WO2024007491A1 - 心脏重建植入体 - Google Patents

心脏重建植入体 Download PDF

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Publication number
WO2024007491A1
WO2024007491A1 PCT/CN2022/128132 CN2022128132W WO2024007491A1 WO 2024007491 A1 WO2024007491 A1 WO 2024007491A1 CN 2022128132 W CN2022128132 W CN 2022128132W WO 2024007491 A1 WO2024007491 A1 WO 2024007491A1
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WIPO (PCT)
Prior art keywords
heart
fixed
mesh
isolation body
layer
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PCT/CN2022/128132
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English (en)
French (fr)
Inventor
阮成民
王焱
凌友
姜亚伦
郝振华
梁玉麟
郑宇铎
Original Assignee
广东脉搏医疗科技有限公司
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Publication of WO2024007491A1 publication Critical patent/WO2024007491A1/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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart 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
    • A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
    • A61F2/2487—Devices within the heart chamber, e.g. splints
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart 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
    • A61F2/2493—Transmyocardial revascularisation [TMR] devices
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart 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
    • A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
    • A61F2002/249—Device completely embedded in the heart wall
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes

Definitions

  • the present disclosure relates to the technical field of medical devices, and in particular, to a cardiac reconstruction implant.
  • Heart failure is the final outcome of most cardiovascular diseases and can lead to death.
  • the patient's heart cannot provide sufficient blood flow to meet the body's needs.
  • Symptoms of heart failure can have a negative impact on quality of life and include shortness of breath, persistent coughing or wheezing, excessive fluid accumulation in body tissues (edema), fatigue, loss of appetite or nausea, slowed thinking, and rapid heart rate.
  • the prevalence of heart failure has increased year by year and has become a serious public health problem; after a heart attack, many patients develop left ventricular enlargement, resulting in reduced cardiac output, which in turn causes heart failure symptoms such as shortness of breath.
  • the device is a minimally invasive catheter-based treatment technology used to isolate damaged myocardium, isolating the non-functioning portion of the heart from the healthy, functioning portion, thereby reducing the total volume of the left ventricle and restoring its shape and function .
  • the left ventricular volume reduction device in the prior art has the following defects: since it uses an elastic nickel-titanium support skeleton for support, balloon expansion is required during implantation to fully expand the umbrella body, which increases a certain amount of surgical operation time and risk. ; After implantation, with the movement of the ventricle, the stress on the device skeleton structure is relatively concentrated and it is easy to break; the coating on the skeleton structure is prone to shrink and fold with the movement of the ventricle, resulting in poor sealing and unsatisfactory volume reduction effect; and it is prone to occur in the long term.
  • the left ventricular volume reduction devices in the prior art all use the left ventricular volume reduction device built inside the ventricle to reduce the ventricular volume, and cannot provide contraction during the systole of the heart, so the heart expands and contracts. Inadequacies still exist.
  • the present disclosure provides a cardiac reconstruction implant, including: an isolation main body and a contractile outer mesh;
  • the isolating main body and the contractile outer mesh are integrally woven and formed.
  • the isolating main body is released into the ventricle of the heart to isolate ineffective cardiac chambers; the contractile outer mesh is wrapped on the surface of the heart to provide contraction to the outside of the heart. force.
  • the cardiac reconstruction implant further includes a fixed waist
  • the isolation main body and the shrinkable outer mesh are connected through an integrated braiding of the fixed waist, which is fixed at the apex of the heart, so that the shrinkable outer mesh diffuses and covers the heart with the fixed waist as the center. surface.
  • the isolation main body, the fixed waist and the shrinkable outer mesh are sequentially knitted and formed by elastic wire, and the shrinkable outer mesh cover is provided on the outside of the isolation main body.
  • the isolation body includes an expansion section and an extension section
  • the expansion section is connected to the fixed waist through the extension section.
  • the expansion section is located at the end of the heart away from the apex.
  • the expansion section is used to fit with the ventricular wall, and the extension section can follow the expansion. It fits along the ventricular wall from the segment to the apex of the heart.
  • the diameter of the expansion section is larger than the diameter of the extension section, and the extension section completely conforms to the shape of the heart.
  • the shrinkable outer mesh opens in an arc along the fixed waist, so that the shrinkable outer mesh completely covers the outside of the heart.
  • the isolation main body is formed in the form of a double-layer woven mesh, and a flow-blocking film is fixed between the double-layer woven mesh of the isolation body; and the shrinkable outer mesh is formed in a single-layer or double-layer woven mesh.
  • the isolation body is formed in the form of a double-layer woven mesh, and a flow-blocking film is fixed on the surface of the double-layer woven mesh of the isolation body; and the shrinkable outer mesh is formed in the form of a single-layer or double-layer woven mesh.
  • the isolation body is formed in the form of a single-layer woven mesh, and a flow-blocking film is fixed on the surface or inner cavity of the single-layer woven mesh of the isolation body; and the shrinkable outer mesh is formed in the form of a single-layer woven mesh.
  • the shrinkable outer mesh is formed in the form of a double-layer braided mesh, and a flow-blocking film can be fixed on the shrinkable outer mesh;
  • the isolation body is formed in the form of a single-layer or double-layer braided mesh, and a flow-blocking film is fixed on the isolation body.
  • the present disclosure also provides a cardiac reconstruction implant, including: an isolation body and a contractile outer mesh;
  • the isolation body and the contractile outer mesh are fixedly connected, and the isolation body is released into the ventricle of the heart to isolate the ineffective cardiac chamber; the contraction outer mesh covers the surface of the heart to provide contraction force to the outside of the heart. .
  • the cardiac reconstruction implant further includes a fixed waist
  • the isolation main body and the shrinkable outer mesh are fixedly connected through the fixed waist, which is fixed at the apex of the heart, so that the shrinkable outer mesh spreads and covers the heart surface with the fixed waist as the center.
  • the isolation body, the fixed waist and the shrinkable outer mesh are made of elastic material, and the shrinkage outer mesh cover is provided on the outside of the isolation body.
  • the isolation body includes an expansion section and an extension section
  • the expansion section is connected to the fixed waist through the extension section.
  • the expansion section is located at the end of the heart away from the apex.
  • the expansion section is used to fit with the ventricular wall, and the extension section can follow the expansion. It fits along the ventricular wall from the segment to the apex of the heart.
  • the diameter of the expansion section is larger than the diameter of the extension section, and the extension section completely conforms to the shape of the heart.
  • the shrinkable outer mesh opens in an arc along the fixed waist, so that the shrinkable outer mesh completely covers the outside of the heart.
  • the isolation body has a double-layer mesh structure, and a flow-blocking film is fixed to the double-layer mesh structure of the isolation body;
  • the shrinkable outer net has a single-layer or double-layer mesh structure.
  • the shrinkable outer net has a double-layer mesh structure, and a flow-blocking film is fixed on the shrinkable outer net;
  • the isolation body has a single-layer or double-layer mesh structure, and a flow-blocking film is fixed on the isolation body.
  • the shrinkable outer net has a single-layer mesh structure, and a flow-blocking film is fixed on the shrinkable outer mesh;
  • the isolation main body has a single-layer mesh structure, and the flow-blocking film is fixed on the isolation main body.
  • the cardiac reconstruction implant further includes a connector
  • the connecting piece is connected to the fixed waist, and the connecting piece is used to connect with an external delivery system to shrink the isolation body, the fixed waist and the shrinkable outer net in the external delivery system.
  • the braided layer of the isolation body in contact with the ventricular wall is provided with at least one fixed anchor spine, and the fixed anchor spine extends along the braided layer of the isolation body into the ventricular wall.
  • the mesh structure layer in contact between the isolation body and the ventricular wall is provided with at least one fixed anchor, and the fixed anchor extends along the braided layer of the isolation body into the ventricular wall.
  • the fixed waist (300) is provided with one or more fixed anchors (600), and the fixed anchors (600) extend along the fixed waist (300) to the cardiac reconstruction implant.
  • the present disclosure also provides a method for cardiac reconstruction, which method includes: implanting any of the above cardiac reconstruction implants into the heart via apical intervention or percutaneous intervention.
  • Figure 1 is a schematic diagram of the overall structure of a cardiac reconstruction implant provided by some embodiments of the present disclosure
  • FIG. 2 is a partial enlarged structural schematic diagram of a cardiac reconstruction implant provided by some embodiments of the present disclosure
  • Figure 3 is a schematic structural diagram of the isolation body of the cardiac reconstruction implant provided by the embodiment of the present disclosure, which is formed in the form of a double-layer braided mesh;
  • Figure 4 is a schematic diagram of the overall structure of a cardiac reconstruction implant provided by some embodiments of the present disclosure.
  • Figure 5 is a schematic diagram of the preliminary process of percutaneously releasing the cardiac reconstruction implant into the left ventricle and covering the outside of the heart provided by the embodiment of the present disclosure
  • Figure 6 is a schematic diagram of the intermediate process of percutaneously releasing the cardiac reconstruction implant into the left ventricle and covering the outside of the heart provided by the embodiment of the present disclosure
  • Figure 7 is a schematic diagram of the completion process of percutaneously releasing the cardiac reconstruction implant into the left ventricle and covering the outside of the heart provided by the embodiment of the present disclosure
  • Figure 8 is a schematic diagram of the preliminary process of releasing the cardiac reconstruction implant into the left ventricle through the apex and covering the outside of the heart according to an embodiment of the present disclosure
  • Figure 9 is a schematic diagram of the intermediate process of the cardiac reconstruction implant provided by the embodiment of the present disclosure being released to the left ventricle through the apex and covering the outside of the heart;
  • Figure 10 is a schematic diagram of the completion process of the cardiac reconstruction implant provided by the embodiment of the present disclosure being released to the left ventricle through the apex and covering the outside of the heart;
  • Figure 11 is a schematic diagram of a state in which the cardiac reconstruction implant provided by an embodiment of the present disclosure is released into the left ventricle and covers the outside of the heart.
  • Icon 100-Isolation body; 101-Extension section; 102-Extension section; 200-Shrinkable outer mesh; 300-Fixed waist; 400-Connector; 500-Conveying system; 600-Fixed anchor spine.
  • a cardiac reconstruction implant including: an isolation body 100 and a contractile outer mesh 200;
  • the isolation main body 100 and the contractile outer mesh 200 are fixedly connected.
  • the isolation main body 100 is released into the ventricle of the heart to isolate ineffective cardiac chambers; the contractile outer mesh 200 covers the surface of the heart to provide contraction force to the outside of the heart.
  • the isolation main body 100 and the shrinkable outer mesh 200 are fixedly connected by a fixed connection method including but not limited to integrated molding, gluing, nailing, welding, or fixed connection via a connector (such as a sleeve, etc.).
  • a fixed connection method including but not limited to integrated molding, gluing, nailing, welding, or fixed connection via a connector (such as a sleeve, etc.).
  • integrated molding includes, but is not limited to, integrated weaving molding, integrated cutting molding, integrated molding molding, integrated printing (such as 3D printing) molding, and the like.
  • integration refers to an integrated combination structure composed of one or more structures. Multiple structures can be selected from the same material or a combination of multiple materials of the same type of material, or each of them can be selected from the same material.
  • Category Materials A combination of different substances or substances.
  • braiding refers to organizing or combining thread-like bodies or filament-like bodies (such as wires, wires) by interlacing or hooking each other.
  • a cardiac reconstruction implant includes: an isolation body 100 and a contractile outer mesh 200;
  • the isolation main body 100 and the shrinkable outer mesh 200 are integrally woven and formed.
  • the isolation main body 100 is released into the ventricle of the heart to isolate ineffective cardiac chambers; the shrinkable outer mesh 200 covers the surface of the heart to provide contraction force to the outside of the heart.
  • the cardiac reconstruction implant further includes a fixed waist 300;
  • the isolation main body 100 and the shrinkable outer mesh 200 are fixedly connected through a fixed waist 300, which is fixed at the apex of the heart, so that the shrinkable outer mesh 200 spreads and covers the heart surface with the fixed waist 300 as the center.
  • the cardiac reconstruction implant further includes a fixed waist 300;
  • the isolation main body 100 and the shrinkable outer mesh 200 are integrally knitted and connected through a fixed waist 300.
  • the fixed waist 300 is fixed at the apex of the heart, so that the shrinkable outer mesh 200 spreads and covers the heart surface with the fixed waist 300 as the center.
  • the apex is the location of the perforation caused by the penetration of the cardiac reconstruction implant through the heart.
  • the isolation main body 100, the fixed waist 300 and the shrinkable outer net 200 are made of elastic materials, and the shrinkable outer net 200 is covered outside the isolation main body 100.
  • the elastic material includes a polymer compound (such as resin, elastic polyurethane), metal (such as platinum, palladium, cobalt alloy, nickel titanium alloy or cobalt chromium alloy), etc.
  • the elastic material may include wire or molten material.
  • the isolation main body 100, the fixed waist 300 and the shrinkable outer net 200 are sequentially knitted and formed by elastic wires, and the shrinkable outer net 200 is covered on the outside of the isolation main body 100.
  • the isolation main body, the fixed waist and the shrinkable outer net can also be made of elastic materials other than elastic wires, and the shrinkable outer net cover is provided on the outside of the isolation main body.
  • isolation body 100 includes expansion section 101 and extension section 102;
  • the expansion section 101 is connected to the fixed waist 300 through the expansion section 102.
  • the expansion section 101 is located at the end of the heart away from the apex.
  • the expansion section 101 is used to fit the ventricular wall, and the extension section 102 can follow the expansion section 101 to the apex along the ventricle. Wall fit.
  • the diameter of the expansion section 101 is larger than the diameter of the extension section 102, and the extension section 102 completely conforms to the shape of the heart.
  • the contractile outer mesh 200 opens in an arc along the fixed waist 300 so that the contractile outer mesh 200 completely covers the outside of the heart.
  • the distance from the end of the shrinkable outer mesh 200 away from the fixed waist 300 to the fixed waist 300 is greater than the distance from the expansion section 101 to the fixed waist 300, so that the shrinkable outer mesh 200 can gradually wrap around the outside of the heart.
  • the distance from the end of the contraction outer mesh 200 away from the fixed waist 300 to the fixed waist 300 can be equal to or smaller than the distance from the expansion section 101 to the fixed waist 300 .
  • the isolation body 100 has a double-layer mesh structure
  • the flow-blocking film can also be fixed on the outer surface of the double-layer mesh structure of the isolation body 100 to adapt to different needs of patients
  • the shrinkable outer mesh 200 has a single-layer mesh structure. layer or double layer mesh structure
  • the isolation body 100 is formed in the form of a double-layer woven mesh, and a flow-blocking film is fixed between the double-layer woven mesh of the isolation body 100; the shrinkable outer mesh 200 is formed in the form of a single-layer or double-layer woven mesh.
  • the shrinkable outer net 200 has a double-layer mesh structure, and a flow-blocking film is fixed on the shrinkable outer net 200;
  • the isolation body 100 has a single-layer or double-layer mesh structure, and the isolation body 100 is fixed with There is a flow blocking film.
  • the shrinkable outer mesh 200 is formed in the form of a double-layer woven mesh, and the shrinkable outer mesh 200 can be fixed with a flow-blocking film;
  • the isolation body 100 is formed in the form of a single-layer or double-layer woven mesh, and the isolation body 100 is fixed with a flow-blocking film. membrane.
  • the shrinkable outer mesh 200 has a single-layer mesh structure, and a flow-blocking film is fixed on the shrinkable outer mesh 200;
  • the isolation body 100 has a single-layer mesh structure, and a flow-blocking film is fixed on the isolation body 100.
  • the membrane and the delivery system 500 can be directly and fixedly connected to the end of the fixed waist 300 near the apex of the heart, and can retract and unfold the implant.
  • the flow-blocking film includes at least one of a polymer film, a fabric film, or a biological tissue film.
  • the cardiac reconstruction implant further includes a connector 400;
  • the connecting piece 400 is connected to the fixed waist 300 , and the connecting piece 400 is used to connect with the external delivery system 500 to shrink the isolation body 100 , the fixed waist 300 and the shrinkable outer net 200 in the external delivery system 500 .
  • the connector 400 is located at an end of the contractile outer mesh 200 near the cardiac apex.
  • the fixed waist 300 may be a single-layer or double-layer mesh structure.
  • the fixed waist 300 is connected to the extension section 102 at a distal end, and is connected to the contractile outer mesh 200 at an end close to the apex.
  • the mesh structure layer of the isolation body 100 in contact with the ventricular wall is provided with at least one fixed anchor 600, and the fixed anchor 600 extends along the braided layer of the isolation body 100 into the ventricular wall.
  • the braided layer of the isolation body 100 in contact with the ventricular wall is provided with at least one fixed anchor 600, and the fixed anchor 600 extends along the braided layer of the isolation body 100 into the ventricular wall.
  • the fixed waist 300 is provided with a plurality of fixed anchor spines 600 that extend along the fixed waist 300 until the cardiac reconstruction implant penetrates the inner myocardial wall of the apex.
  • the isolation body 100 may have a wine glass-shaped/straw hat-shaped structure
  • the isolation body 100 may have no fixed anchors 600, and the isolation body 100 may be in contact with the ventricular wall after deployment. Without being bound by theory, the isolation body 100 achieves an effective isolation and sealing function.
  • the height of the isolation body 100 ranges from 1 mm to 100 mm; the height of the shrinkable outer net 200 ranges from 1 to 100 mm.
  • the elastic wires of the isolation body 100, the fixed waist 300 and the shrinkable outer net 200 are at least one of metal wires, polymer wires or ceramic wires.
  • the metal wire includes, but is not limited to, at least one of elastic platinum wire, elastic palladium wire, cobalt alloy, nickel titanium alloy or cobalt chromium alloy.
  • both the isolation body 100 and the shrink outer mesh 200 are selected from nickel-titanium alloys.
  • the isolation body 100 is selected from nickel-titanium alloy, and the shrinkable outer mesh 200 is selected from elastic palladium wire.
  • the isolation body 100 is selected from a combination of elastic cobalt alloys and elastic platinum wires (such as via hybrid braiding) and the shrink outer mesh 200 is selected from elastic platinum wires.
  • the connector 400 may be riveted or flat-ended without rivets.
  • a fixation anchor 600 is provided on the side of the fixed waist 300 close to the apex of the heart (that is, on the outside of the fixed waist 300 ).
  • the fixed anchor spines 600 on the fixed waist 300 can further enhance the fixing effect of the fixed waist 300 .
  • transapical intervention or percutaneous intervention is possible.
  • the size of the required delivery sheath is small, which is beneficial to reducing damage to blood vessels and complications.
  • Some embodiments of the present disclosure also provide a method for cardiac reconstruction, which method includes: implanting the cardiac reconstruction implant into the heart via apical intervention or percutaneous intervention.
  • the cardiac reconstruction implant provided by the present disclosure relieves the existing support skeleton in the prior art to support the ventricular wall. Balloon expansion is required to increase the operation time and risk. The stress concentration on the device skeleton structure is easy to break, and the volume is reduced. The effect is not ideal, and technical problems still exist in the case of insufficient cardiac contractility.
  • the cardiac reconstruction implant includes: an isolation body 100 and a shrinkable outer mesh 200; the isolation body 100 and the shrinkage outer mesh 200 are fixedly connected (such as integrated braiding and molding), and the isolation body 100 is released into the ventricle of the heart, such as The isolation body 100 formed by knitting isolates ineffective cardiac chambers.
  • the isolation body 100 of a mesh structure (such as a braided structure) has self-expandability (the self-expandability can be derived from a material with a shape memory function or a certain elasticity).
  • the isolation body 100 of a mesh structure (such as a braided structure) moves with the ventricle, and the force on the isolation body 100 is dispersed, thereby improving the isolation body 100
  • the outer contractile net 200 is wrapped on the surface of the heart, and the outer contractile net 200 can provide contraction force to the outside of the heart, that is, the outer contractile net 200 can be stored during diastole.
  • a certain amount of stress can promote the contraction of the heart during systole, thereby achieving the purpose of reducing ventricular volume and pressure, preventing ventricular dilation, and further improving the contractile function of the heart by isolating the interior of the ventricular wall of the heart and the exterior of the heart.
  • the contraction force thereby improving the ventricular pumping capacity, relieves the existing technology of the support skeleton to support the ventricular wall, which requires the use of balloon expansion to increase the operation time and risk.
  • the stress concentration on the device skeleton structure is easy to break, reducing Technical problems still exist in the case of unsatisfactory cosmetic results and insufficient cardiac contractility.
  • the integrated molding of the cardiac reconstruction implant can further improve the stability of the implant in the heart and the lifespan and durability of the implant during use.
  • fixing the waist 300 not only ensures the smooth connection between the isolation body 100 and the contraction outer mesh 200 inside and outside the heart, but also ensures the stability of the isolation body 100 and the contraction outer mesh 200; and fixing the waist structure 300 at the apex of the heart can also prevent the heart from The discharge of exudate (such as oozing blood).
  • this embodiment provides a cardiac reconstruction implant, which includes: an isolation body 100 and a shrinkable outer mesh 200; the isolation body 100 and the shrinkage outer mesh 200 are integrally woven and formed, and the isolation body 100 is released in The inner ventricle of the heart is isolated from inactive cardiac chambers; the contractile outer mesh 200 covers the surface of the heart to provide contraction force to the outside of the heart.
  • this embodiment provides a device for cardiac reconstruction and assisting cardiac contraction, which uses a braided structure to isolate the main body 100 and the contractile outer mesh 200 to integrate a cardiac reconstruction implant.
  • the isolation body 100 and the contractile outer mesh 200 are integrally knitted and formed.
  • the isolation body 100 can isolate the dilated ventricle into a static chamber and a dynamic chamber, thereby isolating ventricular aneurysms and reducing ventricular volume; in addition, , the outer contractile net 200 can be wrapped on the outer surface of the heart, and the outer contractile net 200 can be used to assist the contraction of the heart during systole, and since the isolation body 100 and the outer contraction net 200 are integrally formed, that is, the isolation body 100 can isolate and support the heart ventricle.
  • this embodiment provides a cardiac reconstruction implant, which includes: an isolation body 100 and a shrinkable outer mesh 200; the isolation body 100 and the shrinkage outer mesh 200 are integrally woven and formed, and the isolation body 100 is released from the heart In the ventricle, the isolation body 100 formed by knitting isolates the ineffective cardiac chamber.
  • the isolation body 100 of the knitted structure has further self-expandability (that is, the self-expansion properties of the elastic material can be further improved through knitting, thereby further improving the implant's The stability of being fixed to the heart and the lifespan and durability of the implant during use.), so balloon expansion is no longer required during implantation, and the isolation body 100 of the braided structure moves with the ventricle, and the isolation body 100 is protected
  • the force is dispersed, thereby improving the mechanical properties of the isolation body 100 and making it less likely to break;
  • the shrinkable outer mesh 200 is wrapped on the surface of the heart, and the shrinkable outer mesh 200 can provide contraction force to the outside of the heart, that is,
  • the outer systolic net 200 can store a certain stress during the diastolic period of the heart, and can promote the contraction of the heart during the systolic period, thereby achieving the purpose of reducing the ventricular volume and ventricular wall stress, preventing ventricular expansion, and further improving the systolic function of
  • the device skeleton structure is easily broken due to stress concentration, the volume reduction effect is not ideal, and there are still technical problems such as insufficient cardiac contractility.
  • the cardiac reconstruction implant further includes a fixed waist 300; the isolation main body 100 and the shrinkable outer mesh 200 are integrally knitted and connected through the fixed waist 300, and the fixed waist 300 is fixed to the heart. at the apex of the heart, so that the contractile outer mesh 200 spreads and covers the heart surface with the fixed waist 300 as the center.
  • the end of the isolation body 100 is tightened by the fixed waist 300, and the shrinkable outer mesh 200 is expanded outward through the position of the fixed waist 300.
  • the fixed waist 300 can completely penetrate the apex position during transportation, that is, fixed
  • the waist 300 is fixed at the apex of the heart, and the shrinkable outer mesh 200 covers the surface of the heart along the position of the fixed waist 300.
  • the fixed waist 300 serves as a connecting transition structure of the integrated braided structure.
  • the fixed waist 300 can integrate all the braided lines to pass through.
  • the fixed waist 300 ensures the smooth connection between the isolation body 100 and the contraction outer mesh 200 inside and outside the heart.
  • the fixed waist 300 can ensure the stability of the isolation body 100 and the contraction outer mesh 200.
  • the isolation main body 100, the fixed waist 300 and the shrinkable outer net 200 are knitted and formed by elastic wires in sequence, and the shrinkable outer net 200 is covered on the outside of the isolation main body 100.
  • the weaving starting point of the isolation main body 100 and the shrinkable outer net 200 can be the fixed waist 300 as the starting point, that is, all the elastic wires of the isolation main body 100 and all the elastic wires of the shrinkable outer net 200 will be concentrated at the fixed waist.
  • the isolation body 100, the fixed waist 300 and the shrinkable outer net 200 are formed by using elastic wire weaving.
  • the shrinkable outer net 200 is diffusely covered on the heart surface with the fixed waist 300 as the center.
  • the isolation main body 100 is also centered on the fixed waist 300.
  • the central extension is arranged on the surface of the ventricular wall, and the fixed waist 300 can realize the fixation of the entire device at the heart.
  • the isolation body 100, the fixed waist 300 and the shrinkable outer mesh 200 are sequentially knitted and formed by the elastic wire, based on the characteristics of the elastic wire, there is no need for the balloon to expand when the isolation body 100 is implanted, and the isolation body 100 can be
  • the movement of the ventricle completely fits the surface of the ventricular wall, and the contractile outer mesh 200 will also expand along with the surface of the heart during the implantation process.
  • the contractile outer mesh 200 can be completely attached to the surface of the heart, using the elastic wire.
  • the knitting characteristics allow the contractile outer mesh 200 to store a certain amount of stress as the heart opens during diastole. During systole, it can exert force on the outside of the covered heart to promote cardiac contraction, thereby reducing ventricular volume. and ventricular wall stress to prevent ventricular dilation.
  • the elastic wires of the isolation body 100, the fixed waist 300 and the shrinkable outer net 200 are at least one of metal wires, polymer wires or ceramic wires.
  • the isolation body 100 may have a wine glass-shaped/straw hat-shaped structure.
  • the isolation body 100 includes an expansion section 101 and an extension section 102; the expansion section 101 is connected to the fixed waist 300 through the extension section 102, the expansion section 101 is located at the end of the heart away from the apex, and the expansion section 101 is used to fit with the ventricular wall, And the extension section 102 can follow the expansion section 101 to the cardiac apex and fit along the ventricular wall.
  • the expansion section 101 can be in a planar expansion structure, that is, the isolation body 100 is in an open umbrella-like shape, and the expansion section 101 can be positioned away from the heart's apex, that is, the expansion section 101 is a static ventricle after expansion.
  • both the extended section 101 and the extended section 102 can fit into the ventricular wall of the heart, that is, the extended section 101 to the extended section 102 can isolate the heart myocardium, and the pressure of the isolated myocardium can be transmitted to
  • the forces at the cardiac apex are reduced, reducing ventricular wall stress; in addition, in addition to reducing the load on the static cardiac chambers, the reduction in dynamic cardiac chambers will also lead to a reduction in normal myocardial pressure, resulting in an overall reduction in ventricular load.
  • the diameter of the expansion section 101 is larger than the diameter of the extension section 102, and the extension section 102 completely conforms to the shape of the heart.
  • the expansion section 101 has an open umbrella-like shape to expand the ventricle, and since the interior of the ventricle of the heart is a gradually decreasing chamber to the apex, optionally, the extension section 102 can be used to extend along the expansion section 101 to a fixed position.
  • the waist 300 is arranged in a tapered shape, that is, the extension section 102 can gradually shrink in the shape of an umbrella rib, so that the extension section 102 can conform to the shape of the ventricle, ensuring that the resting heart chamber is always in an expanded state.
  • the tapered arrangement of the extension section 102 can make a smooth transition between the end far away from the extension section 101 and the position of the fixed waist 300, thereby ensuring the stable fixation of the fixed waist 300 and the apex; and because the extension section 101, extension section 102 and The fixed waist 300 is formed by integrally knitting elastic wires, that is, the stresses on the expansion section 101, the extension section 102 and the fixed waist 300 are dispersed, which avoids stress concentration in the strut skeleton structure and improves the mechanical strength of the overall isolation body 100. performance, is less likely to break, and improves the stability of the isolation body 100.
  • the shrinkable outer mesh 200 opens in an arc along the fixed waist 300, so that the shrinkable outer mesh 200 completely covers the outside of the heart.
  • the shrinkable outer mesh 200 is centered on the fixed waist 300 and opens in a concave arc shape toward the isolation body 100 away from the cardiac apex, so that the shrinkable outer mesh 200 can completely cover the outside of the heart.
  • the shrinkable outer mesh 200 can be in a bowl-shaped shape, that is, the shrinkable outer mesh 200 is in an unfolded shape with the fixed waist 300 as the center, and the inner diameter of the shrinkable outer mesh 200 is the smallest at the apex of the heart.
  • the shrinkable outer mesh 200 can be centered at the apex of the heart. It gradually covers the surface of the heart, and the shrinkable outer mesh 200 is also woven and formed by elastic wire, the fixed waist 300 and the isolation body 100. That is, the stress exerted by the shrinkable outer mesh 200 on the heart is also in a dispersed state, avoiding damage to the heart.
  • a certain position causes stress concentration to cause damage to the heart surface; optionally, the inner diameter of the contractile outer mesh 200 can change non-linearly, that is, the inner diameter of the contractile outer mesh 200 can be specifically set according to the outside of the heart, as discussed here No restrictions.
  • the distance from the end of the shrinkable outer mesh 200 away from the fixed waist 300 to the fixed waist 300 is greater than the distance from the expansion section 101 to the fixed waist 300, so that the shrinkable outer mesh 200 can gradually wrap around the outside of the heart.
  • the delivery sheath is used for delivery.
  • the isolation body 100 is needed.
  • the isolation body 100 is used to extend to the apex of the heart, and then the contractile outer mesh 200 is released.
  • the net 200 implements the method of transporting the isolation main body 100 and the contractile outer net 200 to the inside and outside of the heart respectively.
  • the height of the isolation body 100 ranges from 1 mm to 100 mm; the height of the shrinkable outer net 200 ranges from 1 mm to 100 mm.
  • the isolation body 100 is formed in the form of a double-layer woven mesh, and a flow-blocking film is fixed between the double-layer woven mesh of the isolation body 100; the shrinkable outer mesh 200 is formed in the form of a single-layer or double-layer woven mesh.
  • the isolation main body 100 when the instrument is inserted percutaneously, the isolation main body 100 should be formed of a double-layer braided mesh.
  • the shrinkable outer mesh 200 can be a single-layer braided mesh or a double-layer braided mesh; wherein, the isolation main body 100 is double-layered.
  • the expansion section 101 extends to the center of the isolation body and is gathered into the connector 400.
  • the connector 400 is used to connect the implant to the delivery system 500; a flow-blocking film should be fixed inside or outside the isolation body 100.
  • a flow-blocking film should be fixed inside or outside the isolation body 100.
  • the shrinkable outer mesh 200 is a single-layer braided mesh, no fixings are needed, and the single-layer braided mesh of the shrinkable outer mesh 200 can be arranged with or without a flow-blocking film.
  • the flow-blocking membrane of the single-layer braided mesh of the shrinkable outer mesh 200 can be arranged on the side that is in contact with the heart or the side that is not in contact with the heart.
  • the double-layer woven net of the shrinkable outer net 200 may not be gathered into the fixing member, or may be gathered into the fixing member, and the outer part or The interior may also be provided with a flow blocking film or may not be provided with a flow blocking film.
  • the flow-blocking film may include at least one of a polymer film, a fabric film, or a biological tissue film.
  • the shrinkable outer mesh 200 is formed in the form of a double-layer woven mesh, and the shrinkable outer mesh 200 may be fixed with a flow-blocking film; the isolation body 100 is formed in the form of a single-layer or double-layer woven mesh, and the flow-blocking film is fixed on the isolation body 100 .
  • the shrinkable outer mesh 200 when the instrument is inserted through the cardiac apex, the shrinkable outer mesh 200 should be formed into a double-layer braided mesh.
  • the isolation main body 100 can be a single-layer braided mesh or a double-layered braided mesh; wherein, the shrinkable outer mesh 200 is woven
  • the wire is gathered into the connector 400, which is used to connect the implant and the delivery system 500; a flow-blocking film should be fixed inside or outside the isolation body 100.
  • the isolation main body 100 is a single-layer braided mesh
  • no fixings are needed, and a flow-blocking film should be fixed on one side of the single-layer braided mesh of the shrinkable outer mesh 200 to isolate functional cardiac chambers and inactive cardiac chambers;
  • the isolating main body 100 is When the double-layer woven mesh is used, the double-layer woven mesh of the isolation main body 100 does not need to be gathered into the fixing piece, or it can be folded into the fixing piece, and the double-layer woven mesh of the isolating main body 100 shrinking outer mesh 200 should be fixed on the outside or inside.
  • the flow-blocking membrane serves to isolate functional cardiac chambers from ineffective cardiac chambers.
  • the isolation main body 100 can be formed into a single-layer woven mesh by fixing the waist 300 position, or the shrinkable outer mesh 200 can also be formed into a single-layer woven mesh by fixing the waist 300 position, and the single-layer mesh structure is used to achieve good elasticity.
  • the soft nature can better protect the apex of the heart; the use of high-density braided mesh structure can better improve the compliance and fit of the ventricular wall, which is beneficial to improving the volume reduction effect of the device and ensuring recyclability.
  • the flow-blocking film includes at least one of a polymer film, a fabric film, or a biological tissue film.
  • the single-layer braided mesh is in contact with the ventricular wall, the apex and the heart surface respectively, by fixing a flow-blocking membrane on at least one side of the single-layered braided mesh, immediate isolation of the ventricles can be achieved, and the heart surface can also be and a better fit to the ventricular wall.
  • the flow-blocking film can be fixed to any side of the single-layer woven mesh by sewing; or, the flow-blocking film can also be sutured on both sides of the single-layer woven mesh, which is not limited here.
  • the isolation main body 100, the fixed waist 300 and the shrinkable outer mesh 200 are formed in the form of a double-layer woven mesh.
  • the isolation main body 100 can be returned to form a double-layer braided mesh through the position of the fixed waist 300 , that is, the isolation main body 100 can be woven back in an arc shape at a position away from the fixed waist 300 , or the shrinkable outer mesh 200 can also be formed through the fixed waist 300
  • the position is shaped like a double-layer braided mesh, that is, the shrinkable outer mesh 200 is positioned away from the fixed waist 300 (in the direction away from the apex of the isolation body 100) and is woven back in an arc.
  • the double-layered braided mesh structure can better ensure the stability of the overall device.
  • the high-density braided mesh structure can better improve the compliance and fit of the ventricular wall, which is beneficial to improving the volume reduction effect of the device.
  • a blocking film is fixed between the double-layer braided mesh, that is, on the basis that the double-layered braided mesh structure can be in contact with the heart surface and the ventricular wall, the ventricular instantaneity can also be achieved through the blocking film. isolation.
  • the flow-blocking film can be fixed inside the double-layer braided mesh by sewing.
  • the cardiac reconstruction implant further includes a connector 400; the connector 400 is connected to an end of the fixed waist 300 away from the isolation body 100, and the connector 400 is used to connect to the external delivery system 500 to connect the The isolation body 100 , the fixed waist 300 and the shrinkable outer mesh 200 are collapsed in the external delivery system 500 .
  • the connecting piece 400 is fixedly connected to the fixed waist 300 , and the diameter range of the connecting piece 400 is the diameter range of the fixed waist 300 or smaller than the diameter of the fixed waist 300 .
  • the connector 400 is located at an end of the contractile outer mesh 200 near the cardiac apex, and the connector 400 is configured to connect the cardiac reconstruction implant to the external delivery system 500 to transport the cardiac reconstruction implant via the delivery system 500 Delivered to the site of action.
  • the fixed waist 300 is used as the contraction assembly position.
  • the fixed waist 300 is connected to the external delivery system 500 through the connector 400, using the connector 400.
  • the connector 400 can realize the connection and delivery between the external delivery system 500 and the implant; optionally, the connector 400 can be a riveted type or a flat-end non-riveted type, where the connector 400 only needs to be able to ensure that the implant is connected to the external delivery system 500. Yes, the structure of the connector 400 is not limited here.
  • the braided layer of the isolation body 100 that is in contact with the ventricular wall is provided with multiple fixed anchors 600 , and the fixed anchors 600 extend along the braided layer of the isolation body 100 into the ventricular wall.
  • the fixed anchor spine 600 is located at the outer periphery of the expansion section 101.
  • the fixed anchor spine 600 can penetrate into the myocardium of the ventricular wall.
  • the fixed anchor spine 600 can ensure the overall anchoring of the isolation body 100. , improving the overall placement stability of the isolation body 100.
  • a plurality of fixed anchor spurs 600 may be arranged, and the plurality of fixed anchor spurs 600 may be inclined along multiple directions.
  • myocardial contraction/diastole in addition to the expansion and contraction of the ventricle, it is also accompanied by the spiral movement of the myocardium; there are certain differences in the amplitude and direction of the myocardial movement at the fixed position of each fixed anchor 600, and the direction of the fixed anchor 600 is designed It is multi-directional and can improve device implantation.
  • the plurality of fixed anchors 600 When the plurality of fixed anchors 600 are anchored to the myocardium of the ventricular wall, they can penetrate into the ventricular wall along with the movement direction of the heart, thereby better improving the stability of the anchoring and improving the anchoring efficiency of the isolation body 100 steady state.
  • the isolation body 100 may be provided with fixed anchors 600 or without fixed anchors 600.
  • the isolation body 100 may be provided without fixed anchors 600, and the deployed isolation body 100 contacts and fits the ventricular wall. That’s it.
  • the fixed waist 300 is also provided with a plurality of fixed anchor spines 600 .
  • the fixed anchor spines 600 extend along the fixed waist 300 until the cardiac reconstruction implant penetrates the inner myocardial wall of the apex to further improve the performance of the heart. Restores the stability of the implant to the heart.
  • the implant can be inserted through the apex or percutaneously. Through the overall braided structure, the size of the required delivery sheath is small, which is beneficial to reducing damage to blood vessels and complications.
  • this embodiment provides a device for cardiac reconstruction and assisting cardiac contraction, which uses a braided structure to isolate the main body 100 and the contractile outer mesh 200 to integrate a cardiac reconstruction implant.
  • the isolation body 100 and the contractile outer mesh 200 are integrally knitted and formed.
  • the isolation body 100 can isolate the dilated ventricle into a static chamber and a dynamic chamber, thereby isolating ventricular aneurysms and reducing ventricular volume; in addition, , the outer contractile net 200 can be wrapped on the outer surface of the heart, and the outer contractile net 200 can be used to assist the contraction of the heart during systole, and since the isolation body 100 and the outer contraction net 200 are integrally formed, that is, the isolation body 100 can isolate and support the heart ventricle.
  • the contraction force of the contraction outer network 200 can interact, that is, the isolation body 100 provides contraction support force to the contraction outer network 200, and at the same time, the contraction outer network 200 ensures the isolation of the heart chambers by the isolation body 100, realizing ventricular isolation and isolation of the heart.
  • the dual function of providing shrinkage force from the outside makes the overall design more perfect.
  • the cardiac reconstruction implant is released into the left ventricle and wrapped around the outside of the heart under the guidance of the delivery system 500 in the initial, intermediate and final processes, cardiac reconstruction
  • the implant Under the guidance of the delivery system 500, the implant first releases the contractile outer mesh 200 outside the heart, and at the same time the fixed waist 300 is fixed at the apex of the heart.
  • the contractile outer mesh 200 is centered on the fixed waist 300 and extends along the fixed waist 300.
  • the contractile outer mesh 200 is used to assist the contraction of the heart during systole; then the isolation body 100 is released into the ventricle of the heart to isolate the expanded ventricle.
  • They are static chambers and dynamic chambers.
  • the cardiac reconstruction implant is released into the left ventricle and wrapped around the outside of the heart under the traction of the delivery system 500.
  • 300 As the center, and opens in an arc along the fixed waist 300, and as the outside of the heart is completely covered on the outer surface of the heart, it assists the contraction of the heart during systole, further improving the contractile function of the heart.
  • the present disclosure provides a cardiac reconstruction implant. Its special braided structure eliminates the need for balloon expansion when the isolation body is implanted.
  • the stress on the isolation body is dispersed, which improves the mechanical properties of the isolation body; the outer mesh shrinks. Covering the surface of the heart can achieve the purpose of reducing ventricular volume and pressure, preventing ventricular expansion, improving the ventricular pumping capacity, and alleviating the surgical operation time and risks existing in the existing technology.
  • the stress concentration on the device skeleton structure is easily There are still technical problems such as fracture, unsatisfactory volume reduction effect, and insufficient cardiac contractility. Therefore, the cardiac reconstruction implant of the present disclosure has excellent industrial practical performance and broad market prospects.

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Abstract

一种心脏重建植入体，涉及医疗器械的技术领域，包括隔离主体（100）和收缩外网（200）；隔离主体（100）和收缩外网（200）一体化编织成型，隔离主体（100）释放于心脏的心室内，通过编织形成的隔离主体（100）对无效心腔隔离，编织结构的隔离主体（100）植入时不再需要球囊扩张，隔离主体（100）的受力呈分散状，提高了隔离主体（100）的机械性能；收缩外网（200）包覆于心脏表面，通过收缩外网（200）能够对心脏外部提供收缩作用力，达到降低心室容积和心室压力、防止心室扩张的目的，提高了心室泵血能力，缓解了现有技术中存在的支撑骨架对心室壁进行支撑，需要采用球囊扩张增加手术操作时间和风险，器械骨架结构所受应力集中易断裂，减容效果不理想，以及心脏收缩力不足的情况仍然存在的技术问题。

Description

心脏重建植入体
相关申请的交叉引用
本公开要求于2022年07月08日提交中国专利局的申请号为CN202210805770.8、名称为“心脏重建植入体”的中国专利申请的优先权，其全部内容通过引用结合在本公开中。
技术领域
本公开涉及医疗器械技术领域，尤其是涉及一种心脏重建植入体。
背景技术
心力衰竭是大多数心血管疾病的最终归宿，并可能致死亡，患者的心脏无法提供足够的血流来满足机体的需求。心力衰竭的症状对生活质量有负面影响，包括呼吸短促、持续咳嗽或喘息、机体组织中过度积液(水肿)、疲乏、食欲减退或恶心、思维迟钝、心率加快。近年来心力衰竭的患病率逐年增高，成为严重的公共卫生问题；心脏病发作后，许多患者出现左心室扩大，导致心排量降低，继而引起呼吸急促等心力衰竭症状，左心室减容装置器械是一项用于隔离受损心肌的基于导管的微创治疗技术，将无功能的心脏部分与健康的、有功能的部分隔离开来，从而缩小左心室的总容积，恢复其形态和功能。
现有技术中的左心室减容装置存在下列缺陷：由于是利用弹性的镍钛支撑骨架进行支撑，因此植入时需要采用球囊扩张，使伞体充分展开，增加一定的手术操作时间和风险；植入后，随心室运动，器械骨架结构所受应力比较集中，易断裂；骨架结构上的覆膜随心室运动易发生收缩折叠、密封性不好，减容效果不理想；且长期易发生撕裂；另外，现有技术中的左心室减容装置均是利用内置心室内部的左心室减容装置以减小心室容积，并不能对心脏的收缩期过程中提供收缩，因此心脏扩张收缩力不足的情况仍然存在。
发明内容
本公开提供的一种心脏重建植入体，包括：隔离主体和收缩外网；
所述隔离主体和所述收缩外网一体化编织成型，所述隔离主体释放于心脏的心室内，以对无效心腔隔离；所述收缩外网包覆于心脏表面，以对心脏外部提供收缩作用力。
可选地，所述心脏重建植入体还包括固定腰部；
所述隔离主体和所述收缩外网通过所述固定腰部一体化编织连接，所述固定腰部固定于心脏的心尖处，以使所述收缩外网以所述固定腰部为中心扩散包覆于心脏表面。
可选地，所述隔离主体、所述固定腰部和所述收缩外网依次通过弹性丝材编织成型，且所述收缩外网罩设于所述隔离主体的外部。
可选地，所述隔离主体包括扩展段和延伸段；
所述扩展段通过所述延伸段与所述固定腰部连接，所述扩展段位于心脏远离心尖的一端，所述扩展段用于与心室壁贴合，且所述延伸段能够随着所述扩展段至心尖处沿着心室壁贴合。
可选地，所述扩展段的直径大于所述延伸段的直径，所述延伸段随着心脏的形状完全随形贴合。
可选地，所述收缩外网沿着所述固定腰部呈弧形张开，以使所述收缩外网随着心脏的外部完全包覆。
可选地，所述隔离主体呈双层编织网成型，所述隔离主体的双层编织网内部间固定有阻流膜；所述收缩外网呈单层或双层编织网成型。
可选地，所述隔离主体呈双层编织网成型，所述隔离主体的双层编织网的表面固定有阻流膜；所述收缩外网呈单层或双层编织网成型。
可选地，所述隔离主体呈单层编织网成型，所述隔离主体的单层编织网的表面或内腔固定有阻流膜；所述收缩外网呈单层编织网成型。
可选地，所述收缩外网呈双层编织网成型，所述收缩外网可固定有阻流膜；
所述隔离主体呈单层或双层编织网成型，且所述隔离主体上固定有阻流膜。
本公开还提供一种心脏重建植入体，包括：隔离主体和收缩外网；
所述隔离主体和所述收缩外网固定连接，所述隔离主体释放于心脏的心室内，以对无效心腔隔离；所述收缩外网包覆于心脏表面，以对心脏外部提供收缩作用力。
可选地，所述心脏重建植入体还包括固定腰部；
所述隔离主体和所述收缩外网通过所述固定腰部固定连接，所述固定腰部固定于心脏的心尖处，以使所述收缩外网以所述固定腰部为中心扩散包覆于心脏表面。
可选地，所述隔离主体、所述固定腰部和所述收缩外网经由弹性材料制备成型，且所述收缩外网罩设于所述隔离主体的外部。
可选地，所述隔离主体包括扩展段和延伸段；
所述扩展段通过所述延伸段与所述固定腰部连接，所述扩展段位于心脏远离心尖的一端，所述扩展段用于与心室壁贴合，且所述延伸段能够随着所述扩展段至心尖处沿着心室壁贴合。
可选地，所述扩展段的直径大于所述延伸段的直径，所述延伸段随着心脏的形状完全随形贴合。
可选地，所述收缩外网沿着所述固定腰部呈弧形张开，以使所述收缩外网随着心脏的外部完全包覆。
可选地，所述隔离主体呈双层网状结构，所述隔离主体的双层网状结构固定有阻流膜；
所述收缩外网呈单层或双层网状结构。
可选地，所述收缩外网呈双层网状结构，所述收缩外网固定有阻流膜；
所述隔离主体呈单层或双层网状结构，且所述隔离主体上固定有阻流膜。
可选地，所述收缩外网呈单层网状结构，所述收缩外网固定有阻流膜；所述隔离主体呈单层网状结构，且所述隔离主体上固定有阻流膜。
可选地，所述心脏重建植入体还包括连接件；
所述连接件与所述固定腰部连接，所述连接件用于与外部输送系统连接，以将所述隔离主体、所述固定腰部和所述收缩外网收缩于外部输送系统中。
可选地，所述隔离主体与心室壁接触的编织层至少设置有一根固定锚刺，所述固定锚刺沿着所述隔离主体的编织层延伸至心室壁中。
可选地，所述隔离主体与心室壁接触的网状结构层至少设置有一根固定锚刺，所述固定锚刺沿着所述隔离主体的编织层延伸至心室壁中。
可选地，所述固定腰部(300)设置有一根或多根固定锚刺(600)，所述固定锚刺(600)沿着所述固定腰部(300)延伸至所述心脏重建植入体贯穿所述心尖的心肌内壁。
本公开还提供一种心脏重建的方法，所述方法包括：将上文任一项所述的心脏重建植入体经心尖介入或经皮介入植入心脏内。
附图说明
为了更清楚地说明本公开实施方式或现有技术中的技术方案，下面将对实施方式或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本公开的一些实施方式，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为本公开一些实施方式提供的心脏重建植入体的整体结构示意图；
图2为本公开一些实施方式提供的心脏重建植入体的局部放大结构示意图；
图3为本公开实施方式提供的心脏重建植入体的隔离主体呈双层编织网成型的结构示意图；
图4为本公开一些实施方式提供的心脏重建植入体的整体结构示意图；
图5为本公开实施方式提供的心脏重建植入体经皮介入释放到左心室和包覆心脏外部的初步过程示意图；
图6为本公开实施方式提供的心脏重建植入体经皮介入释放到左心室和包覆心脏外部的中间过程示意图；
图7为本公开实施方式提供的心脏重建植入体经皮介入释放到左心室和包覆心脏外部的完成过程示意图；
图8为本公开实施方式提供的心脏重建植入体经心尖释放到左心室和包覆心脏外部的初步过程示意图；
图9为本公开实施方式提供的心脏重建植入体经心尖释放到左心室和包覆心脏外部的中间过程示意图；
图10为本公开实施方式提供的心脏重建植入体经心尖释放到左心室和包覆心脏外部的完成过程示意图；
图11为本公开实施方式提供的心脏重建植入体释放到左心室和包覆心脏外部的状态示意图。
图标：100-隔离主体；101-扩展段；102-延伸段；200-收缩外网；300-固定腰部；400-连接件；500-输送系统；600-固定锚刺。
具体实施方式
下面将结合实施方式对本公开的技术方案进行清楚、完整地描述，显然，所描述的实施方式是本公开一部分实施方式，而不是全部的实施方式。基于本公开中的实施方式，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施方式，都属于本公开保护的范围。
应注意到：相似的标号和字母在下面的附图中表示类似项，因此，一旦某一项在一个附图中被定义，则在随后的附图中不需要对其进行进一步定义和解释。
在本公开的描述中，还需要说明的是，除非另有明确的规定和限定，若出现术语“设置”、“安装”、“相连”、“连接”等应做广义理解，例如，可以是固定连接，也可以 是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本公开中的具体含义。
需要说明的是，在不冲突的情况下，本公开的实施方式中的特征可以相互结合。
本公开一些实施方式提供的一种心脏重建植入体，包括：隔离主体100和收缩外网200；
隔离主体100和收缩外网200固定连接，隔离主体100释放于心脏的心室内，以对无效心腔隔离；收缩外网200包覆于心脏表面，以对心脏外部提供收缩作用力。
在一些实施方式中，隔离主体100和收缩外网200固定连接方式包括但不限于一体化成型、胶接、钉接、焊接、或经由连接件(诸如套管等)固定连接。
在一些实施方式中，一体化成型包括但不限于一体化编织成型、一体化切割成型、一体化模塑成型、一体化打印(诸如3D打印)成型等。
不受理论的约束，本文所用术语“一体化”是指由一个或多个结构组成的一体化组合结构，多个结构可以选自同一类别材料的相同物质或多种物质组合或者各自选自同一类别材料的不同物质或多种物质的组合。
不受理论的约束，本文所用术语“编织”是指将线状体或丝状体等(诸如丝材、线材)互相交错或钩连而组织或组合起来。
在一些实施方式中，心脏重建植入体包括：隔离主体100和收缩外网200；
隔离主体100和收缩外网200一体化编织成型，隔离主体100释放于心脏的心室内，以对无效心腔隔离；收缩外网200包覆于心脏表面，以对心脏外部提供收缩作用力。
在一些实施方式中，心脏重建植入体还包括固定腰部300；
隔离主体100和收缩外网200通过固定腰部300固定连接，固定腰部300固定于心脏的心尖处，以使收缩外网200以固定腰部300为中心扩散包覆于心脏表面。
在一些实施方式中，心脏重建植入体还包括固定腰部300；
隔离主体100和收缩外网200通过固定腰部300一体化编织连接，固定腰部300固定于心脏的心尖处，以使收缩外网200以固定腰部300为中心扩散包覆于心脏表面。不受理论的约束，该心尖处为心脏重建植入体穿过心脏而产生的穿孔位置处。
在一些实施方式中，隔离主体100、固定腰部300和收缩外网200经由弹性材料制备成型，且收缩外网200罩设于隔离主体100的外部。可选地，弹性材料包括高分子化合物(诸如树脂、弹性聚氨酯)、金属(诸如铂、钯、钴合金、镍钛合金或钴铬合金)等。可选地，弹性材料可以包括丝材或熔融态材料等。
在一些实施方式中，隔离主体100、固定腰部300和收缩外网200依次通过弹性丝材编织成型，且收缩外网200罩设于隔离主体100的外部。
可选地，所述隔离主体、所述固定腰部和所述收缩外网还可以由除弹性丝材以外的弹性材料制备成型，且所述收缩外网罩设于所述隔离主体的外部。
在一些实施方式中，隔离主体100包括扩展段101和延伸段102；
扩展段101通过延伸段102与固定腰部300连接，扩展段101位于心脏远离心尖的一端，扩展段101用于与心室壁贴合，且延伸段102能够随着扩展段101至心尖处沿着心室壁贴合。
在一些实施方式中，扩展段101的直径大于延伸段102的直径，延伸段102随着心脏的形状完全随形贴合。
在一些实施方式中，收缩外网200沿着固定腰部300呈弧形张开，以使收缩外网200随着心脏的外部完全包覆。
在一些实施方式中，收缩外网200远离固定腰部300的一端至固定腰部300的间距大于扩展段101至固定腰部300的间距，以使收缩外网200能够逐渐包覆于心脏外部。
在一些实施方式中，还可以根据患者临床需求或者根据患者心脏的形态，还可以使收缩外网200远离固定腰部300的一端至固定腰部300的间距等于或小于扩展段101至固定腰部300的间距。
在一些实施方式中，隔离主体100呈双层网状结构，也可以将阻流膜固定于隔离主体100的双层网状结构的外表面，以适应患者不同的需求；收缩外网200呈单层或双层网状结构，
在一些实施方式中，隔离主体100呈双层编织网成型，隔离主体100的双层编织网内部间固定有阻流膜；收缩外网200呈单层或双层编织网成型。
在一些实施方式中，收缩外网200呈双层网状结构，所述收缩外网200固定有阻流膜；隔离主体100呈单层或双层网状结构，且所述隔离主体100上固定有阻流膜。
在一些实施方式中，收缩外网200呈双层编织网成型，收缩外网200可固定有阻流膜；隔离主体100呈单层或双层编织网成型，且隔离主体100上固定有阻流膜。
在一些实施方式中，收缩外网200呈单层网状结构，所述收缩外网200固定有阻流膜；隔离主体100呈单层网状结构，且所述隔离主体100上固定有阻流膜，输送系统500可以直接与固定腰部300的靠近心尖的一端固定连接，并对植入体进行收放。
在一些实施方式中，阻流膜包括高分子膜、织物膜或生物组织膜中的至少一种。
在一些实施方式中，心脏重建植入体还包括连接件400；
连接件400与固定腰部300连接，连接件400用于与外部输送系统500连接，以将隔离主体100、固定腰部300和收缩外网200收缩于外部输送系统500中。在一些实施方式中，连接件400位于收缩外网200靠近心尖的一端。
在一些实施方式中，固定腰部300可以是单层或双层网状结构。
在一些实施方式中，固定腰部300在远离的一端连接延伸段102，在靠近心尖的一端连接收缩外网200。
在一些实施方式中，隔离主体100与心室壁接触的网状结构层至少设置有一根固定锚刺600，所述固定锚刺600沿着所述隔离主体100的编织层延伸至心室壁中。
在一些实施方式中，隔离主体100与心室壁接触的编织层至少设置有一根固定锚刺600，固定锚刺600沿着隔离主体100的编织层延伸至心室壁中。
在一些实施方式中，固定腰部300设置有多根固定锚刺600，该固定锚刺600沿着固定腰部300延伸至所述心脏重建植入体贯穿所述心尖的心肌内壁。
在一些实施方式中，隔离主体100可以呈酒杯状/草帽状结构；
在一些实施方式中，隔离主体100可以无固定锚刺600，通过展开后的隔离主体100与心室壁接触贴合。不受理论的约束，隔离主体100实现了有效隔离密封的作用。
在一些实施方式中，隔离主体100的高度范围为1mm-100mm；收缩外网200的高度为1-100mm。
在一些实施方式中，隔离主体100、固定腰部300和收缩外网200的弹性丝材为金属丝、高分子丝材或陶瓷丝材中的至少一种。
可选地，金属丝包括但不限于弹性铂丝、弹性钯丝、钴合金、镍钛合金或钴铬合金中的至少一种。
例如，隔离主体100和收缩外网200均选自镍钛合金。可选地，隔离主体100选自镍钛合金，收缩外网200选自弹性钯丝。可选地，隔离主体100选自弹性钴合金和弹性铂丝(诸如经由混合编织)的组合弹性丝材，收缩外网200选自弹性铂丝。
在一些实施方式中，连接件400可为有铆式或平端无铆式。
在一些实施方式中，固定腰部300靠近心脏的心尖处一侧(即固定腰部300的外侧)设置有固定锚刺600。不受理论的约束，固定腰部300上的固定锚刺600可以进一步加强固定腰部300的固定作用。
在一些实施方式中，可经心尖介入或经皮介入，通过整体编织结构，所需输送鞘管尺寸小，有利于降低对血管的损伤及并发症。
本公开一些实施方式还提供一种心脏重建的方法，该方法包括：将该心脏重建植入体经心尖介入或经皮介入植入心脏内。
本公开提供的心脏重建植入体，缓解了现有技术中存在的支撑骨架对心室壁进行支撑，需要采用球囊扩张增加手术操作时间和风险，器械骨架结构所受应力集中易断裂，减容效果不理想，以及心脏收缩力不足的情况仍然存在的技术问题。
本公开提供的心脏重建植入体，包括：隔离主体100和收缩外网200；隔离主体100和收缩外网200固定连接(诸如一体化编织成型)，隔离主体100释放于心脏的心室内，诸如通过编织形成的隔离主体100对无效心腔隔离，网状结构(诸如编织结构)的隔离主体100具有自膨性(自膨性可以源于具有形状记忆功能的材料，也可来源于具有一定弹性的其他材料)，因此植入时不再需要球囊扩张，而且网状结构(诸如编织结构)的隔离主体100随着心室运动，隔离主体100的受力呈分散状，进而提高了隔离主体100的机械性能，不易发生断裂的情况；可选地，收缩外网200包覆于心脏表面，通过收缩外网200能够对心脏外部提供收缩作用力，即收缩外网200可以在心脏舒张期时存储一定的应力，当心脏收缩期时可以促进心脏的收缩，从而达到降低心室容积和心室压力、防止心室扩张的目的，进一步提升对心脏的收缩功能，通过对心脏的心室壁内部隔离和心脏外部的收缩作用力，进而提高心室泵血能力，缓解了现有技术中存在的支撑骨架对心室壁进行支撑，需要采用球囊扩张增加手术操作时间和风险，器械骨架结构所受应力集中易断裂，减容效果不理想，以及心脏收缩力不足的情况仍然存在的技术问题。此外，心脏重建植入体的一体化成型可以进一步提高植入体的固定于心脏的稳固性和植入体在使用过程中的寿命和耐久性。
此外，固定腰部300不仅保证了心脏内外的隔离主体100和收缩外网200的顺滑连接，以及确保隔离主体100和收缩外网200的稳定性；而且腰部结构300固定于心尖处还可以防止心脏渗液(如渗血)的流出。
如图1-图11所示，本实施方式提供一种心脏重建植入体，包括：隔离主体100和收缩外网200；隔离主体100和收缩外网200一体化编织成型，隔离主体100释放于心脏的心室内，以对无效心腔隔离；收缩外网200包覆于心脏表面，以对心脏外部提供收缩作用力。
需要说明的是，本实施方式提供了一种用于心脏重建以及协助心脏收缩的装置，利用编织结构隔离主体100和收缩外网200一体化的心脏重建植入体。可选地，隔离主体100和收缩外网200通过一体化编织成型，隔离主体100能够将扩张后的心室隔离为静止心腔 和动态心腔，从而达到隔绝室壁瘤，减小心室容积；另外，收缩外网200能够包覆在心脏的外部表面，利用收缩外网200对心脏收缩期辅助收缩，并且由于隔离主体100和收缩外网200是一体成型，即隔离主体100对心脏心室的隔离支撑以及收缩外网200的收缩作用力能够相互作用，即隔离主体100对收缩外网200提供收缩支撑力，同时收缩外网200保证隔离主体100对心腔的隔离，实现了对心脏的心室隔离和外部提供收缩作用力的双重作用，使得整体设计更加完善。如图1和3所示，本实施方式提供一种心脏重建植入体，包括：隔离主体100和收缩外网200；隔离主体100和收缩外网200一体化编织成型，隔离主体100释放于心脏的心室内，通过编织形成的隔离主体100对无效心腔隔离，编织结构的隔离主体100具有进一步的自膨性(即经由编织可以进一步提高弹性材料自膨特性，从而更进一步提高植入体的固定于心脏的稳固性和植入体在使用过程中的寿命和耐久性。)，因此植入时不再需要球囊扩张，而且编织结构的隔离主体100随着心室运动，隔离主体100的受力呈分散状，进而提高了隔离主体100的机械性能，不易发生断裂的情况；可选地，收缩外网200包覆于心脏表面，通过收缩外网200能够对心脏外部提供收缩作用力，即收缩外网200可以在心脏舒张期时存储一定的应力，当心脏收缩期时可以促进心脏的收缩，从而达到降低心室容积和室壁应力、防止心室扩张的目的，进一步提升对心脏的收缩功能，通过对心脏的心室壁内部隔离和心脏外部的收缩作用力，进而提高心室泵血能力，缓解了现有技术中存在的支撑骨架对心室壁进行支撑，需要采用球囊扩张增加手术操作时间和风险，器械骨架结构所受应力集中易断裂，减容效果不理想，以及心脏收缩力不足的情况仍然存在的技术问题。
在上述实施方式的基础上，可选地，可选地，心脏重建植入体还包括固定腰部300；隔离主体100和收缩外网200通过固定腰部300一体化编织连接，固定腰部300固定于心脏的心尖处，以使收缩外网200以固定腰部300为中心扩散包覆于心脏表面。
本实施方式中，隔离主体100的端部通过固定腰部300进行收紧，并且收缩外网200通过固定腰部300的位置向外进行张开，固定腰部300能够在输送中完全贯穿心尖位置，即固定腰部300固定在心尖处，收缩外网200沿着固定腰部300的位置向心脏的表面进行包覆，固定腰部300作为一体化编织结构的连接过渡结构，固定腰部300能够集成了所有编织线通过，利用固定腰部300保证了心脏内外的隔离主体100和收缩外网200的顺滑连接，同时固定腰部300能够保证隔离主体100和收缩外网200的稳定性。可选地，隔离主体100、固定腰部300和收缩外网200依次通过弹性丝材编织成型，且收缩外网200罩设于隔离主体100的外部。
本实施方式中，隔离主体100和收缩外网200的编织起点均可以以固定腰部300为起点，即隔离主体100的所有弹性丝材和收缩外网200的所有弹性丝材均会集中在固定腰部300位置，利用弹性丝材编织形成隔离主体100、固定腰部300和收缩外网200，并且收缩外网200是以固定腰部300为中心扩散包覆于心脏表面，隔离主体100也是以固定腰部300为中心延伸布置于心室壁表面，固定腰部300能够实现整体器械位于心脏处的固定。
可选地，由于隔离主体100、固定腰部300和收缩外网200依次通过弹性丝材编织成型，基于弹性丝材的特性，当隔离主体100植入时无需球囊进行扩张，隔离主体100能够随着心室运动与心室壁的表面完全贴合，而且收缩外网200在植入过程中也会随着心脏的表面进行扩张，收缩外网200能够完全贴附在心脏表面上，利用弹性丝材的编织特性，使得收缩外网200在心脏舒张期时，随着心脏的张开存储一定的应力，当心脏收缩期时可以 对包覆的心脏外部施加作用力，促进心脏收缩，从而达到降低心室容积和室壁应力、防止心室扩张的目的。
可选地，隔离主体100、固定腰部300和收缩外网200的弹性丝材为金属丝、高分子丝材或陶瓷丝材中的至少一种。
可选地，隔离主体100可以呈酒杯状/草帽状结构。可选地，隔离主体100包括扩展段101和延伸段102；扩展段101通过延伸段102与固定腰部300连接，扩展段101位于心脏远离心尖的一端，扩展段101用于与心室壁贴合，且延伸段102能够随着扩展段101至心尖处沿着心室壁贴合。本实施方式中，扩展段101可以呈平面扩张结构，即隔离主体100呈张开的类似伞面形态，扩展段101能够与心脏远离心尖的位置，即扩展段101是作为扩张后的心室呈静止心腔和动态心腔的分隔位置，扩展段101和延伸段102均能够与心脏的心室壁贴合，即以扩展段101至延伸段102能够隔离心脏心肌，被隔离的心肌的压力以及传递至心尖处的力均减小，降低了室壁应力；另外，除了静止心腔的负荷减轻外，动态心腔的减少也会导致正常心肌压力的降低，使心室的负荷全面降低。
可选地，扩展段101的直径大于延伸段102的直径，延伸段102随着心脏的形状完全随形贴合。
其中，扩展段101呈张开的类似伞面形态扩展心室，并且由于心脏的心室内部至心尖处是呈逐渐减小的腔室，可选地，可以利用延伸段102沿着扩展段101至固定腰部300呈锥形布置，即延伸段102能够作为伞骨的形态进行逐渐收缩，从而能够使得延伸段102随着心室的形状进行随形贴合的基础上，能够保证静止心腔一直处于扩张状态，同时延伸段102的锥形布置能够使得远离扩展段101的一端与固定腰部300位置进行顺滑过渡，进而能够保证固定腰部300与心尖处的稳定固定；并且由于扩展段101、延伸段102以及固定腰部300是通过弹性丝材一体编织形成，即扩展段101、延伸段102以及固定腰部300受到的应力是呈分散状态的，避免了支杆骨架结构应力集中，提高了整体隔离主体100的机械性能，不易发生断裂的情况，提高了隔离主体100的稳定性。
可选地，收缩外网200沿着固定腰部300呈弧形张开，以使收缩外网200随着心脏的外部完全包覆。可选地，收缩外网200以固定腰部300为中心，向隔离主体100远离心尖的方向呈内凹弧形张开，以使收缩外网200随着心脏的外部完全包覆。
本实施方式中，收缩外网200可以呈碗状形态，即收缩外网200以固定腰部300为中心呈展开形态，收缩外网200在心尖处的内径最小，此时收缩外网200能够以心尖处向心脏表面逐渐包覆，并且收缩外网200同样是通过弹性丝材与固定腰部300以及隔离主体100编织成型，即收缩外网200对心脏施加的应力也是呈分散状态，避免了针对心脏的某个位置造成应力集中，以对心脏表面造成损伤；可选地，收缩外网200的内径可以为非线性变化，即收缩外网200的内径可以根据心脏外部进行具体设定，此处对此不做限定。
可选地，收缩外网200远离固定腰部300的一端至固定腰部300的间距大于扩展段101至固定腰部300的间距，以使收缩外网200能够逐渐包覆于心脏外部。
本实施方式中，由于收缩外网200、固定腰部300以及隔离主体100均是安装在外部输送系统500中，利用输送鞘管进行输送，当输送鞘管到达心尖位置后，此时需要隔离主体100可选地进入至心室中，再释放收缩外网200包覆心脏表面，为了便于手术操作，当输送鞘管释放植入装置时，利用隔离主体100伸入至心尖处后，再开始释放收缩外网200，实现了对心脏内外分别输送隔离主体100和收缩外网200的方式。
可选地，隔离主体100的高度范围为1mm-100mm；收缩外网200的高度为1mm-100mm。
可选地，隔离主体100呈双层编织网成型，隔离主体100的双层编织网内部间固定有阻流膜；收缩外网200呈单层或双层编织网成型。在一些实施方式中，当器械经皮介入，隔离主体100应该是双层编织网成型，此时收缩外网200可以是单层编织网也可以为双层编织网；其中，隔离主体100为双层编织网，扩展段101延伸至隔离体中心，并收拢至连接件400中，连接件400用于植入体与输送系统500的连接；隔离主体100的内部或外部应固定有阻流膜。以实现隔离功能心腔和无效心腔的作用；当收缩外网200为单层编织网，无需固定件，收缩外网200的单层编织网可以布置有阻流膜也可以不设置阻流膜，并且收缩外网200的单层编织网的阻流膜可以布置与心脏接触的一面或不与心脏接触的一面均可。当收缩外网200为双层编织网时，收缩外网200的双层编织网可以不收拢至固定件中，也可以收拢至固定件中，并且收缩外网200的双层编织网的外部或内部同样可以设置有阻流膜也可以不设置有阻流膜。
阻流膜可以包括高分子膜、织物膜或生物组织膜中的至少一种。
可选地，收缩外网200呈双层编织网成型，收缩外网200可固定有阻流膜；隔离主体100呈单层或双层编织网成型，且隔离主体100上固定有阻流膜。
本实施方式中，当器械经心尖介入，收缩外网200应该是双层编织网成型，此时隔离主体100可以是单层编织网也可以为双层编织网；其中，收缩外网200的编织丝收拢至连接件400中，连接件400用于植入体与输送系统500的连接；隔离主体100的内部或外部应固定有阻流膜。当隔离主体100为单层编织网，无需固定件，收缩外网200的单层编织网一面应固定有阻流膜，以起到隔离功能心腔和无效心腔的作用；当隔离主体100为双层编织网时，隔离主体100的双层编织网可以不收拢至固定件中，也可以收拢至固定件中，并且隔离主体100收缩外网200的双层编织网的外部或内部应固定有阻流膜，以起到隔离功能心腔和无效心腔的作用。
本实施方式中，隔离主体100可以经由固定腰部300位置呈单层编织网成型，或者收缩外网200也可以经由固定腰部300位置呈单层编织网成型，利用单层网状结构实现弹性好，柔软性质，可以更好的保护心尖处；利用高密度的编织网结构，可以更好提高心室壁的顺应性和贴合性，有利于提升器械的减容效果，同时可以保证可回收。
可选地，阻流膜包括高分子膜、织物膜或生物组织膜中的至少一种。
本实施方式中，由于单层编织网分别与心室壁、心尖处以及心脏表面进行接触，通过在单层编织网的至少一面固定有阻流膜，可以实现心室即刻隔离，同时还能够对心脏表面以及心室壁更好贴合。
可选地，阻流膜可以通过缝合的方式固定于单层编织网的任意一面；或者，也可以在单层编织网的两侧均缝合有阻流膜，此处对此不作限制。
可选地，隔离主体100、固定腰部300和收缩外网200呈双层编织网成型。
本实施方式中，隔离主体100可以经由固定腰部300位置呈双层编织网回位成型，即隔离主体100远离固定腰部300位置呈弧形回位编织，或者收缩外网200也可以经由固定腰部300位置呈双层编织网成型，即收缩外网200远离固定腰部300位置(沿隔离主体100远离心尖的方向)呈弧形回位编织，通过双层编织网结构可以更好的保证整体器械的稳定性，同时利用高密度的编织网结构，可以更好提高心室壁的顺应性和贴合性，有利于提升器械的减容效果。
本实施方式中，通过在双层编织网之间的位置固定有阻流膜，即双层编织网结构能够与心脏表面和心室壁接触贴合的基础上，还可以通过阻流膜实现心室即刻隔离。
可选地，阻流膜可以通过缝合的方式固定于双层编织网内部。
如图2所示，可选地，心脏重建植入体还包括连接件400；连接件400与固定腰部300背离隔离主体100的一端连接，连接件400用于与外部输送系统500连接，以将隔离主体100、固定腰部300和收缩外网200收缩于外部输送系统500中。
本实施方式中，连接件400与固定腰部300位置固定连接，其中连接件400的直径范围为固定腰部300的直径范围或小于固定腰部300的直径。在一些实施方式中，连接件400位于收缩外网200靠近心尖的一端，并连接件400被设置为将心重建植入体与外部输送系统500连接，以经由输送系统500将心重建植入体递送至作用位置。在一些实施方式中，固定腰部300当收缩外网200和隔离主体100完全收缩后，此时固定腰部300作为收缩集合位置，固定腰部300通过连接件400与外部输送系统500形成连接，利用连接件400能够实现外部输送系统500与植入体的连接输送；可选地，连接件400可以为有铆式或平端无铆式，其中连接件400只要能够保证植入体与外部输送系统500连接即可，此处对连接件400的结构不作限定。
如图4所示，可选地，隔离主体100与心室壁接触的编织层设置有多根固定锚刺600，固定锚刺600沿着隔离主体100的编织层延伸至心室壁中。
本实施方式中，固定锚刺600位于扩展段101的外周位置，当隔离主体100放置后固定锚刺600可以刺入心室壁的心肌内，利用固定锚刺600能够保证隔离主体100的整体锚定，提高了隔离主体100的整体放置的稳定性。
可选地，固定锚刺600可以布置有多个，多个固定锚刺600可以沿着多个方向进行倾斜。可选地，心肌收缩/舒张过程中除了心室的扩大缩小，同时伴随着心肌螺旋运动；每个固定锚刺600的固定位点的心肌运动幅度，方向存在一定差异，通过固定锚刺600方向设计为多方向，能够提高器械植入。当多个固定锚刺600与心室壁的心肌锚定后，可以随着心脏的运动方向刺入至心室壁，进而能够更好的提高了锚定的稳定性，提高了隔离主体100锚定的稳定状态。
可选地，隔离主体100可以设置有固定锚刺600，也可以无固定锚刺600，可选地，隔离主体100可以无固定锚刺600，通过展开后的隔离主体100与心室壁接触贴合即可。
如图4所示，固定腰部300还设置有多根固定锚刺600，该固定锚刺600沿着固定腰部300延伸至所述心脏重建植入体贯穿所述心尖的心肌内壁，以进一步提高心脏重建植入体固定于心脏的稳定性。可选地，植入体可经心尖介入或经皮介入，通过整体编织结构，所需输送鞘管尺寸小，有利于降低对血管的损伤及并发症。
需要说明的是，本实施方式提供了一种用于心脏重建以及协助心脏收缩的装置，利用编织结构隔离主体100和收缩外网200一体化的心脏重建植入体。可选地，隔离主体100和收缩外网200通过一体化编织成型，隔离主体100能够将扩张后的心室隔离为静止心腔和动态心腔，从而达到隔绝室壁瘤，减小心室容积；另外，收缩外网200能够包覆在心脏的外部表面，利用收缩外网200对心脏收缩期辅助收缩，并且由于隔离主体100和收缩外网200是一体成型，即隔离主体100对心脏心室的隔离支撑以及收缩外网200的收缩作用力能够相互作用，即隔离主体100对收缩外网200提供收缩支撑力，同时收缩外网200保证隔离主体100对心腔的隔离，实现了对心脏的心室隔离和外部提供收缩作用力的双重作用，使得整体设计更加完善。
参照图5-7，通过经皮介入，即经由穿刺体表血管，在输送系统500的引导下将心脏重建植入体释放到左心室和包覆心脏外部的初步、中间和完成过程，心脏重建植入体在输送系统500的引导下，首先将收缩外网200释放于心脏外部，同时固定腰部300固定于心脏的心尖处，收缩外网200以固定腰部300为中心，并沿着固定腰部300呈弧形张开，并随着心脏的外部完全包覆在心脏的外部表面，利用收缩外网200对心脏收缩期辅助收缩；随后隔离主体100释放于心脏的心室内，将扩张后的心室隔离为静止心腔和动态心腔。
参照图8-11，通过经心尖介入，在输送系统500的牵引下将心脏重建植入体释放到左心室和包覆心脏外部的初步、中间和完成过程，心脏重建植入体在输送系统500的牵引下，首先将隔离主体100释放于心脏的心室内，将扩张后的心室隔离为静止心腔和动态心腔，随后固定腰部300固定于心脏的心尖处，最后收缩外网200以固定腰部300为中心，并沿着固定腰部300呈弧形张开，并随着心脏的外部完全包覆在心脏的外部表面对心脏收缩期辅助收缩，进一步提升对心脏的收缩功能。
最后应说明的是：以上各实施方式仅用以说明本公开的技术方案，而非对其限制；尽管参照前述各实施方式对本公开进行了详细的说明，本领域的普通技术人员应当理解：其依然可以对前述各实施方式所记载的技术方案进行修改，或者对其中部分或者全部技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本公开各实施方式技术方案的范围。
工业实用性
本公开提供了一种心脏重建植入体，其特殊的编织结构使得隔离主体植入时不再需要球囊扩张，隔离主体的受力呈分散状，提高了隔离主体的机械性能；收缩外网包覆于心脏表面，可以达到降低心室容积和心室压力、防止心室扩张的目的，提高了心室泵血能力，缓解了现有技术中存在的手术操作时间和风险，器械骨架结构所受应力集中易断裂，减容效果不理想，以及心脏收缩力不足的情况仍然存在的技术问题，因此本公开的心脏重建植入体具有优异的工业实用性能，同时具有广阔的市场前景。

Claims (20)

  1. 一种心脏重建植入体，其特征在于，包括：隔离主体(100)和收缩外网(200)；
    所述隔离主体(100)和所述收缩外网(200)一体化编织成型，所述隔离主体(100)释放于心脏的心室内，以对无效心腔隔离；所述收缩外网(200)包覆于心脏表面，以对心脏外部提供收缩作用力。
  2. 根据权利要求1所述的心脏重建植入体，其特征在于，还包括固定腰部(300)；
    所述隔离主体(100)和所述收缩外网(200)通过所述固定腰部(300)一体化编织连接，所述固定腰部(300)固定于心脏的心尖处，以使所述收缩外网(200)以所述固定腰部(300)为中心扩散包覆于心脏表面。
  3. 根据权利要求2所述的心脏重建植入体，其特征在于，所述隔离主体(100)、所述固定腰部(300)和所述收缩外网(200)依次通过弹性丝材编织成型，且所述收缩外网(200)罩设于所述隔离主体(100)的外部。
  4. 根据权利要求2或3所述的心脏重建植入体，其特征在于，所述隔离主体(100)包括扩展段(101)和延伸段(102)；
    所述扩展段(101)通过所述延伸段(102)与所述固定腰部(300)连接，所述扩展段(101)位于心脏远离心尖的一端，所述扩展段(101)用于与心室壁贴合，且所述延伸段(102)能够随着所述扩展段(101)至心尖处沿着心室壁贴合。
  5. 根据权利要求4所述的心脏重建植入体，其特征在于，所述扩展段(101)的直径大于所述延伸段(102)的直径，所述延伸段(102)随着心脏的形状完全随形贴合。
  6. 根据权利要求5所述的心脏重建植入体，其特征在于，所述收缩外网(200)沿着所述固定腰部(300)呈弧形张开，以使所述收缩外网(200)随着心脏的外部完全包覆。
  7. 根据权利要求3-6中任一项所述的心脏重建植入体，其特征在于，所述隔离主体(100)呈双层编织网成型，所述隔离主体(100)的双层编织网内部间固定有阻流膜；
    所述收缩外网(200)呈单层或双层编织网成型；
    可选地，所述隔离主体(100)呈双层编织网成型，所述隔离主体(100)的双层编织网表面固定有阻流膜；所述收缩外网(200)呈单层或双层编织网成型；
    可选地，所述隔离主体(100)呈单层编织网成型，所述隔离主体(100)的单层编织网的表面或内腔固定有阻流膜；所述收缩外网(200)呈单层编织网成型。
  8. 根据权利要求3-6中任一项所述的心脏重建植入体，其特征在于，所述收缩外网(200)呈双层编织网成型，所述收缩外网(200)可固定有阻流膜；
    所述隔离主体(100)呈单层或双层编织网成型，且所述隔离主体(100)上固定有阻流膜。
  9. 一种心脏重建植入体，其特征在于，包括：隔离主体(100)和收缩外网(200)；
    所述隔离主体(100)和所述收缩外网(200)固定连接，所述隔离主体(100)释放于心脏的心室内，以对无效心腔隔离；所述收缩外网(200)包覆于心脏表面，以对心脏外部提供收缩作用力。
  10. 根据权利要求9所述的心脏重建植入体，其特征在于，还包括固定腰部(300)；
    所述隔离主体(100)和所述收缩外网(200)通过所述固定腰部(300)固定连接，所述固定腰部(300)固定于心脏的心尖处，以使所述收缩外网(200)以所述固定腰部(300)为中心扩散包覆于心脏表面。
  11. 根据权利要求10所述的心脏重建植入体，其特征在于，所述隔离主体(100)、所述固定腰部(300)和所述收缩外网(200)经由弹性材料备成型，且所述收缩外网(200)罩设于所述隔离主体(100)的外部。
  12. 根据权利要求11所述的心脏重建植入体，其特征在于，所述隔离主体(100)包括扩展段(101)和延伸段(102)；
    所述扩展段(101)通过所述延伸段(102)与所述固定腰部(300)连接，所述扩展段(101)位于心脏远离心尖的一端，所述扩展段(101)用于与心室壁贴合，且所述延伸段(102)能够随着所述扩展段(101)至心尖处沿着心室壁贴合。
  13. 根据权利要求12所述的心脏重建植入体，其特征在于，所述扩展段(101)的直径大于所述延伸段(102)的直径，所述延伸段(102)随着心脏的形状完全随形贴合。
  14. 根据权利要求13所述的心脏重建植入体，其特征在于，所述收缩外网(200)沿着所述固定腰部(300)呈弧形张开，以使所述收缩外网(200)随着心脏的外部完全包覆。
  15. 根据权利要求11-14中任一项所述的心脏重建植入体，其特征在于，所述隔离主体(100)呈双层网状结构，所述隔离主体(100)的双层网状结构固定有阻流膜；
    所述收缩外网(200)呈单层或双层网状结构。
  16. 根据权利要求11-15中任一项所述的心脏重建植入体，其特征在于，所述收缩外网(200)呈双层网状结构，所述收缩外网(200)固定有阻流膜；
    所述隔离主体(100)呈单层或双层网状结构，且所述隔离主体(100)上固定有阻流膜；
    可选地，所述收缩外网(200)呈单层网状结构，所述收缩外网(200)固定有阻流膜；所述隔离主体(100)呈单层网状结构，且所述隔离主体(100)上固定有阻流膜。
  17. 根据权利要求2-8、10-16中任一项所述的心脏重建植入体，其特征在于，还包括连接件(400)；
    所述连接件(400)与所述固定腰部(300)连接，所述连接件(400)用于与外部输送系统(500)连接，以将所述隔离主体(100)、所述固定腰部(300)和所述收缩外网(200)收缩于外部输送系统(500)中。
  18. 根据权利要求3-8中任一项所述的心脏重建植入体，其特征在于，所述隔离主体(100)与心室壁接触的编织层至少设置有一根固定锚刺(600)，所述固定锚刺(600)沿着所述隔离主体(100)的编织层延伸至心室壁中；
    可选地，所述固定腰部(300)设置有一根或多根固定锚刺(600)，所述固定锚刺(600)沿着所述固定腰部(300)延伸至所述心脏重建植入体贯穿所述心尖的心肌内壁。
  19. 根据权利要求9-16中任一项所述的心脏重建植入体，其特征在于，所述隔离主体(100)与心室壁接触的网状结构层设置有一根或多根固定锚刺(600)，所述固定锚刺(600)沿着所述隔离主体(100)的编织层延伸至心室壁中；
    可选地，所述固定腰部(300)设置有一根或多根固定锚刺(600)，所述固定锚刺(600)沿着所述固定腰部(300)延伸至所述心脏重建植入体贯穿所述心尖的心肌内壁。
  20. 一种心脏重建的方法，其特征在于，所述方法包括：将权利要求1-19中任一项所述的心脏重建植入体经心尖介入或经皮介入植入心脏内。
PCT/CN2022/128132 2022-07-08 2022-10-28 心脏重建植入体 WO2024007491A1 (zh)

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