Emphysema treatment instrument

Abstract

The emphysema treatment instrument is provided with a near-end end face, a far-end end face, an air inlet hole and an air outlet hole, at least one main channel communicated with the air inlet hole and the air outlet hole and at least one containing groove are formed in the emphysema treatment instrument, and the containing groove extends from the near-end end face to the far-end end face. After the instrument is extruded by radial external force, the wall, corresponding to the containing groove, of the instrument deforms, so that the instrument has a small radial size in the extreme extrusion state, the instrument can be conveyed to a preset position through a thin conveying catheter, and damage to the trachea can be reduced or avoided.

Description

Technical Field

[0001] This invention relates to the field of interventional medical devices, and more particularly to a device for treating emphysema. Background Technology

[0002] Emphysema is a common disease, especially prevalent among the elderly. Statistics show that the 5-year survival rate for patients with end-stage emphysema is less than 50%. Traditional medical treatments for emphysema include oxygen therapy, prevention of lung infections, and bronchodilators, but their effectiveness is extremely limited. Surgical treatment primarily involves lung volume reduction surgery, which has many limitations, such as stringent surgical indications, numerous complications, anesthesia and anesthesia-related complications, unpredictable preoperative outcomes, and the inability to compensate for unsatisfactory results due to excessive or insufficient resection postoperatively. It also involves high surgical costs and significant physical and psychological suffering. Furthermore, because some patients have poor lung function and cannot tolerate surgery, the postoperative mortality rate is high, which limits the application of surgical procedures.

[0003] To better treat emphysema, improve patients' quality of life, and reduce surgical trauma, international research has explored interventional techniques such as transbronchial bio-adhesive, steam ablation, elastic coils, and one-way valves. Bio-adhesive, by completely sealing the emphysematous area, has consistently failed to effectively address postoperative inflammation. Steam ablation, by disrupting the original tissue structure of the emphysematous area, also leads to postoperative inflammation. Elastic coils, after release, cannot effectively control the lung tissue requiring compression, resulting in inaccurate treatment and additional harm to the patient. One-way valves, implanted through a delivery catheter into the diseased trachea, control the unidirectional flow of gas in the bronchi, allowing only inflow and no outflow. However, with prolonged use, individual valves are prone to failure or wear due to long-term fatigue, remaining permanently open and allowing bidirectional airflow, exacerbating emphysema. Furthermore, existing one-way valves, even after radial compression, still have a relatively large diameter, requiring a larger delivery catheter diameter to implant the device into the intended position along the bronchus. However, bronchi are usually narrow, so a thicker delivery tube can easily cause friction bleeding or implantation failure in the bronchus during the process of delivering the device to the intended position, which will undoubtedly increase the patient's suffering. Summary of the Invention

[0004] In view of the deficiencies of the prior art, the purpose of the present invention is to provide a pulmonary emphysema treatment device with a small radial dimension after being compressed radially to its limit.

[0005] One technical solution adopted in this invention is: a pulmonary emphysema treatment device, having a proximal end face, a distal end face, an air inlet, and an air outlet. The device interior has at least one main channel communicating with the air inlet and the air outlet, and at least one receiving groove extending from the proximal end face toward the distal end face.

[0006] Because the device has the accommodating groove, when the device is compressed radially by an external radial force, the wall of the device corresponding to the accommodating groove will be compressed radially, thereby causing radial deformation of the device. After being compressed to the limit, the radial dimension of the device is reduced to a minimum, and the corresponding delivery tube will be thinner, thus avoiding damage to the bronchus.

[0007] In a pulmonary emphysema treatment device provided in one embodiment of the present invention, the device has a plurality of receiving slots arranged around the air inlet in the circumferential direction of the device, with adjacent receiving slots separated by an isolator. Therefore, the device can undergo greater radial deformation, thereby further reducing the radial dimension under ultimate compression.

[0008] As a preferred embodiment, in the emphysema treatment device provided in one embodiment of the present invention, the length of the receiving groove is L3, the total length of the device is L4, and the ratio of L3 to L4 satisfies: 1 / 10 < L3 / L4 < 1 / 8.

[0009] Various structures are available for the main channel of the emphysema treatment device suitable for this invention. In a preferred embodiment of the emphysema treatment device provided by this invention, the main channel includes at least one cavity; the cavity has a first constriction and a second constriction, the first constriction communicating with the air inlet and the second constriction communicating with the air outlet; the cavity has a starting surface perpendicular to the airflow direction at the first constriction and an ending surface perpendicular to the airflow direction at the second constriction; a first point and a second point are arbitrarily selected on the inner wall of the cavity near the second constriction, with the first point being closer to the second constriction than the second point; a third point and a fourth point are arbitrarily selected on the inner wall of the cavity near the first constriction, with the fourth point being closer to the first constriction than the third point; a ray perpendicularly passing through the ending surface and extending distally is defined as a normal; the angle α between the ray with the second point as its endpoint and passing through the first point and the normal satisfies 90°≤a≤180°; and the angle b between the ray with the fourth point as its endpoint and passing through the third point and the normal is less than 90°.

[0010] Because this emphysema treatment device has at least one cavity, when gas flows through the device, the gas flowing towards the first and second constrictions can be diverted by reducing the diameter of the first and second constrictions relative to the rest of the cavity. This reduces the flow rate and velocity of the gas flowing out of the first and second constrictions, thus reducing the amount of gas flowing into the diseased bronchus during intake and allowing the gas to flow out of the diseased bronchus quickly during exhaust. This alleviates the patient's clinical symptoms and achieves precise treatment.

[0011] The device provided by this invention can have only one main channel or multiple main channels. Each main channel may include multiple cavities connected in series. The cavity closest to the proximal end communicates with an air inlet through its first constriction, and the cavity closest to the distal end communicates with an air outlet through its second constriction. When there are multiple main channels, there can also be multiple air inlets and air outlets. In each main channel, the cavity closest to the proximal end communicates with an air inlet through its first constriction, and the cavity closest to the distal end communicates with an air outlet through its second constriction, meaning that the multiple main channels operate independently. Furthermore, as an alternative embodiment, some of the multiple main channels can be connected in parallel and communicate with one air inlet and one air outlet, meaning that several main channels share one air inlet and one air outlet.

[0012] The extension path of each main channel within the device can be parallel to the central axis of the device, or it can be a straight line intersecting the central axis of the device. The extension path of each main channel within the device can also be a spiral extending around the central axis of the device; or the extension path of the main channel within the device can be a paperclip shape, extending in a straight line parallel to the central axis of the device between the air inlet and the air outlet, and meandering near the air inlet and the air outlet respectively. Except for the case where the extension path of each main channel within the device is parallel to the central axis of the device, the other design methods of the aforementioned main channel extension paths can increase the length of the main channel within the limited device size, thereby increasing the number of times the gas flow rate and velocity are reduced within the device. This results in less gas entering the diseased bronchus during inhalation and faster gas expulsion from the diseased bronchus during exhalation, further reducing the patient's pain during an inspiratory and expiratory cycle.

[0013] To further increase the number of times the gas is diverted and slowed down as it flows through the device, the device may also have at least one diversion channel, which includes at least one cavity. One end of the diversion channel communicates with the cavity of the main channel, and the other end is closed or also communicates with the cavity of the main channel.

[0014] To enhance the airflow diversion effect at the second constriction, a first protrusion can be provided at the second constriction. The suspended end of the first protrusion extends towards the proximal end and the endpoint of the suspended end is located within the end surface. As a result, the airflow will be blocked by the first protrusion and diverted when it flows through the first protrusion.

[0015] Furthermore, the emphysema treatment device provided in one embodiment of the present invention is also provided with at least one second protrusion, the suspended end of each second protrusion extending proximally and located within the cavity, so that the airflow is blocked by the second protrusion before entering the second constriction and diverted, thereby further reducing the flow rate of gas entering the second constriction and reducing the gas velocity.

[0016] The shape of the cavity can vary. For example, the cavity can be rotationally symmetrical about the normal circumference, and its radial dimension increases from the proximal end to the distal end before contracting to form its second constriction. Alternatively, the cavity can be a frustum of a cone rotationally symmetrical about the normal circumference, and its radial dimension increases from the proximal end to the distal end before contracting to form its second constriction, with the included angle α being 90°. Alternatively, as an example, the device can have multiple mutually spaced third protrusions and multiple mutually spaced fourth protrusions, each third protrusion opposite a fourth protrusion. The overhanging ends of all protrusions extend towards the proximal end, and the overhanging end of the fourth protrusion is close to the fixed end of the third protrusion. The multiple third protrusions and the multiple fourth protrusions cooperate to divide the inner cavity of the device into multiple cavities conforming to the aforementioned included angles α and β. Attached Figure Description

[0017] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0018] Figure 1 The left, right, and front views of an emphysema treatment device provided in an embodiment of the present invention are schematically shown.

[0019] Figure 2 schematically shown Figure 1 The trajectory line of the main channel of the instrument shown;

[0020] Figure 3 It shows Figure 1 A schematic diagram of a modified structure of the main channel of the device shown.

[0021] Figure 4 It shows Figure 3 The trajectory line of the main channel of the instrument shown;

[0022] Figure 5 Another trajectory line of the main channel of the emphysema treatment device provided by the present invention is shown;

[0023] Figure 6 The diagram schematically illustrates another trajectory line of the main channel of the emphysema treatment device provided by the present invention;

[0024] Figure 7 The schematic diagram illustrates another trajectory line of the main channel of the emphysema treatment device provided by the present invention;

[0025] Figure 8 The diagram schematically illustrates the structure of a branch channel and a main channel of the device provided in an embodiment of the present invention after being cut along the axial direction.

[0026] Figure 9 The diagram illustrates the axially cut-out structure of a device with multiple branch channels and a main channel according to an embodiment of the present invention.

[0027] Figure 10 The diagram schematically illustrates the structure of a branch channel and a main channel of the device provided in an embodiment of the present invention after being cut along the axial direction.

[0028] Figure 11 schematically shown Figure 1 The diagram shows the structure of the main channel of the instrument after it has been cut open axially.

[0029] Figure 12 schematically shown Figure 11 A magnified schematic diagram of the first cavity and the second cavity of the main channel of the device shown;

[0030] Figure 13 The filling is shown schematically. Figure 1 A schematic diagram of a structure for the filling material removed from the cavity of the device shown;

[0031] Figure 14 A schematic diagram of the structure of the filling material removed after filling the cavity of the device provided in another embodiment of the present invention is shown.

[0032] Figure 15 A schematic diagram of the structure of the filling material removed after filling the cavity of the device provided in another embodiment of the present invention is shown.

[0033] Figures 16a to 16e Several contour shapes of the cavity of the emphysema treatment device provided by the present invention are schematically shown;

[0034] Figure 17 A schematic diagram illustrating the treatment of emphysema using the emphysema treatment device provided by the present invention is shown.

[0035] Figure 18 A schematic diagram illustrating the outline of a cavity of the emphysema treatment device provided in the second embodiment of the present invention is shown.

[0036] Figure 19 The diagram illustrates the structure of the emphysema treatment device provided in the third embodiment of the present invention after being cut along the DD line along its axial direction.

[0037] Figure 20 schematically shown Figure 19 A schematic diagram showing the outline of one cavity of the device shown.

[0038] Figure 21 The diagram illustrates the structure of the emphysema treatment device provided in the fourth embodiment of the present invention after being cut along the FF line along its axial direction.

[0039] Figure 22 The diagram illustrates the structure of the emphysema treatment device provided in the fifth embodiment of the present invention after being cut along the GG line along its axial direction.

[0040] Figure 23 schematically shown Figure 22 A schematic diagram showing the outline of one cavity of the device shown.

[0041] Figure 24 The diagram illustrates the structure of the emphysema treatment device provided in the sixth embodiment of the present invention after being cut along the HH line along its axial direction.

[0042] Figure 25 schematically shown Figure 24 A schematic diagram showing the outlines of the two cavities of the instrument shown.

[0043] Figure 26 The diagram illustrates the structure of the emphysema treatment device provided in the seventh embodiment of the present invention after being cut along its axial direction.

[0044] Figure 27 schematically shown Figure 26 Enlarged schematic diagram of the F-structure;

[0045] Figure 28 schematically shown Figure 26 An enlarged schematic diagram of the G structure. Detailed Implementation

[0046] The technical solutions of various embodiments of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are merely a part of the embodiments of the present invention. Furthermore, all other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0047] It should be noted that all directional indications in the embodiments of the present invention are only used to explain the relative positional relationship and movement of the components in a specific posture. If the specific posture changes, the directional indications will also change accordingly.

[0048] In the description of this invention, "a plurality of" means two or more, such as two, three, etc. Unless otherwise explicitly specified and limited, the term "communicating" should be interpreted broadly. For example, the "communicating" nature of two cavities described in this invention can mean that the two are directly connected, or that they are connected through a third component with a channel located between them. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0049] Furthermore, the technical solutions of the various embodiments of the present invention can be combined with each other, but this must be based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such combination of technical solutions does not exist and is not within the scope of protection claimed by the present invention.

[0050] It should be noted that "distal" and "proximal" are commonly used terms in the medical device field. "Distal" refers to the end furthest from the operator during surgery, while "proximal" refers to the end closest to the operator. Axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the medical device; radial direction refers to the direction perpendicular to the axial direction. According to common knowledge understood by those skilled in the art, a "cavity" refers to an object that is sealed and isolated from the outside while being hollow inside. "Limiting state" refers to the state in which the device can no longer undergo radial deformation under radial external force.

[0051] See Figure 1An embodiment of the present invention provides an instrument 1 for treating emphysema, which is generally cylindrical, having a proximal end face 11 and a distal end face 12, an air inlet 13 at the proximal end, an air outlet 14 at the distal end, and a main channel 10 communicating with the air inlet 13 and the air outlet 14. The instrument 1 also has four receiving slots 15. Adjacent receiving slots 15 are separated by a separator 16. The proximal end of each receiving slot 15 extends through the proximal end face 11, and the distal end terminates at a position between the proximal end face 11 and the distal end face 12; that is, the proximal end of each receiving slot 15 is open, and the distal end is closed, extending from the proximal end face 11 towards the distal end face 12. The four receiving slots are arranged circumferentially around the air inlet 13, spaced apart from each other. Each receiving slot 15 may be cylindrical, irregularly shaped, or other shapes. The shape and size of each receiving slot 15 may be the same or different. Preferably, the shape and size of the cross-section of each receiving slot 15 in the direction perpendicular to the axis of the instrument 1 are the same. It is understood that in other embodiments of the present invention, the number of receiving slots 15 may be adaptively increased or decreased according to the actual clinical application scenario.

[0052] The length of the receiving groove 15 is L3, and the total length of the device 1 is L4. Preferably, the ratio of L3 to L4 satisfies: 1 / 10 < L3 / L4 < 1 / 8. If the ratio of L3 to L4 is too small, the distance between the distal end of the receiving groove 15 and the distal end face 12 of the device 1 is small, meaning the thickness of the distal end face of the device 1 is small. This makes it easy for the distal end face of the device 1 to deform easily after being compressed by the radial force of the trachea after implantation into the diseased trachea, resulting in the device 1 not being well supported in the trachea. If the ratio of L3 to L4 is too large, the distance between the distal end of the receiving groove 15 and the distal end face 12 of the device 1 is large, meaning the thickness of the distal end face of the device 1 is large. This makes it easy for the device 1 to deform less under the action of radial compression force, making it difficult to compress. Ultimately, this results in the radial dimension of the device 1 still being large after compression, thus requiring a thicker delivery tube to deliver it into the diseased trachea.

[0053] The device 1 provided in this embodiment has a receiving groove 15. Under the action of radial external force, the receiving groove 15 will be squeezed and deformed, and the isolator 16 will be compressed into the receiving groove 15. Therefore, the device 1 can be compressed radially to its limit, that is, to have the minimum radial diameter. Correspondingly, a thinner delivery tube can be used to deliver the device 1 along the bronchus to the diseased trachea without causing complications such as friction damage to the bronchus.

[0054] Understandably, the outer diameter and length of device 1 can be adaptively set in actual application scenarios based on the diameter of the lesion trachea, the relative position of the branch trachea near the lesion area to the lesion trachea, and the number of nearby branch tracheas.

[0055] See Figure 1The main channel 10 is connected at both ends to an air inlet 13 and an air outlet 14, respectively, for inhaling air through the air inlet 13 and exhaling air through the air outlet 14, and for providing a flow path for fluids such as sputum to be expelled from the body. The main channel 10 is formed by connecting one or a group of cavities in series as repeating units. For ease of explanation, as shown... Figure 11 As shown, each repeating unit in this embodiment includes a first cavity 102a and a second cavity 102b. It is understood that in some other embodiments, the repeating unit may include only one cavity.

[0056] Understandably, the outer diameter and length of device 1 can be adaptively set in actual application scenarios based on the diameter of the lesion trachea, the relative position of the branch trachea near the lesion area to the lesion trachea, and the number of nearby branch tracheas.

[0057] This invention defines the path of the main channel extending from the air inlet to the air outlet within the instrument as its trajectory line. In this embodiment, as... Figure 2 As shown, the trajectory line 101 is a straight line that is approximately parallel to the central axis x of the device 1. In other embodiments, the device 1 may also be frustoconical or elliptical in shape, preferably a frustoconical shape with a distal radial dimension larger than the proximal radial dimension, to better adapt to the tracheal anatomy and facilitate easier delivery to the target location during implantation.

[0058] Trajectory line 101 can also be different from Figure 2 Other shapes are shown. For example, in other embodiments, such as Figure 3 The device shown has a trajectory line 101 that can be presented as follows: Figure 4 The straight line shown intersects the central axis x of instrument 1; it can also be as follows: Figure 5 As shown, trajectory line 101 rotates spirally around the central axis x of device 1 at equal intervals; or as... Figure 6 As shown, trajectory line 101 extends randomly around the central axis x; or as... Figure 7 As shown, the trajectory line 101 is similar to a paperclip, extending back and forth in a straight line parallel to the central axis x of the device 1 between the proximal end face 11 and the distal end face 12, and bending near these two end faces to form multiple loops. These differ from... Figure 2 The different designs of the main channel trajectory shown allow the main channel 10 to be made longer without changing the length of the device 1. The reduced gas flow rate and velocity when the patient inhales (i.e., gas enters the main channel 10 from the inlet 13 and flows out from the outlet 14) and the enhanced gas flow rate when the patient exhales (i.e., gas flows out of the lesion area from the outlet 14 and enters the main channel 10 before being discharged from the inlet 13) are better, resulting in better clinical treatment effects.

[0059] The interior of the device 1 may also include at least one branch channel. Each branch channel includes at least one of the aforementioned repeating units. One end of each branch channel may communicate with a cavity in the main channel 10, and the other end may be closed; or the other end may also communicate with a cavity in the main channel 10.

[0060] As an example, see Figure 8 The device 1 provided in one embodiment of the present invention includes a main channel 10 and a branch channel 18. The branch channel 18 includes multiple cavities with the same structure as the first cavity 102a and the second cavity 102b, and its first and last cavities are respectively connected to the two cavities of the main channel 10. See also Figure 9 In another embodiment of the present invention, the device 1 includes a main channel 10 and a plurality of branch channels 18. Each branch channel 18 includes a plurality of cavities with the same structure as the first cavity 102a and the second cavity 102b, and one of its cavities near the proximal end communicates with the main channel 10, while the other end is closed. Figure 9 The diagram only shows the extension path of the cavity within device 1, illustrating the branch channel 18. See also... Figure 10 In another embodiment of the present invention, the two ends of the diversion channel 18 are respectively connected to the two cavities of the main channel 10. The diversion channel further extends the flow path of gas in the device 1 and increases the number of cavities contained in the device 1, thereby further reducing the flow rate and velocity of gas discharged from the outlet, and increasing the flow rate and velocity of gas discharged from the inlet, resulting in better clinical treatment effect of the device 1.

[0061] Device 1 is composed of materials with good biocompatibility and elasticity, such as one or more of silicone, silicone, silicone rubber, ePTFE, etc., which can be molded stepwise or integrally, or directly molded or 3D printed.

[0062] The shape and structure of the cavity of the main channel and the cavity of the branch channel of the device provided by the present invention can be varied. Currently, a device having... Figure 11 The cavity shown is as follows Figure 1 The device 1 shown is illustrated as an example. Figure 1 The local magnification of the repeating unit composed of the first cavity 102a and the second cavity 102b in the device 1 shown is as follows: Figure 12 As shown. Please refer to [the original text]. Figure 12 The first cavity 102a is enclosed by a starting surface A1, an ending surface A2, and a curved surface located between the starting surface A1 and the ending surface A2. The starting surface A1 and the ending surface A2 are perpendicular to the direction of airflow from the near end to the far end within the main channel 10. A ray that passes perpendicularly through the ending surface A2 and extends toward the far end is defined as a normal.

[0063] Both the first cavity 102a and the second cavity 102b have a first constriction 21 and a second constriction 22. The diameters of the first constriction 21 and the second constriction 22 are smaller than the diameters of the rest of the cavity in the direction perpendicular to the normal. The first constriction 21 of the first cavity 102a communicates with the air inlet 13 of the instrument 1. The second cavity 102b communicates with the first cavity 102a at the second constriction 22 of the first cavity 102a. The first constriction of the second cavity 102b can be integrated with the second constriction 22 of the first cavity 102a and communicates with the air outlet 14 of the instrument 1. In a special case, the first constriction 21 can be integrated with the air inlet 13, and the second constriction of the second cavity 102b can be integrated with the air outlet 14. It is understood that since the second cavity 102b communicates with the first cavity 102a, the starting surface A1' of the second cavity 102b is the ending surface A2 of the first cavity 102a. Specifically, in this invention, "constriction" refers to the proximal and distal ends of the cavity, both of which have a smaller diameter than the diameter of other parts of the cavity in the direction perpendicular to the normal. The first constriction 21 corresponds to the starting surface A1, and the second constriction 22 corresponds to the ending surface A2. The device 1 has a first protrusion 108 extending proximally at the second constriction, and the endpoint of the first protrusion 108 is located within the ending surface A2. Therefore, when the airflow flows from the proximal end to the distal end to the first protrusion 108, it will be blocked by the first protrusion 108, changing its flow direction and thus causing diversion and a reduction in flow velocity.

[0064] In a preferred embodiment of the present invention, the cross-section of the first constriction 21 of the first cavity 102a is circular, and the ratio of the maximum diameter area to the minimum diameter area of ​​the first cavity 102a is less than or equal to 8 and greater than or equal to 2. It is understood that the cross-section of the first constriction 21 can be of other shapes, and the ratio of its maximum diameter area to its minimum diameter area can be flexibly set according to the actual application scenario, as long as the first cavity 102a can change the flow direction, outflow velocity, and flow rate of the gas.

[0065] Starting from the starting surface A1, the line extends along the first cavity 102a to the ending surface A2. Arbitrarily select a first point 1 and a second point 2 on the inner wall of the first cavity 102a near the ending surface A2. The first point 1 is closer to the second constriction 22 of the first cavity 102a than the second point 2. Define the ray with the second point 2 as its endpoint and passing through the first point 1 as direction 2. The angle α between the normal and direction 2 satisfies the following condition: 90° ≤ α ≤ 180°.

[0066] Starting from the starting surface A1, the line extends along the first cavity 102a to the ending surface A2. Arbitrarily select a third point 3 and a fourth point 4 on the inner wall of the first cavity 102a near the starting surface A1. The fourth point 4 is closer to the starting surface A1 than the third point 3. Then, take the ray with the fourth point 4 as its endpoint and passing through the third point 3 as direction 3. The angle b between the normal and direction 3 satisfies the following condition: b < 90°.

[0067] To facilitate understanding of the shape of each cavity by those skilled in the art, the following will be described: Figure 12 The cavity shown is completely filled with material, and then the material is removed from the cavity to obtain the following: Figure 13 The structure shown. See also Figure 13 The first cavity 102a and the second cavity 102b have the same shape and volume, and are roughly wedge-shaped. They are arranged symmetrically about the main channel 105 at 180°. The main channel 105 refers to the flow channel that connects the first cavity 102a and the second cavity 102b and has the same diameter as the diameter of the first constriction 21 and the diameter of the second constriction 22.

[0068] Each cavity can also be presented as Figure 14 The circular shape shown, such as Figure 15 The angular shape shown, or as in 16a to Figure 16e The shapes shown in sequence include S-shaped, irregular, elliptical, figure-eight, or arrowhead shapes with the tip pointing towards the proximal end. The above are merely illustrative examples of possible shapes for each cavity and do not represent a complete list of all cavity shapes applicable to the device of this invention. As long as the surface of each cavity is smooth, ensuring unimpeded airflow, it is acceptable. The volumes of the repeating units can be the same or different.

[0069] Now Figure 1 and Figure 12 Taking the device 1 shown as an example, the working principle of the device 1 provided by the present invention will be explained. When the airflow flows from the air inlet 13 of the device 1 toward the distal end, after the airflow enters the first cavity 102a and reaches the area where the first point 1 and the second point 2 are located, since the included angle α is an obtuse angle, most of the airflow will be rebounded and remain in the first cavity 102a. The flow rate and volume of the airflow entering the main channel 105 are greatly reduced, and consequently, the flow rate and volume of the airflow entering the second cavity 102b through the main channel 105 are also greatly reduced accordingly. When the airflow flows from the air outlet of the device 1 toward the proximal end, a small portion of the airflow enters the first cavity 102a and reaches the area where the third point 3 and the fourth point 4 are located. Since the included angle β is an acute angle, the flow rate and volume of the airflow are basically not reduced. Thus, the degree of airflow reduction when the airflow flows from the proximal end to the distal end is greater than the degree of airflow reduction when the airflow flows from the distal end to the proximal end.

[0070] The number of air inlets 13 and air outlets 14 in device 1 corresponds one-to-one, and there can be multiple such inlets and outlets; that is, device 1 can include multiple such inlets and outlets. Figure 2 , 5 The trajectory line shown in Figure 7 includes multiple main channels 10, the same number as the number of air inlets 13. When there are multiple air inlets 13 and air outlets 14, the lines connecting all air inlets 13 or all air outlets 14 on their corresponding end faces can form one or more circles, or one or more matrices. Multiple air inlets 13 and multiple air outlets 14 can also be randomly distributed. The number of cavities can also be set to only one or more as needed. When the device 1 has multiple cavities, after inserting the bronchus, it can ensure that during air intake, the gas is diverted multiple times through the cavities, with only a small amount of gas entering the lesion site. This can alleviate the clinical symptoms of patients with emphysema and allow for the rapid discharge of exhaled air and sputum cleared from the airway after treatment.

[0071] It is worth mentioning that when the device 1 has multiple main channels 10, all main channels can be connected in parallel, and after being connected in parallel, only the first and last cavities are connected to an air inlet 13 and an air outlet 14, respectively. As an alternative embodiment, in each of the multiple main channels, the cavity closest to the proximal end is connected to an air inlet through its first constriction, and the cavity closest to the distal end is connected to an air outlet through its second constriction; or, some of the multiple main channels are connected in parallel to each other and then connected to an air inlet and an air outlet.

[0072] When actually using the device 1 provided by this invention, such as Figure 17 As shown, due to the presence of emphysematous areas in the bronchi, device 1 can be placed into the target airway through a bronchoscope, with its proximal inlet 13 closer to the emphysematous area. During the inspiratory cycle, i.e., the airflow passes through the cavities from near to far, the flow rate and velocity of the gas entering through inlet 13 gradually decrease after passing through each cavity, making it difficult or very difficult for the gas to reach the emphysematous area. During the expiratory cycle, i.e., the airflow passes through the cavities from far to near, the flow rate and velocity of the gas entering through outlet 14 slightly decrease after passing through each cavity, making it easy for the gas to reach inlet 13, meaning the gas is more easily expelled from the emphysematous area. Thus, device 1 can block inhaled airflow but allows exhaled airflow and mucus cleared from the treated airway to pass through, thereby resolving the chest tightness and chest pain that may occur in unidirectional occlusion therapy, alleviating the clinical symptoms of emphysema patients, and ensuring that the diseased gas is rapidly expelled through the gradual increase in air pressure during exhalation.

[0073] The internal cavity structure of device 1 is illustrated below with reference to the accompanying drawings. See also... Figure 18 The device provided in the second embodiment of the present invention has the same characteristics as... Figure 1 and Figure 12The device provided in the first embodiment has a generally similar structure, except that in this embodiment, the device 1 has a second protrusion 1081 in areas other than near the second constriction 109, with its suspended end extending proximally and located within the first cavity 102a. Thus, when the airflow flows from the proximity to the second protrusion 1081, it is diverted due to the obstruction and guidance of the second protrusion 1081. Points 1' and 2' are arbitrarily selected on the inner wall of the device 1 near the second protrusion 1081 as described in the first embodiment, and the extension direction of the ray passing through point 1' with point 2' as its endpoint is defined as direction 2'. Similarly, the angle α between the normal and direction 2' satisfies the following condition: 90° ≤ α' ≤ 180°.

[0074] It is understandable that device 1 may include multiple such devices. Figure 18 The second protrusion 1081 is shown. With this configuration, when the airflow flows into the second constriction 109 in the first cavity 102a, it will be weakened multiple times due to the presence of multiple second protrusions 1081, and the flow rate and volume of the gas entering the second cavity 102b will become smaller and smaller.

[0075] In the device 1 provided in the third embodiment of the present invention, as follows: Figure 19 and Figure 20 As shown, the device 1 includes multiple cavities 102 with identical structure and shape. Each cavity 102 is rotationally symmetrical along the normal and has a first constriction 107 communicating with the air inlet 13 and a second constriction 109 communicating with the main flow channel 105. The size of the cavity 102 increases from the proximal end to the distal end and then narrows to form the second constriction 109. Near the second constriction 109, the device 1 has first protrusions 108 extending into the cavity 102 on both sides of the second constriction 109. It is understood that the surface of the first protrusion 108 forms part of the inner wall of the cavity 102. (Refer to...) Figure 19 Take any first point 1 (located on the surface of the first protrusion 108) and second point 2 on the inner wall of cavity 102 near the second constriction 109, and any third point 3 and fourth point 4 on the inner wall of cavity 102 near the first constriction 107. Define the starting surface, ending surface, normal, included angle α and included angle β in the same way as in the first embodiment. Similarly, as... Figure 20 As shown, the degree of included angle α satisfies the condition: 90°≤a≤180°, and the degree of included angle b is less than 90°. Furthermore, by taking points 1' and 2' on the horizontal plane of the first protrusion 108 and defining the normal and included angle α' using the same method as in the first embodiment, the degree of α' can be obtained as 180°.

[0076] See Figure 21 The fourth embodiment of the present invention provides that each cavity 102 of the device 1 has only the following... Figure 19The structure shown is the result of cutting the instrument in half along its central axis x. This structure is easier to form and simpler to manufacture than the latter.

[0077] See Figure 22 and Figure 23 The device 1 provided in the fifth embodiment of the present invention includes five air inlets 13, five air outlets 14, and five main channels 10. The cavity 102 is a frustum of a cone that is rotationally symmetrical about the normal circle, with a roughly trapezoidal cross-sectional shape. Its dimensions increase from the proximal end to the distal end and then contract to form its own second constriction 109. Gas flowing in from the air inlets 13 is split through the cavity 102 and then converges at the second constriction 109 before flowing into the next cavity near the distal end. Since any first point 1 and second point 2 on the inner wall of the cavity 102 near the second constriction 109 are located on the same plane as the ending surface A2, the included angle α is 90° and the included angle β is less than 90°. When the airflow flows from near to far, a large portion of the airflow encounters the area where the first point 1 and the second point 2 are located. Since the included angle α is a right angle, most of the airflow is bounced back, and the airflow velocity and flow rate are significantly reduced. Similarly, when airflow moves from near to far, the degree of airflow weakening is greater than when airflow moves from far to near.

[0078] Compared with the cavity structures shown in all the previous embodiments, this cavity structure has the advantage that, since the first point 1, the second point 2 and the end surface A2 are located on the same plane, and the two adjacent cavities 102 do not overlap in the direction of the central axis of the instrument 1, the wall thickness is eliminated, the structural size can be made smaller, and it is easier to form.

[0079] See Figure 24 and Figure 25 The device 1 provided in the sixth embodiment of the present invention has a plurality of mutually spaced and arrayed third protrusions 1082 and a plurality of mutually spaced and arrayed fourth protrusions 1083 extending from its inner wall. The inner wall between two adjacent third protrusions 1082 is smooth, and the inner wall between two adjacent fourth protrusions 1083 is also smooth. Each third protrusion 1082 is opposite to one fourth protrusion 1083, and the overhanging ends 120 of all protrusions extend towards the proximal end, and the overhanging ends of the fourth protrusions 1083 are close to the fixed ends 1084 of the third protrusions 1082. Thus, all the third protrusions 1082 and all the fourth protrusions 1083 cooperate to divide the inner cavity of the device 1 into a plurality of cavities 102. It is understood that in this embodiment, the surface of all the protrusions constitutes part of the inner wall of the cavity 102.

[0080] See Figure 25Each cavity 102 has a starting surface A1 and an ending surface A2. Taking any first point 1 and a second point 2 on the inner wall of the cavity 102 near the second constriction 109, the starting surface, ending surface, normal, direction 2, and direction 3 are defined using the same method as in the first embodiment. Then, the included angle α satisfies: 90 ≤ a° ≤ 180°. Taking any third point 3 and a fourth point 4 on the surface near the first constriction 107, the included angle β is less than 90°.

[0081] Take any five points (5, 6, 7, and 8) on the inner wall of the cavity near the end face A2. The ray extending from point 6 to point 5 is direction 4, and the ray extending from point 8 to point 7 is direction 5. The angle a' between direction 4 and the normal satisfies: 90 ≤ a'° ≤ 180°. Direction 5 is parallel to the normal.

[0082] See Figures 26 to 28 The seventh embodiment of the device 1 provided by the present invention includes, in addition to the first cavity 102a and the second cavity 102b, a third cavity 102c and a fourth cavity 102d. The first cavity 102a and the second cavity 102b have the same shape and structure as the cavities in the aforementioned embodiments, and will not be described again here. The third cavity 102c and the fourth cavity 102d are both approximately cuboid in shape. The third cavity 102c communicates directly with the air inlet 13, and the fourth cavity 102d communicates directly with the air outlet 14. It is understood that the proximal and distal diameters of the third cavity 102c and the fourth cavity 102d are approximately equal; therefore, they do not have the constriction described in this specification. Both the third cavity 102c and the fourth cavity 102d serve to provide airflow channels.

[0083] The emphysema treatment device provided by this invention has been described in detail above. It is to be understood that the above description should not be construed as limiting the scope of protection claimed by this invention. Any equivalent structural modifications made based on the inventive concept of this invention, utilizing the description and drawings, or direct / indirect applications in other related technical fields are included within the scope of protection of this invention.

Claims

1. An emphysema treatment device having a proximal end face, a distal end face, an air inlet and an air outlet, characterized in that, The instrument has at least one main channel inside, which is in communication with the air inlet hole and the air outlet hole, and at least one accommodating groove, which extends from the proximal end face to the distal end face.

2. The emphysema treatment device of claim 1, wherein The instrument has a plurality of the accommodating grooves, which are arranged around the air inlet hole in the circumferential direction of the instrument, and two adjacent accommodating grooves are separated by a partition.

3. The emphysema treatment device of claim 1, wherein The length of the accommodating groove is L3, and the total length of the instrument is L4, and the ratio of L3 and L4 satisfies: 1 / 10 < L3 / L4 < 1 / 8.

4. The emphysema treatment device of any one of claims 1-3, wherein, The main channel includes at least one cavity; the cavity has a first neck and a second neck, the first neck is in communication with the air inlet hole, and the second neck is in communication with the air outlet hole; the cavity has a starting face perpendicular to the direction of airflow at the first neck and an ending face perpendicular to the direction of airflow at the second neck; any first point and second point are taken on the inner wall of the cavity near the second neck, and the first point is closer to the second neck than the second point; any third point and fourth point are taken on the inner wall of the cavity near the first neck, and the fourth point is closer to the first neck than the third point; a ray perpendicular to the ending face and extending distally is defined as the normal line; the angle a between the ray with the second point as the end point and passing through the first point and the normal line satisfies: 90° ≤ a ≤ 180°; the angle b between the ray with the fourth point as the end point and passing through the third point and the normal line is less than 90°.

5. The emphysema treatment device of claim 4, wherein the at least one of the plurality of airways is a bronchus. The main channel includes a plurality of the cavities, and the plurality of cavities are connected in series; the cavity closest to the proximal side is in communication with one air inlet hole through its first neck, and the cavity closest to the distal side is in communication with one air outlet hole through its second neck.

6. The emphysema treatment device of claim 5, wherein, The instrument has a plurality of the main channels, a plurality of air inlet holes, and a plurality of air outlet holes inside; the cavity closest to the proximal side in each main channel is in communication with one air inlet hole through its first neck, and the cavity closest to the distal side is in communication with one air outlet hole through its second neck, or part of the main channels are connected in parallel and then in communication with one air inlet hole and one air outlet hole.

7. The emphysema treatment device of claim 4, wherein, The extension path of the main channel in the instrument is parallel to the central axis of the instrument, or is a straight line intersecting the central axis of the instrument; or the extension path of the main channel in the instrument is a spiral line spirally extending around the central axis of the instrument; or the extension path of the main channel in the instrument is in the shape of a paperclip, which extends in a straight line parallel to the central axis of the instrument between the air inlet hole and the air outlet hole and detours near the air inlet hole and the air outlet hole respectively.

8. The emphysema treatment device of claim 4, wherein, The instrument further has at least one shunt channel inside, which includes at least one cavity, one end of the shunt channel is in communication with the cavity of the main channel, and the other end is closed or also in communication with the cavity of the main channel.

9. The emphysema treatment device of claim 4, wherein, The instrument is provided with a first protrusion at the second neck, and the overhanging end of the first protrusion extends proximally and the end point of the overhanging end is located in the ending face.

10. The emphysema treatment device of claim 9, wherein, The instrument also has at least one second protrusion, and the free end of each second protrusion extends proximally and is located in the cavity.

11. The emphysema treatment device of claim 4, wherein, The cavity is circumferentially rotationally symmetric about the normal line, and its radial dimension is formed by a proximal-to-distal increasing and then decreasing to form its second necking; or, the cavity is a truncated cone that is circumferentially rotationally symmetric about the normal line, and its radial dimension is formed by a proximal-to-distal increasing and then decreasing to form its second necking, and the angle of the included angle a is 90°.

12. The emphysema treatment device of claim 5, wherein, The instrument has a plurality of third protrusions and a plurality of fourth protrusions that are spaced apart from each other, each third protrusion is opposite to a fourth protrusion, the free end of all protrusions extends proximally, and the free end of the fourth protrusion is close to the fixed end of the third protrusion, and the plurality of third protrusions and the plurality of fourth protrusions cooperatively divide the inner cavity of the instrument into a plurality of cavities.

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