Medical devices
The medical device forms a closed space between tissue walls for controlled drug delivery and diffusion, addressing the challenge of targeted drug delivery between biological tissues.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- TERUMO KK
- Filing Date
- 2022-08-30
- Publication Date
- 2026-07-01
AI Technical Summary
Existing medical devices face challenges in delivering drugs to a specific area between opposing biological tissues, such as the myocardial tissue, due to difficulties in controlling the drug delivery range and risk of unintended diffusion.
A medical device with an enclosure portion at its tip that forms a substantially closed space between opposing walls of biological tissue, allowing controlled drug delivery and diffusion using a movable vibrator.
Enables targeted drug delivery and diffusion within a limited area, suppressing unintended diffusion by forming a closed space between tissue walls.
Smart Images
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Abstract
Description
Technical Field
[0001] The present invention relates to a medical device disposed between opposing walls of a biological tissue.
Background Art
[0002] Medical devices are known that have a tube inserted into the body for delivering a drug, and have a drug release hole at the tip of the tube. As such a medical device, as described in Patent Document 1, there is also known one that granulates a drug by an ultrasonic vibrator in order to effectively deliver the drug.
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 peripheral side of the coronary artery, resulting in myocardial ischemia. In this case, it is difficult to perform treatment even by percutaneous coronary intervention (PCI). Therefore, a procedure for directly delivering a drug to myocardial tissue is considered.
[0005] In order to perform a minimally invasive procedure for directly delivering a drug to myocardial tissue, it is preferable to use an endoscope. However, when an endoscope is used, since the location where the drug is to be delivered is sandwiched between opposing walls of a biological tissue, it is difficult to deliver the drug over a wide range. It is also conceivable to diffuse the drug using an ultrasonic vibrator as in Patent Document 1, but in this case, it is difficult to control the range where the drug is delivered, resulting in a risk that the drug diffuses to an unintended location.
[0006] The present invention was made to solve the above-mentioned problems and aims to provide a medical device that can deliver a drug to an intended area between opposing walls of biological tissue. [Means for solving the problem]
[0007] A medical device (1) according to the present invention that achieves the above objective is a medical device that is placed between two opposing walls of biological tissue, and has an enclosure portion at the tip of the shaft portion that surrounds a certain area, and when the enclosure portion is placed between the two walls, the enclosure portion and both or one of the walls form a substantially closed space. The enclosure is positioned between one wall and the other wall and is composed of a strip-shaped body with both sides in the width direction in contact with both walls. The shaft comprises a support shaft having the enclosure at its tip and an outer cylinder covering the outer circumference of the support shaft. The support shaft is movable along its longitudinal axis relative to the outer cylinder. The enclosure is stored inside the outer cylinder in a folded state and forms a loop when exposed outside the outer cylinder, and deforms so that one end of the strip-shaped body in the longitudinal direction is located near the other end. . [Effects of the Invention]
[0008] The medical device configured as described above can form a nearly closed space between opposing walls of biological tissue, thereby allowing for the delivery of drugs to a limited area.
[0009] (2) The medical device described in (1) above may have a vibrator placed in the space. This allows the medical device to efficiently diffuse the drug within the space.
[0012] (5) In the medical device described in (4) above, the enclosure may have an opening in part. This makes it possible to reduce the thickness of the enclosure in the medical device. [Brief explanation of the drawing]
[0015] [Figure 1] This is a front view of the medical device according to this embodiment. [Figure 2] This is a magnified perspective view of the area near the tip of a medical device. [Figure 3] This is a magnified perspective view of the area near the tip of the medical device with the enclosure retracted into the outer cylinder. [Figure 4] This is an explanatory diagram showing a medical device inserted into a patient's heart. [Figure 5]It is an enlarged perspective view of the vicinity of the tip of the medical device in a state where the drug is disposed inside the enclosure part. [Figure 6] It is a cross-sectional view in which an enclosure part is disposed between walls facing each other. [Figure 7] It is an enlarged perspective view of the vicinity of the tip of the medical device according to a modification. [Figure 8] It is an enlarged perspective view of the vicinity of the tip of the medical device according to a modification in a state where the enclosure part is housed in an outer cylinder. [Figure 9] It is a bottom view of the vicinity of the enclosure part of the medical device according to a modification. [Figure 10] It is an enlarged perspective view of the vicinity of the tip of the medical device provided with an opening in the enclosure part. [Figure 11] It is an enlarged perspective view of the vicinity of the tip of the medical device with the vibrator being movable. [Figure 12] It is an enlarged perspective view of the vicinity of the tip of the medical device having an injection tube. [Figure 13] It is a cross-sectional view in which the enclosure part of FIG. 12 is disposed between walls facing each other.
Mode for Carrying Out the Invention
[0016] Hereinafter, embodiments of the present invention will be described with reference to the drawings. Note that the dimensional ratios in the drawings may be exaggerated for convenience of explanation and may be different from the actual ratios. In this specification, the side of the medical device 10 inserted into the living body will be referred to as "tip" or "tip side", and the hand side for operation will be referred to as "base end" or "base end side".
[0017] The medical device 10 of the present embodiment is inserted into the space between the epicardium and the parietal pericardium of the heart at the tip, and is used to diffuse a gel-like drug injected into the space by another device within a certain range. This medical device 10 is used, for example, in the treatment of severe heart failure due to ischemic heart disease. In the present embodiment, the drug includes, in addition to drugs having a therapeutic effect, cells, exosomes, nucleic acid drugs, and the like. The drug is used in a gel state.
[0018] The configuration of the medical device 10 will be described. As shown in FIG. 1, the medical device 10 includes a long shaft portion 20 and a handpiece portion 30 that supports the shaft portion 20. The handpiece portion 30 is connected to an oscillator 40 that oscillates a high-frequency current.
[0019] The shaft portion 20 has a tubular outer cylinder 21. The outer cylinder 21 houses an enclosure portion 50 inside the tip. The enclosure portion 50 is supported by a support shaft 22 housed inside the outer cylinder 21. The support shaft 22 can move along the longitudinal axis with respect to the outer cylinder 21. Inside the enclosure portion 50, a vibrator 60 connected to the oscillator 40 is provided. The vibrator 60 is connected to the handpiece portion 30 by a connecting body 61. The vibrator 60 can move along the longitudinal axis with respect to the outer cylinder 21 together with the support shaft 22.
[0020] The handpiece portion 30 has an operation handle 32 that moves the support shaft 22 with respect to the outer cylinder 21 and an operation portion 33 that operates the vibration of the vibrator 60. The operator can house the enclosure portion 50 and the vibrator 60 in the outer cylinder 21 or expose them from the outer cylinder 21 by means of the operation handle 32. Further, the operator can ultrasonically vibrate the vibrator 60 by the high-frequency current from the oscillator 40 by operating the operation portion 33.
[0021] As shown in FIG. 2, the enclosure portion 50 is constituted by a belt-like body 52. One end portion 53 of the belt-like body 52 is connected to the support shaft 22. The belt-like body 52 has shape memory and deforms to form a loop in a state of being exposed from the outer cylinder 21. The other end portion 54 of the belt-like body 52 is located in the vicinity of one end portion 53 of the belt-like body 52. The enclosure portion 50 can be formed of an alloy having shape memory such as Ni-Ti. The vibrator 60 is disposed in the region inside the enclosure portion 50 in a state of being exposed outside the outer cylinder 21.
[0022] The enclosure 50 can be housed inside the outer cylinder 21 by moving the support shaft 22 toward the base end relative to the outer cylinder 21. As shown in Figure 3, the enclosure 50 is folded when housed inside the outer cylinder 21.
[0023] The outer cylinder 21 and support shaft 22 that constitute the shaft portion 20 are formed from, for example, a resin material. The constituent materials of the outer cylinder 21 and support shaft 22 are not particularly limited, but 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 support shaft 22 may also be made of a metal material.
[0024] Next, a method for delivering a drug to a target area of a living organism 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 enclosure 50 and the vibrator 60 are exposed from the outer cylinder 21. When preparing the medical device 10, the operator puts the enclosure 50 and the vibrator 60 into the outer cylinder 21.
[0025] The surgeon inserts an endoscope 100 into the thoracic cavity and uses an ultrasonic scalpel (not shown) and forceps (not shown) to make the medical device 10 and injection syringe 110 accessible to the heart S. Next, as shown in Figure 4, the surgeon inserts the medical device 10 and injection syringe 110 into the thoracic cavity through a chest incision. The injection syringe 110 contains a gel-like drug that can be injected into the heart S. The tip of the medical device 10 is inserted into the pericardium, the space formed between the epicardium adjacent to the myocardium and the parietal pericardium adjacent to the pericardium.
[0026] Next, the operator moves the support shaft 22 toward the tip of the outer cylinder 21. This exposes the enclosure 50 and the vibrator 60, which are located at the tip of the support shaft 22, from the tip of the outer cylinder 21. The enclosure 50, exposed from the outer cylinder 21, deforms from a folded state to an open state. As shown in Figure 5, the enclosure 50 exposed from the outer cylinder 21 can open to surround a certain area.
[0027] As the enclosure portion 50, positioned within the pericardial cavity C, opens, the enclosure portion 50 is positioned so as shown in Figure 6, sandwiched between the opposing walls of biological tissue, the epicardium D and the parietal pericardium E. At this time, both sides of the band-shaped body 52 in the width direction of the enclosure portion 50 abut against the epicardium D and the parietal pericardium E, respectively, and the enclosure portion 50 and the walls on both sides (epidamicardium D and parietal pericardium E) form a substantially closed space P.
[0028] Next, the operator uses an injection syringe 110 to inject the gel-like drug 120 into the space P formed by the enclosure 50 and the walls on both sides. This places the gel-like drug 120 within the space P. The gel-like drug 120 is also positioned to be in contact with the vibrator 60.
[0029] Once the drug 120 is placed in the space P, the operator operates the control unit 33 to vibrate the transducer 60. The ultrasonic vibration of the transducer 60 diffuses the gel-like drug 120 that is in contact with it. At this time, the space P in which the drug 120 and the transducer 60 are placed is substantially closed by the enclosure 50 and the walls on both sides, so the diffusion of the drug 120 outside the space P can be suppressed. Therefore, the medical device 10 can diffuse the drug 120 within a certain range and suppress the diffusion of the drug 120 into unintended areas.
[0030] If the drug 120 has been injected into multiple locations in the pericardial cavity C, the operator moves the tip of the medical device 10 so that the drug 120 is positioned within the space P formed by the enclosure 50, and brings the vibrator 60 into contact with the drug 120. The operator then diffuses the drug 120 within the space P using the vibrator 60. Once all of the drug 120 has been diffused, the operator removes the medical device 10 and other devices from the patient, and the procedure is completed.
[0031] Next, a modified version of the medical device will be described. As shown in Figure 7, the modified medical device 70 has a shaft portion 71 in which a support shaft 73 is housed inside an outer cylinder 72, an enclosure portion 74 provided at the tip of the shaft portion 71, and a vibrator 77 arranged so as to be surrounded by the enclosure portion 74. The enclosure portion 74 is composed of a membrane-like body 75 fixed to the tip of the support shaft 73. The membrane-like body 75 can be made of a flexible resin such as silicone. The membrane-like body 75 has a dome shape when exposed from the outer cylinder 72 and is arranged to cover one of the two opposing walls of the biological tissue.
[0032] As shown in Figure 8, the enclosure portion 74 is stored in the outer cylinder 72 in a folded state. As shown in Figure 9, the membrane-like body 75 is provided with a plurality of bone members 76 along the shape of the membrane-like body 75. The bone members 76 are formed in the shape of thin wires using an alloy with shape memory properties. Due to the bone members 76, the membrane-like body 75 exposed from the outer cylinder 72 expands into a dome shape.
[0033] When the enclosure portion 74 is positioned between two opposing walls of biological tissue, it forms a substantially closed space P with one of the walls. Thus, the enclosure portion 74 may be shaped to cover one of the walls.
[0034] As shown in Figure 10, the enclosure portion 74 may have an opening 74a in part. The opening 74a allows the thickness of the enclosure portion 74 to be reduced.
[0035] As shown in Figure 11, the transducer 60 may be movable within the area enclosed by the enclosure 50. The mobility of the transducer 60 allows for more efficient diffusion of the drug.
[0036] As shown in Figures 12 and 13, the medical device 80 may have an injection shaft 84 for injecting the drug 120 into the shaft portion 81. The injection shaft 84 penetrates the inside of the support shaft 83 inserted through the outer cylinder 82, and its tip is located near the vibrator 86. The injection shaft 84 has an injection lumen 84a inside, and the gel-like drug 120 is supplied from the proximal end.
[0037] When using the medical device 80, the surgeon inserts the medical device 80 into the target site, forming a space P with the opposing walls D and E of the biological tissue and the enclosure 85. Then, the surgeon injects the drug 120 into the space P from the injection lumen 84a. After injecting the drug 120 into the space P, the surgeon vibrates the vibrator 86 to diffuse the drug 120 within the space P. In this way, the medical device 80 does not require the use of any other device for injecting the drug 120.
[0038] As described above, the (1) medical device 10 according to this embodiment is a medical device 10 that is positioned between two opposing walls of biological tissue, and has an enclosure portion 50 at the tip of the shaft portion 20 that surrounds a certain area, and when positioned between the two walls, the enclosure portion 50 and both or one of the walls form a substantially closed space portion P. Since the medical device 10 configured in this way can form a substantially closed space portion P between the opposing walls of biological tissue, it is possible to deliver drugs to a limited area.
[0039] (2) The medical device 10 described in (1) above may have a vibrator 60 positioned in the space P. This allows the medical device 10 to efficiently diffuse the drug within the area of the space P.
[0040] (3) In the medical device 10 described in (1) or (2) above, the enclosure portion 50 may be formed in a strip shape and positioned between one wall and the other wall. This allows the medical device 10 to form a closed space P between the enclosure portion 50 and the walls on both sides of the biological tissue.
[0041] (4) In the medical device 70 described in (1) or (2) above, the enclosure portion 74 may be formed in the form of a membrane that covers one of the walls. This allows the medical device 70 to form a closed space P between the enclosure portion 74 and one of the walls of the biological tissue.
[0042] (5) In the medical device 70 described in (4) above, the enclosure portion 74 may have an opening 74a in part. This makes it possible to reduce the thickness of the enclosure portion 74 in the medical device 70.
[0043] (6) In any one of the medical devices 10 described in (1) to (5) above, the shaft portion 20 comprises a support shaft 22 having an enclosure portion 50 at its tip, and an outer cylinder 21 covering the outer circumference of the support shaft 22, wherein the support shaft 22 is movable along the long axis relative to the outer cylinder 21, and the enclosure portion 50 may be stored inside the outer cylinder 21 in a folded state. This allows the medical device 10 to store the enclosure portion 50 in the outer cylinder 21 when inserted into a living body, making insertion to the target site easier.
[0044] (7) In any one of the medical devices 80 described in (1) to (6) above, the shaft portion 81 may have an injection lumen 84a for injecting the drug 120 into the space P formed by the enclosure portion 85. This allows the medical device 80 to inject the drug 120 into the position where the enclosure portion 85 is located, thus enabling the injection and diffusion of the drug 120 without the use of another device.
[0045] 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. In the embodiments described above, the medical device 10 is used to diffuse and deliver a drug injected into the pericardial cavity, but it can also be used to deliver a drug to other parts of the body. [Explanation of Symbols]
[0046] 10 Medical Devices 20 Shaft section 21 Outer cylinder 22 Support shaft 30 Handheld section 32 Operating handles 33 Operation section 40 Oscillators 50 Enclosure 52. Band-shaped body 60 transducers 61 Connectors 100 Endoscopes 110 Injection Syringe 120 medications P space S Heart C Pericardial cavity D Epicardium E. Parietal pericardium
Claims
1. A medical device that is placed between two opposing walls of biological tissue, The tip of the shaft has an enclosure that surrounds a certain area. The enclosure is positioned between the two walls, and together with the walls, it forms a substantially enclosed space. The enclosure is positioned between one wall and the other wall and is composed of a strip-shaped body whose widthwise sides abut both walls. The shaft portion comprises a support shaft having the enclosure portion at its tip, and an outer cylinder covering the outer circumference of the support shaft. The support shaft is movable along its longitudinal axis relative to the outer cylinder. The enclosure portion is stored inside the outer cylinder in a folded state, and is exposed outside the outer cylinder to form a loop, and the medical device deforms so that one end of the strip-shaped body in the longitudinal direction is located near the other end.
2. The medical device according to claim 1, having a vibrator arranged in the aforementioned space.
3. The medical device according to claim 1 or 2, wherein the shaft portion has an injection lumen for injecting a drug into the space formed by the enclosure portion.