Medical device

Abstract

To provide a medical device capable of easily arranging a therapeutic substance at a treatment part in a living body and easily setting an enclosure part in a non-developed state.SOLUTION: A medical device comprising a surface member, an enclosure disposed on one surface of the surface member, the enclosure extending around an enclosed region on the one surface of the surface member, the enclosure comprising a first wall and a second wall which is more flexible than the first wall, and a shaft supporting the enclosure, the second wall being located on a central axis of the shaft when viewed in a normal direction perpendicular to the enclosed region of the surface member. A medical device comprising: a shaft; and an outer cylinder configured to accommodate the shaft inside in a radial direction, wherein the enclosing part and the surface member change from a non-expanded state in which the enclosing part and the surface member are accommodated in the outer cylinder in a folded state to an expanded state in which the enclosing part and the surface member are expanded by being discharged to a distal side of the outer cylinder.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates to medical devices. [Background technology]

[0002] A medical device is known that has an enclosure that extends around a predetermined area, a shaft that supports the enclosure, and an outer tube that houses the shaft radially inward, and in which the enclosure changes from a folded, undeployed state housed in the outer tube to an undeployed state when ejected from the tip side of the outer tube, and a therapeutic substance is placed at a treatment site inside the living body (see, for example, Patent Document 1). [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Patent Application Publication No. 2024-33301 Summary of the Invention [Problem to be solved by the invention]

[0004] An object of the present disclosure is to provide a medical device that allows a therapeutic substance to be easily placed at a treatment site inside a living body and that allows the surrounding portion to be easily set in a non-deployed state. [Means for solving the problem]

[0005] One aspect of the present disclosure is as follows.

[0006] [1] A medical device comprising: A face material portion; an enclosure portion installed on one side of the face material portion, the enclosure portion extending so as to surround the enclosed area on the one side of the face material portion, and consisting of a first wall portion and a second wall portion that is softer than the first wall portion; a shaft supporting the surrounding portion, the second wall portion being located on the central axis of the shaft when viewed in a normal direction that is a direction perpendicular to the surrounded area of ​​the face material portion; an outer cylinder that accommodates the shaft radially inside, wherein the surrounding portion and the face material portion change from a non-deployed state in which they are accommodated in the outer cylinder in a folded state to a deployed state in which they are deployed by being ejected to the tip side of the outer cylinder; Medical devices.

[0007] [2] the first wall portion is fixed to the one surface of the face material portion, The medical device described in [1], wherein the second wall portion is in contact with the one surface of the face material portion without being fixed to the one surface.

[0008] [3] The medical device described in [1] or [2], wherein the second wall portion consists of a pair of second walls that face each other in a direction along the central axis of the shaft when viewed in the normal direction and are each located on the central axis.

[0009] [4] The outer cylinder has an inner peripheral surface that is round when viewed in an axial direction along a central axis of the outer cylinder, A medical device described in any one of [1] to [3], wherein the surrounding portion and the surface material portion, when in the unexpanded state, have a rounded shape along the inner surface of the outer tube when viewed in the axial direction of the outer tube.

[0010] [5] The medical device according to any one of [1] to [4], which has a supply lumen for supplying a treatment liquid to the inside of the enclosure.

[0011] [6] a suction part that sucks the inside of the enclosure part; The medical device according to any one of [1] to [4], further comprising a supply needle that, in the deployed state, changes from a non-extending state in which it does not extend into the inside of the enclosing portion to a protruding state in which it extends into the inside of the enclosing portion, and supplies the treatment liquid in the protruding state.

[0012] [7] A treatment method using the medical device according to any one of [1] to [6], a delivery step of delivering the surrounding portion and the face material portion in the undeployed state to a treatment site in a living body; and an unfolding step of unfolding the surrounding portion and the face material portion delivered to the treatment portion to bring them into the unfolded state.

[0013] [8] the medical device includes a suction unit that suctions the inside of the enclosure, and a supply needle that changes from a non-extending state in which it does not extend into the inside of the enclosure in the deployed state to a protruding state in which it extends into the inside of the enclosure, and supplies a therapeutic liquid in the protruding state; an opposing step of causing one surface of the face material portion in the expanded state to face the treatment portion; a suction step of drawing the treatment portion into the inside of the enclosure by suction of the suction part with the one surface of the face material part facing the treatment portion; [7] The treatment method described in [7], further comprising an injection step of inserting the supply needle into the retracted treatment portion by changing the supply needle from the non-inserted state to the inserted state, and injecting the treatment liquid into the treatment portion. [Effects of the Invention]

[0014] According to the present disclosure, it is possible to provide a medical device that allows a therapeutic substance to be easily placed at a treatment site inside a living body and also allows the enclosing portion to be easily set in a non-deployed state. [Brief explanation of the drawings]

[0015] [Figure 1] FIG. 1 is a perspective view showing a deployed state of a medical device according to a first embodiment of the present disclosure. [Figure 2] FIG. 2 is a projection view of the medical device of FIG. 1 when viewed in the normal direction. [Figure 3] FIG. 2 is a perspective view of the medical device of FIG. 1 in an undeployed state. [Figure 4] FIG. 4 is a projection view as seen in the direction of arrow A in FIG. 3. [Figure 5A] FIG. 10 is a perspective view showing a state when an opposing step is performed in a medical device according to a second embodiment of the present disclosure. [Figure 5B] FIG. 5B is a perspective view showing a state when a suction step is performed from the state of FIG. 5A. [Figure 5C] FIG. 5C is a perspective view showing a state when an injection step is performed from the state of FIG. 5B. DETAILED DESCRIPTION OF THE INVENTION

[0016] Hereinafter, embodiments of the present disclosure will be described in detail with reference to the drawings.

[0017] As shown in Figures 1 to 4, the medical device 1 according to the first embodiment of the present disclosure comprises a surface material portion 2, an enclosure portion 3 installed on one side of the surface material portion 2, the enclosure portion 3 extending around the enclosed area 2a on one side of the surface material portion 2 and consisting of a first wall portion 3a and a second wall portion 3b that is softer than the first wall portion 3a, a shaft 4 supporting the enclosure portion 3, the second wall portion 3b being located on the central axis O of the shaft 4 when viewed in the normal direction, which is perpendicular to the enclosed area 2a of the surface material portion 2 (see Figure 2), and an outer tube 5 that houses the shaft 4 radially inward, the enclosure portion 3 and the surface material portion 2 changing from an unexpanded state (see Figures 3 to 4) in which they are housed in the outer tube 5 in a folded state to an expanded state (see Figures 1 to 2) when they are ejected to the tip side of the outer tube 5.

[0018] In this embodiment, the flexibility changes discontinuously at the boundary between the first wall portion 3a and the second wall portion 3b, but this is not limited to this, and for example, the flexibility may be configured to change gradually across the boundary between the first wall portion 3a and the second wall portion 3b.

[0019] The first wall portion 3a is fixed to one side of the face material portion 2 by fusion or the like, and the second wall portion 3b is in contact with the one side of the face material portion 2 without being fixed to the one side. The outer diameter of the face material portion 2 may be configured to be larger than the outer diameter of the enclosure portion 3.

[0020] The enclosure 3 has an inner wall surface 3c that extends around the enclosed area 2a on one side of the face material 2. The enclosure 3 has an outer wall surface 3d that extends around the enclosed area 2a along the inner wall surface 3c. The enclosure 3 has an opposing surface 3e that faces one side of the face material 2, extends around the enclosed area 2a, and connects the inner wall surface 3c and the outer wall surface 3d. The enclosure 3 has a top surface 3f that is located on the opposite side of the opposing surface 3e, extends around the enclosed area 2a, and connects the inner wall surface 3c and the outer wall surface 3d.

[0021] The enclosure 3 has an annular shape when viewed in the normal direction (see FIG. 2). In this embodiment, the enclosure 3 has a circular annular shape, but is not limited to this and may have an annular shape other than a circle, such as an elliptical shape. The enclosure 3 may have a cut extending from the inner wall surface 3c to the outer wall surface 3d, the cut being large enough to prevent leakage of the treatment liquid described below.

[0022] The surrounding portion 3 is soft and porous and sponge-like, and is made of, for example, urethane resin, etc. The difference in flexibility between the first wall portion 3a and the second wall portion 3b can be appropriately set by, for example, different types of materials or different foaming ratios.

[0023] The second wall portion 3b is made up of a pair of second walls 3b1 that face each other in a direction along the central axis O of the shaft 4 when viewed in the normal direction (see FIG. 2) and are each located on the central axis O. Each of the pair of second walls 3b1 contacts one side of the face material portion 2 without being fixed to that side.

[0024] The first wall portion 3a is made up of a pair of first walls 3a1 that face each other in a direction perpendicular to the central axis O of the shaft 4 when viewed in the normal direction (see FIG. 2). Each of the pair of first walls 3a1 is fixed to one side of the face material portion 2.

[0025] As shown in Figure 1, the face material part 2 has a part having an enclosed area 2a on one side, a part connected to this part and having an area facing the enclosure part 3 on the other side, and a connecting part 2b that integrally connects this part to the tip part of the shaft 4, and the shaft 4 supports the enclosure part 3 via the connecting part 2b. The structure in which the shaft 4 supports the enclosure part 3 is not limited to this, and for example, the tip part of the shaft 4 may be directly connected to the enclosure part 3. The shaft 4, together with the enclosure part 3, is rotatable relative to the outer cylinder 5 about the central axis O.

[0026] The face material portion 2 is flexible and is formed from, for example, silicone rubber, polyurethane, polyethylene, polycarbonate, polyamide, polystyrene, polypropylene, polyacetal resin, polyimide, polyetherimide, polyetheretherketone, polyethylene terephthalate, or fluororesin.

[0027] 4, the outer cylinder 5 has an inner peripheral surface that is rounded when viewed in the axial direction along the central axis O of the outer cylinder 5, and in the undeployed state, the surrounding portion 3 and the face material portion 2 have a rounded shape along the inner peripheral surface of the outer cylinder 5 when viewed in the axial direction of the outer cylinder 5. In the undeployed state, portions of the outer wall surfaces 3d of the pair of first walls 3a1 may come into contact with each other.

[0028] In this embodiment, the surrounding portion 3 and the face material portion 2 are folded so that the face material portion 2 is positioned radially outward of the surrounding portion 3 when viewed in the axial direction of the outer tube 5 in the unexpanded state as shown in Figure 4. However, this is not limiting, and the surrounding portion 3 and the face material portion 2 may also be configured to be folded so that the face material portion 2 is positioned radially inward of the surrounding portion 3 when viewed in the axial direction of the outer tube 5.

[0029] The outer cylinder 5 has a circular cylindrical shape, but is not limited to this, and may have a cylindrical shape other than a circular shape. The outer cylinder 5 may have a notch such as a slit extending in the axial direction or the like.

[0030] 1 and other figures, the medical device 1 has a supply lumen 6 that supplies a therapeutic liquid to the inside of the enclosure 3. The medical device 1 has a supply tube 7 that extends through the inside of the shaft 4 and penetrates the outer wall surface 3d of the enclosure 3, and the supply tube 7 has the supply lumen 6.

[0031] The medical device 1 of this embodiment can realize the following exemplary treatment method. In this example, the treatment method includes a delivery step of delivering the enclosure 3 and face material 2 in a non-deployed state to a treatment site 8 in a living body such as a human, and a deployment step of unfolding the enclosure 3 and face material 2 delivered to the treatment site 8 to a deployed state. This configuration allows the enclosure 3 and face material 2 to be easily delivered to the treatment site 8. Furthermore, the expanded enclosure 3 and face material 2 can be used to place a therapeutic substance at the treatment site 8. Furthermore, the second wall 3b (see FIG. 3 ), which is positioned on the central axis O of the shaft 4 when viewed in the normal direction and thus has the greatest curvature when viewed from the outer wall surface 3d toward the inner wall surface 3c in the folded, non-deployed state, is more flexible than the first wall 3a. Therefore, the enclosure 3 can be easily set to the non-deployed state before delivery. Furthermore, in this embodiment, the second wall 3b, which has the greatest curvature, is not fixed to one side of the face material 2, as described above, making the device easier to fold and more easily settable.

[0032] The treatment portion 8 is not particularly limited and may be, for example, the pericardium or abdominal wall. The therapeutic substance is not particularly limited and may be, for example, a drug or cells. The drug is not particularly limited and may be, for example, a low molecular weight compound, a protein, a plasmid, a gene, a growth factor, a chemoattractant, a synthetic polypeptide, an extracellular vesicle, or an exosome. The cells are not particularly limited and may be, for example, somatic cells or stem cells. The cells are, for example, cardiomyocytes derived from somatic stem cells (adult stem cells), mesenchymal stem cells, or iPS cells (induced pluripotent stem cells). The somatic stem cells are preferably skeletal myoblasts (myoblast cells).

[0033] The treatment method of this example includes a supply step of supplying a treatment liquid to the inside of the enclosure 3 in the expanded state through the supply lumen 6. According to the above configuration, after supplying the treatment liquid containing a therapeutic substance, it can be temporarily held by the enclosure 3 and the face material 2 before being placed in the treatment unit 8. The treatment liquid flows through the supply lumen 6 and is supplied to the inside of the enclosure 3. The treatment liquid may be supplied with the face material 2 positioned below the enclosure 3, or it may be supplied inside the space formed by the face material 2, enclosure 3, and treatment unit 8 with the face material 2 positioned above the enclosure 3 and the enclosure 3 pressed against the treatment unit 8 positioned below. At this time, the orientation of the enclosure 3 can be adjusted by appropriately rotating the shaft 4 relative to the outer tube 5.

[0034] In this example, the treatment liquid has a hardening property that hardens into a gel, and the treatment method includes a hardening step of hardening the treatment liquid inside the enclosure 3 and an arrangement step of placing the hardened treatment liquid in the treatment section 8. With the above configuration, the treatment substance can be easily arranged and retained in the treatment section 8. The hardened treatment liquid may be arranged in the treatment section 8 located below the enclosure 3 and the face material section 2 as shown in FIG. 1, or may be arranged in the treatment section 8 located above the enclosure 3 and the face material section 2, although this is not shown.

[0035] The treatment liquid contains, in addition to the treatment substance, a sclerosing agent, which is a liquid agent with a hardening property that causes the treatment substance to lose its fluidity. The sclerosing agent is not particularly limited, and may be, for example, a two-component mixture (e.g., a mixture of fibrinogen and thrombin) that hardens by mixing two types of liquid agents. In this case, the first and second agents may be supplied sequentially through the supply lumen 6, may be supplied simultaneously, or may be mixed in advance before supply. A supply lumen 6 for supplying the first agent and another supply lumen 6 for supplying the second agent may be provided.

[0036] In the first embodiment, the shaft 4 supports the enclosure 3 via the connecting portion 2b of the face material portion 2. However, this is not a limitation, and for example, as in the second embodiment shown in FIGS. 5A to 5C, the shaft 4 may be configured to directly support the enclosure 3. Furthermore, in the first embodiment, the supply lumen 6 is provided for flowing the treatment fluid. However, this is not a limitation, and for example, as in the second embodiment, the supply needle 10 may be provided for sucking the inside of the enclosure 3 and for supplying the treatment fluid. The supply needle 10 changes from a non-insertion state (see FIGS. 5A to 5B) in which it is not inserted into the enclosure 3 in the deployed state to a protrusion state (see FIG. 5C) in which it is inserted into the enclosure 3 and supplies the treatment fluid in the protrusion state. The suction portion 9 is provided with a suction lumen 9a for flowing the fluid sucked from the inside of the enclosure 3. The supply needle 10 protrudes into the enclosure 3 through the supply lumen 6. The supply lumen 6 may not be provided, and the supply needle 10 may be inserted into the inside of the enclosure 3 through the suction lumen 9a.

[0037] The medical device 1 of the second embodiment can realize the following exemplary treatment method. In this example, the treatment method includes a facing step (see FIG. 5A) in which one side of the face material portion 2 in the deployed state faces the treatment portion 8 after the delivery step and the deployment step; a suction step (see FIG. 5B) in which, with one side of the face material portion 2 facing the treatment portion 8, the treatment portion 8, such as the pericardium, is drawn into the enclosure portion 3 by suction with the suction unit 9 (see the hollow arrow in FIG. 5B); and an injection step (see FIG. 5C) in which the supply needle 10 is inserted into the drawn treatment portion 8 by changing its non-insertion state from an insertion state to an insertion state, and a treatment liquid is injected into the treatment portion 8. The treatment liquid does not need to contain a sclerosing agent. According to the above configuration, the treatment liquid can be easily supplied directly to the treatment portion 8, such as the pericardium. In the suction step, even if the opposing surface 3e of the second wall 3b1 and one side of the face material portion 2 are not in close contact, the suction with the suction unit 9 can bring them into close contact, thereby exerting a suction force that draws the treatment portion 8 into the enclosure portion 3.

[0038] Although the embodiments of the present disclosure have been described above, the present disclosure is not limited to the above-described embodiments, and the above-described embodiments can be modified in various ways without departing from the gist of the present disclosure. [Explanation of symbols]

[0039] 1. Medical Devices 2. Surface material section 2a Enclosed area 2b Connecting part 3 Enclosure 3a 1st wall 3a1 1st wall 3b 2nd wall part 3b1 2nd wall 3c Inner wall surface 3d exterior wall surface 3e Opposite surface 3F top 4 shafts 5 outer cylinder 6 Lumens Delivered 7 Supply Tube 8 Treatment Department 9 Suction part 9a suction lumen 10 supply needle O center axis

Claims

1. A medical device comprising: A face material portion; an enclosure portion installed on one surface of the face material portion, the enclosure portion extending so as to surround the enclosed area on the one surface of the face material portion, the enclosure portion comprising a first wall portion and a second wall portion that is softer than the first wall portion; a shaft supporting the surrounding portion, the second wall portion being located on a central axis of the shaft when viewed in a normal direction that is a direction perpendicular to the surrounded area of ​​the face material portion; an outer cylinder that accommodates the shaft radially inside, wherein the surrounding portion and the face material portion change from a non-deployed state in which they are accommodated in the outer cylinder in a folded state to a deployed state in which they are deployed by being ejected to the tip side of the outer cylinder; Medical devices.

2. the first wall portion is fixed to the one surface of the face material portion, The medical device according to claim 1 , wherein the second wall portion contacts the one surface of the face material portion without being fixed to the one surface.

3. The medical device according to claim 1 , wherein the second wall portion comprises a pair of second walls that face each other in a direction along the central axis of the shaft when viewed in the normal direction and are each located on the central axis.

4. The outer cylinder has an inner peripheral surface that is round when viewed in an axial direction along a central axis of the outer cylinder, The medical device according to claim 1, wherein the surrounding portion and the surface material portion, when viewed in the axial direction of the outer tube, have a rounded shape along the inner circumferential surface of the outer tube in the undeployed state.

5. The medical device of claim 1 , further comprising a supply lumen for supplying a therapeutic fluid to the interior of the enclosure.

6. a suction part that sucks the inside of the enclosure part; 2. The medical device of claim 1, further comprising a supply needle that changes from a non-extending state in which it does not extend into the interior of the enclosure in the deployed state to a protruding state in which it extends into the interior of the enclosure, and that supplies therapeutic fluid in the protruding state.

7. A method of treatment using the medical device of claim 1, comprising: a delivery step of delivering the surrounding portion and the face material portion in the undeployed state to a treatment site in a living body; and an unfolding step of unfolding the surrounding portion and the face material portion delivered to the treatment portion to bring them into the unfolded state.

8. the medical device includes a suction unit that suctions the inside of the enclosure, and a supply needle that changes from a non-extending state in which it does not extend into the inside of the enclosure in the deployed state to a protruding state in which it extends into the inside of the enclosure, and supplies a therapeutic liquid in the protruding state; an opposing step of causing one surface of the face material portion in the expanded state to face the treatment portion; a suction step of drawing the treatment portion into the inside of the enclosure by suction of the suction part with the one surface of the face material part facing the treatment portion; The treatment method according to claim 7, further comprising an injection step of inserting the supply needle into the retracted treatment portion by changing the supply needle from the non-inserted state to the inserted state, and injecting the treatment liquid into the treatment portion.

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