WO2021258772A1 - 一种医用装置 - Google Patents

一种医用装置 Download PDF

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Publication number
WO2021258772A1
WO2021258772A1 PCT/CN2021/078993 CN2021078993W WO2021258772A1 WO 2021258772 A1 WO2021258772 A1 WO 2021258772A1 CN 2021078993 W CN2021078993 W CN 2021078993W WO 2021258772 A1 WO2021258772 A1 WO 2021258772A1
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Prior art keywords
catheter
proximal end
handle
perfusion catheter
medical device
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PCT/CN2021/078993
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English (en)
French (fr)
Inventor
朱清
孙立忠
刘金宏
王丽文
袁振宇
王韶霞
Original Assignee
上海微创心脉医疗科技(集团)股份有限公司
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Publication of WO2021258772A1 publication Critical patent/WO2021258772A1/zh

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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
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027Type of occlusion
    • A61B17/1204Type of occlusion temporary occlusion
    • A61B17/12045Type of occlusion temporary occlusion double occlusion, e.g. during anastomosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136Balloons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires
    • 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
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • 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
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/12127Double occlusion, e.g. for creating blood-free anastomosis site
    • 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
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1052Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • 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
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1097Balloon catheters with special features or adapted for special applications with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon

Definitions

  • the invention relates to the technical field of medical devices, in particular to a medical device, which is used in the treatment of combined aortic total arch replacement surgery and stent elephant trunk surgery.
  • Aortic dissection means that the blood in the aortic lumen enters the aortic media from the tear of the aortic intima to separate the media and expands along the long axis of the aorta to form a true and false two-lumen separation state of the aortic wall.
  • Stanford type B dissections with breaches located in the descending aorta are generally treated with interventional treatments
  • Stanford type A dissections with breaches involving the ascending aorta and aortic arch generally use total aortic arch replacement surgery and The stent is combined with elephant trunk surgery for treatment.
  • Elephant trunk surgery refers to the implantation of a free artificial blood vessel in the descending aorta during ascending aorta and aortic arch replacement surgery, so that deep hypothermic circulatory arrest is no longer required during the second-stage descending aortic surgery.
  • Elephant trunk surgery shortens the aortic occlusion time and reduces the risk of ischemic complications.
  • traditional elephant trunk surgery can easily lead to aortic wall tear due to limited visual field and difficulty in accessing and removing needles.
  • due to the time of intraoperative circulatory arrest Long it is easy to cause postoperative brain complications.
  • the Sun’s surgery in the prior art is (namely, total aortic arch replacement surgery + stent elephant trunk surgery) for the treatment of Stanford A-type dissection, which further simplifies the surgical process, but the surgery also requires circulatory arrest at deep hypothermia. Under the conditions.
  • the purpose of the present invention is to provide a medical device for providing a clear surgical field of vision, and performing descending aortic anastomosis under conditions of extracorporeal circulation, which greatly shortens the time for deep hypothermic circulatory arrest and reduces the impact on vital organs of the patient’s lower body.
  • the ischemia and low temperature injury of the patient are beneficial to the postoperative recovery of the patient.
  • the medical device also improves the fit of the elephant trunk stent and the patient’s own blood vessel, facilitates the anastomosis operation, and shortens the anastomosis time.
  • the present invention provides a medical device, which includes:
  • the blocking mechanism includes a balloon and a catheter body; the balloon is arranged on the outer surface of the perfusion catheter; the catheter body is in communication with the balloon and is used to infuse the balloon with a filling agent; and,
  • the supporting mechanism includes a supporting body and a driving body.
  • the supporting body is arranged on the outer surface of the perfusion catheter and is located on the proximal side of the balloon; the driving body is connected to the supporting body for driving The support body expands outwardly or contracts inwardly along its radial direction.
  • the driving body is sleeved on the outer surface of the perfusion catheter and can move along the axial direction of the perfusion catheter; the distal end of the support body is fixedly connected to the perfusion catheter, and the support body The proximal end of the drive body is fixedly connected to the distal end of the driving body;
  • the supporting mechanism is configured to: when the driving body moves to the distal end of the perfusion catheter, the driving body drives the proximal end of the supporting body to move to the distal end of the perfusion catheter, so that the The support body deforms and expands; when the driver body moves toward the proximal end of the perfusion catheter, the driver body drives the proximal end of the support body to move toward the proximal end of the perfusion catheter, so that the support Body contraction.
  • the support body is woven from a plurality of braided wires, and at least part of the braided wires are metal wires.
  • the maximum diameter of the support body when it is expanded is 35 mm-40 mm.
  • the supporting mechanism further includes a first handle which is arranged on the outer surface of the perfusion catheter and can move along the axial direction of the perfusion catheter.
  • the proximal end of the driving body is fixedly connected.
  • the support mechanism further includes a locking component, the locking component is arranged on the first handle for selectively connecting or disconnecting with the perfusion catheter;
  • the support mechanism is configured to prevent the first handle, the driving body, and the proximal end of the support body from moving along the axial direction of the irrigation catheter when the locking assembly is connected to the irrigation catheter When the locking assembly is disconnected from the perfusion catheter, the proximal end of the first handle, the driving body and the support body are allowed to move along the axial direction of the perfusion catheter.
  • the locking assembly includes a locking portion and a nut; the locking portion is provided at the proximal end of the first handle and has a hollow tubular structure, and the locking portion is provided with an external thread, And the proximal end of the locking part is provided with a plurality of opening grooves; the nut is used for sleeved on the outer surface of the locking part, and is threadedly connected with the locking part.
  • the catheter body is inserted into the interior of the perfusion catheter, and the distal end of the catheter body penetrates the distal end wall of the perfusion catheter to communicate with the balloon.
  • the blocking mechanism further includes an injection tube, the injection tube is spirally wound inside the first handle, and the distal end of the injection tube extends into the perfusion catheter and interacts with the The proximal end of the catheter body is connected, and the proximal end of the injection tube penetrates the first handle and protrudes to the outside of the first handle;
  • the proximal end of the injection tube moves synchronously with the first handle, so that the injection tube is stretched and deformed.
  • it further comprises a second handle which is arranged on the outer surface of the irrigation catheter and is located at the proximal end of the first handle.
  • the blocking mechanism further includes an injection tube, the distal end of the injection tube extends into the perfusion catheter and is connected to the proximal end of the catheter body, and the proximal end of the injection tube penetrates the first Two handles extend to the outside of the second handle.
  • a one-way valve is provided at the proximal end of the injection tube.
  • the medical device of the present invention has the following advantages:
  • the medical device includes a perfusion catheter, a blocking mechanism, and a supporting mechanism; wherein, the blocking mechanism includes a balloon and a catheter body, and the balloon is disposed on the outer surface of the perfusion catheter; the catheter body is connected to the catheter body.
  • the balloon is in communication and is used to infuse the balloon with filling agent;
  • the support mechanism includes a support body and a driving body, the support body is arranged on the outer surface of the perfusion catheter and is located near the balloon The end side; the driving body is connected to the support body, and is used to drive the support body to expand or contract inward along its radial direction.
  • the catheter body is used to infuse the balloon with filling agent so that the balloon is inflated to fit the inner wall of the trunk stent, thereby Separate the inside of the elephant trunk stent into two disconnected parts to block the blood returning from the descending aorta, so that the blood in the descending aorta will not flow back into the aortic arch and the ascending aorta, providing a clear vision for the operation;
  • the perfusion catheter is connected to an external circulation machine to perfuse the patient's lower body with blood, so that an anastomosis operation can be performed without deep hypothermic circulatory arrest, which significantly shortens the deep hypothermia and circulatory arrest time during the operation, and reduces the impact on the patient's lower body.
  • Damage to important organs is conducive to the patient’s postoperative recovery; more particularly, by arranging a support body on the perfusion catheter and placing the support body on the proximal side of the elephant trunk stent, the balloon is filled After that, and before resuming the cardiopulmonary bypass, the driving body drives the support body to expand to support the proximal end of the elephant trunk stent, so that the proximal end of the elephant trunk stent is re-expanded and is connected to the patient’s autologous blood vessel.
  • the internal wall fit on the one hand, blocks the blood return between the outer side of the elephant trunk stent and the autogenous blood vessel, and further provides a clean surgical field.
  • the support body is woven from a plurality of braided wires, and at least part of the braided wires are metal wires. That is, the support body is mainly made of metal materials to ensure that the support body has sufficient strength to effectively support the proximal end of the elephant trunk stent, so that the proximal end of the elephant trunk stent can be expanded again to match The inner walls of the autologous blood vessels fit together.
  • the supporting mechanism includes a first handle, the first handle is arranged on the outer surface of the perfusion catheter, and can move along the axial direction of the perfusion catheter, and the first handle and the drive The proximal end of the body is fixedly connected, which is convenient for the surgeon to hold to push the driving body to move along the axial direction of the perfusion catheter. Further, the supporting mechanism further includes a locking component, which is provided on the first handle, and is used to selectively connect or disconnect the perfusion catheter.
  • the locking assembly When the locking assembly is disconnected from the perfusion catheter, the proximal end of the first handle, the driving body, and the support body is allowed to move along the axial direction of the perfusion catheter, so that the support body Expandable; when the support body is expanded to a suitable extent to support the proximal end of the elephant trunk stent to closely fit the inner wall of the autologous blood vessel, the locking assembly is connected to the perfusion catheter to prevent the first The handle, the driving body and the proximal end of the support body move along the axial direction of the perfusion catheter to achieve the purpose of locking the support body in the expanded state and facilitate the operation of the anastomosis by the surgeon.
  • Fig. 1 is a schematic structural diagram of a medical device according to an embodiment of the present invention.
  • Fig. 2 is a schematic diagram of the state of use of the medical device shown in Fig. 1;
  • Fig. 3 is a structural schematic diagram of a support body of a medical device according to an embodiment of the present invention when it is expanded;
  • FIG. 4 is a schematic structural diagram of a driving body of a supporting mechanism of a medical device according to an embodiment of the present invention
  • FIG. 5 is a schematic structural diagram of a locking assembly of a supporting mechanism of a medical device according to an embodiment of the present invention, in which the locking part is separated from the nut in the figure;
  • Fig. 6 is a schematic structural diagram of a medical device provided according to another embodiment of the present invention.
  • Fig. 7 is an enlarged schematic diagram of the medical device shown in Fig. 6 at A;
  • Fig. 8 is a schematic diagram of a state of use of the medical device shown in Fig. 6.
  • each embodiment of the following description has one or more technical features.
  • this does not mean that the user of the present invention must implement all the technical features in any embodiment at the same time, or can only implement separately in different embodiments. Part or all of the technical characteristics of the In other words, on the premise that implementation is possible, those skilled in the art can selectively implement some or all of the technical features in any embodiment according to the disclosure of the present invention and depending on design specifications or implementation requirements, or The combination of some or all of the technical features in multiple embodiments is selectively implemented, thereby increasing the flexibility of the implementation of the present invention.
  • the singular forms “a”, “an” and “the” include plural objects, and the plural form “plurality” includes two or more objects, unless the content clearly indicates otherwise.
  • the term “or” is usually used to include the meaning of “and/or”, unless the content clearly indicates otherwise, and the terms “installed”, “connected”, and “connected” shall be used. In a broad sense, for example, it may be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected, or indirectly connected through an intermediate medium, and it can be a communication between two elements or an interaction relationship between two elements. For those of ordinary skill in the art, the specific meanings of the above-mentioned terms in the present invention can be understood according to specific situations.
  • proximal and distal refer to the relative position, relative position, and direction of elements or actions relative to each other from the perspective of the doctor using the medical device, although the “proximal” and “distal” “Is not restrictive, but “proximal” usually refers to the end of the medical device that is close to the doctor during normal operation, and “distal” usually refers to the end that first enters the patient's body. Unless the content clearly indicates otherwise.
  • the purpose of the present invention is to provide a medical device, including a perfusion catheter, a blocking mechanism and a supporting mechanism.
  • the blocking mechanism includes a balloon and a catheter body, the balloon is arranged on the outer surface of the perfusion catheter, the catheter body is in communication with the balloon, and is used to infuse the balloon with a filling agent .
  • the supporting mechanism includes a supporting body and a driving body, and the supporting body is arranged on the outer surface of the perfusion catheter and located on the proximal side of the balloon.
  • the driving body is connected with the support body and is used to drive the support body to expand outward or contract inward along its radial direction.
  • the medical device is used in combination with an elephant trunk stent to perform surgical treatment on aortic dissection, for example, in Sun's surgery.
  • the perfusion catheter is first connected to the elephant trunk stent, so that the medical device is fixed in the aorta, wherein the balloon is located in the middle of the inner cavity of the elephant trunk stent, and the support body is located at the center of the lumen of the elephant trunk stent.
  • the proximal lumen of the elephant trunk stent is described.
  • the catheter body is used to infuse the balloon with a filling agent to inflate the balloon to fit the inner wall of the elephant trunk stent, so as to separate the interior of the elephant trunk stent into two disconnected parts.
  • the balloon expansion is used to block the blood returning from the descending aorta, to prevent the blood in the descending aorta from entering the aortic arch and the ascending aorta, and to provide a clear vision for the operation.
  • the surgeon manipulates the driving body to drive the support body to expand and support the proximal end of the elephant trunk stent, so that the proximal end of the elephant trunk stent expands again until the proximal end of the elephant trunk stent is in contact with the body.
  • the inner wall of the blood vessel closely fits, on the one hand, it can block the blood return between the outer wall of the elephant trunk stent and the proximal rupture of the descending aorta, and further provide a clean surgical field of vision.
  • the perfusion catheter is connected to an extracorporeal circulation machine to perform extracorporeal circulation. Finally, the doctor performs anastomosis and other surgical operations.
  • the medical device provided by the present invention provides a clean surgical field of vision through the cooperation of the balloon and the support, uses the perfusion catheter to establish extracorporeal circulation, reduces the time of deep hypothermia circulatory arrest, and supports
  • the function of the body can also facilitate the anastomosis operation and provide convenience for the operation.
  • the surgical treatment of aortic dissection can be carried out according to the following process: when the temperature of the cardiopulmonary bypass reaches about 28°C, the selective anterograde perfusion of the brain can be maintained; after that, the circulation can be stopped, the aortic arch can be opened, and the elephant trunk stent can be implanted. Medical device; then use the balloon of the blocking mechanism to block the aortic blood flow; then restore the circulation, and finally perform anastomosis and other operations.
  • the medical device when used for the surgical treatment of aortic dissection, on the one hand, the patient's body temperature does not need to be lowered too low, thereby effectively protecting the patient's visceral function and blood coagulation function, and avoiding the patient's related organs.
  • Time ischemia and hypoxia damage reduce the complications caused by postoperative coagulation dysfunction.
  • blood circulation can be carried out during the intraoperative anastomosis, which reduces the pressure of the surgeon due to the long anastomosis time.
  • a support mechanism is also provided on the perfusion catheter, and the support mechanism is used to support the proximal end of the elephant trunk stent, so that the proximal end of the elephant trunk stent is closely attached to the inner wall of the patient’s own blood vessel. It is convenient for anastomosis and further shortens the operation time.
  • the support body is mainly made of metal materials, so that when the support body supports the proximal end of the elephant trunk stent, it can provide a sufficient radial support force to ensure the The proximal end then expands and fits closely with the inner wall of the autologous blood vessel.
  • Fig. 1 shows a schematic structural diagram of a medical device provided by a preferred embodiment of the present invention
  • Fig. 2 shows a schematic diagram of a use state of the medical device.
  • the medical device 10 includes a perfusion catheter 100, a blocking mechanism 200 and a supporting mechanism 300.
  • the perfusion catheter 100 is a hollow structure.
  • the blocking mechanism 200 includes a balloon 210 and a catheter body 220.
  • the balloon 210 is sleeved on the outer surface of the perfusion catheter 100.
  • the catheter body 220 is in communication with the balloon 210 and is used to The balloon 210 is filled with a filling agent.
  • the supporting mechanism 300 includes a supporting body 310 and a driving body 320.
  • the supporting body 310 is sleeved on the outer surface of the perfusion catheter 100 and located at the proximal end of the balloon 210.
  • the driving body 320 is connected to the supporting body 310 for driving the supporting body 310 to expand outward or contract inward along its radial direction.
  • the patient's aortic arch is opened, and the elephant stent 20 is implanted in the descending aorta region of the patient's aorta, and the elephant stent 20 is expanded to support the wall of the descending aorta.
  • the medical device 10 is placed in the aorta, and the distal end of the perfusion catheter 100 is connected to the trunk stent 20, and the balloon 210 is set in the middle section of the trunk stent 20
  • the supporting body 310 is arranged in the inner cavity of the proximal end of the trunk bracket 20. It is well known to those skilled in the art that, in order to facilitate the connection between the two, the distal end of the perfusion catheter 100 may protrude from the distal end of the balloon 210.
  • the catheter body 220 is used to infuse the balloon 210 with a filling agent, so that the balloon 210 is inflated to fit the inner wall of the trunk stent 20.
  • the inner cavity of the elephant trunk stent 20 is divided into two parts that are not connected to each other, thereby blocking the blood circulation in the aorta, so that the blood in the descending aorta cannot flow back into the aortic arch and the aorta .
  • the driving body 320 is used to drive the supporting body 310 to expand, and the expanded supporting body 310 supports the proximal end of the elephant trunk stent 20 so that the proximal end of the elephant trunk stent 20 is in line with the patient’s own blood vessels.
  • the inner wall fits closely to block the blood return between the outer side of the elephant trunk stent 20 and the proximal rupture of the descending aorta.
  • the balloon 210 is used to block the blood flow of the aorta to prevent the aorta from returning blood
  • the support body 310 is used to support the proximal end of the trunk stent 20 to prevent The blood return between the elephant trunk stent 20 and the proximal rupture of the descending aorta is broken, thereby providing a clean and clear surgical field of vision at the aortic arch and the ascending aorta.
  • the perfusion catheter 100 can be used to restore extracorporeal circulation, which reduces the time of stopping the circulation, so there is no need to reduce the patient's body temperature to too low, which effectively protects the patient's visceral function and coagulation function, and greatly reduces postoperative coagulation dysfunction. Complications caused.
  • the support body 310 is used to support the proximal end of the elephant trunk stent 20, so that the elephant trunk stent 20 fits the inner wall of the autologous blood vessel, which is also convenient for the doctor to perform the anastomosis operation, facilitates the operation, and shortens the anastomosis time. , Thereby shortening the operation time.
  • the perfusion catheter 100 is used to perfuse the patient's lower body with blood. Therefore, the perfusion catheter 100 is made of a flexible and flexible medical polymer tube so that the perfusion catheter 100 can enter Any angle of the descending aorta, and for blood circulation. In this embodiment, the diameter of the perfusion catheter 100 is 8mm-12mm.
  • the balloon 210 can be a compliant balloon, which can be expanded according to the size of the elephant trunk stent 20 until it fits closely with the inner wall of the elephant trunk stent 20 to block the descending aorta from returning blood.
  • the support body 310 has an expanded state and a contracted state.
  • the operator uses the driving body 320 to drive the proximal end of the support body 310 to move along the axial direction of the perfusion catheter 100 to realize the expansion of the support body 310.
  • the driving body 320 is sleeved on the outer surface of the perfusion catheter 100 and can move along the axial direction of the perfusion catheter 100.
  • the distal end of the support body 310 is fixedly connected to the perfusion catheter 100, so that the distal end of the support body 310 and the perfusion catheter 100 remain relatively static, and the proximal end of the support body 310 is connected to the driving body 320.
  • the distal end of the supporting body 310 is fixedly connected, so that the proximal end of the supporting body 310 can move synchronously with the driving body 320.
  • the supporting mechanism 300 is configured such that when the driving body 320 moves to the distal end of the perfusion catheter 100, the proximal end of the supporting body 310 is synchronized with the driving body 320 to the perfusion catheter 100. The distal end moves to deform the support body 310 to the expanded state.
  • the proximal end of the support body 310 moves synchronously with the driving body 320 to the proximal end of the perfusion catheter 100, so that the support The shape of the body 310 is restored and returns to the contracted state.
  • the diameter of the support body 310 in the contracted state is 9mm-13mm, and when the support body 310 is in the expanded state, the maximum diameter of the support body 310 can reach 35mm-40mm.
  • the supporting body 310 is sufficient to support the proximal end of the elephant trunk bracket 20 so that it fits with the inner wall of the patient's own blood vessel.
  • the supporting body 310 is mainly made of metal materials, which can ensure that when the supporting body 310 is in the expanded state, it can provide sufficient supporting force for the proximal end of the trunk stent 20, so that the The proximal end of the elephant trunk bracket 20 fits with the inner wall of the patient's own blood vessel.
  • the support body 310 is formed by braiding and shaping a plurality of braided wires, and at least part of the braided wires are metal wires, preferably the All braided wires are metal wires.
  • the metal wire is made of a shape memory alloy such as Nitinol. The high elasticity of the shape memory alloy can realize the deformation and recovery of the support body 310, so that the support body 310 is in the expanded state and the Switch between contracted states.
  • the supporting body 310 when the supporting body 310 is in the expanded state, the supporting body 310 has a cage-like structure. As shown in FIG.
  • the The supporting body 310 has a pipe network structure.
  • the distal end of the support body 310 may be fixedly connected to the perfusion catheter 100 through a snap ring, and the proximal end of the support body 310 may be fixedly connected to the distal end of the driving body 320 through a snap ring.
  • the driving body 320 moves along the axial direction of the perfusion catheter 100, and it needs to have good flexibility and good supporting force, so that the driving body 320 follows the bending of the perfusion catheter 100 at the same time,
  • the proximal end of the support body 310 can also be pushed to move, so that the support body 310 is switched from the contracted state to the expanded state. Therefore, as shown in FIG. 4, it is preferable that the driving body 320 includes an inner tube body 321, a supporting wire 322 and an outer tube body 323.
  • the inner tube body 321 and the outer tube body 323 are both polymer tubes, the supporting metal wire 322 is spirally wound on the outer surface of the inner tube body 321, and the outer tube body 323 is sheathed
  • the inner tube body 321 is covered with the supporting metal wire 322.
  • the inner and outer polymer tubes are used to improve the flexibility of the driving body 320, and at the same time, the support wire 322 is used to improve the support force, so as to achieve the effect of balancing the two.
  • the supporting mechanism 300 further includes a first handle 330
  • the first handle 330 has an axially penetrating inner cavity
  • the perfusion catheter 100 can movably penetrate the first handle 330
  • the first handle 330 is sleeved on the outer surface of the perfusion catheter 100 and can move along the axial direction of the perfusion catheter 100.
  • the first handle 330 is fixedly connected to the proximal end of the driving body 320. The surgeon holds the first handle 330 and pushes the first handle 330 to move along the axial direction of the perfusion catheter 100 to move the driving body 320, which is convenient for operation.
  • the supporting mechanism 300 further includes a locking assembly 340, the locking assembly 340 is arranged on the first handle 330, for selectively connecting with the perfusion catheter 100 Or disconnect.
  • the locking assembly 340 is connected to the perfusion catheter 100, the proximal ends of the first handle 330, the driving body 320 and the support body 310 are prevented from moving along the axial direction of the perfusion catheter 100.
  • the locking assembly 340 is disconnected from the perfusion catheter 100, the proximal end of the first handle 330, the driving body 320 and the support body 310 are allowed to move along the axial direction of the perfusion catheter 100.
  • the locking assembly 340 can be used to lock the state of the support body 310, so that when the support body 310 is in the expanded state, the proximal end of the trunk stent 20 is tightly connected to the inner wall of the patient’s own blood vessel.
  • the locking assembly 340 and the perfusion catheter 100 are connected to maintain the support body 310 in the expanded state, so that the trunk stent 20 and the lower main body can be continuously blocked during the operation.
  • the blood return between the breaches at the proximal end of the artery is helpful for the surgeon to perform the anastomosis conveniently and quickly.
  • FIG. 5 shows a schematic structural diagram of an optional locking assembly 340.
  • the locking assembly 340 includes a locking portion 341 and a nut 342, and the locking portion 341 can be fixedly arranged at the proximal end of the first handle 330.
  • the locking portion 341 has a hollow tubular structure and is sleeved on the outer surface of the perfusion catheter 100.
  • the outer surface of the locking portion 341 is provided with external threads, and the proximal end of the locking portion 341 is provided with a plurality of opening grooves 341a to divide the proximal side wall of the locking portion 341 into a plurality of Clip 341b.
  • the nut 342 is sleeved on the outer surface of the locking portion 341 and is threadedly connected with the locking portion 341. By tightening the nut 342, the nut 342 radially presses the buckle 341b Then, the buckle 341b presses the outer surface of the perfusion catheter 100 to realize the connection with the perfusion catheter 100.
  • the support 310 is in the contracted state. Therefore, when the medical device 10 is used for surgery, the surgeon pushes the first handle 330 to the distal end of the perfusion catheter 100 to drive the driving body 320 to move, so as to drive the support body 310 to move closer to the support body 310. The end moves toward the distal end of the perfusion catheter 100 to deform the support body 310 to the expanded state to support the proximal end of the elephant trunk stent 20. After that, the surgeon connects the locking assembly 340 with the perfusion catheter 100 by rotating the nut 342 to lock the support body 310, and then the surgeon can perform an anastomosis operation.
  • the outer diameter of the catheter body 220 is smaller than the inner diameter of the perfusion catheter 100, and it is preferable that the catheter body 220 is disposed in the perfusion catheter 100.
  • the distal end penetrates the distal side wall of the perfusion catheter 100 and communicates with the balloon 210.
  • the catheter body 220, the perfusion catheter 100, and the driving body 320 are nested, so that the medical device 10 has a compact structure and avoids entanglement.
  • the medical device 10 further includes a second handle 400, the second handle 400 is fixedly arranged on the irrigation catheter 100 and is located at the proximal end of the first handle 330.
  • the blocking mechanism 200 further includes an injection tube 230.
  • the distal end of the injection tube 230 penetrates the side wall of the perfusion catheter 100 and then extends into the perfusion catheter 100, and is connected to the proximal end of the catheter body 220 ,
  • the proximal end of the injection tube 230 penetrates from the second handle 400 and extends to the outside of the second handle 400.
  • the balloon 210 is filled with filling agent by connecting the injection tube 230 with a syringe, so that the balloon 210 is filled.
  • the setting of the second handle 400 is convenient for injection operation.
  • the proximal end of the injection tube 230 is provided with a one-way valve 240, when the balloon 210 is filled to a suitable size, the one-way valve 240 is used to prevent the filling agent from being discharged from the balloon 210 .
  • the one-way valve 240 can be bonded to the proximal end of the injection tube 230 by UV glue.
  • the injection tube 230 has a spiral structure. 6-8, the first handle 330 is a hollow structure, the injection tube 230 is spirally wound inside the first handle 330, and the distal end of the injection tube 230 penetrates the perfusion catheter
  • the side wall of 100 extends into the perfusion catheter 100 and is connected to the proximal end of the catheter body 220.
  • the proximal end of the injection tube 230 penetrates from the first handle 330 and extends to the outside of the first handle 330.
  • a one-way valve 240 is provided on the proximal end of the injection tube 230.
  • the injection tube 230 is made of medical grade PVC material, which can be stretched and deformed, so that when the operator drives the first handle 330 to move to the distal end of the perfusion catheter 100, the injection tube 230 The proximal end of the first handle 330 moves synchronously and stretches and deforms. At this time, the connection between the distal end of the injection tube 230 and the catheter body 220 remains relatively static, and when the surgeon drives the first handle 330 toward the infusion catheter When the proximal end of 100 moves, the injection tube 230 can rebound.
  • the distal end refers to the end connected to the catheter body 220
  • the proximal end refers to the end away from the catheter body 220.
  • the medical device provided by the embodiment of the present invention includes a perfusion catheter, a blocking mechanism and a supporting mechanism.
  • the blocking mechanism includes a balloon and a catheter body, the balloon is sleeved on the outer surface of the perfusion catheter, and the catheter body is in communication with the balloon and is used to infuse the balloon with a filling agent .
  • the supporting mechanism includes a supporting body and a driving body. The supporting body is sleeved on the outer surface of the perfusion catheter and located at the proximal end of the balloon.
  • the driving body is connected to the supporting body and used for The support body is driven to expand outward or contract inward along its radial direction.
  • the medical device uses the balloon to block the returning blood from the descending aorta, and uses the support to re-expand the proximal end of the elephant trunk stent to block the
  • the blood return between the outer wall of the elephant trunk stent and the breach at the proximal end of the descending aorta provides a clean and clear surgical field of vision.
  • the perfusion catheter is used to perform extracorporeal circulation, shorten the time of deep hypothermia circulatory arrest, reduce the possibility of the vital organs of the patient's lower body being damaged due to hypothermia and ischemia, and facilitate the postoperative recovery of the patient.
  • the proximal end of the elephant trunk stent fits closely with the inner wall of the patient's own blood vessel, which is convenient for doctors to perform anastomosis operations and can shorten the operation time. That is, when the medical device is applied to the surgical treatment of aortic dissection, it can reduce the organ damage to the patient, facilitate the operation of the surgeon, and reduce the stress of the surgeon.

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Abstract

一种医用装置,医用装置(10)包括:灌注导管(100);阻断机构(200),包括球囊(210)和导管体(220),球囊(210)设置在灌注导管(100)的外表面上;导管体(220)与球囊(210)连通,用于向球囊(210)灌注充盈剂;以及,支撑机构(300),包括支撑体(310)和驱动体(320),支撑体(310)设置在灌注导管(100)的外表面上,并位于球囊(210)的近端;驱动体(320)与支撑体(310)连接,用于驱使支撑体(310)沿其径向向外扩张或向内收缩。该装置用于主动脉夹层的手术治疗时,可提供干净的手术视野,方便医生操作,降低停循环的时间。还公开了一种具有容纳注射管(230)的手柄和锁紧组件(340)的医用装置。

Description

一种医用装置 技术领域
本发明涉及医疗器械技术领域,具体涉及一种医用装置,应用在主动脉全弓置换术和支架象鼻术结合的治疗中。
背景技术
主动脉夹层是指主动脉腔内的血液从主动脉内膜撕裂处进入主动脉中膜使中膜分离,并沿主动脉长轴方向扩张形成主动脉壁的真假两腔分离状态,是一种病情危急、进展迅速、死亡率较高的主动脉疾病。主动脉中层的夹层血肿可引起严重的心血管急症,其中65%-70%的患者在急性期因心脏压塞、心率失常等原因死亡,因此主动脉夹层的早期治疗非常有必要。目前对于主动脉夹层主要采用手术治疗,其中,破口位于降主动脉的Stanford B型夹层一般采用介入治疗,破口累及升主动脉和主动脉弓的Stanford A型夹层一般采用主动脉全弓置换手术与支架象鼻手术结合的方式进行治疗。
象鼻手术是指在行升主动脉和主动脉弓置换术时,在降主动脉内植入一段游离的人工血管,从而在二期降主动脉手术时不再需要深低温停循环。象鼻手术缩短了主动脉阻断时间,降低了缺血并发症发生的风险,但是传统的象鼻手术因视野有限、进出针困难,容易导致主动脉壁撕裂,同时由于术中停循环时间长,极易导致术后脑并发症发生。现有技术中的孙氏手术是(即主动脉全弓置换手术+支架象鼻手术)治疗Stanford A型夹层的经典术式,其进一步简化了手术过程,但该手术同样需要在深低温停循环的条件下进行。
综上,现有技术中存在如下问题:手术视野显露困难,降主动脉回血进一步影响视野清晰度,手术需要在体外循环状态下进行,在进行降主动脉吻合时,往往由于各种原因导致象鼻支架近端与患者的自体血管贴合不良,不利于吻合,造成吻合时间过长,这就导致深低温停循环时间的延长,进而使得脊髓、肝脏、胃肠等器官受到缺血缺氧的损伤的可能性增大,不利于患者的术后恢复。
发明内容
本发明的目的在于提供一种医用装置,用于提供清晰的手术视野,并可在体外循环条件下进行降主动脉吻合操作,极大地缩短了深低温停循环的时间,降低对患者下半身重要器官的缺血和低温损伤,有利于患者的术后恢复,特别地,该医用装置还改善象鼻支架与患者自体血管的贴合性,便于吻合操作,缩短吻合时间。
为实现上述目的,本发明提供了一种医用装置,包括:
灌注导管;
阻断机构,包括球囊和导管体;所述球囊设置在所述灌注导管的外表面上;所述导管体与所述球囊连通,用于向所述球囊灌注充盈剂;以及,
支撑机构,包括支撑体和驱动体,所述支撑体设置在所述灌注导管的外表面上,并位于所述球囊的近端侧;所述驱动体与所述支撑体连接,用于驱使所述支撑体沿其径向向外扩张或向内收缩。
可选地,所述驱动体套设在所述灌注导管的外表面,并能够沿所述灌注导管的轴向移动;所述支撑体的远端与所述灌注导管固定连接,所述支撑体的近端与所述驱动体的远端固定连接;
所述支撑机构被配置为:当所述驱动体向所述灌注导管的远端移动时,所述驱动体驱使所述支撑体的近端向所述灌注导管的远端移动,以使所述支撑体发生变形而扩张;当所述驱动体向所述灌注导管的近端移动时,所述驱动体驱使所述支撑体的近端向所述灌注导管的近端移动,以使所述支撑体收缩。
可选地,所述支撑体由多根编织丝编织而成,且至少部分所述编织丝为金属丝。
可选地,所述支撑体扩张时的最大直径为35mm-40mm。
可选地,所述支撑机构还包括第一手柄,所述第一手柄设置在所述灌注导管的外表面上,并能够沿所述灌注导管的轴向移动,且所述第一手柄与所述驱动体的近端固定连接。
可选地,所述支撑机构还包括锁紧组件,所述锁紧组件设置在所述第一 手柄上,用于选择性地与所述灌注导管连接或解除连接;
所述支撑机构被配置为:当所述锁紧组件与所述灌注导管连接时,阻止所述第一手柄、所述驱动体及所述支撑体的近端沿所述灌注导管的轴向移动;当所述锁紧组件与所述灌注导管解除连接时,允许所述第一手柄、所述驱动体及所述支撑体的近端沿所述灌注导管的轴向移动。
可选地,所述锁紧组件包括锁紧部和螺母;所述锁紧部设置在所述第一手柄的近端,并为中空的管状结构,所述锁紧部上设置有外螺纹,且所述锁紧部的近端设置有多个开口槽;所述螺母用于套设在所述锁紧部的外表面上,并与所述锁紧部螺纹连接。
可选地,所述导管体穿设在所述灌注导管的内部,且所述导管体的远端贯穿所述灌注导管的远端管壁而与所述球囊连通。
可选地,所述阻断机构还包括注射管,所述注射管螺旋地盘绕在所述第一手柄的内部,且所述注射管的远端伸入所述灌注导管内,并与所述导管体的近端连接,所述注射管的近端贯穿所述第一手柄而伸出至所述第一手柄的外部;
当所述第一手柄朝向所述灌注导管的远端移动时,所述注射管的近端随所述第一手柄同步移动,以使所述注射管拉伸变形。
可选地,还包括第二手柄,所述第二手柄设置在所述灌注导管的外表面上,并位于所述第一手柄的近端。
可选地,所述阻断机构还包括注射管,所述注射管的远端伸入所述灌注导管内并与所述导管体的近端连接,所述注射管的近端贯穿所述第二手柄而伸出至所述第二手柄的外部。
可选地,所述注射管的近端设置有单向阀。
与现有技术相比,本发明的医用装置具有如下优点:
所述医用装置包括灌注导管、阻断机构和支撑机构;其中,所述阻断机构包括球囊和导管体,所述球囊设置在所述灌注导管的外表面上;所述导管体与所述球囊连通,并用于向所述球囊灌注充盈剂;所述支撑机构包括支撑体和驱动体,所述支撑体设置在所述灌注导管的外表面上,并位于所述球囊 的近端侧;所述驱动体与所述支撑体连接,并用于驱使所述支撑体沿其径向向外扩张或向内收缩。将所述医用装置应用于主动脉夹层的手术治疗时,利用所述导管体向所述球囊灌注充盈剂,以使所述球囊充盈至与所述象鼻支架的内壁相贴合,从而将所述象鼻支架的内部分隔为互不连通的两部分,阻断降主动脉回血,这样降主动脉中的血液不会逆流进入主动脉弓及升主动脉,为手术提供清晰的视野;利用所述灌注导管与外部的循环机相连,以对患者的下半身进行血液灌注,由此无需进行深低温停循环便可进行吻合操作,显著缩短手术过程中的深低温及停循环时间,减少对患者下半身重要器官的损伤,有利于患者的术后恢复;更特别地,通过在灌注导管上设置支撑体,并将所述支撑体设置在所述象鼻支架的近端侧,在所述球囊充盈之后,以及在恢复体外循环之前,所述驱动体驱动所述支撑体扩张,以支撑所述象鼻支架的近端,使得所述象鼻支架的近端再扩张,并与患者的自体血管的内壁贴合,一方面阻断象鼻支架的外侧与自体血管之间的回血,进一步提供干净的手术视野,另一方面还便于医生进行吻合操作,缩短吻合时间,进而缩短手术时间。
第二、所述支撑体由多根编织丝编织而成,且至少部分所述编织丝为金属丝。即所述支撑体主要由金属材料制作而成,确保所述支撑体具有足够的强度,以有效地支撑所述象鼻支架的近端,使所述象鼻支架的近端再扩张,以与自体血管的内壁相贴合。
第三、所述支撑机构包括第一手柄,所述第一手柄设置在所述灌注导管的外表面上,并能够沿所述灌注导管的轴向移动,且所述第一手柄与所述驱动体的近端固定连接,方便术者握持以推送所述驱动体沿所述灌注导管的轴向移动。进一步地,所述支撑机构还包括锁紧组件,所述锁紧组件设置在所述第一手柄上,其用于选择性地与所述灌注导管连接或解除连接。当所述锁紧组件与所述灌注导管解除连接时,允许所述第一手柄、所述驱动体及所述支撑体的近端沿所述灌注导管的轴向移动,以使所述支撑体可扩张;当所述支撑体扩张至合适程度以支撑所述象鼻支架的近端与自体血管的内壁紧密贴合时,使所述锁紧组件与所述灌注导管连接而阻止所述第一手柄、所述驱动 体及所述支撑体的近端沿所述灌注导管的轴向移动,达到将所述支撑体锁定在扩张状态的目的,方便术者进行吻合操作。
附图说明
图1是本发明根据一实施例所提供的医用装置的结构示意图;
图2是图1所示的医用装置的使用状态示意图;
图3是本发明根据一实施例所提供的医用装置的支撑体在扩张时的结构示意图;
图4是本发明根据一实施例所提供的医用装置的支撑机构的驱动体的结构示意图;
图5是本发明根据一实施例所提供的医用装置的支撑机构的锁紧组件的结构示意图,图示中锁紧部与螺母相分离;
图6是本发明根据另一实施例所提供的医用装置的结构示意图;
图7是图6所示的医用装置的A处放大示意图;
图8是图6所示的医用装置的使用状态示意图。
[附图标记说明如下]:
10-医用装置;
100-灌注导管;
200-阻断机构;
210-球囊,220-导管体,230-注射管,240-单向阀;
300-支撑机构;
310-支撑体;
320-驱动体;
321-内管体,322-支撑金属丝,323-外管体;
330-第一手柄;
340-锁紧组件;
341-锁紧部,341a-开口槽,341b-卡扣;
342-螺母;
400-第二手柄;
20-象鼻支架。
具体实施方式
以下通过特定的具体实例说明本发明的实施方式,本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用,本说明书中的各项细节也可以基于不同观点与应用,在没有背离本发明的精神下进行各种修饰或改变。需要说明的是,本实施例中所提供的图示仅以示意方式说明本发明的基本构想,遂图式中仅显示与本发明中有关的组件而非按照实际实施时的组件数目、形状及尺寸绘制,其实际实施时各组件的型态、数量及比例可为一种随意的改变,且其组件布局型态也可能更为复杂。
另外,以下说明内容的各个实施例分别具有一或多个技术特征,然此并不意味着使用本发明者必需同时实施任一实施例中的所有技术特征,或仅能分开实施不同实施例中的一部或全部技术特征。换句话说,在实施为可能的前提下,本领域技术人员可依据本发明的公开内容,并视设计规范或实作需求,选择性地实施任一实施例中部分或全部的技术特征,或者选择性地实施多个实施例中部分或全部的技术特征的组合,借此增加本发明实施时的弹性。
如在本说明书中所使用的,单数形式“一”、“一个”以及“该”包括复数对象,复数形式“多个”包括两个以上的对象,除非内容另外明确指出外。如在本说明书中所使用的,术语“或”通常是以包括“和/或”的含义而进行使用的,除非内容另外明确指出外,以及术语“安装”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接。可以是机械连接,也可以是电连接。可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本发明中的具体含义。
在本文中,术语“近端”、“远端”是从使用该医疗器械的医生角度来看 相对于彼此的元件或动作的相对方位、相对位置、方向,尽管“近端”、“远端”并非是限制性的,但是“近端”通常指该医疗设备在正常操作过程中靠近医生的一端,而“远端”通常是指首先进入患者体内的一端。除非内容另外明确指出外。
本发明的目的在于提供一种医用装置,包括灌注导管、阻断机构和支撑机构。其中,所述阻断机构包括球囊和导管体,所述球囊设置在所述灌注导管的外表面上,所述导管体与所述球囊连通,并用于向所述球囊灌注充盈剂。所述支撑机构包括支撑体和驱动体,所述支撑体设置在所述灌注导管的外表面上,并位于所述球囊的近侧。所述驱动体与所述支撑体连接,并用于驱使所述支撑体沿其径向向外扩张或向内收缩。
所述医用装置与象鼻支架联合使用,以对主动脉夹层进行手术治疗,例如应用在孙氏手术中。具体地,手术时先将所述灌注导管与象鼻支架连接,使得所述医用装置固定于主动脉内,其中所述球囊位于所述象鼻支架的内腔中部,所述支撑体位于所述象鼻支架的近端内腔。利用所述导管体向所述球囊中灌注充盈剂,使所述球囊充盈至与所述象鼻支架的内壁相贴合,以将所述象鼻支架的内部分隔为互不连通的两部分,即利用所述球囊扩张来阻断降主动脉回血,避免降主动脉内的血液逆流进入主动脉弓及升主动脉,为手术提供清晰的视野。之后,术者操控所述驱动体以驱使所述支撑体扩张而支撑所述象鼻支架的近端,使得所述象鼻支架的近端再扩张,直至所述象鼻支架的近端与自体血管的内壁紧密贴合,一方面可阻断象鼻支架的外壁与降主动脉近端破口之间的回血,进一步提供干净的手术视野,另一方面方便医生后续进行吻合操作,缩短吻合时间。接着,将所述灌注导管与体外的循环机相连,进行体外循环。最后,医生进行吻合操作及其他手术操作。也就是说,本发明所提供的医用装置通过所述球囊和所述支撑体共同作用来提供干净的手术视野,利用所述灌注导管建立体外循环,降低深低温停循环的时间,并且通过支撑体的作用还可便于吻合操作的进行,给手术提供便利。
因此,主动脉夹层的手术治疗可按照以下流程进行:在体外循环温度达到28℃左右时,维持对大脑的选择性顺行灌注;之后可停循环,打开主动脉 弓,植入象鼻支架和所述医用装置;接着利用所述阻断机构的球囊来阻断主动脉血流;接着恢复循环,最后进行吻合操作及其他操作。即,利用所述医用装置进行主动脉夹层的手术治疗时,一方面,不需要将患者的体温降至过低,从而有效地保护患者的内脏功能和凝血功能,避免了患者的有关器官因长时间缺血缺氧而损伤,降低因术后凝血功能障碍引起的并发症。另一方面,术中吻合过程中可进行血液循环,降低了术者因吻合时间过长带来的压力。特别地,本发明中还在所述灌注导管上设置了支撑机构,利用所述支撑机构支撑所述象鼻支架的近端,使所述象鼻支架的近端与患者自体血管的内壁紧密贴合,方便吻合,进一步缩短手术时间。
较佳地,所述支撑体主要由金属材料制作而成,这样所述支撑体在支撑所述象鼻支架的近端时,可提供足够大的径向支撑力,确保所述象鼻支架的近端再扩张并与自体血管的内壁紧密贴合。
为使本发明的目的、优点和特征更加清楚,以下结合附图对本发明作进一步详细说明。需说明的是,附图均采用非常简化或示意的形式且均使用非精准的比例,仅用以方便、明晰地辅助说明本发明实施例的目的。附图中相同或相似的附图标记代表相同或相似的部件。还应理解,以下仅对所述医用装置的各个部件的优选结构进行描述,但其并不是唯一的实现方式,不应对本发明构成限制。
图1示出了本发明一优选实施例所提供的医用装置的结构示意图,图2示出了所述医用装置的使用状态示意图。
请参考图1,所述医用装置10包括灌注导管100,阻断机构200及支撑机构300。其中,所述灌注导管100为中空结构。所述阻断机构200包括球囊210和导管体220,所述球囊210套设在所述灌注导管100的外表面上,所述导管体220与所述球囊210连通,用于向所述球囊210灌注充盈剂。所述支撑机构300包括支撑体310和驱动体320,所述支撑体310套设在所述灌注导管100的外表面上,并位于所述球囊210的近端。所述驱动体320与所述支撑体310连接,用于驱使所述支撑体310沿其径向向外扩张或向内收缩。
请参考图2,利用所述医用装置与象鼻支架进行主动脉夹层的手术治疗的 过程如下:
首先,建立体外循环,维持对大脑的选择性顺行灌注,之后停循环。
接着,打开患者的主动脉弓,并将所述象鼻支架20植入在患者的主动脉的降主动脉区域,所述象鼻支架20膨胀以支撑所述降主动脉壁。
接着,将所述医用装置10放置到主动脉中,并使所述灌注导管100的远端与所述象鼻支架20连接,同时所述球囊210设置在所述象鼻支架20的中段内腔,所述支撑体310设置在所述象鼻支架20的近端内腔。本领域技术人员熟知,为便于两者连接,所述灌注导管100的远端可从所述球囊210的远端伸出。
接着,利用所述导管体220向所述球囊210灌注充盈剂,以使所述球囊210充盈至与所述象鼻支架20的内壁贴合。所述球囊210充盈后将所述象鼻支架20的内腔分隔为互不连通的两部分,从而阻断主动脉中的血液循环,使得降主动脉中的血液不能逆流进入主动脉弓及主动脉。
接着,利用所述驱动体320驱使所述支撑体310扩张,扩张后的所述支撑体310支撑所述象鼻支架20的近端,使得所述象鼻支架20的近端与患者自体血管的内壁紧密贴合,阻断所述象鼻支架20的外侧与降主动脉近端破口之间的回血。
接着,将所述灌注导管100与体外的循环机连接,恢复体外循环。
最后,进行吻合操作及其他手术操作。
也就是说,本发明实施例所提供的医用装置中,利用所述球囊210阻断主动脉血流,避免主动脉回血,以及利用支撑体310支撑所述象鼻支架20的近端,阻断所述象鼻支架20与降主动脉近端破口之间的回血,从而在主动脉弓及升主动脉处提供干净清晰的手术视野。之后便可利用所述灌注导管100恢复体外循环,降低了停循环的时间,因而不需要将患者体温降至过低,有效保护患者的内脏功能和凝血功能,极大地降低术后因凝血功能障碍引发的并发症。此外,利用所述支撑体310支撑所述象鼻支架20的近端,以使所述象鼻支架20与自体血管的内壁贴合,还便于医生进行吻合操作,为手术提供便利,缩短吻合时间,进而缩短手术时间。
本实施例中,所述灌注导管100用于对患者的下半身进行血液灌注,因此,所述灌注导管100选用抗弯折且较为柔软的医用高分子管材制造,以使所述灌注导管100能够进入降主动脉的任何角度,并供血液流通。本实施例中,所述灌注导管100的直径为8mm-12mm。所述球囊210可选用顺应性球囊,顺应性球囊可根据所述象鼻支架20的尺寸扩张,直至与所述象鼻支架20的内壁紧密贴合,阻断降主动脉回血。
所述支撑体310具有扩张状态和收缩状态,术者通过所述驱动体320驱使所述支撑体310的近端沿所述灌注导管100的轴向移动来实现所述支撑体310在所述扩张状态和所述收缩状态之间切换。具体而言,所述驱动体320套设在所述灌注导管100的外表面上,并能够沿所述灌注导管100的轴向移动。所述支撑体310的远端与所述灌注导管100固定连接,使得所述支撑体310的远端与所述灌注导管100保持相对静止,所述支撑体310的近端与所述驱动体320的远端固定连接,以使所述支撑体310的近端可随所述驱动体320同步移动。所述支撑机构300被配置为:当所述驱动体320向所述灌注导管100的远端移动时,所述支撑体310的近端随所述驱动体320同步地向所述灌注导管100的远端移动,以使所述支撑体310变形至所述扩张状态。当所述驱动体320向所述灌注导管100的近端移动时,所述支撑体310的近端随所述驱动体320同步地向所述灌注导管100的近端移动,以使所述支撑体310的形态恢复而回到所述收缩状态。
所述支撑体310在所述收缩状态时的直径为9mm-13mm,而当所述支撑体310处于所述扩张状态时,所述支撑体310的最大直径可达到35mm-40mm,该直径的所述支撑体310足以支撑所述象鼻支架20的近端,使其与患者自体血管的内壁相贴合。进一步地,所述支撑体310主要由金属材料制作而成,这样可确保所述支撑体310处于所述扩张状态时,能够为所述象鼻支架20的近端提供足够的支撑力,使所述象鼻支架20的近端与患者自体血管的内壁相贴合。
为实现上述目的,在一种可选的实施方式中,如图3所示,所述支撑体310由多根编织丝编织定型而成,且至少部分所述编织丝为金属丝,优选所述 编织丝全部为金属丝。所述金属丝由形状记忆合金例如镍钛合金制作而成,利用形状记忆合金的高弹性可实现所述支撑体310的形变与恢复,从而使得所述支撑体310在所述扩张状态和所述收缩状态之间切换。如图3所示,当所述支撑体310处于所述扩张状态时,所述支撑体310呈笼状结构,如图1中所示,当所述支撑体310处于所述收缩状态时,所述支撑体310呈管网状结构。本实施例中,所述支撑体310的远端可通过卡环与所述灌注导管100固定连接,所述支撑体310的近端可通过卡环与所述驱动体320的远端固定连接。
所述驱动体320沿所述灌注导管100的轴向移动,其既需要具有良好的柔韧性,又需要具有较好的支撑力,这样所述驱动体320在跟随灌注导管100弯折的同时,还能够推动所述支撑体310的近端移动,以使所述支撑体310从所述收缩状态切换至所述扩张状态。因此,如图4所示,优选所述驱动体320包括内管体321、支撑金属丝322及外管体323。其中,所述内管体321和所述外管体323均为高分子管,所述支撑金属丝322螺旋地缠绕在所述内管体321的外表面上,所述外管体323套设在所述内管体321上,以包覆所述支撑金属丝322。利用内外层的高分子管改善所述驱动体320的柔韧性,同时利用所述支撑金属丝322提高支撑力,达到两者相平衡的效果。
进一步地,请返回参考图1,所述支撑机构300还包括第一手柄330,所述第一手柄330具有轴向贯通的内腔,所述灌注导管100可活动地贯穿所述第一手柄330的所述内腔,使得所述第一手柄330套设在所述灌注导管100的外表面上,并能够沿所述灌注导管100的轴向移动。所述第一手柄330与所述驱动体320的近端固定连接。术者握持所述第一手柄330,通过推动所述第一手柄330沿所述灌注导管100的轴向移动,以使所述驱动体320移动,方便操作。
更进一步地,请继续参考图1,所述支撑机构300还包括锁紧组件340,所述锁紧组件340设置在所述第一手柄330上,用于选择性地与所述灌注导管100连接或解除连接。当所述锁紧组件340与所述灌注导管100连接时,阻止所述第一手柄330、所述驱动体320及所述支撑体310的近端沿所述灌注 导管100的轴向移动。当所述锁紧组件340与所述灌注导管100解除连接时,允许所述第一手柄330、所述驱动体320及所述支撑体310的近端沿所述灌注导管100的轴向移动。即,所述锁紧组件340可用于锁定所述支撑体310的状态,这样当所述支撑体310处于所述扩张状态,且使所述象鼻支架20的近端与患者自体血管的内壁紧密贴合时,连接所述锁紧组件340与灌注导管100,以将所述支撑体310保持在所述扩张状态,从而可在手术过程中持续性地阻断所述象鼻支架20与降主动脉近端的破口之间的回血,并有利于术者方便、快速地进行吻合操作。
图5示出了一种可选的锁紧组件340的结构示意图。如图5所示,所述锁紧组件340包括锁紧部341和螺母342,所述锁紧部341可固定地设置在所述第一手柄330的近端。所述锁紧部341为中空的管状结构,并套设在所述灌注导管100的外表面上。所述锁紧部341的外表面上设有外螺纹,且所述锁紧部341的近端设置有多个开口槽341a,以将所述锁紧部341的近端侧壁分割成多个卡扣341b。所述螺母342套设在所述锁紧部341的外表面上,并与所述锁紧部341螺纹连接,通过拧紧所述螺母342,使得所述螺母342径向挤压所述卡扣341b,进而所述卡扣341b压紧所述灌注导管100的外表面,实现与所述灌注导管100的连接。
一般地,所述医用装置10在使用前,所述支撑体310处于所述收缩状态。因此,在利用所述医用装置10进行手术时,术者通过向所述灌注导管100的远端推送所述第一手柄330来驱动所述驱动体320移动,以带动所述支撑体310的近端向所述灌注导管100的远端移动,使所述支撑体310变形至所述扩张状态,以支撑所述象鼻支架20的近端。之后术者通过旋转所述螺母342来使所述锁紧组件340与所述灌注导管100连接,以锁定所述支撑体310,之后,术者便可进行吻合操作。
请返回参考图1,本实施例中,所述导管体220的外径小于所述灌注导管100的内径,且优选所述导管体220设置在所述灌注导管100中,所述导管体220的远端贯穿所述灌注导管100的远端侧壁后与所述球囊210连通。换句话说,本实施例中,所述导管体220、所述灌注导管100及所述驱动体320嵌套 设置,使得所述医用装置10的结构紧凑,避免缠绕。
请继续参考图1,所述医用装置10还包括第二手柄400,所述第二手柄400固定地设置在所述灌注导管100上,并位于所述第一手柄330的近端。所述阻断机构200还包括注射管230,所述注射管230的远端贯穿所述灌注导管100的侧壁后伸入所述灌注导管100内,并与所述导管体220的近端连接,所述注射管230的近端从所述第二手柄400上穿出而延伸至所述第二手柄400的外部。通过所述注射管230与一注射器连接来向所述球囊210中灌注充盈剂,以使所述球囊210充盈。所述第二手柄400的设置方便注射操作。进一步地,所述注射管230的近端设置有单向阀240,当所述球囊210充盈至合适尺寸后,利用所述单向阀240阻止所述充盈剂从所述球囊210中排出。所述单向阀240可通过UV胶粘接在所述注射管230的近端。
在其他实施例中,所述注射管230是螺旋形结构。请参考图6至图8,所述第一手柄330为中空结构,所述注射管230螺旋地盘绕在所述第一手柄330的内部,且所述注射管230的远端贯穿所述灌注导管100的侧壁后伸入所述灌注导管100内,并与所述导管体220的近端连接。所述注射管230的近端从所述第一手柄330上穿出而延伸至所述第一手柄330的外部。所述注射管230的近端上设置有单向阀240。本实施例中,所述注射管230采用医用级PVC材料,其可拉伸变形,这样当术者驱动所述第一手柄330向所述灌注导管100的远端移动时,所述注射管230的近端随第一手柄330同步移动而拉伸变形,此时所述注射管230远端与导管体220连接处保持相对静止,而当术者驱动所述第一手柄330向所述灌注导管100的近端移动时,所述注射管230可回弹。此外,应知晓,对于所述注射管230而言,远端是指与所述导管体220连接的一端,近端是指远离所述导管体220的一端。
本发明实施例所提供的医用装置,包括灌注导管、阻断机构和支撑机构。其中所述阻断机构包括球囊和导管体,所述球囊套设在所述灌注导管的外表面上,所述导管体与所述球囊连通,用于向所述球囊灌注充盈剂。所述支撑机构包括支撑体和驱动体,所述支撑体套设在所述灌注导管的外表面上,并位于所述球囊的近端,所述驱动体与所述支撑体连接,并用于驱使所述支撑 体沿其径向向外扩张或向内收缩。在进行主动脉夹层的手术治疗时,所述医用装置利用所述球囊阻断降主动脉回血,并利用所述支撑体对所述象鼻支架的近端进行再扩张,以阻断所述象鼻支架的外壁与降主动脉近端的破口之间的回血,提供干净清晰的手术视野。利用所述灌注导管进行体外循环,缩短深低温停循环时间,降低患者下半身的重要器官因低温、缺血而受到损伤的可能性,有利于患者的术后恢复。此外,在所述支撑体的作用下,所述象鼻支架的近端与患者自体血管的内壁紧密贴合,便于医生进行吻合操作,可缩短手术时间。即,所述医用装置在应用于主动脉夹层的手术治疗时,可减少对患者的器官损伤、方便术者操作,降低术者的压力。
虽然本发明披露如上,但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样,倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内,则本发明也意图包含这些改动和变型在内。

Claims (12)

  1. 一种医用装置,其特征在于,包括:
    灌注导管;
    阻断机构,包括球囊和导管体;所述球囊设置在所述灌注导管的外表面上;所述导管体与所述球囊连通,用于向所述球囊灌注充盈剂;以及,
    支撑机构,包括支撑体和驱动体,所述支撑体设置在所述灌注导管的外表面上,并位于所述球囊的近端侧;所述驱动体与所述支撑体连接,用于驱使所述支撑体沿其径向向外扩张或向内收缩。
  2. 根据权利要求1所述的医用装置,其特征在于,所述驱动体套设在所述灌注导管的外表面,并能够沿所述灌注导管的轴向移动;所述支撑体的远端与所述灌注导管固定连接,所述支撑体的近端与所述驱动体的远端固定连接;
    所述支撑机构被配置为:当所述驱动体向所述灌注导管的远端移动时,所述驱动体驱使所述支撑体的近端向所述灌注导管的远端移动,以使所述支撑体发生变形而扩张;当所述驱动体向所述灌注导管的近端移动时,所述驱动体驱使所述支撑体的近端向所述灌注导管的近端移动,以使所述支撑体收缩。
  3. 根据权利要求2所述的医用装置,其特征在于,所述支撑体由多根编织丝编织而成,且至少部分所述编织丝为金属丝。
  4. 根据权利要求1-3中任一项所述的医用装置,其特征在于,所述支撑体扩张时的最大直径为35mm-40mm。
  5. 根据权利要求2所述的医用装置,其特征在于,所述支撑机构还包括第一手柄,所述第一手柄设置在所述灌注导管的外表面上,并能够沿所述灌注导管的轴向移动,且所述第一手柄与所述驱动体的近端固定连接。
  6. 根据权利要求5所述的医用装置,其特征在于,所述支撑机构还包括锁紧组件,所述锁紧组件设置在所述第一手柄上,用于选择性地与所述灌注导管连接或解除连接;
    所述支撑机构被配置为:当所述锁紧组件与所述灌注导管连接时,阻止所述第一手柄、所述驱动体及所述支撑体的近端沿所述灌注导管的轴向移动;当所述锁紧组件与所述灌注导管解除连接时,允许所述第一手柄、所述驱动体及所述支撑体的近端沿所述灌注导管的轴向移动。
  7. 根据权利要求6所述的医用装置,其特征在于,所述锁紧组件包括锁紧部和螺母;所述锁紧部设置在所述第一手柄的近端,并为中空的管状结构,所述锁紧部上设置有外螺纹,且所述锁紧部的近端设置有多个开口槽;所述螺母用于套设在所述锁紧部的外表面上,并与所述锁紧部螺纹连接。
  8. 根据权利要求5所述的医用装置,其特征在于,所述导管体穿设在所述灌注导管的内部,且所述导管体的远端贯穿所述灌注导管的远端管壁而与所述球囊连通。
  9. 根据权利要求8所述的医用装置,其特征在于,所述阻断机构还包括注射管,所述注射管螺旋地盘绕在所述第一手柄的内部,且所述注射管的远端伸入所述灌注导管内,并与所述导管体的近端连接,所述注射管的近端贯穿所述第一手柄而伸出至所述第一手柄的外部;
    当所述第一手柄朝向所述灌注导管的远端移动时,所述注射管的近端随所述第一手柄同步移动,以使所述注射管拉伸变形。
  10. 根据权利要求8所述的医用装置,其特征在于,还包括第二手柄,所述第二手柄设置在所述灌注导管的外表面上,并位于所述第一手柄的近端。
  11. 根据权利要求10所述的医用装置,其特征在于,所述阻断机构还包括注射管,所述注射管的远端伸入所述灌注导管内并与所述导管体的近端连接,所述注射管的近端贯穿所述第二手柄而伸出至所述第二手柄的外部。
  12. 根据权利要求9或11所述的医用装置,其特征在于,所述注射管的近端设置有单向阀。
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