CN106473839B - One kind can expand catheter sheath and intervention apparatus conveying device - Google Patents

One kind can expand catheter sheath and intervention apparatus conveying device Download PDF

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Publication number
CN106473839B
CN106473839B CN201610845799.3A CN201610845799A CN106473839B CN 106473839 B CN106473839 B CN 106473839B CN 201610845799 A CN201610845799 A CN 201610845799A CN 106473839 B CN106473839 B CN 106473839B
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China
Prior art keywords
tube wall
catheter sheath
expand
wall
sheath
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CN106473839A (en
Inventor
王建安
曾敏
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HANGZHOU QIMING MEDICAL DEVICES CO Ltd
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HANGZHOU QIMING MEDICAL DEVICES CO Ltd
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Priority to CN201610845799.3A priority Critical patent/CN106473839B/en
Publication of CN106473839A publication Critical patent/CN106473839A/en
Priority to PCT/CN2017/102199 priority patent/WO2018054275A1/en
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    • 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
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0662Guide tubes
    • 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
    • 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor
    • 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • 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
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M2025/0024Expandable catheters or sheaths

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The invention discloses one kind can expand catheter sheath and intervention apparatus conveying device, the catheter sheath that the present invention can expand, including tube wall, the tube wall is volume wall construction, cross section is winding escalator, the tube wall has the pre-setting state for by swollen state and voluntarily restoring winding-structure of expansion corresponding site volume wall construction, catheter sheath of the present invention, with specific cross sectional shape, when conveying intervention apparatus, only change shape (i.e. sectional area) according to the external dimensions of intervention apparatus on the position that intervention apparatus passes through, after intervention apparatus passes through, it can restore by natural resiliency to the state of former pre-setting, be conducive to penetrate thinner blood vessel, calcification plate is avoided to fall off, reduce operation risk.

Description

One kind can expand catheter sheath and intervention apparatus conveying device
Technical field
The present invention relates to the interposers of intervention apparatus technical field more particularly to a kind of catheter sheath and the application catheter sheath Tool conveying device.
Background technique
With the extensive use of Endovascular interventional treatment worldwide, complication also increasingly shows.With intervention For aortic valve and cusps of pulmonary valve replacement operation, due to, needing to wear through femoral artery or femoral vein in the course of surgery Then thorn is mounted with the delivery sheath of valve through femoral artery or femoral vein conveying, need at this time first at cavity of resorption openings in blood vessels It is placed in a catheter sheath, to protect cavity of resorption blood vessel.Since the size of current aortic valve or pulmonary valve delivery sheath exists Between 16F-24F, sheath is directly transported, it is easy to the problem of leading to vascular dissection or even rupture of blood vessel.
Referring to Fig. 1, existing intervention apparatus delivery sheath 1 is slim-lined construction on the whole, and it is (such as artificial to upload intervention apparatus Valve) after, the position of the loading section 2 of delivery sheath is diameter largest segment, ordinary circumstance diameter >=6mm (18Fr) diameter≤ 8.7mm (26Fr), in the prior art, in order to allow delivery sheath 1 to pass through, the internal diameter of entire catheter sheath needs bigger catheter sheath 3 Load the outer diameter of section 2 in delivery sheath, i.e., so that conduit minimum diameter size also has to be larger than the most thick diameter that conveying sheath passes through, So that catheter sheath gabarit diameter entire body is thicker.
In the prior art, the outer diameter of catheter sheath is fixed, therefore cannot cover the cavity of resorption blood vessel diameter of all patients There are the aorta vessel of calcification, especially patient's cavity of resorption blood vessel of China and other Asian countries to become narrow with vascular wall, If therefore can not adapt to that catheter sheath can not be placed, patient will be reduced at puncture to the protection of blood vessel;Even some Aged Patients Aorta vessel have a calcification, merging large-diameter guide sheath is likely to result in calcification plate and falls off.And catheter sheath is to be put into earliest Instrument that is intravascular, finally withdrawing from, the time is longer in the blood vessels, if long-time major diameter expansion blood vessel be easy to cause blood vessel convulsion Contraction threatens and increases postoperative complication probability.
Summary of the invention
The present invention provides a kind of catheter sheath, and tube wall has specific cross sectional shape, and pre-setting diameter is small, logical in intervention equipment Out-of-date, tube wall contour dimension resiliency synchronization changes shape (i.e. sectional area) in the intervention equipment external dimensions passed through, small straight Diametered duct sheath not only contributes to penetrate thinner blood vessel and adapts to more patient's ranges, and is also applied for aorta vessel and has calcium Change patient, calcification plate is avoided to fall off to form thrombus, reduce operation risk, moreover it is possible to reduce the lasting expansionary force to blood vessel, reduce Complications.
A kind of catheter sheath expanded, including tube wall, the tube wall are volume wall construction, and cross section is winding escalator, the tube wall With expansion corresponding site volume wall construction, by swollen state and voluntarily, the pre-setting state of wall construction is rolled up in recovery.
In the present invention, tube wall by swollen state, when referring to delivery sheath by way of tube wall, tube wall by external force effect, hair It gives birth to elastic deformation and expands.In the present invention, the pre-setting state of tube wall refers to original state when the non-stress of tube wall, or warp After external force revocation, original state when restoring to non-stress or close to the state of original state.Such as: when delivery sheath passes through After crossing tube wall, original state when tube wall restores to non-stress or close to the state of original state.When tube wall elasticity is good enough When, after external force revocation, tube wall can restore slightly to expand to original state or tube wall relative to original state, restore to close Original state.Thus, can tube wall after, restore to pre-setting state through delivery sheath, this depends on the choosing of tube wall material It selects.
In the present invention, proximal end, which refers to, distally refers to one end far from lesion close to one end of lesion.Such as tube wall, it leans on One end (one end far from handle) of nearly lesion, referred to as proximal end;And far from lesion, it is known as distal end close to one end of handle.
Existing delivery sheath is slim-lined construction on the whole, and usually only local diameter is larger (such as the dress of loading intervention apparatus Carry section), in order to allow delivery sheath to pass through, the selection of mating catheter sheath need to can be passed through the catheter sheath of the prior art with its internal diameter Subject to the local maxima diameter of delivery sheath (and off board section of transportation system is often very thin), i.e. catheter sheath entire body is thicker, this So that catheter sheath can not adapt to the patient of thinner blood vessel.
Catheter sheath of the present invention is using volume wall construction circumferentially and has pre-setting state, it should be understood that Has certain elasticity for its material itself or at least can deformation occurs and can restore after external force is cancelled to the non-stress of catheter sheath When pre-setting state, the tube wall of catheter sheath of the present invention can be by natural resiliency part/all by swollen state and pre-setting It is converted between state, therefore catheter sheath pre-setting diameter can be made carefully, internal diameter can be less than delivery sheath local maxima There are many diameter dimension.
Tube wall corresponds only to be unfolded on major diameter position locating for intervention apparatus when use, once intervention apparatus passes through, volume Wall construction restores immediately, and so, catheter sheath can be inserted into thinner blood vessel with its pre-setting state, only in intervention apparatus Do that of short duration expansion is thicker on the position passed through, by blood vessel dilatating and deformable and stimulation be minimized.
The tube wall is can be by the elastic material switched between swollen state and pre-setting state.Such as the material of tube wall Selected from HDPE or Pebax etc.;In order to guarantee that tube wall can independently restore after external force is cancelled, and keeps certain intensity and comply with Property, preferably, the tube wall with a thickness of 0.2~0.5mm.
Preferably, the tube wall outer diameter of pre-setting state is 4~9mm.Further preferred 5-6mm.
Suitable outer diameter allows catheter sheath to be suitable for thinner blood vessel, can also obtain more submissive and passability.
In order to coat and formed the channel of delivery sheath, preferably, the tube wall winding of pre-setting state is greater than a circle It is mutually stacked with beyond 360 degree of circumferential sections and the part in 360 degree in week.
Due to require delivery sheath by rear tube wall voluntarily restore roll up wall construction pre-setting state, mutual clinch Position has smooth contact surface, i.e., there is no the shape or the components that mutually stop to influence to restore.
I.e. on the same place cross section of pre-setting state tube wall, extend in the circumferential from the origination side of winding to end side big In 360 degree, tube wall extends 360 degree or more of position overlap joint stacked on top of each other.
As further preferred, it is more than or equal to 360 degree by the tube wall winding of swollen state.It can guarantee internal conveying in this way Sheath and intervention apparatus be not exposed.
Significant difference with existing catheter sheath is that existing catheter sheath can be considered 360 degree of winding, i.e., one week lucky, in addition existing The tube wall of catheter sheath be in the circumferential it is closed, cross sectional shape will not change.
It is not closed although part is stacked on top of each other in the circumferential for catheter sheath of the invention.This is also volume wall construction The reason of being unfolded, separately circumferentially when, can make along smooth curved path, can also have circuitous configuration, Such as circumferentially extended along wave or zig-zag path, such that it is more flexible in the variation of catheter sheath cross sectional shape, certainly, When selecting other forms, the forfeiture of tube wall compliance radially can not be ignored.
The degree of tube wall winding is corresponding central angle, and degree is bigger, and tube wall allows variation degree bigger, but is wound It excessively will also result in excessive wait of mounted resistance to negatively affect, specific degree can be calculated according to the diameter change of two states It arrives, i.e., tube wall will have enough perimeters to surround the channel of intervention apparatus.
Preferably, the tube wall winding of pre-setting state is less than or equal to 720 degree.
In order to form the closed channel of intervention apparatus under different conditions, preferably, the volume wall construction exists The origination side wound in circumferential direction is connected with end side by flexible envelope film.
Tube wall is rolled up wall construction in release corresponding site under by swollen state and keeps the envelope of catheter sheath by flexible envelope film It closes.Flexible envelope film should have slightly lower rigidity relative to other positions of tube wall, that is, be more easier to be bent or roll in the circumferential It is folded, it is formed to circuitous configuration.
In order to store flexible envelope film, at least part of the flexibility envelope film is in the centre of tube wall overlap Layer.
Preferably, in the present invention, the entire body thickness of tube wall can be uniform, it can also be uneven, such as in order to more preferable Storage flexibility envelope film, can be set to relatively thin tube wall in the origination side of tube wall and end side, and in tube wall Between relatively thick tube wall is partially set.
It is flexible on the path that tube wall extends since flexible envelope film is connected between origination side and end side Envelope film can be considered detour position in the circumferential, and the detour position between origination side and end side is opened up under by swollen state in tube wall Open and be in the middle layer of tube wall overlap.It can keep smooth inside and outside tube wall in this way, such as conveying sheath The movement of pipe.
Preferably, the turning point of the flexibility envelope film is equipped with crease line.Crease line can be handled by thermal finalization to be added Work, under pre-setting state, turning point can be more smooth.
The effect of flexible envelope film is that the origination side and end side that will roll up wall construction connect, and forms closed channel, into One step improves safety, and flexible envelope film is due to that will give a discount or twist in tube wall switching state, wall thickness and rigidity ratio Tube wall itself wants low.
Flexible envelope film can be using the materials such as PTFE, wall thickness 0.1-1mm.It is preferred that 0.25-0.5mm.
As a further preference, the flexible envelope film is circumferentially closed tubular structure, the flexibility envelope membrane tube The wall that shape structural section perimeter is greater than tube wall section is long, the fixed outer wall for being covered in flexible envelope film of tube wall.
The factors such as in order to further improve the security and easy to process, flexible envelope film itself are tubular structure, this Sample can be torn to avoid tube wall and flexible envelope film connecting portion, and the local discounting detour of flexible envelope film is accommodated in tube wall Overlap in.
Preferably, distal end (one end far from patient's lesion when use) periphery of catheter sheath is enclosed with resilient sleeve.It can be with Anti- Hemostatic Oral Liquid (or body fluid) escapes from the gap of tube wall overlap.Preferably, the distal end of catheter sheath is connect with sheath handle, even Socket part is wrapped up by the resilient sleeve.
The axial length of the resilient sleeve is 5~50cm.
The material of resilient sleeve is stretchy nylon, with a thickness of 0.1-0.2mm.
As better embodiment of the invention, the origination side and end side that volume wall construction is wound in the circumferential pass through flexibility While envelope film connects, it is arranged resilient sleeve in the outside of tube wall, plays duplicate protection, anti-Hemostatic Oral Liquid or body fluid escape.
The position that tube wall and flexible envelope film are contacted with delivery sheath has smooth surface, can reduce delivery sheath shifting Dynamic frictional force can select the prior art for tube wall and resilient sleeve own material.
It is inserted into blood vessel for the ease of guiding catheter sheath, the proximal end (close to one end of patient's lesion when use) of catheter sheath is to receive Mouth structure.
Catheter sheath of the invention can use extrusion molding in processing, for tube wall, then be made a reservation for by heat treatment The tube wall of type state.
If being additionally provided with flexible envelope film, it can use and first squeeze out tube wall, then flexible envelope film is welded on corresponding position, Then heat treatment shaping.Tube wall and this double-layer structure of flexible envelope film can also be disposably squeezed out, then heat treatment shaping.
Preferably, the outside of the tube wall is surrounded by the collar for tube wall to be limited to pre-setting state, and the collar It is split up under by swollen state in tube wall.
Preferably, the collar is along the axially extending tube wall proximal end out of tube wall, the position extended is closing-in structure.It is described Collar can also axially extend in resilient sleeve proximal end or resilient sleeve distal end or resilient sleeve along tube wall or only cover a part of tube wall.
Collar further increases the slickness of catheter sheath periphery, in conjunction with closing-in structure, penetrates blood vessel convenient for guidance.
Preferably, being corner cut knot closing on tube wall proximal end on the end side that the volume wall construction is wound in the circumferential Structure.
As winding-structure, the corner of end side, which is easy to turn over, sticks up, and influence penetrates blood vessel and advances in the blood vessel, therefore this Invention does corner cut processing at the position, and in order to avoid corner cut, when flexible envelope film is arranged, flexible envelope film is along tube wall axial direction court When proximal end extends, the end of tube wall is not extended to, but avoids corner cut position.
The present invention also provides a kind of intervention apparatus conveying devices, are connected including handle and by connector with the handle Catheter sheath, the catheter sheath are catheter sheath of the present invention.
Catheter sheath of the present invention is using takeup type structure, it can be achieved that local expansion and recovery, have under pre-setting state Lesser outer diameter is conducive to penetrate thinner blood vessel, and the scope of application is wider, eliminates security risk.
Detailed description of the invention
Fig. 1 is catheter sheath in the prior art and the cooperation schematic diagram for the delivery sheath for being mounted with artificial valve;
Fig. 2 is the structural schematic diagram of catheter sheath of the present invention (belt lacing);
Fig. 3 is that the catheter sheath of Fig. 2 wraps up the structural schematic diagram after resilient sleeve;
Structural schematic diagram of the catheter sheath part that Fig. 4 is Fig. 3 by swollen expansion volume wall construction;
The catheter sheath that Fig. 5 is Fig. 4 changes the structural schematic diagram after by swollen position;
The catheter sheath that Fig. 6 is Fig. 5 changes the structural schematic diagram after by swollen position;
Fig. 7 is that intervention apparatus passes completely through the schematic diagram after catheter sheath;
Fig. 8 is catheter sheath of the present invention (under pre-setting state) schematic cross-section;
Schematic cross-section of the catheter sheath by swollen expansion that Fig. 9 is Fig. 8;
Figure 10 is the schematic cross-section that catheter sheath of the present invention changes winding angle;
Figure 11 is the schematic cross-section that flexible envelope film is equipped in catheter sheath of the present invention;
Figure 12 is the schematic cross-section that flexible envelope film of the invention is integral tubular;
Schematic cross-section of the catheter sheath that Figure 13 is Figure 12 by swollen expansion volume wall construction.
Figure 14 is the tube wall end view of catheter sheath, and tube wall not yet surrounds in figure;
Figure 15 is the schematic diagram after the tube wall in Figure 14 surrounds;
Figure 16 is the schematic diagram that collar is surrounded by outside tube wall.
Specific embodiment
Embodiment 1
Referring to fig. 2, in the present embodiment, the tube wall 4 of catheter sheath is volume wall construction, and cross section is winding escalator, and tube wall 4 has exhibition Open the pre-setting state that wall construction is rolled up by swollen state and recovery of corresponding site volume wall construction.
Under pre-setting state, catheter sheath outer diameter is 5mm (15Fr), internal diameter 4mm.In internal diameter under by swollen state up to 8mm (24Fr) can pass through corresponding diameter delivery sheath.
Referring to Fig. 3, the distal end of catheter sheath is equipped with the connector 5 with conveying device cooperation, the junction of catheter sheath and connector 5 It is wrapped up by resilient sleeve 6.Can anti-Hemostatic Oral Liquid (or body fluid) escaped from the gap of tube wall overlap.Resilient sleeve selects elastic Buddhist nun Dragon, with a thickness of 0.1-0.2mm.
In the circumferential, volume wall construction is extended spirally by origination side, until end side, the end lateral boundaries of origination side can Axially extending along catheter sheath or extend spirally around catheter sheath axis, visible end lateral boundaries 7 are straight line and along catheter sheath axis in Fig. 3 To extension.When using helix, distribution of force when catheter sheath can be made to be bent is more more evenly.
In conjunction with Fig. 4~Fig. 7, intervention apparatus is walked from right to left, can be squeezed on the inside of tube wall by place, so that the volume of tube wall Wall construction is accordingly unfolded, and compression position 8 is transferred to by swollen state.
After intervention apparatus 100 passes through, since the elasticity of tube wall 4 itself can voluntarily restore, initial pre-setting state is returned to.
Tube wall material is selected from HDPE or Pebax etc. in the present embodiment, in order to guarantee that tube wall can independently restore, and keeps one Fixed intensity and compliance, tube wall with a thickness of 0.5mm.
Referring to Fig. 8, when being non-implantation instrument, the section in pre-setting state (when original state) downcomer sheath is illustrated Figure, in order to coat and formed the channel of delivery sheath, the tube wall winding of pre-setting state is greater than 360 degree, i.e., from the starting of winding Side 9 to end side 10 extends greater than 360 degree in the circumferential, is stacked beyond 360 degree of parts with the part without departing from 360 degree.
As it can be seen that mutually being overlapped beyond part 11 with without departing from part 12 in Fig. 8, it is wrapped in beyond part 11 without departing from part 12 periphery, tube wall inside form complete channel.
Fig. 9 be implantation instrument 18 when, catheter sheath by it is swollen when schematic cross-section.In order to avoid delivery sheath under by swollen state And implantation instrument is not exposed, Fig. 9 still has overlapping overlap as it can be seen that the tube wall winding under by swollen state is more than or equal to 360 degree Domain 13.
It is overlapped overlapping regions 13 in Figure 10 to increase, the degree of tube wall winding, which is that the corresponding central angle the big, further to be added Greatly 540 degree, bigger internal diameter can be obtained after expansion, is allowed through thicker intervention apparatus.
Embodiment 2
As shown in figure 8, although mutually being overlapped beyond part 11 with without departing from part 12, it is not relatively fixed, they it Between can opposite sliding, form gap, can be with shape in order under different conditions so that blood or body fluid are possible to disengaging tube wall At the closed channel of intervention apparatus, the present invention provides another embodiments, by setting in the origination side of tube wall and end side The form of flexible envelope film is set, tube wall is closed.
In Figure 11, the origination side 9 of tube wall winding and end side 10 pass through flexible envelope film 14 and connect.Flexible envelope film is main The support force of a radial direction is played, implantation instrument is fettered, prevents its exposed, while can also prevent blood or body fluid discharger wall.
Flexible envelope film 14 is due to that will give a discount or twist in tube wall switching state, and wall thickness and rigidity are than tube wall sheet Body wants low.The present embodiment flexibility envelope film 14 uses PTFE material, wall thickness 0.25-0.5mm.
For tube wall no matter for which kind of state, flexible envelope film 14 can keep the closing of catheter sheath, flexible envelope film 14 It can mutually be fixed by modes such as welding with tube wall.
In order to store flexible envelope film 14, flexible envelope film 14 is in the middle layer of tube wall overlap.Flexible envelope film 14 can extend one section, the i.e. inner cavity there is no the 360 entire tube wall of envelope in the circumferential, flexible under pre-setting state Envelope film 14 is tightened between the origination side 9 and end side 10 of tube wall winding, and the effect of flexible envelope film 14 is closing origination side 9 The gap formed between end side 10, anti-Hemostatic Oral Liquid or body fluid have disengaging tube wall.Therefore flexible envelope film 14 and tube wall are consolidated Fixed point is not strict in origination side 9 and end side 10, can also be with appropriate adjustment.
In Figure 12, alternatively, flexible envelope film 14 is circumferentially closed tubular structure, and tube wall fixation pastes It is circuity part 15 in a portion of the outer wall of flexible envelope film 14, flexible envelope film 14, circuity part 15 is in tube wall Origination side 9 and end side 10 between.
The turning point 16 and turning point 17 at detour position 15 are equipped with crease line, and crease line can be handled by thermal finalization to be added Work, under pre-setting state, crease line may make the turning point at detour position more smooth.
Referring to Figure 13, detour position 15 is unfolded under by swollen state in tube wall, and tube wall can be allowed to have bigger deformation model It encloses.
The present embodiment also provides a kind of intervention apparatus conveying device (omitting in figure), including handle and passes through connector and hand The connected catheter sheath of handle, the tube wall of the catheter sheath select the mode in Figure 12.
It referring to Figure 14, Figure 15, rolls up on the end side that wall construction is wound in the circumferential, is corner cut closing on 4 proximal end of tube wall Structure 19.As winding-structure, the corner of end side, which is easy to turn over, sticks up, and the present invention does corner cut processing at the position, in favor of penetrating Blood vessel avoids turning over the blocking stuck up.
Referring to Figure 16, the outside of tube wall 4 is surrounded by the collar for tube wall 4 to be limited to pre-setting state, and the collar exists Tube wall is split up under by swollen state.For collar along the axially extending tube wall proximal end out of tube wall, the position extended is closing-in structure 20.Collar The slickness of catheter sheath periphery is further improved, in conjunction with closing-in structure, penetrates blood vessel convenient for guidance.The pipe that the present embodiment uses Wall material has the compliance of preferable elasticity, and the expansion of tube wall is radial dilatation under by swollen state, not will cause wound to blood vessel Evil, will not generate angiorrhoxis or interlayer.After the major diameter position of delivery sheath passes through, the intact recovery of catheter sheath.

Claims (16)

1. the catheter sheath that one kind can expand, including tube wall, which is characterized in that the tube wall is volume wall construction, and cross section is winding escalator, The tube wall has the pre-setting state for by swollen state and voluntarily restoring volume wall construction of expansion corresponding site volume wall construction, institute The origination side that volume wall construction is wound in the circumferential is stated to connect with end side by flexible envelope film.
2. the catheter sheath that can expand as described in claim 1, which is characterized in that the tube wall is can be by swollen state and predetermined The elastic material independently switched between type state.
3. the catheter sheath that can expand as claimed in claim 2, which is characterized in that the tube wall outer diameter of pre-setting state is 4-9mm.
4. the catheter sheath that can expand as described in claim 1, which is characterized in that the tube wall winding of pre-setting state is greater than a circle It is mutually stacked with beyond 360 degree of circumferential sections and the part in 360 degree in week.
5. the catheter sheath that can expand as claimed in claim 4, which is characterized in that be mutually stacked with position with smooth contact surface.
6. the catheter sheath that can expand as claimed in claim 5, which is characterized in that the tube wall of pre-setting state is wound less than 720 degree.
7. the catheter sheath that can expand as described in claim 1, which is characterized in that the turning point of the flexibility envelope film is equipped with folding line Line.
8. the catheter sheath that can expand as described in claim 1, which is characterized in that flexible envelope membranous wall thickness is 0.1-1mm.
9. the catheter sheath that can expand as described in claim 1, which is characterized in that the flexibility envelope film is circumferentially closed tubulose Structure, the wall that the flexibility envelope membrane tube shape structural section perimeter is greater than the tube wall section is long, and tube wall fixation is covered in flexibility The outer wall of envelope film.
10. the catheter sheath that can expand as described in claim 1, which is characterized in that the distal periphery of tube wall is enclosed with resilient sleeve.
11. the catheter sheath that can expand as claimed in claim 10, which is characterized in that the distal end of tube wall is connect with sheath handle, interconnecting piece It is wrapped up by the resilient sleeve.
12. the catheter sheath that can expand as claimed in claim 10, which is characterized in that the axial length of the resilient sleeve be 5~ 50cm。
13. the catheter sheath that can expand as described in claim 1, which is characterized in that the outside of the tube wall is surrounded by for by tube wall It is limited to the collar of pre-setting state, and the collar is split up under by swollen state in tube wall.
14. the catheter sheath that can expand as claimed in claim 13, which is characterized in that the collar is along the axially extending tube wall out of tube wall Proximal end, the position extended are closing-in structure.
15. the catheter sheath that can expand as described in claim 1, which is characterized in that the end that the volume wall construction is wound in the circumferential It is corner cut structure closing on tube wall proximal end in caudal.
16. a kind of intervention apparatus conveying device, including handle and the catheter sheath being connected by connector with the handle, feature It is, the catheter sheath is the described in any item catheter sheaths expanded of claim 1~15.
CN201610845799.3A 2016-09-23 2016-09-23 One kind can expand catheter sheath and intervention apparatus conveying device Active CN106473839B (en)

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