator assembly comprises: a disk controller, rotatable by the user; a coil with a barrel, inserted into the through hole of the housing; a lock washer mounted on the barrel; at least one washer for friction, locayed on the barrel; and a fastener located on the barrel and intended to create a compressive force acting on the washer, which creates friction. The coil has a drum on which the pull-out element is wound. The lock washer is rotationally coupled with the disk controller to transmit rotary motion from the disk controller to the barrel. The lock washer has a protrusion moving in the groove to guide lock washer movement. A catheter comprises: an elongated body; a distal assembly with adjustable configuration; a pull-out element extending through the elongated body and the distal assembly; and the previously mentioned control handle.
EFFECT: invention allows more precise control of the catheter position and direction.
20 cl, 20 dwg
SUBSTANCE: device for centesis and intraoperative cito lavage of gall bladder lumen is a 30 cm metal needle with a diameter of 4 mm, a chlorovinyl tube with a diameter of 2 mm passes in its lumen from the distal end over 28 cm, the chlorovinyl tube is pulled out from the proximal end of the metal needle at a distance of 1.0-2.0 cm. The distal ends of the chlorovinyl tube and the metal needle are cut parallel at an angle of 60°.
EFFECT: invention enables to minimize abdominal cavity infection, accelerate gall bladder lumen sanation, reduce the frequency of intra- and post-operative complications during LCE.
SUBSTANCE: control handle for a medical device, which has at least the first function and the second function controlled by the user. The medical device further comprises at least the first pull wire and the second pull wire to control the first and the second control functions. Control handle comprises: a housing including the first and the second portions; the first actuating unit and the second actuating unit, independently rotating around the common axis of rotation. The first actuating unit comprises the first actuator, an arm rotating around the said common axis of rotation, and the first bore. The first actuator and the arm are rotatably connected by the first bore. The arm has at least one pulley. The first pull wire is engaged with at least one said pulley. The second actuating unit comprises the second actuator and the second bore with a coil. Rotation of the first actuator results in arm rotation moving at least one pulley to pull the first wire to control the first function of the medical device, while rotation of the second actuator results in coiling of the second pull wire serving to control the second function of the medical device. A catheter comprises: an elongated body; a distal assembly with adjustable configuration; the first and the second pull wires extending through the elongated body; the third tensioning wire extending through the elongated body and the distal assembly; and the previously mentioned control handle.
EFFECT: invention allow more precise control of the catheter position and direction.
13 cl, 16 dwg