A pressure regulating device for the atrium of the heart

Abstract

The application provides a heart chamber pressure regulating device, which is a hollow structure with both ends being open, comprising a stent and a covering film on the stent; the stent is a contractible and expandable structure, which is divided into an inflow section, a middle section and an outflow section along the axial direction; wherein the diameters of the inflow section and the outflow section are greater than that of the middle section in the expanded state of the stent, and the diameter of the inflow section and the outflow section connected to one end of the middle section is smaller than that far away from the one end of the middle section; the middle section adopts a radial support force enhanced structure.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an atrial pressure regulating device. Background Art

[0002] Heart failure (HF) refers to a condition characterized by an inability to adequately drain venous blood from the heart due to impairment of the heart's systolic and / or diastolic function. This leads to venous congestion and insufficient arterial perfusion, resulting in a complex syndrome of circulatory disturbances. HF is a serious illness with a high incidence and mortality rate. It can be categorized as left ventricular failure, right ventricular failure, or total heart failure based on the location of the heart failure. It can also be divided into systolic and diastolic heart failure based on its clinical manifestations. Diastolic heart failure (DHF) accounts for approximately half of all HF patients. In China, there are over 12 million HF patients, representing a prevalence of approximately 2-3%. Of these, approximately 6 million suffer from diastolic heart failure. Diastolic heart failure is the most common HF condition among the elderly, accounting for 66.99% of all HF patients.

[0003] When it comes to treating heart failure, all existing methods have their flaws. Drug therapy cannot fundamentally eliminate the cause of the disease and may still cause recurrent attacks; cardiac resynchronization therapy (CRT) is ineffective for at least 20% of heart failure patients; left ventricular assist device (LVAD) surgery requires extracorporeal circulation, which is not only traumatic and has a high incidence of complications, but is also expensive and difficult to obtain; heart transplantation can fundamentally solve the problem, but the source of donors is very limited and expensive.

[0004] Interatrial shunts are a new approach for treating heart failure. This involves creating a stoma in the atrial septum between the patient's left and right atria and implanting a shunt device, thereby creating a shunt between the left and right atria. Implantable interatrial shunt devices have been successfully used in patients with severe symptomatic heart failure. By diverting or shunting blood from the left atrium (LA) to the right atrium (RA), pressure in the left atrium is reduced or prevented from rising (left atrial decompression). This approach can prevent, alleviate, or limit symptoms, signs, and syndromes associated with pulmonary congestion, including severe shortness of breath, pulmonary edema, and hypoxia. The shunt system involved in this approach must possess excellent deliverability and long-term stable blood flow. Relatively speaking, the smaller the overall size of the stent, the easier it is to deliver. However, to ensure long-term stable blood flow, the stent must have sufficient orifice area and good radial support. Balancing these two factors, deliverability and long-term stable blood flow, remains a pressing challenge for experts and researchers. Existing shunt devices require further optimization in terms of structure and performance. For example, Corvia Medical has designed an all-metal alloy stent for left-to-right atrial shunts in diastolic heart failure. While this stent offers excellent support and a large effective orifice area, it effectively ensures blood flow. However, the stent's large size necessitates a larger delivery catheter, complicating delivery. Germany's Occlutech's AFR, a braided nickel-titanium wire closure device, uses a similar shape to an ASD occluder and includes a stoma for shunting. However, the braided structure offers low support and is prone to endothelialization and rapid heal-up, compromising shunting effectiveness. Summary of the Invention

[0005] In response to the problems in the background technology, the present invention provides an intra-atrial pressure regulating device, which is a hollow structure with openings at both ends, including a stent and a coating covering the stent; the stent is a contractible and expandable structure, which is divided into an inflow section, an intermediate section and an outflow section along its axial direction; wherein, in the expanded state of the stent, the diameters of the inflow section and the outflow section are larger than the diameter of the intermediate section, and the diameters of the inflow section and the outflow section at one end connected to the intermediate section are smaller than the diameters away from the end of the intermediate section; the intermediate section adopts a radial support force enhanced structure.

[0006] Preferably, the middle section is a closed circular ring structure.

[0007] Preferably, the middle section includes a plurality of circumferentially arranged S-shaped reinforcement ribs, and both ends of the S-shaped reinforcement ribs are respectively connected to the inflow section and the outflow section.

[0008] Preferably, the inflow section and the outflow section both include a plurality of circumferentially arranged first support rods, and the first support rods are arranged parallel to the axial direction of the bracket; at least one first wave-shaped connecting member is connected between adjacent first support rods.

[0009] Preferably, the inflow section and the outflow section are connected to the middle section through the first support rod or the first wave-shaped connecting member.

[0010] Preferably, the bracket includes a plurality of circumferentially arranged second support rods, and the second support rods are all inclined to one side relative to the axial direction; and adjacent second support rods are connected by at least one second wave-shaped connecting member.

[0011] Preferably, the inclination angle of the second support rod relative to the axial direction is 20°-45°.

[0012] Preferably, adjacent second support rods are connected with reinforcing ribs at middle sections.

[0013] Preferably, in the expanded state of the stent, the maximum diameter of the inflow section is greater than the maximum diameter of the outflow section.

[0014] Preferably, the stent is further provided with a fixing portion for connecting the intra-atrial pressure regulating device to a conveying device.

[0015] Preferably, the stent and the covering are made of biocompatible materials.

[0016] Preferably, the coating is wrapped around the stent, and skirts extend from both ends of the stent in the axial direction.

[0017] Preferably, at least one anchor is further included, wherein the anchor is arranged on the outer side wall of the pressure regulating device, and the end of the anchor extends toward one side of the middle section and contacts the atrial septal wall.

[0018] Preferably, a U-shaped portion is provided at the end of one end of the anchor extending toward the middle section.

[0019] Due to the adoption of the above technical solution, the present invention has the following advantages and positive effects compared with the prior art:

[0020] The intraatrial pressure regulating device provided by the present invention utilizes a midsection with a reinforced support structure. This midsection, embedded within the atrial septum, ensures both flow performance and a strong radial support force. This prevents device displacement during use and compression, ensuring long-term stable blood flow and preventing the puncture hole from reclosing. Furthermore, the interatrial pressure regulating device provided by the present invention is relatively small overall, so the corresponding delivery device is also relatively small, resulting in minimal trauma to the human body and excellent transportability and operability. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The above and other features and advantages of the present invention will be more clearly understood through the following detailed description in conjunction with the accompanying drawings, in which:

[0022] Figure 1 Schematic diagram of the overall structure of the pressure regulating device in the central room of Example 1 Figure 1 ;

[0023] Figure 2 Schematic diagram of the overall structure of the pressure regulating device in the central room of Example 1 Figure 2 ;

[0024] Figure 3 This is a schematic diagram of the stent in Example 1 after being longitudinally cut open and flattened;

[0025] Figure 4 Schematic diagram of the fixing portion being installed on the bracket in Example 1 Figure 1 ;

[0026] Figure 5 Schematic diagram of the fixing portion being installed on the bracket in Example 1 Figure 2 ;

[0027] Figure 6 This is a schematic diagram of the overall structure of the pressure regulating device in the central room of Example 2;

[0028] Figure 7 This is a schematic diagram of the stent in Example 2 after being longitudinally cut open and flattened;

[0029] Figure 8 This is a schematic diagram of the overall structure of the pressure regulating device in the central room of Example 3;

[0030] Figure 9 Schematic diagram of the stent in Example 3 after being longitudinally cut open and flattened Figure 1 ;

[0031] Figure 10 Schematic diagram of the stent in Example 3 after being longitudinally cut open and flattened Figure 2 . DETAILED DESCRIPTION

[0032] The application will be described in greater detail with reference to the accompanying drawings, in which embodiments of the application are shown. The application may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the application to those skilled in the art. In the drawings, the size and relative sizes of layers and regions can be exaggerated for clarity.

[0033] It should be noted that all directional references (e.g., upper, lower, left, right, front, rear, etc.) are in relation to the exemplary embodiment of the application, as illustrated in the drawings, and are used only for purposes of explanation and illustration, and do not limit the application.

[0034] Embodiment 1

[0035] With reference to Figure 1-5 The application provides a pressure regulating device for atrium, which is a hollow structure with both ends open, comprising a support and a film covering the support; the support is a contractile and expandable structure, which is divided into an inflow section 1, an intermediate section 2 and an outflow section 3 along the axial direction; wherein, in the expanded state, the diameter of the inflow section 1 and the outflow section 2 is larger than that of the intermediate section 2, and the diameter of the inflow section 1 and the outflow section 3 connected to one end of the intermediate section 2 is smaller than that of the other end of the intermediate section 2; the intermediate section 2 adopts a radial support force enhanced structure.

[0036] In use, the pressure regulating device for atrium is compressed and folded in the delivery device, and then delivered to the target position by the delivery device, so that the inflow section 1 is located in the left atrium, the outflow section 3 is located in the right atrium, and the intermediate section 2 is embedded in the puncture hole between the two atria; preferably, the outflow section 3 penetrates into the right atrium at least 5mm, so that the outlet of the outflow section 3 is located outside the natural circulation flow path of the blood from the inferior vena cava into the patient's atrium, which can prevent emboli entrained in the inferior vena cava flow from being guided into the outlet of the outflow section 3. After the pressure regulating device for atrium is delivered to the target position, it is released from the contracted delivery state to the expanded deployment state, thereby forming a hollow structure for blood flow from the left atrium to the right atrium.

[0037] The pressure regulating device for atrium provided by the application can ensure that the intermediate section 2 embedded in the atrial septum has a large radial support force while ensuring flow performance, which can prevent the device from shifting in use, and can prevent the device from being compressed and reduced in size, thereby ensuring long-term stable blood flow and avoiding the puncture hole from being closed again. Moreover, the overall size of the pressure regulating device for atrium is relatively small, so the size of the delivery device matched therewith is also relatively small, which causes less trauma to the human body and has good deliverability and operability.

[0038] In the embodiment, referring to Figure 2-3 , the intermediate section 2 is a closed circular ring structure; the closed circular ring structure can ensure the circumferential strength of the stent intermediate section 2 and will not produce non-uniform deformation under external pressure, maintaining the effective passage area of the stent and improving the smoothness of blood flow. The width of the circular ring structure in the axial direction can be adjusted according to the thickness of the heart tissue, which is not limited here.

[0039] In the embodiment, referring to Figure 2-3 , the inflow section 1 and the outflow section 3 of the stent have the same structure; specifically, the inflow section 1 includes a plurality of circumferentially distributed first support rods 101, the first support rods 101 are arranged parallel to the axial direction of the stent, and one end of the first support rods 101 is connected to the intermediate section 2; at least one first wave-shaped connecting piece 102 is connected between adjacent first support rods 101, thereby forming a ring-shaped support structure and ensuring the circumferential strength and compliance of the inflow section of the stent.

[0040] In the embodiment, two first wave-shaped connecting pieces 102 are connected between adjacent first support rods 101, of course, in other embodiments, the number of first wave-shaped connecting pieces 102 between adjacent first support rods 101 can be adjusted according to the length of the first support rods 101 and other factors, which is not limited here.

[0041] In the embodiment, each first wave-shaped connecting piece 102 located in the same radial direction constitutes a continuous wave shape; the first wave-shaped connecting piece 102 is connected at the connection between the first support rod 101.

[0042] In the embodiment, the outflow section 3 also includes a plurality of circumferentially distributed first support rods 201, and a first wave-shaped connecting piece 202 is arranged between adjacent first support rods 201, and the connection relationship therebetween can be referred to the structure description in the inflow section 1, which will not be described here.

[0043] In the embodiment, the inflow section 1, the intermediate section 2 and the outflow section 3 of the stent are integrally formed, and in the expanded state of the stent, the maximum diameter of the inflow section 1 is greater than that of the outflow section 3. When the incompressible fluid moves in the pipe, in order to maintain the stability of the flow, the flow rate is large at the small cross section and small at the large cross section. According to Bernoulli's equation, the increase of flow rate is accompanied by the decrease of fluid pressure, so the pressure is small at the small cross section and large at the large cross section; based on the above principle, in the embodiment, preferably, the blood flow inlet diameter of the inflow section 1 of the stent is greater than the blood flow outlet diameter of the outflow section 3, so that the pressure on the left atrial side is greater than that on the right atrial side, which is conducive to the blood flow from the left atrium to the right atrium, while preventing blood reflux.

[0044] The length LI of the inflow section 1 is 3-10 mm, and the inner diameter DI of the inflow end is 10-20 mm. The length L2 of the middle section 2 is 1-2 mm, and the minimum inner diameter D2 is 4-8 mm, preferably 5-6.5 mm. The length L3 of the outflow section 3 is 5-10 mm, and the inner diameter D3 of the outflow end is 9-15 mm. Of course, in other embodiments, the dimensions of the sections of the stent can be adjusted according to the specific circumstances, which are not limited here.

[0045] In the present embodiment, the stent can be made of a biocompatible metal frame or a laser-cut solid metal tube made of, for example, Nitinol, Titanium alloy, Cobalt-Chromium alloy, MP35n, 316 stainless steel, L605, Phynox / Fgiloy, Platinum-Chromium, or other biocompatible metals known to those skilled in the art. Preferably, the stent is made of a shape memory alloy, but alternatively, it can also include elastically or plastically deformable materials, such as balloon-expandable, or can be a shape memory alloy that is responsive to temperature changes to shift between a contracted delivery state and an expanded deployed state. More preferably, the distance, thickness, composition and / or growth pattern of the pannus formation can be controlled by increasing the surface finish of the stent, for example, the outer surface of the stent can be electropolished to inhibit pannus formation.

[0046] In the present embodiment, the stent is further provided with a fixing part for connecting the pressure regulating device of the atrium to the delivery device. The fixing part can be realized in the form of an eyelet, a hook, etc., which are not limited here. Further, the fixing part contains a radiopaque marker made of platinum-iridium, gold, tantalum or any other similar suitable material, which can enhance the visibility of the pressure regulating device under fluoroscopy.

[0047] In the present embodiment, the stent is further provided with an anchor 4, which bends towards one side of the atrial septum after release.

[0048] The pressure regulating device is to divert or shunt blood from the left atrium (LA) to the right atrium (RA) to reduce the pressure of the left atrium. The blood flow through the fossa ovalis can generate pressure, and the shape of the fossa ovalis can be irregular or gradually grow into an irregular shape, which can cause the pressure regulating device to tilt or sway. In order to prevent the device from tilting or swaying unpredictably and causing adverse effects, an anchor can be provided at one or more of the following positions: near the outflow end of the middle section (as shown), near the inflow end of the middle section, near the outflow end of the outflow section (as shown), and near the inflow end of the inflow section. Figure 4 Figure 5

[0049] ​​Further, the anchor of the present embodiment can also be a U-shaped inverted end 5 that contacts but does not penetrate the wall of the atrial septum in the fully deployed state; preferably, the anchor 4 is entirely encapsulated with a polymeric material that can prevent the formation of pannus.

[0050] In the present embodiment, the covering is made of a biocompatible material.

[0051] Specifically, the biocompatible material can be a polymer such as expanded polytetrafluoroethylene (ePTFE), polyurethane, DACRON (polyethylene terephthalate), silicone, polycarbonate urethane, ultra-high molecular weight polyethylene (UHMWPE), or PTFE, or a metal, ceramic, carbon nanotube array, or any other suitable material known to those skilled in the art that provides the following properties to the pressure regulating device. As those skilled in the art will appreciate, the covering can optionally sandwich the stent between inner and outer layers of biocompatible material using suitable biocompatible adhesives, sintering techniques, electrospinning techniques, etc.; preferably, the covering can comprise ePTFE with up to 30 micron pitch distances, with inner and outer layers sintered together to form an integral lumen; the present invention is not limited to the use of other encapsulation methods and other suitable polymers that prevent the transmural ingrowth of pannus tissue. One of the purposes of the biocompatible covering is to form a closed lumen in which the covering serves as a barrier separating the stent from the external portion of the pressure regulating device, but the fixation ear 204 is bare metal, i.e., without a covering.

[0052] Further, the covering is encapsulated on the stent and extends with a skirt on both ends of the stent in the axial direction, the skirt can promote laminar flow and limit the ingrowth of pannus during healing of the pressure regulating device.

[0053] Embodiment 2

[0054] With reference to Figure 6-7 , the present embodiment is an adjustment based on Embodiment 1.

[0055] Specifically, in the present embodiment, the intermediate section comprises a plurality of circumferentially arranged S-shaped reinforcing ribs 201; by adjusting the shape and size of the S-shaped reinforcing ribs 201, it can be ensured that the approximate circular annular inner wall is close to each other, the circumferential strength of the intermediate section of the stent is improved, and at the same time, it can be ensured that the stent will not produce non-uniform deformation under external pressure, maintain the effective passage area of the stent, and improve the smoothness of blood flow.

[0056] In the present embodiment, with reference again to Figure 6-7The inflow section 1 and the outflow section 3 of the stent have the same structure; specifically, the inflow section 1 includes a plurality of circumferentially uniformly distributed first support rods 103, and the first support rods 103 are arranged parallel to the axial direction of the stent; at least one first wavy connecting member 104 is connected between adjacent first support rods 103, thereby forming an annular support structure, which ensures the circumferential strength and compliance of the inflow section of the stent.

[0057] Furthermore, in this embodiment, a first wave-shaped connecting member 104 is connected to each end of adjacent first support rods 103 , and the first wave-shaped connecting member 104 near the middle section 2 is connected to the S-shaped reinforcement rib 201 .

[0058] The first wave-shaped connecting members 104 located in the same radial direction form a continuous wave shape; the first wave-shaped connecting members 104 are connected to the connecting portion of the first support rod 103 .

[0059] In this embodiment, the outflow section 3 also includes a plurality of circumferentially evenly distributed first support rods 203, and a first wave-shaped connecting member 204 is arranged between adjacent first support rods 203. The connection relationship between them can refer to the structural description in the inflow section 1 and is not limited here.

[0060] In this embodiment, the remaining structures of the intraatrial pressure regulating device can refer to the description in Example 1 and are not limited here.

[0061] Example 3

[0062] Reference Figure 8-9 This embodiment is an adjustment based on embodiment 1.

[0063] In this embodiment, the bracket includes a plurality of circumferentially uniformly distributed second support rods 6, and the second support rods 6 are inclined relative to the axially uniform side; adjacent second support rods are connected by at least one second wavy connecting member 7 to form a spiral cylindrical structure, and the inclination direction of the second support rods 6 can be adjusted as needed to design it into a positive spiral or a negative spiral.

[0064] Preferably, the inclination angle of the second support rod relative to the axial direction is 20°-45°.

[0065] Preferably, both ends of the second support rod 6 are connected with second wave-shaped connecting members 7 .

[0066] Further, such as Figure 10 As shown in the figure, adjacent second support rods 6 are connected with reinforcing ribs 8 at the middle section to form an annular inner wall, which can further improve the circumferential strength of the middle section of the stent. The annular inner wall will not produce non-uniform deformation under external pressure, which can maintain the effective passage area of ​​the stent and improve blood flow smoothness.

[0067] In this embodiment, the remaining structures of the intraatrial pressure regulating device can refer to the description in Example 1 and are not limited here.

[0068] Those skilled in the art will appreciate that the present invention may be implemented in many other specific forms without departing from its spirit or scope. Although embodiments of the present invention have been described, it should be understood that the present invention is not limited to these embodiments, and those skilled in the art may make changes and modifications within the spirit and scope of the present invention as defined by the appended claims.

Claims

1. An intraatrial pressure regulating device, characterized in that: The whole is a hollow structure with two ends open, including a stent and a membrane covering the stent; the stent is a shrinkable and expandable structure, and is divided into an inflow section, an intermediate section and an outflow section along its axial direction; wherein, in the expanded state of the stent, the diameters of the inflow section and the outflow section are larger than the diameter of the intermediate section, and the diameters of the ends of the inflow section and the outflow section connected to the intermediate section are smaller than the diameters of the ends away from the intermediate section; the intermediate section adopts a radial support force enhanced structure, and the inflow section and the outflow section of the stent have the same structure, while the structure of the intermediate section of the stent is different from that of the inflow section and the outflow section; The inflow section or the outflow section includes a plurality of circumferentially uniformly distributed first support rods, the first support rods being arranged parallel to the axial direction of the bracket; at least one first wavy connector is connected between adjacent first support rods, and the mutually adjacent first wavy connectors form an annular support structure; and The middle section is a closed circular ring structure, the inflow section and the outflow section are connected to the middle section through the first support rod, and the axial width of the circular ring structure is adjusted according to the thickness of the heart tissue; or, the middle section includes a plurality of circumferentially arranged S-shaped reinforcing ribs, and the first wavy connecting piece close to the middle section on the inflow section or the outflow section is connected to the S-shaped reinforcing ribs, and the shape and size of the S-shaped reinforcing ribs are adjusted to make them close to each other to form an approximate circular ring inner wall.

2. An intraatrial pressure regulating device, characterized in that: The whole is a hollow structure with two ends open, including a stent and a coating covering the stent; the stent is a shrinkable and expandable structure, and is divided into an inflow section, an intermediate section and an outflow section along its axial direction; wherein, in the expanded state of the stent, the diameters of the inflow section and the outflow section are larger than the diameter of the intermediate section, and the diameters of the ends of the inflow section and the outflow section connected to the intermediate section are smaller than the diameters of the ends away from the intermediate section; the intermediate section adopts a radial support force enhanced structure, and the structure of the intermediate section of the stent is different from that of the inflow section and the outflow section; wherein, The bracket includes a plurality of second support rods uniformly distributed circumferentially, and the second support rods are all inclined to one side relative to the axial direction, and the inclination angle of the second support rods relative to the axial direction is 20°-45°; adjacent second support rods are connected by at least one second wavy connecting member to form a spiral cylindrical structure, and the spiral cylindrical structure is a positive spiral or a negative spiral; adjacent second support rods are connected with reinforcing ribs at the middle section.

3. The intraatrial pressure regulating device according to claim 1 or 2, characterized in that: In the expanded state of the stent, the maximum diameter of the inflow section is greater than the maximum diameter of the outflow section.

4. The intraatrial pressure regulating device according to claim 1 or 2, characterized in that: The support is also provided with a fixing portion for connecting the intra-atrial pressure regulating device to a conveying device.

5. The intraatrial pressure regulating device according to claim 1 or 2, characterized in that: The stent and the covering membrane are made of biocompatible materials.

6. The intraatrial pressure regulating device according to claim 1 or 2, characterized in that: The coating is wrapped around the stent, and skirts are extended from both ends of the stent in the axial direction.

7. The intraatrial pressure regulating device according to claim 1 or 2, characterized in that: It also includes at least one anchoring piece, which is arranged on the outer side wall of the pressure regulating device, and the end of the anchoring piece extends toward one side of the middle section and contacts the atrial septal wall.

8. The intraatrial pressure regulating device according to claim 7, characterized in that: A U-shaped portion is provided at the end of one end of the anchor extending toward the middle section.

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