Medical occlusion balloon and conveyer device thereof
Technical field
This utility model relates to the medical apparatus and instruments that a kind of surgical operation or internal medicine intervene operation are used, and particularly relates to a kind of medical occlusion balloon that congenital heart defect is filled a vacancy that is used for.
Background technology
Please see for details shown in Figure 1ly, general heart has right atrium 1, left atrium 2, right ventricle 3 and 4 four chambeies of left ventricle, isolates by an atrial septum 5 between the wherein left and right atrium, isolates by a ventricle barrier film 6 between the left and right ventricle.Present geneogenous heart defect is one of major disease of harm humans sound development, for example has birth defect 7 (as breach) (ASD and VSD) or patent ductus arteriosus (PDA) etc. on atrial septum or ventricle barrier film.
The apparatus that its treatment is adopted is obstruction appliance such as stopper, vascular plug at present, this obstruction appliance is stretched into the barrier film indentation, there in the heart and this breach is carried out mending-leakage by aorta vessel, and the obstruction appliance 9 that is adopted, its shape is to be made of big, the middle thin metallic framework in two ends, please see Fig. 2 for details, the typical material of this obstruction appliance 9 is a Nitinol.Because the shape memory characteristic of Nitinol, made obstruction appliance can be accommodated in the hollow sheath pipe 8, operative site in arteries is transported to heart, from sheath pipe 8, emit obstruction appliance 9 again, obstruction appliance 9 is promptly recovered original shape, with 7 positions of the breach on the shutoff heart diaphragm.
In addition, in order better to play blocking action,, make heart tissue can climb on the skeleton of obstruction appliance and grow simultaneously also in order to improve the biocompatibility of obstruction appliance, obstruction appliance of the prior art generally all can have biocompatible material, as: polyester material.These materials have plenty of and overlay on the metallic framework surface, have plenty of to be embedded in the metallic framework, and its purpose all is to allow heart tissue be grown on this material, plays the effect of strengthening inaccessible power or fixed blocking apparatus.
There is a problem in the obstruction appliance of prior art, though be exactly that metallic framework has shape memory, but its hardness is higher, tinsel is thinner, place in vivo for a long time, can agingly form cicatrix and hardening, along with flowing and heartthrob of blood, its part that contacts with heart tissue is loosening easily, particularly in heart inside, this effect is more obvious, in the course of time, the edge of metal obstruction appliance and its discous lobe may cause the tissue abrasion of heart tissue passivity or sharp property, make inaccessible failure even death.
The utility model content
The purpose of this utility model be to provide a kind of medical occlusion balloon and conveyer device thereof with and carrying method, to address the above problem.
The purpose of this utility model is to realize like this, a kind of medical occlusion balloon promptly is provided, be used for the breach in the shutoff heart, wherein said occlusion balloon is a kind of resilient bladder that is filled up, in described occlusion balloon, be filled with one and fill up material, it is that plate-like end and centre are the shape of the waist of constriction that the described occlusion balloon that is filled up is two ends, and the diameter of described plate-like end is greater than the diameter of described waist.
According to above-mentioned feature, the described occlusion balloon that is filled up described in the utility model be shaped as a kind of dumbbell shaped.
According to above-mentioned feature, the material that fills up described in the utility model is a kind of liquid.
According to above-mentioned feature, liquid described in the utility model is the stable and harmless liquid of normal saline, biogum or contrast agent character.
According to above-mentioned feature, the material that fills up described in the utility model is a kind of metallic framework with memory distortion.
According to above-mentioned feature, the metallic framework of memory distortion described in the utility model is to constitute a kind of reticulate body by the Nitinol tinsel.
According to above-mentioned feature, the waist of occlusion balloon described in the utility model is coarser than the waist of described metallic framework in it.
According to above-mentioned feature, this utility model has several little shape holes on the part surface of described occlusion balloon, when described occlusion balloon is positioned at outside the heart, can get rid of gas in the described occlusion balloon by described a plurality of little shapes hole; When described occlusion balloon placed in the heart, the blood of described heart can enter in the occlusion balloon by described a plurality of micro-holes.
According to above-mentioned feature, the material of resilient bladder described in the utility model can be selected one of poly terephthalic acid ethanol ester PET, polythene PE or polytetrafluoroethylene PTFE for use.
According to above-mentioned feature, this utility model coats one deck biomaterial on the surface of described occlusion balloon, so that described heart tissue can be grown on the described biomaterial.
According to above-mentioned feature, biomaterial described in the utility model is a kind of polyester material.
According to above-mentioned feature, occlusion balloon described in the utility model also is connected with a delivery guidewire that is used for occlusion balloon is delivered to the indentation, there of described heart.
According to above-mentioned feature, delivery guidewire described in the utility model comprises: first section seal wire, and fixedly connected with described occlusion balloon in the stage casing of described first section seal wire; And second section seal wire, it removably is connected with an end of described first section seal wire.
According to above-mentioned feature, first section seal wire described in the utility model and described second section seal wire are for being threaded.
According to above-mentioned feature, first section seal wire described in the utility model passes described occlusion balloon and protrudes in respectively outside the plate-like end at the described two ends of described occlusion balloon, so that described first section seal wire fixedlyed connected with described occlusion balloon.
According to above-mentioned feature, this utility model also is pasted with one deck rubber membrane on the plate-like end of described occlusion balloon.
According to above-mentioned feature, occlusion balloon described in the utility model is threadedly connected to described delivery guidewire.
According to above-mentioned feature, occlusion balloon described in the utility model is connected in described delivery guidewire by a solder joint, and the fusing point of described solder joint is lower than the fusing point of described delivery guidewire.
According to above-mentioned feature, the centre of solder joint described in the utility model has one and is used for the through hole that described liquid passes through.
This utility model also provides a kind of conveyer device of medical occlusion balloon, be used for described occlusion balloon is sent into the indentation, there of heart, described occlusion balloon is a kind of resilient bladder that is filled up, it is that plate-like end and centre are the shape of the waist of constriction that the described occlusion balloon that is filled up is two ends, the diameter of described plate-like end is greater than the diameter of described waist, wherein said conveyer device comprises: a delivery guidewire, and it removably is connected with a plate-like end of described occlusion balloon; Do not send into when described occlusion balloon before the breach of heart, described delivery guidewire is connected with described occlusion balloon; After described occlusion balloon was sent into the breach of heart, described delivery guidewire can disassemble from described occlusion balloon.
According to above-mentioned feature, delivery guidewire described in the utility model and described occlusion balloon are rotated described delivery guidewire by rotating described delivery guidewire for being threaded from described occlusion balloon.
According to above-mentioned feature, delivery guidewire described in the utility model is connected by a phase of solder joint with described occlusion balloon, and the fusing point of described solder joint is lower than the fusing point of described delivery guidewire.
According to above-mentioned feature, this utility model is when filling up material when being a liquid, and the centre of described solder joint is a through hole, is used for described liquid and passes.
According to above-mentioned feature, conveyer device described in the utility model also comprises a sheath pipe, be used to carry the indentation, there of described occlusion balloon to heart, described sheath pipe be hollow and two ends be the pipe of opening, pack among the described pipe with the described occlusion balloon that will not fill up and described delivery guidewire.
According to above-mentioned feature, delivery guidewire described in the utility model comprises: first section seal wire, and fixedly connected with described occlusion balloon in the stage casing of described first section seal wire; And second section seal wire, it removably is connected with a wherein end of described first section seal wire.
According to above-mentioned feature, second section seal wire described in the utility model is hollow tubular, and being provided with one in the hollow pipe of described second section seal wire can be with respect to described second section axially movable injection device of seal wire.
According to above-mentioned feature, injection device described in the utility model comprises: syringe is used to inject a liquid; Conduit be arranged in described second section seal wire, and an end of described conduit is connected with described syringe; And miniature syringe needle, be used for thrusting described occlusion balloon, the other end of described conduit is connected with described miniature syringe needle, after described occlusion balloon is admitted to the heart indentation, there by described conveyer device, by described syringe, described conduit and described miniature syringe needle described liquid is injected among the described occlusion balloon, so that described occlusion balloon is filled up and the breach of the described heart of shutoff; When needs disconnect described guide wire apparatus and occlusion balloon, earlier the described conduit of described injection device is extracted in described occlusion balloon together with described miniature syringe needle, and then described second section seal wire disassembled from described occlusion balloon.
According to above-mentioned feature, occlusion balloon described in the utility model also is pasted with a rubber membrane in the place of being thrust by described miniature syringe needle, when described miniature syringe needle was pulled out, described rubber membrane can seal pin hole automatically because of the elasticity of himself, flow backwards outside the described occlusion balloon to avoid described liquid.
This utility model also provides a kind of carrying method of medical occlusion balloon, be used for described occlusion balloon is transported to the indentation, there of heart, described occlusion balloon is a kind of resilient bladder that is filled up, in described occlusion balloon, be filled with one and fill up material, it is that plate-like end and centre are the shape of the waist of constriction that the described occlusion balloon that is filled up is two ends, the diameter of described plate-like end is greater than the diameter of described waist, described occlusion balloon removably is connected with a conveyer device, and wherein said carrying method is: the described occlusion balloon that a) will not fill up is sent into the indentation, there of heart by conveyer device; B) described occlusion balloon is filled up, with the described heart breach of shutoff; C) described conveyer device is disassembled from described occlusion balloon; D) described conveyer device is extracted out.
Advantage of the present utility model is, owing to adopted the sacculus formula obturation that can fill up to place the indentation, there of heart, it is impaired that heart tissue is difficult for, especially sacculus full of liquid or the band metallic framework can better adapt to the shape of breach, reduces the wearing and tearing of occlusion balloon to the heart surrounding tissue simultaneously effectively; Moreover, this occlusion balloon is in the process that is transported to the affected part and take out delivery guidewire, catheter procedure, and is also convenient and reliable, and can not bring misery to the patient.
Description of drawings
Fig. 1 stretches into the sketch map of this breach for jagged on the atrial septum of heart and a sheath pipe;
Fig. 2 is the sketch map that existing metal obstruction appliance envelope is mended this atrial septum breach;
The sketch map that Fig. 3 is filled up for the described occlusion balloon of first embodiment of the present utility model;
Fig. 4 is the sketch map of the dirty breach of this utility model occlusion balloon envelope reinforcing the heart;
The decomposing schematic representation that Fig. 5 is threaded with seal wire for the described occlusion balloon of Fig. 3;
Fig. 6 is the sketch map of the described occlusion balloon of second embodiment of the present utility model;
The sketch map that Fig. 7 is connected for the metal solder joint for this utility model delivery guidewire and occlusion balloon.
The specific embodiment
First embodiment
This utility model is designed to a kind of occlusion balloon 20 with described obstruction appliance, described occlusion balloon 20 is a kind of resilient bladder that is filled up, the material of this resilient bladder can be selected poly terephthalic acid ethanol ester PET for use, polythene PE, the polytetrafluoroethylene PTFE elastomeric material, has the cavity that can charge into liquid in these occlusion balloon 20 inside, after this liquid charges in this cavity by an injection device, the shape of this occlusion balloon as shown in Figure 3, promptly the two ends of this occlusion balloon 20 are plate-like end 202,203, the centre is the waist 201 of constriction shape, plate-like end, two ends 202,203 diameter should be greater than the diameter of middle waist 201, so can claim that generally this occlusion balloon is shaped as a dumb-bell shape.When this occlusion balloon 20 was placed barrier film breach 7 places in the heart, the middle waist 201 of this occlusion balloon was arranged in this breach 7, and its plate-like both ends 202,203 lay respectively at the both sides of this breach 7 with sealing gap 7 (please see Fig. 4 for details).
Have, the central shaft of the middle waist 201 of this occlusion balloon 20 can be coaxial with the central shaft of plate-like end 202,203 again, also can disalignment, and it can be selected according to the position and the shape of breach 7; Equally, the diameter of this centre waist 201 can be selected according to the size of breach 7, in any case but the diameter of selected this centre waist 201, the diameter of this centre waist 201 is all less than the discous diameter in the two ends of this occlusion balloon.
Please see Fig. 3 and Fig. 5 for details again, this utility model also discloses a delivery guidewire 26, be used for occlusion balloon 20 is delivered to by aorta vessel the indentation, there of heart, this delivery guidewire 26 comprises first section seal wire 261 and second section seal wire 262, fixedly connected with this occlusion balloon 20 in the stage casing of this first section seal wire 261, promptly this first section seal wire 261 passes this occlusion balloon and protrudes in two plate-like portions 202 of this occlusion balloon 20 respectively, outside 203, one end of this first section seal wire 261 is fixed with a bolt 23 or a nut, its material can be rubber or metal material, one end of this second section seal wire 262 has a nut 24 or a bolt, is used for removably being connected with described bolt 23 or nut.Described second section seal wire 262 is hollow tubular, also being provided with one in 262 hollow pipes of this second section seal wire can be with respect to these second seal wire, 262 axially movable injection device, this injection device includes the syringe (not shown), conduit 21 and miniature syringe needle 25 (see figure 5)s, this syringe needle 25, this conduit 21 and syringe are connected, wherein this conduit 21 is located in this second section seal wire 262, this miniature syringe needle 25 is arranged in the endoporus of the nut 24 (or bolt) of this second section seal wire 262, and be connected with an end of this conduit 21, the other end of this conduit 21 is communicated with this syringe, and this syringe is positioned at external.
Before this occlusion balloon 20 is sent into heart, this occlusion balloon 20 is the state of not filling up, and thrust this syringe needle 25 in this occlusion balloon 20 and deviate from this first section seal wire 261, again nut 24 is rotatably connected with bolt 25, so that first section seal wire 261 and second section seal wire 262 constitute mechanical connection, at this moment the occlusion balloon that will not fill up is delivered to breach 7 places of heart by arteries by delivery guidewire 26, with syringe the liquid that is placed in one is injected in this occlusion balloon 20 by this conduit 21 and this syringe needle 25 then its sacculus is filled up into dumbbell shaped, so that the middle waist 201 of the sacculus that fills up is arranged in this breach 7, and this two plate-likes end 202,203 are positioned at the both sides of these breach 7 place barrier films 5, but this breach 7 of shutoff thus.The liquid of wherein said injection can be stable in properties and harmless liquid such as normal saline, biogum or contrast agent.
The place, described plate-like end of being thrust by this syringe needle 25 on this occlusion balloon 20 is a rubber membrane 22 (see figure 3)s, this rubber membrane sticks on these occlusion balloon 20 1 plate-like ends 202, after this occlusion balloon 20 fills up, need be from the removal syringe needle 25 on this occlusion balloon 20 and second guidewire sections 262, it is specifically: the conduit 21 that can will have syringe needle earlier axially outwards extracts along second seal wire 261, extract this occlusion balloon 20 to spur this syringe needle 25, at this moment, this rubber membrane 22 is owing to its elasticity is understood the auto-closing pin hole, to avoid liquid by this pin hole this occlusion balloon 20 that flows backwards, then, rotate second guidewire sections 262 again, make this second guidewire sections 262 being connected by outward winding bolt 23 and this nut 24, and disconnect itself and being connected of first guidewire sections 261, in the lump take out external together with conduit 21 and syringe needle 25 second guidewire sections 262 more at last.
In addition, please see Fig. 4 for details, the occlusion balloon 20 of this utility model said structure can also cooperate an existing sheath pipe (can referring to the described sheath pipe 8 of Fig. 1) to send in the body, and this sheath pipe 8 is an opening for hollow pipe and its two ends.At first, with the occlusion balloon 20 that do not fill up together with delivery guidewire 26, syringe needle 25 and conduit 21 etc. thereof are inserted in this sheath pipe, then, this sheath pipe is sent into the indentation, there of heart by arteries, this sheath Guan Yiduan that treats this occlusion balloon 20 puts (being described indentation, there) in place afterwards, the occlusion balloon that will not fill up by delivery guidewire 26 is released the port of sheath pipe, then by foregoing implementation process, after promptly in occlusion balloon, charging into liquid, extract syringe needle out, the step such as be threaded of outwarding winding is at last again with the sheath pipe, delivery guidewire 26, syringe needle 25 and conduit 21 thereof take out external in the lump.
The cut-out occlusion balloon that technique scheme is mentioned and the connecting interface of delivery guidewire can also be by the following technical solutions: please see Fig. 7 for details, this occlusion balloon 60 can be connected by a low-melting-point metal solder joint 67 with delivery guidewire 66, there is a through hole (not shown) centre of metal solder joint 67, and this conduit in this delivery guidewire communicates by this through hole with this occlusion balloon 60.This delivery guidewire 66 oneself forms a circuit, the metal solder joint 67 of lower, the easy heating of the part employing resistance that is connected with this occlusion balloon 60 of this delivery guidewire 66 wherein, the higher metal of remainder employing resistance.During separation, make the 66 moments energising of this delivery guidewire, the heat that this energising produced is sent to this solder joint 67 places, and solder joint 67 is melted and be disconnected, the solder joint 67 that is melted is simultaneously automatically blocked the conduit in the delivery guidewire 66 and the path of this occlusion balloon 60, also can reach thus this occlusion balloon 60 and delivery guidewire 66 disengagings, and seal this occlusion balloon, to avoid the effusive effect of liquid in this occlusion balloon.
Second embodiment
This utility model also discloses a kind of occlusion balloon, please see for details shown in Figure 6, it is as skeleton with the Nitinol metal, this metallic framework 50 constitutes a reticulate body by the Nitinol tinsel, and be plate-like end 51 by its two ends, 52 and middle waist 53 for constriction form a kind of dumbbell shape, outer surface at above-mentioned metallic framework 50 is coated with sacculus 54, encase this metallic framework 50 tightly, be slightly larger than the waist 53 of metallic framework at the waist 55 of sacculus, so that its waist 53 has a flexibility, surface at whole sacculus 54 can coat one deck biomaterial (not shown) again, as polyester material, heart tissue is grown on this biomaterial.
In possessing the sacculus that metallic framework is arranged, can not charge into liquid, only be fixed on the breach by the tension force of balloon material waist with sacculus, part surface in occlusion balloon one plate-like end has the micropore (not shown), before putting into heart, it is used for getting rid of in advance the gas of this sacculus, bring in the body to avoid gas, after it puts into the breach of heart, have the right side of the balloon surface of micropore towards heart, and make the blood in the heart enter this sacculus by this micropore, so that this sacculus has more elasticity and more is adapted to heart tissue.
Equally, the structure of this occlusion balloon also can adopt existing sheath pipe (as Fig. 2 and shown in Figure 4) to send into the indentation, there of heart more than.At first, described occlusion balloon removably is connected with a delivery guidewire, the plate-like end of wherein said occlusion balloon is provided with a nut or bolt, it is fixed on the plate-like end of metallic framework 50, end in this delivery guidewire is connected with a bolt or nut, be used for this occlusion balloon on nut or bolt mechanical connection.Before this occlusion balloon is sent into the heart indentation, there, earlier this occlusion balloon 50 is put among the sheath pipe in the lump together with delivery guidewire, because this metallic framework 50 in this occlusion balloon 50 adopts the Nitinol metal material, be memorial alloy, then this occlusion balloon can be arranged light by its micropore with the gas in the sacculus, thereby put into the sheath pipe of hollow after the reduced volume, the sheath pipe that at this moment this occlusion balloon 50 will be housed is sent into the indentation, there of heart by arteries, after treating that this interior occlusion balloon of this sheath pipe puts in place, this occlusion balloon is released an opening of this sheath pipe with delivery guidewire, at this moment occlusion balloon is extended to a dumb bell owing to the characteristic of its memorial alloy and the elasticity of sacculus, its waist is arranged in the breach of heart, and the tension force by this occlusion balloon self is fixed in this indentation, there, two plate-like end is positioned at the both sides of breach, with sealing gap.Afterwards, this delivery guidewire of outwarding winding is threaded with occlusion balloon, so that this sheath pipe and this delivery guidewire are extracted in the two disengagement then out.