CN103446655A - Deflectable sheathing canal and delivery system with deflectable sheathing canal - Google Patents

Deflectable sheathing canal and delivery system with deflectable sheathing canal Download PDF

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Publication number
CN103446655A
CN103446655A CN2013103973126A CN201310397312A CN103446655A CN 103446655 A CN103446655 A CN 103446655A CN 2013103973126 A CN2013103973126 A CN 2013103973126A CN 201310397312 A CN201310397312 A CN 201310397312A CN 103446655 A CN103446655 A CN 103446655A
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CN
China
Prior art keywords
reinforcement
traction fiber
adjustable bending
sheath tube
far
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CN2013103973126A
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Chinese (zh)
Inventor
曾敏
张志飞
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HANGZHOU QIMING MEDICAL DEVICE CO Ltd
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HANGZHOU QIMING MEDICAL DEVICE CO Ltd
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Application filed by HANGZHOU QIMING MEDICAL DEVICE CO Ltd filed Critical HANGZHOU QIMING MEDICAL DEVICE CO Ltd
Priority to CN201320549231.9U priority Critical patent/CN203539840U/en
Priority to CN2013103973126A priority patent/CN103446655A/en
Publication of CN103446655A publication Critical patent/CN103446655A/en
Priority to PCT/CN2014/085428 priority patent/WO2015032291A1/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436Deployment by retracting a sheath
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00243Type of minimally invasive operation cardiac
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003Steerable
    • A61B2017/00318Steering mechanisms
    • A61B2017/00323Cables or rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/00336Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means with a protective sleeve, e.g. retractable or slidable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M2025/0062Catheters; Hollow probes characterised by structural features having features to improve the sliding of one part within another by using lubricants or surfaces with low friction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/005Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Transplantation (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The invention discloses a deflectable sheathing canal and a delivery system with the deflectable sheathing canal, wherein the deflectable sheathing canal comprises a canal body; the canal body is provided with a far end and a near end; a reinforcing rib and a traction wire are arranged in the canal wall of the canal body along the axial direction; a far end of the traction wire is fixedly arranged on the far end of the canal body; a near end of the traction wire extends out of the canal body and is used for being connected with an operation handle; the delivery system comprises the deflectable sheathing canal, a sheath core and the operation handle; the sheath core is arranged in the sheathing canal; the operation handle is fixed with the near ends of the deflectable sheathing canal and the sheath core; the near end of the traction wire is fixedly arranged on the operation handle. The deflectable sheathing canal provided by the invention contributes to adjusting the far end direction of the sheathing canal; the controllability of the far end bending direction of the sheathing canal is improved; the movement of the far end of the sheathing canal towards a diseased region can be easily controlled.

Description

Adjustable bending sheath tube and there is the induction system of this adjustable bending sheath tube
Technical field
The invention belongs to technical field of medical instruments, relate in particular to a kind of adjustable bending sheath tube and there is the induction system of this adjustable bending sheath tube.
Background technology
The wound that intervene operation causes human body is little, invasive is few, it is the medical skill of rising and promoting rapidly in recent years, usually need to be by mediatory type diagnosis and treatment sheath pipe (as delivery sheath, guiding sheath pipe etc.), set up passage between lesion locations in patient body and external operation end, to import medical instruments, medicine, implantation instrument etc. to diseased region.Mediatory type diagnosis and treatment sheath pipe has far-end and near-end, far-end can enter the vascular system of human body, near-end is connected with operating grip, in use, normally set up in advance the seal wire track, by the far-end of sheath pipe or be communicated with in other assistive devices puncture intravasations, the doctor controls sheath pipe far-end by operating grip marches to diseased region release medicine, apparatus etc. along the seal wire track established in advance.
Full of twists and turns characteristic and the remote operated consideration based on the body vessels system, the sheath pipe should possess enough axial and radial support power and good compliance usually, reaching before diseased region, propelling movement by the doctor, the compliance that the sheath pipe possesses self can make the far-end of sheath pipe in the process of advancing along the seal wire track, and adaptive adjustment bending direction is to comply with the venation of human body.Impact due to blood flow in blood vessel, the sheath pipe normally advances along blood vessel wall, in early stage, this course to the sheath pipe there is no too much influence, but when medicine, apparatus discharge, need the far-end of sheath pipe to aim at diseased region, obvious, now must carry out regulation and control to the direction of the far-end of sheath pipe, move it to target location.
Take cardiac valve replacement as example, the cardiac valve of human body is positioned at the middle position of blood vessel, when needs during to cardiac valve replacement, the far-end of sheath pipe need arrive the center of valve, again the cardiac valve replacement device carried is discharged, make the cardiac valve replacement device replace the valve driving functions of self, because the sheath pipe advances along blood vessel wall, therefore near the pathological changes site time, just need to adjust the direction of sheath pipe far-end, its center towards valve is moved, as the diameter of aortic valve is about 26mm, and the diameter of this place's blood vessel obviously is greater than the diameter of aortic valve, and the diameter of sheath pipe far-end is the 7mm left and right usually, so at least should make the far-end of sheath pipe move the 9mm left and right in the diametric(al) of blood vessel.
A kind of solution be according to human vas distribution shape or organization of human body to the processing that formalizes of the far-end of conduit, customize difform conduit in conjunction with different shapes, structure and meet the demand that arrives diseased region in roundabout blood vessel.As U.S. Pat 2003144657 has disclosed a kind of conduit tube component, this conduit tube component is used with the outer catheter of preform far-end with preformed inner catheter, the relatively rotating and extend the shape-adjustable that the conduit tube component distal tip is provided of inside and outside conduit, to improve by the location of right atrium and to insert coronary sinus with conduit.But this can not adapt one by one with the dissect physiology structure of individuation, is easy to affect surgical outcome.
At present, usually the solution adopted is to use the sheath pipe of far-end adjustable bending, one or more traction fiber (the title bracing wire is also arranged) is normally arranged, its far-end is fixed in the far-end of sheath pipe, and extends to sheath pipe near-end always, with the governor motion on sheath pipe proximal handle, is connected, this traction fiber can slide in conduit, to allow doctor's change conduit curvature initiatively, by the bending of sheath pipe far-end, guide its turning to advance to target site.
The Chinese patent literature that is CN102921089A as publication number discloses a kind of for interventional therapy head controlled deflection conduit, the multi-cavity catheter head is connected with the soft head of main pipe, the afterbody of multi-cavity catheter is connected with extension tube by connector, extension tube is provided with the hands handle outward, be connected with the handle carriage in handle, carriage coordinates with the extension tube extruding, the two ends up and down of carriage extend to outside the housing of handle, the both sides up and down of carriage are connected with respectively a traction fiber, the other end of traction fiber is fixedly connected on the head of the soft head of main pipe through the auxiliary chamber of multi-cavity catheter and the upper homonymy of the soft head of main pipe, the extension tube other end extends to outside handle, be connected with joint.After in conduit enters body, according to the structure of blood vessel or region of interest, control traction fiber by handle, traction fiber pulls the soft head of main pipe of distal end of catheter at the pull strength that is subject to the handle carriage, the pulling force that the soft head of main pipe is subject to traction fiber is back crooked, thereby realizes the adjusting of direction.
The conduit of said structure (being the sheath pipe) is although allow the doctor initiatively to change conduit curvature, realized any angular bend of 360 ° of distal end of catheter, but in actual operation technique, deflection due to sheath pipe far-end angle, coordinate and need reaffirm adjustment between the flexible direction and goal of far-end position, and the reflection of interventional therapy plane projection reflection often increases in the actual mechanical process of knowing clearly the dependency to doctors experience greatly.
Therefore, be necessary to provide a kind of sheath pipe, make the doctor be easy to steering to arrive desirable position in patient body.
Summary of the invention
The invention provides a kind of adjustable bending sheath tube, be conducive to the adjusting of sheath pipe distal direction, improved the controllability of sheath pipe far-end bending direction, the far-end that can be easy to control the sheath pipe moves to diseased region.
A kind of adjustable bending sheath tube, comprise body, described body has far-end and near-end, is provided with vertically reinforcement and traction fiber in the tube wall of described body, the far-end of described traction fiber is fixed in the far-end of described body, and the proximal extension of described traction fiber goes out body for being connected with operating grip.
Reinforcement the wrap direction of having located body is set, on reinforcement and body axis line direction radially, the sheath pipe is difficult for bending, when when the sheath pipe, along seal wire, in blood vessel, bending is advanced, the sheath pipe completes BENDING PROCESS by the adaptive side with the easiest bending, in the vertical line direction bending of reinforcement and body axis line, with the vascular system of complying with human body, advance, after sheath pipe tracking passes through the crooked position of blood vessel, the sheath pipe can be adaptive by flexible direction towards vasotropic center, now pull traction fiber, can make the vasotropic center curvature of far-end of sheath pipe, mobile.
The number of reinforcement is too much unsuitable, can arrange one or two.
When reinforcement is one, as a kind of selection mode wherein, described traction fiber is one, and described reinforcement is one.A traction fiber is merely able to realize that unidirectional tune is curved, when the sheath pipe being adjusted when curved to the opposing direction in traction fiber, after the sheath pipe can being rotated approximately to 180 °, then pulls traction fiber.When traction fiber is set, traction fiber should be avoided excessively close reinforcement, otherwise need apply the far-end bending that larger pulling force can affect the sheath pipe to traction fiber, and operation easier is larger.Preferably, on the arbitrary section of body, the center angle of reinforcement and traction fiber is 30~150 °.Preferably, the center angle of reinforcement and traction fiber is 80~100 °.
The cross section that it will be understood by those in the art that above-mentioned body refers to the radial section of body, and the center angle of reinforcement and traction fiber is the angle of reinforcement, traction fiber and kernel of section.
As another kind of selection mode, described reinforcement is one, and described traction fiber is two, and two traction fibers are distributed in the both sides of reinforcement and body axis line radially.Two traction fibers are set and can realize that two-way tune is curved.
Reinforcement is one, and when traction fiber is two, on the arbitrary section of body, the center angle of reinforcement and any traction fiber is 30~150 °.Preferably, the center angle of reinforcement and any traction fiber is 80~100 °.
A reinforcement may cause the sheath pipe ceaselessly to reverse in traveling process, and for overcoming this defect, reinforcement can be set to two, and in addition, two reinforcements also can be stricter to the restriction of sheath pipe bending direction.
When reinforcement is two, as a kind of selection mode wherein, described traction fiber is one, and described reinforcement is two.
Reinforcement is two, and when traction fiber is one, two reinforcements are in the axle center offside of described body, and on the arbitrary section of body, the center angle of any reinforcement and traction fiber is 30~150 °.Preferably, the center angle of any reinforcement and traction fiber is 80~100 °.
As another kind of selection mode, described traction fiber is two, and described reinforcement is two, and described traction fiber and reinforcement are upwards spaced apart in the week of body.
When traction fiber is two, when reinforcement is two, two reinforcements are in the axle center offside of described body, and on the arbitrary section of body, any reinforcement is 30~150 ° with the center angle of a traction fiber wherein.Preferably, any reinforcement is 80~100 ° with the center angle of a traction fiber wherein.
Article two, the axle center offside that reinforcement is in described body i.e. two reinforcements is in the two opposite sides of described body, like this, the sheath pipe is difficult for bending at two reinforcements on line direction radially, can only be in the perpendicular bisector direction bending of two reinforcement lines, while pulling traction fiber, the far-end of sheath pipe certainty and the most flexible direction of easier court (direction of traction fiber) bending.
Certainly, also positioned opposite not of two reinforcements.On the arbitrary section of body, the center angle of two reinforcements is less than 180 °, the side of traction fiber in any reinforcement and body axis line radially.Like this, the sheath pipe is all unsuitable crooked at every reinforcement and body axis line direction radially, therefore, when traction fiber is set, should avoid traction fiber to be distributed in any reinforcement and body axis line direction radially.
Described adjustable bending sheath tube also comprises the expansion arc be communicated with described body, and described expansion arc is connected with far-end one side of body and for holding implantation instrument.
Between described expansion arc and body, by the changeover portion thickened, be connected, and the outer wall of this changeover portion and described expansion arc and body all seamlessly transit, the remote extension of described reinforcement also is fixed in this changeover portion.The position that body is connected with expansion arc is weak link, changeover portion can avoid adjusting this place when curved to kill folding, affect the release of implantation instrument, in addition, in traveling process, accommodate implantation instrument in expansion arc, and make implantation instrument in compressive state, therefore expansion arc has stronger radial support power, and implantation instrument affected the compliance of expansion arc to a certain extent, and the far-end of reinforcement is fixed in this changeover portion can avoid reinforcement to exert an influence to its compliance.
The present invention also provides a kind of induction system, comprise described adjustable bending sheath tube, be placed in sheath core in described adjustable bending sheath tube and with described adjustable bending sheath tube and the fixing operating grip of sheath core near-end, the near-end of traction fiber is fixed on described operating grip.
Described sheath core comprises the core pipe, the far-end of described core pipe is fixed with seeker and intervention apparatus fixing head, the position of described core pipe between seeker and implantation instrument fixing head is that the periphery of described construction section is provided with the tube wall thickening layer for placing the construction section of implantation instrument.
By the tube wall thickening layer is set, can fill the gap between implantation instrument and construction section, overcome the unsettled phenomenon existed between some position of implantation instrument and construction section, avoided induction system existence because of larger space when turning to bend.Architectural difference due to different implantation instruments, the position that between itself and construction section, gap exists, size etc. are difference to some extent also, therefore, the position of tube wall thickening layer, shape, thickness etc. can be arranged according to the structure of concrete implantation instrument, and itself and corresponding gap are adapted.For guaranteeing the compliance of induction system, described tube wall thickening layer can adopt the elasticity such as organosilicon, polyurethane preferably material make.
For the not strict restriction of the mounting means of tube wall thickening layer, described tube wall thickening layer and construction section is one-body molded or fixed cover is located at the outside of construction section.
At least one end of described tube wall thickening layer is the taper that external diameter reduces gradually.Pyramidal structure makes the external diameter transition gradually of tube wall thickening layer, can better fill the overhead positions between implantation instrument and construction section, and can avoid damaging implantation instrument, does not also affect the release of implantation instrument simultaneously.
Those skilled in the art are appreciated that, the far-end of mentioned sheath pipe, traction fiber, reinforcement etc. refers in induction system in the present invention, away from an end of operating grip, the near-end of described sheath pipe, traction fiber, reinforcement etc. refers in induction system, near an end of operating grip.
Compared with prior art, beneficial effect of the present invention is:
(1) Chinese patent literature that publication number is CN102743196A discloses a kind of multiple tube, comprise the internal layer, enhancement Layer and the skin that set gradually, by the radial force of reinforcement with reinforced composite pipe is set at enhancement Layer, and the present invention changes mentality of designing, utilize reinforcement to bring into play the curved effect of self-align tune, and traction fiber and reinforcement are rationally arranged, improved the controllability of sheath pipe far-end bending direction, the doctor is can be easily crooked by sheath pipe far-end by traction fiber, move to target direction or site, reduced operating difficulty.
(2) fold resistance of sheath pipe of the present invention is good, has improved safety.
The accompanying drawing explanation
The structural representation that Fig. 1 is adjustable bending sheath tube of the present invention;
Fig. 2 is the cutaway view of the adjustable bending sheath tube shown in Fig. 1 along the A-A direction;
State diagram when Fig. 3 is the adjustable bending sheath tube far-end bending shown in Fig. 1;
The structural representation that Fig. 4 is another kind of traction fiber and reinforcement arrangement in the adjustable bending sheath tube shown in Fig. 1;
Fig. 5 is the structural representation that the present invention is provided with the sheath pipe of a reinforcement and two traction fibers;
Fig. 6 is the structural representation that the present invention is provided with the sheath pipe of a reinforcement and a traction fiber;
Fig. 7 is the structural representation that the present invention is provided with the sheath pipe of two reinforcements and a traction fiber;
Fig. 8 is the structural representation that the present invention is provided with the another kind of sheath pipe of two reinforcements and a traction fiber;
The structural representation of the second embodiment that Fig. 9 is adjustable bending sheath tube of the present invention;
The structural representation that Figure 10 is induction system of the present invention;
The structure that Figure 11 is aortic valve replacement device in prior art;
Figure 12 is in prior art, the structural representation when aortic valve replacement device shown in Figure 11 is loaded into induction system.
Figure 13 is the structural representation of the aortic valve replacement device shown in Figure 11 while being loaded into induction system of the present invention.
Figure 14 is the structural representation that induction system of the present invention is passed through aortic arch;
The enlarged drawing that Figure 15 is aortic arch position in Figure 14;
Figure 16 is the cutaway view of Figure 15 along the B-B direction;
Figure 17 is after induction system of the present invention is passed through aortic arch, the structural representation that the far-end of sheath pipe moves to blood vessel center;
Figure 18 is that induction system of the present invention marches to the structural representation that discharges the aortic valve replacement device after implantation site.
The specific embodiment
Below in conjunction with specific embodiment, the present invention is further explained.
Fig. 1 has shown the structure of the first embodiment of adjustable bending sheath tube of the present invention, comprises the expansion arc 102 and the body 101 that are communicated with successively.
Expansion arc 102 is tubular structure, in intervene operation, expansion arc 102 can the precommpression implantation instrument, make implantation instrument in confined state until after advancing to implantation site by its release, expansion arc should possess certain elastic force radially and axial support force, the expansion arc inwall should be smooth as much as possible simultaneously, to facilitate release, to reclaim implantation instrument.
Body 101 is connected with expansion arc 102, and the bore of this body 101 is less than expansion arc 102.As shown in Figure 2, in axial direction offer two path 10s 3 in the tube wall of body 101, be equipped with a traction fiber 104 in each path 10 3, traction fiber 104 can be in the interior slip of path 10 3, the far-end of these two traction fibers 104 is fixed on the distal end of body 101, and the near-end of traction fiber 104 extends body 101 along passage separately and is connected with joystick.
In axial direction also be provided with the reinforcement 105 of two bar shapeds in the tube wall of body 101, these two reinforcements 105 are in the two opposite sides in body 101 axle center, and extend to proximal end from the distal end of body 101.Usually, radially, body 101 comprises internal layer 106, enhancement Layer 107 and outer 108 from the inside to the outside successively.Internal layer 106 and outer 108 can adopt identical or different macromolecular lubricating materials to make, and as internal layer 106 can adopt polytetrafluoroethylmaterial material, outer 108 can adopt the materials such as polyethylene, polyurethane.The spring tube structure that enhancement Layer 107 is braided steel wire, spring tube structure not only makes the standby certain axial support power of sheath pipe, simultaneously, its crooked flexility is good, make the sheath caliber to compliance better, in the present invention, reinforcement 105 can be close to enhancement Layer 107 and arrange.
Week at body 101 makes progress, and reinforcement 105 is spaced apart with traction fiber 104.
Article two, reinforcement has not only strengthened the tensile strength of body, improve the axial support intensity of body, guaranteed the propelling movement of sheath pipe, simultaneously, also located the wrap direction of body, the sheath pipe is difficult for bending at two reinforcements on line direction (being the z direction of principal axis shown in Fig. 1) radially, when the sheath pipe, along blood vessel wall, be traveling in the body vessels system of winding complex, the bending of the sheath pipe meeting adaptive direction of the vertical line at two reinforcement lines (being the y direction of principal axis shown in Fig. 1), Fig. 3 shows the far-end of sheath pipe state when crooked, after sheath pipe tracking passes through the crooked position of blood vessel, the sheath pipe can be adaptive by flexible direction towards vasotropic center, and traction fiber and reinforcement are upwards spaced apart in the week of body, direct pull traction fiber now, can make the vasotropic center curvature of far-end of sheath pipe.
When traction fiber is set, traction fiber should be avoided excessively close reinforcement, otherwise need apply the far-end bending that larger pulling force can affect the sheath pipe to traction fiber, and operation easier is larger.Usually, on the arbitrary section of body, wherein a traction fiber 104 is not less than 30 ° with any reinforcement 105 center included angle A, when the center angle of any traction fiber and any reinforcement is 90 ° (as Fig. 4), required pulling force minimum when now traction fiber pulls the bending of sheath pipe far-end, very easily control.
It should be noted that, in the present invention, the number of reinforcement is not limited in two, as shown in 5, in axial direction offer two path 10s 3 in the tube wall of body 101, be equipped with a traction fiber 104 in each path 10 3, in axial direction be provided with a reinforcement 105 in the tube wall of body 101, the sheath pipe still is difficult for occurring bending on the direction of reinforcement, still can reach the curved purpose of self-align tune, but in order to obtain better effect, in the situation that a reinforcement 106 only is set, the overstriking of these reinforcement 106 adaptabilities (comparing with the situation that two reinforcements are set).
In addition, traction fiber also can only be set to one, Fig. 6 and Fig. 7 show the structure of body when a traction fiber is set, as shown in Figure 6, in axial direction offer a path 10 3 in the tube wall of body 101, be provided with a traction fiber 104 in path 10 3, in axial direction be provided with a reinforcement 105 in the tube wall of body 101.Structure and the Fig. 6 of body shown in Fig. 7 are similar, difference is, in axial direction be provided with two reinforcements 105 in the tube wall of body 101, these two reinforcement two opposite sides in the body axle center, on the arbitrary section of body, two reinforcement 105 center angles are 180 °, certainly, two reinforcement 105 center angles also can be less than 180 °, as shown in Figure 8, the center angle of two reinforcements is about 130 °, now, every reinforcement and body axis line direction (m and n) radially are all unsuitable crooked, therefore, traction fiber should avoid being in reinforcement and axis line direction radially.Obvious, the quantity of traction fiber does not affect the curved function of self-align tune of reinforcement, because a traction fiber is merely able to realize that unidirectional tune is curved, when adjusting when curved to the opposing direction in traction fiber, can be by operating grip by behind sheath pipe Rotate 180 ° left and right, then pull traction fiber.
Fig. 9 shows the second embodiment of adjustable bending sheath tube of the present invention, present embodiment and the first embodiment are similar, different parts are: between expansion arc 102 and body 101, by the changeover portion 109 thickened, be connected, and the outer wall of this changeover portion 109 and expansion arc 102 and body 101 all seamlessly transit, the remote extension of reinforcement 104 also is fixed in changeover portion 109.In Fig. 9, dotted line has been illustrated the structure of expansion arc 102 and body 101 connecting portions in existing sheath pipe, and expansion arc 102 directly is docking together with body 101, both connecting portion weaknesses, and easily bending, can overcome this defect by changeover portion is set.
It should be noted that between the different embodiments of the present invention, unless, outside obviously capable of being combined, the technical characterictic of each embodiment all can be used for reference mutually.
Referring to Figure 10, the present invention also provides a kind of induction system, comprises sheath pipe 100, sheath core 200 and the joystick (not shown) fixed with the near-end of the near-end of sheath pipe, sheath core.
The sheath core comprises core pipe 201, seeker 202 and implantation instrument fixing head 203.
Seeker 202 is fixedly connected with the distal end of core pipe 201, implantation instrument fixing head 203 is with through hole and locating slot, be positioned at the far-end of core pipe 201, specifically can adopt conventional structure, as can be CN101953724A with reference to publication number, the Chinese patent literature that denomination of invention is " for loading the bracket fixing head of valvular prosthetic replacement's device ".
Core pipe 201 is the hollow pipe with through hole, and the position of core pipe 201 between seeker 202 and implantation instrument fixing head 203 is the construction section 204 for placing implantation instrument.The periphery fixed cover of this construction section 204 is provided with tube wall thickening layer 205.
Tube wall thickening layer 205 is for filling the hanging part between implantation instrument and construction section, due to the difference existed between implantation instrument, hanging part between implantation instrument and construction section, unsettled size, shape etc. also can be different thus, therefore, the size of the position of the shape of tube wall thickening layer, setting and tube wall thickening layer all can be arranged according to specific implantation instrument.
For guaranteeing the compliance at induction system implantation instrument position, tube wall thickening layer 205 can adopt elasticity preferably material make, as organosilicon, polyurethane etc.
In addition, tube wall thickening layer and construction section are except the mounting means that can adopt fixing suit, and tube wall thickening layer and construction section also can adopt integrated mode to be processed.
Sheath pipe 100 is enclosed within the outside of sheath core 200, and sheath core 200 slides relatively, and implantation instrument is discharged or reclaims, and sheath pipe 100 can adopt structure as above.
Now in conjunction with aortic valve replacement, further explain the present invention.
Figure 11 has shown the structure of existing a kind of aortic valve replacement device, by support and the prosthetic valve (not shown) be fixed in support, formed, support serve as reasons the successively aortic stents 401, the valve bracket 402 that connect and flow to the netted tubular construction that support 403 forms, flow to support 403 with overlay film, prosthetic valve is made at the valve bracket place.The top of aortic stents 401 is along being provided with three latch fittings 404, and the height of these three latch fittings can be identical or not identical.Support is the state drawn in when not discharging, and is fine and close tubular structure, and the tubing by memory metal material forms through Laser cutting.
During art, first the aortic valve replacement device is loaded on induction system, at first make the implantation instrument fixing head of sheath core stretch out the sheath pipe, seeker is through after the aortic valve replacement device of tubulose, the aortic valve replacement device is fixed in the locating slot of implantation instrument fixing head outer wall, then the sheath pipe is wrapped to the aortic valve replacement device fully.
Figure 13 shows the state after induction system of the present invention is loaded into the aortic valve replacement device, now, the expansion arc 102 of sheath pipe 100 is enclosed within the seeker 202 of sheath core 200, the outside of construction section 204 and implantation instrument fixing head 203, aortic valve replacement device 400 is sleeved on the construction section 204 of sheath core, whole aortic valve replacement device 400 section of being inflated 102 compressions, and tube wall thickening layer 205 roughly is positioned at the prosthetic valve of aortic valve replacement device with upper part, compare (Figure 12) with the existing induction system that is not provided with the tube wall thickening layer, owing to not being provided with the tube wall thickening layer, present more loose rare space between aortic stents 401 positions and sheath core 500, between latch fitting 404 positions of support and sheath core 500, unsettled 600 is obvious, easily from hanging part or sparse position, produce bending when crooked, many times can cause that discounting appears killing in sheath pipe distortion resembles.And tube wall thickening layer of the present invention has just in time been filled above-mentioned gap, between implantation instrument 400 and sheath core, closely cooperate, effectively prevented that induction system from the discounting phenomenon occurring in this position when turning, greatly reduce after the sheath pipe gives a discount and cause apparatus discharge/to reclaim unsuccessfully, the fracture of sheath pipe enhancement Layer is stung out and is waited the risk that the patient is caused to life danger.
After the aortic valve replacement device has loaded, by induction system together with the aortic valve replacement device along the seal wire track established, be delivered to the valve implantation site.General first from femoral artery puncture, through ventral aorta, descending aorta, then, through aortic arch, drive in the wrong direction and carry out the displacement of valve to the aortic valve position of aortic root.In whole process, the doctor makes it advance along seal wire by joystick pushing sheath tube and sheath core, although the vascular system winding complex of human body, but the sheath pipe self has good compliance, can adaptive adjustment bending direction, with the vascular system of complying with human body, advance forward, because the crooked tension force of sheath pipe is outside, the sheath pipe nestles up all the time blood vessel wall and advances (as Figure 14, shown in Figure 15), aortic arch 300 is that sheath pipe far-end arrives implantation site by last macrobending of going through, be provided with reinforcement in body due to the sheath pipe, located the wrap direction of body, when the far-end process aortic arch of sheath pipe, the bending of the adaptive direction of the vertical line at two reinforcement lines of sheath pipe meeting, after passing aortic arch, the far-end of sheath pipe (is provided with two traction fibers and two reinforcements with body as shown in figure 16 at endovascular state, on the body cross section, it is the illustration meaning that the center angle of any traction fiber and reinforcement is 90 °), visible sheath pipe 100 is near blood vessel wall 301, and traction fiber 104 is over against the center of blood vessel, be the center of the flexible direction of sheath pipe over against blood vessel, now, directly affect traction fiber 104, as shown in figure 17, the sheath pipe just is easy to vasotropic center and moves (M direction), continue to promote sheath pipe and sheath core, just can make it pass the valve center O of aortic valve 302, now, the sheath pipe is moved to the direction away from seeker, the aortic valve replacement device can be discharged to (as shown in figure 18), after the aortic valve replacement device discharges fully, reclaim the sheath core, the sheath pipe, the aortic valve replacement device spreading under the body temperature effect discharged, be fixed on implantation site, substitute autologous valve functionating.

Claims (14)

1. an adjustable bending sheath tube, comprise body, it is characterized in that, described body has far-end and near-end, be provided with vertically reinforcement and traction fiber in the tube wall of described body, the far-end of described traction fiber is fixed in the far-end of described body, and the proximal extension of described traction fiber goes out body for being connected with operating grip.
2. adjustable bending sheath tube as claimed in claim 1, is characterized in that, described traction fiber is one, and described reinforcement is one.
3. adjustable bending sheath tube as claimed in claim 2, is characterized in that, on the arbitrary section of body, the center angle of reinforcement and traction fiber is 30~150 °.
4. adjustable bending sheath tube as claimed in claim 1, is characterized in that, described reinforcement is one, and described traction fiber is two, and two traction fibers are distributed in the both sides of reinforcement and body axis line radially.
5. adjustable bending sheath tube as claimed in claim 4, is characterized in that, on the arbitrary section of body, the center angle of reinforcement and any traction fiber is 30~150 °.
6. adjustable bending sheath tube as claimed in claim 1, is characterized in that, described traction fiber is one, and described reinforcement is two.
7. adjustable bending sheath tube as claimed in claim 6, is characterized in that, two reinforcements are in the axle center offside of described body, and on the arbitrary section of body, the center angle of any reinforcement and traction fiber is 30~150 °.
8. adjustable bending sheath tube as claimed in claim 1, is characterized in that, described traction fiber is two, and described reinforcement is two, and described traction fiber and reinforcement are upwards spaced apart in the week of body.
9. adjustable bending sheath tube as claimed in claim 8, is characterized in that, two reinforcements are in the axle center offside of described body, and on the arbitrary section of body, any reinforcement is 30~150 ° with the center angle of a traction fiber wherein.
10. adjustable bending sheath tube as described as claim 6 or 8, is characterized in that, on the arbitrary section of body, the center angle of two reinforcements is less than 180 °, the side of traction fiber in any reinforcement and body axis line radially.
11. adjustable bending sheath tube as claimed in claim 1, is characterized in that, also comprises the expansion arc be communicated with described body, described expansion arc is connected with far-end one side of body and for holding implantation instrument.
12. adjustable bending sheath tube as claimed in claim 11, it is characterized in that, between described expansion arc and body, by the changeover portion thickened, be connected, and the outer wall of this changeover portion and described expansion arc and body all seamlessly transit, the remote extension of described reinforcement also is fixed in this changeover portion.
A 13. induction system, it is characterized in that, comprise as the described adjustable bending sheath tube of right 1~12 any one, be placed in as described in sheath core in adjustable bending sheath tube and with as described in adjustable bending sheath tube and the fixing operating grip of sheath core near-end, the near-end of traction fiber is fixed on described operating grip.
14. induction system as claimed in claim 13, it is characterized in that, described sheath core comprises the core pipe, the far-end of described core pipe is fixed with seeker and intervention apparatus fixing head, the position of described core pipe between seeker and implantation instrument fixing head is that the periphery of described construction section is provided with the tube wall thickening layer for placing the construction section of implantation instrument.
CN2013103973126A 2013-09-04 2013-09-04 Deflectable sheathing canal and delivery system with deflectable sheathing canal Pending CN103446655A (en)

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PCT/CN2014/085428 WO2015032291A1 (en) 2013-09-04 2014-08-28 Adjustable bent sheath tube, and delivery system having same

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Application publication date: 20131218