Medical devices

Abstract

To provide a medical device capable of performing a puncture on a wide area of a living body surface.SOLUTION: A medical device 10 includes a long-sized shaft part 20 and a carrier member 30 provided at a tip of the shaft part 20. The carrier member 30 has a first surface 31 facing one side and a second surface 32 facing the other side opposite to the first surface 31. The first surface 31 is provided with an expandable expansion body 40, and the second surface 32 is provided with a plurality of needle-like projection parts 33. The shaft part 20 has an inner cylinder 22 having a carrier member 30 at the tip and an outer cylinder 21 covering an outer peripheral side of the inner cylinder 22. The inner cylinder 22 can be moved along a longitudinal direction with respect to the outer cylinder 21, and the carrier member 30 is stored in a state of being folded inside the outer cylinder 21.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a medical device that can puncture needle-like protrusions while adhering to the body surface.

Background Art

[0002] As a method for performing minimally invasive treatment, endoscopic surgery can be mentioned. For example, as in Patent Document 1, a medical device for delivering a medical sheet to a predetermined position in a living body under an endoscope is known.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] In coronary microvascular dysfunction, sufficient blood flow is not supplied to the arteries after the coronary microvessels on the more peripheral side than the coronary artery, resulting in myocardial ischemia. In this case, it is difficult to perform treatment even by percutaneous coronary intervention (PCI). Therefore, a treatment for directly delivering a drug or cells to be transplanted to myocardial tissue is considered.

[0005] In order to enhance the therapeutic effect of the above treatment, it is desirable for the medical device to be able to access the myocardial cavity within the pericardium and puncture a large area. To perform puncture, it is necessary to generate a force that can counteract the reaction force against the needle from the body surface. The medical device as described in Patent Document 1 can contact the surface of the pericardium and deliver a medical sheet, but it is not configured to enable puncture. <00​​​[Means for solving the problem]

[0007] The medical device according to the present invention, which achieves the above objective, comprises a long shaft portion and a portion provided at the tip of the shaft portion. Thin film The device comprises a carrier member, the carrier member having a first surface facing one side and a second surface facing the other side opposite to the first surface, the first surface being provided with an expandable extension and the second surface being provided with a plurality of needle-like projections. The shaft portion comprises an inner cylinder having the carrier member at its tip and an outer cylinder covering the outer circumference of the inner cylinder, the inner cylinder being movable along the longitudinal axis relative to the outer cylinder, the carrier member being stored inside the outer cylinder in a folded state and becoming open when exposed to the outside of the outer cylinder, having pleats at both ends in the open state, and the expandable body being positioned on the first surface of the carrier member toward the tip side of the pleats. . [Effects of the Invention]

[0008] As described above, the (1) medical device, when the carrier member is placed in the lumen of the living body, is pressed against the second surface by the reaction force when the expandable body expands, allowing the needle-like projection to puncture the living body surface. This enables the medical device to puncture a wide area of ​​the living body surface.

[0009] (2) In the medical device described in (1) above, the shaft portion may have a fluid injection lumen along the longitudinal axis, and the needle-shaped projection may have a hollow portion that communicates with the fluid injection lumen and has an open tip. This allows the medical device to administer drugs to a living body via the needle-shaped projection.

[0010] (3) In the medical device described in (1) above, the needle-shaped projection may be solid inside. This allows the medical device to be used for adhering a medical sheet or for administering a drug applied to the needle-shaped projection.

[0012] (5) In any one of the medical devices described in (1) to (4) above, the shaft portion may have an expansion lumen along the longitudinal axis, and the expansion lumen may communicate with the inside of the expansion body. This allows the medical device to reliably expand the expansion body at a desired timing. [Brief explanation of the drawing]

[0013] [Figure 1] This is a perspective view of the medical device according to this embodiment. [Figure 2] This is a perspective view of a medical device with an extended structure. [Figure 3] This is a magnified perspective view of the area near the tip of the outer cylinder where the carrier components are housed. [Figure 4] This is a cross-sectional view of a medical device in which a carrier component is placed within the pericardial cavity. [Figure 5] This is a cross-sectional view of a medical device in which an expanded carrier component is placed in the pericardial cavity. [Figure 6] This is a cross-sectional view of a modified medical device, in which an expanded carrier member placed in the pericardial cavity is expanded. [Modes for carrying out the invention]

[0014] Embodiments of the present invention will be described below with reference to the drawings. Note that the dimensional ratios in the drawings may be exaggerated for illustrative purposes and may differ from the actual ratios. In this specification, the side of the medical device 10 that is inserted into the body will be referred to as the "tip" or "tip side," and the side that is operated by the user will be referred to as the "proximal end" or "proximal end side."

[0015] The medical device 10 of this embodiment is for contacting the surface of a living body and puncturing it with a needle-shaped projection 33. This medical device 10 is used, for example, to treat severe heart failure due to ischemic heart disease. In this case, the medical device 10 is inserted into the pericardial cavity within the pericardium of the heart, and the needle-shaped projection 33 punctures the epicardium on the myocardial side of the pericardial cavity.

[0016] First, the configuration of the medical device 10 will be described. As shown in Figure 1, the medical device 10 comprises a long shaft portion 20 and a carrier member 30 provided at the tip of the shaft portion 20. The carrier member 30 is formed in the shape of a thin film. An expandable expander 40 is placed on the carrier member 30. As shown in Figure 2, the expander 40 can be expanded on the carrier member 30.

[0017] The shaft portion 20 has an inner cylinder 22 having a carrier member 30 at its tip end, and an outer cylinder 21 covering the outer peripheral side of the inner cylinder 22. The inner cylinder 22 can move along the long axis direction with respect to the outer cylinder 21. By moving the inner cylinder 22 toward the proximal end side with respect to the outer cylinder 21, the carrier member 30 can be housed inside the outer cylinder 21. As shown in FIG. 3, when the carrier member 30 is housed inside the outer cylinder 21, it is in a folded state. The carrier member 30 has hinge portions 30a at both ends in a state of being exposed outside the outer cylinder 21. The hinge portions 30a are formed so as to have a certain angle with respect to the surface of the central portion of the carrier member 30. Therefore, when the carrier member 30 is housed inside the outer cylinder 21, it is likely to be rounded starting from the hinge portions 30a.

[0018] The inner cylinder 22 has an expansion port 50 and a fluid injection port 51 at its proximal end. The expansion port 50 is used to supply expansion fluid to the expander 40. The fluid injection port 51 is used to supply fluid containing a drug to the carrier member 30.

[0019] The outer cylinder 21 and the inner cylinder 22 constituting the shaft portion 20 are formed of, for example, a resin material. The constituent materials of the outer cylinder 21 and the inner cylinder 22 are not particularly limited, and examples include polyethylene, polypropylene, fluororesin, polyethylene terephthalate, polymethyl methacrylate, polyamide resin, polystyrene, polycarbonate, polyimide, polyetherimide, polyetheretherketone, polyvinyl chloride, ABS resin, etc. The outer cylinder 21 and the inner cylinder 22 may be constituted of a metal material.

[0020] The carrier member 30 is formed of a resin material having flexibility. The constituent materials of the carrier member 30 are not particularly limited, and examples include polycarbonate, polyamide, polystyrene, polypropylene, polyacetal resin, polyimide, polyetheretherketone, polyethylene terephthalate, fluororesin, etc.

[0021] The expandable body 40 is formed of a flexible material. Examples of such a material include, but are not limited to, silicone. The expandable body 40 is placed on the first surface 31 facing one of the carrier members 30. Further, the expandable body 40 is disposed in a region on the tip side from the central portion on the first surface 31 of the carrier member 30. Note that the expandable body 40 may be disposed at the central portion of the first surface 31. The expandable body 40 can expand and bulge into a hemispherical shape.

[0022] As shown in FIG. 4, an expandable fluid supply pipe 23 inserted into the inner cylinder 22 is connected to the expandable body 40. An expansion lumen 24 is formed inside the expandable fluid supply pipe 23 and communicates with the inside of the expandable body 40. The expansion port 50 of the inner cylinder 22 communicates with the expansion lumen 24 and can be connected to a fluid supply unit (not shown) such as a syringe. The fluid supply unit can expand the expandable body 40 by injecting an expansion fluid through the expansion lumen 24. The expansion fluid may be a gas or a liquid. For example, gases such as helium gas, CO2 gas, and O2 gas, or liquids such as physiological saline and contrast agents can be used.

[0023] The carrier member 30 has a plurality of needle-like protrusions 33 on the second surface 32 facing the other side opposite to the first surface 31. The needle-like protrusion 33 has a hollow portion 33a with an open tip. The carrier member 30 has a communication lumen 34 communicating with the hollow portion 33a of the needle-like protrusion 33. A drug supply pipe 25 inserted into the inner cylinder 22 is connected to the communication lumen 34. The drug supply pipe 25 has a fluid injection lumen 26 inside. The drug supply pipe 25 communicates with the fluid injection port 51 of the inner cylinder 22. The needle-like protrusion 33 is formed in a range of 0.1 mm to 1.0 mm in length, 0.05 mm to 0.5 mm in outer diameter, and 0.03 mm to 0.4 mm in inner diameter. Further, the needle-like protrusions 33 are provided in a range of 25 to 10,000 on the second surface 32 of the carrier member 30. However, the dimensions and the number of the needle-like protrusions 33 are not limited to this.

[0024] By injecting a fluid containing the drug through the fluid injection port 51, the fluid containing the drug reaches the needle-shaped projection 33 via the fluid injection lumen 26 and the communication lumen 34. In this embodiment, the drug includes not only therapeutic drugs but also cells, exosomes, nucleic acid drugs, etc. The drug may be a liquid including a gel, a solid, or a gas.

[0025] Next, a method for performing a puncture on a target area of ​​a living body using the medical device 10 of this embodiment will be described. The operator prepares the medical device 10 of this embodiment in advance. At this time, the medical device 10 is in a state where the expandable body 40 is contracted and the carrier member 30 is exposed from the outer cylinder 21. When preparing the medical device 10, the operator connects the fluid supply unit for expansion to the expansion port 50 and the fluid supply unit for a drug-containing fluid to the fluid injection port 51. The operator also puts the carrier member 30 inside the outer cylinder 21.

[0026] Once the medical device 10 is prepared, the surgeon inserts the medical device 10 into the thoracic cavity through an incision in the chest. The surgeon then positions the tip of the outer cannula 21 into the pericardial cavity C, a space formed between the pericardium D adjacent to the myocardium A and the parietal pericardium E adjacent to the pericardial sac, within the pericardial cavity B that covers the myocardium A of the heart. At this time, the tip of an endoscope (not shown) is also inserted into the pericardial cavity C.

[0027] Next, the surgeon moves the inner cylinder 22 toward the tip of the outer cylinder 21. This exposes the carrier member 30, which is located at the tip of the inner cylinder 22, from the tip of the outer cylinder 21. The carrier member 30, now exposed from the outer cylinder 21, deforms from a folded state to an open state. As the carrier member 30 opens, as shown in Figure 4, the first surface 31 of the carrier member 30 faces the parietal pericardium E, and the second surface 32 of the carrier member 30 faces the epicardium D. Therefore, the expander 40 on the first surface 31 of the carrier member 30 faces the parietal pericardium E, and the needle-shaped projection 33 on the second surface 32 of the carrier member 30 faces the epicardium D.

[0028] Next, the operator injects dilation fluid through the dilation port 50 to expand the expander 40. As shown in Figure 5, by expanding the expander 40, it presses against the pericardium B, and the needle-shaped projection 33 located on the opposite side is pressed against the myocardium A. This allows the needle-shaped projection 33 to puncture the biological surface. The medical device 10 can reliably puncture a wide area of ​​the biological surface with the needle-shaped projection 33 due to the reaction force acting from the pericardium B to the expander 40.

[0029] Since the expander 40 is positioned in the area of ​​the carrier member 30 that is closer to the tip than the central part, the expansion of the expander 40 within the pericardial cavity C can change the angle of the carrier member 30 and the shaft portion 20 connected thereto. Therefore, even if the carrier member 30 is positioned at an angle to the epicardium D before the expander 40 is expanded, the carrier member 30 can be positioned parallel to the epicardium D when the expander 40 is expanded. This allows the needle-shaped projection 33 to puncture perpendicular to the biological surface. Similarly, even if the expander 40 is positioned in the central part of the carrier member 30, the position of the carrier member 30 can be optimized when the expander 40 is expanded.

[0030] Once the needle-shaped projection 33 is punctured into the living surface, the operator injects a fluid containing the drug through the fluid injection port 51. The fluid containing the drug reaches the hollow portion 33a of the needle-shaped projection 33 via the fluid injection lumen 26 of the drug supply tube 25 and the communication lumen 34 of the carrier member 30. Since the needle-shaped projection 33 is punctured into the parietal pericardium E, the drug is delivered to the living body from the hollow portion 33a of the needle-shaped projection 33.

[0031] Once drug delivery is complete, the operator retracts the expander 40. This eliminates the force pressing the needle-shaped projection 33 against the body surface, causing the needle-shaped projection 33 to be withdrawn from the body surface. Next, the operator moves the inner cylinder 22 towards the proximal end and stores the carrier member 30 inside the outer cylinder 21. As a result, the carrier member 30 is stored in the outer cylinder 21 in a folded state. After that, the operator removes the medical device 10 and the endoscope from the body and completes the procedure.

[0032] A modified version of the medical device will now be described. As shown in Figure 6, the modified medical device 60 has a carrier member 80 at the tip of the inner cylinder 72 that constitutes the shaft portion 70. An expandable body 90 is provided on the first surface 81 of the carrier member 80, and a plurality of needle-shaped projections 83 are provided on the second surface 82 of the carrier member 80. In this example of the medical device 60, the inside of the needle-shaped projections 83 is solid.

[0033] The medical device 80 in this example can improve the adhesion of the medical sheet 100 to the biological surface and prevent peeling by puncturing the medical sheet 100, which is pre-attached to the epicardium D, with its needle-shaped projection 83. The needle-shaped projection 83 has a length that allows it to penetrate the medical sheet 100 and puncture the biological surface. This makes it possible to make the medical sheet 100 adhere more closely to the biological surface.

[0034] Furthermore, the medical device 80 in this example can be used for purposes other than adhering to the medical sheet 100. For example, the medical device 80 can also be used to administer drugs to a living body by pre-applying a drug to the needle-shaped projection 83 and then puncturing the living body surface with the needle-shaped projection 83.

[0035] As described above, the medical device 10 according to this embodiment comprises a long shaft portion 20 and a carrier member 30 provided at the tip of the shaft portion 20. The carrier member 30 has a first surface 31 facing one side and a second surface 32 facing the other side opposite to the first surface 31. The first surface 31 is provided with an expandable expander 40, and the second surface 32 is provided with a plurality of needle-shaped projections 33. With the medical device 10 configured in this way, when the carrier member 30 is placed in the lumen of a living body, the second surface 32 is pressed by the reaction force when the expander 40 expands, allowing the needle-shaped projections 33 to puncture the living body surface. As a result, the medical device 10 can puncture a wide area of ​​the living body surface.

[0036] The medical device 10 has a shaft portion 20 with a fluid injection lumen 26 along its long axis, and the needle-shaped projection 33 may have a hollow portion 33a that communicates with the fluid injection lumen 26 and has an open tip. This allows the medical device 10 to administer drugs to a living body via the needle-shaped projection 33.

[0037] The medical device 60 may have a solid core inside the needle-shaped projection 83. This allows the medical device 60 to be used for adhering the medical sheet 100 or for administering a drug applied to the needle-shaped projection 83.

[0038] The medical device 10 has a shaft portion 20 which includes an inner cylinder 22 having a carrier member 30 at its tip and an outer cylinder 21 covering the outer circumference of the inner cylinder 22. The inner cylinder 22 is movable along its long axis relative to the outer cylinder 21, and the carrier member 30 may be stored inside the outer cylinder 21 in a folded state. This allows the medical device to easily deliver the carrier member 30 to the target site.

[0039] The medical device 10 has a shaft portion 20 with an expansion lumen 24 along its long axis, and the expansion lumen 24 may communicate with the inside of the expansion body 40. This allows the medical device 10 to reliably expand the expansion body 40 at the desired timing.

[0040] It should be noted that the present invention is not limited to the embodiments described above, and various modifications can be made by those skilled in the art within the technical framework of the present invention. [Explanation of symbols]

[0041] 10 Medical Devices 20 Shaft section 21 Outer cylinder 22 Inner cylinder 23. Expanding fluid supply pipe 24 Extended Lumens 25 Drug supply tube 26 Fluid injection lumens 30 Carrier components 31 Page 1 32 Side 2 33 Needle-like protrusion 33a Hollow part 34 continuous lumens 40 extensions 50 expansion ports 51 Fluid injection port 60 medical devices 70 Shaft section 72 Inner cylinder

Claims

1. The long shaft section, The shaft portion comprises a thin-film carrier member provided at the tip of the shaft portion, The carrier member has a first surface facing one side and a second surface facing the other side opposite to the first surface. The first surface is provided with an expandable extension, The second surface is provided with a plurality of needle-like projections, The shaft portion comprises an inner cylinder having the carrier member at its tip, and an outer cylinder covering the outer circumference of the inner cylinder. The inner cylinder is movable along the longitudinal axis relative to the outer cylinder, The carrier member is stored inside the outer cylinder in a folded state, and becomes open when exposed to the outside of the outer cylinder, and in this open state has pleated portions at both ends. The expansion body is a medical device positioned on the first surface of the carrier member toward the tip of the pleat.

2. The shaft portion has a fluid injection lumen along the longitudinal axis, The medical device according to claim 1, wherein the needle-shaped projection communicates with the fluid injection lumen and has a hollow portion with an open tip.

3. The medical device according to claim 1, wherein the needle-shaped projection is solid inside.

4. The shaft portion has an expanded lumen along the longitudinal axis, The medical device according to any one of claims 1 to 3, wherein the expanded lumen is in communication with the inside of the expanded body.

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