|Número de publicación||WO1991001772 A1|
|Tipo de publicación||Solicitud|
|Número de solicitud||PCT/SE1990/000503|
|Fecha de publicación||21 Feb 1991|
|Fecha de presentación||25 Jul 1990|
|Fecha de prioridad||31 Jul 1989|
|Número de publicación||PCT/1990/503, PCT/SE/1990/000503, PCT/SE/1990/00503, PCT/SE/90/000503, PCT/SE/90/00503, PCT/SE1990/000503, PCT/SE1990/00503, PCT/SE1990000503, PCT/SE199000503, PCT/SE90/000503, PCT/SE90/00503, PCT/SE90000503, PCT/SE9000503, WO 1991/001772 A1, WO 1991001772 A1, WO 1991001772A1, WO 9101772 A1, WO 9101772A1, WO-A1-1991001772, WO-A1-9101772, WO1991/001772A1, WO1991001772 A1, WO1991001772A1, WO9101772 A1, WO9101772A1|
|Solicitante||Radi Medical Systems Ab|
|Exportar cita||BiBTeX, EndNote, RefMan|
|Citas de patentes (2), Citada por (30), Clasificaciones (9), Eventos legales (3)|
|Enlaces externos: Patentscope, Espacenet|
CATHETER, MANIPULATOR AND COMBINATION THEREOF.
The present invention relates to a catheter, a manipulator and a combination thereof.
Navigating a catheter from a large vessel to a small vessel is difficult. To succeed in doing this, the tip of the catheter has to be tilted and turned to the desired position. Insertion of a catheter from the femoral vein to, for example, one of the kidneys is presently performed in that a guide first is inserted to the branching point of the vein, i.e. in this case the renal vein, and thereafter a catheter having a pre-shaped bend in the distal end thereof is pulled over the guide. The catheter, controlled by the guide, is forwarded to the branching point, after which the guide is removed and the catheter is forwarded to some extent, whereby it is intended that the pre-shaped bend "jumps into" the right position. The distal end of the catheter is provided with an X-ray marker permitting observation of the position of the catheter. However, the navigation involves moments of unsatisfactory hazardous nature. At the time the catheter is in position, contrast medium is often injected under high pressure through the catheter into the organ. When the catheter is submitted to this high pressure the position of the tip of the catheter is often changed and in unfortunate cases the tip jumps out of the smaller vessel and the final phase of the navigating operation has to be repeated.
From EO 0 306 010 A2 a catheter is known having controlled flexibility but not controlled dirigibility.
An object of the invention is to provide a catheter with twisting strength and which is easily forwarded. The catheter shall be provided with a tip being soft enough not to damage the vessel walls and being dirigible from a location outside the body for the catheter to be inserted under thoroughly controlled condi¬ tions.
Another object of the invention is to accomplish a manipulator intended for catheters, endoscopes, guides etc. , which from a location outside the body permits manipulation of the position of the tip or similar with high precision.
One further object of the invention is a manipulator of said kind that is irreversible, i.e. the operator set position of a setting means, below designated as a motion transmitting device, belonging to the manipulator is neither changed when the operator lets go of his grip of the setting means, nor when the catheter or similar to which the manipulator is intended to be connected is pressurized (e.g. with contrast medium) or alternatively is subjected to other external forces.
Another object of the invention-is to provide a combination of a catheter and a manipulator.
Yet another object of the invention is to accomplish two or more manipulators connected in series, each of these directing the tip of the catheter or similar in the same direction but with different amounts.
Yet a further object of the invention is also to accomplish two or more pairs of manipulators connected in parallel, whereby each pair of manipulators connected in parallel permit motion of the tip into opposite directions.
The features characterizing the invention are stated in the enclosed patent claims.
Below the invention will be described more closely in association with the enclosed drawings, in which
Fig. 1 is a schematic longitudinal view of the catheter according to the invention,
Fig. 2 is a longitudinal section of the catheter, Fig. 3 is a cross-section of the catheter taken along line A- A in Fig. 2,
Fig. 4 is a longitudinal section of the manipulator according to the invention,
Fig. 5 is a cross-section taken along line A-A in Fig. 4, seen from above,
Fig. 6 is a cross-section taken along line B-B in Fig. 4, seen from above,
Fig. 7 is an exploded view of"some of the parts shown in Fig. 4,
Figs. 8-10 show the function of the manipulator shown in Fig. 4,
Fig. 11 shows a modified embodiment of the manipulator according to the invention,
Figs. 12-13 show the function of the manipulator shown in Fig. 11,
Figs. 14-15 show a modified form of the manipulator according to the invention with the setting means being set in the respective outermos position, and
Figs. 16-17 show the function of the manipulator shown in Figs. 14-15.
Fig. 1 is a longitudinal view of the catheter according to the invention, whereby the catheter generally has been designated with the reference numeral 1. The catheter comprises a feed-in portion 2, a soft guide portion 3 and an extra soft tip 4. The feed-in portion 2 is about 1000 mm long, the guide portion 3 about 40 mm and the tip 4 about 5 mm. These values are exemplary and not o be construed as limiting the invention. The upper or proximal end of the catheter is intended to be connected to a hypodermic syringe or similar, and its lower or distal end is intended to be inserted into, for example, a vein of a patient.
In Figs. 2-3 the construction of the parts 2, 3, 4 is shown in more detail. The feed-in portion 2 consists of an inner tube 5 of relatively rigid plastic or other suitable material, a reinforcement 6 attached to this inner tube 5 and an outer tube 7 placed outside the reinforcement and being of softer material than the inner tube 5. The feed-in portion 2 is slightly flexible, rigid when twisted and easily forwarded into, for example, a blood vessel. The guide portion 3 is constructed in the same way as the feed-in portion 2 except that the reinfor¬ cement is missing. Instead a softer material, the same as in the outer tube 7, has been used for this portion. Furthermore, an X- ray marker 9, is provided in the distal end of the guide portion 3. The X-ray marker is annular and located between the inner tube 5 and the outer tube 7. On one side of the catheter, the left in Figs. 2, 3, a pull line 8 is provided extending along the overall catheter 1 in a channel 10 provided in the softer outer material (see Fig. 3). The distal end of the pull line is fixedly mounted in the X-ray marker 9. The pull line 8 can be a Teflon®-treated flat wire able to slide freely in the channel 10. Owing to the Teflon®-treatment a plastic can be extruded on the pull line, the Teflon®-treatment preventing the pull line from sticking to the extruded plastic. Finally the catheter 1 is provided with a tapered tip 4 consisting solely of soft material, for example plastic, the same as in the outer tube 7. This construction prevents damage on vessel walls and suchlike at the insertion of the catheter.
The manipulator according to the invention shown in Figs. 4-7 comprises a setting means 11 displaceable along an elongated housing consisting of an upper stationary part 12 and a lower stationary part 13. The manipulator is intended to be mounted at a catheter 1 or similar, axially penetrating the housing. The manipulator also comprises an inner spindle 14 arranged in the housing onto which a pull line 8 is intended to be fastened. Finally the manipulator also comprises a motion transmitting means 15, 16, 17 arranged between the setting means 11 and inner spindle 14 to transmit displacement movement of the setting means into a diminished displacement movement of the spindle. The motion transmitting means comprises an adjusting sleeve 15 with an outer thread 18 (see Fig. 7) and an inner thread 19, and pin means 16, 17 arranged internally in the setting means 11 and engaged with the outer thread of the adjusting sleeve. The pin means 16, 17 are engaged with the outer thread 18 having a coarse pitch and being arranged externally on the adjusting sleeve. The inner spindle 14 is provided with an outer thread engaging the thread 19 having a fine pitch and being arranged internally on the adjusting sleeve 15. From Figs. 4 and 5 it is clear that the spindle is provided with a projection 20 sliding in a guide slot 21 in the housing part 12. The purpose of this slot is that the turning movement of the adjusting sleeve is converted to an axial movement of the spindle. The setting means 11 and stationary part 12 of the housing are each provided with a circular flange 22 and 23 respectively, which are gripped for setting of the tip of the catheter by the setting means 11.. The housing part 12 is internally provided with a recess for the inner spindle 14.
Fig. 6 is a cross-section along line B-B in Fig. 4 showing the motion transmitting means. The pins 16, 17 of the setting means are engaged in the thread 18 of the adjusting sleeve.
Fig. 7 shows an exploded view of the housing part 12 with two guide slots 21 and the gripping flange 23, the inner spindle 14 with an external thread 24 provided on the lower part and a guide projection 20 intended to slide in one of the guide slots 21 of the housing. The adjusting sleeve 15 is threaded over the internal spindle.
In Figs. 8-10 the functioning is shown of the manipulator shown in Figs. 4-7 in combination with the catheter according to the invention shown in Figs. 1-3. The proximal end of the pull line 8 is fastened to the spindle 14 of the manipulator and the distal end is fastened to the X-ray marker 9 of the catheter, as mentioned in connection with Figs. 1-3. The adjusting sleeve 15 rotates when the setting means 11 is moved upwardly or downward¬ ly, which in turn results in that the spindle 14 threaded in the adjusting sleeve by its outer thread 24, which extends on the lower half of the spindle 14, is moved upwardly and downwardly, whereby the line 8 slideable in the catheter is tensioned and relaxed accordingly. By the use of the setting means 11 three different positions of the tip 4 of the catheter and the guide portion 3 have been set irreversibly. Fig. 8 shows the maximum relaxed position of the line 8,- Fig. 9 shows an intermediate position, and Fig. 10 shows the maximum tensioned position of the line.
In Figs. 11-13 a modified embodiment of the manipulator is shown in combination with the catheter according to the invention. In this embodiment the manipulator is provided with two lines 8, 8' , which are pulled out of and fastened at two different positions in the distal end of the catheter 1. The line 8 is fastened at the distal end of a soft end portion 3, and the line 8' is fastened at the distal end of a soft end portion 3' (see Figs. 12, 13). In this embodiment the end can be bent in two different positions independent of each other but in the same direction. To permit this, two setting means 11, 11', two adjusting sleeves 15, 15' and two spindles 14, 14' are arranged on and in respec¬ tively the axial housing portions 12, 13 in series after each other with a disc 25 between the adjusting sleeves 15, 15'. The housing portion 12 is provided with a recess for the spindle 14 and a guide slot 21 for the projection 20 of the spindle, and the housing portion 13 is provided with a recess for the spindle 14' and a slot for the projection of this spindle. The proximal ends of the lines 8, 8' are fastened on the same side of the manipula¬ tor, in respective spindles 14, 14'. In Figs. 14-17 yet another modified form of the manipulator is shown in combination with the catheter according to the in¬ vention. According to this embodiment the softer end portion 3 of the distal end of the catheter can be bent into two different, opposed positions. Also in this embodiment two lines 8, 8' are arranged with the proximal ends being fastened on each side of the manipulator in the spindles 14, 14', and the distal ends being fastened at the distal end of the catheter 1 comprising the softer portion 3. The difference is that the adjusting sleeve 27 is dimensioned to be engaged with both spindles, and that the adjusting sleeve is internally threaded in a right-handed manner in the upper portion and internally threaded in a left-handed manner in the lower portion. By means of internal pins 28, 29 the setting means 26 can be displaced along the overall length of the adjusting sleeve 27. The lines 8, 8' are fastened to the upper portion of their spindle 14, 14', whereby that portion of the adjusting sleeve 27, which is threaded in a right-handed manner affects movement of the distal end of the catheter 1 in one direction whereas that portion, which is threaded in a left- handed manner affects motion that is opposed relative to the first direction. In Figs. 15 and 17 the setting means 26 is arranged in the maximum outermost position. In this position the line 8' is maximally tensioned via the portion that is threaded in a left-handed manner, whereby the line is maximally relaxed. In Figs. 14 and 16 the setting means 26 is in the maximum innermost position. In this position the line 8 is maximally tensioned via that thread, which is threaded in a right-handed manner, whereby the line 8' is maximally relaxed.
The catheter 1 can optionally be provided with a pre-shaped bend in the distal end thereof to facilitate insertion of the catheter 1 or similar. Observation of the end of the catheter 1 during its route through the human body is accomplished in that the coating is preferably provided with an X-ray marker 9 in the distal end of the catheter. All embodiments according to the invention are constructed in such a way that the position(-s) set by the setting means is (are) irreversible.
The insertion of the catheter in the different combined em¬ bodiments is also done in the same way. The line(-s) is (are) relaxed at the beginning of the insertion and are thereafter directed to the correct position in the human body. The attained precision with which this can be done is very great since a comparatively long travel of the setting means only affects a relatively small axial movement of the spindle, and thus the tensioning of the line. During for example injection of contrast medium, the stress that arises on the tip of the catheter can be counteracted by the pre-tensioning of the line to a suitable extent.
Owing to the twisting strength of the catheter, the distal end portion of the catheter can be directed simultaneously as the catheter can be turned to a desired position.
From the above it is clear that the drawbacks mentioned in the introduction are prevented in a simple and convenient way according to the present invention. Although the manipulator according to the present invention has been described in connection with, the catheter, it is appreciated that the manipulator also can be used to direct, for example, guides or endoscopes. Also, it is possible to manipulate the catheter according to the invention by another device than the manipulator described herein.
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|Clasificación internacional||A61M25/01, A61M25/00|
|Clasificación cooperativa||A61M25/0147, A61M2025/0161, A61M25/0136, A61M25/005|
|Clasificación europea||A61M25/01C10K, A61M25/01C10A, A61M25/00S2|
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