WO2017177915A1 - 血管支架输送***及其导管组件 - Google Patents
血管支架输送***及其导管组件 Download PDFInfo
- Publication number
- WO2017177915A1 WO2017177915A1 PCT/CN2017/080216 CN2017080216W WO2017177915A1 WO 2017177915 A1 WO2017177915 A1 WO 2017177915A1 CN 2017080216 W CN2017080216 W CN 2017080216W WO 2017177915 A1 WO2017177915 A1 WO 2017177915A1
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- WIPO (PCT)
- Prior art keywords
- tube
- inner tube
- housing
- outer sleeve
- delivery system
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0069—Sealing means
- A61F2250/007—O-rings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M2025/0019—Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
- A61M2025/0046—Coatings for improving slidability
- A61M2025/0047—Coatings for improving slidability the inner layer having a higher lubricity
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
- A61M25/0012—Making of catheters or other medical or surgical tubes with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
Definitions
- the present invention relates to the field of medical devices, and more particularly to a vascular stent delivery system and method of manufacturing the same, and a catheter assembly for a vascular stent delivery system.
- Stent therapy is a minimally invasive interventional procedure with stent treatment. It has less trauma, less complications and good effect. It has become the main method for the treatment of peripheral vascular stenosis.
- a vascular stent delivery system generally includes an interconnected catheter assembly and a handle portion.
- the catheter assembly generally includes an outer cannula and an inner tube.
- the vascular stent can be disposed between the inner tube and the outer tube, and the outer tube and the inner tube are both
- the hollow portion is configured to pass the guide wire;
- the handle portion includes a housing adapted to be gripped and a drive assembly for driving the inner tube to reciprocate, the outer sleeve being fixed to the housing, and the drive assembly being operatively engaged with the inner tube.
- the doctor uses the guide wire to guide the catheter assembly of the delivery system to the surgical site, and then operates the drive assembly to move the inner tube axially forward to bring the stent into the blood vessel, after which the stent can be deployed and supported on the inner wall of the blood vessel. .
- Prior art delivery systems typically have a cleaning tube that is typically at least partially located in the hand
- the housing of the handle communicates with the lumen of the inner tube.
- the cleaning port can be placed at the end of the cleaning tube so that the lumen portion of the inner and inner tubes can be cleaned after the delivery system is used.
- the cleaning tube generally comprises a middle steel tube that is sleeved on the outer side of the inner tube and that can be connected to the driving assembly, and a connecting member that fixes the medium steel tube to the housing.
- a middle steel tube that is sleeved on the outer side of the inner tube and that can be connected to the driving assembly, and a connecting member that fixes the medium steel tube to the housing.
- the catheter assembly is difficult to reach at some curved lesion position due to its low flexibility. If the catheter hardness is increased, the catheter assembly will bend at a place where stress is concentrated, which affects the system release performance.
- the inner tube 800' is integrally formed, and the barb 900' is connected to the inner tube 800'.
- the rigidity is insufficient at the barb. Discounts may occur.
- the tapered head (TIP) of the catheter assembly is directly bonded to the inner tube, the joint strength is limited, and there is a risk of accidental shedding.
- the present invention provides a vascular stent delivery system and method of manufacturing the same, and a catheter assembly for a vascular stent delivery system.
- a vascular stent delivery system may include: a housing; an outer sleeve, the outer sleeve being located outside the housing and connected to the first end of the housing; a cleaning tube, the a cleaning tube is coupled to the second end of the housing, and the first end of the cleaning tube is located inside the housing, the second end of the cleaning tube is extended to the outside of the housing; the inner tube, the A portion of the inner tube is located within the housing, and a first end of the inner tube extends into the interior of the outer sleeve, and a second end of the inner tube extends from the first end of the cleaning tube to the cleaning a lumen of the tube; a drive assembly, a portion of the drive assembly being located within the housing, operatively engaged with a portion of the inner tube within the housing for driving the inner tube to cause the inner tube
- the outer sleeve and the cleaning tube are axially movable;
- the method of manufacturing the vascular stent delivery system may include: providing a housing; providing An outer sleeve, the outer sleeve is disposed to be external to the housing and connected to the first end of the housing; a cleaning tube is provided, the cleaning tube is disposed to be: a second with the housing The end is connected, and the first end of the cleaning tube is located inside the housing, the second end of the cleaning tube protrudes to the outside of the housing; an inner tube is provided, the inner tube is disposed: the inner a portion of the tube is disposed in the housing, a first end of the inner tube extends into the interior of the outer sleeve, and a second end of the inner tube extends from the first end of the cleaning tube into the cleaning tube Providing a drive assembly, the drive assembly being disposed such that a portion of the drive assembly is located within the housing and operatively engaged with a portion of the inner tube within the housing for driving the inner tube
- the inner tube is axially movable within the outer sleeve
- a vascular stent delivery system can include: a housing; an outer sleeve positioned external to the housing and coupled to the housing by a stress diffusion assembly, wherein the stress diffusion assembly is for diffusing the outer sleeve a stress concentrated at a junction with the housing; an inner tube, a portion of the inner tube being located within the housing, and one end of the inner tube being capable of extending into the interior of the outer sleeve; a drive assembly, the drive assembly A portion is located within the housing and operatively engages a portion of the inner tube within the housing for driving the inner tube to enable axial movement of the inner tube within the outer sleeve.
- the manufacturing method of the vascular stent delivery system may include: providing a housing; providing an outer sleeve configured to be external to the housing and connected to the housing by a stress diffusion assembly, wherein a stress diffusion assembly for diffusing stress concentrated at a joint of the outer sleeve and the housing; providing an inner tube, the inner tube being configured such that a portion of the inner tube is disposed in the housing, the inner tube One end can extend into the interior of the outer sleeve; a drive assembly is provided, the drive assembly being configured such that a portion of the drive assembly is located within the housing and operatively engages a portion of the inner tube within the housing And for driving the inner tube to enable the inner tube to move axially within the outer sleeve.
- a catheter assembly for a vascular stent delivery system may include: an outer sleeve; an inner tube, at least a portion of the inner tube being located in the outer sleeve, the inner tube comprising a metal braided tube and a metal tube connected to the metal braided tube; On the metal tube of the inner tube, the barb is configured to move the blood vessel stent when the inner tube moves relative to the outer sleeve.
- the vascular stent delivery system can include: a housing; The catheter assembly of the above embodiment, wherein an outer sleeve of the catheter assembly is located outside of the housing and is coupled to the housing, a portion of the inner tube of the catheter assembly is located within the housing, and the inner tube Another portion is located inside the outer sleeve; a drive assembly, a portion of the drive assembly being located within the housing, operatively engaged with a portion of the inner tube within the housing for driving the inner tube
- the outer sleeve can move in the axial direction.
- a catheter assembly for a vascular stent delivery system may include an outer sleeve, an inner tube capable of axially passing through the outer sleeve, and a guide head having a passage extending through the guide head in an extension direction, the guide head a portion is inserted into the outer sleeve and connected to the inner tube through a connecting tube for guiding a direction of travel of the outer sleeve and the inner tube within the blood vessel, wherein the connecting tube is in the passage of the guiding head Injection molding.
- the vascular stent delivery system can include: a housing; the catheter assembly of the above embodiment, wherein an outer sleeve of the catheter assembly is external to the housing and coupled to the housing, the catheter assembly a portion of the inner tube is located within the housing, and one end of the inner tube can extend into the interior of the outer sleeve; a drive assembly, a portion of the drive assembly is located within the housing, located with the inner tube A portion of the housing is operatively coupled for driving the inner tube to move axially within the outer sleeve.
- the operability of the vascular stent delivery system can be effectively improved, and the service life can be improved.
- the cleaning tube is an integrally formed member, the liquid sealing property is good, and liquid leakage is less likely to occur than in the prior art, thereby further improving the operability and reliability of the system.
- the stress diffusion component can be used to diffuse the concentrated stress at the joint between the outer sleeve and the housing to ensure the flexibility of the tube body. At the same time, it ensures that the tube body is not easily broken, and can effectively improve the operability of the vascular stent delivery system and prolong its service life.
- the inner tube is composed of a metal braided tube and a metal tube, and the barb is placed on the metal tube, the rigidity of the barb can be improved, and the folding phenomenon due to insufficient rigidity can be solved compared with the prior art.
- the joint strength can be increased, the accidental falling of the guiding head into the human body can be prevented, the reliability of the operation of the vascular stent delivery system is improved, and the patient is lowered. risks of.
- FIG. 1 is an exploded perspective view showing a blood vessel stent delivery system according to an embodiment of the present invention
- FIG. 2 is a perspective view of a cleaning tube of a blood vessel stent delivery system in accordance with an embodiment of the present invention
- Figure 3 is a perspective view of a cleaning tube of a blood vessel stent delivery system according to an embodiment of the present invention when viewed from a different perspective from Figure 2;
- FIG. 4 is a cross-sectional view of the cleaning tube of the blood vessel stent delivery system taken along line A-A of FIG. 3, in which an inner tube is inserted in the cleaning tube, in accordance with an embodiment of the present invention
- Figure 5 is an enlarged view of a portion B of Figure 4.
- Figure 6 is a cross-sectional view of the cleaning tube of the blood vessel stent delivery system taken along line A-A of Figure 3, in which the inner tube is not inserted, in accordance with an embodiment of the present invention
- Figure 7 is a partial cross-sectional view of a tee of a vascular stent delivery system in accordance with an embodiment of the present invention.
- Figure 8 is a cross-sectional view of an O-ring of a vascular stent delivery system in accordance with an embodiment of the present invention.
- FIG. 9 is an exploded perspective view of a vascular stent delivery system including a stress diffusion assembly in accordance with an embodiment of the present invention.
- Figure 10 is a cross-sectional view of a stress diffusion assembly in accordance with an embodiment of the present invention.
- FIG. 11 is a schematic view showing an example of an inner tube according to an embodiment of the present invention.
- Figure 12 is an enlarged view of a portion B of Figure 11;
- Figure 13 illustrates an inner tube of a prior art vascular stent delivery system
- Figure 14 shows a cross-sectional view of an example of a catheter assembly in accordance with an embodiment of the present invention
- Figure 15 shows a cross-sectional view of an inner tube and a guide head of a catheter assembly in accordance with an embodiment of the present invention
- Figure 16 is an enlarged cross-sectional view showing an example of an inner tube according to an embodiment of the present invention.
- Fig. 17 is an enlarged cross-sectional view showing another example of the inner tube according to an embodiment of the present invention.
- the delivery system for delivering the vascular stent to the body may include, but is not limited to, a housing composed of the right half shell 110 and the left half shell 120, an outer cannula 200, and a cleaning Tube 300, inner tube 800, and drive assembly 400.
- the outer sleeve 200 is located outside the housing and is connected to the first end 101 of the housing, for example, through the rubber head 600 (joint member), the tee tube 500 and the first end 101 of the housing Fixed connection.
- the outer sleeve 200 passes through the rubber head 600 and extends to a first end 501 with the tee tube 500 (which will be specifically described below with respect to the specific structure of the tee tube 500), thereby interacting with the tee tube 500 Connected, and the rubber head 600 is fixed to the housing, for example, the right half shell 110 and the left half shell 120 clamp the rubber head 600, and cooperate with the connecting feature 111 (for example, a screw hole) through the nut 121, and the right half The shell 110 and the left half shell 120 are fixed.
- the rubber head 600 and the tee tube 500 may be omitted, and the outer sleeve 200 may be directly fixedly coupled to the housing.
- the cleaning tube 300 is used for cleaning the vascular stent delivery system after the end of the vascular stent delivery.
- the cleaning tube 300 may be an integrally formed two-way tube, for example, a Luer tee integrally formed of a PC (polycarbonate) material, and a second of the housing The end 102 is connected and the first end 301 of the cleaning tube 300 is located inside the housing and the second end 302 is extended to the exterior of the housing.
- the cleaning tube 300 is provided with connection features 303, 304, and the corresponding positions on the right half shell 110 of the housing are provided with connection features 113, 114 that cooperate with the connection features 303, 304.
- the cleaning tube 300 is fixed to the housing by embedding the connecting features 303, 304 into the connecting features 113, 114 while the right half shell 110 and the left half shell 120 are joined to hold the cleaning tube 300.
- a part of the inner tube 800 is located in the housing, which may be a steel tube (ie, an inner steel tube).
- the housing may be a steel tube (ie, an inner steel tube).
- the invention is not limited thereto, and the inner tube may also be formed of other suitable materials that can be used for the vascular stent delivery system.
- a first end (not shown) of the inner tube 800 extends into the outer sleeve 200
- the inner tube 800 is inserted from the second end 502 of the tee 500 and extends through the tee tube 500 into the lumen of the outer cannula 200.
- the tee tube 500 may be omitted, whereby the first end of the inner tube 800 extends directly into the lumen of the outer cannula 200.
- the second end of the inner tube extends from the first end 301 of the cleaning tube 300 into the lumen of the cleaning tube 300 (refer to Figures 4 and 5).
- a portion of the drive assembly 400 is located within the housing, operatively engaged with a portion of the inner tube 800 that is located within the housing, and specifically, the drive assembly 400 is primarily comprised of a thumb drive member 401 and a rail 402.
- the drive assembly 400 is located between the first end and the second end of the inner tube, wherein the right half shell 110 of the housing is coupled to the drive assembly 400 by connection features 112, 115, 116, and the nut 121 passes through the left half of the housing
- the hole in the 120, and through the hole in the retaining spring 122 and the guide rail 402 protrudes into the screw hole 111 on the right half shell 110, and the left half shell 120 and the right half shell 110 are joined by the nut 121 and the screw hole 111.
- the inner tube 800 passes through the guide rail 402 and engages with a portion of the thumb drive member 401.
- the inner tube 800 moves along the guide rail 402 under the push-pull of the thumb drive member 401.
- the inner tube is axially moved in the inner lumen of the outer cannula and the cleaning tube, in particular, the first end of the inner tube is relatively moved within the outer cannula 200 such that the blood vessel stent advances along the outer cannula 200 And into the blood vessel, after which it can be deployed and supported on the inner wall of the blood vessel.
- the second end of the inner tube moves within the cleaning tube 300 with the overall movement of the inner tube.
- the end of the second end of the inner tube is arranged to prevent the end of the second end of the inner tube from scratching the inner wall of the cleaning tube. Therefore, in the process of transporting the blood vessel stent, the end of the inner tube can be effectively prevented from scratching the wall of the cleaning tube, which makes the operation more convenient, and can reduce the system failure rate and improve the service life thereof.
- the end of the second end of the inner tube is configured to prevent the end of the second end of the inner tube from scraping the inner wall of the cleaning tube, including: providing a heat shrink tube at the second end of the inner tube 800 801, wherein an end of the second end of the inner tube 800 is inserted into the heat shrinkable tube 801.
- the portion of the inner tube that is in contact with the heat shrinkable tube is non-slip treated.
- the heat shrinkable tube 801 is a FEP (polyfluoroethylene propylene) ultrathin wall heat shrinkable tube, and the inner tube 800 (ie, the inner steel tube) is subjected to sandblasting and anti-slip treatment.
- the assembly is eccentric, the relative sliding when the inner tube is pushed and pulled does not cause scratching of the inner wall of the cleaning tube. Moreover, the FEP surface is smooth and has less frictional resistance with PC. The doctor feels less resistance. It should be understood by those skilled in the art that the present invention is not limited thereto, and the end of the second end of the inner tube may also be fixedly connected with the heat shrinkable tube, for example, bonding the heat shrinkable tube to the end of the second end of the inner tube. .
- the end of the second end of the inner tube is arranged such that preventing the end of the second end of the inner tube from scratching the inner wall of the cleaning tube may comprise forming the end of the second end of the inner tube into a rounded end surface, ie Rounding the end of the second end of the inner tube, for example, rounding the end of the second end, thereby reducing the frictional resistance between the end of the second end of the inner tube and the tube wall of the cleaning tube, The scraping phenomenon does not occur in the relative sliding when the inner tube is pushed and pulled.
- the cleaning tube 300 can be an integrally formed two-way tube, such as a Luer two-way tube integrally formed from a PC material.
- the liquid tightness of the cleaning tube is good, and liquid leakage is not easily caused as in the prior art, thereby further improving the operability and reliability of the system.
- the integrated design the cost is lower.
- the end of the second end 302 of the cleaning tube 300 has an opening and a joint cap 320 that closes the opening.
- the connector cap 320 closes the opening to prevent body fluid (ie, blood) from flowing out of the opening; after the vascular stent is delivered, the connector cap 320 can be opened, and the cleaning fluid is added through the opening, The vascular stent delivery system is cleaned.
- body fluid ie, blood
- a guide wire insertion interface 305 is disposed in the lumen of the cleaning tube 300 and between the first end and the second end of the cleaning tube, and the cleaning is performed.
- the inner diameter of the lumen at the guide wire insertion interface of the tube is gradually reduced to form a gradual design.
- the gradual design of the inner cavity of the cleaning tube 300 increases the smoothness of the guide wire, and prevents the step and jamming when the guide wire is introduced.
- the tee tube 500 in the present embodiment will be described below.
- the tee 500 is used to clean the front portion of the vascular stent delivery system (ie, the portion adjacent to the outer cannula).
- the tee can be a Luer tee, and of course, can also be used for a vascular stent.
- Other suitable tees for the delivery system As shown in FIG. 1, a tee 500 is located at a first end 101 of the housing, and the tee 500 can have a first end 501 that projects to the exterior of the housing, is located within the housing, and A first end 501 is in line with the second end 502, and a third end 503 is disposed between the first end 501 and the second end 502 and extends to the exterior of the housing.
- the first end 501 of the tee tube 500 is in communication with the outer sleeve 200, for example, connected and communicated with the outer sleeve 200 through the rubber head 600.
- a first end of the inner tube extends from the second end 502 of the tee 500 and through the tee tube 500, extending from the first end 501 thereof and into the outer sleeve 200.
- the end of the third end 503 of the tee tube 500 has an opening and a joint that closes the opening Cap 522.
- the connector cap 522 closes the opening to prevent body fluid (ie, blood) from flowing out of the opening; after the vascular stent is delivered, the connector cap 522 can be opened, and the cleaning fluid is added through the opening, The front portion of the vascular stent delivery system is cleaned.
- body fluid ie, blood
- a seal assembly (311, 312 and 511, 512) is provided at the end of the first end 301 of the cleaning tube 300 and the second end 502 of the tee tube 500, the inner tube being wearable
- the seal assembly has a passage for the inner tube to pass through.
- a sealing assembly including an O-ring 311 and a cover plate 312 for fixing the O-ring is provided; as shown in FIGS. 1 and 7.
- a seal assembly including an O-ring 511 and a cover plate 512 that secures the O-ring is disposed at the end of the second end 502 of the tee 500.
- One or both of the O-ring 311 and the O-ring 511 are disposed such that the thickness is gradually thinned from the center toward the edge, that is, as shown in FIG. 8, the two sides 513, 514 of the O-ring are formed substantially as tapered surface.
- the O-ring of the tapered design cooperates with the Luer two-way and the three-way pipe, and there is always a line in the circumferential direction with the Luer two-way or the three-way pipe interference fit, even if the inner tube is slid, relative to the plane O-ring The tilt in the axial direction will be smaller.
- a surface of the O-ring contacting the inner tube is coated with a lubricating layer, and the body material of the lubricating layer may include Parylene, PTFE (PTFE) Any one of polyvinylpyrrolidone (PVP) and silicone oil, for example, the lubricating layer may be a Parylene coating.
- PTFE PTFE
- PVP polyvinylpyrrolidone
- silicone oil for example, the lubricating layer may be a Parylene coating. Due to the certain blood pressure in the human body, if there is no seal after connecting with the interventional catheter, there will be blood reflux phenomenon. Therefore, the O-ring and the inner tube must be interference fit, but this will definitely cause the doctor's conveyance feel.
- the effect of the combination of the O-ring and the Parylene coating is that the smoothness of the coating itself reduces the friction and is more conducive to the doctor's operation.
- the above is an illustration of the present invention, and the present invention is not limited thereto.
- only the first end 301 of the cleaning tube 300 and the second end of the three-way tube 500 may be used.
- the seal assembly described above is provided at one of the ends 502.
- the seal assembly described above is only provided at the second end 502 of the tee 500.
- the anti-scratch treatment between the inner tube and the cleaning tube can effectively improve the operability and service life of the vascular stent delivery system.
- a method of manufacturing a blood vessel stent delivery system may comprise Including, but not limited to, the following operations:
- the outer sleeve being disposed outside the housing and connected to the first end of the housing;
- the cleaning tube being disposed to be coupled to the second end of the housing, and the first end of the cleaning tube is located inside the housing, and the second end of the cleaning tube is extended to the The exterior of the housing;
- the inner tube is disposed such that a portion of the inner tube is disposed in the housing, a first end of the inner tube extends into the inner portion of the outer sleeve, and the second end of the inner tube The first end of the cleaning tube extends into the lumen of the cleaning tube;
- the drive assembly being disposed such that a portion of the drive assembly is located within the housing and operatively engaged with a portion of the inner tube within the housing for driving the inner tube to cause the
- the inner tube is movable in the axial direction in the outer sleeve and the cleaning tube;
- end of the second end of the inner tube is arranged to prevent the end of the second end of the inner tube from scratching the inner wall of the lumen of the cleaning tube.
- positioning the end of the second end of the inner tube to prevent the end of the second end of the inner tube from scraping the inner wall of the lumen of the cleaning tube may include: an end surface of the second end of the inner tube Processed into a rounded end face.
- positioning the end of the second end of the inner tube to prevent the end of the second end of the inner tube from scraping the inner wall of the lumen of the cleaning tube may include: providing a heat shrink tube to the inner The end of the second end of the tube is inserted into the heat shrinkable tube. Wherein, the portion of the inner tube that is in contact with the heat-shrinkable tube may be subjected to an anti-slip treatment. Alternatively, the end of the second end of the inner tube may be fixedly coupled to the heat shrinkable tube.
- the cleaning tube is an integrally formed two-way tube, such as a Luer two-way tube integrally formed from a PC material.
- a guide wire insertion interface is disposed in the lumen of the cleaning tube and between the first end and the second end of the cleaning tube.
- the lumen of the wash tube is designed such that the inner diameter of the lumen tapers at the guidewire insertion interface. The internal cavity gradual design of the cleaning tube increases the smoothness of the guide wire, and prevents the step and jamming when the guide wire is introduced.
- an opening is provided at the end of the second end of the wash tube and a joint cap that closes the opening is provided.
- the connector cap closes the opening to prevent blood from flowing out of the opening; after the vascular stent is delivered, the connector cap can be opened, and the cleaning solution is added through the opening to clean the vascular stent delivery system.
- the method may further include: providing a tee, such as a Luer tee, the diverter being disposed at a first end of the housing, the tee having an extension a first end to the exterior of the housing, a second end in the housing and in direct communication with the first end, and a first end and a second end disposed between the first end and the second end a third end of the outer portion of the housing; wherein the first end of the tee tube is in communication with the outer sleeve, the first end of the inner tube extends from the second end of the tee tube and passes through the A tee extends from the first end of the tee into the outer casing.
- a tee such as a Luer tee
- An opening is provided at an end of the third end of the tee and a joint cap that closes the opening is provided.
- the connector cap closes the opening to prevent body fluid (ie, blood) from flowing out of the opening; after the vascular stent is delivered, the connector cap can be opened, and the cleaning fluid is added through the opening to the vascular stent The front part of the conveyor system is cleaned.
- a seal assembly is provided at an end of at least one of the first end of the wash tube (ie, the two-way tube) and the second end of the three-way tube, the inner tube capable of Through the seal assembly.
- the seal assembly may include an O-ring and a cover plate that fixes the O-ring, and the O-ring is disposed such that the thickness of the O-ring is gradually thinned from the center toward the edge.
- a surface of the O-ring that is in contact with the inner tube is coated with a lubricating layer.
- the body material of the lubricating layer may include any one of Parylene, polytetrafluoroethylene (PTFE), polyvinylpyrrolidone (PVP), and silicone oil.
- the lubricating layer may be a Parylene coating.
- the vascular stent delivery system manufactured by the above method can effectively improve the operability and service life of the vascular stent delivery system.
- the vascular stent delivery system may include, but is not limited to, a housing composed of a right half shell 110 and a left half shell 120, an outer sleeve 200, a cleaning tube 300, an inner tube 800, and a drive assembly 400.
- the specific structure of the inner tube 800, the drive assembly 400, the tee tube 500, and the cleaning tube 300 is as described in detail in the foregoing embodiments.
- the tee tube 500 may be omitted.
- the vascular stent delivery system may not have a tee tube 500 whereby the first end of the inner tube 800 extends directly into the lumen of the outer cannula 200.
- the outer sleeve 200 is located outside the housing and is connected to the first end 101 of the housing by a stress diffusion assembly.
- the stress diffusion assembly can include, but is not limited to, a joint member 600, a stress diffuser tube 700, a conductive tube (in this example, a tee tube 500).
- the stress diffusion tube 700 passes through the joint member 600 and extends into the first end 501 of the tee tube 500, and the outer sleeve 200 is inserted into the stress diffusion tube and extends to the first end 501 of the tee tube 500, Thereby communicating with the tee tube 500 (ie, the first end 501 of the tee tube 500 is connected and communicated with the outer sleeve 200 through the stress diffusion tube 700 and the joint member 600), and the joint member 600 is fixed to the housing
- the right half shell 110 and the left half shell 120 sandwich the joint member 600 and cooperate with the joint feature 111 by the nut 121 to fix the right half shell 110 and the left half shell 120.
- the outer sleeve of the vascular stent delivery system is coupled to the housing by a stress diffusion assembly, and the stress diffusion assembly is used to diffuse the concentrated stress at the junction of the outer sleeve and the housing, thereby ensuring the tube body The flexibility ensures that the pipe body is not easily broken.
- the stress diffusion assembly is configured such that the joint member 600 has a lengthwise direction (ie, an axial direction of the tubular body) extending from the first end 601 to the second. a passage of the end 602, and the second end 602 of the joint member 600 is fixedly coupled to the housing, as described above; a portion of the conduit (ie, the first end 501 of the tee 500) is from the The second end 602 of the connector member 600 extends into the passage of the connector member 600, and another portion of the conduit (eg, the second end 502 of the tee tube 500) is located within the housing; the stress diffusion A portion of the tube 700 is located outside of the joint member 600, and another portion of the stress diffuser tube 700 extends from the first end 601 of the joint member 600 into the passage of the joint member 600, extending through the passage to the guide The interior of the conduit (i.e., from the first end 501 of the tee 500 into the tee 500
- the outer sleeve 200 extends into the stress diffusion tube 700 and extends inside the stress diffusion tube 700 to be located inside the joint member 600, the inner tube 800 can pass through the conduction tube and Stress diffusion tube 700 And extending into the interior of the outer cannula 200 to move axially relative to each other within the outer cannula 200 under operation of the drive assembly 400 to deliver the stent.
- the outer sleeve 200 may be a PEBAX (block polyetheramide resin) steel braided tube
- the stress diffuser tube 700 may be a PA12 (polydolactam) tube
- the joint member 600 It may be a rubber head, which may be made of ABS (ABS, a terpolymer of acrylonitrile, butadiene and styrene, A for acrylonitrile, B for butadiene, S for styrene).
- the PEBAX steel wire braided tube may be composed of three layers: the outer layer is PEBAX; the middle layer is a stainless steel wire woven mesh; and the inner layer is PTFE (polytetrafluoroethylene).
- the outer sleeve 200 is bonded to the stress diffusion tube 700, and the stress diffusion tube 700 is bonded to the conduction tube. Further, an inner diameter of a portion of the passage of the joint member 600 that accommodates the conduit is larger than an inner diameter of a portion that accommodates the stress diffusion tube 700.
- the hardness is sequentially increased from left to right.
- the first stage the outer sleeve 200 is made of PEBAX steel wire braided tube;
- the second stage the outer sleeve 200 is covered with a PA12 tube to increase the hardness:
- the third stage The rubber head is added to increase the hardness;
- the fourth stage the conduction tube, that is, the tee tube 500 is ABS material.
- the outer sleeve is bonded to the stress diffusion tube, the stress diffusion tube is bonded to the tee tube, and the rubber head cover is at the connection point of the three.
- a four-stage gradual hardness type stress diffusion structure is formed.
- the four-stage gradient hardness stress diffusion structure ensures better flexibility of the pipe body while ensuring that the pipe body is not easily broken.
- the above embodiment is only an example of the stress diffusion component of the present invention.
- the material may be selected from other suitable materials known in the art, and the connection of each component may also be adopted.
- Other suitable attachment means or means are known in the art.
- a method of manufacturing a blood vessel stent delivery system may include, but is not limited to, the following operations:
- An outer sleeve is provided, the outer sleeve being configured to be external to the housing and coupled to the housing by a stress diffusion assembly, wherein the stress diffusion assembly is for diffusing the outer sleeve and the housing The stress concentrated at the joint;
- the inner tube is configured such that a portion of the inner tube is disposed in the housing, and one end of the inner tube can extend into the inner portion of the outer sleeve;
- the drive assembly being configured such that a portion of the drive assembly is located within the housing and operatively engaged with a portion of the inner tube within the housing for driving the inner tube to cause the
- the inner tube is axially movable within the outer sleeve.
- the stress diffusion assembly can be configured as a component in a corresponding third embodiment.
- the conduit is configured as a tee, such as a Luer tee, wherein the tee has a first end that extends into the interior of the joint member and is located a second end in the housing and in linear communication with the first end, and a third end disposed between the first end and the second end and projecting to an exterior of the housing; and, the inner A tube extends from the second end of the tee and passes through the tee and extends from the first end of the tee into the outer sleeve.
- An opening is provided at an end of the third end of the tee and a joint cap that closes the opening is provided.
- the connector cap closes the opening to prevent body fluid (ie, blood) from flowing out of the opening; after the vascular stent is delivered, the connector cap can be opened, and the cleaning fluid is added through the opening to the vascular stent The front part of the conveyor system is cleaned.
- body fluid ie, blood
- a seal assembly can be provided at the end of the second end of the tee, the inner tube being able to pass through the seal assembly.
- the seal assembly may include an O-ring and a cover plate that fixes the O-ring, and the O-ring is disposed such that the thickness of the O-ring is gradually thinned from the center toward the edge. For example, a surface of the O-ring that is in contact with the inner tube is coated with a lubricating layer.
- the vascular stent delivery system manufactured by the above method ensures that the tubular body is not easily broken while ensuring the flexibility of the tubular body. At the same time, it can effectively improve the operability and service life of the vascular stent delivery system.
- the vascular stent delivery system may include, but is not limited to, a housing composed of the right half shell 110 and the left half shell 120, a cleaning tube 300, a catheter assembly mainly composed of the outer sleeve 200 and the inner tube 800, And a drive assembly 400.
- the specific structure of the vascular stent delivery system such as the outer cannula 200, the connection relationship between the inner tube 800 and other components, the specific structure of the driving assembly 400, the tee tube 500, and the cleaning tube 300 can be as A detailed description of the foregoing embodiments.
- the cleaning tube 300 may be omitted, for example, for a disposable vascular stent delivery system, since it is discarded once, it is not required to be cleaned using the cleaning tube 300, and thus, such a blood vessel stent
- the delivery system may not have a wash tube 300.
- the tee tube 500 may be omitted.
- vascular stent delivery system For example, for a disposable vascular stent delivery system, it is discarded once it is used, and it is not required to be cleaned by using the tee tube 500.
- the vascular stent delivery system may not have a tee tube 500 whereby the first end of the inner tube 800 extends directly into the lumen of the outer cannula 200.
- the inner tube 800 is located within the outer sleeve 200.
- one end of the inner tube 800 is coupled to a tapered head (TIP head) 1100 and the other end is passed through the inner sleeve.
- Tube 1200 is coupled to inner sleeve 1200.
- the TIP head 1100 is located at the end of the outer cannula 200 for guiding the catheter assembly to move within the blood vessel.
- the inner sleeve 1200 maintains the inner tube 800 moving axially within the outer sleeve 200 to prevent the inner tube 800 from being bent within the outer sleeve 200.
- a barb 900 is disposed on the inner tube 800.
- the barb 900 is disposed between the inner tube 800 and the TIP head 1100 on the inner tube 800.
- the barb 900 can be made of an elastic material such as a nickel titanium alloy and configured to move the blood vessel stent to a vascular lesion position as the inner tube 800 moves relative to the outer sleeve 200.
- the barb 900 grasps the inner wall of the blood vessel stent to be released outward, and moves the blood vessel stent to the vascular lesion position, and the barb 900 extends out of the outer cannula.
- the inner tube 800 is pulled back, the barb 900 is returned to the outer sleeve 200, and the inner wall of the section of the blood vessel stent is again grasped again for a period of time, and the action is repeated until it is completely released. Therefore, the inner tube can be applied to the blood vessel stent of any length, and the inner tube is not required to be customized according to different lengths of the blood vessel stent or different blood vessel lesions, thereby improving the compatibility of the blood vessel stent delivery system, thereby simplifying the operation and reducing the operation.
- the cost of the vascular stent delivery system also reduces the cost of treatment for the patient.
- the inner tube 800 may include, but is not limited to, a metal braided tube 801, a metal tube 802 connected to the metal braided tube 801, and a connecting tube 803.
- the connecting pipe 803 is sleeved at a joint of the metal pipe 802 and the metal braided pipe 801, and the connecting pipe 803 passes an adhesive (for example, anaerobic adhesive) and the metal braided pipe 801 and the metal.
- Tube 802 is bonded.
- the metal tube 802 is coupled to the TIP head, and the metal braided tube 801 is coupled to the portion of the inner tube 800 that is coupled to the drive assembly 400 (eg, an additional metal tube).
- the metal tube 802 may be a nickel-titanium tube, for example, a portion of the metal tube 802 that is connected to the connecting tube 803.
- the slit may have a spiral slit (not shown) along the length of the metal tube.
- the barbs 900 are disposed on the metal tube 802 and are adjacent or adjacent or connected to the connecting tube 803.
- the outer surface of the barb 900 is continuous and smoothly transitioned with the outer surface of the connecting tube 803.
- the barb 900 includes a pointed portion 901 and a base portion 902 that extends radially outward from the base portion 902 in the axial direction of the metal tube 802, that is, with the metal tube 802.
- the axis is radially expanded by the center line, and the two pointed corners of the two pointed corners 902 are linearly larger than the radial dimension of the base 902, and the diameter of the base 902 is equal to the diameter of the connecting tube 803.
- the barb 900 may be made of an elastic material such as a shape memory alloy and laser welded to the metal tube of the inner tube 800, thus improving the rigidity of the barb setting, which solves the prior art. Discountation occurs due to insufficient rigidity.
- the metal braided tube 801 is a three-layer structure in which the inner layer is a PTFE (polytetrafluoroethylene) layer and the outer layer is PEBAX (block polyetheramide resin).
- the layer, and the intermediate layer between the inner layer and the outer layer, is a wire braid, such as a stainless steel wire mesh.
- the fixed connection of the metal tube 802 to the metal braided tube 801 includes: the metal tube 802 is welded to the wire braid of the metal braided tube 801, that is, a laser welded nickel-titanium tube and a wire braid.
- the connecting tube 803 can be omitted, the inner tube being composed of a metal braided tube and a metal tube.
- One end of the metal tube is connected to the metal braided tube, and the other end is connected to the TIP head; one end of the metal braided tube is connected to the metal tube, and the other end is passed through the inner sleeve.
- One end portion of the metal tube is inserted into one end portion of the metal braided tube and the metal tube is fixedly coupled to the metal braided tube.
- the inner tube is made of a metal braided tube, a nickel-titanium tube and a connecting tube, in the case of controlling the wall thickness, the connection force between the duct parts is not affected, and the ultra-thin wall connecting tube is used, and the front end of the inner tube is made of a polished ultra-thin
- the wall metal pipe is connected, and the wall thickness after grinding is 0.02 mm, which is not achieved by other polymer plastic pipes.
- connection method is adopted: the nickel-titanium tube is inserted into the metal-made tube, and the connecting tube is sleeved in each of the two tubes, and the anaerobic adhesive is applied to the inner wall of the connecting tube section to be firmly bonded, and the laser-welded nickel-titanium tube and metal preparation are performed. tube.
- the wall thickness of the inner tube connecting tube is effectively controlled, and when the inner tube is repeatedly pushed, the step is prevented from being too large, causing the head end of the connecting tube to scrape the bracket, thereby affecting the pushing effect.
- Adhesive bonding combined with laser welding, Double insurance, even if the anaerobic adhesive has been peeled off for a long time or there is a phenomenon of virtual welding, it can ensure that the TIP of the inner tube will not fall into the human body and cause medical accidents.
- an elastic nickel-titanium barb is added to the inner tube of the metal tube for reciprocating push.
- the barb is barbed in the outer sleeve
- the nickel-titanium elastic barb grabs the inner wall of the stent and releases the outer tube out of the outer tube to the vascular lesion position. Stretch out the outer tube, pull the barb into the outer tube (the position of the bracket is unchanged), grab the inner wall of the bracket again and push it again, repeat this action until it is completely released.
- the barb is made of nickel-titanium cutting heat setting process and expanded into a sharp-horned bell mouth.
- a 6F pipe sheath ie, a 6F diameter outer casing
- the straight distance between the two sharp points is greater than 1.35 mm.
- the inner tube designed by the present invention can be unified into one specification, and all the blood vessel supports conforming to the 6F sheath are introduced, which solves the problem that the existing general delivery system needs to customize the inner tube length according to the length and diameter of the stent.
- the one-hand operation type reciprocating small distance repeatedly pushes is easy to control, and has a stronger hand feeling.
- the vascular stent delivery system may include, but is not limited to, a housing composed of the right half shell 110 and the left half shell 120, a cleaning tube 300, a catheter assembly mainly composed of the outer sleeve 200 and the inner tube 800, And a drive assembly 400.
- the cleaning tube 300 may be omitted, for example, for a disposable vascular stent delivery system, since it is discarded once, it is not required to be cleaned using the cleaning tube 300, and thus, such a blood vessel stent
- the delivery system may not have a wash tube 300.
- the tee tube 500 may be omitted.
- vascular stent delivery system For example, for a disposable vascular stent delivery system, it is discarded once it is used, and it is not required to be cleaned by using the tee tube 500.
- the vascular stent delivery system may not have a tee tube 500 whereby the first end of the inner tube 800 extends directly into the lumen of the outer cannula 200.
- the catheter assembly for the vascular stent delivery system can include: an outer cannula 200; an inner tube 800 that can pass axially through the outer cannula 800;
- the guiding head 1100 has a passage extending through the guiding head in an extension direction, a part of the guiding head 100 is inserted into the outer sleeve 200 and connected and communicated with the inner tube 500 through a connecting tube 1000 for The direction of travel of the outer cannula 200 and inner tube 800 within the blood vessel is directed.
- the connecting tube 1000 is injection molded in the passage of the guiding head 1100.
- the catheter assembly of the embodiment of the present invention will be described in detail below with reference to Fig. 15 on the basis of Fig. 14.
- the outer sleeve is omitted and only the inner tube 800 and the guide head 1100 are shown.
- the guiding head 1100 may include:
- An outer sleeve blocking portion 1102 is connected to the inner tube joint portion 1101 and formed as a stepped structure with the inner tube joint portion 1101, the outer sleeve preventing portion 1102 is in contact with an end portion of the outer sleeve 200 and the outer sleeve is blocked
- the guiding portion 1103 is located on the opposite side of the inner tube joint portion 1101, and is connected to the outer sleeve blocking portion 1102.
- the diameter of the guiding portion 1103 gradually decreases linearly from the outer sleeve blocking portion. That is, the diameter of the guiding portion 1103 is proportional to the axial length or linearly smaller from the outer sleeve blocking portion 1102, that is, the sectional shape of the guiding portion 1103 is formed into a tapered shape, and therefore, the guiding head 1100 can also be Called the TIP header.
- the connecting tube 1000 is a plastic tube that is injection molded in the guiding head 1100.
- the joint strength between the guiding head, the connecting tube and the inner tube is increased, the accidental falling of the guiding head into the human body is prevented, and the reliability of the operation of the vascular stent conveying system is improved.
- the inner wall of the passage of the inner tube joint portion 1101 has a recess 1104, and a part of the connecting tube 1000 is formed by injection molding in a passage of the inner tube joint portion 1101, and the connecting tube 1000 is connected.
- the other portions are formed on the outside of the TIP head by respective molds and are continuous with the portion formed in the passage of the inner tube joint 1101, that is, the two portions can be injection molded at the same time, wherein the inner tube 800 is inserted into the Connected inside the tube 1000.
- the end of the plastic tube inserted into the guide head 1100 has a flared design and is integrally molded and pre-embedded, thus increasing the joint strength between the plastic tube and the guide head.
- the outer wall of the inner tube is bonded to the inner wall of the connecting tube by an adhesive.
- the recess 1104 has a wedge shape in the cross-sectional view of the guide head 1100, but the embodiment of the present invention is not limited thereto, and any other recess of the cross-sectional shape may be employed, for example, a square, a cone, and other irregular shapes. And the number of the recesses is not limited as long as it helps to increase the joint strength between the plastic tube and the guide head.
- the structural adhesive 1200 is disposed at the step formed by the outer surface, so that the structural adhesive 1200 forms a gradual structure in which the size of the connecting tube 1000 from the inner tube joint portion 1101 to the connecting tube 1000 is gradually reduced. It should be noted that the embodiment of the present invention is not limited thereto, and the gradual structure of the structural adhesive may be omitted, and other materials in the field may be used to smooth the step.
- the structural adhesive is gradually fixed and fixed. When the doctor operates, it is easier to make the inner tube joint of the TIP head enter the outer sleeve, and there is no “step jam” phenomenon, which is more convenient for the doctor to operate.
- the connecting tube 1000 can be formed by injection molding only in the TIP head, so that the external molding process can be omitted and the production efficiency can be improved.
- the inner tube 800 may include, but is not limited to, a metal braided tube 801, a metal tube 802 connected to the metal braided tube 801, and a connecting tube 803.
- the connecting pipe 803 is sleeved at a joint of the metal pipe 802 and the metal braided pipe 801, and the connecting pipe 803 passes an adhesive (for example, anaerobic adhesive) and the metal braided pipe 801 and the metal.
- Tube 802 is bonded.
- the metal tube 802 is inserted into the connecting tube 1000, and the metal braided tube 801 is connected to the portion of the inner tube that is engaged with the driving assembly 400 (not separately shown), wherein the portion that is engaged with the driving assembly 400 can It is a rigid tube, for example, a stainless steel tube.
- the metal tube 802 may be a nickel titanium tube.
- the portion of the metal tube 802 that is connected to the connecting tube 1000 has a spiral slit along the length of the metal tube (as shown in FIG. 14). When the metal tube is bonded to the plastic tube, the glue enters the spiral grooving to increase the bonding strength.
- the metal pipe 802 is not limited to a portion that is connected to the connecting pipe 1000, and has a spiral grooving along the length direction of the metal pipe, and other portions of the metal pipe 802 may have a spiral grooving, thereby further improving the metal.
- the metal braided tube 801 is a three-layer structure in which the inner layer is a PTFE (polytetrafluoroethylene) layer and the outer layer is PEBAX (block polyetheramide resin).
- the layer, and the intermediate layer between the inner layer and the outer layer, is a wire braid, such as a stainless steel wire mesh.
- the fixed connection of the metal tube 802 to the metal braided tube 801 includes: the metal tube 802 is welded to the wire braid of the metal braided tube 801, that is, a laser welded nickel-titanium tube and a wire braid.
- the connecting tube 803 can be omitted, the inner tube being composed of a metal braided tube and a metal tube. One end of the metal tube is connected to the metal braided tube, and the other end is connected to the TIP head. One end of the metal tube is inserted into one end of the metal braided tube and the metal tube is woven with the metal The tube is fixedly connected.
- the catheter assembly further includes a barb 900 disposed on the metal tube 802.
- the pointed portion of the barb 900 is flared radially toward the inner tube.
- the base of the lance 900 is coupled to the connecting tube 803 and the radial dimension of the base is equal to the radial dimension of the connecting tube 803, whereby the barb 900 forms a continuous surface with the outer surface of the connecting tube 803, thereby reducing the outer surface of the inner tube
- the steps are conducive to the operation of the doctor.
- the barbs are arranged on the metal pipe, which improves the rigidity of the barbs and solves the problem of folding in the prior art due to insufficient rigidity.
- the guiding head and the inner tube are connected by the connecting member, which increases the joint strength, prevents the guide head from accidentally falling into the human body, improves the reliability of the operation of the vascular stent delivery system, and reduces the risk of the patient. .
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Abstract
一种血管支架输送***,包括:壳体(110,120);外套管(200),外套管(200)位于壳体(110,120)的外部且与壳体(110,120)的第一端(101)连接;清洗管(300),清洗管(300)与壳体(110,120)的第二端(102)连接,并且该清洗管(300)的第一端(301)位于壳体(110,120)的内部,该清洗管(300)的第二端(302)伸出至壳体(110,120)的外部;内管(800),内管(800)的一部分位于壳体(110,120)内,并且该内管(800)的第一端伸入至外套管(200)的内部,该内管(800)的第二端从清洗管(300)的第一端(301)伸入至该清洗管(300)的管腔内;驱动组件(400),驱动组件(400)的一部分位于壳体(110,120)内,与内管(800)的位于该壳体(110,120)内的一部分操作性接合,用于驱动内管(800)以使内管(800)在外套管(200)和清洗管(300)内能沿轴向移动;其中,内管(800)的第二端的端部被设置成防止该内管(800)的第二端的端部刮擦清洗管(300)的管腔内壁。
Description
相关申请的交叉引用
本申请要求于2016年4月12日提交的申请号为201610224890.3的中国专利申请、申请号为201620301833.6的中国专利申请、申请号为201610224524.8的中国专利申请、申请号为201620301792.0的中国专利申请、申请号为201610224686.1的中国专利申请、申请号为201620301609.7的中国专利申请、申请号为201610224595.8的中国专利申请、申请号为201620301791.6的中国专利申请的权益和优先权,上述中国专利申请的全部内容通过引用并入本文。
本发明涉及医疗器械领域,更为具体而言,涉及一种血管支架输送***及其制造方法,以及用于血管支架输送***的导管组件。
支架治疗法采用支架治疗的微创介入手术,创伤小,并发症少,效果好,成为目前治疗周边血管狭窄的主要办法。
支架治疗法通常需要运用输送***以将血管支架植入到体内。在现有技术中,血管支架输送***一般包括相互连接的导管组件和手柄部,导管组件通常包括外套管和内管,血管支架可设置在内管和外套管之间,外套管与内管均为中空设置,可供导丝通过;手柄部包括适于握持的壳体以及用于驱动内管往复移动的驱动组件,外套管与壳体相固定,驱动组件与内管操作性接合。
在手术过程中,医生利用导丝引导输送***的导管组件到达手术部位,之后操作驱动组件使内管沿轴向向前移动,从而带着支架进入血管,之后,支架可展开并支承于血管内壁。
现有技术的输送***一般会设置清洗管,清洗管通常至少部分的位于手
柄部的壳体内,与内管的管腔相连通。例如,清洗口可设置在清洗管的端部,从而在使用完输送***后可以清洗内管和内管的管腔部分。
在现有技术中,清洗管通常包括在内管外侧套着的可以与驱动组件相连接的中钢管、将中钢管固定在壳体上的连通件。但是,由于内管会相对于中钢管移动,两者之间容易产生刮擦,操作性差,且容易造成***故障,减少了输送***的使用寿命。同时,这样的清洗管路由经过多个相连接的部件构成,在各部件的连接处容易造成液体泄漏,导致液体进入驱动组件和壳体中。
在现有技术中,导管组件由于其自身柔韧性较低而难以到达一些弯曲病变位置处,若提高导管硬度,会使导管组件在应力集中的地方出现折弯,影响***释放性能。
并且,在现有技术中,如图13所示,内管800’一体成型,倒刺900’连接在内管800’上,这样,在释放支架过程中,在倒刺处由于刚性不足,有可能发生打折现象。
此外,在现有技术中,导管组件的锥形头(TIP)与内管直接粘接,接合强度有限,存在意外脱落的风险。
发明内容
鉴于上述技术缺陷,本发明提供了一种血管支架输送***及其制造方法,以及血管支架输送***的导管组件。
根据本发明的一种实施方式,提供了一种血管支架输送***。在本发明实施方式中,所述血管支架输送***可以包括:壳体;外套管,所述外套管位于所述壳体的外部且与所述壳体的第一端连接;清洗管,所述清洗管与所述壳体的第二端连接,并且该清洗管的第一端位于所述壳体的内部,该清洗管的第二端伸出至所述壳体的外部;内管,所述内管的一部分位于所述壳体内,并且该内管的第一端伸入至所述外套管的内部,该内管的第二端从所述清洗管的第一端伸入至该清洗管的管腔内;驱动组件,所述驱动组件的一部分位于所述壳体内,与所述内管的位于该壳体内的一部分操作性接合,用于驱动所述内管以使所述内管在所述外套管和清洗管内能沿轴向移动;其中,所述内管的第二端的端部设置成防止该内管的第二端的端部刮擦所述清洗管的管腔内壁。所述血管支架输送***的制造方法可以包括:提供壳体;提供
外套管,将所述外套管设置成:位于所述壳体的外部并与所述壳体的第一端连接;提供清洗管,将所述清洗管设置成:与所述壳体的第二端连接,并且该清洗管的第一端位于所述壳体的内部,该清洗管的第二端伸出至所述壳体的外部;提供内管,将所述内管设置成:该内管的一部分设置于所述壳体内,该内管的第一端伸入至所述外套管的内部,该内管的第二端从所述清洗管的第一端伸入至该清洗管的管腔内;提供驱动组件,将所述驱动组件设置成:该驱动组件的一部分位于所述壳体内,与所述内管的位于该壳体内的一部分操作性接合,用于驱动所述内管以使所述内管在所述外套管和清洗管内能沿轴向移动;其中,将所述内管的第二端的端部设置成防止该内管的第二端的端部刮擦所述清洗管的管腔内壁。
根据本发明的另一种实施方式,提供了一种血管支架输送***。血管支架输送***可以包括:壳体;外套管,所述外套管位于所述壳体的外部且通过应力扩散组件与所述壳体连接,其中,所述应力扩散组件用于扩散所述外套管与所述壳体连接处集中的应力;内管,所述内管的一部分位于所述壳体内,并且该内管的一端能够伸入至所述外套管的内部;驱动组件,所述驱动组件的一部分位于所述壳体内,与所述内管的位于该壳体内的一部分操作性接合,用于驱动所述内管以使所述内管在所述外套管内能沿轴向移动。所述血管支架输送***的制造方法可以包括:提供壳体;提供外套管,将所述外套管配置成:位于所述壳体的外部且通过应力扩散组件与所述壳体连接,其中,所述应力扩散组件用于扩散所述外套管与所述壳体连接处集中的应力;提供内管,将所述内管配置成:该内管的一部分设置于所述壳体内,该内管的一端能够伸入至所述外套管的内部;提供驱动组件,将所述驱动组件配置成:该驱动组件的一部分位于所述壳体内,与所述内管的位于该壳体内的一部分操作性接合,用于驱动所述内管以使所述内管在所述外套管内能沿轴向移动。
根据本发明的又一种实施方式,提供了一种用于血管支架输送***的导管组件。所述导管组件可以包括:外套管;内管,所述内管的至少一部分位于所述外套管内,所述内管包括金属编织管和与该金属编织管连接的金属管;倒刺,设置在所述内管的金属管上,所述倒刺配置成当所述内管相对于外套管移动时能够移动血管支架。所述血管支架输送***可以包括:壳体;根据
上述实施方式的导管组件,其中,所述导管组件的外套管位于所述壳体的外部且与所述壳体连接,所述导管组件的内管的一部分位于所述壳体内,并且该内管的另一部分位于所述外套管的内部;驱动组件,所述驱动组件的一部分位于所述壳体内,与所述内管的位于该壳体内的一部分操作性接合,用于驱动所述内管在所述外套管内能沿轴向移动。
根据本发明的再一种实施方式,提供了一种用于血管支架输送***的导管组件。所述导管组件可以包括:外套管,内管,所述内管能够沿轴向穿过所述外套管;导向头,所述导向头具有延长度方向贯穿该导向头的通道,所述导向头的一部分***所述外套管内并且通过连接管与所述内管连接且相通,用于引导所述外套管和内管在血管内的行进方向,其中,所述连接管在所述导向头的通道内注塑成型。所述血管支架输送***可以包括:壳体;按照上述实施方式所述的导管组件,其中,所述导管组件的外套管位于所述壳体的外部且与所述壳体连接,所述导管组件的内管的一部分位于所述壳体内,并且该内管的一端能够伸入至所述外套管的内部;驱动组件,所述驱动组件的一部分位于所述壳体内,与所述内管的位于该壳体内的一部分操作性接合,用于驱动所述内管在所述外套管内能沿轴向移动。
采用本发明实施方式,具有如下有益效果:
1.若血管支架输送***的内管与清洗管之间经过防刮擦处理,则可以有效改善血管支架输送***的操作性,进而可以提高其使用寿命。并且,若清洗管为一体成型部件,其液密封性好,与现有技术相比不容易造成液体泄漏,从而进一步提高***的操作性、可靠性。
2.若血管支架输送***的外套管通过应力扩散组件与所述壳体连接,则可利用应力扩散组件扩散所述外套管与所述壳体连接处集中的应力,在保证管体的柔韧性的同时,确保了管体不易被折断,还可以有效改善血管支架输送***的操作性,并延长了其使用寿命。
3.若内管由金属编织管和金属管构成,将倒刺设置在金属管上,则可提高倒刺处的刚性,相比现有技术可以解决由于刚性不足而发生的打折现象。
4.若导向头通过在该导向头内注塑成型的连接管与内管连接,则可增加接合强度,防止发生导向头意外脱落进入人体,提高了血管支架输送***操作的可靠性,降低了患者的风险。
图1是示出根据本发明实施方式的血管支架输送***的立体分解图;
图2是根据本发明实施方式的血管支架输送***的清洗管的立体图;
图3是从与图2不同的视角观察时根据本发明实施方式的血管支架输送***的清洗管的立体图;
图4是根据本发明实施方式的血管支架输送***的清洗管沿图3所示的A-A线的剖视图,其中清洗管中***有内管;
图5是图4中B部分的放大视图;
图6是根据本发明实施方式的血管支架输送***的清洗管沿图3所示的A-A线的剖视图,其中清洗管中未***内管;
图7是根据本发明实施方式的血管支架输送***的三通管的局部剖视图;
图8是根据本发明实施方式的血管支架输送***的O型圈的剖面图;
图9是根据本发明实施方式的包括应力扩散组件的血管支架输送***的立体分解图;
图10是根据本发明实施方式的应力扩散组件的剖视图;
图11是根据本发明实施方式的内管的一例的示意图;
图12是图11中B部分的放大图;
图13示出了现有技术的血管支架输送***的内管;
图14示出了根据本发明实施方式的导管组件的一例的剖视图;
图15示出了根据本发明实施方式的导管组件的内管和导向头的剖视图;
图16示出了根据本发明实施方式的内管的一例的放大剖视图;
图17示出了根据本发明实施方式的内管的另一例的放大剖视图。
以下结合附图和具体实施方式对本发明的各个方面进行详细阐述。其中,附图中的部件并非一定是按比例进行绘制,其重点在于对本发明的原理进行举例说明。
在本发明的各个实施例中,众所周知的结构、材料或操作没有示出或未作详细说明。并且,所描述的特征、结构或特性可在一个或多个实施方式中
以任何方式组合。此外,本领域技术人员应当理解,下述的各种实施方式只用于举例说明,而非用于限制本发明的保护范围。还可以容易理解,本文所述和附图所示的各实施方式中的元件或部件可以按多种不同配置进行布置和设计。
【实施例1】
图1示出了根据本发明一种实施方式的血管支架输送***。在本例中,用于将血管支架输送至体内的输送***,即血管支架输送***,可以包括,但不限于:由右半壳110和左半壳120构成的壳体、外套管200、清洗管300、内管800、以及驱动组件400。
其中,所述外套管200位于所述壳体的外部且与所述壳体的第一端101连接,例如,通过橡胶头600(接头件)、三通管500与壳体的第一端101固定连接。具体而言,外套管200穿过橡胶头600并延伸至与三通管500(关于三通管500的具体结构将在下文作具体描述)的第一端501,从而与所述三通管500连通,而橡胶头600与所述壳体固定,例如,右半壳110和左半壳120夹持所述橡胶头600,并通过螺母121与连接特征111(例如螺孔)配合,将右半壳110和左半壳120固定。作为选择,在本发明的其他实施方式中,可以省略橡胶头600、三通管500,将外套管200与壳体直接固定连接。
其中,所述清洗管300用于在血管支架输送结束后对血管支架输送***进行清洗。在本发明的一种实施方式中,清洗管300可以是一体成型的二通管,例如,由PC(聚碳酸酯)材料一体成型的鲁尔二通管,其与所述壳体的第二端102连接,并且该清洗管300的第一端301位于所述壳体的内部,第二端302伸出至所述壳体的外部。在本发明的一种实施方式中,清洗管300上设置有连接特征303、304,壳体的右半壳110上对应的位置设置有与所述连接特征303、304配合的连接特征113、114,通过将连接特征303、304嵌入到连接特征113、114中,将清洗管300与壳体固定,同时通过将右半壳110和左半壳120结合以夹持住所述清洗管300。
其中,所述内管800的一部分位于所述壳体内,其可以为钢管(即内钢管),当然,本发明不限于此,内管也可以由其他可以用于血管支架输送***的合适材料形成。内管800的第一端(未示出)伸入至所述外套管200的内
部,在本例中,内管800从三通管500的第二端502***并穿过三通管500而伸入到外套管200的内腔中。作为选择,在本发明的其他实施方式中,可以省略三通管500,由此,内管800的第一端直接伸入到外套管200的内腔中。所述内管的第二端从所述清洗管300的第一端301伸入至该清洗管300的管腔内(参考图4和5)。
其中,所述驱动组件400的一部分位于所述壳体内,与所述内管800的位于该壳体内的部分操作性接合,具体而言,驱动组件400主要由拇指驱动件401和导轨402构成,驱动组件400位于内管的第一端和第二端之间,其中,壳体的右半壳110通过连接特征112、115、116与驱动组件400连接,螺母121穿过壳体的左半壳120上的孔,并穿过卡簧122和导轨402上的孔,伸入到右半壳110上的螺孔111,通过螺母121与螺孔111的接合将左半壳120和右半壳110结合在一起,从而将驱动组件400的一部分容纳在壳体内,而驱动组件400的拇指驱动件401的一部分从壳体露出以便于被手动操作。内管800穿过导轨402,并与拇指驱动件401的一部分接合,当医生或其他操作者操作拇指驱动件401时,在拇指驱动件401的推拉下,内管800沿着导轨402移动,进而使所述内管在所述外套管和清洗管的内腔中沿轴向移动,具体而言,内管的第一端在外套管200内相对移动,从而使血管支架沿着外套管200前进并进入血管内,之后,可展开并支承于血管内壁。与此同时,内管的第二端伴随内管的整体移动而在清洗管300内移动。
在本实施例中,内管的第二端的端部被设置成防止内管的第二端的端部刮擦清洗管的内壁。由此,在输送血管支架的过程中,可以有效地避免内管的端部刮擦清洗管的管壁,使得操作更为便利,并且可以降低***故障率,提高其使用寿命。
如图4和5所示,所述内管的第二端的端部被设置成防止内管的第二端的端部刮擦清洗管的内壁包括:在内管800的第二端设置热缩管801,其中,所述内管800的第二端的端部***所述热缩管801中。在本发明的一些实施方式中,所述内管的第二端与所述热缩管接触的部分经过防滑处理。例如,热缩管801采用FEP(聚全氟乙丙烯)超薄壁热缩管,并对内管800(即内钢管)进行喷砂防滑处理。即使装配偏心,推拉内管时的相对滑动也不会出现刮擦清洗管内壁的刮壁现象。并且,FEP表面光滑,与PC的摩擦阻力更小,
医生手感阻力会更小。本领域技术人员应当理解,本发明不限于此,所述内管的第二端的端部也可以与所述热缩管固定连接,例如,将热缩管与内管第二端的端部粘接。此外,所述内管的第二端的端部被设置成防止内管的第二端的端部刮擦清洗管的内壁可以包括:将所述内管的第二端的端部形成为圆滑端面,即,对内管的第二端的端部进行圆滑处理,例如,使第二端的端部形成倒圆角,由此减少内管的第二端的端部与清洗管的管壁之间的摩擦阻力,推拉内管时的相对滑动也不会出现所述刮壁现象。
如图2和3所示,所述清洗管300可以是一体成型的二通管,例如,由PC材料一体成型的鲁尔二通管。这样,清洗管的液密封性好,不会像现有技术那样容易造成液体泄漏,从而进一步提高***的操作性、可靠性。同时,一体化设计,成本更低。此外,如图1所示,所述清洗管300的第二端302的端部具有开口和封闭该开口的接头帽320。这样,在血管支架的输送过程中,接头帽320封闭该开口,以防体液(即血液)从该开口流出;在血管支架输送结束后,可以打开接头帽320,通过该开口加入清洗液,对血管支架输送***进行清洗。
在本发明的其他实施方式中,如图6所示,在清洗管300的管腔内且位于该清洗管的第一端和第二端之间设置有导丝穿接口305,并且所述清洗管的导丝穿接口处的管腔的内径逐渐缩小,形成渐变式设计。清洗管300的内腔渐变式设计,增加了导丝通过顺滑性,导入导丝时防止产生台阶、卡壳现象。
此外,可选地,下面对本实施例中的三通管500进行说明。
三通管500用于对血管支架输送***的前部分(即靠近外套管的部分)进行清洗,作为一种可选实施方式,可以为鲁尔三通管,当然,也可以是可用于血管支架输送***的其他合适的三通管。如图1所示,三通管500位于所述壳体的第一端101,该三通管500可具有伸出至所述壳体的外部的第一端501、位于所述壳体内且与第一端501直线相通的第二端502、以及设置在所述第一端501和第二端502之间且伸出至所述壳体的外部的第三端503。
其中,所述三通管500的第一端501与所述外套管200连通,例如,通过橡胶头600与外套管200连接并连通。所述内管的第一端从该三通管500的第二端502伸入并穿过该三通管500,从其第一端501伸出并进入至所述外套管200内。三通管500的第三端503的端部具有开口和封闭该开口的接头
帽522。这样,在血管支架的输送过程中,接头帽522封闭该开口,以防体液(即血液)从该开口流出;在血管支架输送结束后,可以打开接头帽522,通过该开口加入清洗液,对血管支架输送***的前部分的进行清洗。
此外,在本例中,在清洗管300的第一端301和三通管500的第二端502的端部处设置有密封组件(311、312和511、512),所述内管能够穿过所述密封组件,例如密封组件具有供内管穿过的通道。具体而言,如图1和4所示,在清洗管300的第一端301的端部设置有包括O型圈311和固定该O型圈的盖板312的密封组件;如图1和7所示,在三通管500的第二端502的端部处设置有包括O型圈511和固定该O型圈的盖板512的密封组件。O型圈311和O型圈511中的一者或两者被设置成厚度由中央朝向边缘逐渐变薄,即,如图8所示,O型圈的两个侧面513、514大体上形成为锥面。锥面设计的O型圈与鲁尔二通、三通管配合,始终圆周方向有一条线与鲁尔二通或三通管过盈配合,即使滑动内管,相对平面O型圈而言在轴向上的攒动会更小。在本发明的其他实施方式中,在所述O型圈与所述内管接触的表面涂覆润滑层,所述润滑层的本体材质可以包括派瑞林(Parylene)、聚四氟乙烯(PTFE)、聚乙烯吡咯烷酮(PVP)和硅油中的任意一种,例如,所述润滑层可以为Parylene涂层。由于人体体内一定的血压压力,与介入式导管连通后,如果没有密封,会有血液回流现象,因此,O型圈与内管必须过盈配合,但是,这样又会对医生的输送手感产生一定的影响,在此采用O型圈与Parylene涂层的结合设计,由于此涂层本身的光滑特性,会减少摩擦力,从而更利于医生操作。
需要说明的是,以上是对本发明的举例说明,本发明不限于此,例如,在本发明的其他实施方式中,也可以只在清洗管300的第一端301和三通管500的第二端502中的一者处设置上述密封组件。例如,仅在三通管500的第二端502处设置上述密封组件。
根据本发明的各种实施方式,内管与清洗管之间经过防刮处理,可以有效改善血管支架输送***的操作性和使用寿命。
下面对本发明制造上述血管支架输送***的方法进行详细阐述。
根据本发明各种不同实施方式的血管支架输送***的制造方法可以包
括,但不限于下述操作:
提供壳体;
提供外套管,将所述外套管设置成:位于所述壳体的外部并与所述壳体的第一端连接;
提供清洗管,将所述清洗管设置成:与所述壳体的第二端连接,并且该清洗管的第一端位于所述壳体的内部,该清洗管的第二端伸出至所述壳体的外部;
提供内管,将所述内管设置成:该内管的一部分设置于所述壳体内,该内管的第一端伸入至所述外套管的内部,该内管的第二端从所述清洗管的第一端伸入至该清洗管的管腔内;
提供驱动组件,将所述驱动组件设置成:该驱动组件的一部分位于所述壳体内,与所述内管的位于该壳体内的一部分操作性接合,用于驱动所述内管以使所述内管在所述外套管和清洗管内能沿轴向移动;
其中,将所述内管的第二端的端部设置成防止内管的第二端的端部刮擦清洗管的管腔内壁。
在一种实施方式中,将所述内管的第二端的端部设置成防止内管的第二端的端部刮擦清洗管的管腔内壁可以包括:将所述内管的第二端的端面处理成圆滑端面。
在另一种实施方式中,将所述内管的第二端的端部设置成防止内管的第二端的端部刮擦清洗管的管腔内壁可以包括:提供热缩管,使所述内管的第二端的端部***所述热缩管。其中,对所述内管的第二端与所述热缩管接触的部分可以进行防滑处理。作为选择,可以使所述内管的第二端的端部与所述热缩管固定连接。
在一种实施方式中,所述清洗管为一体成型的二通管,例如,由PC材料一体成型的鲁尔二通管。这样,清洗管的液密封性好,不会像现有技术那样容易造成液体泄漏,从而进一步提高***的操作性、可靠性。此外,所述清洗管的管腔内且位于该清洗管的第一端和第二端之间设置导丝穿接口。例如,在一些实施方式中,在导丝穿接口处将所述清洗管的管腔设计成该管腔的内径逐渐缩小。清洗管的这种内腔渐变式设计,增加了导丝通过顺滑性,导丝导入时防止产生台阶、卡壳现象。
在其他实施方式中,在所述清洗管的第二端的端部设置开口,并提供封闭该开口的接头帽。这样,在血管支架的输送过程中,接头帽封闭该开口,以防血液从该开口流出;在血管支架输送结束后,可以打开接头帽,通过该开口加入清洗液,对血管支架输送***进行清洗。
此外,在一种实施方式中,所述方法还可以包括:提供三通管,例如鲁尔三通管,将该三通管设置在所述壳体的第一端,该三通管具有伸出至所述壳体的外部的第一端、位于所述壳体内且与第一端直线相通的第二端、以及设置在所述第一端和第二端之间且伸出至所述壳体的外部的第三端;其中,所述三通管的第一端与所述外套管连通,所述内管的第一端从该三通管的第二端伸入并穿过该三通管,从该三通管的第一端伸入至所述外套管内。在所述三通管的第三端的端部设置开口,并提供封闭该开口的接头帽。这样,在血管支架的输送过程中,接头帽封闭该开口,以防体液(即血液)从该开口流出;在血管支架输送结束后,可以打开接头帽,通过该开口加入清洗液,对血管支架输送***的前部分进行清洗。
在一种实施方式中,在所述清洗管(即二通管)的第一端和所述三通管的第二端中的至少一者的端部处设置密封组件,所述内管能够穿过所述密封组件。作为选择,所述密封组件可以包括O型圈和固定所述O型圈的盖板,并且将所述O型圈设置成该O型圈的厚度由中央朝向边缘逐渐变薄。例如,在所述O型圈与所述内管接触的表面涂覆润滑层。所述润滑层的本体材质可以包括派瑞林(Parylene)、聚四氟乙烯(PTFE)、聚乙烯吡咯烷酮(PVP)和硅油中的任意一种,例如,所述润滑层可以为Parylene涂层。
采用上述方法制造出的血管支架输送***,可以有效改善血管支架输送***的操作性和使用寿命。
【实施例2】
在本实施例中,血管支架输送***可以包括,但不限于:由右半壳110和左半壳120构成的壳体、外套管200、清洗管300、内管800、以及驱动组件400。
其中,关于内管800、驱动组件400、三通管500和清洗管300的具体结构如前述实施例中的具体描述。作为选择,在本发明的其他实施方式中,可
以省略清洗管300,例如,对于一次性血管支架输送***,由于使用一次即丢弃,无需使用清洗管300对其进行清洗,因此,这样的血管支架输送***可以不具有清洗管300。作为选择,在本发明的其他实施方式中,也可以省略三通管500,例如,对于一次性血管支架输送***,由于使用一次即丢弃,无需使用三通管500对其进行清洗,因此,这样的血管支架输送***可以不具有三通管500,由此,内管800的第一端直接伸入到外套管200的内腔中。
其中,所述外套管200位于所述壳体的外部且通过应力扩散组件与所述壳体的第一端101连接。在一些实施方式中,所述应力扩散组件可以包括但不限于接头件600、应力扩散管700、导通管(本例中为三通管500)。具体而言,应力扩散管700穿过接头件600并伸入至三通管500的第一端501中,外套管200***所述应力扩散管并延伸至三通管500的第一端501,从而与所述三通管500连通(即所述三通管500的第一端501通过应力扩散管700和接头件600与外套管200连接并连通),而接头件600与所述壳体固定,例如,右半壳110和左半壳120夹持所述接头件600,并通过螺母121与连接特征111配合,将右半壳110和左半壳120固定。
关于应力扩散组件的具体结构将在下文作具体描述。
根据一些实施方式,所述血管支架输送***的外套管通过应力扩散组件与所述壳体连接,利用应力扩散组件扩散所述外套管与所述壳体连接处集中的应力,在保证管体的柔韧性的同时,确保了管体不易被折断。
在一种实施方式中,结合图9和图10所示,所述应力扩散组件构成为:所述接头件600具有沿长度方向(即管体的轴向)从第一端601贯穿至第二端602的通道,并且所述接头件600的第二端602与所述壳体固定连接,如上所述;所述导通管的一部分(即三通管500的第一端501)从所述接头件600的第二端602伸入至该接头件600的通道内,所述导通管的另一部分(例如,三通管500的第二端502)位于所述壳体内;所述应力扩散管700的一部分位于所述接头件600的外部,该应力扩散管700的另一部分从所述接头件600的第一端601伸入该接头件600的通道、穿过该通道延伸到所述导通管的内部(即从三通管500的第一端501伸入到三通管500内)。其中,所述外套管200伸入所述应力扩散管700并在所述应力扩散管700的内部延伸至位于所述接头件600的内部,所述内管800能够穿过所述导通管和应力扩散管700
并伸入到所述外套管200的内部,以在驱动组件400的操作下在外套管200内沿轴向相对移动,从而输送血管支架。
在一种实施方式中,所述外套管200可以为PEBAX(嵌段聚醚酰胺树脂)钢丝编织管,所述应力扩散管700可以为PA12(聚十二内酰胺)管,所述接头件600可以为橡胶头,所述导通管可以由ABS(ABS即丙烯腈、丁二烯和苯乙烯的三元共聚物,A代表丙烯腈,B代表丁二烯,S代表苯乙烯)材料制成。其中,可选地,所述PEBAX钢丝编织管可以由三层构成:外层为PEBAX;中层为不锈钢丝编织网;内层为PTFE(聚四氟乙烯)。作为选择,或者附加地,所述外套管200与所述应力扩散管700粘接,所述应力扩散管700与所述导通管粘接。此外,所述接头件600的通道的容纳所述导通管的部分的内径大于容纳所述应力扩散管700的部分的内径。
换句话说,在图10中,由左至右依次增加硬度,具体而言,第一阶段:外套管200采用PEBAX钢丝编织管;第二阶段:外套管200外套PA12管增加硬度:第三阶段:再套橡胶头增加硬度;第四阶段:导通管即三通管500为ABS材料。此外,外套管与应力扩散管粘接,应力扩散管与三通管粘接,橡胶头套在这三者连接部位处。由此形成四段渐***度式应力扩散结构。采用四段渐***度式应力扩散结构,在保证管体的柔韧性的同时,可以更好地确保了管体不易被折断。
然而,本领域技术人员应当理解,上述实施方式只是本发明的应力扩散组件的一个例子,除了上述实施方式之外,其材料可以选取本领域已知的其他合适材料,各个部件的连接也可以采用本领域已知的其他合适的连接方式或手段。
下面对制造上述血管支架输送***的方法进行详细阐述。
根据本发明各种不同实施方式的血管支架输送***的制造方法可以包括,但不限于下述操作:
提供壳体;
提供外套管,将所述外套管配置成:位于所述壳体的外部且通过应力扩散组件与所述壳体连接,其中,所述应力扩散组件用于扩散所述外套管与所述壳体连接处集中的应力;
提供内管,将所述内管配置成:该内管的一部分设置于所述壳体内,该内管的一端能够伸入至所述外套管的内部;
提供驱动组件,将所述驱动组件配置成:该驱动组件的一部分位于所述壳体内,与所述内管的位于该壳体内的一部分操作性接合,用于驱动所述内管以使所述内管在所述外套管内能沿轴向移动。
在一种实施方式中,可以将所述应力扩散组件配置成相应的第三实施方式中的部件。
此外,在一种实施方式中,将所述导通管配置为三通管,例如鲁尔三通管,其中,所述三通管具有伸入至所述接头件内部的第一端、位于所述壳体内且与第一端直线相通的第二端、以及设置在所述第一端和第二端之间且伸出至所述壳体的外部的第三端;并且,所述内管从该三通管的第二端伸入并穿过该三通管,从该三通管的第一端伸入至所述外套管内。在所述三通管的第三端的端部设置开口,并提供封闭该开口的接头帽。这样,在血管支架的输送过程中,接头帽封闭该开口,以防体液(即血液)从该开口流出;在血管支架输送结束后,可以打开接头帽,通过该开口加入清洗液,对血管支架输送***的前部分进行清洗。
在一种实施方式中,在所述三通管的第二端的端部处可以设置密封组件,所述内管能够穿过所述密封组件。所述密封组件可以包括O型圈和固定所述O型圈的盖板,并且将所述O型圈设置成该O型圈的厚度由中央朝向边缘逐渐变薄。例如,在所述O型圈与所述内管接触的表面涂覆润滑层。
采用上述方法制造出的血管支架输送***,在保证管体的柔韧性的同时,确保了管体不易被折断。同时,可以有效改善血管支架输送***的操作性和使用寿命。
【实施例3】
在本实施例中,血管支架输送***可以包括,但不限于:由右半壳110和左半壳120构成的壳体、清洗管300、主要由外套管200和内管800构成的导管组件、以及驱动组件400。
其中,血管支架输送***的具体结构,例如外套管200、内管800与其他部件的连接关系、驱动组件400、三通管500和清洗管300的具体结构等可如
前述实施例中的具体描述。作为选择,在本发明的其他实施方式中,可以省略清洗管300,例如,对于一次性血管支架输送***,由于使用一次即丢弃,无需使用清洗管300对其进行清洗,因此,这样的血管支架输送***可以不具有清洗管300。作为选择,在本发明的其他实施方式中,也可以省略三通管500,例如,对于一次性血管支架输送***,由于使用一次即丢弃,无需使用三通管500对其进行清洗,因此,这样的血管支架输送***可以不具有三通管500,由此,内管800的第一端直接伸入到外套管200的内腔中。
在本实施例的导管组件中,内管800的至少一部分位于所述外套管200内,如图11所示,内管800的一端连接锥形头(TIP头)1100,另一端穿过内套管1200,并且与内套管1200连接。其中,TIP头1100位于外套管200的端部,用于引导所述导管组件在血管内移动。所述内套管1200在所述外套管200内保持所述内管800沿轴向移动,防止内管800在外套管200内发生弯折。在所述内管800上设置有倒刺900,具体而言,倒刺900设置在内管800上血管支架装配区域,即内套管1200与TIP头1100之间。所述倒刺900可以由诸如镍钛合金之类的弹性材料制成,并且被配置成当所述内管800相对于外套管200移动时能够将血管支架移动至血管病变位置。具体而言,当倒刺900在外套管200内时,前推内管800,倒刺900抓取血管支架的内壁往外释放,将血管支架移动至血管病变位置,同时倒刺900伸出外套管200,后拉内管800,将倒刺900返回至外套管200内,再次抓取一段血管支架的内壁再次推出一段,反复此动作直至完全释放。由此,内管可以适用于任意长度的血管支架,无需根据不同长度的血管支架或不同的血管病变位置定制内管,改善了血管支架输送***的兼容性,由此操作得以简化,并且降低了血管支架输送***的成本,当然也降低了患者的治疗成本。
在一种实施方式中,如图12所示,内管800可以包括,但不限于:金属编织管801、与该金属编织管801连接的金属管802、连接管803。所述连接管803套在所述金属管802与所述金属编织管801的连接处,所述连接管803通过粘结剂(例如,厌氧胶)与所述金属编织管801和所述金属管802粘接。金属管802连接TIP头,金属编织管801与所述内管800的连接驱动组件400的那部分(例如,另外的金属管)连接。在本发明的一种实施方式中,所述金属管802可以为镍钛管,例如,所述金属管802的与连接管803连接的部
分沿该金属管的长度方向可具有螺旋切槽(未示出)。在金属管802与连接管803粘接时,粘结剂进入螺旋切槽中,增加粘接强度。同时当内管800进入人体弯曲病变时,通过性会更好。
如图12所示,倒刺900设置在金属管802上,且与连接管803邻接或毗连或连接,例如,倒刺900的外表面与连接管803的外表面连续且平滑过渡。这样,可以减少内管外表面上的台阶数量,减少台阶对血管支架输送操作的不利影响。在本发明的一种实施方式中,倒刺900包括尖角部901和基部902,尖角部901自基部902起在金属管802的轴向上径向向外扩展,即,以金属管802的轴线为中心线径向扩展,构成为两尖角部902的两尖角直线距离大于基部902的径向尺寸,并且基部902的直径与连接管803的直径相等。作为选择,倒刺900可以由诸如形状记忆合金之类的弹性材料制成,并通过激光焊接在内管800的金属管上,这样,提高了倒刺设置处的刚性,解决了现有技术中由于刚性不足而发生打折现象。
在一种实施方式中,所述金属编织管801为三层结构,其中,在所述三层结构中内层为PTFE(聚四氟乙烯)层、外层为PEBAX(嵌段聚醚酰胺树脂)层、以及位于所述内层与外层之间的中间层为金属丝编织层,例如不锈钢钢丝编织网。其中,所述金属管802与所述金属编织管801固定连接包括:所述金属管802与所述金属编织管801的金属丝编织层焊接,即激光焊接镍钛管与金属丝编织层。
在另一种实施方式中,可以省略连接管803,内管由金属编织管和金属管构成。金属管的一端与金属编织管连接,另一端与TIP头连接;金属编织管的一端与金属管连接,另一端穿过内套管。所述金属管的一端部***到所述金属编织管的一端部内并且所述金属管与所述金属编织管固定连接。
针对内管由金属编织管、镍钛管和连接管制成时,在控制壁厚情况下,不影响导管零部件之间的连接力,采用超薄壁连接管,内管前端采用研磨的超薄壁金属管联接,研磨后壁厚为0.02mm,这是其它高分子塑料管所达不到的。并且,采用的连接方式:将镍钛管***到金属编制管中,连接管套在两管中各一半,厌氧胶涂在连接管区间内壁粘接牢固后,激光焊接镍钛管与金属编制管。这样,有效控制内管连接管壁厚,并且,内管在反复推送时,避免台阶过大导致连接管的头端刮擦支架,影响推送效果。胶粘结合激光焊接,
双重保险,即使厌氧胶经过长时间脱落或者出现虚焊现象,仍能保证内管的TIP不会掉进人体,出现医疗事故。
此外,内管的金属管上增加一个弹性镍钛倒刺进行往复式推送,当倒刺在外套管内时,镍钛弹性的倒刺抓取支架内壁往外释放支架出外管至血管病变位置,同时倒刺伸出外管,后拉倒刺至外管内(支架位置不变)再次抓取一段支架内壁再次推出一段,反复此动作直至完全释放。
倒刺采用镍钛切割热定型工艺,扩成尖角喇叭口,对于6F管鞘(即直径为6F的外套管),两尖角直线距离大于1.35mm。
这样,本发明设计的内管可统一为一种规格,推出所有符合6F管鞘的血管支架,解决了现有的一般输送***需要根据支架长度和直径定制内管长度的问题。并且,单手操作式往复小距离反复推送,易控制,手感更强。
【实施例4】
在本实施例中,血管支架输送***可以包括,但不限于:由右半壳110和左半壳120构成的壳体、清洗管300、主要由外套管200和内管800构成的导管组件、以及驱动组件400。
其中,血管支架输送***的具体结构,例如外套管200、内管800与其他部件的连接关系、驱动组件400、三通管500和清洗管300的具体结构等可如前述实施例中的具体描述。作为选择,在本发明的其他实施方式中,可以省略清洗管300,例如,对于一次性血管支架输送***,由于使用一次即丢弃,无需使用清洗管300对其进行清洗,因此,这样的血管支架输送***可以不具有清洗管300。作为选择,在本发明的其他实施方式中,也可以省略三通管500,例如,对于一次性血管支架输送***,由于使用一次即丢弃,无需使用三通管500对其进行清洗,因此,这样的血管支架输送***可以不具有三通管500,由此,内管800的第一端直接伸入到外套管200的内腔中。
在本实施例中,如图14所示,用于血管支架输送***的导管组件可以包括:外套管200;内管800,所述内管800能够沿轴向穿过所述外套管800;导向头1100,所述导向头1100具有延长度方向贯穿该导向头的通道,所述导向头100的一部分***所述外套管200内并且通过连接管1000与所述内管500连接且相通,用于引导所述外套管200和内管800在血管内的行进方向。其
中,所述连接管1000在导向头1100的通道内注塑成型。
下面在图14的基础上结合图15对本发明实施方式的导管组件进行详细说明。为了清楚起见,在图15中,省略了外套管,仅示出了内管800和导向头1100。在本发明实施方式中,导向头1100可以包括:
内管接合部1101,用于***所述外套管200内并且通过所述连接管1000与所述内管200的位于所述外套管200内的一部分连接;
外套管阻止部1102,与所述内管接合部1101相连并且与所述内管接合部1101形成为台阶结构,所述外套管阻止部1102与外套管200的端部接触并且所述外套管阻止部1102的直径与所述外套管的直径相等,即D1=D2;
引导部1103,所述引导部1103位于所述内管接合部1101的相反侧,与所述外套管阻止部1102相连,所述引导部1103的直径自所述外套管阻止部起逐渐线性缩小,即,引导部1103的直径从外套管阻止部1102起随轴向长度成比例地或线性变小,也就是说,所述引导部1103的截面形状形成为锥形,因此,导向头1100也可称为TIP头。
在本发明的一种实施方式中,所述连接管1000为在导向头1100内注塑成型的塑料管。通过在导向头内注塑成型的连接管与内管连接,增加了导向头、连接管和内管之间的接合强度,防止发生导向头意外脱落进入人体,提高了血管支架输送***操作的可靠性。在本发明的一种实施方式中,所述内管接合部1101的通道的内壁具有凹部1104,通过在所述内管接合部1101的通道内注塑形成所述连接管1000的一部分,连接管1000的其他部分通过相应的模具形成在TIP头的外部且与在内管接合部1101的通道内形成的那部分连续,即这两部分可以同时注塑成型,其中,所述内管800***到所述连接管1000内。换句话说,塑料管的***导向头1100的那端的轮廓呈喇叭口设计,一体式注塑预埋成型,这样,增加了塑料管与导向头之间的接合强度。所述内管的外壁与所述连接管的内壁通过粘结剂粘接。在本发明实施方式中,导向头1100的截面图中凹部1104呈楔形,但本发明的实施方式不限于此,可以采用其他任何截面形状的凹部,例如,方形、锥形、以及其他不规则形状,并且对凹部的数量不作限定,只要有助于增加塑料管与导向头之间的接合强度即可。
在一种实施方式中,在由所述内管接合部1101的端部和所述连接管1000
的外表面所形成的台阶处设置结构胶1200,使该结构胶1200形成从所述内管接合部1101到所述连接管1000的尺寸逐渐缩小的渐变结构。需要说明的是,本发明实施方式不限于此,可以省略所述结构胶的渐变式结构,也可以采用本领域的其他材料来抹平所述台阶。结构胶渐变式固化固定,在医生操作时,更容易使TIP头的内管接合部进入到外套管内,不会出现“台阶卡壳”现象,更方便医生操作。
作为选择,连接管1000可以仅在TIP头内注塑形成,这样可以省略外部成型工艺,提高生产效率。
在一种实施方式中,如图16所示,内管800可以包括,但不限于:金属编织管801、与该金属编织管801连接的金属管802、连接管803。所述连接管803套在所述金属管802与所述金属编织管801的连接处,所述连接管803通过粘结剂(例如,厌氧胶)与所述金属编织管801和所述金属管802粘接。并且,所述金属管802***连接管1000中,金属编织管801与所述内管的与驱动组件400接合的那部分(未单独示出)连接,其中,与驱动组件400接合的那部分可以是刚性管,例如,不锈钢管。在本发明的一种实施方式中,所述金属管802可以为镍钛管。例如,所述金属管802的与连接管1000连接的部分沿该金属管的长度方向具有螺旋切槽(如图14所示)。在金属管与塑料管粘接时,胶水进入螺旋切槽中,增加粘接强度。同时当内管800进入人体弯曲病变时,通过性会更好。作为选择,所述金属管802不限于与连接管1000连接的部分沿该金属管的长度方向具有螺旋切槽,所述金属管802的其他部分也可以具有螺旋切槽,由此可以进一步改善金属管802的通过性。
在一种实施方式中,所述金属编织管801为三层结构,其中,在所述三层结构中内层为PTFE(聚四氟乙烯)层、外层为PEBAX(嵌段聚醚酰胺树脂)层、以及位于所述内层与外层之间的中间层为金属丝编织层,例如不锈钢钢丝编织网。其中,所述金属管802与所述金属编织管801固定连接包括:所述金属管802与所述金属编织管801的金属丝编织层焊接,即激光焊接镍钛管与金属丝编织层。
在另一种实施方式中,可以省略连接管803,内管由金属编织管和金属管构成。金属管的一端与金属编织管连接,另一端与TIP头连接。所述金属管的一端部***到所述金属编织管的一端部内并且所述金属管与所述金属编织
管固定连接。
在另一种实施方式中,如图17所示,所述导管组件还包括设置在金属管802上的倒刺900,例如,倒刺900的尖角部向内管的径向张开,倒刺900的基部与连接管803连接且所述基部的径向尺寸与连接管803的径向尺寸相等,由此,倒刺900与连接管803的外表面形成连续表面,从而减少内管外表面的台阶,有利于医生的操作。同时,倒刺设置在金属管上,提高了倒刺处的刚性,解决了现有技术中由于刚性不足而发生打折现象。
此外,根据本发明的一些实施方式,导向头与内管通过连接件连接,增加了接合强度,防止发生导向头意外脱落进入人体,提高了血管支架输送***操作的可靠性,降低了患者的风险。
需要说明的是,以上是用于阐述本发明的思想、概念或原理的实施例,本发明并不局限于上述实施例。本领域技术人员根据本发明思想、概念或原理可以对上述实施例进行各种改变,得到更多的实施例。
本发明说明书中使用的术语和措辞仅仅为了举例说明,并不意味构成限定。本领域技术人员应当理解,在不脱离所公开的实施方式的基本原理的前提下,对上述实施方式中的各细节可进行各种变化。因此,本发明的保护范围只由权利要求确定,在权利要求中,除非另有说明,所有的术语应按最宽泛合理的意思进行理解。
Claims (47)
- 一种血管支架输送***,其特征在于,包括:壳体;外套管,所述外套管位于所述壳体的外部且与所述壳体的第一端连接;清洗管,所述清洗管与所述壳体的第二端连接,并且该清洗管的第一端位于所述壳体的内部,该清洗管的第二端伸出至所述壳体的外部;内管,所述内管的一部分位于所述壳体内,并且该内管的第一端伸入至所述外套管的内部,该内管的第二端从所述清洗管的第一端伸入至该清洗管的管腔内;驱动组件,所述驱动组件的一部分位于所述壳体内,与所述内管的位于该壳体内的一部分操作性接合,用于驱动所述内管以使所述内管在所述外套管和清洗管内能沿轴向移动;其中,所述内管的第二端的端部被设置成防止该内管的第二端的端部刮擦所述清洗管的管腔内壁。
- 如权利要求1所述的血管支架输送***,其特征在于,所述内管的第二端的端部被设置成防止该内管的第二端的端部刮擦所述清洗管的管腔内壁包括:所述内管的第二端的端部形成为圆滑端面。
- 如权利要求1所述的血管支架输送***,其特征在于,所述内管的第二端的端部被设置成防止该内管的第二端的端部刮擦所述清洗管的管腔内壁包括:所述内管的第二端的端部***热缩管中。
- 如权利要求3所述的血管支架输送***,其特征在于,所述内管的第二端与所述热缩管接触的部分经过防滑处理。
- 如权利要求3所述的血管支架输送***,其特征在于,所述内管的第二端的端部与所述热缩管固定连接。
- 如权利要求1至5中任意一项所述的血管支架输送***,其特征在于,所述清洗管为一体成型的二通管。
- 如权利要求6所述的血管支架输送***,其特征在于,所述清洗管的管腔内且位于该清洗管的第一端和第二端之间设置有导丝穿接口。
- 如权利要求7所述的血管支架输送***,其特征在于,所述清洗管的导丝穿接口处的管腔的内径逐渐缩小。
- 如权利要求6所述的血管支架输送***,其特征在于,所述清洗管的第二端的端部具有开口和封闭该开口的接头帽。
- 如权利要求6所述的血管支架输送***,其特征在于,还包括:三通管,该三通管位于所述壳体的第一端,该三通管具有伸出至所述壳体的外部的第一端、位于所述壳体内且与第一端直线相通的第二端、以及设置在所述第一端和第二端之间且伸出至所述壳体的外部的第三端;其中,所述三通管的第一端与所述外套管连通,所述内管的第一端从该三通管的第二端伸入并穿过该三通管,从该三通管的第一端伸入至所述外套管内。
- 如权利要求10所述的血管支架输送***,其特征在于,所述三通管的第三端的端部具有开口和封闭该开口的接头帽。
- 如权利要求10所述的血管支架输送***,其特征在于,在所述清洗管的第一端和所述三通管的第二端中的至少一者的端部处设置有密封组件,所述内管能够穿过所述密封组件。
- 如权利要求12所述的血管支架输送***,其特征在于,所述密封组件包括O型圈和固定所述O型圈的盖板。
- 如权利要求13所述的血管支架输送***,其特征在于,所述O型圈的厚度由中央朝向边缘逐渐变薄。
- 如权利要求13所述的血管支架输送***,其特征在于,所述O型圈与所述内管接触的表面具有润滑层。
- 如权利要求15所述的血管支架输送***,其特征在于,所述润滑层的本体材质包括派瑞林、聚四氟乙烯、聚乙烯吡咯烷酮和硅油中的任意一种。
- 一种血管支架输送***,其特征在于,包括:壳体;外套管,所述外套管位于所述壳体的外部且通过应力扩散组件与所述壳体连接,其中,所述应力扩散组件用于扩散在所述外套管与所述壳体连接处集中的应力;内管,所述内管的一部分位于所述壳体内,并且该内管的一端能够伸入至所述外套管的内部;驱动组件,所述驱动组件的一部分位于所述壳体内,与所述内管的位于该壳体内的一部分操作性接合,用于驱动所述内管以使所述内管在所述外套管内能沿轴向移动。
- 如权利要求17所述的血管支架输送***,其特征在于,所述应力扩散组件包括:接头件,所述接头件具有沿长度方向从第一端贯穿至第二端的通道,并且所述接头件的第二端与所述壳体固定连接;导通管,所述导通管的一部分从所述接头件的第二端伸入至该接头件的通道内,所述导通管的另一部分位于所述壳体内;应力扩散管,所述应力扩散管的一部分位于所述接头件的外部,该应力扩散管的另一部分从所述接头件的第一端伸入该接头件的通道、穿过该通道并延伸到所述导通管的内部;其中,所述外套管伸入所述应力扩散管并在所述应力扩散管内延伸至位于所述接头件的内部,所述内管能够穿过所述导通管和应力扩散管并伸入到所述外套管的内部。
- 如权利要求18所述的血管支架输送***,其特征在于,所述外套管为PEBAX钢丝编织管,所述应力扩散管为PA12管,所述接头件为橡胶头,所述导通管由ABS材料制成。
- 如权利要求18所述的血管支架输送***,其特征在于,所述外套管与所述应力扩散管粘接,所述应力扩散管与所述导通管粘接。
- 如权利要求18所述的血管支架输送***,其特征在于,所述接头件的通道的容纳所述导通管的部分的内径大于容纳所述应力扩散管的部分的内径。
- 如权利要求18至21任意一项所述的血管支架输送***,其特征在于,所述导通管为三通管;其中,所述三通管具有伸入至所述接头件内部的第一端、位于所述壳体内且与第一端直线相通的第二端、以及设置在所述第一端和第二端之间且伸出至所述壳体的外部的第三端;其中,所述内管从该三通管的第二端伸入并穿过该三通管,从该三通管的第一端伸入至所述外套管内。
- 如权利要求22所述的血管支架输送***,其特征在于,所述三通管的第三端的端部具有开口和封闭该开口的接头帽。
- 如权利要求23所述的血管支架输送***,其特征在于,在所述三通管的第二端的端部处设置有密封组件,所述内管能够穿过所述密封组件。
- 如权利要求24所述的血管支架输送***,其特征在于,所述密封组 件包括O型圈和固定所述O型圈的盖板。
- 如权利要求25所述的血管支架输送***,其特征在于,所述O型圈的厚度由中央朝向边缘逐渐变薄。
- 如权利要求26所述的血管支架输送***,其特征在于,所述O型圈与所述内管接触的表面具有润滑层。
- 一种用于血管支架输送***的导管组件,其特征在于,所述导管组件包括:外套管;内管,所述内管的至少一部分位于所述外套管内,所述内管包括金属编织管和与该金属编织管连接的金属管;倒刺,设置在所述内管的金属管上,所述倒刺配置成当所述内管相对于外套管移动时能够移动血管支架。
- 如权利要求28所述的导管组件,其特征在于,所述金属管的一端部***到所述金属编织管的一端部内并且彼此固定连接。
- 如权利要求29所述的导管组件,其特征在于,所述金属编织管为三层结构,其中,在所述三层结构中内层为PTFE层、外层为PEBAX层、以及位于所述内层与外层之间的中间层为金属丝编织层。
- 如权利要求30所述的导管组件,其特征在于,所述金属管与所述金属编织管固定连接包括:所述金属管与所述金属编织管的金属丝编织层焊接。
- 如权利要求31所述的导管组件,其特征在于,所述内管还包括连接管,其中,所述连接管套在所述金属管与所述金属编织管的连接处,所述连接管通过粘结剂与所述金属编织管和所述金属管粘接。
- 如权利要求32所述的导管组件,其特征在于,在所述金属管的与所述连接管粘接的部分上沿该金属管的长度方向具有螺旋切槽。
- 如权利要求32所述的导管组件,其特征在于,所述粘结剂包括厌氧胶。
- 如权利要求31所述的导管组件,其特征在于,所述焊接包括激光焊接。
- 如权利要求32所述的导管组件,其特征在于,所述倒刺设置成在所述金属管上与所述连接管邻接。
- 一种血管支架输送***,其特征在于,包括:壳体;按照权利要求28至36中任意一项所述的导管组件,其中,所述导管组件的外套管位于所述壳体的外部且与所述壳体连接,所述导管组件的内管的一部分位于所述壳体内,并且该内管的另一部分位于所述外套管的内部;驱动组件,所述驱动组件的一部分位于所述壳体内,与所述内管的位于该壳体内的一部分操作性接合,用于驱动所述内管在所述外套管内能沿轴向移动。
- 一种用于血管支架输送***的导管组件,其特征在于,所述导管组件包括:外套管;内管,所述内管能够在所述外套管内沿轴向移动;导向头,所述导向头具有沿长度方向贯穿该导向头的通道,所述导向头的一部分***所述外套管内并且通过连接管与所述内管连接且相通;其中,所述连接管在所述导向头的通道内注塑成型。
- 如权利要求38所述的导管组件,其特征在于,所述导向头包括:内管接合部,用于***所述外套管内并且通过所述连接管与所述内管连接;外套管阻止部,与所述内管接合部相连并且与所述内管接合部形成为台阶结构,所述外套管阻止部与外套管的端部接触并且所述外套管阻止部的直径与所述外套管的直径相等;引导部,所述引导部位于所述内管接合部的相反侧,与所述外套管阻止部相连,所述引导部的直径自所述外套管阻止部起沿轴向长度线性缩小。
- 如权利要求39所述的导管组件,其特征在于,所述导向头的所述内管接合部处的通道的内壁具有凹部,所述连接管在具有所述凹部的通道内注塑成型,所述内管***到所述连接管内。
- 如权利要求40所述的导管组件,其特征在于,所述内管的外表面与所述连接管的内壁通过粘结剂粘接。
- 如权利要求40所述的导管组件,其特征在于,在由所述内管接合部的端部和所述连接管的外表面所形成的台阶处通过设置结构胶以形成从所述内管接合部到所述连接管的尺寸逐渐缩小的渐变结构。
- 如权利要求38至42任意一项所述的导管组件,其特征在于,所述内管包括金属编织管和与该金属编织管连接的金属管,其中,所述金属管与所述连接管连接。
- 如权利要求43所述的导管组件,其特征在于,所述金属管为镍钛管。
- 如权利要求44所述的导管组件,其特征在于,所述金属管上沿该金属管的长度方向具有螺旋切槽。
- 如权利要求43所述的导管组件,其特征在于,所述导管组件还包括设置在所述金属管上的倒刺。
- 一种血管支架输送***,其特征在于,包括:壳体;按照权利要求38至46中任意一项所述的导管组件,其中,所述导管组件的外套管位于所述壳体的外部且与所述壳体连接,所述导管组件的内管的一部分位于所述壳体内,并且该内管的一端能够伸入至所述外套管的内部;驱动组件,所述驱动组件的一部分位于所述壳体内,与所述内管的位于该壳体内的一部分操作性接合,用于驱动所述内管在所述外套管内能沿轴向移动。
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CN201620301609.7U CN205698141U (zh) | 2016-04-12 | 2016-04-12 | 血管支架输送***及其导管组件 |
CN201620301792.0U CN205698143U (zh) | 2016-04-12 | 2016-04-12 | 血管支架输送*** |
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CN201610224595.8A CN107280830B (zh) | 2016-04-12 | 2016-04-12 | 血管支架输送***及其导管组件 |
CN201620301833.6U CN205698144U (zh) | 2016-04-12 | 2016-04-12 | 血管支架输送*** |
CN201610224686.1A CN107280831B (zh) | 2016-04-12 | 2016-04-12 | 血管支架输送***及其导管组件 |
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