WO2018072595A1 - 植入体输送装置 - Google Patents

植入体输送装置 Download PDF

Info

Publication number
WO2018072595A1
WO2018072595A1 PCT/CN2017/102959 CN2017102959W WO2018072595A1 WO 2018072595 A1 WO2018072595 A1 WO 2018072595A1 CN 2017102959 W CN2017102959 W CN 2017102959W WO 2018072595 A1 WO2018072595 A1 WO 2018072595A1
Authority
WO
WIPO (PCT)
Prior art keywords
inner tube
tube
locking
delivery device
driving member
Prior art date
Application number
PCT/CN2017/102959
Other languages
English (en)
French (fr)
Inventor
贺志秀
桂宝珠
李�雨
Original Assignee
上海微创心通医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海微创心通医疗科技有限公司 filed Critical 上海微创心通医疗科技有限公司
Priority to KR1020197014517A priority Critical patent/KR102260740B1/ko
Priority to EP17862538.0A priority patent/EP3530236B1/en
Priority to JP2019521045A priority patent/JP6757850B2/ja
Priority to US16/343,562 priority patent/US10966755B2/en
Priority to ES17862538T priority patent/ES2849439T3/es
Publication of WO2018072595A1 publication Critical patent/WO2018072595A1/zh

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3468Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436Deployment by retracting a sheath
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00243Type of minimally invasive operation cardiac
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00969Surgical instruments, devices or methods, e.g. tourniquets used for transplantation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • A61B17/3423Access ports, e.g. toroid shape introducers for instruments or hands
    • A61B2017/3425Access ports, e.g. toroid shape introducers for instruments or hands for internal organs, e.g. heart ports
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B2017/347Locking means, e.g. for locking instrument in cannula
    • 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor

Definitions

  • the present invention relates to the field of medical device technology, and in particular to an implant delivery device.
  • Valvular heart disease is one of the most common heart diseases in China, mainly due to valvular damage caused by rheumatic fever.
  • valve degeneration including calcification and mucus degeneration
  • metabolic valvular lesions are also increasing in China.
  • Traditional heart valve surgery uses a direct heart approach under general anesthesia, which requires cutting the patient's sternum (commonly known as “sternal incision"), and the patient's heart needs to be stopped to allow blood flow. Diverted into the "cardiopulmonary” bypass control machine (also known as “extracorporeal circulation machine”).
  • Microtrauma interventional therapy has the advantages of no need for thoracotomy, small trauma, and rapid recovery of patients, and has been widely used in recent years.
  • cases of interventional therapy in the past 10 years have shown that cases that can be treated by internal surgery can be treated with minimally invasive interventions; and cases that cannot be treated by surgery can be treated with intervention. Therefore, the clinical application of microtrauma interventional therapy is extensive and worthy of further study.
  • the artificial heart valve is implanted into the body through the delivery device.
  • the existing heart valve delivery device has complicated operation, high requirements on the operation of the medical practitioner, and is liable to cause misoperation.
  • the existing heart valve delivery device easily causes secondary damage to the patient's body during the process of recovering the delivery tube after positioning and releasing the artificial heart valve.
  • the existing conveying device introduces an emptying hose in the space between the outer tube and the inner tube when introducing the emptying liquid, and the emptying hose is connected to the external device to be externally The venting liquid is passed into the venting hose and further introduced into the space between the outer tube and the inner tube to remove air, ensuring no air input during the intervention.
  • the conveying device and the evacuation hose need to be fixed, and the fixing operation is likely to cause the evacuation hose to be bent and bent.
  • the delivery tube is transported and recovered, there is no fixed track when the evacuation hose moves in the handle cavity, so that the outer tube or the outer tube is moved.
  • the inner tube is liable to cause the emptying of the hose to bend, which in turn causes difficulty in emptying.
  • the present invention provides an implant delivery device including a housing and an inner tube driving member, an outer tube driving member, an inner tube, a transition tube, an outer tube and a row at least partially housed in the housing
  • the inner tube, the transition tube and the outer tube are sequentially sleeved from the inside to the outside, a first space is formed between the inner tube and the transition tube, and a second space is formed between the inner tube and the outer tube. a space, a third space is formed between the inner tube and the outer tube;
  • the proximal end of the inner tube driving member is sealingly connected to the proximal end of the inner tube
  • the outer tube driving member is sealingly fixedly connected to the proximal end of the outer tube
  • the proximal end of the transition tube is sealed and fixedly connected
  • the inner tube driving member extends through the outer tube driving member and is sealingly connected to the outer tube driving member, and the emptying locking assembly is detachably connected to the inner tube driving member;
  • the inner tube driving member is provided with a first emptying passage
  • the emptying locking assembly is provided with a second emptying passage
  • one end of the second emptying passage is located outside the housing; when the emptying is locked
  • the assembly is connected to the inner tube driving member, the other end of the second emptying passage is communicated through the first emptying passage, the first space is communicated with the second space and the third space, and the inner tube driving member is locked by the emptying
  • the assembly forms an axially opposite fixed relationship with the housing; the inner tube drive member is slidable in the axial direction of the housing when the venting lock assembly is separated from the inner tube drive member.
  • the venting lock assembly includes a locking member detachably coupled to the inner tube drive member, the locking member including a through lumen to form a second venting passage.
  • the locking member includes a locking portion for detachably connecting with the inner tube driving member and a control portion for driving the movement of the locking portion, one end of the control portion is located outside the housing, and
  • the control portion is provided with a first inner cavity penetrating
  • the locking portion is provided with a second inner cavity penetrating
  • the first inner cavity and the second inner cavity are communicated to form the second emptying channel.
  • the implant delivery device further includes a guide member received in the housing, the guide member has a through guiding groove, and the locking portion is opposite to the extending direction of the guiding groove
  • the inner tube drive moves.
  • the inner tube driving member has a third inner cavity and a fourth inner cavity, the third inner cavity axially penetrating the inner tube driving member, and the proximal end of the transition tube is located at a distal end of the third inner cavity, The proximal end of the inner tube is located at a proximal end of the third inner chamber, and the fourth inner chamber constitutes the first evacuation passage and communicates with the first space.
  • the outer tube drive member has a fifth inner cavity extending axially, the proximal end of the outer tube being located in the fifth inner cavity, the transition tube extending from the inner tube drive member through the The fifth lumen.
  • the venting locking assembly includes a locking member detachably coupled to the inner tube driving member and a flow member fixedly coupled to the locking member; a portion of the locking member is located outside the housing, and the locking member Having a sixth inner cavity, the sixth inner cavity being in communication with the first evacuation channel; the flow member having a penetrating seventh inner cavity, the sixth inner cavity and the seventh inner cavity communicating to form the second inner cavity Empty the passage.
  • the locking member includes a locking portion for detachably connecting with the inner tube driving member and a control portion for driving the movement of the locking portion, one end of the control portion is located outside the housing, and The sixth inner cavity is provided at the locking portion.
  • the locking portion includes a locking body detachably coupled to the inner tube driving member and an elastic structure coupled to the locking body, the locking portion being coupled to the inner tube driving member by an elastic structure, when When the elastic structure is stressed, the locking portion is separated from the inner tube driving member.
  • the venting lock assembly includes a flow control having a flow direction that controls the venting medium, the flow control being disposed on the second venting passage.
  • the flow control member comprises a one-way shut-off valve or a controllable lock valve.
  • the distal end of the transition tube is provided with an emptying hole for communicating the first space and the second space, and when the emptying locking assembly is connected with the inner tube driving member, the second emptying passage The other end communicates with the second space and the third space through the first emptying passage, the first space, and the emptying hole.
  • the number of the venting holes is plural, and the plurality of venting holes are evenly arranged along the circumferential direction of the transition tube.
  • the distal end of the transition tube is fixedly connected to the inner tube and is not sealed.
  • the implant delivery device further includes a movement control member and a moving rail, the moving rail is disposed on the housing, and the movement control member is movably disposed on the moving rail and is The outer tube drive is connected.
  • the implant delivery device of the present invention is equipped with an inner tube drive member and an emptying lock assembly.
  • the inner tube can be connected to the housing or moved relative to the housing as needed, so that when the implant is reclaimed in the human body and the transport device is recovered, the outer tube is kept stationary, and the locking assembly and the inner tube drive member are emptied. Unlocking allows the inner tube drive member to move within the housing, thereby bringing the inner tube closer to the outer tube and closing the outer tube, and then removing the delivery device. Since the sheath at the distal end of the outer tube is used to bind the implant in a compressed state, the sheath is required to have a large rigidity.
  • the outer tube and the inner tube are re-actuated, and the human body is easily damaged by the sheath during the process.
  • the inner tube with smaller moving size and better bending performance and softer material makes the distal end of the outer tube and the distal end of the inner tube closed, thereby reducing secondary damage to the human tissue during the process of recovering the delivery tube.
  • the second evacuation passage of the implant delivery device of the present invention is disposed on the venting lock assembly, and is capable of passing the first venting passage on the inner tube drive member, the first between the transition tube and the inner tube
  • the space communicates with the second space between the transition tube and the outer tube, and the third space between the outer tube and the inner tube, and the emptying between the inner tube and the outer tube is smoothly realized.
  • the emptying hose is replaced by the emptying locking assembly, and there is no problem that the cavity is deformed and blocked, thereby solving the problem of difficulty in emptying due to deformation of the evacuated hose.
  • the integrated design of the emptying and locking realizes the integration of the emptying and locking functions, reduces the component configuration, and simplifies the operation steps, thereby making the performance of the conveying device more stable and more convenient to operate.
  • FIG. 1 is a schematic view of an implant delivery device according to a first embodiment of the present invention, in which a housing is omitted;
  • FIG. 2 is a schematic view showing the connection of the emptying locking assembly of the implant delivery device and the inner tube driving member according to the first embodiment of the present invention
  • Figure 3 is a partial enlarged view of the implant delivery device shown in Figure 2 in the M region;
  • FIG. 4 is a partial schematic view showing the emptying locking assembly of the implant delivery device according to the first embodiment of the present invention when separated from the inner tube driving member;
  • Figure 5 is a schematic view of a transition tube according to Embodiment 1 of the present invention.
  • Figure 6 is a cross-sectional view of the transition tube shown in Figure 5 taken along the line H-H;
  • Figure 7 is a schematic view of a one-way stop valve according to a first embodiment of the present invention.
  • Figure 8 is a schematic view of a one-way stop valve according to a preferred embodiment of the present invention.
  • Figure 9 is a schematic view of an implant delivery device according to a second embodiment of the present invention, wherein the housing is omitted;
  • FIG. 10 is a view showing an emptying locking assembly of an implant delivery device according to a second embodiment of the present invention and an inner tube driving member; Schematic diagram of the connection;
  • Figure 11 is a partial schematic view showing the separation locking assembly of the implant delivery device of the second embodiment of the present invention separated from the inner tube driving member.
  • 2121-flowing body 2122-connecting pipe; 1714, 1715-cutting through hole;
  • distal refers to the end of the operator remote from the implant delivery device; correspondingly, the term “proximal” refers to the end of the operator that is proximate to the implant delivery device.
  • the implant delivery device of the present invention can deliver an implant (e.g., a prosthetic heart valve) into the body, positioning and releasing the implant to a designated location.
  • an implant e.g., a prosthetic heart valve
  • FIG. 1 is a schematic view of an implant delivery device according to a first embodiment of the present invention
  • FIG. 2 is a view showing the connection of the emptying lock assembly of the implant delivery device to the inner tube driving member according to the first embodiment of the present invention
  • 3 is a partial enlarged view of the implant delivery device shown in FIG. 2 in the M region
  • FIG. 4 is a view showing the separation of the emptying locking assembly and the inner tube driving member of the implant delivery device according to the first embodiment of the present invention.
  • the implant delivery device 100 of the present embodiment includes a housing 110 and an inner tube 120 partially disposed in the housing 110, a transition tube 130, an outer tube 140, an inner tube driving member 150, an outer tube driving member 160, and an emptying Lock component 170.
  • the inner tube 120, the transition tube 130 and the outer tube 140 are sequentially sleeved from the inside to the outside.
  • a first space is formed between the inner tube 120 and the transition tube 130.
  • a second space is formed between the transition tube 130 and the outer tube 140.
  • a third space is formed between the inner tube 120 and the outer tube 140.
  • the proximal end of the inner tube driving member 150 is sealingly fixedly connected to the proximal end of the inner tube 120, and the inner tube 120 can be driven to move along the axial direction of the housing 110;
  • the outer tube driving member 160 is sealingly fixedly connected to the outer tube 140.
  • the proximal end of the transition tube 130 is sealingly fixedly connected to the inner tube driving member 150, and the transition tube 130 extends through the outer tube driving member 160 and the outer tube
  • the drive member 160 is sealingly coupled; the venting lock assembly 170 is detachably coupled to the inner tube drive member 150.
  • the inner tube driving member 150 (preferably radial) is provided with a first emptying passage A
  • the emptying locking assembly 170 is provided with a second emptying passage B
  • the second emptying passage B One end of the housing is located outside of the housing 110 to receive an external evacuation medium; when the evacuation locking assembly 170 is coupled to the inner tube driving member 150, the other end of the second evacuation passage B passes through the first evacuation passage A, the first space and the second The space and the third space communicate with each other, thereby injecting the external emptying medium into the second space and the third space, thereby draining the air in the space.
  • the venting locking assembly 170 is coupled to the inner tube driving member 150
  • the inner tube driving member 150 is coupled to the housing 110 through the venting locking assembly 170, thereby indirectly realizing the inner tube 120 and the housing 110. Fixed.
  • the venting locking assembly 170 is separated from the inner tube driving member 150
  • the inner tube driving member 150 is slidably coupled to the housing 110, that is, the inner tube driving member 150 can be along the housing in the housing 110. 110 axial movement.
  • the evacuation locking assembly 170 is coupled to an external device for providing an evacuated medium to introduce the evacuated medium into the second evacuation passage B.
  • the transition tube 130 is provided with an venting hole 131 for communicating the first space and the second space (obviously, the venting hole 131 penetrates the wall of the transition tube 130, which is more clearly shown in FIG. 5 and 6), when the emptying locking assembly 170 is connected to the inner tube driving member 150, the other end of the second emptying passage B may also pass through the first emptying passage A, the first space, the emptying hole 131 and The second space and the third space are connected.
  • the implant delivery device 100 of the first embodiment will be described in further detail below with reference to FIGS. 1 through 8.
  • the venting locking assembly 170 includes a locking member 171 that is detachably coupled to the inner tube driving member 150. Wherein, a portion of the locking member 171 is located outside the housing 110 for the user to operate the locking member 171.
  • the locking member 171 includes a through lumen to form a second evacuation passage B.
  • the locking member 171 includes a control portion 1711 and a locking portion 1712; one end of the control portion 1711 is located outside the housing 110 for connecting an external device, and the other end is connected to the locking portion 1712 to drive the locking portion 1712 to be opposite.
  • the inner tube driving member 150 moves; the locking portion 1712 is located inside the housing 110 to be engaged with the inner tube driving member 150 under the driving of the control portion 1711.
  • control portion 1711 and the locking portion 1712 are both hollow structures (ie, each having a through cavity), wherein the hollow structure of the control portion 1711 forms a first inner cavity, and the locking portion 1712 The hollow structure forms a second inner cavity.
  • the first inner chamber and the second inner chamber are in direct communication to form a second emptying passage B.
  • the control portion 1711 is integrally formed with the locking portion 1712.
  • the locking member 171 of the present embodiment can be used to lock the inner tube driving member 150 in addition to the evacuation medium, so that the inner tube driving member 150 is connected to the housing 110.
  • the locking member 171 and the inner tube are When the drive member 150 is disengaged, the inner tube driver 150 is movable relative to the housing 110.
  • the locking member 171 is detachably coupled to the inner tube driving member 150, and when the locking member 171 locks the inner tube driving member 150, the locking member 171 and the housing 110 are in the axial direction of the housing 110.
  • the direction is fixed such that the inner tube driving member 150 cannot move in the axial direction of the housing 110; when the locking member 171 unlocks the inner tube driving member 150, the locking member 171 is separated from the inner tube driving member 150, so that the inner tube
  • the driving member 150 is movable relative to the housing 110 in the axial direction of the housing 110.
  • the inner tube driving member 150 is provided with a card slot (not labeled) for accommodating at least a portion of the length of the locking portion 1712, thereby limiting the inner tube driving member 150 in the axial direction. Displacement.
  • the first evacuation channel A is located in the card slot, that is, connected to the card slot through the locking portion 1712, so that the second evacuation channel B is connected to the first evacuation channel A.
  • the locking portion 1712 can also be configured as a card slot structure.
  • the inner tube driving member 150 is further provided with a convex structure that cooperates with the locking portion 1712, and the locking portion 1712 can also be realized. The tube drive member 150 is engaged, so that the second evacuation passage B is connected to the first evacuation passage A.
  • the locking portion 1712 of the embodiment has a tapered convex structure facing the card slot, and is engaged with the card slot on the inner tube driving member 150.
  • the structure is simple, and the locking portion 1712 can be smoothly inserted into the card. In the slot.
  • a guide 180 is disposed in the housing 110 to be fixedly coupled to the housing 110.
  • the guiding member 180 has a through guiding groove (not labeled), the width of the guiding groove is matched with the width of the locking portion 1712, and the guiding groove is aligned with the first row of the card slot of the inner tube driving member 150.
  • the empty passage A causes the locking portion 1712 to move in the extending direction of the guide groove under the driving of the control portion 1711 to lock the inner tube driving member 150.
  • the locking portion 1712 is threadedly engaged with the guide groove, that is, when the control portion 1711 is rotated, the locking portion 1712 is locked with the inner tube driving member 150 by driving the locking portion 1712 to be screwed with the guiding groove. It is fixed to the housing 110.
  • the locking member 171 further includes a flow control member 1713, and the flow control member 1713 is disposed on the second evacuation passage B for controlling the flow direction of the evacuation medium.
  • the flow control member 1713 includes a one-way shut-off valve or a controllable lock valve.
  • Fig. 7 is a schematic view of a one-way shutoff valve according to a first embodiment of the present invention
  • Fig. 8 is a schematic view of another one-way shutoff valve according to a first embodiment of the present invention.
  • the through hole 1714 in the one-way stop valve is The "I" type, or as shown in Fig. 8
  • the cut-through through hole 1715 in the one-way stop valve is of a "Y" shape.
  • the present invention includes, but is not limited to, the one-way shutoff valves illustrated in Figures 7 and 8, and other valves capable of achieving a one-way cutoff function are applicable to the present invention.
  • the controllable locking valve of this embodiment can control the flow direction of the evacuation medium by the user controlling the opening and closing of the cut-off through hole.
  • the external evacuation medium flows through the second evacuation channel B, the first evacuation channel A, and the first space into the second space and the third space.
  • a part of the emptying medium passes through the second emptying passage B, the first emptying passage A, the first space, the emptying hole 131 to enter the second space and flow into the third space, and the other part of the emptying medium passes through The second empty channel B, the first empty channel A, and the first space directly to the third space.
  • the venting holes 131 are preferably waist-shaped holes as shown in FIG. 5, and more preferably a plurality of venting holes 131 as shown in FIG. 6, such as three.
  • the plurality of evacuation holes 131 are evenly arranged along the circumferential direction of the transition duct 130.
  • 5 is a schematic view of a transition tube according to Embodiment 1 of the present invention
  • FIG. 6 is a cross-sectional view of the transition tube shown in FIG. 5 taken along line H-H.
  • the distal end of the inner tube 120 extends beyond the transition tube 130 to cooperate with the outer tube 140 to form a third space, and the proximal end of the transition tube 130 extends out of the outer tube 140 and is coupled to the inner tube for driving.
  • Piece 150 the length of the transition tube 130 must be sufficiently long to ensure that the outer tube 140 can still cover a portion of the transition tube 130 when the outer tube driver 160 is driven to the distal end of the housing 110, further if the transition tube 130
  • An evacuation hole 131 is provided, and preferably, the evacuation hole 131 can still be covered by the outer tube 140.
  • the venting opening 131 of the present embodiment is preferably disposed on the distal end of the transition duct 130.
  • the inner tube driver 150 is disposed at a proximal end of the housing 110 and has a third inner cavity and a fourth inner cavity, the third inner cavity axially penetrating the inner tube drive 150, and the The fourth lumen forms a first evacuation channel A and is in communication with the first space, preferably the axis of the third lumen is perpendicular to the fourth lumen axis.
  • the proximal end of the inner tube 120 is inserted into the third inner cavity and is sealingly and fixedly connected to the proximal end of the inner tube driving member 150 (for example, welding, bonding or riveting, etc.)
  • the proximal end of the inner tube 120 is located at the proximal end of the third lumen
  • the transition tube 130 is correspondingly inserted into the third lumen
  • the proximal end of the transition tube 130 is located at the distal end of the third lumen and is The four lumens are adjacent. In this way, the evacuation medium flowing out of the first evacuation channel A directly enters the first space between the inner tube 120 and the transition tube 130.
  • the proximal end of the transition tube 130 and the inner tube driving member 150 are welded, riveted, bonded, A sealing ring or the like seals the fixed connection.
  • the transition tube 130 extends distally from the inner tube drive member 150, through the outer tube drive member 160, and is sealingly coupled to the outer tube drive member 160 to prevent leakage of the venting medium from the second space. If the transition tube 130 is provided with an venting opening 131, the position at which the transition tube 130 is sealingly coupled to the outer tube driving member 160 is located at the proximal end of the venting opening 131.
  • the transition tube 130 is sealingly connected to the outer tube drive member 160, for example, by a seal ring 190.
  • a portion of the inner tube driving member 150 is located outside the housing 110 in the axial direction, so that the user can pull or push the inner tube 120 to move in the axial direction by operating the inner tube driving member 150.
  • the proximal end of the inner tube 120 is provided with a luer port to connect an external device, and the empty medium is poured into the inner tube 120 for evacuation.
  • the external device is coupled to the proximal end of the inner tube 120 by an evacuated introduction tube.
  • another flow control member (not shown) is disposed between the evacuation introduction tube and the inner tube 120 to control the one-way flow of the evacuation medium.
  • the flow control member is, for example, a one-way shut-off valve or a controllable lock valve.
  • the outer tube drive member 160 is disposed within the housing 110 and is located at the distal end of the inner tube drive member 150 and has a fifth inner lumen that extends axially therethrough.
  • the outer tube driving member 160 can drive the outer tube to move axially along the housing 110 to achieve loading and release of the valve holder.
  • the proximal end of the outer tube 140 is inserted into the fifth lumen and is sealingly and fixedly coupled to the outer tube driver 160.
  • the outer tube 140 and the outer tube driving member 160 are sealingly and fixedly connected by welding, bonding, riveting, sealing ring or the like.
  • the transition tube 130 extends from the inner tube driving member 150 through the fifth inner cavity, and ensures that the distal end of the transition tube 130 can always be covered by the outer tube 140, and when the transition tube 130 is provided with the venting hole 131, Preferably, the venting opening 131 can always be covered by the outer tube 140.
  • the distal end of the transition tube 130 when the proximal end of the transition tube 130 is sealingly and fixedly connected to the inner tube driving member 150, the distal end of the transition tube 130 is fixedly connected to the inner tube 120 and is not sealed.
  • the distal end of the transition tube 130 is fixedly coupled to the inner tube 120 and is not sealed.
  • the venting medium can directly enter the third space through the venting hole 131 and the second space, and can also directly The first space between the portion enters the third space between the inner tube 120 and the outer tube 140.
  • Such an arrangement can maintain the concentricity of the transition tube 130 and the inner tube 120, and can also prevent the transition tube 130 from forming a cantilever beam.
  • the structure causes uneven force, and at the same time, the first space formed by the emptying medium from the distal end of the transition tube 130 and the inner tube 120 flows directly into the third between the inner tube 120 and the outer tube 140. Space has expanded the circulation space.
  • the transition tube 130 and the inner tube 120 are fixedly connected by mechanical rivets, welding or bonding.
  • the structure and composition of the distal end portion of the inner tube and the outer tube after the inner tube protrudes from the housing are not particularly limited. A person skilled in the art can select a suitable structure depending on the type of implant, the implantation position, and the like.
  • the distal end of the inner tube 120 includes a fixed head 121, a distal inner tube 122 connected to the fixed head 121, and a tapered head 123 disposed at the distal end of the distal inner tube 122.
  • the fixing head 121 is provided with a mounting groove for loading the implant.
  • the distal end of the outer tube 140 is provided with a sheath tube 141 for restraining the implant in a compressed state.
  • the length of the sheath tube 141 matches the length of the distal inner tube 122.
  • the working process of the implant delivery device 100 of the present embodiment is as follows:
  • Tube emptying the outer tube 140 and the distal end portion of the inner tube 120 are placed in an evacuation medium (the empty medium is, for example, water, for example, the distal portion is placed in an aqueous environment), and is evacuated by evacuating the locking assembly 170.
  • the medium is input into the first space, the second space, and the third space, and the air between the outer tube 140 and the inner tube 120 is excluded; the empty medium is input into the inner cavity of the inner tube 120 through the luer port, and the inner tube is excluded.
  • the lug of the implant is sleeved on the fixed head 121 of the inner tube 120, after which the outer tube 140 is operated to move toward the distal end of the implant delivery device 100, so that the sheath 141 is covered.
  • the implant on the distal inner tube 122 and the distal inner tube 122 is constrained to constrain the implant between the outer tube 140 and the inner tube 120;
  • the implant delivery and release of the implant after the implant is loaded, the inner tube 120 and the outer tube 140 are kept relatively stationary, and the implant is delivered to the body, and then, after the implant reaches the target position, the outer tube 140 is operated. Moving to the proximal end of the implant delivery device 100 to disengage the sheath 141 from the implant, the implant is automatically released and positioned in the lesion of the human tissue after the compression force of the sheath 141 is removed;
  • the emptying locking assembly 170 and the inner tube driving member 150 are unlocked, and the inner tube driving member 150 is operated to drive the inner tube 120 toward the implant delivery device 100.
  • the end moves such that the proximal end of the tapered head 123 abuts against the distal end of the outer tube 140 and the distal end of the inner tube 120 is closed with the distal end of the outer tube 140, which in turn removes the delivery device from the body.
  • the housing 110 is, for example, an operating handle that serves to serve as a mounting base for the implant delivery device 100 for housing various components.
  • the inner tube drive member 150, the outer The tube driver 160 is disposed in the housing 110 and is movable relative to the housing 110 along the axial direction of the housing 110; the proximal end of the inner tube 120 is coupled to the inner tube driver 150, the distal end of the inner tube 120 Extending out of the distal end of the housing 110, the proximal end of the outer tube 140 is coupled to the outer tube drive member 160, the distal end of the outer tube 140 extends beyond the distal end of the housing 110; the evacuation locking assembly 170 portion It is housed in the housing 110 and is movable relative to the housing 110.
  • the material, shape and size of the housing 110 are not limited, and existing and future may be suitable for the user to hold and operate and can accommodate a part of the inner tube 120, the transition tube 130, and a part of the outer tube
  • the structure of the tube 140 and the housing 110 of other components can be applied to the implant delivery device 100 of the present invention.
  • the implant delivery device 100 further includes a movement control member and a moving rail, the moving rail is disposed on the housing 110, and the movement control member is movably disposed on the moving rail, and It is connected to the outer tube driving member 160.
  • the user moves along the moving rail by manipulating the movement control member, thereby driving the outer tube driving member 160 to move, and simultaneously driving the outer tube 140 to move.
  • the transition tube 130 is made of a polymer material or a metal material.
  • the metal material may be a metal material such as stainless steel, titanium or gold, or may be an alloy material such as a nickel-titanium alloy or a cobalt-nickel alloy.
  • the polymer material may be one or more of polycarbonate, polypropylene, polyamide, polyimide, acrylonitrile-butadiene-styrene copolymer, etc., of course, those skilled in the art should It can be understood that the material of the transition tube 130 which may be selected in the future according to the environmental requirements of the implant implantation process can be applied to the present invention.
  • the material of the outer tube 140 and the inner tube 120 may be a material prepared by a multi-layer structure, or may be other metals, polymer compounds or chemical materials suitable for medical use. In general, both the outer tube 140 and the inner tube 120 are required to have a strong anti-stretching force in the axial direction and a certain bendability in the direction perpendicular to the axial direction.
  • FIG. 9 is a schematic view of an implant delivery device according to a second embodiment of the present invention
  • FIG. 10 is a schematic view showing the connection between the emptying locking assembly of the implant delivery device and the inner tube driving member according to the second embodiment of the present invention
  • a partial schematic view of the emptying locking assembly of the implant delivery device of the second embodiment of the invention is separated from the inner tube driving member.
  • the housing 110, the outer tube 140, and the outer tube driving member 160 are not shown in FIG.
  • the main difference of the embodiment is that the locking assembly is emptied, and other structural portions can be similarly referred to the first embodiment.
  • the venting locking assembly 210 includes a locking member 211 and a flow member 212.
  • the locking member 211 is detachably coupled to the inner tube driving member 220, and the flow member 212 is The locking members 211 are connected to each other.
  • the venting locking assembly 210 includes a locking member 211 and a flow member 212, a portion of the flow member 212 is located outside the housing 110 to introduce an evacuated medium while the locking member 211 is A portion is located outside of the housing 110 to facilitate manipulation of the locking member 211 by a user.
  • the locking member 211 has a sixth inner cavity, and the sixth inner cavity communicates with the first emptying passage A when the locking member 211 is connected to the inner tube driving member 220.
  • the flow member 212 has a penetrating seventh inner cavity that communicates with the seventh inner cavity to form a second evacuation passage B.
  • the locking member 211 includes a control portion 2111 for engaging with the inner tube driving member 220, and a locking portion 2112 for driving the card.
  • the portion 2112 is moved.
  • one end of the control portion 2111 is located outside the housing 110 to facilitate the user to perform the operation.
  • only the locking portion 2112 is provided with a lumen, that is, the sixth lumen is located in the locking portion 2112.
  • the locking portion 2112 further has an eighth inner cavity that penetrates axially, and the eighth inner cavity causes the locking member 211 to directly fit over the inner tube driving member 220.
  • the eighth lumen is in communication with the sixth lumen, preferably the axis of the eighth lumen is perpendicular to the axis of the sixth lumen.
  • the locking portion 2112 includes a locking body 2113 and an elastic structure 2114, the locking body 2113 is for engaging with the inner tube driving member 220, and the sixth inner cavity is located at the locking body 2113;
  • the elastic structure 2114 is coupled to the locking body 2113.
  • the locking portion 2112 is connected to the inner tube driving member 220 through the elastic structure 2114; when the elastic structure 2114 is stressed, the locking portion 2112 is separated from the inner tube driving member 220 by the elastic structure 2114.
  • the inner tube driving member 220 is provided with a third inner cavity, a fourth inner cavity and a groove, and the third inner cavity axially penetrates the inner tube driving member 220, the fourth The inner cavity is in communication with the third inner cavity.
  • the width of the locking body 2113 in the axial direction matches the groove, and the fourth inner cavity is located as the first emptying channel A in the groove (for example, the groove is a T-shaped structure)
  • the vertical portion thereof constitutes the first emptying passage A, and the horizontal portion thereof is engaged with the locking body 2113.
  • the first emptying passage A Connected with the second empty channel B
  • the external evacuation medium can flow into the second space through the second evacuation channel B, the first evacuation channel A, and the first space (formed between the inner tube 120 and the transition tube 130) (formed on the transition tube 130 and outside) Between the tubes 140) and the third space (formed between the inner tube 120 and the outer tube 140).
  • the venting holes 131 of the transition tube 130 may not be covered by the outer tube 140.
  • a part of the evacuated medium sequentially enters the gap between the transition tube 130 and the outer tube driving member 160 through the second emptying passage B, the first emptying passage A, the first space, and the emptying hole 131
  • the transition tube 130 is sealingly coupled to the outer tube drive member 160
  • the outer tube 140 is also sealingly coupled to the outer tube drive member 160, thereby forming a sealed space for the flow into the gap between the transition tube 130 and the outer tube drive member 160.
  • the empty medium will continue to flow into the second space between the transition tube 130 and the outer tube 140 and flow into the third space, while the other portion of the empty medium passes through the second evacuation channel B, the first evacuation channel A, and the first space. Flow directly to the third space.
  • the elastic structure 2114 includes a resilient arm made of an elastic material, one end of which is connected to the locking body 2113 and the other end is in contact with the supporting member 230.
  • the support member 230 is disposed inside the housing 110 and fixed to the housing 110.
  • the elastic structure 2114 is a spring. One end of the spring is connected to the locking body 2113, and the other end is in contact with the supporting member 230.
  • the locking body 2113 and the inner tube driving member 220 are stuck by the elastic force of the spring. Pick up.
  • the locking body 2113 is engaged with the inner tube driving member 220 by the elastic structure 2114; the elastic force of the elastic structure 2114 is overcome by the control portion 2111 to drive the locking portion 2112 to move downward, so that the locking body 2113 and the inner tube driving member
  • the recess in the 220 is disengaged, and the inner tube drive member 220 is axially movable along the housing 110.
  • the flow member 212 includes a fluid body 2121 and a connecting tube 2122.
  • the fluid body 2121 has an inner cavity extending axially.
  • One end of the connecting tube 2122 is connected to the flow body 2121, and the other end is connected.
  • the inner cavity of the flow member body 2121 communicates with the interior of the connecting tube 2122 to form a seventh inner cavity.
  • the seventh inner cavity and the sixth inner cavity form a second emptying passage B.
  • the flow member body 2121 of the present embodiment is fixed to the housing 110 and a portion is located outside the housing 110 for connection with an external device to receive the evacuation medium.
  • the flow member 212 further includes a flow control member 2123 disposed on the flow member body 2121. to define a flow direction for controlling the evacuation medium.
  • the flow control 2123 comprises a one-way shut-off valve or a controllable lockout valve. More preferably, the flow control member 2123 and the flow member body 2121. are of a unitary structure.
  • the diameter and length of the inner and outer tubes are matched in the present invention and are determined according to the environment of the actual implantation operation.
  • sealed connection means that the two connected components are sealed and relatively movable
  • sealed-fixed connection means that the two connected components are sealed but not relatively movable
  • the implant delivery device of the present invention can be coupled to the housing or moved relative to the housing by the cooperation of the inner tube driving member and the emptying locking assembly, so that the implant is
  • the outer tube is kept stationary, and the emptying locking assembly and the inner tube driving member are unlocked, so that the inner tube driving member can be moved in the housing, so that the inner tube is close to the outer tube and the outer tube
  • the tube is closed and the delivery device is removed.
  • the sheath at the distal end of the outer tube is used to bind the implant in a compressed state, the sheath is required to have a large rigidity.
  • the inner tube having a smaller moving size and better bending performance and a softer material closes the distal end of the outer tube and the distal end of the inner tube, thereby reducing secondary damage to the human tissue during the process of recovering the delivery tube.
  • the second evacuation passage of the implant delivery device of the present invention is disposed on the venting lock assembly, and is capable of passing the first venting passage on the inner tube drive member, the first between the transition tube and the inner tube
  • the space communicates with the second space between the transition tube and the outer tube, and the third space between the outer tube and the inner tube, and the emptying between the inner tube and the outer tube is smoothly realized.
  • the emptying hose is replaced by the emptying locking assembly, and there is no problem that the cavity is deformed and blocked, thereby solving the problem of difficulty in emptying due to deformation of the evacuated hose.
  • the integrated design of the emptying and locking realizes the integration of the emptying and locking functions, reduces the component configuration, and simplifies the operation steps, thereby making the performance of the conveying device more stable and more convenient to operate.

Landscapes

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

Abstract

一种植入体输送装置(100),包括壳体(110)以及至少部分容纳于壳体(110)内的内、外管驱动件(150、160)、内管(120)、过渡管(130)、外管(140)和排空锁定组件(170),三个管子依次套接并且相邻管子间分别形成有第一、二、三空间,内管驱动件(150)的近端密封固连内管(120)的近端,外管驱动件(160)密封固连外管(140)的近端,过渡管(130)的近端密封固连内管驱动件(150)并延伸通过外管驱动件(160)且与外管驱动件(160)密封连接,排空锁定组件(170)与内管驱动件(150)可分离式连接,内管驱动件(150)和排空锁定组件(170)上分别设有第一、二排空通道(A、B),当排空锁定组件(170)与内管驱动件(150)连接时,第二排空通道(B)通过第一排空通道(A)、第一空间与第二空间、第三空间相通,且内管驱动件(150)通过排空锁定组件(170)与壳体(110)连接,当排空锁定组件(170)与内管驱动件(150)分离时,内管驱动件(150)与壳体(110)滑动连接。

Description

植入体输送装置 技术领域
本发明涉及医疗器械技术领域,特别涉及一种植入体输送装置。
背景技术
心脏瓣膜病是我国最常见的心脏病之一,其中主要为风湿热导致的瓣膜损害。近年来随着人口老龄化的发展,瓣膜退行性变(包括钙化和粘液变性等)以及代谢障碍性瓣膜损害在我国也日益增多。传统的心脏瓣膜手术采用的是在全身麻醉下进行的心脏直视方法,这样的手术需要对患者的胸骨进行切割(俗称“胸骨切开术”),并且患者的心脏需要被停止以使血流改道而进入“心肺”旁路控制机(另称“体外循环机”)。传统的外科瓣膜置换手术是一种伴随高风险的创伤性手术,患者可能由于栓子和与体外循环机有关的其它因素被暂时干扰,完全康复需要数月的时间。特别地,老年人以及某些特殊人群一般无法承受这样的外科手术所带来的创伤,术后需要更长的恢复时间或者甚至无法康复。然而,微创伤介入治疗的出现,无疑为心脏瓣膜病的治疗带来了更多希望。
微创伤介入治疗具有无需开胸,创伤小,患者恢复快等优点,近年来被广泛采用。尤其,近10年内介入治疗病例显示出:内外科能够治疗的病例,微创伤介入都能治疗;而且,外科手术不能治疗的病例,介入也能够治疗。因此,微创伤介入治疗的临床应用广泛,值得深入研究。
在心脏瓣膜的微创伤介入治疗中,人造心脏瓣膜通过输送装置植入体内,但是,现有的心脏瓣膜输送装置存在操作复杂,对医者的操作要求高,容易引起误操作的问题,例如,现有心脏瓣膜输送装置在定位并释放人造心脏瓣膜之后,在回收输送管的过程中,容易对患者身体造成二次损伤。此外,现有输送装置在引入排空液时,采用的是,在其外管和内管之间的空间中引申出一根排空软管,该排空软管连接外部设备,以从外部将排空液通入排空软管并进一步导入外管和内管之间的空间从而排除空气,保证介入过程无空气输入。然而,心脏瓣膜输送装置在包装、运输过程中,还需要对输送装置和排空软管进行固定,此固定操作容易造成排空软管受压弯折。另外,手术过程中,在输送和回收输送管时,由于排空软管在手柄腔内移动时没有固定轨道,使得移动外管或 内管易导致排空软管弯折,进而造成排空困难。
发明内容
本发明的目的在于提供一种植入体输送装置,以解决现有技术中提及的一个或多个问题。
为解决上述技术问题,本发明提供了一种植入体输送装置,包括壳体以及至少部分容纳于所述壳体内的内管驱动件、外管驱动件、内管、过渡管、外管和排空锁定组件;所述内管、过渡管和外管从里到外依次套接,所述内管与过渡管之间形成有第一空间,所述过渡管与外管之间形成有第二空间,所述内管与外管之间形成有第三空间;
其中,所述内管驱动件的近端密封固定连接所述内管的近端,所述外管驱动件密封固定连接所述外管的近端,所述过渡管的近端密封固定连接所述内管驱动件,所述过渡管延伸通过所述外管驱动件并与所述外管驱动件密封连接,所述排空锁定组件与内管驱动件可分离式连接;
所述内管驱动件上设有第一排空通道,所述排空锁定组件上设有第二排空通道,所述第二排空通道的一端位于壳体外部;当所述排空锁定组件与内管驱动件连接时,所述第二排空通道的另一端通过第一排空通道、第一空间与第二空间、第三空间相通,且所述内管驱动件通过排空锁定组件与壳体形成轴向相对固定关系;当所述排空锁定组件与内管驱动件分离时,所述内管驱动件能够沿壳体的轴向滑动。
优选地,所述排空锁定组件包括与内管驱动件可分离式连接的锁定件,所述锁定件包括贯通的内腔以形成第二排空通道。
优选地,所述锁定件包括用以与内管驱动件可分离式连接的卡止部分以及用以驱动所述卡止部分运动的控制部分,所述控制部分的一端位于壳体外部,且所述控制部分设有贯通的第一内腔,所述卡止部分设有贯通的第二内腔,所述第一内腔和所述第二内腔连通以形成所述第二排空通道。
优选地,所述植入体输送装置还包括容纳于所述壳体内的导向件,所述导向件具有贯通的导向槽,所述卡止部分沿着所述导向槽的延伸方向相对于所述内管驱动件运动。
优选地,所述内管驱动件具有第三内腔和第四内腔,所述第三内腔轴向贯通内管驱动件,所述过渡管的近端位于第三内腔的远端,所述内管的近端位于第三内腔的近端,所述第四内腔构成所述第一排空通道并与所述第一空间连通。
优选地,所述外管驱动件具有轴向贯通的第五内腔,所述外管的近端位于所述第五内腔中,所述过渡管从所述内管驱动件延伸通过所述第五内腔。
优选地,所述排空锁定组件包括与内管驱动件可分离式连接的锁定件以及与所述锁定件固定连接的流动件;所述锁定件的一部分位于壳体外部,且所述锁定件具有第六内腔,所述第六内腔与第一排空通道相通;所述流动件具有贯通的第七内腔,所述第六内腔和第七内腔连通以形成所述第二排空通道。
优选地,所述锁定件包括用以与内管驱动件可分离式连接的卡止部分以及用以驱动所述卡止部分运动的控制部分,所述控制部分的一端位于壳体外部,且所述第六内腔设于所述卡止部分。
优选地,所述卡止部分包括与内管驱动件可分离式连接的卡止本体以及与所述卡止本体连接的弹性结构,所述卡止部分通过弹性结构与内管驱动件连接,当所述弹性结构受力时,所述卡止部分与内管驱动件分离。
优选地,所述排空锁定组件包括具有控制排空介质的流动方向的流动控制件,所述流动控制件置于所述第二排空通道上。
优选地,所述流动控制件包括单向截止阀或可控锁定阀。
优选地,所述过渡管的远端设有使所述第一空间和第二空间相通的排空孔,当所述排空锁定组件与内管驱动件连接时,所述第二排空通道的另一端通过第一排空通道、第一空间、排空孔与第二空间、第三空间相通。
优选地,所述排空孔的数量多个,多个所述排空孔沿所述过渡管的周向均匀布置。
优选地,所述过渡管的远端与内管固定连接且不密封。
优选地,所述植入体输送装置还包括移动控制件和移动导轨,所述移动导轨设置在所述壳体上,所述移动控制件可移动的设置在所述移动导轨上并与所述外管驱动件连接。
综上所述,本发明的植入体输送装置通过内管驱动件和排空锁定组件的配 合,使得内管能够根据需要与壳体连接或相对于壳体移动,从而当植入体在人体中释放后回收输送装置时,保持外管不动,将排空锁定组件与内管驱动件解锁,使内管驱动件可以在壳体中移动,进而使内管向外管靠近并与外管闭合,然后取出输送装置。由于外管远端的鞘管用于束缚压缩状态的植入体,所以要求鞘管刚度较大。在现有技术中,释放植入体后,重新驱动外管与内管闭合,在此过程中容易导致人体受到鞘管的伤害。而本发明中移动尺寸更小且弯曲性能更好、材料更软的内管,使外管的远端与内管的远端闭合,从而减少回收输送管过程中对人体组织造成的二次损伤。另一方面,本发明的植入体输送装置的第二排空通道设置在排空锁定组件上,能够借由内管驱动件上的第一排空通道、过渡管和内管间的第一空间与过渡管和外管间的第二空间、外管和内管间的第三空间相通,顺利实现了内管和外管之间的排空。这样的设计,用排空锁定组件代替排空软管,没有排空腔变形堵塞的问题,从而解决了因排空软管变形而导致排空困难的问题。将排空和锁定一体设计,实现了排空与锁定功能的集成,减少了零部件配置,简化了操作步骤,从而使输送装置的性能更为稳定,操作更为方便。
附图说明
图1是本发明实施例一的植入体输送装置的示意图,其中省略了壳体;
图2是本发明实施例一的植入体输送装置之排空锁定组件与内管驱动件连接时的示意图;
图3是图2所示的植入体输送装置于M区域的局部放大图;
图4是本发明实施例一的植入体输送装置之排空锁定组件与内管驱动件分离时的局部示意图;
图5是本发明实施例一的过渡管的示意图;
图6是图5所示的过渡管沿H-H连线的剖视图;
图7是本发明实施例一的单向截止阀的示意图;
图8是本发明较佳实施例一的单向截止阀的示意图;
图9是本发明实施例二的植入体输送装置的示意图,其中省略了壳体;
图10是本发明实施例二的植入体输送装置之排空锁定组件与内管驱动件连 接时的示意图;
图11是本发明实施例二的植入体输送装置之排空锁定组件与内管驱动件分离时的局部示意图。
图中的附图标记说明如下:
100、200-植入体输送装置;
110-壳体;
120-内管;
121-固定头;122-远端内管;123-锥形头;
130-过渡管;
131-排空孔;
140-外管;
141-鞘管;
150、220-内管驱动件;
160-外管驱动件;
170、210-排空锁定组件;
171、211-锁定件;
1711、2111-控制部分;1712、2112-卡止部分;
1713、2123-流动控制件;2113-卡止本体;2114-弹性结构;
212-流动件;
2121-流动件本体;2122-连接管;1714、1715-截止通孔;
180-导向件;
190-密封圈;
230-支撑件;
A-第一排空通道;
B-第二排空通道。
具体实施方式
为使本发明的目的、优点和特征更加清楚,以下结合附图1~11对本发明提出的植入体输送装置作进一步详细说明。需说明的是,附图均采用非常简化的 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。
如在本说明书和所附权利要求中所使用的,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。术语“远端”是指远离植入体输送装置的操作者的一端;相应的,术语“近端”是指接近植入体输送装置的操作者的一端。
附图中相同或相似的附图标记代表相同或相似的部件。本发明之植入体输送装置可以将植入体(例如人工心脏瓣膜)送入人体,经定位、释放植入体到指定位置。
<实施例一>
参考图1至图4,图1是本发明实施例一的植入体输送装置的示意图,图2是本发明实施例一的植入体输送装置之排空锁定组件与内管驱动件连接时的示意图,图3是图2所示的植入体输送装置于M区域的局部放大图,图4是本发明实施例一的植入体输送装置之排空锁定组件与内管驱动件分离时的局部示意图,其中图1未示出壳体110,以便于更清楚了解植入体输送装置的内部结构。
本实施例之植入体输送装置100包括壳体110以及部分容置在壳体110内的内管120、过渡管130、外管140、内管驱动件150、外管驱动件160和排空锁定组件170。所述内管120、过渡管130和外管140从里到外依次套接。所述内管120与过渡管130之间形成有第一空间。所述过渡管130与外管140之间形成有第二空间。所述内管120与外管140之间形成有第三空间。
接着,所述内管驱动件150的近端密封固定连接内管120的近端,可以驱动内管120沿壳体110的轴向运动;所述外管驱动件160密封固定连接外管140的近端,可以驱动外管140沿壳体110的轴向运动;所述过渡管130的近端密封固定连接内管驱动件150,所述过渡管130延伸通过外管驱动件160并与外管驱动件160密封连接;所述排空锁定组件170与内管驱动件150可分离式连接。
紧接着,所述内管驱动件150(优选径向)上设有第一排空通道A,所述排空锁定组件170上设有第二排空通道B;所述第二排空通道B的一端位于壳体110外部,以接收外部的排空介质;当所述排空锁定组件170与内管驱动件150连接时,所述第二排空通道B的另一端通过第一排空通道A、第一空间与第二 空间、第三空间相通,从而将外部的排空介质灌注至第二空间、第三空间,进而排净空间中的空气。同时,当所述排空锁定组件170与内管驱动件150连接时,所述内管驱动件150通过排空锁定组件170与壳体110连接,从而间接实现内管120与壳体110之间的固定。另一方面,当所述排空锁定组件170与内管驱动件150分离时,所述内管驱动件150与壳体110滑动连接,即内管驱动件150可在壳体110中沿壳体110轴向移动。应当理解,为了引入排空介质,所述排空锁定组件170连接用以提供排空介质的外部设备,以将排空介质引入第二排空通道B。
优选,所述过渡管130设有使所述第一空间和第二空间相通的排空孔131(明显地,排空孔131贯穿过渡管130的管壁,此更清楚显示于图5和图6),当所述排空锁定组件170与内管驱动件150连接时,所述第二排空通道B的另一端还可以通过第一排空通道A、第一空间、排空孔131与第二空间、第三空间相通。
以下将结合图1至图8更进一步详细说明实施例一的植入体输送装置100。
本实施例中,所述排空锁定组件170包括锁定件171,所述锁定件171与内管驱动件150可分离式连接。其中,所述锁定件171的一部分位于壳体110外部,以便使用者操作锁定件171。特别的,所述锁定件171包括贯通的内腔以形成第二排空通道B。
进一步,所述锁定件171包括控制部分1711和卡止部分1712;所述控制部分1711的一端位于壳体110外部用以连接外部设备,另一端与卡止部分1712连接以驱动卡止部分1712相对内管驱动件150运动;所述卡止部分1712位于壳体110内部,以在控制部分1711的驱动下与内管驱动件150卡接。
更进一步,所述控制部分1711与卡止部分1712均为中空结构(即均设有贯通的内腔),其中,所述控制部分1711的中空结构形成第一内腔,所述卡止部分1712的中空结构形成第二内腔。在本发明的一个实施例中,所述第一内腔和第二内腔直接连通,以形成第二排空通道B。优选地,所述控制部分1711与卡止部分1712一体成型。
本实施例的锁定件171除了可以用于输送排空介质外,还用以锁定内管驱动件150,使得内管驱动件150与壳体110连接,当然,所述锁定件171与内管 驱动件150分离时,使得内管驱动件150相对于壳体110可运动。具体地说,所述锁定件171与内管驱动件150可分离连接,当所述锁定件171锁定内管驱动件150时,由于所述锁定件171与壳体110在壳体110的轴向方向固定,使得内管驱动件150无法沿壳体110的轴向方向移动;当所述锁定件171解锁内管驱动件150时,所述锁定件171与内管驱动件150分离,使得内管驱动件150可相对壳体110沿壳体110轴向方向运动。
为了与卡止部分1712配合,所述内管驱动件150上设有卡槽(未标号),以容置至少一部分长度的卡止部分1712,从而限位内管驱动件150在轴向方向的位移。同时,所述第一排空通道A位于所述卡槽,即通过卡止部分1712与所述卡槽连接,使得第二排空通道B与所述第一排空通道A连接。反之,所述卡止部分1712也可以设为卡槽结构,对应地,所述内管驱动件150上另设置有与卡止部分1712配合的凸起结构,同样可实现卡止部分1712与内管驱动件150的卡接,进而使得第二排空通道B与所述第一排空通道A连接。
优选,本实施例的卡止部分1712面向卡槽的一端呈锥形凸起结构,与所述内管驱动件150上的卡槽卡接,这样结构简单,卡止部分1712可以顺利卡入卡槽中。
在一个实施例中,所述壳体110内设有导向件180,与壳体110固定连接。所述导向件180具有贯通的导向槽(未标号),所述导向槽的宽度与卡止部分1712的宽度相匹配,且所述导向槽对准内管驱动件150之卡槽的第一排空通道A,使得卡止部分1712在控制部分1711的驱动下沿着导向槽的延伸方向运动,以锁定内管驱动件150。
优选地,所述卡止部分1712与导向槽螺纹配合,即当旋转控制部分1711时,通过驱使卡止部分1712与导向槽螺旋锁定,即可控制卡止部分1712与内管驱动件150锁定并与壳体110固定。
优选地,所述锁定件171还包括流动控制件1713,所述流动控制件1713设于第二排空通道B上,用以控制排空介质的流动方向。优选地,所述流动控制件1713包括单向截止阀或可控锁定阀。
图7是本发明实施例一的单向截止阀的示意图,图8是本发明实施例一的另一单向截止阀的示意图。如图7所示,所述单向截止阀内的截止通孔1714呈 “I”型,或者如图8所示,所述单向截止阀内的截止通孔1715呈“Y”型。当然,本发明包括但不限于图7和图8所示的单向截止阀,其他能够实现单向截止功能的阀门,都可以适用于本发明。本实施例的可控锁定阀可以由使用者控制其截止通孔的开闭来控制排空介质的流动方向。
本实施例中,外部的排空介质至少依次通过第二排空通道B、第一排空通道A、第一空间流入第二空间和第三空间。较佳地,一部分排空介质依次通过第二排空通道B、第一排空通道A、第一空间、排空孔131进入第二空间并流入第三空间,而另一部分排空介质依次通过第二排空通道B、第一排空通道A、第一空间直接至第三空间。
本实施例中,所述排空孔131优选为图5所示的腰形孔,更优选为图6所示的多个排空孔131,如三个。较佳地,多个排空孔131沿过渡管130的周向均匀布置。其中,图5是本发明实施例一的过渡管的示意图,图6是图5所示的过渡管沿H-H连线的剖视图。
此外,应当知晓的是,所述内管120的远端伸出过渡管130,以与外管140配合形成第三空间,而所述过渡管130的近端伸出外管140并连接内管驱动件150。另外,所述过渡管130的长度须足够长,以能够保证当外管驱动件160被驱动至壳体110远端时,所述外管140仍然能够覆盖部分过渡管130,进一步如果过渡管130设有排空孔131,那么优选地,所述排空孔131仍然能够被外管140所覆盖。本实施例的排空孔131优选设置在过渡管130的远端上。
继续参考图2,所述内管驱动件150布置在壳体110的近端并具有第三内腔和第四内腔,所述第三内腔轴向贯通内管驱动件150,且所述第四内腔构成第一排空通道A并与第一空间连通,优选所述第三内腔的轴线与第四内腔轴线垂直。
本实施例中,所述内管120的近端插入第三内腔中并与内管驱动件150的近端密封固定连接(例如焊接、粘接或铆接等方式密封固定连接),且所述内管120的近端位于第三内腔的近端,同时,所述过渡管130相应插入第三内腔中,且所述过渡管130的近端位于第三内腔的远端并与第四内腔相邻。这样的做法,使得第一排空通道A流出的排空介质直接进入内管120与过渡管130之间的第一空间中。
可选地,所述过渡管130的近端与内管驱动件150通过焊接、铆接、粘接、 密封圈等方式密封固定连接。
优选方案中,所述过渡管130从内管驱动件150向远端延伸,通过外管驱动件160,而且与外管驱动件160密封连接,以避免排空介质从第二空间泄露。如果过渡管130设有排空孔131,则过渡管130与外管驱动件160密封连接的位置位于排空孔131的近端。所述过渡管130例如通过密封圈190与外管驱动件160密封连接。
进一步,所述内管驱动件150沿轴向的一部分位于壳体110外部,以便于使用者通过操作内管驱动件150,拉动或推动内管120沿轴向运动。更进一步,所述内管120的近端设有鲁尔口以连接外部设备,将排空介质灌注至内管120进行排空。可选地,所述外部设备通过一根排空导入管与内管120的近端连接。为防止反流,在排空导入管与内管120之间设置另一个流动控制件(未图示),以控制排空介质单向流动。该流动控制件,例如是单向截止阀或可控锁定阀。
继续参考图2和图3,所述外管驱动件160布置在壳体110内并位于内管驱动件150的远端,且具有轴向贯通的第五内腔。所述外管驱动件160可以驱动外管沿壳体110轴向移动,以实现瓣膜支架的装载、释放。所述外管140的近端插入第五内腔中并与外管驱动件160密封固定连接。可选,所述外管140与外管驱动件160通过焊接、粘接、铆接、密封圈等方式密封固定连接。对应地,所述过渡管130从内管驱动件150延伸通过第五内腔,并保证过渡管130的远端始终能够被外管140覆盖,并且当过渡管130设有排空孔131时,优选地,排空孔131始终能够被外管140覆盖。
较佳方案中,当所述过渡管130的近端与内管驱动件150密封固定连接时,所述过渡管130的远端与内管120固定连接且不密封。例如在排空孔131的右侧(远离过渡管130近端的一侧),所述过渡管130的远端与内管120固定连接且不密封。在排空孔131的右侧,由于内管120和过渡管130之间还存在部分第一空间,故而,排空介质除了可以通过排空孔131、第二空间进入第三空间,还可以直接通过该部分的第一空间进入内管120和外管140之间的第三空间,这样的设置,既可以保持过渡管130与内管120的同心度,并且还可以防止过渡管130形成悬臂梁结构,导致受力不均,同时可以使排空介质从过渡管130的远端与内管120形成的第一空间直接流入到内管120与外管140之间的第三 空间,扩大了流通空间。可选地,所述过渡管130与内管120通过机械铆钉、焊接或粘结等固定连接。
本发明对所述内管、外管伸出壳体后的远端部分的结构和组成没有特别的限制。本领域的技术人员可以根据植入体的类型、植入位置等选择合适的结构。
在本实施例中,所述内管120的远端包括固定头121,与固定头121连接的远端内管122,设于远端内管122远端的锥形头123。其中所述固定头121设有安装槽用于装载植入体。所述外管140的远端设有鞘管141,所述鞘管141用于约束压缩状态的植入体。所述鞘管141的长度与远端内管122的长度相匹配。
结合上述实施例的具体结构,本实施例的植入体输送装置100的工作过程如下:
管材排空:将外管140和内管120之远端部分置入排空介质中(排空介质例如是水,例如远端部分放置于水环境中),通过排空锁定组件170将排空介质输入到第一空间、第二空间、第三空间中,排除外管140与内管120之间的空气;通过鲁尔口将排空介质输入到内管120的内腔中,排除内管120的内腔中的空气;
植入体的装载:首先将植入体的挂耳套接在内管120之固定头121上,之后,操作外管140向植入体输送装置100的远端运动,使得鞘管141包覆住远端内管122以及远端内管122上的植入体,从而使植入体压缩约束于外管140和内管120之间;
植入体的输送和释放:植入体装载完毕后,保持内管120和外管140相对静止,并将植入体输送至体内,随后,当植入体到达目的位置后,操作外管140向植入体输送装置100的近端运动,以使鞘管141脱离植入体,那么,所述植入体在去除鞘管141的压缩力后,便自动释放定位在人体组织病变部位;
输送装置的回收:植入体释放定位在人体组织病变部位后,将排空锁定组件170与内管驱动件150解锁,操作内管驱动件150带动内管120向植入体输送装置100的近端运动,使得锥形头123的近端端部抵靠在外管140的远端上,且使内管120的远端与外管140的远端闭合,继而从人体中取出输送装置。
在上述公开的实施例中,所述壳体110例如是操作手柄,其用以充当植入体输送装置100的安装底座,以便安放各个部件。例如所述内管驱动件150、外 管驱动件160置于壳体110中,并可沿壳体110轴向相对于壳体110移动;所述内管120的近端与内管驱动件150连接,所述内管120的远端延伸出壳体110的远端,所述外管140的近端与外管驱动件160连接,所述外管140的远端延伸出壳体110的远端;所述排空锁定组件170部分容纳于壳体110中,并可以与壳体110相对运动。在此,所述壳体110的材质、形状和尺寸并不被限制,已有的及今后可能出现的、能够适合使用者持有和操作且能够容纳一部分内管120、过渡管130、一部分外管140以及其他部件的壳体110的结构,均可适用于本发明的植入体输送装置100。
本实施例中,所述植入体输送装置100还包括移动控制件和移动导轨,所述移动导轨设置在壳体110上,所述移动控制件可移动的设置在所述移动导轨上,并与外管驱动件160连接。使用者通过操控移动控制件沿移动导轨移动,进而带动外管驱动件160移动,并同步带动外管140运动。
上述实施例中,所述过渡管130采用高分子材料或金属材料制成。所述金属材料可以是不锈钢、钛、金等金属材料,也可以是镍钛合金、钴镍合金等合金材料。所述高分子材料可以是聚碳酸酯、聚丙烯、聚酰胺、聚酰亚胺、丙烯腈-丁二烯-苯乙烯共聚物等材料中的一种或多种,当然,本领域技术人员应当能够理解,今后可能出现的,根据植入体植入过程的环境要求选择的过渡管130的材质,均可以应用于本发明中。
此外,所述外管140和内管120的材质可以是由多层结构结合的编制材质,也可以是其他金属、高分子化合物或适用于医用的化学材质。一般而言,所述外管140和内管120都要求在轴向方向上具有较强的抗伸缩力,在垂直于轴向方向上具有一定的可弯曲性。
<实施例二>
图9是本发明实施例二的植入体输送装置的示意图,图10是本发明实施例二的植入体输送装置之排空锁定组件与内管驱动件连接时的示意图,图11是本发明实施例二的植入体输送装置之排空锁定组件与内管驱动件分离时的局部示意图,图9中壳体110、外管140、外管驱动件160均未示出。与实施例一相比,本实施例的主要区别在于排空锁定组件,而其他结构部分可类似地参阅实施例一。
本实施例的植入体输送装置200中,所述排空锁定组件210包括锁定件211和流动件212,所述锁定件211与内管驱动件220可分离式连接,所述流动件212与锁定件211相互连接。
与实施例一不同的是,所述排空锁定组件210包括锁定件211与流动件212,所述流动件212的一部分位于壳体110外部,以引入排空介质,同时所述锁定件211的一部分位于壳体110外部,以便于使用者操作锁定件211。与实施例一不同的是,所述锁定件211具有第六内腔,当所述锁定件211与内管驱动件220连接时,所述第六内腔与第一排空通道A相通。所述流动件212具有贯通的第七内腔,所述第六内腔和第七内腔连通以形成第二排空通道B。
另外,与实施例一类似地,所述锁定件211包括控制部分2111和卡止部分2112,所述卡止部分2112用以与内管驱动件220卡接,所述控制部分2111用以驱动卡止部分2112运动。同理,所述控制部分2111的一端位于壳体110外部,以便于使用者实施操作。然而,与实施例一不同的是,仅卡止部分2112设有内腔,即所述第六内腔位于卡止部分2112中。当所述卡止部分2112与内管驱动件220卡接时,所述第六内腔连通第一排空通道A。
进一步,所述卡止部分2112还具有轴向贯通的第八内腔,所述第八内腔使得锁定件211直接套接在内管驱动件220上。所述第八内腔与第六内腔连通,优选所述第八内腔的轴线垂直于第六内腔的轴线。
优选方案中,所述卡止部分2112包括卡止本体2113和弹性结构2114,所述卡止本体2113用以与内管驱动件220卡接,且所述第六内腔位于卡止本体2113;所述弹性结构2114与卡止本体2113连接。所述卡止部分2112通过弹性结构2114与内管驱动件220保持连接;当所述弹性结构2114受力时,所述卡止部分2112通过弹性结构2114与内管驱动件220分离。
进一步,与实施例一类似,所述内管驱动件220设有第三内腔、第四内腔以及一凹槽,所述第三内腔轴向贯通内管驱动件220,所述第四内腔与第三内腔连通。所述卡止本体2113沿轴向方向的宽度与所述凹槽相匹配,同时所述第四内腔作为第一排空通道A位于所述凹槽(例如所述凹槽为T字型结构,其竖直部分构成第一排空通道A,其水平部分与卡止本体2113卡接),当所述卡止本体2113与内管驱动件220卡接时,所述第一排空通道A与第二排空通道B连通, 使得外部的排空介质可通过第二排空通道B、第一排空通道A、第一空间(形成于内管120与过渡管130之间)流入第二空间(形成于过渡管130与外管140之间)和第三空间(形成于内管120与外管140之间)。如图10所示,与图2所示实施例不同的是,过渡管130的排空孔131也可以不被外管140覆盖。在这种情况下,一部分排空介质依次通过第二排空通道B、第一排空通道A、第一空间、排空孔131进入过渡管130与外管驱动件160之间的空隙,由于过渡管130与外管驱动件160密封连接,外管140也与外管驱动件160密封连接,因而形成了一个密封空间,使得流入过渡管130与外管驱动件160之间的空隙内的排空介质会继续流入过渡管130与外管140之间的第二空间并流入第三空间,而另一部分排空介质则依次通过第二排空通道B、第一排空通道A、第一空间直接流至第三空间。
本实施例中,所述弹性结构2114包括由弹性材料制成的弹性臂,所述弹性臂的一端与卡止本体2113连接,另一端与支撑件230接触。所述支撑件230设置在壳体110内部并与壳体110固定。又例如,所述弹性结构2114是弹簧,所述弹簧的一端与卡止本体2113连接,另一端与支撑件230接触,借助于弹簧的弹性力,使得卡止本体2113与内管驱动件220卡接。总之,通过弹性结构2114使得卡止本体2113与内管驱动件220卡接;通过控制部分2111克服弹性结构2114的弹力,驱使卡止部分2112向下移动,使得卡止本体2113与内管驱动件220上的凹槽脱离,进而内管驱动件220可以沿壳体110轴向移动。
本实施例中,所述流动件212包括流动件本体2121和连接管2122,所述流动件本体2121具有轴向贯通的内腔,所述连接管2122的一端与流动件本体2121连接,另一端与卡止部分2112连接,所述流动件本体2121的内腔与连接管2122的内部连通,形成第七内腔。进一步,所述第七内腔与第六内腔形成第二排空通道B。本实施例的流动件本体2121固定在壳体110上且一部分位于壳体110外部,用于与外部设备连接,以接受排空介质。
所述流动件212还包括流动控制件2123,所述流动控制件2123设置于流动件本体2121上,以限定控制排空介质的流动方向。优选地,所述流动控制件2123包括单向截止阀或可控锁定阀。更优选地,所述流动控制件2123与流动件本体2121是一体式结构。
本发明较佳实施如上所述,但并不局限于上述实施例所公开的范围,本领域技术人员应当能够理解,其他可以用于实现锁定件与内管驱动件之间配合固定或分离的方式,都可以以引用的方式包含于此。
此外,本领域技术人员应当能够理解,本发明中所述内管和外管的直径和长度相配合,且根据实际植入操作的环境而确定。
上述实施例中,需要说明的是,“密封连接”指的是两个被连接的部件密封且可相对运动,“密封固定连接”指的是两个被连接的部件密封但不可相对运动。
与现有技术相比,本发明的植入体输送装置通过内管驱动件和排空锁定组件的配合,使得内管能够根据需要与壳体连接或相对于壳体移动,从而当植入体在人体中释放后回收输送装置时,保持外管不动,将排空锁定组件与内管驱动件解锁,使内管驱动件可以在壳体中移动,进而使内管向外管靠近并与外管闭合,然后取出输送装置。特别的,由于外管远端的鞘管用于束缚压缩状态的植入体,所以要求鞘管刚度较大。在现有技术中,释放植入体后,重新驱动外管与内管闭合,在此过程中容易导致人体受到鞘管的伤害。而本发明中移动尺寸更小且弯曲性能更好、材料更软的内管使外管的远端与内管的远端闭合,从而减少回收输送管过程中对人体组织造成的二次损伤。另一方面,本发明的植入体输送装置的第二排空通道设置在排空锁定组件上,能够借由内管驱动件上的第一排空通道、过渡管和内管间的第一空间与过渡管和外管间的第二空间、外管和内管间的第三空间相通,顺利实现了内管和外管之间的排空。这样的设计,用排空锁定组件代替排空软管,没有排空腔变形堵塞的问题,从而解决了因排空软管变形而导致排空困难的问题。将排空和锁定一体设计,实现了排空与锁定功能的集成,减少了零部件配置,简化了操作步骤,从而使输送装置的性能更为稳定,操作更为方便。
上述描述仅是对本发明较佳实施例的描述,并非对本发明范围的任何限定,本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰,均属于权利要求书的保护范围。

Claims (15)

  1. 一种植入体输送装置,其特征在于,包括壳体以及至少部分容纳于所述壳体内的内管驱动件、外管驱动件、内管、过渡管、外管和排空锁定组件;所述内管、过渡管和外管从里到外依次套接,所述内管与过渡管之间形成有第一空间,所述过渡管与外管之间形成有第二空间,所述内管与外管之间形成有第三空间;
    其中,所述内管驱动件的近端密封固定连接所述内管的近端,所述外管驱动件密封固定连接所述外管的近端,所述过渡管的近端密封固定连接所述内管驱动件,且所述过渡管延伸通过所述外管驱动件并与外管驱动件密封连接,所述排空锁定组件与内管驱动件可分离式连接;
    所述内管驱动件上设有第一排空通道,所述排空锁定组件上设有第二排空通道,所述第二排空通道的一端位于壳体外部;当所述排空锁定组件与内管驱动件连接时,所述第二排空通道的另一端通过第一排空通道、第一空间与第二空间、第三空间相通,且所述内管驱动件通过排空锁定组件与壳体形成轴向相对固定关系;当所述排空锁定组件与内管驱动件分离时,所述内管驱动件能够沿壳体的轴向滑动。
  2. 如权利要求1所述的植入体输送装置,其特征在于,所述排空锁定组件包括与内管驱动件可分离式连接的锁定件,所述锁定件包括贯通的内腔以形成所述第二排空通道。
  3. 如权利要求2所述的植入体输送装置,其特征在于,所述锁定件包括用以与内管驱动件可分离式连接的卡止部分以及用以驱动所述卡止部分运动的控制部分,所述控制部分的一端位于壳体外部,且所述控制部分设有贯通的第一内腔,所述卡止部分设有贯通的第二内腔,所述第一内腔和所述第二内腔连通以形成所述第二排空通道。
  4. 如权利要求3所述的植入体输送装置,其特征在于,所述植入体输送装置还包括容纳于所述壳体内的导向件,所述导向件具有贯通的导向槽,所述卡止部分沿着所述导向槽的延伸方向相对于所述内管驱动件运动。
  5. 如权利要求1所述的植入体输送装置,其特征在于,所述内管驱动件具 有第三内腔和第四内腔,所述第三内腔轴向贯通内管驱动件,所述过渡管的近端位于第三内腔的远端,所述内管的近端位于第三内腔的近端,所述第四内腔构成所述第一排空通道并与所述第一空间连通。
  6. 如权利要求1所述的植入体输送装置,其特征在于,所述外管驱动件具有轴向贯通的第五内腔,所述外管的近端位于所述第五内腔中,所述过渡管从所述内管驱动件延伸通过所述第五内腔。
  7. 如权利要求1所述的植入体输送装置,其特征在于,所述排空锁定组件包括与内管驱动件可分离式连接的锁定件以及与所述锁定件固定连接的流动件;所述锁定件的一部分位于壳体外部,且所述锁定件具有第六内腔,所述第六内腔与第一排空通道相通;所述流动件具有贯通的第七内腔,所述第六内腔和第七内腔连通以形成所述第二排空通道。
  8. 如权利要求7所述的植入体输送装置,其特征在于,所述锁定件包括用以与内管驱动件可分离式连接的卡止部分以及用以驱动所述卡止部分运动的控制部分,所述控制部分的一端位于壳体外部,且所述第六内腔设于所述卡止部分。
  9. 如权利要求8所述的植入体输送装置,其特征在于,所述卡止部分包括与内管驱动件可分离式连接的卡止本体以及与所述卡止本体连接的弹性结构,所述卡止部分通过弹性结构与内管驱动件连接,当所述弹性结构受力时,所述卡止部分与内管驱动件分离。
  10. 如权利要求1所述的植入体输送装置,其特征在于,所述排空锁定组件包括具有控制排空介质的流动方向的流动控制件,所述流动控制件置于所述第二排空通道上。
  11. 如权利要求10所述的植入体输送装置,其特征在于,所述流动控制件包括单向截止阀或可控锁定阀。
  12. 如权利要求1所述的植入体输送装置,其特征在于,所述过渡管的远端设有使所述第一空间和第二空间相通的排空孔,当所述排空锁定组件与内管驱动件连接时,所述第二排空通道的另一端通过第一排空通道、第一空间、排空孔与第二空间、第三空间相通。
  13. 如权利要求12所述的植入体输送装置,其特征在于,所述排空孔的数 量多个,多个所述排空孔沿所述过渡管的周向均匀布置。
  14. 如权利要求1所述的植入体输送装置,其特征在于,所述过渡管的远端与内管固定连接且不密封。
  15. 如权利要求1所述的植入体输送装置,其特征在于,所述植入体输送装置还包括移动控制件和移动导轨,所述移动导轨设置在所述壳体上,所述移动控制件可移动的设置在所述移动导轨上并与所述外管驱动件连接。
PCT/CN2017/102959 2016-10-20 2017-09-22 植入体输送装置 WO2018072595A1 (zh)

Priority Applications (5)

Application Number Priority Date Filing Date Title
KR1020197014517A KR102260740B1 (ko) 2016-10-20 2017-09-22 이식물 전달 장치
EP17862538.0A EP3530236B1 (en) 2016-10-20 2017-09-22 Implant delivery apparatus
JP2019521045A JP6757850B2 (ja) 2016-10-20 2017-09-22 インプラントデリバリ装置
US16/343,562 US10966755B2 (en) 2016-10-20 2017-09-22 Implant delivery apparatus
ES17862538T ES2849439T3 (es) 2016-10-20 2017-09-22 Aparato de suministro de implantes

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201610916660.3 2016-10-20
CN201610916660.3A CN107374782B (zh) 2016-10-20 2016-10-20 植入体输送装置

Publications (1)

Publication Number Publication Date
WO2018072595A1 true WO2018072595A1 (zh) 2018-04-26

Family

ID=60338868

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2017/102959 WO2018072595A1 (zh) 2016-10-20 2017-09-22 植入体输送装置

Country Status (7)

Country Link
US (1) US10966755B2 (zh)
EP (1) EP3530236B1 (zh)
JP (1) JP6757850B2 (zh)
KR (1) KR102260740B1 (zh)
CN (1) CN107374782B (zh)
ES (1) ES2849439T3 (zh)
WO (1) WO2018072595A1 (zh)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8579964B2 (en) 2010-05-05 2013-11-12 Neovasc Inc. Transcatheter mitral valve prosthesis
US9554897B2 (en) 2011-04-28 2017-01-31 Neovasc Tiara Inc. Methods and apparatus for engaging a valve prosthesis with tissue
US9308087B2 (en) 2011-04-28 2016-04-12 Neovasc Tiara Inc. Sequentially deployed transcatheter mitral valve prosthesis
US9345573B2 (en) 2012-05-30 2016-05-24 Neovasc Tiara Inc. Methods and apparatus for loading a prosthesis onto a delivery system
US9572665B2 (en) 2013-04-04 2017-02-21 Neovasc Tiara Inc. Methods and apparatus for delivering a prosthetic valve to a beating heart
CN108601645B (zh) 2015-12-15 2021-02-26 内奥瓦斯克迪亚拉公司 经中隔递送系统
EP4183372A1 (en) 2016-01-29 2023-05-24 Neovasc Tiara Inc. Prosthetic valve for avoiding obstruction of outflow
EP3541462A4 (en) 2016-11-21 2020-06-17 Neovasc Tiara Inc. METHODS AND SYSTEMS FOR RAPID RETRACTION OF A TRANSCATHETER HEART VALVE DELIVERY SYSTEM
US10856984B2 (en) 2017-08-25 2020-12-08 Neovasc Tiara Inc. Sequentially deployed transcatheter mitral valve prosthesis
AU2019374743B2 (en) 2018-11-08 2022-03-03 Neovasc Tiara Inc. Ventricular deployment of a transcatheter mitral valve prosthesis
CA3132873A1 (en) 2019-03-08 2020-09-17 Neovasc Tiara Inc. Retrievable prosthesis delivery system
CN113811265A (zh) 2019-04-01 2021-12-17 内奥瓦斯克迪亚拉公司 能够以可控的方式部署的假体瓣膜
AU2020271896B2 (en) 2019-04-10 2022-10-13 Neovasc Tiara Inc. Prosthetic valve with natural blood flow
WO2020236931A1 (en) 2019-05-20 2020-11-26 Neovasc Tiara Inc. Introducer with hemostasis mechanism
WO2020257643A1 (en) 2019-06-20 2020-12-24 Neovasc Tiara Inc. Low profile prosthetic mitral valve

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101553190A (zh) * 2006-09-08 2009-10-07 爱德华兹生命科学公司 一体的心脏瓣膜运送系统
US20090287182A1 (en) * 2008-05-14 2009-11-19 Onset Medical Corporation Expandable iliac sheath and method of use
CN102497907A (zh) * 2009-07-14 2012-06-13 爱德华兹生命科学公司 用于心脏瓣膜的切顶递送系统
CN102764165A (zh) * 2012-08-13 2012-11-07 宁波健世生物科技有限公司 经皮主动脉或主动脉瓣膜支架输送系统
US20130116771A1 (en) * 2011-10-31 2013-05-09 Merit Medical Systems, Inc. Safety mechanism for an implantable device deployment apparatus
CN204709078U (zh) * 2015-04-20 2015-10-21 上海纽脉医疗科技有限公司 一种介入式人工心脏瓣膜输送系统
CN206499552U (zh) * 2016-10-20 2017-09-19 上海微创心通医疗科技有限公司 植入体输送装置

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS53236A (en) 1976-06-23 1978-01-05 Toshiba Corp Apparatus for vanish coating
US5700269A (en) 1995-06-06 1997-12-23 Corvita Corporation Endoluminal prosthesis deployment device for use with prostheses of variable length and having retraction ability
US20030153875A1 (en) * 2002-02-14 2003-08-14 Ishay Ostfeld Indwelling device
US7993384B2 (en) * 2003-09-12 2011-08-09 Abbott Cardiovascular Systems Inc. Delivery system for medical devices
US20090048656A1 (en) * 2005-11-09 2009-02-19 Ning Wen Delivery Device for Delivering a Self-Expanding Stent
US8740976B2 (en) * 2010-04-21 2014-06-03 Medtronic, Inc. Transcatheter prosthetic heart valve delivery system with flush report
US9414915B2 (en) 2010-09-24 2016-08-16 Symetis Sa Stent valve, delivery apparatus and method therefor
US9566087B2 (en) * 2013-03-15 2017-02-14 Access Scientific, Llc Vascular access device
CN104758092B (zh) * 2015-04-20 2018-09-18 上海纽脉医疗科技有限公司 一种介入式人工心脏瓣膜输送系统
CN204600795U (zh) * 2015-04-20 2015-09-02 上海纽脉医疗科技有限公司 一种用于介入式人工心脏瓣膜的输送装置

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101553190A (zh) * 2006-09-08 2009-10-07 爱德华兹生命科学公司 一体的心脏瓣膜运送系统
US20090287182A1 (en) * 2008-05-14 2009-11-19 Onset Medical Corporation Expandable iliac sheath and method of use
CN102497907A (zh) * 2009-07-14 2012-06-13 爱德华兹生命科学公司 用于心脏瓣膜的切顶递送系统
US20130116771A1 (en) * 2011-10-31 2013-05-09 Merit Medical Systems, Inc. Safety mechanism for an implantable device deployment apparatus
CN102764165A (zh) * 2012-08-13 2012-11-07 宁波健世生物科技有限公司 经皮主动脉或主动脉瓣膜支架输送系统
CN204709078U (zh) * 2015-04-20 2015-10-21 上海纽脉医疗科技有限公司 一种介入式人工心脏瓣膜输送系统
CN206499552U (zh) * 2016-10-20 2017-09-19 上海微创心通医疗科技有限公司 植入体输送装置

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP3530236A4 *

Also Published As

Publication number Publication date
US20200046406A1 (en) 2020-02-13
KR20190072604A (ko) 2019-06-25
ES2849439T3 (es) 2021-08-18
KR102260740B1 (ko) 2021-06-03
JP2019531156A (ja) 2019-10-31
JP6757850B2 (ja) 2020-09-23
EP3530236A1 (en) 2019-08-28
EP3530236A4 (en) 2019-10-09
CN107374782A (zh) 2017-11-24
US10966755B2 (en) 2021-04-06
CN107374782B (zh) 2023-04-18
EP3530236B1 (en) 2020-11-18

Similar Documents

Publication Publication Date Title
WO2018072595A1 (zh) 植入体输送装置
JP2020168512A (ja) 紐形要素、特にカテーテルを患者の身体へ挿入するためのシースアセンブリ
JP5596974B2 (ja) Lvad移植用手術器具
US20180116796A1 (en) Transapical introducer
CN112244950B (zh) 介入器械
CN106604687A (zh) 用于包含抽吸、冲洗和材料去除的不同领域的内窥镜式外科手术的鞘套组件和多孔导管
JP2010537725A (ja) 圧縮性部材を含むカニューレ挿入デバイス、システム、および方法
CN104411257A (zh) 憩室反转装置
CN206499552U (zh) 植入体输送装置
CN110602995A (zh) 内窥镜
EP3772357A1 (en) Thrombectomy with venturi suction
US20160066934A1 (en) Devices and methods for removal of calculus
JP7433669B2 (ja) 開閉ユニットを含む内視鏡システム
CN110664513A (zh) 一种瓣膜支架的输送装置
CN214181412U (zh) 介入器械
CN112603547A (zh) 手术器械、从操作设备及手术机器人
US20020198560A1 (en) Flush tool and method for flushing air from catheters
CA3153218A1 (en) Medical connector with automatic sealing on disconnection
JP2021118755A (ja) 内視鏡装置、内視鏡装置の動作方法
US11717200B2 (en) Ergonomic suction syringe and methods of use
US20230010903A1 (en) Locking irrigation valve
US20220211357A1 (en) Systems and methods for performing tissue biopsy
CN112823750B (zh) 瓣膜缝线器及瓣膜缝线系统
CN106659358A (zh) 流体用栓部和插入设备

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 17862538

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2019521045

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 20197014517

Country of ref document: KR

Kind code of ref document: A

ENP Entry into the national phase

Ref document number: 2017862538

Country of ref document: EP

Effective date: 20190520