WO2023221778A1 - 左心耳封堵隔离装置、输送装置及左心耳封堵隔离系统 - Google Patents
左心耳封堵隔离装置、输送装置及左心耳封堵隔离系统 Download PDFInfo
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- WO2023221778A1 WO2023221778A1 PCT/CN2023/092174 CN2023092174W WO2023221778A1 WO 2023221778 A1 WO2023221778 A1 WO 2023221778A1 CN 2023092174 W CN2023092174 W CN 2023092174W WO 2023221778 A1 WO2023221778 A1 WO 2023221778A1
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- Prior art keywords
- atrial appendage
- left atrial
- blocking
- stent
- isolation
- Prior art date
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- 238000002955 isolation Methods 0.000 title claims abstract description 104
- 230000000638 stimulation Effects 0.000 claims abstract description 24
- 230000000903 blocking effect Effects 0.000 claims description 95
- 230000005540 biological transmission Effects 0.000 claims description 72
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- 239000004020 conductor Substances 0.000 claims description 13
- 239000012528 membrane Substances 0.000 claims description 10
- 239000000615 nonconductor Substances 0.000 claims description 5
- 210000001008 atrial appendage Anatomy 0.000 claims description 4
- 230000003044 adaptive effect Effects 0.000 claims description 3
- 238000002679 ablation Methods 0.000 abstract description 30
- 238000001356 surgical procedure Methods 0.000 abstract description 11
- 206010003658 Atrial Fibrillation Diseases 0.000 description 12
- 238000000034 method Methods 0.000 description 12
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Classifications
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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- A61B17/12027—Type of occlusion
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- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
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Definitions
- the present invention relates to the technical field of medical devices, and in particular to a left atrial appendage occlusion and isolation device, a delivery device and a left atrial appendage occlusion and isolation system.
- Atrial fibrillation is the most common sustained arrhythmia.
- blood flow in the atrium is slow and blood clots can easily form in the left atrial appendage.
- Patients with atrial fibrillation have a high probability of developing blood clots, which is 5-6 times higher than that of ordinary people. Therefore, treating atrial fibrillation is of great significance for preventing stroke.
- Research shows that patients with nonvalvular atrial fibrillation have a 90% chance of forming thrombus in the left atrial appendage, and these thrombi can easily enter the brain with blood circulation and cause stroke after breaking off.
- Recent studies have shown that occlusion of the left atrial appendage can effectively prevent the risk of ischemic stroke caused by atrial fibrillation.
- blocking the left atrial appendage is only a temporary measure to prevent the formation of blood clots and further prevent strokes.
- ablation of specific parts of the heart is required to prevent the occurrence of atrial fibrillation.
- left atrial appendage occlusion and ablation are two different surgical procedures. Although there are also joint operations, they are also two different surgical steps. The step-by-step implementation of the two increases the cost of the surgery. On the other hand, it also prolongs the time of surgery and increases the risks of surgery.
- the purpose of the present invention is to provide a left atrial appendage occlusion and isolation device, a delivery device and a left atrial appendage occlusion and isolation system to solve the problem that existing left atrial appendage occlusion and ablation procedures need to be performed in steps.
- a left atrial appendage blocking and isolation device which includes: a blocking component and an electrode component;
- the blocking component is used to block the left atrial appendage;
- the electrode component is disposed on the blocking component and is electrically insulated from the blocking component;
- One end of the electrode assembly is used to be detachably electrically connected to the delivery device, and the other end is used to abut the mouth of the left atrial appendage; the electrode assembly is used to transmit electrical stimulation signals from the delivery device and to the left atrial appendage. The mouth of the atrial appendage releases the electrical stimulation signal.
- the blocking component includes a stent and a membrane
- the electrode component includes an electrode and a transmission member
- One end of the stent is converged along the axial direction, and the other end is arranged circumferentially to form an annular space grid; the coating covers at least part of the surface of the stent;
- the proximal end of the transmission member is connected to one end of the stent that converges, and the distal end of the transmission member passes through the coating, extends out of the coating and is connected to the electrode; the electrode is against the mouth of the left atrial appendage.
- the covering film has an opening corresponding to the location where the transmission member passes.
- the opening is a cross hole or a straight hole.
- the transmission member includes a first section, a second section and a third section connected in sequence from the proximal end to the distal end;
- the first section extends along the axial direction of the stent; the shape of the second section matches the shape of the stent and fits the coating; the third section passes through through the coating; or;
- the first section extends along the axial direction of the stent; the second section is arranged away from the coating; the third section is arranged along the extension direction of the second section and passes through all Said coating.
- the blocking component further includes a stent converging part, a connecting part and a fixing part;
- the proximal end of the stent converging part extends along the axial direction of the stent and has an axial lumen
- the transmission part includes a first section located at the proximal end, and the first section extends along the axial direction of the stent.
- the covering film Extending axially and located in the inner cavity, covers the outside of the stent and extends and folds into the inner cavity; the distal end of the stent converging part is converged with the stent. Connect at one end;
- the connecting piece extends along the axial direction of the stent and is disposed inside the first section.
- the connecting piece is used to press the portion of the covering film that is folded into the inner cavity; the connecting piece Also used for detachable connection with the conveying device;
- the fixing part penetrates and connects the bracket converging part, the covering film, the transmission part and the connecting part in sequence along the transverse direction of the bracket.
- the connecting member is electrically connected to the transmission member.
- the connecting piece has an internal thread for adaptive connection with the external thread of the delivery device.
- the fixing member passes through the axis of the stent; or, the blocking assembly includes more than two fixing members, and more than two fixing members are spaced apart from the axis of the bracket.
- the distal end of the transmission member is electrically insulated from the stent.
- the stent has an electrode fixing part
- the blocking component further includes an isolator, and the isolator is disposed on the electrode fixing part; the isolator It is an electrical insulator, and the distal end of the transmission member is connected to the bracket through the isolation member.
- the electrode fixing part includes a first through hole, the isolation member is inserted into the first through hole; and the isolation member includes a second through hole. , the distal end of the transmission member is inserted into the second through hole.
- the left atrial appendage blocking and isolating device has an expanded state and a contracted state along the radial direction; when the left atrial appendage blocking and isolating device is in the contracted state, it is used to be accommodated in the sheath of the delivery device. .
- the present invention also provides a delivery device for delivering the left atrial appendage blocking and isolation device as described above;
- the delivery device includes: a sheath, a delivery head and a conductor;
- the sheath is used to accommodate the left atrial appendage blocking isolation device
- the delivery head is movably disposed along the axial direction of the sheath, and the delivery head is used for detachable electrical connection with the electrode assembly;
- One end of the conductor is connected to the delivery head, and the other end of the conductor is used to connect to the electrical stimulation signal generating end.
- the delivery head has external threads, and the external threads are used for adaptive connection with the internal threads of the left atrial appendage blocking and isolation device.
- the present invention also provides a left atrial appendage occlusion and isolation system, which includes the left atrial appendage occlusion and isolation device as described above, and the delivery device as described above.
- the left atrial appendage occlusion and isolation device includes a occlusion component and an electrode assembly;
- the blocking component is used to block the left atrial appendage;
- the electrode component is arranged on the blocking component and is electrically insulated from the blocking component; one end of the electrode component is used to be detachably electrically connected to the delivery device, and the other One end is used to abut the mouth of the left atrial appendage;
- the electrode assembly is used to transmit electrical stimulation signals from the delivery device and release the electrical stimulation signals to the mouth of the left atrial appendage.
- the electrode assembly can be used to ablate the mouth of the left atrial appendage, thereby combining the two surgical procedures of blocking and ablation into one, reducing surgical costs and saving money.
- the operation time is improved and the success rate of the operation is improved.
- the electrode assembly is disposed on the blocking assembly, its positioning is reliable and accurate, and it also solves the problem in the prior art that it is inconvenient to ablate and isolate the left atrial appendage alone and is prone to complications.
- the tissue contraction force is reduced, making it less likely for the left atrial appendage blocking and isolation device to slip out from the left atrial appendage orifice, improving the Blocking reliability.
- Figure 1 is a schematic diagram of the left atrial appendage blocking and isolation system according to an embodiment of the present invention
- Figure 2 is a schematic diagram of the left atrial appendage blocking and isolation device according to an embodiment of the present invention
- Figure 3a is a schematic diagram of a preferred example of the opening of the coating according to the embodiment of the present invention.
- Figure 3b is a schematic diagram of another preferred example of the opening of the coating according to the embodiment of the present invention.
- Figure 4a is a schematic diagram of a preferred example of the stent and electrode assembly according to the embodiment of the present invention.
- Figure 4b is an axial cross-sectional view of the bracket and electrode assembly of Figure 4a;
- Figure 5a is a schematic diagram of another preferred example of the stent and electrode assembly according to the embodiment of the present invention.
- Figure 5b is an axial cross-sectional view of the bracket and electrode assembly of Figure 5a;
- Figure 6a is a proximal transverse cross-sectional view of a preferred example of the left atrial appendage occlusion and isolation device according to the embodiment of the present invention
- Figure 6b is a proximal axial cross-sectional view of a preferred example of the left atrial appendage blocking and isolation device according to the embodiment of the present invention.
- Figure 6c is a proximal transverse view of another preferred example of the left atrial appendage occlusion and isolation device according to the embodiment of the present invention. sectional view;
- Figure 7a is a schematic diagram of an application scenario of the left atrial appendage blocking and isolation device shown in Figure 6c;
- Figure 7b is a schematic diagram of another application scenario of the left atrial appendage blocking and isolation device shown in Figure 6c;
- Figure 8 is an overall schematic diagram of the transmission member passing through the bracket according to the embodiment of the present invention.
- Figure 9a is a schematic front view of the transmission member passing through the bracket according to the embodiment of the present invention.
- Figure 9b is a side cross-sectional view of the transmission member passing through the bracket according to the embodiment of the present invention.
- 1-Left atrial appendage blocking and isolation device 11-blocking component; 111-stent; 111a-electrode fixing part; 112- Covering film; 1120-opening; 12-electrode assembly; 121-electrode; 122-transmission member; 1221-first section; 1222-second section; 1223-third section; 13-stent confluence piece; 130- Inner cavity; 14-connecting piece; 15-fixing piece; 16-isolating piece; 16a-second through hole; 2-delivery device; 20-sheath; 21-delivery head; 22-conductor; 23-handle; 231- Electrical connection end; 24 - tee; 31 - mapping catheter; 32 - pig tail catheter; 40 - inside of the left atrial appendage.
- proximal end refers to the position of the component closer to the control end of the left atrial appendage occlusion and isolation system that extends outside the body
- distal end refers to the end of the component closer to the left atrial appendage occlusion and isolation system that is inserted into the human body and therefore It is further away from the control end of the left atrial appendage occlusion and isolation system.
- proximal and distal are defined herein with respect to an operator such as a surgeon or clinician.
- proximal refers to the location of the element closer to the operator
- distal refers to the location of the element closer to the left atrial appendage occlusion isolation system and therefore further away from the operator.
- mounted refers to the location of the element closer to the left atrial appendage occlusion isolation system and therefore further away from the operator.
- mounted refers to the location of the element closer to the left atrial appendage occlusion isolation system and therefore further away from the operator.
- mounted should be interpreted broadly, and usually only mean that there is a connection, coupling, or connection between the two elements.
- the purpose of the present invention is to provide a left atrial appendage occlusion and isolation device, a delivery device and a left atrial appendage occlusion and isolation system to solve the problem that existing left atrial appendage occlusion and ablation procedures need to be performed in steps.
- the contraction process of the left atrial appendage may be completely opposite to that of the left ventricle or atrial fibrillation, and because the three have different shapes and sizes, the possibility of thrombus formation is increased.
- Ablation of the left atrial appendage can help better treat atrial fibrillation and reduce recurrence. Therefore, during the ablation of atrial fibrillation, the left atrial appendage will also be ablated in some application scenarios to isolate the electrical signals of the left atrial appendage (referring to cutting off the body's spontaneous electrocardiographic signals from being transmitted to the left atrial appendage) to reduce the insufficiency of the left atrial appendage. Beats regularly.
- An embodiment of the present invention provides a left atrial appendage occlusion and isolation system, which includes: a left atrial appendage occlusion and isolation device 1 and a delivery device 2.
- the left atrial appendage blocking and isolation device 1 is used to block the left atrial appendage and simultaneously ablate the mouth of the left atrial appendage.
- the delivery device 2 is used to deliver the left atrial appendage occlusion and isolation device 1 and deliver electrical stimulation signals.
- the left atrial appendage blocking and isolation device 1 includes a blocking component 11 and an electrode component 12; the blocking component 11 is used to block the left atrial appendage; the electrode component 12 is disposed on the sealing component. on the occlusion assembly 11 and is electrically insulated from the occlusion assembly 11; one end of the electrode assembly 12 is used to be detachably electrically connected to the delivery device 2, and the other end is used to abut against the mouth of the left atrial appendage; it should be noted that, Here, one end and the other end of the electrode assembly 12 do not specifically refer to its axial ends, but to two opposite parts.
- the other end of the electrode assembly 12 can be a circumferentially expanded spatial grid (see details below), and can be used to abut against the mouth of the left atrial appendage.
- the electrode assembly 12 is used to transmit electrical stimulation signals from the delivery device 2 and release the electrical stimulation signals to the mouth of the left atrial appendage.
- the electrical stimulation signal can be, for example, a high-voltage pulse electrical signal.
- the delivery device 2 includes a sheath 20, a delivery head 21 and a conductor 22; the sheath 20 is used to accommodate the left atrial appendage blocking and isolation device 1; the delivery head 21 extends along the sheath. 20 is movably arranged in the axial direction, and the delivery head 21 is used to be detachably electrically connected to the electrode assembly 12; one end of the conductor 22 is connected to the delivery head 21, and the other end of the conductor 22 is Connected to the electrical stimulation signal generating end.
- the delivery device 2 also includes a handle 23 and a tee 24.
- the side branch of the tee 24 may be provided with a Luer connector for injecting contrast fluid, medical solution or saline.
- the main branch of the tee 24 runs through in the axial direction, the distal end is connected to the sheath 20 , and the proximal end of the tee 24 is connected to the handle 23 .
- the proximal end of the handle 23 is provided with an electrical connection end 231, which is used to connect with the electrical stimulation signal generating end.
- the conductor 22 can be a metal push rod, and its outer layer can be covered with an insulating layer. Persons skilled in the art can understand the specific structures and principles of other components of the conveying device 2 based on existing technologies, and will not be described in detail in this embodiment.
- the delivery device 2 and the left atrial appendage occlusion and isolation are The device 1 remains connected temporarily.
- the occlusion component 11 of the left atrial appendage occlusion and isolation device 1 achieves occlusion of the left atrial appendage, and the proximal end of the transmission member 122 is electrically connected to the delivery head 21 of the delivery device 2 .
- the ablation method is monopolar ablation.
- a generator can be attached to the patient's back, and the delivery device 2 can pass the electrical stimulation signal generating end.
- Conductor 22 ⁇ Delivery head 21 ⁇ Transmission member 122 ⁇ Electrode 121 ⁇
- the transmission path at the mouth of the left atrial appendage transmits the electrical stimulation signal (such as a high-voltage pulse from nanoseconds to microseconds, the voltage of the high-voltage pulse can be 100V-3000V, for example) to The mouth of the left atrial appendage forms a circuit with the generator attached to the back.
- High-voltage pulses can ablate targeted cell apoptosis and achieve the purpose of isolating the left atrial appendage. It can be understood that in other embodiments, the ablation method can also be bipolar ablation or multi-stage ablation. Those skilled in the art can make corresponding improvements to the delivery head 21 and the transmission member 122 according to actual needs. This is the case in the present invention. No limit.
- the delivery device 2 will be separated from the left atrial appendage blocking and isolation device 1 and evacuated from the human body.
- the electrode assembly 12 will eventually be left in the left atrial appendage together with the blocking assembly 11 and will not be withdrawn from the body.
- the plugging component 11 is endothelialized together.
- the blocking component 11 is an internal plug-type blocking component, but in fact, this embodiment does not impose any specific restrictions on the specific structure of the blocking component 11. , for example, some external occlusion-type occlusion components can still be combined with the electrode assembly 12 to form the left atrial appendage occlusion and isolation device 1 .
- some external occlusion-type occlusion components can still be combined with the electrode assembly 12 to form the left atrial appendage occlusion and isolation device 1 .
- the external plugging type plugging assembly 11 based on the existing technology, and will not be described here. Different forms of occlusion components 11 ensure that different atrial appendage shapes and doctors' selection habits are not limited by ablation requirements. occlusion components 11 with different characteristics can be selected, such as fully closed or semi-closed plug-type closure, or Choose to use external disk sealing, etc.
- the electrode assembly 12 can be used to ablate the mouth of the left atrial appendage, thereby combining the two surgical procedures of blocking and ablation into one, reducing the surgical cost. It saves surgical time and improves the success rate of surgery.
- the electrode assembly 12 since the electrode assembly 12 is disposed on the occlusion assembly 11, its positioning is reliable and accurate, and it also solves the problem in the prior art that ablation and isolation of the left atrial appendage alone is inconvenient and prone to complications.
- the tissue contraction force is reduced, making it less likely for the left atrial appendage blocking and isolation device 1 to slip out from the left atrial appendage orifice. Improved blocking reliability.
- the blocking assembly 11 includes a bracket 111 and a coating 112; the electrode assembly 12 includes an electrode 121 and a transmission member 122; one end of the bracket 111 is converged along the axial direction, and the other end is arranged circumferentially to form a ring.
- the coating 112 covers at least part of the surface of the stent 111 (referring to the outer peripheral surface of part of the annular spatial grid); the proximal end of the transmission member 122 converges with the stent 111 One end of the collection is connected, and the distal end of the transmission member 122 passes through the membrane 112, extends out of the membrane 112, and is connected to the electrode 121; the electrode 121 is used to abut the mouth of the left atrial appendage.
- the convergence of one axial end of the bracket 111 means that the axial end of the bracket 111 is roughly converged toward the center, and is not limited to the fact that they must meet at one point.
- the left atrial appendage blocking and isolating device 1 has an expanded state and a contracted state along the radial direction; when the left atrial appendage blocking and isolating device 1 is in the contracted state, it is used to accommodate the delivery device 2 in sheath 20.
- the left atrial appendage blocking and isolation device 1 is in the expansion state when no external force is applied.
- its maximum radial outer dimension should be slightly larger than the inner diameter of the left atrial appendage, so that the blocking component 11 can seal the left atrial appendage tightly.
- the bracket 111 is made of memory metal, such as nickel-titanium alloy.
- its structure can be formed by weaving or laser engraving.
- the stent 111 can be contracted and/or folded under the action of external force, so that it can be accommodated in the sheath 20 of the delivery device 2 . After the stent 111 is released from the distal end of the sheath 20, it expands under its own elastic force, thereby pressing the covering membrane 112 surrounding it against the left atrial appendage to seal the left atrial appendage. Blocking.
- the coating 112 can generally be made of flexible polymer materials, such as PTFE or PET. The coating 112 can shrink or expand together with the stent 111 .
- the coating 112 does not have to completely cover the entire periphery of the stent 111. In fact, it only needs to cover a part of the proximal end of the stent 111. In some embodiments, the maximum radial outer dimension of the stent 111 may be used as the boundary, and the proximal part thereof may be covered with a coating, while the distal part thereof is not limited. During use, after the stent 111 is expanded, the membrane 112 can reliably seal the left atrial appendage.
- both the electrode 121 and the transmission member 122 are made of conductive material, such as metal.
- the transmission member 122 can also be made of memory metal that is the same as or similar to the material of the bracket 111. It is also elastic and can be compressed and folded together with the bracket 111, and can also expand and expand by itself when the external force restriction is removed.
- the electrode 121 is preferably made of metal with good biocompatibility, and is preferably in a sheet shape, such as an oblate shape, to avoid puncturing the left atrial appendage.
- the electrode 121 and the transmission member 122 can be connected by welding, for example.
- the electrode assembly 12 includes a plurality of electrodes 121 and a plurality of transmission members 122, and the electrodes 121 and the transmission members 122 correspond one to one; the plurality of electrodes 121 and the plurality of transmission members 122 are evenly arranged around the circumference of the bracket 111.
- the arrangement of multiple electrodes 121 and transmission parts 122 enables one-time ablation at the left atrial appendage orifice without the need for multiple single-point ablation at the left atrial appendage orifice, which is beneficial to saving operation time and making the ablation more precise.
- the multiple transmission members 122 are evenly arranged around the circumference of the stent 111, which can evenly apply additional support force to the membrane 112, helping the stent 111 to press the membrane 112 against the inner wall of the left atrial appendage.
- the transmission member 122 is spaced apart from the bracket 111 and the two do not have direct contact connection.
- the transmission member 122 is electrically insulated from the blocking component 11 through the covering film 112 .
- the covering film 112 has an opening 1120 corresponding to the part where the transmission member 122 passes; it can be understood that the covering film 112 has the opening 1120, and the transmission member 122 The distal end passes through the opening 1120.
- the opening 1120 is a cross hole (as shown in Figure 3a) or a straight hole (as shown in Figure 3b).
- the cross holes refer to two cross-shaped through grooves cut on the covering film 112
- the straight holes refer to the straight-shaped through grooves cut on the covering film 112 .
- the cross hole or the straight hole can be conveniently opened on the coating 112 without restricting the local positional movement of the transmission member 122 relative to the coating 112. That is, the transmission member 122 can pass through the cross hole or the straight hole, and also can pass through the cross hole or the straight hole. It can move locally relative to the coating 112 in a cross hole or a straight hole.
- the position of the opening 1120 is set near the maximum radial dimension of the covering film 112 corresponding to the stent 111, so that the electrode 121 can be positioned at the part where the occlusion component 11 provides the main supporting force to better abut the left atrial appendage. mouth.
- the transmission member 122 is a rod-shaped member, and the transmission member 122 includes a first section 1221, a second section 1222, and a third section 1223 connected in sequence from the proximal end to the distal end.
- the first section 1221 is along the edge of the bracket 111 Extending axially; the shape of the second section 1222 is adapted to the shape of the bracket 111 and fits the covering film 112 ; the third section 1223 passes through the covering film 112 .
- the shape of the second section 1222 here is adapted to the shape of the stent 111, which refers to the shape of the transmission member 122 and the stent 111 when they are in an expanded state.
- the transmission member 122 itself can also provide a certain additional supporting force for the membrane 112 so that the occlusion component 11 can fit on the left atrial appendage more reliably.
- the shape of the second section 1222 matches the shape of the stent 111, and the two have a higher degree of fit, which can ensure smoother retrieval or adjustment of the left atrial appendage occlusion and isolation device 1.
- the first section 1221 extends along the axial direction of the bracket 111 ; the second section 1222 is arranged away from the coating 112 ; the third section The section 1223 is arranged along the extending direction of the second section 1222 and passes through the covering film 112 .
- the second section 1222 is spaced apart from the coating 112 here, which also refers to the shape of the transmission member 122 and the stent 111 when they are in an expanded state.
- the manner in which the second section 1222 is spaced apart from the covering film 112 can further increase the additional support force for the covering film 112 .
- the second section 1222 may be arc-shaped, with its normal direction pointing toward the proximal end and toward the outside of the stent 111 .
- the third section 1223 is preferably substantially perpendicular to the coating 112 .
- the blocking component 11 also includes a stent converging part 13, a connecting part 14 and a fixing part 15; the proximal end of the stent converging part 13 extends along the axial direction of the stent 111 and has Axial inner cavity 130 , the first section 1221 of the transmission member 122 extends along the axial direction of the stent 111 and is located in the inner cavity 130 , and the coating 112 covers the outside of the stent 111 and extend and fold into the inner cavity 130; the distal end of the stent converging part 13 is connected to one end of the stent 111 that converges; the connecting part 14 extends along the axial direction of the stent 111 and is disposed on The inner side of the first section 1221 is used to press the portion of the covering film 112 that is folded into the inner cavity 130 .
- the connecting piece 14 is also used to detachably connect to the conveying device 2; the fixing piece 15 sequentially penetrates and connects the frame converging member 13, the covering film 112, and the transmission device along the transverse direction of the frame 111. member 122 and the connecting member 14, so that the bracket converging member 13, the covering film 112, the transmission member 122 and the connecting member 14 are fixedly connected to each other.
- the stent converging part 13 may be cylindrical, and its distal end is connected to one end of the stent 111 where the stent 111 converges.
- the connection may be welded, or the stent converging part 13 and the stent 111 may be integrally formed, and the stent 111 may be formed by cutting a pipe.
- the proximal end of the membrane 112 is converged and located inside the stent converging part 13 .
- the proximal end of the transmission member 122 that is, the first section 1221, is located inside the covering film 112. Therefore, the transmission member 122 and the stent converging member 13 are isolated and electrically insulated by the covering film 112. Furthermore, the transmission member 122 is electrically insulated from the stent 111. The energy of the electrical stimulation signal is prevented from being transmitted to the stent 111 to better achieve precise ablation.
- the connecting member 14 is electrically connected to the transmission member 122, and the connecting member 14 has internal threads.
- the delivery head 21 has external threads, and the internal threads are connected to the internal threads.
- the external thread is adapted to connect, so that the left atrial appendage blocking isolation device 1 and the delivery device 2 can be detachably connected.
- the connector 14 and the delivery head 21 are preferably both made of metallic material, both of which are electrically conductive. In this configuration, after the internal thread and the external thread are adapted and connected, the delivery head 21 can be electrically connected to the transmission part 122 through the connection part 14 to transmit the electrical stimulation signal.
- the threaded connection is only an example of the connection method between the left atrial appendage occlusion and isolation device 1 and the delivery device 2 and does not limit the connection method between the left atrial appendage occlusion and isolation device 1 and the delivery device 2.
- connection methods can be selected for the left atrial appendage occlusion and isolation device 1 and the delivery device 2, such as snap connection or interference fit, etc., and the present invention is not limited to this.
- the fixing member 15 passes through the axis of the bracket 111 (referring to the longitudinal central axis of the bracket 111); the fixing part 15 is similar to a lock bolt, and can connect the bracket converging part 13 , the covering film 112, the transmission member 122 and the connecting member 14 are locked and connected to each other. It can be understood that in order to adapt to the fixing part 15, the bracket converging part 13, the covering film 112, the transmission part 122 and the connecting part 14 are all provided with through holes at corresponding positions for fixing. Piece 15 is worn. Furthermore, the fixing member 15 is an electrical insulator to prevent electrical conduction between the bracket converging member 13 and the transmission member 122 .
- the fixing member 15 may be one, which passes through the axis of the bracket 111.
- the blocking assembly 11 may also include more than two fixing members 15, and more than two fixing members 15 may be included.
- the fixing members 15 are spaced apart from the axis of the bracket 111 .
- the two fixing members 15 are arranged in parallel and avoid the inner hole of the connecting member 14. Further, the inner hole of the connecting member 14 axially penetrated.
- the delivery head 21 of the delivery device 2 is a hollow structure, which can allow the mapping catheter 31 (shown in Figure 7a) to pass through and enter the left atrial appendage.
- the pig tail catheter 32 (shown in Figure 7b) can also be allowed to pass through and enter the interior 40 of the left atrial appendage. Contrast fluid can be injected into the pig tail catheter 32. The blocking effect can also be tested from the inside of the left atrial appendage blocking isolation device 1. Complete or not. In this way, the operational complexity of the surgery is reduced and the safety and success rate of the surgery are increased.
- the distal end of the transmission member 122 is electrically insulated from the bracket 111, that is, the position of the transmission member 122 relative to the bracket 111 are fixed and electrically insulated.
- the stent 111 has an electrode fixing part 111a
- the blocking component 11 also includes a spacer 16, which is disposed on the electrode fixation part 111a; the spacer 16 is an electrical insulator, so The distal end of the transmission member 122 is connected to the bracket 111 through the isolation member 16 .
- the arrangement of the electrode fixing part 111a and the separator 16 can fix the position of the transmission member 122.
- the isolation member 16 is an electrical insulator, which can avoid electrical conduction between the bracket 111 and the transmission member 122 . This prevents the energy of the electrical stimulation signal from being transmitted to the stent 111 to better achieve precise ablation.
- the electrode fixing part 111a includes a first through hole, and the isolation member 16 is passed through the first through hole; the isolation member 16 includes a second through hole 16a, and the transmission member The distal end of 122 is inserted into the second through hole 16a.
- the material of the isolation member 16 is an electrically insulating material, such as silicone. It should be noted that the electrode fixing part 111a can be provided at the grid node of the bracket 111 or on the bracket rod of the bracket 111. This embodiment is not limited to this.
- the left atrial appendage occlusion and isolation system provided by this embodiment includes the left atrial appendage occlusion and isolation device 1 as mentioned above, and the delivery device 2 as mentioned above, so it also has the ability to be equipped with the left atrial appendage occlusion and isolation system as mentioned above.
- the structures and principles of other components of the left atrial appendage occlusion and isolation system can be referred to the existing technology, and will not be further described in this embodiment.
- the left atrial appendage occlusion and isolation device includes a occlusion component and an electrode component; the occlusion component is To block the left atrial appendage; the electrode assembly is disposed on the blocking assembly and connected with the sealing assembly.
- the plugging assembly is electrically insulated; one end of the electrode assembly is used to be detachably electrically connected to the delivery device, and the other end is used to abut against the mouth of the left atrial appendage; the electrode assembly is used to transmit electrical stimulation signals from the delivery device, and releases the electrical stimulation signal to the mouth of the left atrial appendage.
- the electrode assembly can be used to ablate the mouth of the left atrial appendage, thereby combining the two surgical procedures of blocking and ablation into one, reducing surgical costs and saving money.
- the operation time is improved and the success rate of the operation is improved.
- the electrode assembly is disposed on the blocking assembly, its positioning is reliable and accurate, and it also solves the problem in the prior art that it is inconvenient to ablate and isolate the left atrial appendage alone and is prone to complications.
- the tissue contraction force is reduced, making it less likely for the left atrial appendage blocking and isolation device to slip out from the left atrial appendage orifice, improving the Blocking reliability.
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Abstract
一种左心耳封堵隔离装置(1)、输送装置(2)及左心耳封堵隔离系统,左心耳封堵隔离装置(1)包括封堵组件(11)和电极组件(12);封堵组件(11)用于封堵左心耳;电极组件(12)设置于封堵组件(11)上,并与封堵组件(11)电绝缘;电极组件(12)的一端用于与输送装置(2)可分离地电连接,另一端用于抵靠左心耳口部;电极组件(12)用于传输来自输送装置(2)的电刺激信号,并向左心耳口部释放电刺激信号。如此配置,通过封堵组件(11)对左心耳进行封堵的同时,可利用电极组件(12)对左心耳口部进行消融,从而将封堵和消融合二为一,降低了手术成本,节省了手术时间,提高了手术的成功率。
Description
本发明涉及医疗器械技术领域,特别涉及一种左心耳封堵隔离装置、输送装置及左心耳封堵隔离系统。
心房颤动是最常见的持续性心律不齐。心房颤动发生时,因为心房的血液流动缓慢,易在左心耳内形成血栓。有房颤的患者发生血栓的概率高,是常人的5-6倍。因此治疗房颤对于预防卒中具有重要的意义。研究表明,非瓣膜性心房颤动的患者有90%的几率会在左心耳内形成血栓,而这些血栓脱落后极易随血液循环进入大脑而致卒中。近年来的研究表明对左心耳进行封堵可以有效地预防因心房颤动而造成缺血性中风的风险。
然而,封堵左心耳仅是预防血栓产生而进一步预防卒中的治标措施,根本上,还需要通过对心脏特定部位的消融来防止房颤的产生。
现有技术中,左心耳封堵与消融术是两个不同的术式,虽也有联合施展的手术,但其也是两个不同的手术步骤,两者的分步骤实施一方面提高了手术成本,另一方面也延长了手术的时间,增加了手术的风险。
发明内容
本发明的目的在于提供一种左心耳封堵隔离装置、输送装置及左心耳封堵隔离系统,以解决现有的左心耳封堵与消融术需分步骤实施的问题。
为解决上述技术问题,本发明提供一种左心耳封堵隔离装置,其包括:封堵组件和电极组件;
所述封堵组件用于封堵左心耳;所述电极组件设置于所述封堵组件上,并与所述封堵组件电绝缘;
所述电极组件的一端用于与输送装置可分离地电连接,另一端用于抵靠左心耳口部;所述电极组件用于传输来自所述输送装置的电刺激信号,并向所述左心耳口部释放所述电刺激信号。
可选的,在所述左心耳封堵隔离装置中,所述封堵组件包括支架和覆膜;所述电极组件包括电极和传输件;
所述支架沿轴向的一端收束汇集,另一端周向环绕排布形成环状的空间网格;所述覆膜包覆于所述支架的至少部分的表面;
所述传输件的近端与所述支架收束汇集的一端连接,所述传输件的远端穿过所述覆膜,伸出所述覆膜外并与所述电极连接;所述电极用于抵靠左心耳口部。
可选的,在所述左心耳封堵隔离装置中,所述覆膜对应于所述传输件穿过的部位具有开口。
可选的,在所述左心耳封堵隔离装置中,所述开口为十字孔或一字孔。
可选的,在所述左心耳封堵隔离装置中,所述传输件自近端至远端包括依次连接的第一区段、第二区段和第三区段;
所述第一区段沿所述支架的轴向延伸;所述第二区段的形状与所述支架的形状相适配,并与所述覆膜相贴合;所述第三区段穿过所述覆膜;或者;
所述第一区段沿所述支架的轴向延伸;所述第二区段远离所述覆膜布置;所述第三区段沿所述第二区段的延伸方向设置,并穿过所述覆膜。
可选的,在所述左心耳封堵隔离装置中,所述封堵组件还包括支架汇合件、连接件及固定件;
所述支架汇合件的近端部沿所述支架的轴向延伸并具有轴向的内腔,所述传输件包括位于近端的第一区段,所述第一区段沿所述支架的轴向延伸并位于所述内腔内,所述覆膜包覆于所述支架的外侧并延伸翻折入所述内腔;所述支架汇合件的远端部与所述支架收束汇集的一端连接;
所述连接件沿所述支架的轴向延伸并设置于所述第一区段的内侧,所述连接件用于压合所述覆膜翻折入所述内腔的部分;所述连接件还用于与所述输送装置可拆卸地连接;
所述固定件沿所述支架的横向依次贯穿连接所述支架汇合件、所述覆膜、所述传输件以及所述连接件。
可选的,在所述左心耳封堵隔离装置中,所述连接件与所述传输件电连
接,所述连接件具有内螺纹,用于与所述输送装置的外螺纹适配连接。
可选的,在所述左心耳封堵隔离装置中,所述固定件穿过所述支架的轴线;或者,所述封堵组件包括两个以上所述固定件,两个以上所述固定件均与所述支架的轴线间隔布置。
可选的,在所述左心耳封堵隔离装置中,所述传输件的远端与所述支架电绝缘连接。
可选的,在所述左心耳封堵隔离装置中,所述支架具有电极固定部,所述封堵组件还包括隔离件,所述隔离件设置于所述电极固定部上;所述隔离件为电绝缘体,所述传输件的远端通过所述隔离件与所述支架连接。
可选的,在所述左心耳封堵隔离装置中,所述电极固定部包括第一通孔,所述隔离件穿设于所述第一通孔中;所述隔离件包括第二通孔,所述传输件的远端穿设于所述第二通孔中。
可选的,所述左心耳封堵隔离装置沿径向具有扩张状态与收缩状态;所述左心耳封堵隔离装置处于所述收缩状态时,用于容置于所述输送装置的鞘管中。
为解决上述技术问题,本发明还提供一种输送装置,其用于输送如上所述的左心耳封堵隔离装置;所述输送装置包括:鞘管、输送头及导体;
所述鞘管用于容纳所述左心耳封堵隔离装置;
所述输送头沿所述鞘管的轴向可移动地设置,所述输送头用于与所述电极组件可分离地电连接;
所述导体的一端与所述输送头连接,所述导体的另一端用于与电刺激信号发生端连接。
可选的,在所述的输送装置中,所述输送头具有外螺纹,所述外螺纹用于与所述左心耳封堵隔离装置的内螺纹适配连接。
为解决上述技术问题,本发明还提供一种左心耳封堵隔离系统,其包括如上所述的左心耳封堵隔离装置,以及如上所述的输送装置。
综上所述,在本发明提供的左心耳封堵隔离装置、输送装置及左心耳封堵隔离系统中,所述左心耳封堵隔离装置包括封堵组件和电极组件;所述封
堵组件用于封堵左心耳;所述电极组件设置于所述封堵组件上,并与所述封堵组件电绝缘;所述电极组件的一端用于与输送装置可分离地电连接,另一端用于抵靠左心耳口部;所述电极组件用于传输来自所述输送装置的电刺激信号,并向所述左心耳口部释放所述电刺激信号。
如此配置,通过封堵组件对左心耳进行封堵的同时,可利用电极组件对左心耳口部进行消融,从而将封堵和消融两个术式合二为一,降低了手术成本,节省了手术时间,提高了手术的成功率。此外,由于电极组件设置于封堵组件上,其定位可靠准确,还解决了现有技术中单独对左心耳进行消融隔离的不便利,且易产生并发症的问题。进一步的,由于对左心耳口部也就是对封堵组件主要提供压力的位置进行了消融后,组织收缩力降低,使得左心耳封堵隔离装置更不容易从左心耳口部滑出,提高了封堵的可靠性。
本领域的普通技术人员将会理解,提供的附图用于更好地理解本发明,而不对本发明的范围构成任何限定。其中:
图1是本发明实施例的左心耳封堵隔离系统的示意图;
图2是本发明实施例的左心耳封堵隔离装置的示意图;
图3a是本发明实施例的覆膜的开口的一个优选示例的示意图;
图3b是本发明实施例的覆膜的开口的另一个优选示例的示意图
图4a是本发明实施例的支架与电极组件的一个优选示例的示意图;
图4b是图4a的支架与电极组件的轴向剖面图;
图5a是本发明实施例的支架与电极组件的另一个优选示例的示意图;
图5b是图5a的支架与电极组件的轴向剖面图;
图6a是本发明实施例的左心耳封堵隔离装置的一个优选示例的近端横向剖面图;
图6b是本发明实施例的左心耳封堵隔离装置的一个优选示例的近端轴向剖面图;
图6c是本发明实施例的左心耳封堵隔离装置的另一个优选示例的近端横
向剖面图;
图7a是图6c所示的左心耳封堵隔离装置的一个应用场景的示意图;
图7b是图6c所示的左心耳封堵隔离装置的另一个应用场景的示意图;
图8是本发明实施例的传输件穿过支架的整体示意图;
图9a是本发明实施例的传输件穿过支架的正视示意图;
图9b是本发明实施例的传输件穿过支架的侧视剖面图。
附图中:
1-左心耳封堵隔离装置;11-封堵组件;111-支架;111a-电极固定部;112-
覆膜;1120-开口;12-电极组件;121-电极;122-传输件;1221-第一区段;1222-第二区段;1223-第三区段;13-支架汇合件;130-内腔;14-连接件;15-固定件;16-隔离件;16a-第二通孔;2-输送装置;20-鞘管;21-输送头;22-导体;23-手柄;231-电连接端;24-三通;31-标测导管;32-猪尾巴导管;40-左心耳的内部。
1-左心耳封堵隔离装置;11-封堵组件;111-支架;111a-电极固定部;112-
覆膜;1120-开口;12-电极组件;121-电极;122-传输件;1221-第一区段;1222-第二区段;1223-第三区段;13-支架汇合件;130-内腔;14-连接件;15-固定件;16-隔离件;16a-第二通孔;2-输送装置;20-鞘管;21-输送头;22-导体;23-手柄;231-电连接端;24-三通;31-标测导管;32-猪尾巴导管;40-左心耳的内部。
为使本发明的目的、优点和特征更加清楚,以下结合附图和具体实施例对本发明作进一步详细说明。需说明的是,附图均采用非常简化的形式且未按比例绘制,仅用以方便、明晰地辅助说明本发明实施例的目的。此外,附图所展示的结构往往是实际结构的一部分。特别的,各附图需要展示的侧重点不同,有时会采用不同的比例。
如在本发明中所使用的,单数形式“一”、“一个”以及“该”包括复数对象,术语“或”通常是以包括“和/或”的含义而进行使用的,术语“若干”通常是以包括“至少一个”的含义而进行使用的,术语“至少两个”通常是以包括“两个或两个以上”的含义而进行使用的,此外,术语“第一”、“第二”、“第三”仅用于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”、“第三”的特征可以明示或者隐含地包括一个或者至少两个该特征,“一端”与“另一端”以及“近端”与“远端”通常是
指相对应的两部分,其不仅包括端点。术语“近端”和“远端”在本文中相对于左心耳封堵隔离系统定义,该左心耳封堵隔离系统具有用于介入人体的一端与伸出体外的操控端。术语“近端”是指元件的更靠近左心耳封堵隔离系统之伸出体外的操控端的位置,术语“远端”是指元件的更靠近左心耳封堵隔离系统之介入人体的一端且因此更远离左心耳封堵隔离系统之操控端的位置。可选的,在手动或用手操作的应用场景中,术语“近端”和“远端”在本文中相对于操作者诸如外科医生或临床医生来定义。术语“近端”是指元件的更靠近操作者的位置,并且术语“远端”是指元件的更靠近左心耳封堵隔离系统并且因此更远离操作者的位置。此外,如在本发明中所使用的,“安装”、“相连”、“连接”,一元件“设置”于另一元件,应做广义理解,通常仅表示两元件之间存在连接、耦合、配合或传动关系,且两元件之间可以是直接的或通过中间元件间接的连接、耦合、配合或传动,而不能理解为指示或暗示两元件之间的空间位置关系,即一元件可以在另一元件的内部、外部、上方、下方或一侧等任意方位,除非内容另外明确指出外。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本发明中的具体含义。此外,诸如上方、下方、上、下、向上、向下、左、右等的方向术语相对于示例性实施方案如它们在图中所示进行使用,向上或上方向朝向对应附图的顶部,向下或下方向朝向对应附图的底部。
本发明的目的在于提供一种左心耳封堵隔离装置、输送装置及左心耳封堵隔离系统,以解决现有的左心耳封堵与消融术需分步骤实施的问题。
以下参考附图进行描述。
在房颤过程中左心耳的收缩过程与左心室或心房的颤动可能是完全相反的,又因三者的形态和大小各异,因此增加了产生血栓的可能性。消融左心耳可以帮助更好地治疗房颤,减少复发。由此,对于房颤的消融术中,一些应用场景中也会对左心耳进行消融,隔离左心耳的电信号(指切断人体自发的心电信号传输至左心耳),以减少左心耳的不规律跳动。
然而,发明人发现,现有消融术对于左心耳的消融存在一定的难度,受
器械和消融方式影响,易产生例如血栓、心包填塞等诸多并发症。发明人进一步发现,房颤不规律的心脏跳动可能会让左心耳封堵器更容易脱落。
基于上述研究,请参考图1,本发明实施例提供一种左心耳封堵隔离系统,其包括:左心耳封堵隔离装置1以及输送装置2。所述左心耳封堵隔离装置1用于封堵于左心耳,同时可对左心耳口部进行消融。所述输送装置2则用于输送左心耳封堵隔离装置1,并用于传递电刺激信号。
请参考图2至图5b,所述左心耳封堵隔离装置1包括封堵组件11和电极组件12;所述封堵组件11用于封堵左心耳;所述电极组件12设置于所述封堵组件11上,并与所述封堵组件11电绝缘;所述电极组件12的一端用于与输送装置2可分离地电连接,另一端用于抵靠左心耳口部;需要说明的,这里电极组件12的一端和另一端并非特指其沿轴向的端部,而是至两个相对的部分。实际中,电极组件12的另一端如可为周向扩张后的空间网格(详见下文说明),并以此抵靠在左心耳口部。所述电极组件12用于传输来自所述输送装置2的电刺激信号,并向所述左心耳口部释放所述电刺激信号。电刺激信号如可为高压脉冲电信号。
请参考图1,所述输送装置2包括鞘管20、输送头21及导体22;所述鞘管20用于容纳所述左心耳封堵隔离装置1;所述输送头21沿所述鞘管20的轴向可移动地设置,所述输送头21用于与所述电极组件12可分离地电连接;所述导体22的一端与所述输送头21连接,所述导体22的另一端用于与电刺激信号发生端连接。
可选的,所述输送装置2还包括手柄23和三通24,三通24的旁支可设置有鲁尔接头,用于注入造影液、药液或盐水等。三通24的主干支沿轴向贯通,远端与鞘管20连接,三通24的近端与手柄23连接。手柄23的近端则设有电连接端231,其用于与电刺激信号发生端连接。优选的,导体22如可采用金属推杆,其外层可包有绝缘层。本领域技术人员可根据现有技术对输送装置2的其它部件的具体结构和原理进行理解,本实施例不再赘述。
请结合参考图1,本实施例提供的左心耳封堵隔离系统中,在利用输送装置2将左心耳封堵隔离装置1植入左心耳后,输送装置2与左心耳封堵隔离
装置1暂时保持连接,此时,左心耳封堵隔离装置1的封堵组件11实现对左心耳的封堵,传输件122的近端与输送装置2的输送头21电连接。
本实施例对于消融方式亦不作特别的限定,在一个示范例中,消融方式为单极消融,术中可在患者的后背上贴上一个发生器,输送装置2能够通过电刺激信号发生端~导体22~输送头21~传输件122~电极121~左心耳口部的传递路径将电刺激信号(如纳秒到微秒的高压脉冲,高压脉冲的电压如可为100V~3000V)传输至左心耳口部,并与后背上贴的发生器形成回路。高压脉冲可使目标消融细胞凋亡,达到隔离左心耳的目的。可以理解的,在另一些实施例中,消融方式也可以为双极消融或多级消融,本领域技术人员可根据实际需求对输送头21和传输件122进行相应的改进,本发明例对此不限。
完成消融后,输送装置2将与左心耳封堵隔离装置1脱离并撤离人体,电极组件12最终将随封堵组件11一同被留置于左心耳而不会撤出体外,而随植入的封堵组件11一同内皮化。
可以理解的,图2至图5b示出的示范例中,封堵组件11为一种内塞式的封堵组件,但实际上本实施例对于封堵组件11的具体结构并不作特征的限制,例如一些外堵式的封堵组件,依然可以与电极组件12相结合而形成左心耳封堵隔离装置1。本领域技术人员可根据现有技术对外堵式的封堵组件11进行理解,这里不再展开说明。不同形式的封堵组件11,保证了针对不同的心耳形状和医生选用习惯不受消融需求的限制,可以选择不同特点的封堵组件11例如全封闭式或半封闭的塞式封堵,也可以选择使用外盘式封堵等。
如此配置,通过封堵组件11对左心耳进行封堵的同时,可利用电极组件12对左心耳口部进行消融,从而将封堵和消融两个术式合二为一,降低了手术成本,节省了手术时间,提高了手术的成功率。此外,由于电极组件12设置于封堵组件11上,其定位可靠准确,还解决了现有技术中单独对左心耳进行消融隔离的不便利,且易产生并发症的问题。进一步的,由于对左心耳口部也就是对封堵组件11主要提供压力的位置进行了消融后,组织收缩力降低,使得左心耳封堵隔离装置1更不容易从左心耳口部滑出,提高了封堵的可靠性。
下面结合图2至图5b,示范性地对内塞式的封堵组件11的一个实施例进行说明。所述封堵组件11包括支架111和覆膜112;所述电极组件12包括电极121和传输件122;所述支架111沿轴向的一端收束汇集,另一端周向环绕排布形成环状的空间网格;所述覆膜112包覆于所述支架111的至少部分的表面(指部分环状空间网格的外周表面);所述传输件122的近端与所述支架111收束汇集的一端连接,所述传输件122的远端穿过所述覆膜112,伸出所述覆膜112外并与所述电极121连接;所述电极121用于抵靠左心耳口部。需要说明的,支架111沿轴向的一端收束汇集是指支架111的轴向一端朝向中心大致收拢,并不限于其必须交汇于一点。
可选的,所述左心耳封堵隔离装置1沿径向具有扩张状态与收缩状态;所述左心耳封堵隔离装置1处于所述收缩状态时,用于容置于所述输送装置2的鞘管20中。左心耳封堵隔离装置1在未受外力时,处于所述扩张状态。左心耳封堵隔离装置1处于扩张状态时,其最大径向外尺寸应略大于左心耳的内径,使得封堵组件11能够严密地对左心耳进行封堵。由此可以理解的,左心耳封堵隔离装置1被植入左心耳后,其植入后的径向外尺寸因被左心耳限制而小于其处于扩张状态时的径向外尺寸。
在一个可替代的示范例中,支架111由记忆金属制成,如镍钛合金等。其结构如可采用编织或激光雕刻的方式成型,具体可参考现有技术。支架111能够在外力的作用下收缩和/或折叠,从而能够容纳于输送装置2的鞘管20中。支架111在从鞘管20的远端被释放出后,其在自身弹力作用下膨胀而扩张,从而能够将包覆于其外的覆膜112压靠在左心耳上,实现对左心耳的封堵。覆膜112一般可采用柔性的高分子材料制成,如PTFE或PET等。覆膜112能够随支架111一同收缩或扩张。需要说明的,覆膜112并非必须将整个支架111的外周均完整地包裹住,实际上其只要能包裹住支架111的近端的一部分即可。一些实施例中,可以按支架111的最大径向外尺寸为界,其近端的部分包裹有覆膜,而其远端的部分则不限。使用中,支架111扩张后,覆膜112即能够可靠地对左心耳进行封堵。
可选的,电极121和传输件122均由导电材料制成,如金属。特别的,传输件122也可以采用与支架111的材料相同或相似的记忆金属制成,其也具有弹性,能够随支架111一同被压缩、折叠,也能够在撤去外力限制时自膨、展开。电极121优选采用具有较好生物相容性的金属制成,其优选呈片状,如扁圆形,以避免刺伤左心耳。电极121和传输件122如可通过焊接连接。
优选的,所述电极组件12包括多个电极121和多个传输件122,电极121与传输件122一一对应;多个电极121和多个传输件122围绕支架111周向均匀排布。多个电极121和传输件122的设置,能够在左心耳口部一次消融完成而无需多次在左心耳口部多次进行单点消融,有利于节约手术时间,也可使得消融更精准。同时多个传输件122围绕支架111周向均匀排布的方式,能均匀地对覆膜112施加额外的支撑力,帮助支架111一同将覆膜112压靠在左心耳的内壁上。
在一些实施例中,所述传输件122与所述支架111相间隔,两者不直接产生接触连接,传输件122通过覆膜112与封堵组件11电绝缘地连接。可选的,如图3a和图3b所示,所述覆膜112对应于所述传输件122穿过的部位具有开口1120;可以理解,所述覆膜112具有开口1120,所述传输件122的远端穿过所述开口1120。优选的,所述开口1120为十字孔(如图3a所示)或一字孔(如图3b所示)。十字孔是指在覆膜112上划开的十字形的两条通槽,一字孔是指在覆膜112上划开的一字形的通槽。十字孔或一字孔能够方便地开设在覆膜112上,且不会对传输件122相对覆膜112的局部位置移动产生限制,即传输件122能够穿过十字孔或一字孔,并还能够在十字孔或一字孔中相对覆膜112局部地移动。可选的,开口1120的位置设置在覆膜112对应于支架111的最大径向尺寸附近,以使得电极121能定位在封堵组件11提供主要支撑力的部位,以更好地贴靠左心耳口部。
进一步的,传输件122为杆状件,所述传输件122自近端至远端包括依次连接的第一区段1221、第二区段1222和第三区段1223。
在图4a和图4b示出的示范例中,所述第一区段1221沿所述支架111的
轴向延伸;所述第二区段1222的形状与所述支架111的形状相适配,并与所述覆膜112相贴合;所述第三区段1223穿过所述覆膜112。特别的,这里第二区段1222的形状与支架111的形状相适配,是指传输件122和支架111处于扩张状态时的形状。
传输件122除了用于传输电刺激信号,其本身还能够为覆膜112提供一定的额外支撑力,使封堵组件11更可靠地贴合在左心耳上。第二区段1222的形状与支架111的形状相适配,两者的贴合度更高,能够保证左心耳封堵隔离装置1在回收或调整期间更顺畅。
在图5a和图5b示出的示范例中,所述第一区段1221沿所述支架111的轴向延伸;所述第二区段1222远离所述覆膜112布置;所述第三区段1223沿所述第二区段1222的延伸方向设置,并穿过所述覆膜112。特别的,这里第二区段1222与所述覆膜112相间隔布置,亦是指传输件122和支架111处于扩张状态时的形状。第二区段1222与覆膜112相间隔布置的方式,能进一步提高对覆膜112的额外支撑力。可选的,第二区段1222如可呈弧形,其法向指向近端,并朝向支架111的外部。第三区段1223则优选大致垂直于覆膜112。
请参考图6a至图6c,所述封堵组件11还包括支架汇合件13、连接件14及固定件15;所述支架汇合件13的近端部沿所述支架111的轴向延伸并具有轴向的内腔130,所述传输件122的第一区段1221沿所述支架111的轴向延伸并位于所述内腔130内,所述覆膜112包覆于所述支架111的外侧并延伸翻折入所述内腔130;所述支架汇合件13的远端部与所述支架111收束汇集的一端连接;所述连接件14沿所述支架111的轴向延伸并设置于所述第一区段1221的内侧,其用于压合覆膜112翻折入所述内腔130的部分。所述连接件14还用于与所述输送装置2可拆卸地连接;所述固定件15沿所述支架111的横向依次贯穿连接所述支架汇合件13、所述覆膜112、所述传输件122以及所述连接件14,以使得所述支架汇合件13、所述覆膜112、所述传输件122以及所述连接件14相互固定连接。
如图6a和图6b所示,在一个示范例中,所述支架汇合件13、所述覆膜
112、所述传输件122以及所述连接件14围绕支架111的轴线同轴依次排布。支架汇合件13如可为圆柱状,其远端与支架111收束汇集的一端连接,例如可焊接连接,也可以是支架汇合件13与支架111一体成型,支架111通过对一管材切割成型。覆膜112的近端收束,并位于支架汇合件13的内侧。传输件122的近端即第一区段1221位于覆膜112的内侧,由此,传输件122与支架汇合件13被覆膜112相隔离而电绝缘,进而传输件122与支架111电绝缘,防止电刺激信号的能量传递给支架111,以更好地实现精确消融。
在一个实施例中,所述连接件14与所述传输件122电连接,所述连接件14具有内螺纹,相适配的,所述输送头21具有外螺纹,所述内螺纹与所述外螺纹适配连接,以使左心耳封堵隔离装置1与输送装置2实现可分离地连接。连接件14和输送头21优选均由金属材料制成,其两者均可导电。如此配置,内螺纹与外螺纹适配连接后,输送头21可通过连接件14与传输件122实现电连接,以传输电刺激信号。
当然可以理解的,螺纹连接仅为左心耳封堵隔离装置1与输送装置2连接方式的一种示范例而非对左心耳封堵隔离装置1与输送装置2连接方式的限定,本领域技术人员还可根据现有技术,为左心耳封堵隔离装置1与输送装置2选择其它的连接方式,如卡扣连接或过盈配合等,本发明对此不限。
请参考图6a,在一个实施例中,所述固定件15穿过所述支架111的轴线(指支架111纵向的中轴线);固定件15类似于锁栓,可以将所述支架汇合件13、所述覆膜112、所述传输件122以及所述连接件14各个部件相互锁扣连接在一起。可以理解的,为了与固定件15相适配,所述支架汇合件13、所述覆膜112、所述传输件122以及所述连接件14上对应的位置均设有通孔,以供固定件15穿设。进一步的,固定件15为电绝缘体,以避免使支架汇合件13与传输件122电导通。
固定件15可以是一个,其穿过支架111的轴线,在其它的一些实施例中,如图6c所示,封堵组件11也可包括两个以上所述固定件15,两个以上所述固定件15均与所述支架111的轴线间隔布置。在一个示范例中,两个所述固定件15平行布置,并避让开连接件14的内孔,进一步的,连接件14的内孔
沿轴向贯通。如此配置,如图7a和图7b所示,在一些实施例中,输送装置2的输送头21为中空结构,其可以允许标测导管31(如图7a所示)穿过,并进入左心耳的内部40,以辅助检测消融后的隔离是否完全。也可以允许猪尾巴导管32(如图7b所示)穿过,并进入左心耳的内部40,往猪尾巴导管32中注入造影液同样也可以从左心耳封堵隔离装置1内侧检验封堵效果是否完全。这样,减少了手术的操作复杂性并增加了手术的安全性和成功率。
可选的,请参考图8、图9a和图9b,在另一些实施例中,所述传输件122的远端与所述支架111电绝缘地连接,即传输件122相对于支架111的位置是固定的,且两者电绝缘。优选的,所述支架111具有电极固定部111a,所述封堵组件11还包括隔离件16,所述隔离件16设置于所述电极固定部111a上;所述隔离件16为电绝缘体,所述传输件122的远端通过所述隔离件16与所述支架111连接。电极固定部111a和隔离件16的设置,能够对传输件122的位置进行固定。使得传输件122与支架111配合得更紧密,提高支架111的支撑性能。同时,隔离件16为电绝缘体,可以避免使支架111与传输件122电导通。从而防止电刺激信号的能量传递给支架111,以更好地实现精确消融。
在一个示范例中,所述电极固定部111a包括第一通孔,所述隔离件16穿设于所述第一通孔中;所述隔离件16包括第二通孔16a,所述传输件122的远端穿设于所述第二通孔16a中。隔离件16的材料为电绝缘材料,例如可选用硅胶。需要说明的,电极固定部111a可以设置在支架111的网格节点处,也可以设置在支架111的支架杆上,本实施例对此不限。
进一步的,本实施例提供的左心耳封堵隔离系统包括如上所述的左心耳封堵隔离装置1,以及如上所述的输送装置2,因此其也具备由如上所述的左心耳封堵隔离装置1以及如上所述的输送装置2所带来的有益效果。左心耳封堵隔离系统的其它部件的结构和原理可参考现有技术,本实施例不再展开说明。
综上所述,在本发明提供的左心耳封堵隔离装置、输送装置及左心耳封堵隔离系统中,所述左心耳封堵隔离装置包括封堵组件和电极组件;所述封堵组件用于封堵左心耳;所述电极组件设置于所述封堵组件上,并与所述封
堵组件电绝缘;所述电极组件的一端用于与输送装置可分离地电连接,另一端用于抵靠左心耳口部;所述电极组件用于传输来自所述输送装置的电刺激信号,并向所述左心耳口部释放所述电刺激信号。
如此配置,通过封堵组件对左心耳进行封堵的同时,可利用电极组件对左心耳口部进行消融,从而将封堵和消融两个术式合二为一,降低了手术成本,节省了手术时间,提高了手术的成功率。此外,由于电极组件设置于封堵组件上,其定位可靠准确,还解决了现有技术中单独对左心耳进行消融隔离的不便利,且易产生并发症的问题。进一步的,由于对左心耳口部也就是对封堵组件主要提供压力的位置进行了消融后,组织收缩力降低,使得左心耳封堵隔离装置更不容易从左心耳口部滑出,提高了封堵的可靠性。
需要说明的,上述若干实施例之间可相互组合。上述描述仅是对本发明较佳实施例的描述,并非对本发明范围的任何限定,本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰,均属于权利要求书的保护范围。
Claims (14)
- 一种左心耳封堵隔离装置,其特征在于,包括:封堵组件和电极组件;所述封堵组件用于封堵左心耳;所述电极组件设置于所述封堵组件上,并与所述封堵组件电绝缘;所述电极组件的一端用于与输送装置可分离地电连接,另一端用于抵靠左心耳口部;所述电极组件用于传输来自所述输送装置的电刺激信号,并向所述左心耳口部释放所述电刺激信号。
- 根据权利要求1所述的左心耳封堵隔离装置,其特征在于,所述封堵组件包括支架和覆膜;所述电极组件包括电极和传输件;所述支架沿轴向的一端收束汇集,另一端周向环绕排布形成环状的空间网格;所述覆膜包覆于所述支架的至少部分的表面;所述传输件的近端与所述支架收束汇集的一端连接,所述传输件的远端穿过所述覆膜,伸出所述覆膜外并与所述电极连接;所述电极用于抵靠左心耳口部。
- 根据权利要求2所述的左心耳封堵隔离装置,其特征在于,所述覆膜对应于所述传输件穿过的部位具有开口。
- 根据权利要求2所述的左心耳封堵隔离装置,其特征在于,所述传输件自近端至远端包括依次连接的第一区段、第二区段和第三区段;所述第一区段沿所述支架的轴向延伸;所述第二区段的形状与所述支架的形状相适配,并与所述覆膜相贴合;所述第三区段穿过所述覆膜;或者;所述第一区段沿所述支架的轴向延伸;所述第二区段远离所述覆膜布置;所述第三区段沿所述第二区段的延伸方向设置,并穿过所述覆膜。
- 根据权利要求2所述的左心耳封堵隔离装置,其特征在于,所述封堵组件还包括支架汇合件、连接件及固定件;所述支架汇合件的近端部沿所述支架的轴向延伸并具有轴向的内腔,所述传输件包括位于近端的第一区段,所述第一区段沿所述支架的轴向延伸并 位于所述内腔内,所述覆膜包覆于所述支架的外侧并延伸翻折入所述内腔;所述支架汇合件的远端部与所述支架收束汇集的一端连接;所述连接件沿所述支架的轴向延伸并设置于所述第一区段的内侧,所述连接件用于压合所述覆膜翻折入所述内腔的部分;所述连接件还用于与所述输送装置可拆卸地连接;所述固定件沿所述支架的横向依次贯穿连接所述支架汇合件、所述覆膜、所述传输件以及所述连接件。
- 根据权利要求5所述的左心耳封堵隔离装置,其特征在于,所述连接件与所述传输件电连接,所述连接件具有内螺纹,用于与所述输送装置的外螺纹适配连接。
- 根据权利要求5所述的左心耳封堵隔离装置,其特征在于,所述固定件穿过所述支架的轴线;或者,所述封堵组件包括两个以上所述固定件,两个以上所述固定件均与所述支架的轴线间隔布置。
- 根据权利要求2所述的左心耳封堵隔离装置,其特征在于,所述传输件的远端与所述支架电绝缘连接。
- 根据权利要求8所述的左心耳封堵隔离装置,其特征在于,所述支架具有电极固定部,所述封堵组件还包括隔离件,所述隔离件设置于所述电极固定部上;所述隔离件为电绝缘体,所述传输件的远端通过所述隔离件与所述支架连接。
- 根据权利要求9所述的左心耳封堵隔离装置,其特征在于,所述电极固定部包括第一通孔,所述隔离件穿设于所述第一通孔中;所述隔离件包括第二通孔,所述传输件的远端穿设于所述第二通孔中。
- 根据权利要求1所述的左心耳封堵隔离装置,其特征在于,所述左心耳封堵隔离装置沿径向具有扩张状态与收缩状态;所述左心耳封堵隔离装置处于所述收缩状态时,用于容置于所述输送装置的鞘管中。
- 一种输送装置,其特征在于,用于输送根据权利要求1~11中任一项所述的左心耳封堵隔离装置;所述输送装置包括:鞘管、输送头及导体;所述鞘管用于容纳所述左心耳封堵隔离装置;所述输送头沿所述鞘管的轴向可移动地设置,所述输送头用于与所述电极组件可分离地电连接;所述导体的一端与所述输送头连接,所述导体的另一端用于与电刺激信号发生端连接。
- 根据权利要求12所述的输送装置,其特征在于,所述输送头具有外螺纹,所述外螺纹用于与所述左心耳封堵隔离装置的内螺纹适配连接。
- 一种左心耳封堵隔离系统,其特征在于,包括根据权利要求1~11中任一项所述的左心耳封堵隔离装置,以及根据权利要求12或13所述的输送装置。
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Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2016033170A1 (en) * | 2014-08-26 | 2016-03-03 | Mayo Foundation For Medical Education And Research | Closure and ablation of body viscera and conduits |
CN109124755A (zh) * | 2017-06-16 | 2019-01-04 | 诺芮医疗器械(上海)有限公司 | 左心耳封堵消融装置 |
US20200008870A1 (en) * | 2018-07-09 | 2020-01-09 | Boston Scientific Scimed, Inc. | Ablation and occlusive system |
CN111150483A (zh) * | 2018-10-19 | 2020-05-15 | 杭州诺芮医疗科技有限公司 | 消融封堵装置 |
CN114246666A (zh) * | 2020-09-23 | 2022-03-29 | 杭州诺芮医疗科技有限公司 | 消融封堵装置与消融封堵系统 |
CN217938364U (zh) * | 2022-05-17 | 2022-12-02 | 上海佐心医疗科技有限公司 | 左心耳封堵隔离装置、输送装置及左心耳封堵隔离系统 |
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Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2016033170A1 (en) * | 2014-08-26 | 2016-03-03 | Mayo Foundation For Medical Education And Research | Closure and ablation of body viscera and conduits |
CN109124755A (zh) * | 2017-06-16 | 2019-01-04 | 诺芮医疗器械(上海)有限公司 | 左心耳封堵消融装置 |
US20200008870A1 (en) * | 2018-07-09 | 2020-01-09 | Boston Scientific Scimed, Inc. | Ablation and occlusive system |
CN111150483A (zh) * | 2018-10-19 | 2020-05-15 | 杭州诺芮医疗科技有限公司 | 消融封堵装置 |
CN114246666A (zh) * | 2020-09-23 | 2022-03-29 | 杭州诺芮医疗科技有限公司 | 消融封堵装置与消融封堵系统 |
CN217938364U (zh) * | 2022-05-17 | 2022-12-02 | 上海佐心医疗科技有限公司 | 左心耳封堵隔离装置、输送装置及左心耳封堵隔离系统 |
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