The foley's tube of flexible joint is provided between a kind of head end and sacculusTechnical field
The present invention relates to technical field of medical instruments, between specifically a kind of head end and sacculusFoley's tube provided with flexible joint.
Background technology
Percutaneous coronary intervention (pci) (Percutaneous Coronary Intervention,PCI), refer to that Transcatheter technology dredges narrow or even inaccessible coronary artery tube chamber, so as to changeThe treatment method of the blood perfusion of mercy flesh.The treatment method have short treating period, wound it is small, treatImitate the advantages that notable, quickly grow in recent years.According to the difference for implementing technology, PCI can divideFor percutaneous coronary blood vessel Transluminal Angioplasty (PTCA), coronary artery stent implantation, coronalArtery turnery art, Cutting balloon angioplasty, coronary thrombosis aspiration etc..
As shown in Fig. 1~2, the head end of the foley's tube of Clinical practice is to be sleeved on inner tube at presentEnd simultaneously directly offsets short and small coniform with sacculus, and this be designed with pushes away beneficial to foley's tubeThe transmission of power, be advantageous to what foley's tube had just been opened by narrow diseased region or seal wireChronic coronary artery occlusion position, but the blood vessel that is not weighed for tortuous blood vessel, luminal stenosis andImplantation support and after needing for the blood vessel expanded, when foley's tube head end by when because headEnd is flexible poor, it is difficult to which blood vessel may be propped up along the curved shape deflecting of blood vessel, head end in timeOr support, cause to damage.Because coronary artery is mostly bending, therefore for this areaTechnical staff for, how to design a kind of foley's tube, make it by bending diseased regionOr can be in time along blood vessel bending deflecting during dilation procedure after being carried out to support, being passed to propertyDo not influenceed by vascular bending or rack beams, in order to which rear process of expansion is smoothed out and is reducedThe problem of generation of risk is in the urgent need to address.
In addition, as shown in Fig. 1~2, foley's tube head end of the prior art is tinyIt is coniform, although this design is advantageous to foley's tube by narrow diseased region, or leadThe Chronic coronary artery occlusion that silk has just been opened, but for rear expansion of balloon catheter, due to itIt is mainly used in expanding to inserting after endovascular support is carried out, so that support fully opens and is close toBlood vessel medial surface, if by the header terminal design of rear expansion of balloon catheter into predilation foley's tubeConsistent is coniform, as shown in Fig. 2 a less planar end surface is had in conduit head end front end,When foley's tube is sent into support along seal wire, the planar end surface of the conduit head end front end is oftenRack beams are withstood, cause foley's tube to cause deformation of timbering by difficulty, severe patient,Trigger thrombus, therefore the head end structure of foley's tube is also required to make improvements, so that it is rightAfter support is carried out during dilation procedure, it will not be influenceed by property by rack beams.
The content of the invention
It is an object of the invention to provide flexible joint is provided between a kind of head end and sacculusFoley's tube, can be in time along blood vessel bending deflecting, will not be by support mesh or rack beamsInfluence, be easy to rear process of expansion to be smoothed out, reduce the generation of risk.
The purpose of the present invention is achieved through the following technical solutions：
It is provided with the foley's tube of flexible joint between a kind of head end and sacculus, including it is inner tube, outerPipe, sacculus and head end, inner tube are arranged in outer tube, and by being passed through in inner tube, sacculus is arranged seal wireIn the distal end of inner tube, and one end of the sacculus is connected with the outer tube, the other end with it is described interiorPipe is connected, and is provided with flexible joint on rear side of the head end, after the distal end stretching sacculus of said inner tubeIt is connected with the flexible joint, it is curved to comply with shape of blood vessel after the flexible joint intravasationIt is bent.
The head end is tapered, and the external diameter of the flexible joint is greater than, equal to or less than instituteState the maximum outside diameter of head end.
Be provided with lug boss on front side of the head end, the lug boss maximum outside diameter more than the head end itsThe external diameter of remaining part point, and by described convex between the inner side hole wall and lateral wall on front side of the head endPortion's transition and linkage is played, the lug boss outer surface is shiny surface, or the lug boss and head endHole wall connected side in inner side is in inclined face on rear side of head-end.
It is provided with front side of the head end on different lug bosses, or the outer surface of the head end front endOnly some sets lug boss.
Be provided with connecting rod on rear side of the lug boss of the head end, the head end by the connecting rod andThe flexible joint is connected.
Be provided with a gradually narrowed transition face on front side of the head end, the head end exit it is interiorIt is connected between side opening wall and lateral wall by the transition face, the transition face is shiny surface, orTransition face described in person is with the side that hole wall on the inside of head end is connected in inclined face on rear side of head-end.
The end of the sacculus is provided with connecting tube, and the sacculus is by the connecting pipe box loaded on interiorGuan Shang, the diameter of the flexible joint and head end are all higher than the connection pipe diameter of the sacculus.
It is arranged to taper or inclined-plane on rear side of the head end；The original shape of the flexible jointShape of blood vessel bending is further complied with bending, and after the flexible joint intravasation.
The radial section of the head end is rounded or polygon, the radial direction of the flexible joint are cutFace is rounded or polygon.
The flexible joint and head end are Split type structure, or are structure as a whole.
Advantages of the present invention is with good effect：
1st, the present invention is provided with flexible joint between head end and sacculus, and head end can be made timelyAlong blood vessel bending deflecting, being passed to performance will not be by vascular bending or the shadow of rack beamsRing.
2nd, head end of the invention is provided with lug boss or transition face, so as to be not present on front side of head endPlanar end surface, foley's tube will not be hindered when being in contact with intravascular stent by rack beams, canSmoothly slip over rack beams.
Brief description of the drawings
Fig. 1 is foley's tube distal structure schematic diagram of the prior art,
Fig. 2 is enlarged drawing at the A in Fig. 1,
Fig. 3 is the structural representation of embodiments of the invention one,
Fig. 4 is enlarged drawing at B in Fig. 3,
Fig. 5 is enlarged drawing at C in Fig. 3,
Fig. 6 is enlarged drawing at D in Fig. 3,
Fig. 7 is enlarged drawing at E in Fig. 3,
Fig. 8 is the distal structure schematic diagram of embodiments of the invention two,
Fig. 9 is the distal structure schematic diagram of embodiments of the invention three,
Figure 10 is the distal structure schematic diagram of embodiments of the invention four,
Figure 11 is the distal structure schematic diagram of embodiments of the invention five,
Figure 12 is the distal structure schematic diagram of embodiments of the invention six,
Figure 13 is the distal structure schematic diagram of embodiments of the invention seven,
Figure 14 is the distal structure schematic diagram of embodiments of the invention eight,
Figure 15 is the distal structure schematic diagram of embodiments of the invention nine,
Figure 16 be the present invention be by schematic diagram during seal wire (OTW) type foley's tube,
Figure 17 is a kind of structural representation when head end is provided with lug boss,
Figure 18 is another structural representation when head end is provided with lug boss,
Figure 19 is another structural representation when head end is provided with lug boss,
Figure 20 is axial view when head end is provided with lug boss,
Figure 21 is a kind of structural representation when head end is provided with asymmetric lug boss,
Figure 22 is another structural representation when head end is provided with asymmetric lug boss,
Figure 23 is axial view when head end is provided with asymmetric lug boss,
Figure 24 is a kind of structural representation when head end is provided only with part lug boss,
Figure 25 is another structural representation when head end is provided only with part lug boss,
Figure 26 is the schematic diagram when axial cross sectional edge of head end lug boss is in polygon,
Figure 27 is the schematic diagram when radial section of head end lug boss is in polygon,
Figure 28 is a kind of structural representation when head end wall thickness thickeies,
Figure 29 is another structural representation when head end wall thickness thickeies,
Figure 30 is axial view when head end wall thickness thickeies,
Figure 31 is another structural representation when head end wall thickness thickeies,
Figure 32 is the head end axial view in Figure 31,
Figure 33 is that head end wall thickness thickeies a kind of structural representation that rear side simultaneously is provided with the conical surface,
Figure 34 is that head end wall thickness thickeies another structural representation that rear side simultaneously is provided with the conical surface,
Figure 35 is that head end wall thickness thickeies another structural representation that rear side simultaneously is provided with the conical surface,
Figure 36 is schematic diagram when axial cross sectional edge is in polygon when head end wall thickness thickeies,
Figure 37 is schematic diagram when radial section is in polygon when head end wall thickness thickeies.
Wherein, 1 is inner tube, and 11 be head end, and 111 be connecting rod, and 12 be guide wire exit openings, 13It is outer tube for developing ring, 2,3 be sacculus, and 31 be fluid-through chamber, and 32 be connecting tube, and 4 be softProperty connecting portion, 41 be intermediate incline, and 5 be joint, and 6 be conduit, and 7 be strain relief pipe, 8For planar end surface.
Embodiment
The invention will be further described below in conjunction with the accompanying drawings.
As shown in figure 3 to figure 7, the present invention include inner tube 1, outer tube 2, sacculus 3, joint 5,Conduit 6 and strain relief pipe 7, wherein inner tube 1 are arranged in outer tube 2, are passed through inside inner tube 1Pass to and passed through for seal wire, as shown in Fig. 3, Fig. 5 and Fig. 7, sacculus 3 is sheathed on inner tube 1Distally (the i.e. one end away from operating personnel, namely free end in the distal end), and the sacculus3 one end is connected with the outer tube 2, and the other end is connected with said inner tube 1, the sacculus 3Interior is fluid-through chamber 31, as shown in figs. 34, one section of inner tube 1 being arranged in the sacculus 3Outside is provided with multiple developing rings 13, and the position of developing ring 13 can be shown by corresponding instrument,So as to help operating personnel to understand the position of sacculus, as shown in fig. 6, in the near-end (institute of outer tube 2Near-end is stated i.e. close to one end of operating personnel) in be provided with conduit 6, and the conduit 6 is arranged atThe outside of inner tube 1, as shown in figure 3, the near-end of the conduit 6 is connected with joint 5, describedJoint 5 is provided with strain relief pipe 7, and the spiral-lock of strain relief pipe 7 is in the joint 5Distal end, the strain relief pipe 7 be used for avoid stress concentration, to improve making for foley's tubeUse the life-span.
The sacculus 3 uses pressurized, heated blow molding, is 0.3~1.5mm by internal diameter, outerThe nylon pipe that footpath is 0.6~2.0mm, length is 400~600mm, pressure be 300~600PSI, blow under conditions of 160~220 degrees Celsius, obtain a diameter of 2.0~5.0mm,A length of 5.0~30.0mm cylinder is the main body of sacculus 3, as shown in figure 5 and figure 7, in instituteState the both ends of sacculus 3 and be respectively arranged with connecting tube 32, the external diameter of the connecting tube 32 for 0.60~1.02mm, length are 1.0~10.0mm, and sacculus 3 is covered respectively by the connecting tube 32 at both endsLoaded in said inner tube 1 and outer tube 2, it is connected so as to realize with inner tube 1 and outer tube 2, sacculusFluid-through chamber 31, the energy after developer solution is passed through of fluid-through chamber 31 are formed between 3 and inner tube 1Enough swell, so as to which support be strutted.
The outer tube 2 is being squeezed using nylon, polyethylene, polypropylene or block polyamide materialGo out 200~280 degrees Celsius of temperature, extruded under conditions of 15~40 degrees Celsius of chilling temperature a length ofThe tubing that 250~1600mm, external diameter are 0.76~0.86mm, thickness is 0.04~0.14mmObtain the outer tube 2.
Said inner tube 1 is and outer using nylon, polyethylene, polypropylene or block polyamide materialPipe 2 is made under the same conditions, and length is 250~1600mm, and external diameter is 0.50~0.61mm。
As shown in fig. 7, the distal end of said inner tube 1 passes through flexible joint 4 after stretching out sacculus 3It is connected with head end 11, when foley's tube enters curved blood vessel, the flexible joint 4 existsBlood vessel curve-shaped bend can be complied with external force effect, so as to effectively avoid head end 11 from withstanding rack beams,Ensure conduit by the way that the flexible joint 4 is using nylon, polyethylene, polypropylene or blockPolyamide material is made.
The flexible joint 4 may be designed to Split type structure with head end 11, can also be designed toIntegrative-structure.When flexible joint 4 and head end 11 are Split type structure, the flexible connectionPortion 4 can use nylon, polyethylene, polypropylene, block polyamide or polyurethane material and pass throughExtrusion way is molded, and in 200~280 degrees Celsius of extrusion temperature, chilling temperature 15~40 is CelsiusExtruding pipe material under conditions of degree, long 0~20mm, external diameter be 0.50~2mm, thickness for 0.07~0.82mm.When flexible joint 4 and head end 11 are structure as a whole, the flexible joint4 and head end 11 using nylon, polyethylene, polypropylene, block polyamide or polyurethane material,And utilize the method being molded injection moulding integrated molding in the mould of respective shapes.
The head end 11 may be designed to taper as needed, in addition as shown in Fig. 1~2, ifRear expansion of balloon catheter is also designed to taper, due to the front end of head end 11 have one it is lessPlanar end surface 8, when foley's tube is sent into support along seal wire, the planar end surface 8 often pushes upFirmly rack beams and make conduit can not be by order to solve this problem, the structure of head end 11It need to make improvements.
Embodiment 1
As shown in figure 3, the present embodiment is rapid-exchange version foley's tube, portion is provided with the catheterGuide wire exit openings 12.
As shown in fig. 7, tapered head end 11 is used in the present embodiment, and the head end 11It is Split type structure with flexible joint 4.Described one end of flexible joint 4 is sleeved in inner tube 1,The other end of the flexible joint 4 is coordinated by seam to be connected with the rear side of the head end 11,The diameter of the flexible joint 4 is identical while described with the diameter of connecting tube 32 of sacculus 3The diameter of flexible joint 4 is also identical with the maximum gauge of the male cone (strobilus masculinus) of head end 11.Work as ballWhen ductus bursae enters curved blood vessel, the flexible joint 4 is also easy to produce under external force to be complied withThe bending of blood vessel bending, so as to ensure that conduit passes through.
Embodiment 2
As shown in figure 8, the present embodiment difference from Example 1 be the head end 11 withFlexible joint 4 is formed in one structure, described soft when foley's tube enters curved blood vesselProperty connecting portion 4 and head end 11 are also easy to produce the bending for complying with blood vessel bending under external force,So as to ensure that conduit passes through.
Embodiment 3
As shown in figure 9, the present embodiment difference from Example 1 is outside the head end 11The maximum outside diameter of the conical surface is less than the diameter of the flexible joint 4, and in the flexible connectionOne end that portion 4 is connected with head end 11 is provided with intermediate incline 41, the flexible joint 4 it is straightFootpath is identical with the diameter of connecting tube 32 of sacculus 3.
Embodiment 4
As shown in Figure 10, the present embodiment difference from Example 1 is outside the head end 11The maximum gauge of the conical surface is more than the diameter of the flexible joint 4, the flexible joint 4Diameter is identical with the diameter of connecting tube 32 of sacculus 3.
Embodiment 5
As shown in figure 3, the present embodiment is rapid-exchange version foley's tube, portion is provided with the catheterGuide wire exit openings 12.
As shown in figure 11, the present embodiment uses the head end 11 provided with lug boss, and the head end11 and flexible joint 4 are Split type structure.The head end 11 includes the lug boss of front side with afterThe connecting rod 111 of side, described one end of flexible joint 4 are sleeved in inner tube 1, and the other end leads toCrossing seam coordinates the connecting rod 111 with the rear side of head end 11 to be connected, the flexible jointThe connecting rod 111 of 4 diameter, the diameter of connecting tube 32 of the sacculus 3 and the head end 11Diameter all same, the lug boss maximum outside diameter of the front side of head end 11 are more than the flexible connectionThe diameter in portion 4 and the diameter of the other parts of head end 11, and the lug boss of the head end 11Maximum height be more than the distance of support and blood vessel so that conduit smoothly slips over rack beams.
As shown in figure 11, the lug boss is arranged at the front side of head end 11, and the head end 11Transition, the lug boss are connected by the lug boss between the inner side hole wall and lateral wall of front sideOuter surface could be arranged to shiny surface, and the planar end surface 8 for propping up rack beams is so just not present, fromAnd conduit is smoothly slipped over rack beams, or as shown in figure 26, the lug boss appearance breadInclude multiple planes, the angle between two planes of arbitrary neighborhood is obtuse angle, is so just formed nearLike the shape of cambered surface, and lug boss outer surface and the plane that the inner side hole wall of head end 11 is connected toThe rear side of head end 11 tilts, and the planar end surface 8 that can prop up rack beams is so just not present, also may be usedSupport beam action smoothly is slipped over to play, plus the flexible joint 4 under external forceThe bending for complying with blood vessel bending is also easy to produce, so as to be further ensured that conduit passes through.Such as figureShown in 19, because seal wire is passed through by the endoporus of head end 11, on the inside of the outlet of the head end 11Can be arranged to flip to the outside and with the smooth cambered surface being connected of lug boss in the outside of head end 11,So that the outlet of head end 11 is more smooth when being contacted with seal wire.Also may be used the lug boss outer surfaceTo be arranged to the structure that shiny surface is connected with plane, as long as front side and the inner hole wall phase of head end 11Face even does not form the planar end surface 8 that can prop up rack beams.
As shown in Figure 17~20, the lug boss on the head end 11 can be symmetrical structure around instituteState the rotary body that the rotation of the axis of head end 11 forms, namely any axial cross section of the lug bossIt is symmetrical structure, only the outward flange of the lug boss axial cross section is arranged as required intoLug boss on different radians, or the head end 11 can also be designed to unsymmetric form,For example shown in Figure 21~23, the both sides of head end 11 are respectively equipped with different convex of outer surface radianThe portion of rising, or as shown in Figure 24~25, on the front side outer surface of head end 11 someLug boss is set, remainder is the conical surface that taper points to the front side of head end 11, or to headThe inclined inclined-plane in the inner side of end 11, head end 11 and flexible joint 4 radial section can be setCircle is counted into, or as shown in figure 27, is looked along the axial direction of the head end 11, the headEnd 11 and the radial section of flexible joint 4 can also be designed to be in approximate circle polygon.
Embodiment 6
As shown in figure 12, the present embodiment and the difference of embodiment 5 are：The head end11 eliminate connecting rod 111 in a tubular form, and the lug boss of head end 11 directly connects with the flexibilitySocket part 4 is connected.
Embodiment 7
As shown in figure 13, the present embodiment and the difference of embodiment 5 are：The head end11 are structure as a whole with flexible joint 4, described when foley's tube enters curved blood vesselFlexible joint 4 and head end 11 are also easy to produce under external force complies with the curved of blood vessel bendingSong, so as to ensure that conduit passes through.
Embodiment 8
As shown in figure 3, the present embodiment is the foley's tube of rapid-exchange version, portion is set in the catheterThere are guide wire exit openings 12.
As shown in figure 14, the head end 11 thickeied in the present embodiment using wall thickness, and the head end11 and flexible joint 4 are Split type structure.Described one end of flexible joint 4 is sleeved on inner tube 1On, the other end is coordinated by seam and is connected with the rear side of head end 11, the flexible joint4 diameter is identical with the diameter of the head end 11, and is all higher than the connection of the sacculus 3The diameter of pipe 32, and the wall thickness of the head end 11 is more than the distance of support and blood vessel, withConduit is set smoothly to slip over rack beams.
A gradually narrowed transition face is provided with the front side of the head end 11, before the head end 11It is connected between the inner side hole wall and lateral wall of side by the transition face, as shown in figure 14, instituteIt can be the shiny surface being directly connected with the inner hole wall of head end 11 to state transition face, just do not deposited soThe planar end surface 8 of rack beams can be being propped up, conduit can smoothly slip over rack beams, or such as Figure 36Shown, the transition face includes multiple planes, and the angle between the plane of arbitrary neighborhood two is obtuse angle,So just form the shape of approximate cambered surface, and with the plane that the inner side hole wall of head end 11 is connected toThe rear side of head end 11 tilts, and the planar end surface 8 that can prop up rack beams is so just not present, also may be usedSupport beam action smoothly is slipped over to play, plus the flexible joint 4 under external forceThe bending for complying with blood vessel bending is also easy to produce, so as to be further ensured that conduit passes through.The mistakeThe face of crossing can also be arranged to the structure that shiny surface is connected with plane, as long as front side and head end 11The connected face of inner hole wall does not form the planar end surface 8 that can prop up rack beams.
As shown in Figure 14 and Figure 28, the shiny surface of the front side of head end 11 is arranged at head end 11Outside and the different shiny surface of radian can be arranged to according to being actually needed.As shown in figure 29,Because seal wire is passed through by the endoporus of head end 11, can also be arranged on the inside of the outlet of the head end 11Flip to the outside and with the smooth cambered surface being connected of transition face in the outside of head end 11 so that head end11 outlets are more smooth when being contacted with seal wire.As shown in figure 30, the head end 11 can beThe rotary body that symmetrical structure forms around the axis of head end 11 rotation, i.e., along the head end 11Axial direction look, the radial section of the head end 11 is rounded, or as shown in figure 37, edgeThe axial direction for the head end 11 is looked, head end 11 and flexible joint 4 radial sectionIt can be designed to be in approximate circle polygon.As shown in Figure 31~32, before the head end 11Some is arranged to transition face to side external surface, and remainder is arranged to the conical surface or inclined-plane, such asShown in Figure 33~35, the rear side of the head end 11 can be further designed to taper and point to head endThe taper or inclined-plane of 11 rear sides.
Embodiment 9
As shown in figure 16, the present embodiment is to be connect by seal wire (OTW) type foley's tube, seal wireMouth 12 is arranged on joint 5.
As shown in figure 15, the head end 11 in the present embodiment and flexible joint 4 are Split type structure,And the original shape of the flexible joint 4 is in bending, the one end of flexible joint 4 setIn inner tube 1, the other end is coordinated by seam and is connected with the head end 11, when sacculus is ledWhen pipe enters curved blood vessel, the flexible joint 4 can further comply with blood under external forceThe bending of pipe bending, so as to ensure that conduit passes through.
The flexible joint 4 can be in smooth bowing, can also be in horn shape bending.
The flexible joint 4 may be designed to Split type structure with head end 11, can also be designed toIntegrative-structure, the head end 11 can also use the structure in other embodiment.