WO2022142239A1 - 一种植入物输送系统 - Google Patents

一种植入物输送系统 Download PDF

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Publication number
WO2022142239A1
WO2022142239A1 PCT/CN2021/104351 CN2021104351W WO2022142239A1 WO 2022142239 A1 WO2022142239 A1 WO 2022142239A1 CN 2021104351 W CN2021104351 W CN 2021104351W WO 2022142239 A1 WO2022142239 A1 WO 2022142239A1
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WO
WIPO (PCT)
Prior art keywords
handle
rod
push rod
implant
hook
Prior art date
Application number
PCT/CN2021/104351
Other languages
English (en)
French (fr)
Inventor
左斌
Original Assignee
上海领闻医疗科技有限公司
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
Priority claimed from CN202011642708.9A external-priority patent/CN112603599A/zh
Application filed by 上海领闻医疗科技有限公司 filed Critical 上海领闻医疗科技有限公司
Priority to EP21912993.9A priority Critical patent/EP4272700A1/en
Publication of WO2022142239A1 publication Critical patent/WO2022142239A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526—Methods of manufacturing
    • A61B2017/0053—Loading magazines or sutures into applying tools
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1139—Side-to-side connections, e.g. shunt or X-connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/001—Figure-8-shaped, e.g. hourglass-shaped

Definitions

  • the invention relates to the technical field of medical device design, in particular to an implant delivery system.
  • Heart failure (heart failure) is referred to as heart failure, which means that due to the dysfunction of the systolic and/or diastolic function of the heart, the venous return blood cannot be fully discharged from the heart, resulting in blood stasis in the venous system and insufficient blood perfusion in the arterial system, which in turn causes the heart Circulatory Disorder Syndrome.
  • Heart failure is a serious disease with high incidence and mortality. According to the location of heart failure, it can be divided into left heart failure, right heart failure and total heart failure. According to the clinical manifestations of heart failure, it can also be divided into systolic heart failure. Heart failure and diastolic heart failure, of which diastolic heart failure (DHF) accounts for about half of all heart failure patients.
  • DHF diastolic heart failure
  • the method of using atrial shunt is a new solution for the treatment of heart failure.
  • This program is to make a stoma in the atrial septum between the left atrium and the right atrium of the patient, and implant a shunt device to form a shunt between the left and right atrium, which can be implanted.
  • Intra-atrial shunt devices have been successfully used in patients with severe symptomatic heart failure. By diverting or shunting blood from the left atrium (LA) to the right atrium (RA), the pressure in the left atrium is lowered or prevented from increasing (left atrial decompression). This regimen can prevent, relieve, or limit symptoms, signs, and syndromes associated with pulmonary congestion, including severe shortness of breath, pulmonary edema, hypoxia, and more.
  • Implantation of shunt devices requires manipulation with the aid of a delivery system.
  • the implant is introduced into the interatrial septum through the delivery system along the introducer sheath, and the movement of the delivery system catheter releases the left atrial portion of the implant first and then the right atrial portion.
  • the control is difficult, and the precision of the control will directly affect the release effect. If the push distance is too long, there is a risk of the implant falling into the left atrium, and if the push distance is too short, it will affect the release of the right atrial portion.
  • manual control is only depended on the experience of the operator, which is prone to cause positioning errors, resulting in the fall of the implant and the failure of the operation.
  • an implant delivery system which includes a first handle connected with an outer sheath, a second handle connected with an inner push rod, and a second handle connected with an inner push rod.
  • an implant loading device on the distal ends of two handles, wherein the outer sheath can be adjusted and moved axially relative to the first handle, and the inner push rod can be adjusted and moved axially relative to the second handle;
  • a connecting assembly is also arranged between the first handle and the second handle. After the first handle and the second handle are connected through the connecting assembly, the inner push rod is passed through the outer handle. inside the sheath.
  • the proximal end of the outer sheath tube and the proximal end of the inner push rod are respectively axially adjustable on the first handle portion and the second handle portion through a fine adjustment assembly; in some cases, the fine-tuning component includes:
  • an adjusting rod one end of which is axially movably installed in the first handle/second handle, and an adjusting part is provided on the other end; the proximal end of the outer sheath tube/the inner push rod is connected to the adjusting rod coaxial connection;
  • the adjusting piece is installed on the first handle/second handle, and is matched and connected with the adjusting part, and drives the adjusting piece to drive the adjusting rod to move axially.
  • the adjustment part adopts a threaded rod
  • the adjustment member adopts a threaded knob
  • the threaded knob is sleeved on the threaded rod and is threadedly connected
  • the threaded knob is axially limited and circumferentially limited. It is rotatably mounted on the first handle/second handle.
  • the adjustment rod is provided with at least one guide protrusion
  • the guide protrusion is parallel to the axial direction of the adjustment rod
  • the first handle/second handle is provided with a guide groove correspondingly, so The guide protrusion is placed in the guide groove and can move along the guide groove.
  • a locking device is provided between the first handle, the second handle and the adjusting rod, and the locking device is used to limit the axis of the adjusting rod relative to the first handle and the second handle to move.
  • the locking device includes a locking ring, the locking ring is sleeved on a circle of the adjusting rod, and one side of the locking ring is between the inner wall of the first handle/second handle A locking ring elastic member is arranged between them, and a button extending out of the first handle/second handle is arranged on the opposite side;
  • a locking portion is provided on the inner ring of the locking ring opposite to the elastic member. Under the action of the elastic member of the locking ring, the locking portion abuts on the adjusting rod to achieve locking, and pressing the button drives the The locking ring moves, and the locking portion is disengaged from the adjusting rod to realize unlocking.
  • the locking part is a threaded part matched with the threaded rod, and the threaded part cooperates with the threaded rod to achieve locking.
  • connection assembly includes a first hook-like structure disposed on the first handle and a second hook-like structure disposed on the second handle, and disposed on the first handle or the unlocking structure on the second handle;
  • the first handle and the second handle are coaxially butted, and the first hook-shaped structure and the second hook-shaped structure are fastened together to realize fixing; the unlocking structure is pushed, and the unlocking structure pushes the first hook-shaped structure.
  • the unlocking structure includes:
  • the casing of the second handle is provided with a chute, and the sliding block is placed in the chute;
  • a first inclined surface structure located in the second handle and connected with the slider;
  • first inclined surface structure and the second inclined surface structure are abutted; sliding the slider, the first inclined surface structure moves along the The sliding of the second inclined surface structure pushes the second hook-shaped structure to move radially along the second handle, and is separated from the second hook-shaped structure.
  • a slider elastic member is provided between the slider and the chute.
  • the slider elastic member deforms and stores energy, and the unlocking is completed. Afterwards, the sliding block is reset under the action of the sliding block elastic member.
  • the implant loading device includes a loading catheter disposed on the distal end of the inner push rod, and the distal end of the inner push rod is axially movable through the loading catheter;
  • the distal end of the inner push rod is also provided with a fixing member for fixing the implant.
  • a reinforcing tube is further provided on the proximal end of the inner push rod close to the second handle.
  • the present invention has the following advantages and positive effects due to the adoption of the above technical solutions:
  • the outer sheath tube and the inner push rod are independently arranged, and the movement can be controlled independently, so that they can be used as the function of the catheter sheath and the function of the push rod respectively;
  • the rod can also be connected through the first handle, the second handle and the connecting component, and the two cooperate to complete the stable and precise delivery function of the implant, which greatly broadens the scope of application; further, when the first handle and the second handle cooperate
  • the implant is first loaded into the implant loading device at the distal end of the inner push rod, the implant loading device with the implant and the inner push rod are inserted into the outer sheath, and the inner push rod loads the implant.
  • the inner push rod pushes the implant to the distal end along the outer sheath, until the first handle and the second handle are connected together to form a complete handle; then adjust The inner push rod is moved axially to the distal end relative to the second handle.
  • the outer sheath is relatively fixed, pushes the implant part to be gradually released from the distal end of the outer sheath, and then adjusts the outer sheath to make it relative to the first.
  • a handle is moved axially proximally, while the inner push rod is relatively fixed, so that the remaining portion of the implant is gradually released from the distal end of the outer sheath.
  • FIG. 1 is a schematic diagram of the overall structure of the implant delivery system provided by the present invention.
  • Fig. 2 is the schematic diagram that the inner push rod is loaded into the outer sheath tube in the present invention
  • Fig. 3 is the schematic diagram of the separation of inner push rod and outer sheath in the present invention.
  • FIG. 4 is a cross-sectional view of an implant delivery system provided by the present invention.
  • Figure 6 is a schematic diagram of the present invention when the adjusting rod is locked
  • Figure 7 is a schematic diagram of the present invention after the adjustment lever is unlocked
  • connection assembly 8 is a schematic structural diagram of a connection assembly in the present invention.
  • FIG. 9 is a schematic structural diagram of an implant loading device in the present invention.
  • Figure 10 is a schematic diagram of the implant being loaded on the fixture in the present invention.
  • FIG. 11 is a schematic structural diagram of a cardiac shunt device in the present invention.
  • Fig. 12 is a schematic diagram of the cardiac shunt device installed on the atrial septum in the present invention.
  • the present invention provides an implant delivery system, including a first handle 1 connected with an outer sheath 3, a second handle 2 connected with an inner push rod 4, and the inner push rod 4 is arranged away from the first handle 1.
  • the implant loading device on the distal end of the two handles, and the outer sheath 3 can be adjusted and moved axially relative to the first handle 1, and the inner push rod 4 can be adjusted and moved axially relative to the second handle 2; the first handle 1 A connecting assembly 5 is also provided between the second handle 2 and the first handle 1 and the second handle 2 through the connecting assembly 5, and the inner push rod 4 is inserted into the outer sheath 3.
  • the end close to the operator is defined as the proximal end, and the end away from the operator is defined as the distal end; that is, in the present invention, the end close to the first handle and the second handle is the proximal end, and the opposite end is the distal end .
  • the outer sheath tube 3 and the inner push rod 4 are set independently, and the movement can be controlled independently, so that they can be used as the function of the catheter sheath and the function of the push rod respectively; the outer sheath tube 3 It can also be connected with the inner push rod 4 through the first handle, the second handle and the connecting component, and the two cooperate to complete the stable and precise delivery function of the implant, which greatly expands the scope of application.
  • the implant is first loaded into the implant loading device 11 at the distal end of the inner push rod 4, and the loading device with the implant and the inner push rod Inserted into the outer sheath tube 3, the inner push rod pushes the implant from the implant loading device into the outer sheath tube; the inner push rod pushes the implant to the distal end along the outer sheath tube until the first handle Connect with the second handle to form a complete handle; then adjust the inner push rod to move it axially distally relative to the second handle 2, at this time the outer sheath is relatively fixed, and pushes the implant part from the outer sheath The distal end is gradually released, and then the outer sheath is adjusted to move axially toward the proximal end relative to the first handle 1.
  • the inner push rod is relatively fixed, so that the remaining part of the implant is removed from the distal end of the outer sheath. gradually released.
  • This implantation and push method can effectively control the speed and distance of implant release at each stage. Compared with the prior art method of directly pushing the implant by hand, it realizes the controllability of the implant release and effectively prevents the The release accident caused by the control error caused by the push of the inner push rod during the implant release process.
  • the implant delivery system provided by the present invention is suitable for the delivery of various types of implants, which is not limited here; it is especially suitable for the delivery of a cardiac shunt device.
  • the proximal end of the outer sheath tube 3 is axially adjustable on the first handle 1 through the first fine adjustment assembly.
  • the first fine adjustment assembly includes a first adjustment rod 12 and a first adjustment member 6 .
  • the proximal end of the first adjustment rod 12 is axially movably installed in the first handle 1
  • the distal end of the first adjustment rod 12 is installed in the first handle 1 .
  • the end is provided with a first adjusting part 1201;
  • the proximal end of the outer sheath tube 3 is coaxially connected with the first regulating rod 12, and the first regulating rod 12 is provided with a through hole communicating with the outer sheath tube 3 in the axial direction;
  • An adjusting member 6 is installed on the first handle 1 and is matched and connected with the first adjusting portion 1201 .
  • Driving the first adjusting member 6 can drive the first adjusting rod 12 to move axially, thereby driving the axial movement of the outer sheath 3 to adjust.
  • the first fine-tuning component realizes the precise control of the moving speed and the moving distance of the outer sheath tube 3 relative to the first handle 1 when it moves axially, so that the release speed of the implant can be controlled to prevent the implant from rapidly moving
  • the first adjustment rod 12 and the sheath seat of the outer sheath tube 3 are combined into one, which not only satisfies the basic sheath seat function, but also realizes the fine adjustment movement of the outer sheath tube. , while saving the space of the first handle 1 to a great extent.
  • the proximal end 1203 of the first adjusting rod 12 is axially movably installed on the first handle 1, and a hemostatic valve is added to the port, so that it can be used alone as a sheath seat.
  • one or more first guide protrusions 1202 are also provided on the outer wall of the first adjusting rod 12, and a matching first guide groove is provided on the inner wall of the first handle 1 corresponding to each of the first guide protrusions 1202, and the first The guide protrusions 1202 and the first guide grooves are arranged parallel to the axial extension of the outer sheath tube 3 ; the first guide protrusions 1202 are placed in the first guide grooves and can move along the first guide grooves.
  • the first guide protrusion 1202 and the first guide groove are arranged in cooperation to ensure the axial linear movement of the first adjustment rod 12 and the outer sheath tube 3, and also realize the function of radial position limit.
  • the guiding structure of the first adjusting rod 12 and the first handle 1 is not limited to the above-mentioned, for example, it can also be a guiding protrusion structure provided on the first handle 1,
  • the guide groove structure on the rod 12 is not limited here, and can be adjusted according to specific conditions.
  • the inner wall of the first handle 1 is provided with a first convex ring 101
  • the first guide groove is provided on the inner wall of the first convex ring 101
  • the first adjusting rod 12 is penetrated in the first convex ring 101
  • the first guide The protrusions 1202 are placed in the first guide grooves
  • the first adjustment rod 12 is also provided with two first limit rings 1203 , and the two first limit rings 1203 are located at both ends of the first guide protrusions 1202 and on the first convex ring
  • the first limiting rings 1203 are provided to limit the distance that the first adjusting rod 12 moves axially relative to the first handle 1 .
  • the first adjustment part 1201 adopts a threaded rod
  • the first adjustment member 6 adopts a threaded knob
  • the threaded knob is sleeved on the threaded rod and is threadedly connected
  • the threaded knob is axially limited and circumferentially rotatable and is installed on the first handle 1, turn the threaded knob clockwise or counterclockwise to control the forward and backward movement of the outer sheath.
  • the first handle 1 is provided with a depression so that the threaded knob at least partially extends out of the first handle, so as to facilitate the operator to control the threaded knob; further, a concave-convex structure is added on the surface of the threaded knob to increase the friction during contact. force.
  • the implementation scheme of the first adjusting portion and the first adjusting member is not limited to the matching scheme of the threaded rod and the threaded knob, but can also be other fine-tuning structures, such as the matching scheme of a rack and a gear, or The sliding rail-type matching method, or the ratchet-type matching method, etc., as long as the rotation and movement process can be made slow and controllable, there are no restrictions here, and they can be adjusted according to the specific situation.
  • a first locking device 8 is further provided between the first handle 1 and the first adjusting rod 12, and the first locking device 8 is used to limit the axial movement of the first adjusting rod 12 relative to the first handle 1; Under normal circumstances, the first locking device 8 realizes the fixed setting of the outer sheath tube 3 relative to the first handle 1. When the outer sheath tube 3 needs to be adjusted, the first locking device 8 is unlocked. Avoid unnecessary handle manipulation and sheath movement.
  • the first locking device 8 includes a first locking ring 801 , the first locking ring 801 is sleeved on a circle of the threaded rod of the first adjusting rod 12 , and the first locking ring 801 is A first locking ring elastic member 802 is arranged between one side and the inner wall of the first handle 1, and a button 804 extending out of the first handle 1 is arranged on the opposite side; A first locking portion 803 is disposed opposite the ring elastic member 802. Under the action of the first locking ring elastic member 802, the first locking portion 803 is pressed against the threaded rod to achieve locking. As shown in FIG. 6, pressing the first button 804 drives the The first locking ring 801 moves, and the first locking portion 803 is disengaged from the threaded rod to achieve unlocking, as shown in FIG. 7 .
  • first locking ring elastic member 802 may be implemented by a spring or the like, which is not limited here.
  • first locking portion 803 is a threaded portion matched with the threaded rod, and the threaded portion and the threaded rod are fitted together to achieve locking.
  • first locking portion 803 can also be a protruding member or the like that is clipped into the threaded portion of the threaded rod, which is not limited here and can be adjusted according to specific conditions.
  • the implementation of the first locking device 8 is not limited to the above, and can be adjusted according to specific conditions; in some embodiments, when the first fine-tuning component has a self-locking function, the first The setting of a locking device 8 is not limited here, and can be adjusted according to specific conditions.
  • the proximal end of the inner push rod 4 is axially adjustable on the second handle 2 through the second fine adjustment assembly.
  • the second fine adjustment assembly includes a second adjustment rod 13 and a second adjustment member 7 , and the distal end of the first adjustment rod 13 is axially movably installed in the second handle 2 , and is close to the second handle 2 .
  • a second adjusting part 1301 is arranged on the end; the proximal end of the inner push rod 4 is coaxially and fixedly connected with the second adjusting rod 13; , driving the second adjusting member 7 can drive the second adjusting rod 13 to move axially, thereby driving the inner push rod 4 to adjust the axial movement.
  • precise control of the movement speed and movement distance of the inner push rod 4 when the inner push rod 4 moves axially relative to the second handle 2 is achieved through the second fine adjustment assembly, thereby ensuring the safety and accuracy of the release process.
  • one or more second guide protrusions 1302 are also provided on the outer wall of the second adjusting rod 13, and a matching second guide groove is provided on the inner wall of the second handle 2 corresponding to each of the second guide protrusions 1302, and the second The guide protrusions 1302 and the second guide grooves are arranged parallel to the axial extension of the inner push rod 4 ; the second guide protrusions 1302 are placed in the second guide grooves and can move along the second guide grooves.
  • This embodiment ensures the axial linear motion of the second adjusting rod 13 and the inner push rod 4 through the cooperative arrangement of the second guide groove and the second guide protrusion 1302 , and also realizes the function of radial limit.
  • the guiding structure of the second adjusting rod 13 and the second handle 2 is not limited to the above-mentioned, for example, it can also be a guiding protrusion structure provided on the second handle 2, a structure provided on the second adjusting rod
  • the guide groove structure on the rod 13 is not limited here, and can be adjusted according to specific conditions.
  • the inner wall of the second handle 2 is provided with a second convex ring 201
  • the second guide groove is provided on the inner wall of the second convex ring 201
  • the second adjusting rod 13 is penetrated in the second convex ring 201
  • the second guide The protrusions 1302 are placed in the second guide grooves
  • the second adjustment rod 13 is also provided with two second limit rings 1303
  • the two second limit rings 1303 are located at both ends of the second guide protrusions 1302 and are located on the second convex ring
  • the setting of the second limiting ring 1303 is used to limit the distance of the axial movement of the second adjusting rod 13 relative to the second handle 2 .
  • the second adjusting part 1301 adopts a threaded rod
  • the second adjusting member 7 adopts a threaded knob
  • the threaded knob is sleeved on the threaded rod and is threadedly connected
  • the threaded knob is axially limited and rotatably installed on the second handle 2, turn the threaded knob clockwise or counterclockwise to control the forward and backward movement of the inner push rod 4.
  • the second handle 2 is provided with a depression so that the threaded knob at least partially protrudes from the second handle 2, thereby facilitating the operator to control the threaded knob; further, a concave-convex structure is added on the surface of the threaded knob to increase the contact resistance. friction.
  • the implementation scheme of the second adjusting portion and the second adjusting member is not limited to the matching scheme of the threaded rod and the threaded knob, but can also be other fine-tuning structures, such as the matching scheme of a rack and a gear, or The sliding rail-type matching method, or the ratchet-type matching method, etc., as long as the rotation and movement process can be made slow and controllable, there are no restrictions here, and they can be adjusted according to the specific situation.
  • the proximal end of the inner push rod 4 connected to the second handle 2 is further provided with a reinforcement tube 10 , and the reinforcement tube 10 is used to increase the rigidity of the proximal end of the inner push rod 4 .
  • the material of the reinforcing tube 10 can be selected from stainless steel metal material with good biocompatibility, or a polymer material with high hardness, etc., which can prevent the inner push rod 4 from being bent due to its insufficient rigidity when it is pushed, and it cannot continue to be conveyed. The problem.
  • the reinforcing tube 10 can be connected to the inner push rod 4 by means of splicing or the like, or can be connected by means of sleeves or the like, which is not limited here and can be adjusted according to specific conditions.
  • a second locking device 9 is further provided between the second handle 2 and the second adjusting rod 13, and the second locking device 9 is used to limit the axial movement of the second adjusting rod 13 relative to the second handle 2; Under normal circumstances, the second locking device 9 realizes the fixed setting of the inner push rod 4 relative to the second handle 2. When the outer and inner push rod 4 needs to be adjusted, the second locking device 9 is unlocked. Through the setting of the second locking device 9 Unnecessary handle manipulation and movement of the inner push rod can be avoided.
  • the second locking device 9 includes a second locking ring, the second locking ring is sleeved on a circle of the threaded rod of the second adjusting rod 13 , and one side of the second locking ring is connected to the inner wall of the second handle 2 .
  • a second locking ring elastic member is arranged between them, and a button extending out of the second handle 2 is arranged on the opposite side; a second locking portion is arranged on the inner ring of the second locking ring opposite to the second locking ring elastic member, Under the action of the elastic member of the second locking ring, the second locking portion abuts on the threaded rod to achieve locking, and pressing the second button drives the second locking ring to move, and the second locking portion separates from the threaded rod to unlock.
  • the specific structure of the second locking device 9 can be similar to the first locking device 8 .
  • the second locking portion is a threaded portion matched with the threaded rod, and the threaded portion and the threaded rod are matched together to achieve locking.
  • the second locking portion can also be a protruding piece that is clipped into the threaded portion of the threaded rod, etc., which is not limited here and can be adjusted according to specific conditions.
  • the implementation of the second locking device 9 is not limited to the above, and can be adjusted according to specific conditions; in some embodiments, when the second fine-tuning component has a self-locking function, the first The setting of the second locking device 9 is not limited here, and can be adjusted according to specific conditions.
  • the connecting assembly includes a first hook-like structure 501 arranged on the first handle 1 and a second hook-like structure 502 arranged on the second handle 2 , and a second hook-like structure 502 arranged on the first handle 1 .
  • the unlocking structure includes a slider 503 , a first inclined surface structure 504 and a second inclined surface structure 505 ;
  • the side wall of the second handle 2 is provided with a chute 202 , and the slider 503 is placed in the chute 202, and can move along the chute 202, and the moving direction is parallel to the axial direction of the inner push rod 4 and the outer sheath tube 3;
  • the first inclined surface structure 504 is located in the second handle 2, and is connected with the slider 503 through a connecting part ;
  • the second hook-shaped structure 502 is located below the chute 202, the second inclined surface structure 505 is arranged on the second hook-shaped structure 502, and is set opposite to the first inclined surface structure 504; the first hook-shaped structure 501 and the second hook-shaped structure After the structures 502 are connected together, the first inclined surface structure 504 and the second inclined surface structure 505 abut; slide the slider 503, the first inclined surface structure 504 slides along the second inclined surface structure 505, and pushes the second hook
  • a slider elastic member 506 is provided between the slider 503 and the chute 202.
  • the slider elastic member 506 deforms and stores energy. Under the action of 506, the slider is reset.
  • the slider elastic member 506 can be specifically implemented by a structure such as a spring, which is not limited here.
  • connection components provided in this embodiment are implemented in the form of elastic buckles, which have the advantages of simple structure and convenient operation.
  • connection structures can also be selected in other embodiments, which are not limited here.
  • the implant loading device 11 includes a loading guide tube 1101 disposed on the distal end of the inner push rod 4 .
  • the loading guide tube 1101 is installed on the inner push rod through a loading guide tube seat 1103 4, and the inner push rod 4 can move axially relative to the loading catheter 1101 and the loading catheter base 1103, and the distal end of the inner push rod 4 is axially movable through the loading catheter 1101; the inner push rod 4
  • the distal end is also provided with a fixing member 1102 for fixing the implant.
  • the fixing member 1102 is provided with a groove structure 1104 for fixing the implant 14. As shown in FIG. 10, the implant is sleeved on the end of the fixing member 1102 and partially placed in the groove structure 1104;
  • the specific structure of the fixing member 1102 is not limited to the above, and can be adjusted according to the structure of the implant, which is not limited here.
  • the material of the fixing member 1102 can be selected from a metal or polymer material with suitable hardness and good biocompatibility, such as stainless steel, which is not limited here and can be adjusted according to specific conditions.
  • the cardiac shunt device 14 may be implanted by forming a puncture through the atrial septum and then percutaneously inserting and passing the cardiac shunt device 14 therethrough such that the first region 1401 extends into the patient's left atrium and the second region 1402 is embedded in the puncture, and the third region 1403 extends into the patient's right atrium, preferably, the third region 1403 extends at least 5mm into the patient's right atrium, such that the outlet of the third region 1403 is located from the inferior vena cava into the patient. This prevents emboli entrained in the inferior vena cava flow from being directed into the outlet of the third region 1403 outside of the natural circulation flow path of blood in the right atrium.
  • the release of the implant 14 is divided into the release of the left atrial stent and the release of the right atrial stent.
  • the specific operations are as follows:
  • the implant 14 is loaded and crimped into the loading conduit 1101, specifically, the mounting lug structure on the implant 14 is matched and connected with the groove structure 1104 on the fixing member 1102, and then crimped into the loading conduit 1101;
  • the inner push rod 4 pushes the implant 14 to advance along the inner wall of the outer sheath tube 3, until the first handle 1 and the second handle 2 are merged, and locked through the connecting assembly , fixed to each other to form a complete handle.
  • the implant 14 has a distance of 3-5mm from the head end exposing the distal end of the outer sheath tube 3 (this distance tolerance is compensated according to the assembly error);

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Abstract

本发明提供了一种植入物输送系统，包括连接有外鞘管的第一手柄、连接有内推杆的第二手柄、设置在所述内推杆远离所述第二手柄的远端上的植入物装载装置，且所述外鞘管可相对于所述第一手柄轴向调节移动、所述内推杆可相对于所述第二手柄轴向调节移动；所述第一手柄与所述第二手柄之间还设置有连接组件，当所述第一手柄与所述第二手柄通过所述连接组件连接后，所述内推杆穿设在所述外鞘管内。本发明提供的植入物输送系统，能够有效控制各阶段植入物释放的速度和距离，相对现有技术中直接通过手控推送植入物的方式，实现了植入物释放的可控性，有效防止了在植入物释放过程中由于内推杆推送或外鞘管后撤形成的控制误差造成的释放意外。

Description

一种植入物输送系统 技术领域
本发明涉及医疗器械设计技术领域，具体涉及一种植入物输送系统。
背景技术
心力衰竭(heart failure)简称心衰，是指由于心脏的收缩功能和/或舒张功能发生障碍，不能将静脉回心血量充分排出心脏，导致静脉系统血液淤积，动脉系统血液灌注不足，进而引起心脏循环障碍症候群。心衰是一种发生率和致死率均较高的严重疾病，根据心力衰竭发生的部位可分为左心衰竭、右心衰竭和全心衰竭，根据心力衰竭的临床表现也可以划分为收缩性心力衰竭和舒张性心力衰竭，其中舒张性心衰(diastolic heart failure，DHF)约占全部心衰患者的一半。在中国约有1200万以上的心衰患者，即心衰发病率约为2～3％，其中，舒张性心衰患者约600万，老年人心力衰竭多以舒张性心衰为主，老年人舒张性心衰患者数量占舒张性心衰患者总数量的66.99％。
在治疗心衰时，现有的各种手段都存在缺陷，药物治疗，不能从根本上去除病因，仍有反复发作的可能；心脏再同步化治疗(CRT)，对至少20％心衰患者无效；左心室辅助装置(LVAD)手术，需进行体外循环，不仅创伤大并发症发生率高，而且价格昂贵难以获得；心脏移植，能够从根本上解决问题，但是供体来源非常有限，且价格昂贵。
用心房间分流的方法是治疗心衰的一种新方案，该方案是在患者左心房与右心房之间的房间隔处造口，并植入分流装置，从而形成左右心房间的分流，可植入的心房间分流装置已成功用于患有严重症状性心力衰竭的患者。通过将血液从左心房(LA)转移或分流到右心房(RA)，左心房中的压力被降低或被防止升高(左心房减压)。这种方案可以预防、缓解或限制与肺充血有关的症状、体征和综合征，包括严重的气促、肺水肿、缺氧等等。
分流装置的植入需要借助输送系统进行操作。通常来说，植入物通过输送系统沿着导管鞘，被送入到房间隔位置，通过输送系统导管的移动，先释放植 入物的左心房部分，后释放右心房部分。因为心房分流器的植入需要通过多次控制输送系统不同部件间的相对运动来依次释放植入物的左心房和右心房部分，控制难度较大，控制的精确程度会直接影响释放效果。如果推送距离过长，则植入物就会有掉入左心房的风险，如果推送距离过短，则会影响右心房部分的释放。在现有技术中，仅仅依靠术者经验手动控制，这容易造成定位误差，导致植入物脱落，手术失败。
因此，亟需一种释放速度和释放距离可控和易控的输送系统，以保证植入位置的准确，提高手术成功率。
发明内容
针对背景技术中的问题，本发明提供了一种植入物输送系统，包括连接有外鞘管的第一手柄、连接有内推杆的第二手柄、设置在所述内推杆远离所述第二手柄的远端上的植入物装载装置，且所述外鞘管可相对于所述第一手柄轴向调节移动、所述内推杆可相对于所述第二手柄轴向调节移动；所述第一手柄与所述第二手柄之间还设置有连接组件，当所述第一手柄与所述第二手柄通过所述连接组件连接后，所述内推杆穿设在所述外鞘管内。
在一些实施例中，所述外鞘管的近端、所述内推杆的近端分别通过微调组件轴向可调节地安装于所述第一手柄部、所述第二手柄部；在一些实施例中，所述微调组件包括：
调节杆，其一端轴向可移动的安装于所述第一手柄/第二手柄内，另一端上设置有调节部；所述外鞘管/所述内推杆的近端与所述调节杆同轴连接；
调节件，安装于所述第一手柄/第二手柄，并与所述调节部匹配连接，驱动所述调节件以带动所述调节杆轴向移动。
在一些实施例中，所述调节部采用螺纹杆，所述调节件采用螺纹旋钮，所述螺纹旋钮套设在所述螺纹杆上并螺纹连接，且所述螺纹旋钮轴向限位、周向可转动的安装于所述第一手柄/第二手柄上。
在一些实施例中，所述调节杆上设有至少一个导向突起，所述导向突起平行于所述调节杆的轴向，所述第一手柄/第二手柄上对应处设置有导向槽，所述导向突起置于所述导向槽内，并可沿所述导向槽移动。
在一些实施例中，所述第一手柄、第二手柄与所述调节杆之间均设置锁定装置，所述锁定装置用于限定所述调节杆相对于所述第一手柄、第二手柄轴向移动。
在一些实施例中，所述锁定装置包括有锁定环，所述锁定环套设于所述调节杆的一圈，且所述锁定环的一侧与所述第一手柄/第二手柄内壁之间设置有锁定环弹性件，相对的另一侧上设置有伸出所述第一手柄/第二手柄的按键；
所述锁定环内圈上与所述弹性件相对处设置有锁定部，在所述锁定环弹性件的作用下所述锁定部抵在所述调节杆上实现锁定，按压所述按键带动所述锁定环移动，所述锁定部脱离所述调节杆实现解锁。
在一些实施例中，当所述调节杆上的调节部为螺纹杆时，所述锁定部为与所述螺纹杆匹配的螺纹部，所述螺纹部与所述螺纹杆配合在一起实现锁定。
在一些实施例中，所述连接组件包括设置在所述第一手柄上的第一钩状结构和设置在所述第二手柄上的第二钩状结构，以及设置在所述第一手柄上或第二手柄上的解锁结构；
所述第一手柄与所述第二手柄同轴对接，所述第一钩状结构与所述第二钩状结构扣在一起实现固定；推动所述解锁结构，所述解锁结构推动所述第一钩状结构或者所述第二钩状结构，使得所述第一钩状结构与所述第一钩状结构分离实现解锁。
在一些实施例中，所述解锁结构包括：
滑块，所述第二手柄的壳体上设置有滑槽，所述滑块置于所述滑槽内；
第一斜面结构，位于所述第二手柄内，并与所述滑块连接；
第二斜面结构，设置在所述第二钩状结构上；
所述第一钩状结构与所述第二钩状结构连接在一起后，所述第一斜面结构与所述第二斜面结构相抵；滑动所述滑块，所述第一斜面结构沿所述第二斜面 结构滑动，推动所述第二钩状结构沿所述第二手柄径向移动，与所述第二钩状结构分离。
在一些实施例中，所述滑块与所述滑槽之间设置有滑块弹性件，所述滑块沿所述滑槽移动解锁的时候，所述滑块弹性件形变蓄能，解锁完成后，在所述滑块弹性件的作用下所述滑块复位。
在一些实施例中，所述植入物装载装置包括有设置在所述内推杆远端上的装载导管，且所述内推杆的远端轴向可移动的穿设在装载导管内；所述内推杆远端端部上还设置有用于固定植入物的固定件。
在一些实施例中，所述内推杆靠近所述第二手柄的近端上还设有加强管。
本发明由于采用以上技术方案，使之与现有技术相比，具有以下的优点和积极效果：
本发明提供的植入物输送系统，外鞘管与内推杆独立设置，可单独控制运动，使其分别作为导管鞘的功能进行使用、作为推送杆的功能进行使用；外鞘管与内推杆还可通过第一手柄和第二手柄以及连接组件进行连接，两者配合完成植入物的稳定、精准的输送功能，大大拓宽了适用范围；进一步的，当第一手柄和第二手柄配合使用时，植入物先装载在内推杆远端的植入物装载装置内，带有植入物的植入物装载装置和内推杆插入到外鞘管内，内推杆将植入物从植入物装载装置内推入到外鞘管内；内推杆推动着植入物沿外鞘管向远端前进，直至第一手柄与第二手柄连接在一起构成一完整的手柄；然后调节内推杆使其相对于第二手柄轴向向远端移动，此时外鞘管相对固定，推动植入物部分从外鞘管远端逐渐释放出来，再调节外鞘管使其相对于第一手柄轴向近端移动，此时内推杆相对固定，以使得植入物剩下的部分从外鞘管的远端逐渐释放出来。这种植入推送方式，能够有效控制各阶段植入物释放的速度和距离，相对现有技术中直接通过手控推送植入物的方式，实现了植入物释放的可控性，有效防止了在植入物释放过程中由于内推杆推送或外鞘管后撤形成的控制误差造成的释放意外。
附图说明
结合附图，通过下文的述详细说明，可更清楚地理解本发明的上述及其他特征和优点，其中：
图1为本发明提供的植入物输送系统的整体结构示意图；
图2为本发明中内推杆装载到外鞘管内的示意图；
图3为本发明中内推杆与外鞘管分离的示意图；
图4为本发明提供的植入物输送系统的剖视图；
图5为本发明中微调组件、锁定装置的局部剖视图；
图6为本发明中调节杆锁定时的示意图；
图7为本发明中调节杆解锁后的示意图；
图8为本发明中连接组件的结构示意图；
图9为本发明中植入物装载装置的结构示意图；
图10为本发明中植入物装载在固定件上的示意图；
图11为本发明中心脏分流装置的结构示意图；
图12为本发明中心脏分流装置安装在房间隔上的示意图。
具体实施方式
参见示出本发明实施例的附图，下文将更详细地描述本发明。然而，本发明可以以许多不同形式实现，并且不应解释为受在此提出之实施例的限制。相反，提出这些实施例是为了达成充分及完整公开，并且使本技术领域的技术人员完全了解本发明的范围。这些附图中，为清楚起见，可能放大了层级区域的尺寸及相对尺寸。
需要说明，本发明实施例中所有方向性指示(诸如上、下、左、右、前、后……)仅用于解释在某一特定姿态(如附图所示)下各部件之间的相对位置关系、运动情况等，如果该特定姿态发生改变时，则该方向性指示也相应地随之改变。
参照图1-10，本发明提供了一种植入物输送系统，包括连接有外鞘管3的第一手柄1、连接有内推杆4的第二手柄2、设置在内推杆4远离第二手柄的远端上的植入物装载装置，且外鞘管3可相对于第一手柄1轴向调节移动、内推杆4可相对于第二手柄2轴向调节移动；第一手柄1与第二手柄2之间还设置有连接组件5，当第一手柄1与第二手柄2通过连接组件5连接后，内推杆4穿设在外鞘管3内。
其中，将靠近操作者的一端定义为近端，远离操作者的一端定义为远端；即在本发明中靠近第一手柄、第二手柄的一端为近端，相对的另一端即为远端。
本发明提供的植入物输送系统，外鞘管3与内推杆4独立设置，可单独控制运动，使其分别作为导管鞘的功能进行使用、作为推送杆的功能进行使用；外鞘管3与内推杆4还可通过第一手柄、第二手柄以及连接组件进行连接，两者配合完成植入物的稳定、精准的输送功能，大大拓宽了适用范围。
进一步的，当第一手柄1和第二手柄2配合使用时，植入物先装载在内推杆4远端的植入物装载装置11内，带有植入物的装载装置和内推杆插入到外鞘管3内，内推杆将植入物从植入物装载装置内推入到外鞘管内；内推杆推动着植入物沿外鞘管向远端前进，直至第一手柄与第二手柄连接在一起构成一完整的手柄；然后调节内推杆使其相对于第二手柄2轴向向远端移动，此时外鞘管相对固定，推动植入物部分从外鞘管远端逐渐释放出来，再调节外鞘管使其相对于第一手柄1轴向向近端移动，此时内推杆相对固定，以使得植入物剩下的部分从外鞘管的远端逐渐释放出来。这种植入推送方式，能够有效控制各阶段植入物释放的速度和距离，相对现有技术中直接通过手控推送植入物的方式，实现了植入物释放的可控性，有效防止了在植入物释放过程中由于内推杆推送形成的控制误差造成的释放意外。
本发明提供的植入物输送系统适用于各种类型植入物的输送，此处不做限制；尤其适用于心脏分流装置的输送，下面以运用于心脏分流装置为例作具体说明。
在本实施例中，外鞘管3的近端通过第一微调组件轴向可调节的安装于第一手柄1上。
具体的，如图4中所示，第一微调组件包括有第一调节杆12和第一调节件6，第一调节杆12的近端轴向可移动的安装于第一手柄1内，远端上设置有第一调节部1201；外鞘管3的近端与第一调节杆12同轴连接，且第一调节杆12的轴向上设置有与外鞘管3连通的通孔；第一调节件6安装于第一手柄1上，并与第一调节部1201匹配连接，驱动第一调节件6能够带动第一调节杆12轴向移动，从而带动外鞘管3的轴向移动调节。本实施例通过第一微调组件实现了外鞘管3相对于第一手柄1轴向移动时的移动速度和移动距离的精准控制，从而可以控制植入物的释放速度，以防止植入物迅速释放而导致发生移位的问题；另外，本实施例中将第一调节杆12与外鞘管3的鞘座合二为一，即满足了基本鞘座功能，又实现了外鞘管微调移动，同时很大程度节省了第一手柄1空间。
其中，第一调节杆12的近端1203轴向可移动的安装于第一手柄1，且其端口上加设止血阀门，以使其作为鞘座功能单独使用。
其中，第一调节杆12的外壁上还设置有一个或多个第一导向突起1202，第一手柄1内壁上与各第一导向突起1202对应处设置有匹配的第一导向槽，且第一导突起1202、第一导向槽均平行于外鞘管3的轴向延伸设置；第一导向突起1202置于第一导向槽内，并可沿第一导向槽移动。本实施例通过第一导向突起1202和第一导槽的配合设置从而保证了第一调节杆12、外鞘管3的轴向直线运动，同时还实现了径向限位的功能。当然，在其他实施例中，第一调节杆12与第一手柄1的导向结构并不局限于以上所述，例如也可为设置在第一手柄1上的导向突起结构、设置在第一调节杆12上的导向槽结构，此处不做限制，均可根据具体情况进行调整。
进一步的，第一手柄1的内壁上设置有第一凸环101，第一导向槽设置在第一凸环101内壁上，第一调节杆12穿设在第一凸环101内，第一导向突起1202置于第一导向槽内；第一调节杆12上还设置有两第一限位环1203，两第一限位环1203位于第一导向突起1202的两端，且位于第一凸环101轴向上的两侧，第一限位环1203的设置用于限定第一调节杆12相对于第一手柄1轴向移动的距离。
其中，第一调节部1201采用螺纹杆，第一调节件6采用螺纹旋钮，螺纹旋钮套设在螺纹杆上并螺纹连接，且螺纹旋钮轴向限位、周向可转动的安装于第一 手柄1上，顺时针或者逆时针转动螺纹旋钮，可以控制外鞘管的前后移动。进一步的，第一手柄1上设置有凹陷使得螺纹旋钮至少部分伸出第一手柄，从而便于操作者对螺纹旋钮的控制；进一步的，螺纹旋钮的表面上增加凹凸结构，以增加接触时的摩擦力。
当然，在其他实施例中第一调节部和第一调节件的实现方案并不局限于螺纹杆与螺纹旋钮的配合方案，也可为其他的微调结构，例如齿条与齿轮的配合方案，或者滑轨式的配合方式，或者棘轮式的配合方式等，只要能够让转动和移动过程变成缓慢可控即可，此处不做限制，均可根据具体情况进行调整。
在本实施例中，第一手柄1与第一调节杆12之间还设有第一锁定装置8，第一锁定装置8用于限定第一调节杆12相对于第一手柄1轴向移动；正常情况下第一锁定装置8实现了外鞘管3相对于第一手柄1的固定设置，当需要调节外鞘管3时，第一锁定装置8才解锁，通过第一锁定装置8的设置能够避免不必要的手柄操作和外鞘管移动。
具体的，结合图5-7，第一锁定装置8包括有第一锁定环801，第一锁定环801套设于第一调节杆12的螺纹杆的一圈上，且第一锁定环801的一侧与第一手柄1内壁之间设置有第一锁定环弹性件802，相对的另一侧上设置有伸出第一手柄1的按键804；第一锁定环801内圈上与第一锁定环弹性件802相对处设置有第一锁定部803，在第一锁定环弹性件802的作用下第一锁定部803抵在螺纹杆上实现锁定，如图6所示，按压第一按键804带动第一锁定环801移动，第一锁定部803脱离螺纹杆实现解锁，如图7所示。
进一步的，第一锁定环弹性件802具体可以采用弹簧等方式实现，此处不做限制。
进一步的，第一锁定部803为与螺纹杆匹配的螺纹部，螺纹部与螺纹杆配合在一起实现锁定。当然，在其他实施例中第一锁定部803也可为卡进螺纹杆的螺纹部内的凸起件等，此处不做限制，可根据具体情况进行调整。
当然，在其他实施例中第一锁定装置8的实现方案并不局限于以上所述，可根据具体情况进行调整；在一些实施例中当第一微调组件具有自锁功能时，也可省略第一锁定装置8的设置，此处不做限制，可根据具体情况进行调整。
在本实施例中，内推杆4的近端通过第二微调组件轴向可调节的安装于第二手柄2上。
具体的，如图4中所示，第二微调组件包括有第二调节杆13和第二调节件7，第一调节杆13的远端轴向可移动的安装于第二手柄2内，近端上设置有第二调节部1301；内推杆4的近端与第二调节杆13同轴固定连接；第二调节件7安装于第二手柄2上，并与第二调节部1301匹配连接，驱动第二调节件7能够带动第二调节杆13轴向移动，从而带动内推杆4的轴向移动调节。本实施例通过第二微调组件实现了内推杆4相对于第二手柄2轴向移动时的移动速度和移动距离的精准控制，从而保证了释放过程的安全性和准确性。
其中，第二调节杆13的外壁上还设置有一个或多个第二导向突起1302，第二手柄2内壁上与各第二导向突起1302对应处设置有匹配的第二导向槽，且第二导向突起1302、第二导向槽均平行于内推杆4的轴向延伸设置；第二导向突起1302置于第二导向槽内，并可沿第二导向槽移动。本实施例通过第二导向槽和第二导向突起1302的配合设置从而保证了第二调节杆13、内推杆4的轴向直线运动，同时还实现了径向限位的功能。当然，在其他实施例中，第二调节杆13与第二手柄2的导向结构并不局限于以上所述，例如也可为设置在第二手柄2上的导向突起结构、设置在第二调节杆13上的导向槽结构，此处不做限制，均可根据具体情况进行调整。
进一步的，第二手柄2的内壁上设置有第二凸环201，第二导向槽设置在第二凸环201内壁上，第二调节杆13穿设在第二凸环201内，第二导向突起1302置于第二导向槽内；第二调节杆13上还设置有两第二限位环1303，两第二限位环1303位于第二导向突起1302的两端，且位于第二凸环201轴向上的两侧，第二限位环1303的设置用于限定第二调节杆13相对于第二手柄2轴向移动的距离。
其中，第二调节部1301采用螺纹杆，第二调节件7采用螺纹旋钮，螺纹旋钮套设在螺纹杆上并螺纹连接，且螺纹旋钮轴向限位、周向可转动的安装于第二手柄2上，顺时针或者逆时针转动螺纹旋钮，可以控制内推杆4的前后移动。进一步的，第二手柄2上设置有凹陷使得螺纹旋钮至少部分伸出第二手柄2，从而 便于操作者对螺纹旋钮的控制；进一步的，螺纹旋钮的表面上增加凹凸结构，以增加接触时的摩擦力。
当然，在其他实施例中第二调节部和第二调节件的实现方案并不局限于螺纹杆与螺纹旋钮的配合方案，也可为其他的微调结构，例如齿条与齿轮的配合方案，或者滑轨式的配合方式，或者棘轮式的配合方式等，只要能够让转动和移动过程变成缓慢可控即可，此处不做限制，均可根据具体情况进行调整。
在本实施例中，内推杆4连接第二手柄2的近端上还设置有加强管10，加强管10用于增加内推杆4近端的刚度。
其中，加强管10的材料可选用生物相容性良好的不锈钢金属材料，或者硬度较大的高分子材料等，可以避免内推杆4在推动时因自身刚度不足而造成弯折，无法继续输送的问题。
其中，加强管10可以采用拼接等方式与内推杆4连接，也可采用套设等方式连接，此处不做限制，可根据具体情况进行调整。
在本实施例中，第二手柄2与第二调节杆13之间还设有第二锁定装置9，第二锁定装置9用于限定第二调节杆13相对于第二手柄2轴向移动；正常情况下第二锁定装置9实现了内推杆4相对于第二手柄2的固定设置，当需要调节外内推杆4时，第二锁定装置9才解锁，通过第二锁定装置9的设置能够避免不必要的手柄操作和内推杆的移动。
具体的，第二锁定装置9包括有第二锁定环，第二锁定环套设于第二调节杆13的螺纹杆的一圈上，且第二锁定环的一侧与第二手柄2内壁之间设置有第二锁定环弹性件，相对的另一侧上设置有伸出第二手柄2的按键；第二锁定环内圈上与第二锁定环弹性件相对处设置有第二锁定部，在第二锁定环弹性件的作用下第二锁定部抵在螺纹杆上实现锁定，按压第二按键带动第二锁定环移动，第二锁定部脱离螺纹杆实现解锁。第二锁定装置9的具体结构可类似第一锁定装置8。
进一步的，第二锁定部为与螺纹杆匹配的螺纹部，螺纹部与螺纹杆配合在一起实现锁定。当然，在其他实施例中第二锁定部也可为卡进螺纹杆的螺纹部内的凸起件等，此处不做限制，可根据具体情况进行调整。
当然，在其他实施例中第二锁定装置9的实现方案并不局限于以上所述，可根据具体情况进行调整；在一些实施例中当第二微调组件具有自锁功能时，也可省略第二锁定装置9的设置，此处不做限制，可根据具体情况进行调整。
在本实施例中，结合图4和图8，连接组件包括设置在第一手柄1上的第一钩状结构501和设置在第二手柄2上的第二钩状结构502，以及设置在第一手柄1上或第二手柄2上的解锁结构；第一手柄1与第二手柄2同轴对接，第一钩状结构501与第二钩状结构502钩扣在一起实现锁定连接；向后滑动解锁结构，解锁结构推动第一钩状结构501或者第二钩状结构502，使得第一钩状结构501与第二钩状结构502分离，实现解锁。
进一步的，如图8中所示，解锁结构包括滑块503、第一斜面结构504和第二斜面结构505；第二手柄2的侧壁上设置有滑槽202，滑块503置于滑槽202内，并可沿滑槽202移动，移动方向平行于内推杆4、外鞘管3的轴向；第一斜面结构504位于第二手柄2内，并通过一连接部与滑块503连接；第二钩状结构502位于滑槽202的下方，第二斜面结构505设置在第二钩状结构502上，且与第一斜面结构504相对设置；第一钩状结构501与第二钩状结构502连接在一起后，第一斜面结构504与第二斜面结构505相抵；滑动滑块503，第一斜面结构504沿第二斜面结构505滑动，推动第二钩状结构502沿第二手柄2径向移动，从而使其与第一钩状结构501分离，实现解锁。
进一步的，滑块503与滑槽202之间设置有滑块弹性件506，滑块503沿滑槽202移动解锁的时候，滑块弹性件506形变蓄能，解锁完成后，在滑块弹性件506的作用下滑块复位。其中，滑块弹性件506具体可通过弹簧等结构来实现，此处不做限制。
本实施例提供的连接组件采用弹性卡扣的形式来实现，其具有结构简单、操作方便等优点，当然在其他实施例中也可选用其他连接结构，此处不做限制。
在本实施例中，参照图9-10，植入物装载装置11包括有设置在内推杆4远端上的装载导管1101，具体的，装载导管1101通过装载导管座1103安装在内推杆4的远端上，且内推杆4可相对于装载导管1101、装载导管座1103轴向移动，内推 杆4的远端轴向可移动的穿设在装载导管1101内；内推杆4远端端部上还设置有用于固定植入物的固定件1102。
其中，固定件1102上设置有用于固定植入物14的凹槽结构1104，如图10中所示，植入物套设在固定件1102端部上，且部分置于凹槽结构1104内；当然，固定件1102的具体结构并不局限于以上所述，可根据植入物的结构进行调整，此处不做限制。
其中，固定件1102的材料可以选择不锈钢等硬度合适且具有良好的生物相容性的金属或者高分子材料，此处不做限制，可根据具体情况进行调整。
下面就本发明运用于心脏分流装置的输送为例，做具体说明；其中，如图11-12所示，心脏分流装置分为第一区域1401、第二区域1402和第三区域1403。心脏分流装置14可通过下述方式被植入：形成通过房间隔的穿刺部，然后将心脏分流装置14经皮插入并通过其中，使得第一区域1401延伸到患者的左心房中，第二区域1402嵌入在穿刺部中，第三区域1403延伸到患者的右心房中，优选地，第三区域1403延伸到患者的右心房中至少5mm，使得第三区域1403的出口位于从下腔静脉进入患者右心房的血液的自然循环流动路径之外，这样可以防止下腔静脉流动中夹带的栓子被导引至第三区域1403的出口中。
植入物14的释放分为左心房支架的释放和右心房支架的释放。具体操作如下：
1、植入物14装载压握至装载导管1101中，具体的通过植入物14上的挂耳结构与固定件1102上的凹槽结构1104配合连接，然后压握至装载导管1101中；
2、将装有植入物的装载导管1101推送入外鞘管3中，然后推动内推杆4，通过固定件1102将植入物14从装载导管中推送入外鞘管3中，装载导管1101停留在外鞘管3的近端处；
3、继续推送第二手柄2，内推杆4推动植入物14，使其沿着外鞘管3内壁前进，一直推送至第一手柄1与第二手柄2合并，并通过连接组件进行锁定，相互固定，形成一个完整的手柄。合并后，植入物14距离露出外鞘管3远端的头端有3-5mm的距离(此距离公差根据装配误差进行补偿)；
4、下压第二锁定装置9的按键，并保持下压状态，然后旋转第二手柄2上的螺纹旋钮，以推动内推杆4继续向远端推进；植入物14的左心房部分缓慢从外鞘管3头端释放出来，当释放至植入物14的腰部(1402区域)时，停止螺纹旋钮的操作，松开第二锁定装置9，从而使得恢复内推杆4相对于第二手柄2固定；
5、待左心房部分完全释放后，整体后撤输送系统，使输送系统与植入物14整体后撤，直到植入物14的腰部正好卡在房间隔上；
6、下压第一锁定装置8的按键804，保持下压状态，转动第一手柄上的螺纹旋钮，使外鞘管3后撤，缓慢释放植入物14的右心房部分(1403区)，直至挂耳完全露出，植入物14脱离固定件，实现完全释放，然后松开第一锁定装置8的按键804；
7、释放结束后，整体后撤将输送系统撤出体外。
本技术领域的技术人员应理解，本发明可以以许多其他具体形式实现而不脱离其本身的精神或范围。尽管已描述了本发明的实施案例，应理解本发明不应限制为这些实施例，本技术领域的技术人员可如所附权利要求书界定的本发明的精神和范围之内作出变化和修改。

Claims (11)

  1. 一种植入物输送系统，其特征在于，包括连接有外鞘管的第一手柄、连接有内推杆的第二手柄、设置在所述内推杆远离所述第二手柄的远端上的植入物装载装置，且所述外鞘管可相对于所述第一手柄轴向调节移动、所述内推杆可相对于所述第二手柄轴向调节移动；所述第一手柄与所述第二手柄之间还设置有连接组件，当所述第一手柄与所述第二手柄通过所述连接组件连接后，所述内推杆穿设在所述外鞘管内。
  2. 根据权利要求1所述的植入物输送系统，其特征在于，所述外鞘管的近端、所述内推杆的近端分别通过微调组件轴向可调节地安装于所述第一手柄部、所述第二手柄部；优选地，所述微调组件包括：
    调节杆，其一端轴向可移动的安装于所述第一手柄/第二手柄内，另一端上设置有调节部；所述外鞘管/所述内推杆的近端与所述调节杆同轴连接；
    调节件，安装于所述第一手柄/第二手柄，并与所述调节部匹配连接，驱动所述调节件以带动所述调节杆轴向移动。
  3. 根据权利要求2所述的植入物输送系统，其特征在于，所述调节部采用螺纹杆，所述调节件采用螺纹旋钮，所述螺纹旋钮套设在所述螺纹杆上并螺纹连接，且所述螺纹旋钮轴向限位、周向可转动的安装于所述第一手柄/第二手柄上。
  4. 根据权利要求2所述的植入物输送系统，其特征在于，所述调节杆上设有至少一个导向突起，所述导向突起平行于所述调节杆的轴向，所述第一手柄/第二手柄上对应处设置有导向槽，所述导向突起置于所述导向槽内，并可沿所述导向槽移动。
  5. 根据权利要求2或3所述的植入物输送系统，其特征在于，所述第一手柄、第二手柄与所述调节杆之间均设置锁定装置，所述锁定装置用于限定所述调节杆相对于所述第一手柄、第二手柄轴向移动。
  6. 根据权利要求5所述的植入物输送系统，其特征在于，所述锁定装置包括有锁定环，所述锁定环套设于所述调节杆的一圈，且所述锁定环的一侧与所 述第一手柄/第二手柄内壁之间设置有锁定环弹性件，相对的另一侧上设置有伸出所述第一手柄/第二手柄的按键；
    所述锁定环内圈上与所述弹性件相对处设置有锁定部，在所述锁定环弹性件的作用下所述锁定部抵在所述调节杆上实现锁定，按压所述按键带动所述锁定环移动，所述锁定部脱离所述调节杆实现解锁。
  7. 根据权利要求6所述的植入物输送系统，其特征在于，当所述调节杆上的调节部为螺纹杆时，所述锁定部为与所述螺纹杆匹配的螺纹部，所述螺纹部与所述螺纹杆配合在一起实现锁定。
  8. 根据权利要求1所述的植入物输送系统，其特征在于，所述连接组件包括设置在所述第一手柄上的第一钩状结构和设置在所述第二手柄上的第二钩状结构，以及设置在所述第一手柄上或第二手柄上的解锁结构；
    所述第一手柄与所述第二手柄同轴对接，所述第一钩状结构与所述第二钩状结构扣在一起实现固定；按压所述解锁结构，所述解锁结构推动所述第一钩状结构或者所述第二钩状结构，使得所述第一钩状结构与所述第二钩状结构分离实现解锁。
  9. 根据权利要求8所述的植入物输送系统，其特征在于，所述解锁结构包括：
    滑块，所述第二手柄的壳体上设置有滑槽，所述滑块置于所述滑槽内；
    第一斜面结构，位于所述第二手柄内，并与所述滑块连接；
    第二斜面结构，设置在所述第二钩状结构上；
    所述第一钩状结构与所述第二钩状结构连接在一起后，所述第一斜面结构与所述第二斜面结构相抵；滑动所述滑块，所述第一斜面结构沿所述第二斜面结构滑动，推动所述第二钩状结构沿所述第二手柄径向移动，与所述第一钩状结构分离。
  10. 根据权利要求9所述的植入物输送系统，其特征在于，所述滑块与所述滑槽之间设置有滑块弹性件，所述滑块沿所述滑槽移动解锁的时候，所述滑块弹性件形变蓄能，解锁完成后，在所述滑块弹性件的作用下所述滑块复位。
  11. 根据权利要求1所述的植入物输送系统，其特征在于，所述植入物装载装置包括有设置在所述内推杆远端上的装载导管，且所述内推杆的远端轴向可移动的穿设在装载导管内；所述内推杆远端端部上还设置有用于固定植入物的固定件，优选地，所述内推杆靠近所述第二手柄的近端上还设有加强管。
PCT/CN2021/104351 2020-12-30 2021-07-02 一种植入物输送系统 WO2022142239A1 (zh)

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