CN1174084A - Balloon catheter and its casing - Google Patents

Abstract

The invention provides a balloon catheter which is easy to be inserted into body and does not rupture when used, and a catheter exotheca which does not cause snagged blood circulation. The double-channel balloon catheter consists of a balloon, an outside pipe, an inside pipe, a front-end prong, a fixed flap, a mark and a Y-shaped connector. The front-end prong is made of soft material such as the polyurethane, the hardness of which is 95 A of a durometer, containing 40 percent BaSO4 for opacification, the length of the front-end prong is 20 mm. When the balloon catheter is used, using the catheter exotheca with a lateral aperture does not result in the snagged blood circulation.

Description

Ballon catheter and catheter jacket

The present invention relates in the large artery trunks in Therapeutic Method such as acute cardiac functional defect balloon and pump the ballon catheter of using in the method, the catheter jacket of using when particularly inserting ballon catheter in the body.

Up to the present, LABP (the large artery trunks inner catheter is pumped) is as the simple and easy assist circulation method because of symptoms such as the cardiac insufficiency behind decline of left heart functions such as acute myocardial infarction and the operation on heart, heart blood discharge amount deficiencies is extensive use of.Described LABP is inserted in ballon catheter in the large artery trunks, makes the synchronised ground shrinkage expansion (pumping) of beating of the balloon that is arranged on the end of conduit and heart assist cardiac function then.

Normally this ballon catheter is inserted into large artery trunks from the tremulous pulse of patient's huckle, but under the situation that blood vessel is being wriggled, it is difficult inserting ballon catheter in blood vessel, if insert by force then have the danger of the blood vessel of damaging.

In addition, when inserting conduit or when making conduit rest on the assigned position, in case balloon touches endovascular calcification part, the balloon of then may damaging has the danger that breaks up.

Though when in body, inserting ballon catheter, adopt catheter jacket, do tending to like this because of catheter jacket overslaugh blood flow in order to insert conduit easily.

Though just ballon catheter is inserted intravital method because the circulatory disorders that catheter jacket causes also can adopt without catheter jacket in order to prevent, but, this method requires high to technical merit, requirement accomplish finish balloon inserted intravital operation before, balloon does not almost have folded part, and such insertion often is difficult to realize.

The purpose of this invention is to provide a kind of can address the above problem and insert easily in the body and in use can disruptive ballon catheter.

Another object of the present invention provides a kind of catheter jacket that hinders blood flow that is not easy to cause.

In order to achieve the above object, ballon catheter of the present invention comprises: be elongated tubulose and soft flexible catheter main body, be arranged on the described catheter main body distal side and carry out the balloon of expansion by the fluid that described catheter main body inner chamber is supplied with and discharged, also comprise: the front end of the distal side of described catheter main body is provided with the front end tip that the mixture by softish resin and material that can not transmitted X-rays forms.

In order to achieve the above object, ballon catheter of the present invention comprises: be elongated tubulose and soft flexible catheter main body, be arranged on the described catheter main body distal side and carry out the balloon of expansion by the fluid that described catheter main body inner chamber is supplied with and discharged, in addition, the length of described balloon is shorter.

According to the present invention, owing to the front end tip is made with softish resin, so even the wriggling blood vessel is also inserted easily.In addition, because the front end tip contains roentgenopaque material, so can on the X ray image, confirm on position.

The resin that constitutes the front end tip can be Polyurethane, polrvinyl chloride, polyamide, polyethylene or latex rubber etc., but is not limited to these.There is no particular limitation to roentgenopaque material, can use BaSO₄, bismuth oxide or bismuth subcarbonate etc., use BaSO₄The time preferred mixing ratio be 20-60%.

The front end tip is preferably soft and longer, and the preferred length of front end tip is 10mm to 30mm, when front end is stressed, can be crooked more than 45 °, and 90 ° of energy bendings are best.If the length of front end tip is also longer than 30mm, then because when the front end of conduit rested on the needed position, it is interior and inadvisable that the rear end of balloon is in narrower blood vessel scope.In this case, if balloon is on the abdominal artery, then may overslaugh the blood flow of this part.

In addition, the front end tip is preferably formed as and is the thin shape in front.Particularly under situation about inserting without catheter jacket, the thinner part in front is inserted easily.

In addition, if what use is conduit without the catheter jacket type, hemostasis can be arranged on the catheter main body movably with parts.

Ballon catheter of the present invention comprises: coat the parcel overcoat of this balloon periphery under the balloon folded state, also comprise: described parcel overcoat has and can insert endovascular structure simultaneously with the described balloon that coats.

Ballon catheter according to this configuration, owing to the balloon that coats with the parcel overcoat can be inserted in the blood vessel, remove later the parcel overcoat again in the intravasation fully in the balloon part, do not remove overcoat before in balloon inserts blood vessel, thereby can not occur because of removing the insertion difficulty that overcoat causes, can not make the damage skin of insert division of balloon yet, can not damage the problem of balloon certainly yet because of removing overcoat.In addition, the balloon surface of parcel is compared with folding balloon, does not have concavo-convex smooth surface owing to form, so insert in the human body easily.

In addition, in the ballon catheter of said structure, be preferably in the outstanding front end tip that is provided with in described balloon distal side, the front end of described parcel overcoat forms the thin shape of front end, is close to the described relatively front end tip of intensity of the degree do not rolled under simultaneously can the frictional resistance when the front end tip inserts.

Adopt the parcel overcoat of this structure, even contact with human body when inserting in the body, owing to front is entered in the body glossily, so front can not rolled.In addition, though that described parcel is enclosed within outward under the stressed degree when inserting is indeformable, if the resin film making that can extend when being subjected to forceful action, even then front end is made to such an extent that very carefully also can at an easy rate this parcel overcoat be removed from the proximal lateral extraction.

Not the outstanding front end tip that is provided with on described balloon but on the distal side in addition, simultaneously on this front end tip, not to make the distal side but make the diameter parts of the proximal lateral formation end difference that attenuates, the front end of described parcel overcoat is positioned at the proximal lateral of described end difference, preferably make diameter thinner than this end difference distal side, if adopt the parcel overcoat of this structure, even contact with human body in the insertion body, because human body can directly touch the front end side hardly, so the front of parcel overcoat is difficult to roll.

Ballon catheter of the present invention comprises: be elongated tubulose and soft flexible catheter main body, be arranged on the described catheter main body distal side and carry out the balloon of expansion by the fluid that described catheter main body inner chamber is supplied with and discharged, also comprise: be arranged near the described balloon and around in the blood vessel of this balloon stop place of energy measurement blood pressure pressure transducer, not only linked to each other but also be drawn out to the outside and energy will send the signal transmission line of external device (ED) from the output signal of described pressure transducer to through described catheter main body with this pressure transducer.

As according to the ballon catheter of formation, can be being transferred to external device (ED) by signal transmission line from the output signal that is configured near the pressure transducer the ballon catheter, handle this output signal by external device (ED) again and show or record etc.

Therefore, even the lumen (lumen) that does not have to be communicated with also can be measured the endovascular blood pressure in balloon stop place,, also can measure blood pressure in blood vessel even thus under the situation of the ballon catheter of so-called single chamber type.Its result for the thin patient of blood vessel diameter or angiosteosis is serious and patient that blood vessel is narrowed down also is suitable for, and can not hinder blood flow etc.Owing to there is no need to install other blood pressure measuring device etc., do not need expensive time, also minimize for patient's human body misery.In addition, even owing to can keep more blood flow to the too thin patient of blood vessel, so do not worry hindering blood flow, and can alleviate the misery of patient's human body.

In addition, described signal transmission line preferably is made of the compliant member of described balloon of axial perforation and catheter main body internal configurations.

As constituting signal transmission line with the compliant member that axially connects balloon and catheter main body internal configurations, then these parts also play reinforcement feature except that being used as signal transmission line, so even reinforcement feature that other is not set etc. also has the effect that prevents balloon and catheter main body bending.

Described balloon has the parcel overcoat that coats this balloon periphery under folded state, and this parcel overcoat is inserted in the blood vessel with the balloon that is coated, and this structure is comparatively desirable.

Ballon catheter of the present invention comprises: the balloon by carrying out expansion/contraction at the fluid of internal feed and discharge, the rearward end of this balloon be bonded on the distal side and by the inner chamber that is communicated with this balloon interior make outboard tube that described fluid can supply with in balloon from the proximal lateral and discharge, from the proximal lateral of this outboard tube to the leading section of described balloon for connecting the inside tube that outboard tube and balloon interior dispose, also comprise: the fixing reinforcement feature that constitutes by metal wire on described inside tube.

In ballon catheter of the present invention, though balloon, outboard tube and inside tube same as the prior art be to make of being fit to separately the resin material of needs, it is worthy of note that especially inside tube fixed by the reinforcement feature that metal wire constitutes.Though described metal wire is can be with the soft crooked lametta of inside tube, it is high and can make the warping resistance of inside tube and the effect of the ability raising that blocks to have intensity than resin material.

Therefore, the inside tube with this reinforcement feature is than the intensity height of the pipe that only is made of resin material, than the pipe softness that only is made of metal material.Therefore, compare, realize thinner caliber easily, and have in endovascular good propulsive performance with resinous pipe; Compare with metal pipe, the flexibility height is even also can follow the tracks of introducing smoothly under the situation that blood vessel is being wriggled.That is to say, under the prerequisite of not sacrificing flexibility or propelling property, these two performances are taken into account be improved.

In ballon catheter of the present invention, reinforcement feature can be made of a wires, also can be made of many wires.Reinforcement feature can be fixed on the outer peripheral face of inside tube or on any one side face on the inner peripheral surface, also can adopt the mode that is embedded in the resin material to fix.In addition, can be linearity metal wire along the direction of principal axis secured in parallel of inside tube, also can be the spiral helicine metal wire that is wound into that is fixed on around the axis of inside tube.

In addition, described reinforcement feature preferably is wound into left-handed spiral helicine one or more metal wire and the interlaced reticulate body of weaving into of one or more metal wire that is wound into the right hand helix shape by inside tube.

According to this configuration, both used the high lametta of flexibility also can obtain than higher intensity.

In addition, described reinforcement feature constitutes by being wound into spiral helicine metal wire, and the pitch of axial advancement is short in the distal side when preferably making described spiral turn round one time, and the proximal lateral is long.

According to this configuration, that part ofly have high propulsive performance but be not easy bending near what metal wire was straight extension state vertically in the proximal lateral, like this, even the big load of temporary transient use also is not easy bending when inserting operation, and fine and close reel that part of because soft easy bending of distal side metal wire, even so under the progressive situation in vascular bending ground, the also operation that can be well on.

In addition, described reinforcement feature also can be arranged on the distal portion that is not described outboard tube but distal side and be not that the assigned position of the distal portion of described inside tube but proximal lateral is in the scope of the close end of described outboard tube.According to this configuration, because can further improve the flexibility of balloon front, so can insert operation easilier.And, with regard to outboard tube portion and balloon portion, because the bending stiffness of balloon portion is low, the warpage of inside tube takes place near the junction surface between outboard tube and the balloon usually easily, but because be provided with reinforcement feature and make inside tube be difficult for warpage in this one, institute is so that be not easy to take place warpage near the junction surface.

Ballon catheter of the present invention comprises: be elongated tubulose and soft flexible catheter main body, be arranged on described catheter main body distal side and carry out the balloon of expansion by the fluid that described catheter main body inner chamber is supplied with and discharged, be arranged on the described catheter main body proximal lateral and be used for the joint that is connected and waits with the machine of supplying with described gas, also comprise: the installing component that relative human body can not be installed movably, and not only be arranged on this installing component rotationally but also made described catheter main body or described joint is fixed and make described balloon follow the rotation of self and the rotatable parts that rotate.

The balloon portion of ballon catheter of the present invention and the balloon portion of prior art are inserted in vivo in the same manner, and near the external relative human body of described installing component ballon catheter inserts the position immovably installed.Described rotatable parts are set, A/C main body and joint on these rotatable parts on this installing component.When rotatable parts were rotated, the catheter main body and the joint that are fixed on the rotatable parts also rotated simultaneously, and this rotation passes to balloon through catheter main body.

Therefore, ad-hoc location and endovascular ad-hoc location at balloon continue contacted long-time (for example more than two days) before, rotate in vivo and the balloon part of always bearing load can be moved on another index position by balloon, thereby the part that can prevent balloon takes place overtired.Its result, even also can use this ballon catheter for the patient who in blood vessel, has sharp keen calcification part, can reach at balloon makes before breaking the tired position of balloon move on other position, so compare with the situation that intactly continues the use balloon, balloon was not broken through the longer time.

Described ballon catheter, its installing component are that relative human body can not be installed movably, wherein can adopt on the skin surface that for example directly this installing component is sewn to human body or adopt the method that is installed on the irremovable any parts of relative human body.

In addition, though rotatable parts can be fixed on catheter main body or the joint, with regard to catheter main body, can be fixed on when inserting in the body and expose on the external part.

After balloon turns on the specific angle, should adopt certain method that balloon is not turned back to and rotate preceding angle, or not turn to undesirable angle.Simple method is with strip of glue etc. rotatable parts to be attached on the installing component to fix.

Ballon catheter of the present invention comprises: the balloon by can carrying out expansion/contraction at the fluid of internal feed and discharge, the rearward end that the distal side is bonded on described balloon and can supply with and discharge described fluidic outboard tube and connect the inside tube of outboard tube and balloon interior from this outboard tube proximal lateral to described balloon leading section by the inner chamber that is communicated with this balloon interior are fixed on described inside tube on this outboard tube in the distal portion of described outboard tube.

According to ballon catheter of the present invention, because the relative outboard tube of inside tube is fixed on the distal portion of outboard tube, so when being inserted into this ballon catheter in the blood vessel,, also inside tube can be pressed in the outboard tube even meet obstructions at the front end of balloon.Therefore, can not make balloon shaft be enough to disruptive degree, be inserted in the blood vessel and carry out smoothly than prior art in endovascular guiding to being pressed onto.

In addition, because outboard tube and inside tube only fix in the distal portion of outboard tube, so on the position that inside tube can enough obtain outside this position, have degree of freedom to a certain degree in outboard tube.For example, when guiding-tube bend, because inside tube is freely on the most demulcent position of steering pressure, so can not damage the flexibility of conduit.Particularly different with the situation that whole inside tube is fixed on the outboard tube inwall, because not to the unbending directivity of specific direction, so can not damage endovascular operability at irregular wriggling.

Ballon catheter of the present invention, with regard to the position of fixing inside tube, outboard tube distolateral farthest self-evident, if also can not make balloon that the scope of loose shape takes place when inside tube is crooked on the distal side far away than the fixed position, so fixedly the position of inside tube can be the position of being partial to the proximal lateral from the end of distal-most end slightly.

The tubular type catheter jacket that has continuous hollow-core construction from the base end part to the terminal part of the present invention comprises one or more side openings.

According to catheter jacket of the present invention, owing to have side opening, thus even because of catheter jacket overslaugh vascular flow, also can open side opening and make blood flow to lower limb, thus can the overslaugh blood flow.Therefore, even also can guarantee to flow to the blood flow of lower limb to tiny blood vessel, the diseases such as inserting side lower limb blood resistance, lower limbs necrosis or renal insufficiency that cause owing to the blood flow that hinders lower limb can be taken place hardly, seldom run into serious situation.

Brief description of drawings is as follows:

Fig. 1 is the summary structure chart of the ballon catheter of expression first embodiment of the invention.

Fig. 2 is the figure that is used to illustrate balloon length.

Fig. 3 is the figure of the catheter jacket that the present invention relates to of expression.

Fig. 4 is the figure that is used for illustrating the using method of the catheter jacket that is shown in Fig. 3, wherein

(a) expression penetrates state in the large artery trunks with puncture needle;

(b) expression is inserted endovascular state with lead.

Fig. 5 is the figure that is used for illustrating the using method of the catheter jacket that is shown in Fig. 3, wherein

(a) expression is placed on lead state on every side to catheter jacket;

(b) expression is inserted endovascular state with catheter jacket.

Fig. 6 is the blood flow state diagram of expression catheter jacket when just inserting in the blood vessel.

Fig. 7 is the summary structure chart of the ballon catheter of expression second embodiment of the invention.

Fig. 8 is expression ballon catheter figure of the present invention, wherein

(a) integral body of expression ballon catheter;

(b) state of parcel overcoat is taken off in expression;

(c) expression makes the state of balloon expansion.

Fig. 9 is near the partial sectional view of the structure of leading section of expression parcel overcoat, wherein

(a) expression front end tip is not established the example of end difference;

(b) expression front end tip is provided with the example of end difference.

Figure 10 is the figure that is used to illustrate the step of inserting ballon catheter, wherein

(a) expression is being inserted endovascular state with ballon catheter;

(b) state of parcel overcoat is taken off in expression.

Figure 11 is the figure of the ballon catheter of expression third embodiment of the invention, wherein

(a) state of parcel overcoat is taken off in expression;

(b) expression is equipped with the state of parcel overcoat.

Figure 12 is the figure of the ballon catheter of expression fourth embodiment of the invention, wherein

(a) integral body of expression ballon catheter;

(b) ruggedized construction of expression inner conduit.

Figure 13 is the figure of the ballon catheter of expression fifth embodiment of the invention.

Figure 14 is the figure of the ballon catheter of expression sixth embodiment of the invention.

Figure 15 is the figure that expression makes the device of ballon catheter rotation of the present invention, wherein

(a) integral body of expression ballon catheter;

(b) sectional view analysed and observe along the M-M line of Figure 15 (a) of expression;

(c) sectional view analysed and observe along the N-N line of Figure 15 (b) of expression.

Figure 16 is the cutaway view of the modified example of expression ballon catheter of the present invention.

Embodiments of the invention are described with reference to the accompanying drawings, yet the present invention is not subjected to the qualification of following examples, can implements with various embodiments.

Fig. 1 is the outside drawing of the ballon catheter of one embodiment of the invention.The ballon catheter 1 of present embodiment is a bicavate as shown in Figure 1, is made up ofballoon 2,outboard tube 4, insidetube 6,front end tip 8,stator 10, sign 11 andconnection wye 12 etc.In the following description,connection wye 12 sides of conduit 1 are called the proximal lateral, andfront end tip 8 sides of conduit are called the distal side.

Gap between the outer peripheral face of the inner peripheral surface ofoutboard tube 4 and insidetube 6 constitutesfirst chamber 14 of conduit,first chamber 14 is connected on thesupply outlet 16 ofconnection wye 12 in the proximal lateral, in the distal side was communicated toballoon 2,first chamber 14 can be being supplied withballoon 2 by the helium of supplying withoutlet 16 supplies again as making helium be discharged to the supply discharge line of supplying withoutlet 16 fromballoon 2.

The inner chamber ofinside tube 6 constitutessecond chamber 18 ofconduit.Second chamber 18 is connected on theguidewire port 20 ofconnection wye 12 in the proximal lateral, be communicated with respectively with opening foremost 22 atfront end tip 8 in the distal side,second chamber 18 has in advance plays and can insert logical path effect inserting and rest on endovascular lead (not shown).

In addition,stator 10 is to be used for conduit 1 is fixed on parts on thepatient body.Sign 11 is the labellings that are used for inserting from vitro detectionintravital balloon 2 proximal locations, is formed by roentgenopaque material.

As shown in Figure 1, opening 22 is set on the distal front end offront end tip 8,front end tip 8 is to be that the polyurethanes of 95A constitutes by the flexible material scleroscopic hardness of sieve of for example shutting out, and contains 40% BaSO for radiography₄The length offront end tip 8 is 20mm.

Balloon 2 is designed to be fit to Asian build, for example, is the balloon of 40CC for inner product, and as shown in Figure 2, the long A of balloon is 225mm, and diameter D is 15.5mm.And be 250mm to 275mm from the balloon A of the prior art of America and Europe input, if adopt this balloon, then the proximal lateral of balloon may be trapped on the thinner part of large artery trunks, the possibility of result exists and because of airballoon cover contacts with blood vessel wall disruptive danger takes place.When ramose coeliac artery of large artery trunks and renal artery insertion balloon, the danger of kidney obstacle may appear in addition.According to the present invention, because the length of balloon is short, so it is little the probability of this problem to occur.

In addition, the length of balloon can also be shorter, and for example the length A of balloon can be 175mm, and diameter D is 19mm.According to this structure, the balloon part of inserting the intravital conduit of people can be positioned at than common balloon and more on the position of top (heart side), break with regard to more difficult like this.In addition, owing to the ratio with the corresponding balloon diameter of blood vessel diameter has increased, so increased the effect of IABP.

Conduit 1 as shown in Figure 1 can utilize for example in catheter jacket shown in Figure 3 inserts human body.

Catheter jacket 50 as shown in Figure 3 53 is the tubulose of internal diameter 4mm fromterminal part 51 to base end part, from distance terminal part 511cm to theside opening 63 that on the length of the whole 9cm of base end part 5310cm, has several row diameter 1mm at four direction (top 55, bottom 57, leftpart 59 andright part 61).For the balloon damage that prevents to insert, and makeside opening 63 have little opening, and make its edge form the obtuse angle.Side opening 63 be arranged as along top 55 and each ten of the both directions of bottom 57, along each longitudinally uniformly-spaced side by side nine of the both directions ofleft part 59 andright part 61, form 38 holes altogether.

On the part of extending 10cm frombase end part 53distads 51 directions, can notopen side opening 63 and be in order not make blood flow to pars inguinalis subcutaneous from theside opening 63 ofcatheter jacket 50.

Describedcatheter jacket 50 uses shown in Fig. 4 (a) and (b) and Fig. 5 (a) and (b) like that.That is, it is such at first to press Fig. 4 (a), and puncture needle 72 is penetrated thigh tremulous pulse 70, press again shown in Fig. 4 (b) like that, by puncture needle 72 with in thelead 74insertion blood vessels 76, along 74 groups of following puncture needles 72 of the lead that stays.Press then shown in Fig. 5 (a) like that, around thelead 74 that stays, coat guider80.Catheter jacket 50 withadnexaes 75 such as haemostatic valve is set on theguider 80, thisguider 80 is inserted in theblood vessel 76, simultaneously,catheter jacket 50 is also inserted in theblood vessel 76, press shown in Fig. 5 (b) such at last,extract lead 74 andguider 80 out, only staycatheter jacket 50, the ballon catheter (not shown) is inserted by catheter jacket 50.At this moment, subcutaneous in order not make blood flow to pars inguinalis from theside opening 63 ofcatheter jacket 50, must be with slotting deeply,catheter jacket 50 can not expose more than pars inguinalis skin 5cm.

Thiscatheter jacket 50 is used for 36 patients, just comprises the incidence rate that complication such as lower limb ischemia take place, compare research with 179 examples of using existing catheter jacket to insert same IABP ballon catheter.With regard to statistical disposition, relevant to meansigma methods calibrating the t-calibrating, relevant with the calibrating of the incidence rate x that uses²Calibrating.

About age structure, sex composition and the height of 179 examples (I group) of using existing catheter jacket and 36 examples (II group) of usingcatheter jacket 50 shown in Figure 3, never confirming statistically has deliberate difference between two colonies.Take out the lower limb ischemia incidence rate of the complication headed by the probability of IABP too early to have to owing to lower limb ischemia, I group's incidence rate is 17.9% (32/179 example), and II group is 0% (0/36 example), and its incidence rate (P＜0.01) is lower in II group.

As shown in Figure 6,blood side opening 63 bycatheter jacket 50 shown in the arrow in theblood vessel 76 flows, just can keep the blood flow of lower limb like this.

When inserting in the manner described above, note dark inserting,catheter jacket 50 is exposed more than the pars inguinalis skin 5cm.The result who does like this is in II group's (using thecatheter jacket 50 of present embodiment), and the incidence rate of the inserting side pars inguinalis hematoma of anticipation (side opening 63 ofimagination catheter jacket 50 may take place when exceeding blood vessel a 76) example does not have yet.In addition becauseside opening 63 is processed to little blunt edge, so thecatheter jacket 50 thatside opening 63 do not take place to have yet by the time example of damage balloon takes place.In addition, effusive blood can form hematoma from theside opening 63 ofcatheter jacket 50 though imagination is followed when IABP pulls up, so to its some worry of problem of carrying out hemostasis by compression, such problem does not take place also, therefore, the use of ballon catheter of the present invention is a safety.

In addition, thecatheter jacket 50 that use is had aside opening 63 carries out the lower limb toe point pulse wave that case that IABP inserts carried out during IABP drives to be measured, and the result shows that inserting side lower limb blood flow keeps kilter.

In addition, if use thecatheter jacket 50 of internal diameter in the present embodiment, because the balloon diameter of the diameter of catheter jacket and insertion is poor, even and the feasible blood flow that also can keep lower limb during insertion bycatheter jacket 50 as 4mm.Promptly using internal diameter also can keep good blood flow state at the inserting side lower limb as the catheter jacket of 3.7mm in IABP drives, is operable therefore.

The foregoing description shows: make blood flow out the maintenance blood flow from side opening 63 byside opening 63 is set oncatheter jacket 50, and very little owing to making that withcatheter jacket 50 influence that hinders blood flow drops to, therefore can prevent that inserting side lower limb blood is obstructed or blood circulation generation obstacle.Because can prevent that disappearances of beating, lower limb tip skin temperature of dorsal artery of foot and ossa tibiale posterius tremulous pulse from descending, the tip skin color is not normal, leg pain, the numb low of consciousness nervus motorius and the necrosis of bone lattice muscle, so the out of use situation of IABP has become history.

In addition,side opening 63 is processed into helical form, perhaps uses cancellous net to replace side opening is set, can obtain same effect with sufficient intensity.The spacing ofside opening 63 and pitch can suitably be selected.

Though the total length ofcatheter jacket 50 is 20cm in the present embodiment, the end portion E that does not haveside opening 63 is 1cm, having the side opening face of cylinder ofside opening 63 that part F is set is 9cm, not having the cardinal extremity part G ofside opening 63 is 10cm, but also can select the total length ofcatheter jacket 50 according to pathological changes and patient's physique is 8cm-30cm, the end portion E that does not haveside opening 63 is 3mm-20mm, have the side opening face of cylinder ofside opening 63 that the 20%-80% that part F is a total length is set, remaining length is the catheter jacket that does not have the cardinal extremity part G ofside opening 63.

In addition,, also can choose diameter and be 0.5mm-2mm, be shaped as circular or oval-shaped side opening according to conduit that uses and pathological changes etc. thoughside opening 63 is the circular hole of diameter 1mm in the present embodiment.

In this case, having the voidage R that the side opening face of cylinder with side opening 63 with formula (1) expression is provided with part F is 0.5-20%, is preferably 1%-10%.

R (%)=(area * number of side opening) * 100/ (the side opening face of cylinder is provided with the external surface area of part F) ... (1)

For example, be 4mm at external diameter, the side opening face of cylinder is provided with under the situation that partial-length F is 10cm, and the side opening diameter is 1mm, can adopt following parameter:

The number of side opening is 38, and voidage is 2.4%;

The number of side opening is 40, and voidage is 2.5%;

The number of side opening is 60, and voidage is 3.7%;

The number of side opening is 80, and voidage is 5.0% a side opening diameter when being 2mm, can adopt following parameter:

The number of side opening is 38, and voidage is 9.5%;

The number of side opening is 40, and voidage is 10%;

The number of side opening is 60, and voidage is 15%;

The number of side opening is 80, and voidage is 20%.

Though thecatheter jacket 50 usefulness politef of usefulness are manufactured in the present embodiment, but be not limited to this, as long as when insertingblood vessel 76, have sufficient intensity, and can and not cause that the material of damage is just passable with living tissue generation adverse reaction, polyester etc. for example.

Fig. 7 is the figure of expression without the ballon catheter of catheter jacket formula.Such ballon catheter 101 is the same with ballon catheter shown in Figure 1 all to be dual-chamber type, is made of balloon 102, outboard tube 104, inside tube 106, front end tip 108, stator 110, sign 111, connection wye 112 and hemostasis parts 119 etc.

Gap between the outer peripheral face of the inner peripheral surface of outboard tube 104 and inside tube 106 constitutes first chamber 114 of conduit.First chamber 114 links to each other with the supply outlet 116 of connection wye 112 in the proximal lateral, in the distal side is communicated to balloon 102, also play a part from balloon 102 the supply drain passageway of helium gas emission to supply outlet 116 when supplying with balloon 102 by the helium of supplying with outlet 116 supplies in first chamber 114.

The inner chamber of inside tube 106 constitutes second chamber 118 of conduit.Second chamber 118 links to each other with the guidewire port 120 of connection wye 112 in the proximal lateral, the distal side be positioned at front end tip 108 opening 122 foremost and link to each other respectively, and rest on endovascular lead (not shown) and play and can insert logical path effect inserting in advance.

Fixture 110 is to be used for conduit 101 is fixed on parts on the patient body, and sign 111 is the parts that are used for inserting from vitro detection intravital balloon 102 peri position end positions, and it is to be made by material that can not transmitted X-rays.

Hemostasis parts 119 are to prevent that blood from flowing to external parts when being used in conduit 101 inserts bodies, it can with respect to outboard tube 104 conduit axially on be free to slide.The part of hemostasis parts 119 is inserted in the body, and it can constitute horn-like lateral any part by it and block blood vessel.Along with the insertion depth of conduit 101 increases gradually, hemostasis parts 119 slide to the proximal lateral from the distal side, because hemostasis parts 119 are fixed on the cut-away portions of skin, so can not move.

As shown in Figure 7, on the front end of the distal side of front end tip 108 opening 122 is set.The material of front end tip 108 can be that the polyurethane of 95A is made by the softish material scleroscopic hardness of sieve of for example shutting out, and contains 40% BaSO in order to carry out radiography₄The length of front end tip is shorter than the length of using overcoat shown in Figure 1 to insert, is preferably 8-16mm, for example 12mm.

More than Shuo Ming ballon catheter preferably press shown in Fig. 8 (a) and (b), (c) like that, use after wrapping the parcel overcoat.

Shown in Fig. 8 (a)-Fig. 8 (c),ballon catheter 201 is byfront end tip 208,balloon 202, the bicavate ballon catheter that cathetermain body 207,connection wye 212 etc. constitute usesparcel overcoat 213 to coat the periphery of theseballoons 202 down atballoon 202 folded states (seeing Fig. 8 (b)).

Describedparcel overcoat 213 is to form as the flexible film system pouch that substrate is coated with last layer hydrophilic polymer coating from the teeth outwards with polyurethane resin.Shown in Fig. 8 (a),front end 213a is shortened into the thin shape in front, a rear end 213b part is cut into two forks, andplastic handgrip 215 is installed in the portion in its back-end.In addition, cuttingline 217 extends towardsfront end 213 from the above-mentioned root of cutting part open, so that this part is torn apart than other parts are easier.

Thefront end 213a ofparcel overcoat 213 like that, is close on the periphery offront end tip 208 shown in Fig. 9 (a).In order to carry out this fluid-tight engagement, can be whenparcel overcoat 213 be shaped, the external diameter offront end 213a ofparcel overcoat 213 is squeezed into thinner, thenfront end tip 208 is pressed intoparcel overcoat 213, so just will wrap upovercoat 213 and be contained on theballoon 202 than the external diameter offront end tip 208.

Perhaps replace the structure shown in Fig. 9 (a), such shown in Fig. 9 (b), the external diameter of segmentproximal side 208b that makesfront end tip 208 is thinner and form end difference than the external diameter ofdistal side 208a, thefront end 213a ofparcel overcoat 213 is positioned on the proximal lateral 208b of end difference, and its diameter can be thinner than the diameter of end differencedistal side 208a.

The following describes the using method of thisballon catheter 201.

At first do the preparation of insertingballon catheter 201 by the step identical with general overcoat insertion.Promptly thesupply outlet 216 on theconnection wye 212 that is arranged at ballon catheter 201 (seeing Fig. 8 (a)) goes up unidirectional cock is installed, attract to makeballoon 202 inside become negative pressure with injection tube by unidirectional cock, use puncture needle (for example: the thigh tremulous pulse) to penetrate blood vessel then, inner chamber by puncture needle inserts lead, extracts puncture needle.Then insert guider, fully enlarge puncturing hole, extract guider along lead.Be pressed intoballon catheter 201 along lead then.

Existing ballon catheter will be removed the parcel overcoat at least before inserting human body, and ballon catheter of thepresent invention 201 is such as Figure 10 (a) shown in, and the ballon catheter band coatingouter cover 213 and 274 imported to theblood vessel 276 fromskin 271 along lead.Describedballon catheter 201 is different with existing ballon catheter, because thefront end 213a ofparcel overcoat 213 has the structure that can not roll, soparcel overcoat 213 can not tangled byskin 271 grades.

Like this, thisballon catheter 201 can be inserted into needed length in theballoon 202complete intravasations 276, and, under this state, can makeparcel overcoat 213 have the enough length of extracting to expose outside the skin 217.Therefore, ifcatch parcel overcoat 213 on hand to extracting out, just the parcel overcoat can be pulled out to external.Theparcel overcoat 213 that is drawn out of like that, is tornhandgrip 215 with two handss respectively, just can unload from cathetermain body 207 shown in Figure 10 (b) laterally.

At last, identical with existing ballon catheter, (for example: in the large artery trunks) advances in rapid succession towards the target location alonglead 274 withballoon 202, just can carry out assist circulation by linking to each other with known driving device.

Figure 11 represents described parcel overcoat is used for the example of single-chamber type conduit.

Ballon catheter 301 is so-called single-chamber type ballon catheters, shown in Figure 11 a, it comprises: be elongated tubular product such and soft flexible catheter main body 307, be arranged on catheter main body 307 distal sides and utilize the fluid of discharging to carry out the balloon 302 of expansion by the supply of catheter main body 307 inner chambers, the connection wye 312 that is arranged on catheter main body 307 proximal laterals and has the supply outlet 316 that is communicated with catheter main body 307 inner chambers, be configured in the soft flexible front end tip 308 of balloon 302 front, be arranged on front end tip 308 foremost and can detect the pressure transducer 321 of ambient pressure, and holding wire 325, this holding wire one end links to each other with pressure transducer 321, and the other end is drawn out to the outside and the output signal of pressure transducer 321 is transferred to pressure monitoring device M from connection wye 312.In addition, shown in Figure 11 (b), the parcel overcoat 313 that is coating these balloon 302 peripheries under the folded state of balloon 302 is being housed on the periphery of described balloon 302.

Pressure transducer 321 in these structures is to change the semiconductor strain gauge that resistance variations takes place in the distortion that causes according to pressure.

In addition, holding wire 325 is by flowing into as electric current respectively and the conductor of the mutual insulating of effusive route is formed.Described holding wire 325 is to connect the form configuration of balloon 302 and catheter main body 307 inside vertically, and because have the pliability to a certain degree that can prevent balloon 302 and catheter main body 307 warpages, so can send from the function of pressure transducer 321 signals except that having, also have the function of reinforcement material.

Parcel overcoat 313 can be processed into and coat balloon 302 and insert endovascular structure in company with balloon 302.Described particularly parcel overcoat 313 is to form as the thin and softish thin film system pouch that substrate is coated with last layer hydrophilic polymers coating from the teeth outwards with polyurethane resin.Shown in Figure 11 (b), front end 313a is squeezed into the thin shape in front, cut into the part of rear end 313b open two forks, plastic handgrip 315 is installed by portion in its back-end, cutting line 317 extends towards front end 313a from the above-mentioned root of cutting part open, and this part is torn apart than other parts are easier.

The following describes the using method of described ballon catheter 301.

At first do the preparation of inserting ballon catheter 301 by the step identical with general overcoat insertion.Promptly the supply outlet 316 (seeing Figure 11 (a)) at ballon catheter 301 goes up the unidirectional cock of installation, attract with injection tube by unidirectional cock, make the inside of balloon 302 become negative pressure state, use puncture needle (for example: the thigh tremulous pulse) to penetrate blood vessel then, inner chamber by puncture needle inserts lead, extracts puncture needle.Then, insert guider, fully enlarge puncturing hole, extract lead and guider along lead.

Existing ballon catheter will remove the parcel overcoat at least before inserting human body, and this ballon catheter 301 is identical with example shown in Figure 10, and the ballon catheter band parcel overcoat 313 and imported in the blood vessel from skin.Described ballon catheter 301 is different with existing ballon catheter, because the front end 313a of parcel overcoat 313 has the structure that can not roll, so parcel overcoat 313 can not tangled by skin etc.

Like this, this ballon catheter 301 can be inserted into needed length in the balloon 302 complete intravasations, and under this state, parcel overcoat 313 has the enough length of extracting and exposes external.Therefore, if catch parcel overcoat 313 on hand to extracting out, just can only overcoat 313 be pulled out to external.Can with two handss handgrip 315 be torn laterally respectively, just the parcel overcoat 313 that is drawn out of can be unloaded from catheter main body 307.

At last, identical with existing single-chamber type ballon catheter, with balloon 302 head for target position (for example: in the large artery trunks) propelling in rapid succession,, just can carry out assist circulation by linking to each other with known driving device.At this moment the endovascular blood pressure that stops balloon 302 detects by pressure transducer 321, sends pressure monitoring device M to through holding wire 325.Therefore, even sharply change or can not keep because the failure and other reasons that does not reckon with takes place driving device under the situation of blood pressure of expection, also can directly perceive in patient's the state of an illness.

Constitute the parcel overcoat of the condition that satisfies above explanation, there is no particular limitation to its material, and generally the synthetic resin material of using as medical apparatus and instruments (for example: polyurethane, polrvinyl chloride, polyamide, polypropylene, polyester etc.) can utilize.The soft characteristic in order to obtain especially thin also can be with fluorine series plastics (for example: polyflon (PTFE), fluorinated ethylene propylene (FEP) copolymer resins (FEP), perfluor ethylene fluoride alkyl vinyl ether copolymer resins (PFA), ethylene fluoride-ethylene copolymer (ETFE), gather and fluoridize ethlyene dichloride (CTFE), Kynoar (PFV) etc.).

In addition, easy in order to make in the conduit insertion body, subtract the frictional resistance that wraps up the overcoat outer peripheral face the smaller the better, external for a parcel overcoat easily is retracted to again, subtract the frictional resistance that wraps up outer sheath inner circumferential surface the smaller the better.In order to reduce above-mentioned frictional resistance, can use hydrophilic polymer (for example: polyvinyl alcohol, polyacrylic acid, sodium polyacrylate, polyacrylic acid amide, poly-carboxymethyl cellulose, hydroxyethyl meth acrylate, polyvinyl methyl ether, polyvinylpyridine, poly(ethylene oxide), polyvinylpyrrolidone etc.) coating one deck coating.

Last mask body has been enumerated the essential condition that is used to constitute the parcel overcoat, and still, the condition that use can not produce the material of adverse effect to human body is most important.

In addition, after having determined material and wall thickness,, then can form countless micropores, also a plurality of grooves or slit etc. can be set in the side of parcel overcoat if think the flexibility words that are absolutely necessary.In addition, can make the parcel overcoat not become tubular, and form the banded overcoat of helical form spiral, can improve flexibility with respect to balloon.

The structure of rolling as the front that prevents to wrap up overcoat except the above-mentioned bonding and method of combining closely, also can adopt by screw structural is set to engage, and utilizes moment of torsion to remove the method that engages then.

As the method for removing the parcel overcoat, except will wrapping up the overcoat extraction, it is also conceivable that selection can form the method for wrapping up overcoat by dissolved material (for example: saccharide, starch, ossein, heparin, wafer etc.) in blood vessel.If adopt this method, remove by making the dissolving of parcel overcoat just can insert the back at conduit.In this case, though can identical prior formation with above-mentioned resin material wrap up overcoat, and then install on the balloon,, also the raw material before being shaped can be coated on the surface of balloon, on balloon, directly form the parcel overcoat.

Insert endovascular structure with balloon various concrete considerations can be arranged being coated on parcel overcoat on the balloon, no matter but which kind of all before balloon is in inserting body, do not open, so compare, can more successfully be inserted in the body with existing balloon.

Figure 12 is the figure of the example of the expression inside tube of reinforcing ballon catheter.

Ballon catheter 401 is bicavates, and shown in Figure 12 (a), it comprises:balloon 402,outboard tube 404, insidetube 406, front end tip 408 and connection wye 412.Gap between the outer peripheral face of the inner peripheral surface ofoutboard tube 404 and insidetube 406 is communicated with thesupply outlet 416 ofconnection wye 412 in the proximal lateral respectively, be communicated with in distal side andballoon 402, formation can be supplying with the supply discharge line ofballoon 402 by supplying with helium thatoutlet 416 supplies with.The inner chamber ofinside tube 406 is communicated with theguidewire port 420 ofconnection wye 412 in the proximal lateral respectively, and theopening 422 in the distal side with the portion foremost of front end tip 408 is communicated with, and the endovascular road all of inserting is inserted lead and rest in formation in advance.

In addition, as the feature structure of described ballon catheter 401, ininside tube 406, be fixed with reinforcement feature 440.Thisreinforcement feature 440 is that diameter is the metal wire (material: rustless steel (SUS316)) of 0.03mm, two wires Shu Chengyi are organized, eight groups of dextrorotation abreast of restrainting like this are rolled into helical form, again with other eight groups of left-handed abreast helical forms that are rolled into, make this dextral eight groups and left-handed eight groups overlap each other intersect weave into netted, as amplification among Figure 12 (b) illustrates, inside tube 406 (the about 1.4mm of external diameter, the about 1.0mm of internal diameter) be to be provided with by the form of in polyamide, imbedding reinforcement assembly, therefore, insidetube 406 becomesexternal resin layer 406a,reinforcement feature 440, and the three-decker ofinternal resin layer 406.

Reinforcement feature 440 is shown in Figure 12 (a), and progressive vertically pitch was short in the distal side when it's a week was past the helix revolution, and is long in the proximal lateral.In the figure, though at obvious expression pitch different aspect and actual pitch strict conformance not, but each metal wire in distal side with about 4mm, reel with the pitch of about 5mm at the near-end sidepiece, eight groups of metal wires of close wind stagger to axial direction with every eighth pitch, equally spaced reel mutually whereby.As according to the change spiral shell short, then because at the flexural rigidity of theinside tube 406 of proximal lateral than distal side height, so even the proximal lateral also can be crooked when applying big power when inserting, in addition, need can not be subjected to big infringement along the flexibility of the progressive distal side of vascular bending, so can more successfully insert operation.

In addition,reinforcement feature 440 is arranged near the approximate centre ofballoon 402 the position, and be not arranged on the distal side, so the flexibility of the front ofballoon 402 increases, and, suppressed near the incidental warpage phenomenon junction surface ofballoon 402 andoutboard tube 404 by reinforcement feature 440.In addition, the pitch of metal wire can also can be divided into several zones and change pitch respectively by above-mentioned two zone changes, can also change pitch on the whole continuously.

Ballon catheter 401 according to above-mentioned formation, because theinside tube 406 withreinforcement feature 440 is compared with the pipe that only is made of resin material higher intensity is arranged, and compare with the pipe that only constitutes and to have flexibility by metal material, so it is better in endovascular propelling than resinous pipe, than metal pipe flexibility height, both do not damage the flexibility of existing product and propelling property, taken into account the performance of having improved both sides again.

In addition, described ballon catheter 401 is different with the resinous pipe that adopts prior art, can also obtain the conduit radiography effect under actinoscopy X, if warpage takes place on the slotting path of conduit, can find problematic position easily.

Figure 13 is the figure of a useful variation of expression.

Ballon catheter 501 shown in Figure 13 is different with above-mentioned ballon catheter 401, and wholeinside tube 506 is provided with reinforcement feature 540.The pitch that the metal wire of describedreinforcement feature 540 forms all is identical, the intensity thatsuch reinforcement feature 540 can improve insidetube 506 is set, has higher propelling (inserting easily) than pitch tube, compare the soft pliable song with metal tube, taken into account the relation of good flexibility and propelling property rightly.

Thepressure transducer 521 that can detect ambient pressure is set in the portion foremost of described ballon catheter 501.Thispressure transducer 521 is to change the semiconductor strain gauge that the distortion resistance cause changes according to pressure, byreinforcement feature 540 be directed to 525 maintenances of outside lead fromconnection wye 512 and be electrically connected.Promptly in thisballon catheter 501,reinforcement feature 540 also uses as holding wire except the propelling and flexibility that improve inside tube 506.According tosuch ballon catheter 501, lead 525 is linked to each other with pressure monitoring device M, just can monitor near the blood pressure in balloon stop place.

In addition, though above-mentioned ballon catheter 401,501 is provided with by weaving into the reinforcement feature that netted metal wire is formed, but also but the ballon catheter shown in theimage pattern 14 601 is such, the reinforcement feature that is made of a wires is fixed on the inside tube 606 abreast, so also can improve the intensity of inside tube 606, have better propelling than pitch tube, have more the soft pliable song, so taken into account good flexibility and propelling property rightly than metal tube.But the method that reinforcement feature is made helical form encirclement inside tube is considered to more effectively to improve the intensity that the inside tube opposing shrivels.

Below with reference to Figure 15 (a) and (b), (c) in use disruptive other method of ballon catheter that prevents is described.

Shown in Figure 15 (a), ballon catheter 701 is made of the sign 711 of front end tip 708, balloon 702, inside tube 706, outboard tube 704, connection wye 712 and detection balloon position.Ballon catheter 701 is bicavates, have from guidewire port 720 through the inner chamber of inside tube 706 until connect and make inside to become first chamber of the slotting access line of lead (not shown), and supply with outlet 716 from intake-gas and be communicated to the inside of balloon 702 and make inside become second chamber of helium flow path through the gap between inside tube 706 and the outboard tube 704 with the front end of front end tip 708.

This ballon catheter 701 comprises: be provided with on the proximal lateral of outboard tube 704 and be sewn to the installing component 710 that relative human body can not be installed movably on the skin, on installing component 710 rotatable configuration and make outboard tube 704 fixed rotatable parts 782, be threaded with installing component 710 and make the rotational angle of rotatable parts 782 can maintain hold-down screw 784 on the special angle, and configuration detects the detection sign 786 that X ray does not see through the bending of material formation by linear scanning on the periphery of balloon 702 and outboard tube 704.

Wherein, installing component 710 has on the alar part 710a of both sides and is used for by sutural wire casing 710b, in addition, shown in Figure 15 (b), (c), also has and makes dead eye 710c that rotatable parts 782 embed and the screwed hole 710d that is screwed into hold-down screw 784.

Rotatable parts 782 are formed by embedding the axial region 782a among the described dead eye 710c and being processed with graduated operating portion 782b, form the locational groove 782c of scale that the front end 784a of hold-down screw 784 is embedded in the 782b of respective operations portion on axial region 782a.In this object lesson, on whole circumference, form a groove 782c and form eight altogether every 45 °, be marked with the numerical value of 1-8 at the scale of respective slot 782c, so that the turned position of identification rotatable parts 782 is arranged.In addition, form through hole 782d on rotatable parts 782, make this through hole 782d connect outboard tube 704, outboard tube 704 and rotatable parts 782 pass through adhesive securement.

Hold-down screw 784 with the screw thread 710d threaded engagement of installing component in, by front end 784a is projected into its front end 784a is embedded among the recess 782c of rotatable parts 782.Whereby, hold-down screw 784 is also shared the task of preventing that rotatable parts 782 from deviating from from installing component 710 when bearing prevention rotatable parts 782 rotation tasks.

The following describes the using method of described ballon catheter 701, about inserting the operation of human body, because with above-mentioned identical, so peculiar place among this embodiment only is described.

When ballon catheter 701 arrives target locations, installing component 701 is sewn on patient's the skin fixing.Supply with the known air flow drive device of connection on the outlet 716 at the gas of ballon catheter 701 then, carry out the IABP operation.

If through 24 hours, then unclamp hold-down screw 784 and make 782 of rotatable parts turn over 1 scale (promptly 45 °) after IABP begins, again hold-down screw is locked.Make ballon catheter integral body turn over 45 ° whereby, if the part of balloon 702 with partly contact attached to the sharp keen calcification on the blood vessel, do to make this contact position move away and contact like this with other part.Whether the integral body of ballon catheter 701 rotates smoothly, can confirm that the case of bending of curved detection sign 786 judges by radioscopic image.If rotate not smoothly, then from guidewire port 720, insert metal wire, provide torque to eliminate bending by inboard from inside tube 706.

Like this, if rotatable parts 782 are rotated once, can make the ad-hoc location of balloon 702 and the ad-hoc location of blood vessel when reach 24 hours time of contact, just move on other position, so also be suitable for the ballon catheter 701 of this explanation for the patient that sharp keen calcification part is arranged in blood vessel, balloon 702 tired positions are moved on other position, do not rotate to rest on the position with balloon 702 always and compare, can not cause that balloon breaks.

Point out that in passing described ballon catheter 701 can rotate a week by rotation operation once on the one in eight days.Because IABP often used about three-seven days, so under a lot of situations, can tackle with this ballon catheter 701.In addition, surpass under eight days the situation between in use,, compare, also be difficult to cause breaking of balloon with the ballon catheter of prior art even the rotation of this ballon catheter 701 surpasses 360 °.

In addition, ballon catheter 701 is rotated.

Though ballon catheter of the present invention has above-mentioned various features, can also have the various modification that are not limited to these features.

For example, as shown in figure 16, by inside tube and outboard tube are coupled together on a part to improve the insertion performance.

In Figure 16, theballon catheter 801 that IABP uses is bicavates, is made ofballoon 802,outboard tube 804, insidetube 806,front end tip 808 andconnection wye 812 etc.Gap between the outer peripheral face of the inner peripheral surface ofoutboard tube 804 and insidetube 806 is by being connected with thesupply outlet 816 ofconnection wye 812 in the proximal lateral, be connected in distal side andballoon 802, formation can be supplying with the supply discharge path ofballoon 802 from supplying with helium thatoutlet 816 supplies with.The inner chamber ofinside tube 806 is communicated with the opening foremost 822 that is positioned atfront end tip 808 in the distal side by being communicated with theguidewire port 820 ofconnection wye 812 in the proximal lateral, forms in advance to make insertion blood vessel lead interior and that stop therein can insert logical path.In addition, thoughouter conduit 804 and insidetube 806 are by cutting off line a part to be shown elliptically in the drawings, be actually the elongated pipe of identical shaped partial continuous.

In addition, as the feature structure of ballon catheter 810 of the present invention, extend toformation ledge 890 in theballoon 802 by a part that makesoutboard tube 804 onoutboard tube 804 distal sides, insidetube 806 is fixed on this ledge 890.Describedledge 890 is tongue-shaped outthrust integrally formed withoutboard tube 804, and insidetube 806 andledge 890 are by the adhesive securement of between.In addition, butledge 890 has resilient flexible distortion and crooked pliability equally withinside tube 806, whenoutboard tube 804 and insidetube 806 under near the situationcrooked ledge 890, by makingledge 890 deflections, can prevent the rapid warpage ofinside tube 806.

Ballon catheter 801 according to above-mentioned formation, distal side inoutboard tube 804, because fixing insidetube 806 on as theledge 890 of the part ofoutboard tube 804, so when being inserted into thisballon catheter 801 in the blood vessel, evenfront end tip 808 grades meet obstructions, insidetube 806 can not take place yet push back situation in the outboard tube 804.Therefore,balloon 802 is shriveled vertically and loose, make to be inserted in the blood vessel and more smooth than the ballon catheter of prior art in endovascular guiding.

In addition, because 806 ofoutboard tube 804 and inside tube are fixed on the distal portion ofoutboard tube 804, so inoutboard tube 804, can freely change relative position ininside tube 806 on other the position, therefore, if the dual tube portion bending that constitutes byoutboard tube 804 and insidetube 806, then becauseinside tube 806 is freely moved on the most demulcent stressed position, so can not damage the flexibility of ballon catheter 801.Particularly owing to, can not occur only being difficult to crooked directivity, so can not damage the endovascular operability of irregular wriggling to specific direction with different the ballon catheter ofinside tube 806 overall fixed on the inwall ofoutboard tube 804 yet.

Claims (17)

1. ballon catheter comprises: be elongated tubular product such and soft flexible catheter main body, be arranged on described catheter main body distal side and utilize the fluid of supplying with and discharging by described catheter main body inner chamber to carry out the balloon of expansion, it is characterized in that:

The front end tip that forms at the mixture of the useful soft resin of front-end configuration of described catheter main body distal side and roentgenopaque material.

2. ballon catheter as claimed in claim 1 is characterized in that: described front end tip is soft microscler.

3. ballon catheter as claimed in claim 1 or 2 is characterized in that: described front end tip forms the thin shape in front.

4. a ballon catheter is characterized in that: dispose along the transportable hemostasis parts of this catheter main body on catheter main body.

5. a ballon catheter is included in the parcel overcoat that coats this balloon periphery under the balloon folded state, it is characterized in that:

Described parcel overcoat has the structure that can insert blood vessel with the described balloon through coating.

6. ballon catheter as claimed in claim 5, it is characterized in that: the outstanding setting front end tip in the distal side of described balloon, the front end of described parcel overcoat form the thin shape of front end and the frictional resistance when inserting and are unlikely its intensity rolled and front end tip are adjacent to.

7. ballon catheter as claimed in claim 5 is characterized in that: outstanding on than described balloon distal side far away the front end tip is set, simultaneously, top, proximal lateral nearer than the distal side on described front end tip forms the end difference that diameter diminishes; The front end of described parcel overcoat is in the proximal lateral of described end difference, and the diameter of this proximal lateral is thinner than the distal side diameter of end difference.

8. ballon catheter, comprise: be elongated tubular product such and soft flexible catheter main body, be arranged on this catheter main body distal side and utilize the fluid of supplying with and discharging by the inner chamber of this catheter main body to carry out the balloon of expansion, it is characterized in that, also comprise:

Be configured near the described balloon and can measure in the blood vessel that this balloon stops around blood pressure pressure transducer and link to each other with this pressure transducer so that the signal transmission line that is directed to the outside and the output signal of described pressure transducer is sent to external device (ED) through described catheter main body.

9. ballon catheter as claimed in claim 8 is characterized in that: described signal transmssion line route connects the flexual parts that are configured in described balloon and catheter main body inside vertically and constitutes.

10. ballon catheter as claimed in claim 8 is characterized in that: have at described balloon and be under the folding state parcel overcoat that coats this balloon periphery, described parcel overcoat has with the described balloon through coating and inserts endovascular structure.

11. ballon catheter, comprise: carry out the balloon of expansion/contraction, rearward end that the distal side is bonded on this balloon and can make described fluid supply with and be discharged to the outboard tube of balloon interior from the proximal lateral and connect the inside tube of outboard tube and balloon internal configurations by the fluid of internal feed and discharge, it is characterized in that from the proximal lateral of described outboard tube to the leading section of described balloon by the inner chamber that is communicated with this balloon interior:

At described inside tube internal fixation the reinforcement feature that is made of metal wire is arranged.

12. ballon catheter as claimed in claim 11 is characterized in that: described reinforcement feature be the relative inner pipe by left-handed helical coil around one or a few metal wire and by dextral helical coil around the reticulate body weaved into of the interlaced spiral of one or a few metal wire.

13. ballon catheter as claimed in claim 11 is characterized in that: described reinforcement feature constitutes by being rolled into spiral helicine metal wire, and described one week of helical rotation, progressive vertically pitch was short in the distal side, and is long in the proximal lateral.

14. ballon catheter as claimed in claim 11 is characterized in that: described reinforcement feature be arranged on from than the position of the defined of the distal portion of described outboard tube distal side far away and the proximal lateral nearer than the distal portion of described inside tube in the scope of described outboard tube close end.

15. ballon catheter, comprise: be elongated tubular product such and soft flexible catheter main body, be arranged on this catheter main body distal side and utilize by the inner chamber of this catheter main body and supply with the joint that carries out that the balloon of expansion, the proximal lateral that is arranged on described catheter main body are used for being connected with the machine of the described gas of supply etc. with the fluid of discharging, it is characterized in that, also comprise:

Can not the relatively move installing component installed and being arranged on rotationally of human body is fixed described catheter main body and described joint simultaneously and followed and self rotate the rotatable parts that described balloon is rotated on this installing component.

16. ballon catheter, comprise: the balloon, distal side that can carry out expansion/contraction by the fluid of internal feed and discharge engage with the rearward end of described balloon and by the inner chamber that is communicated with this balloon interior can make outboard tube that described fluid supplies with and discharge, from the proximal lateral of described outboard tube to the leading section perforation outboard tube of described balloon and the inside tube of balloon interior, it is characterized in that:

Be fixed on this outboard tube in the described inside tube of described outboard tube distal portion.

17. a catheter jacket is the cast catheter jacket with continuous hollow-core construction from the base end part to the terminal part, it is characterized in that: have one or more side openings on the described catheter jacket.

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