CN107582130A - A kind of blood vessel expansion appliance of the tie bracket and application of non-built-in mode the foley's tube tie bracket - Google Patents

Abstract

A kind of tie bracket of non-built-in mode foley's tube, including for the main part being coated on outside foley's tube and the fixed part for being used to be fixedly connected foley's tube for being connected to the main part both ends, the tie bracket is for following balloon catheter expansion or contraction and suppressing the maximum swelling volume of foley's tube in tubular construction；A kind of non-built-in mode blood vessel expansion appliance, including foley's tube, also include foregoing tie bracket, the foley's tube and the tie bracket each have the compressed configuration that is used for inserting in blood vessel and for supporting the expansion form expanded in the blood vessel, the maximum gauge of the maximum gauge of the tie bracket under expansion form less than the foley's tube under expansion form.The present invention is simple in construction, easy to use, greatly improves therapeutic effect, reduces the damage to blood vessel and the probability of happening of complication.

Description

A kind of blood vessel of the tie bracket and application of non-built-in mode the foley's tube tie bracket Extension fixture

Technical field

The present invention relates to angioplasty fixture technology field, and in particular to a kind of constraint of non-built-in mode foley's tube The blood vessel expansion appliance of support and the application tie bracket.

Background technology

For angiocardiopathy, balloon angioplasty is one of the most frequently used treatment means.Traditional foley's tube root According to the size of patient vessel and the length of lesion locations, be fabricated to different-diameter and length is filled with air into columned ball Capsule, its operation principle are：Using induction system, a sacculus dilating catheter is positioned over lesion, after airbag aeration, blood vessel quilt Expansion, realize that tube chamber expands.

Traditional balloon angioplasty is frequently accompanied by the damage of blood vessel, such as because balloon proximal during balloon expandable, Distal diameter is more than sacculus mid diameter, i.e. " dog bone effect ", causes the blood vessel overdistension of the end in contact of sacculus two, causes blood Vessel wall damage and cause sacculus longitudinally elongation accelerate vascular dissection（＞ 30%）, while the acute vascular of diseased region can be triggered Occlusion（5%~12%）And postoperative restenosis（50%）.

Because traditional balloon angioplasty has many injury of blood vessel, therefore it is used frequently as angiocardiopathy Initial therapy means, bare bracket or drug stent are often implanted into after treating in the early stage.Although bare metal stent and drug stent Have been found the patency rate after its treatment and be better than balloon angioplasty, but the bad clinical effectiveness being chronically implanted still be present And the ISR in late period, particularly artery of lower extremity are may result in dynamic stress caused by support in support fracture or support ISR.

Vascular dissection, Acute vessel closure, vascular damaged are all more serious vascular traumas, the formation of this wound It is in close relations with the mechanism of action of the angioplasty using conventional balloon.

The sacculus that traditional foley's tube mechanism of action includes folding reverses in expansion process is applied to cutting for vascular wall Shear force；Because conventional balloon is limited by structure and material, and the morphological differences at vascular lesion position, anisotropic spy Point, cause in use sacculus inevitable " dog bone effect " be present, cause the further wound of blood vessel and non- The injury of blood vessel of diseased region.

Patent document such as Patent No. CN105963848A discloses a kind of foley's tube, possesses：Sacculus；Outboard tube, It is connected to the cardinal extremity of above-mentioned sacculus；Inside tube, it is configured at the inside of above-mentioned outboard tube, and the top of the inside tube is connected to State the top of sacculus；In the jog that the periphery of above-mentioned inside tube is formed；And cored wire, its be configured at above-mentioned outboard tube with it is above-mentioned Between inside tube, wherein, above-mentioned cored wire possesses the bulge portion being clamped between the recess of above-mentioned outboard tube and above-mentioned jog, Although it can ensure that the flexibility of foley's tube and the good communication of push-pull effort, foregoing described problem is still had.

The content of the invention

One of technical purpose of the present invention is to provide a kind of tie bracket of non-built-in mode foley's tube, the about bundle branch Frame structural strength is high, can allow for and follows balloon catheter expansion or contraction, while suppresses foley's tube and fully or over expand, I.e. foley's tube carries out optimization expansion by standard of the expansion pattern of the tie bracket, real while blood vessel dilatation is ensured Now injury of blood vessel is minimized.

The concrete technical scheme of the present invention is as follows：A kind of tie bracket of non-built-in mode foley's tube, including tie in a tubular form Structure for the main part that is coated on outside foley's tube be connected to the main part both ends be used for be fixedly connected with foley's tube Fixed part, the tie bracket is used to follow balloon catheter expansion or contraction and suppresses the maximum swelling volume of foley's tube； The main part includes multiple remembering grids units and the spacer units between the remembering grids unit, the memory net Lattice unit is along the main part length direction array and simultaneously along the main part circumferential direction array, the adjacent memory It is directly connected between grid cell.

The tie bracket wraps up whole foley's tube, and being proximally and distally fixedly connected in foley's tube, The tie bracket is not easy to come off from foley's tube in itself, together inserts or withdraws from foley's tube.The tie bracket has One initial collapsed condition is simultaneously close to balloon portion surface, makes the diameter of balloon portion as small as possible in collapsed condition.It is described Tie bracket is slowly expanded as balloon portion is inflated, and balloon portion is limited by the tie bracket and homogeneous soft is expanded, Balloon portion will not because of self-characteristic and moment has expanded or toward the smaller non-lesion area expansion of resistance, and to vascular wall or non-lesion Cause to damage in area.In inflated or during pressure release, tie bracket can be carried out to the length of sacculus, diameter and spreading rate Effectively control, reduces or eliminates axial force and radial load of the sacculus to blood vessel, disperses three-dimensional shearing force of the sacculus to blood vessel, increase Controllability to vascular treatment process and predictable, to Long lesion blood vessel（100~300mm）There is splendid therapeutic effect.Institute State remembering grids unit, the spacer units allow sacculus to be continued across after expansion is limited by the tie bracket and produce and connect The projection of vascular wall is touched, vascular wall is carried out necessarily equably to have expanded support, the patch being also beneficial to after load medicine is touched.

Preferably, each remembering grids unit is provided with two the first tie points and two the second tie points, institute State and be joined directly together on the length direction of main part between the adjacent remembering grids unit by respective first tie point, It is joined directly together on the circumferencial direction of the main part between the adjacent remembering grids unit by respective second tie point.

It is directly connected between the remembering grids unit by first tie point and second tie point, in structure On accomplish to simplify as far as possible, uniformity is good, and make it that remembering grids unit tie bracket expansion in other words is smooth, Also ensure that generation and its space accounting of the spacer units are as big as possible, the memory is passed through after being advantageous to balloon catheter expansion Grid cell, the spacer units form more array of protrusions and corresponding array of depressions, and array of protrusions is soft with vascular wall Uniformly contact, it is easier to open diseased region, while array of depressions provides space for hematoblastic flowing, ensure that circulation Property, it is allowed to hematoblastic reconstruct, promote wound healing, as far as possible reduction or pre- anti-restenosis, exclude the danger that advanced thrombus is formed Danger.

Preferably, the gauge between two first tie points of each remembering grids unit is the note Recall the maximum length direction gauge of grid cell, between two second tie points of each remembering grids unit every Away from the largest circumference direction gauge for remembering grids unit this described；Maximum length direction gauge is constant all the time and causes institute Main part is stated not stretch on length room direction, largest circumference direction gauge expanded with the remembering grids unit or Contraction changes and causes main part expansion or shrinkage in radial directions.

The expanded size for defining the remembering grids unit is so set, i.e., actually described tie bracket is because of the note Recall this expansion characteristics of grid cell, very slight numerical value only occurs without substantial variations and becomes in other words for final stent length Change, and stent diameter is variable and the numerical value for the maximum swelling diameter for being used to suppress foley's tube be present, namely when ball intraluminal pressure When further increasing, foley's tube will not extend or have slight axial elongation, and the remembering grids unit and the interval are single The presence of member causes foley's tube due to being more difficult to elongate through rear caused resistance, simultaneously because the limitation of stent diameter, Foley's tube is only allowed the swell diameter for reaching limited, set, and sacculus compliance value in this case is significantly higher than biography Unite sacculus, effectively avoid " dog bone effect ", the inflation of foley's tube has predictable, is effectively controlled, also because This greatly reduces the generation for being damaged possibility, being avoided vascular dissection in non-lesion region, reduces the restenosis rate of blood vessel.In addition If the remembering grids unit is designed to smaller, the nominal pressure and burst pressure of sacculus are higher.

Preferably, the remembering grids unit is made up of multiple side sections, the length direction of each side section and blood vessel It is misaligned with the circumferential direction of blood vessel and cause the tie bracket that the week of relative vascular wall does not occur in expansion or shrinkage To rotation or axial dipole field.

So design causes the remembering grids unit side section described in each of which is all without along blood in expansion or shrinkage The length direction of pipe, circumferential direction elongate or shorten, that is, the side section described in change procedure can be all the time different from blood vessel Length direction, circumferential direction top offset simultaneously produce dispersed shearing force, easily open diseased region, reduce to vascular wall Damage, and will not make it that the whole tie bracket rotates in a circumferential direction or axial dipole field.

Preferably, the remembering grids unit assumes diamond in shape.The grid of rhombus perfect can meet foregoing design condition, and two Bar diagonal overlaps with the length direction and circumferential direction of blood vessel respectively, i.e. described along two summits in blood vessel circumferential direction Second tie point, it is first tie point along two summits on length of vessel direction, is not grown per one side section with blood vessel Direction, circumferential direction coincidence are spent, is expanded in diseased region together with foley's tube accurate stable.Complex degree of structure is low, work Skill makes relatively simple, it is easy to accomplish.

Preferably, the fixed part includes being connected to the memory linkage section at the main part both ends and is connected to the note Recall the welding section of linkage section.Memorability is preferable in actual use, and is not easy to make the tie bracket rotate or offset.

Preferably, the memory linkage section, which interlocks, is divided into the both ends of the main part.In actual use Memorability compared with It is good, and be not easy to make the tie bracket rotate or offset.

Preferably, the memory linkage section of homonymy is connected with a welding section jointly.Memorability in actual use Preferably, and it is not easy to make the tie bracket rotate or offset.

The present invention another technical purpose be to provide a kind of non-built-in mode blood vessel expansion appliance, avoid conventional balloon such as from leading Pipe overdistension, and vascular wall stress is soft uniformly, reduces lesion locations wound and non-lesion position blood vessel in the blood vessels like that Damage, the probability of happening of other vascular complications is reduced, promote healing.

A kind of non-built-in mode blood vessel expansion appliance, including foley's tube, in addition to foregoing tie bracket, the ball Ductus bursae each has the compressed configuration for being used for inserting in blood vessel and the expansion for supporting expansion in the blood vessel with the tie bracket Form, the maximum that the maximum gauge of the tie bracket under expansion form is less than the foley's tube under expansion form are straight Footpath.

The tie bracket is inserted blood vessel with the foley's tube or therefrom withdrawn from, the expansion of the foley's tube or Contraction is limited by the tie bracket, avoids expanding too fast or overdistension and producing damage to blood vessel.

Preferably, the foley's tube surface part under expansion form passes through the hollow of the remembering grids unit The hollow part of portion and the spacer units and the lug boss for forming the lattice-like for contradicting blood vessel, the ball under expansion form Ductus bursae surface another part is by the reality in addition to the hollow part of the remembering grids unit and the hollow part of the spacer units Center portion stops and forms the depressed part relative to the lug boss.

Because the maximum gauge of the tie bracket is less than the maximum gauge of the foley's tube, the foley's tube is from expansion The remembering grids unit and the spacer units openning in extrude, the lug boss realize the point of blood vessel by Power, while uniform, the soft blood vessel to expansion, the damage to blood vessel is smaller, and the depressed part forms clearance space, is blood platelet Flowing provide passage, it is allowed to blood platelet slowly reconstructs, promote wound healing, reduce or pre- anti-restenosis, exclude late period blood The danger that bolt is formed.

Preferably, the maximum gauge of the tie bracket under expansion form is than the foley's tube under expansion form The small 0.1 ~ 0.6mm of maximum gauge.

Preferably, it is covered with drug-carried coat in the foley's tube and/or the tie bracket.

Drug-carried coat contacts with lesion vascular wall, treats lesion region blood vessel, reduces rejection.

The tie bracket of non-built-in mode foley's tube described in the technological merit of the present invention and the blood vessel with the tie bracket Extension fixture is simple in construction, easy to use, and the foley's tube is limited by the tie bracket and kept in the blood vessel preferable Length and expansion diameter are expanded, while foley's tube is also limited and soft equably expands, and avoids too fast, the excessive expansion to blood vessel , reduce radial load and axial force of the foley's tube to vascular wall, the foley's tube and the tie bracket are not easy to send out Raw rotation or skew relative to lesion vesselses, shearing force suffered by vascular wall is uniform, and whole therapeutic process has controllability and can Foresight, therapeutic effect is greatly improved, reduce the damage to blood vessel and the probability of happening of complication.

Brief description of the drawings

Fig. 1 is the compressed configuration structural representation of tie bracket of the present invention；

Fig. 2 is the expansion form structural representation of tie bracket of the present invention；

Each toponym corresponding to numbering is respectively in figure：1- main parts, 2- fixed parts, 21- memory linkage sections, 22- welding sections, 11- remembering grids units, 12- spacer units, the tie points of 111- first, the tie points of 112- second.

Embodiment

Below in conjunction with accompanying drawing, by specific embodiment, the invention will be further described：

See that Fig. 1, Fig. 2, a kind of non-built-in mode blood vessel expansion appliance, including foley's tube and its tie bracket, foley's tube do not show Go out, tie bracket includes being used for the main part 1 that is coated on outside foley's tube and be connected to the both ends of main part 1 in tubular construction For being fixedly connected with the fixed part 2 of foley's tube, tie bracket is used to follow balloon catheter expansion or contraction and suppress sacculus to lead The maximum swelling volume of pipe, foley's tube is with tie bracket each with the compressed configuration for being used to insert in blood vessel and in blood The expansion form expanded is supported in pipe, the maximum gauge of the tie bracket under expansion form is less than foley's tube under expansion form most Major diameter.Restraining structure can have metal pipe material, polymer pipe by laser cutting form, also can by wire, polymer or Fiber is worked out.At least one is covered with drug-carried coat for foley's tube and tie bracket, after device is expanded, drug-carried coat with Lesion contact is transferred on blood vessel, treats lesion region blood vessel.The memory that fixed part 2 includes being connected to the both ends of main part 1 connects Connect section 21 and be connected to the welding section 22 of memory linkage section 21.Memory linkage section 21, which interlocks, is divided into the both ends of main part 1.Homonymy Memory linkage section 21 be connected with a welding section 22 jointly.The welding manner of welding section 22 can be welded by laser welding, adhesive Connect, the interconnection technique that this area such as thermal weld is more ripe.

Before present apparatus expansion, foley's tube is in collapsed condition, tie bracket in a state of nature, i.e. unexpanded state. The foley's tube diameter range of collapsed condition can be 0.8 ~ 1.0mm, and tie bracket is whole after being attached on foley's tube now Assembly dia scope can be 1.0 ~ 1.3mm.Tie bracket and the big I of foley's tube formulate difference according to the size of blood vessel Specification, but following relation between tie bracket and foley's tube be present, the maximum gauge of the tie bracket under expansion form is than swollen Small 0.1 ~ the 0.6mm of maximum gauge of foley's tube under bulging state, depends primarily on material and technique used by tie bracket.

Main part 1 includes multiple remembering grids units 11 and the spacer units 12 between remembering grids unit 11.Note Grid cell 11 is recalled along the length direction array of main part 1 and simultaneously along the circumferential direction array of main part 1, adjacent memory grid It is directly connected between unit 11.Each remembering grids unit 11 is provided with two the first tie points 111 and two the second tie points 112, it is joined directly together between adjacent memory grid cell 11 by respective first tie point 111 on the length direction of main part 1, It is joined directly together on the circumferencial direction of main part 1 between adjacent memory grid cell 11 by respective second tie point 112.Accordingly , spacer units 12 are also such as array as remembering grids unit 11.More preferably remembering grids unit 11 is network unit, Structure and the complexity of technique manufacture are smaller, and other polygonal shaped embodiments can also be realized, but not be set out herein.Led in sacculus During pipe inflation, foley's tube has uniformly expanded with tie bracket until fully expanded or close to fully expanded, under expansion form Foley's tube surface a part through remembering grids unit 11 hollow part and spacer units 12 hollow part and form conflict The lug boss of the lattice-like of blood vessel, foley's tube surface another part under expansion form is by except remembering grids unit 11 Solid part outside the hollow part of hollow part and spacer units 12 stops and forms the depressed part relative to lug boss, forms height Pattern staggeredly, lug boss realize the point stress of vascular wall, vascular wall uniform force and open mode is good, reduce blood vessel by The radial load arrived, it is damaged possibility and substantially reduces, depressed part provides space for hematoblastic flowing, and device is in process of expansion Middle blood platelet also changes position in the blood vessel, promotes hematoblastic reconstruct, the healing of acceleration of wound.Meanwhile remembering grids list Member 11 is made up of multiple side sections, and the circumferential direction of the length direction or blood vessel of each side section and blood vessel is misaligned and causes constraint Support do not occur in expansion or shrinkage relative vascular wall rotate in a circumferential direction or axial dipole field, ensure the stable realization of point stress, Conventional foley's tube easily may be rotated or offset in process of expansion, cause tearing or to disease to vascular wall Become incomplete treatment, the accidental injury to non-lesion position at position.

Gauge between two the first tie points 111 of each remembering grids unit 11 for the remembering grids unit 11 most Long length direction gauge, the gauge between two the second tie points 112 of each remembering grids unit 11 is the remembering grids list The largest circumference direction gauge of member 11；Maximum length direction gauge is constant all the time and main part 1 is not sent out in the longitudinal direction Raw flexible, largest circumference direction gauge changes with the expansion or shrinkage of remembering grids unit 11 and causes main part 1 radially Expansion or shrinkage on direction.The length and diameter of tie bracket are actual to be determined by remembering grids unit 11, the length of tie bracket Slight change constant or without materially affect, the diameter of tie bracket is variable, namely the foley's tube of belt restraining support will not allow Balloon portion has expanded according to the characteristic moment of itself or toward the smaller non-lesion area expansion of resistance, also diseased region surprisingly will not have been produced Raw excessive pressure, reduces or eliminates axial force and radial load of the foley's tube to blood vessel, disperses foley's tube to the three of blood vessel Shearing force is tieed up, foley's tube is limited in preferably in expansion length and diameter range, and it, which has, is significantly higher than conventional balloon and leads The compliance value of pipe, effectively avoid " dog bone " effect.Mitigate the damage to blood vessel as far as possible.The treatment of whole extension fixture The structure design of Cheng Yinwei tie brackets and have controllability and predictable, significantly improve the effect of angioplasty.

Claims (12)

1. A kind of 1. tie bracket of non-built-in mode foley's tube, it is characterised in that：Including in tubular construction for being coated on ball Main part outside ductus bursae（1）Be connected to the main part（1）The fixed part for being used to be fixedly connected foley's tube at both ends （2）, the tie bracket is for following balloon catheter expansion or contraction and suppressing the maximum swelling volume of foley's tube；The master Body portion（1）Including multiple remembering grids units（11）With positioned at the remembering grids unit（11）Between spacer units（12）, The remembering grids unit（11）Along the main part（1）Length direction array is simultaneously simultaneously along the main part（1）Girth Direction array, the adjacent remembering grids unit（11）Between be directly connected to.
2. A kind of 2. tie bracket of non-built-in mode foley's tube according to claim 1, it is characterised in that：Each note Recall grid cell（11）It is provided with two the first tie points（111）With two the second tie points（112）, the main part（1）'s The adjacent remembering grids unit on length direction（11）Between pass through respective first tie point（111）It is joined directly together, The main part（1）Circumferencial direction on the adjacent remembering grids unit（11）Between pass through each second tie point （112）It is joined directly together.
3. A kind of 3. tie bracket of non-built-in mode foley's tube according to claim 2, it is characterised in that：Each note Recall grid cell（11）Two first tie points（111）Between gauge be the remembering grids unit（11）Most Long length direction gauge, each remembering grids unit（11）Two second tie points（112）Between gauge be The remembering grids unit（11）Largest circumference direction gauge；Maximum length direction gauge is constant all the time and causes institute State main part（1）Do not stretched on length room direction, largest circumference direction gauge is with the remembering grids unit （11）Expansion or shrinkage changes and causes the main part（1）Expansion or shrinkage in radial directions.
4. A kind of 4. tie bracket of non-built-in mode foley's tube according to claim 1, it is characterised in that：The memory net Lattice unit（11）It is made up of multiple side sections, each the side section and the length direction of blood vessel and the circumferential direction of blood vessel are misaligned And cause the tie bracket do not occur in expansion or shrinkage relative vascular wall rotate in a circumferential direction or axial dipole field.
5. A kind of 5. tie bracket of non-built-in mode foley's tube according to claim 1, it is characterised in that：The memory net Lattice unit（11）Assume diamond in shape.
6. A kind of 6. tie bracket of non-built-in mode foley's tube according to claim 1, it is characterised in that：The fixed part （2）Including being connected to the main part（1）The memory linkage section at both ends（21）Be connected to the memory linkage section（21）Weldering Connect section（22）.
7. A kind of 7. tie bracket of non-built-in mode foley's tube according to claim 6, it is characterised in that：The memory connects Connect section（21）Staggeredly it is divided into the main part（1）Both ends.
8. A kind of 8. tie bracket of non-built-in mode foley's tube according to claim 6, it is characterised in that：Homonymy it is described Remember linkage section（21）A welding section is connected with jointly（22）.
9. 9. a kind of non-built-in mode blood vessel expansion appliance, including foley's tube, it is characterised in that：Also include such as claim 1 ~ 7 times Tie bracket described in one, the foley's tube each have the compressed configuration for being used for inserting in blood vessel with the tie bracket With the expansion form for supporting expansion in the blood vessel；The maximum gauge of the tie bracket under expansion form is less than under expansion form The foley's tube maximum gauge.
10. A kind of 10. non-built-in mode blood vessel expansion appliance according to claim 9, it is characterised in that：Institute under expansion form State a foley's tube surface part and pass through the remembering grids unit（11）Hollow part and the spacer units（12）It is hollow Portion and the lug boss for forming the lattice-like for contradicting blood vessel, foley's tube surface another part under expansion form by except The remembering grids unit（11）Hollow part and the spacer units（12）Hollow part outside solid part stop and formed Relative to the depressed part of the lug boss.
11. A kind of 11. non-built-in mode blood vessel expansion appliance according to claim 9, it is characterised in that：Institute under expansion form The maximum gauge for stating tie bracket is smaller 0.1 ~ 0.6mm than the maximum gauge of the foley's tube under expansion form.
12. A kind of 12. non-built-in mode blood vessel expansion appliance according to claim 9, it is characterised in that：The foley's tube and/ Or it is covered with drug-carried coat in the tie bracket.