Pericardial puncture device

Abstract

[Problem] To provide a pericardial puncture device capable of notifying an operator of a state in which the pericardium is held by a holding part and a state in which a needle part of a puncture part penetrates the pericardium. [Solution] A pericardial puncture device 10 comprises: a sheath part 100 that includes a holding part 110 configured to be capable of holding part of a pericardium L2 so as to be distanced from an epicardium L1, and a first lumen 120 extending from the holding part to a base end side and in communication with the inside of the holding part; a puncture part 200 that is disposed inside the sheath part and includes a second lumen 220 through which a drug d to be administered to a pericardial space S between the epicardium and the pericardium can flow, and a needle part 230 which punctures the pericardium held by the holding part; a first detection unit 310 for detecting that the holding part holds the pericardium; a second detection unit 320 for detecting that the needle part has penetrated the pericardium; a first notification unit 410 for notifying of a detection result of the first detection unit; and a second notification unit 420 for notifying of a detection result of the second detection unit.

Description

Pericardial puncture device

[0001] The present invention relates to a pericardial puncture device having a puncture portion that is inserted into the pericardium.

[0002] Various medical devices for locally administering drugs to target sites in biological organs have been developed. For example, when the target biological organ is the heart, drugs are delivered to the heart by intravenous injection or coronary artery injection, but these methods rely on the bloodstream to transport the drugs to the heart, which can make it difficult to administer the expected amount of drug locally.

[0003] In relation to the above-mentioned problems, Patent Document 1 discloses a medical device that can realize local administration of a drug into the pericardial cavity between the epicardium (visceral pericardium) and pericardium (parietal pericardium) of the heart.

[0004] The medical device of Patent Document 1 has a sheath portion (outer jacket) with a lumen, a holding portion (grasping portion) that is positioned at the tip of the sheath portion and holds the pericardium so that it floats above the epicardium, and a puncture portion that is positioned inside the sheath portion.

[0005] The holding portion has a space therein capable of accommodating a portion of the pericardium. A suction device for generating a negative pressure (negative pressure) within the space of the holding portion can be attached to the sheath portion. When the suction device creates a negative pressure within the space, the holding portion draws a portion of the pericardium into the space. This causes the holding portion to separate the portion of the pericardium from the epicardium. The holding portion can maintain the pericardium in a state where it is lifted off the epicardium while the suction device maintains the negative pressure within the space.

[0006] A lumen through which a drug can flow is formed inside the puncture part. When the puncture part is disposed inside the sheath part, it is configured to be movable forward and backward along the axial direction of the sheath part. With the pericardium raised by the holding part as described above, the surgeon can move the puncture part toward the holding part side (tip side), thereby causing the needle part formed at the tip of the puncture part to penetrate the pericardium. When the needle part of the puncture part penetrates the pericardium and the needle part is disposed in the pericardial cavity, the surgeon can deliver the drug through the lumen of the puncture part, thereby locally administering the drug into the pericardial cavity.

[0007] U.S. Patent Application Serial No. 09 / 158,024

[0008] The medical device of Patent Document 1 can realize local administration of a drug into the pericardial cavity, but has the following problems.

[0009] The medical device of Patent Document 1 does not have a structure for informing the surgeon of the state of holding of the pericardium by the holding part and the state of penetration of the needle part into the pericardium. Therefore, in a procedure using the medical device of Patent Document 1, the surgeon cannot confirm the state of gripping of the pericardium or the state of penetration of the needle part, which may lead to a complicated procedure or make it difficult to properly administer a drug locally into the pericardial cavity.

[0010] At least one embodiment of the present invention has been made in consideration of the above-mentioned circumstances, and aims to provide a pericardial puncture device that can notify the surgeon of the holding state of the pericardium by the holding portion and the penetration state of the needle portion of the puncture portion into the pericardium.

[0011] The present invention can be achieved by any one of the following means (1) to (10).

[0012] (1) A pericardial puncture device comprising: a holding portion configured to hold a portion of the pericardium so as to separate it from the epicardium; a sheath portion having a first lumen extending from the holding portion toward the base end and communicating with the inside of the holding portion; a second lumen through which a drug to be administered into the pericardial cavity between the epicardium and the pericardium can flow; and a needle portion that punctures the pericardium held by the holding portion, the pericardial puncture device having a puncture portion disposed within the sheath portion; a first detection portion that detects that the holding portion has held the pericardium; a second detection portion that detects that the needle portion has penetrated the pericardium; a first notification portion that notifies the detection result of the first detection portion; and a second notification portion that notifies the detection result of the second detection portion.

[0013] (2) The pericardial puncture device described in (1) above, wherein the holding portion has a storage portion capable of storing a portion of the pericardium and an opening that allows the pericardium to move inside and outside the storage portion, and the holding portion is configured to store a portion of the pericardium within the storage portion and hold the portion of the pericardium when the inside of the first lumen is suctioned and the inside of the storage portion becomes negative pressure.

[0014] (3) The pericardial puncture device described in (2) above, wherein the first detection unit is configured to detect the holding state of the pericardium by the holding unit based on at least one of changes in the fluid flow state inside and outside the accommodating unit through the opening, the contact state of the pericardium with the accommodating unit, and changes in the shape of the pericardium, and the second detection unit is configured to detect the penetration state of the pericardium by the needle unit based on pressure changes within the second lumen and / or the contact state between the pericardium and the needle unit before and after the needle unit penetrates the pericardium.

[0015] (4) A pericardial puncture device as described in (3) above, which has a first detection space communicating with the first lumen and the storage section, the first detection section being arranged in the first detection space, and the first detection section being configured to detect the retention state of the pericardium based on the flow state of fluid flowing into the first detection space through the first lumen when the flow of fluid between the inside of the storage section and the outside of the storage section is not obstructed by a part of the pericardium, and the first detection section being configured to function as the first notification section.

[0016] (5) The pericardial puncture device described in (3) above, wherein the first detection unit is arranged in the accommodating unit so as to detect the contact state between the accommodating unit and the pericardium and / or changes in the shape of the pericardium.

[0017] (6) A pericardial puncture device described in any one of (3) to (5), which has a second detection space communicating with the second lumen and the storage section, the second detection section being arranged in the second detection space, and the second detection section being configured to detect the penetration state of the needle section into the pericardium based on the change in pressure in the second detection space before and after the needle section penetrates the pericardium held by the holding section when the inside of the second lumen is suctioned, and the second detection section being configured to function as the second notification section.

[0018] (7) The pericardial puncture device described in (6) above, wherein the sheath portion has a switching portion that can selectively switch between a state in which fluid communication is established between the second lumen and the second detection space and a state in which fluid communication is restricted.

[0019] (8) A pericardial puncture device according to any one of (3) to (5), wherein the second detection unit is arranged in the needle portion or the housing portion.

[0020] (9) A pericardial puncture device described in any one of (1) to (8) above, wherein the puncture portion extends in an approximately linear manner from the tip where the needle portion is located to the base end, and the sheath portion has a moving mechanism that enables the puncture portion to move along the axial direction of the sheath portion.

[0021] (10) A pericardial puncture device described in any one of (1) to (8) above, wherein the puncture portion has a straight portion extending in an approximately straight line along the axial direction of the sheath portion, a curved portion curved relative to the straight portion in a direction protruding outside the holding portion, and the needle portion located at the tip side of the curved portion.

[0022] According to at least one embodiment of the present invention, the state of holding of the pericardium by the holding unit can be easily confirmed based on the first notification unit, and the state of penetration of the needle of the puncture unit into the pericardium can be easily confirmed based on the second notification unit, thereby enabling a smooth procedure and appropriate local administration of a drug into the pericardial cavity.

[0023] 1 is a side view showing a pericardial puncture device according to an embodiment; FIG. 2 is a top view showing a pericardial puncture device according to an embodiment; FIG. 3 is a partially enlarged cross-sectional view of the vicinity of the holding part of the pericardial puncture device, showing a state in which the holding part is not holding the pericardium; FIG. 4 is a view showing the first detection part (first notification part) in a state in which the holding part is not holding the pericardium; FIG. 5 is a partially enlarged cross-sectional view of the vicinity of the holding part of the pericardial puncture device, showing a state in which the holding part is holding the pericardium; FIG. 6 is a view showing the first detection part (first notification part) in a state in which the holding part is holding the pericardium; FIG. 7 is a partially enlarged cross-sectional view of the vicinity of the holding part of the pericardial puncture device, showing a state before the needle part of the puncture part penetrates the pericardium; FIG. 8 is a view showing the second detection part (second notification part) in a state before the needle part of the puncture part penetrates the pericardium; FIG. 9 is a partially enlarged cross-sectional view of the vicinity of the holding part of the pericardial puncture device, showing a state in which the needle part of the puncture part has penetrated the pericardium; 10 is a cross-sectional view showing a simplified configuration of a switching unit of a pericardial puncture device. FIG. 10 is a cross-sectional view showing a simplified configuration of a switching unit of a pericardial puncture device. FIG. 10 is a view for explaining a first detection unit (first notification unit) according to Modification 1. FIG. 10 is a view for explaining a first detection unit (first notification unit) according to Modification 1. FIG. 10 is a view for explaining a first detection unit according to Modification 2. FIG. 10 is a view for explaining a first notification unit according to Modification 2. FIG. 10 is a view for explaining a first detection unit according to Modification 2. FIG. 10 is a view for explaining a first notification unit according to Modification 2. FIG. 10 is a view for explaining a second detection unit (second notification unit) according to Modification 3. FIG. 10 is a view for explaining a second detection unit (second notification unit) according to Modification 3. FIG. 10 is a view for explaining a second detection unit according to Modification 4. FIG. 10 is a view for explaining a second detection unit according to Modification 4. FIG. 10 is a view for explaining a second detection unit according to Modification 5. FIG. 10 is a view for explaining a second detection unit according to Modification 6. FIG. 10 is a top view showing a pericardial puncture device according to Modification 7. FIG. 13 is a partially enlarged cross-sectional view showing a pericardial puncture device according to Modification 8.

[0024] Hereinafter, embodiments of the present invention will be described with reference to the drawings. The embodiments shown here are merely examples for embodying the technical concept of the present invention and are not intended to limit the present invention. Furthermore, all other embodiments, examples, and operational techniques that can be conceived by those skilled in the art without departing from the spirit of the present invention are included within the scope and spirit of the present invention, as well as within the scope of the claims and their equivalents.

[0025] Furthermore, for the convenience of illustration and ease of understanding, the drawings attached to this specification may be represented schematically with the scale, aspect ratio, shape, etc. appropriately changed from the actual product, but these are merely examples and do not limit the interpretation of the present invention.

[0026] Furthermore, in the following description, when ordinal numbers such as "first" and "second" are used, unless otherwise specified, they are used for convenience and do not stipulate any particular order.

[0027] In the pericardial puncture device 10 described below, the side on which the holding portion 110 is positioned is referred to as the "tip side," the side on which the hub portion 130 is positioned is referred to as the "base side," and the direction from the tip side to the base side (or from the base side to the tip side) is referred to as the "axial direction."

[0028] The arrow X1 in each drawing indicates the distal end side, and the arrow X2 indicates the proximal end side. The arrows Z1 and Z2 in the side view of the pericardial puncture device 10 shown in Fig. 1 indicate the height direction of the pericardial puncture device 10. The arrows Y1 and Y2 in the top view of the pericardial puncture device 10 shown in Fig. 2 indicate the depth direction of the pericardial puncture device 10.

[0029] A pericardial puncture device 10 according to an embodiment will be described.

[0030] The pericardial puncture device 10 is used to locally administer a drug d into a pericardial cavity S (see FIG. 9 ) separating the epicardium L1 and the pericardium L2. The membrane structure located on the heart side across the pericardial cavity S is the epicardium (visceral pericardium) L1, and the membrane structure located on the outside is the pericardium (parietal pericardium) L2.

[0031] As shown in Figures 1 and 2, the pericardial puncture device 10 has a sheath portion 100, a puncture portion 200, a first detection portion 310, a second detection portion 320, a first notification portion 410, and a second notification portion 420.

[0032] (Sheath portion 100) The sheath portion 100 has a holding portion 110 configured to be able to hold a part of the pericardium L2 so as to separate it from the epicardium L1, a first lumen 120 extending from the holding portion 110 toward the base end and communicating with the inside of the holding portion 110, and a hub portion 130 disposed at the base end of the sheath portion 100.

[0033] The sheath portion 100 has a main body portion 101 made of a hollow tubular member. The first lumen 120 extends through the inside of the main body portion 101. The first lumen 120 communicates with the internal space of the hub portion 130 (the "first region 131" described below) at the proximal end of the main body portion 101.

[0034] As shown in Figures 3 and 5, the holding portion 110 has a housing portion 111 that can house a part of the pericardium L2, and an opening 113 that allows the pericardium L2 to move inside and outside the housing portion 111.

[0035] The accommodation portion 111 is configured to have a space with a predetermined volume and cross-sectional shape. The volume and cross-sectional shape of the accommodation portion 111 are not particularly limited as long as they can accommodate a portion of the pericardium L2 to be held. In this embodiment, the accommodation portion 111 is configured to have a bowl-shaped cross-sectional shape with rounded corners.

[0036] The opening 113 is open so as to face the side facing the pericardium L2 when viewed from the housing portion 111. The "side facing the pericardium L2" is the side indicated by the arrow Z2 in FIG.

[0037] Hub portion 130 is provided with a connection portion 140 to which a drug supply portion 600 can be connected for supplying drug d (see FIG. 9) into second lumen 220 of puncture portion 200 .

[0038] Drug supply unit 600 can be configured, for example, as a known syringe. As shown in Figures 1 and 2, connecting unit 140 is disposed in the internal space of hub unit 130 and is configured to be connectable to a certain range on the distal side of connecting unit 140. The tip tube portion of drug supply unit 600 and the base end portion of puncturing unit 200 can be configured to include a locking mechanism that maintains a liquid-tight connection with each other when puncturing unit 200 is moved to a position where needle 230 punctures pericardium L2 and drug supply unit 600 is connected to connecting unit 140 (the state shown in Figures 1 and 2).

[0039] The specific configuration of the drug supply unit 600 is not particularly limited as long as it can supply the drug d into the pericardial cavity S through the second lumen 220 of the puncture unit 200. The drug supply unit 600 may be configured to include, for example, a reservoir filled with the drug d and a pump or the like that enables the drug d to be supplied from the reservoir.

[0040] Examples of the drug (medicinal solution) d include vasodilators, antiplatelet drugs, anticoagulants, thrombolytic agents, anti-inflammatory drugs, antiarteriosclerotic drugs, angiogenic agents, myocardial protective drugs, antiarrhythmic drugs, anticancer drugs, cardiotonic drugs, antihypertensive drugs, myocardial regenerative drugs, growth factors, nucleic acid drugs, viral vectors, cells, contrast agents, etc. However, the specific types of drug d are not limited to those exemplified above, as long as they are intended for administration into the pericardial cavity S.

[0041] A predetermined seal member 730 is disposed inside the hub portion 130. The seal member 730 prevents fluid communication between a region (referred to as the "first region 131") distal to the position where the seal member 730 is disposed in the internal space of the hub portion 130, the storage portion 111 of the holding portion 110, and the second lumen 220 of the puncture portion 200, and a region (referred to as the "second region 132") proximal to the position where the seal member 730 is disposed in the internal space of the hub portion 130. The seal member 730 can be formed of a known elastic member such as an O-ring, packing, or one-way valve.

[0042] The hub portion 130 has a movement mechanism 720 that enables the puncture portion 200 to move along the axial direction of the sheath portion 100 .

[0043] The movement mechanism 720 has a slider 721 connected to a predetermined position of the puncture unit 200, and a slide groove 723 that allows axial movement of the slider 721. The surgeon can move the puncture unit 200 along the axial direction of the sheath unit 100 in conjunction with the movement of the slider 721 by gripping the slider 721 with the fingers or the like and operating it to move it back and forth.

[0044] The hub portion 130 may be provided with a first installation portion 510 having a first detection space 511. The first installation portion 510 may be arranged so as to communicate with the first region 131 of the hub portion 130. The first installation portion 510 may be arranged so as to extend from the hub portion 130 in the depth direction (the direction of the arrow Y1 or Y2), for example.

[0045] As shown in FIGS. 2, 4, and 6, the first detection section 310 can be disposed in the first detection space 511.

[0046] A suction mechanism 800 for generating negative pressure in the accommodation portion 111 of the holding portion 110 can be connected to one end side of the first installation portion 510 (the end side located on the side away from the hub portion 130). The suction mechanism 800 can be configured, for example, by a known pump or the like.

[0047] The hub portion 130 may be provided with a second installation portion 520 having a second detection space 521. The second installation portion 520 may be provided so as to communicate with the second lumen 220 of the puncture portion 200 at a position on the proximal side of the position where the seal member 730 is disposed in the hub portion 130. The second installation portion 520 may be disposed in a part of the hub portion 130, for example, as shown in FIG.

[0048] As shown in FIGS. 2, 8, and 10, the second detection section 320 can be disposed in the second detection space 521.

[0049] The sheath portion 100 has a switching portion 710 that can selectively switch between a state in which fluid communication is established between the second lumen 220 of the puncture portion 200 and the second detection space 521 of the second installation portion 520 and a state in which fluid communication is restricted.

[0050] 8 and 10 , the second lumen 220 of the puncture unit 200 and the second detection space 521 in which the second detection unit 320 is disposed are in communication with each other via a communication path 523. By using the switching unit 710, it is possible to selectively switch between a state in which the second lumen 220 of the puncture unit 200 and the second detection space 521 are in fluid communication with each other via the communication path 523, as shown in Fig. 11 , and a state in which the fluid communication between the second lumen 220 of the puncture unit 200 and the second detection space 521 via the communication path 523 is restricted, as shown in Fig. 12 .

[0051] The surgeon can use the switching unit 710 to fluidly connect the second lumen 220 of the puncture unit 200 to the second detection space 521, thereby allowing the second detection unit 320 disposed in the second detection space 521 to detect the penetration state of the needle portion 230 into the pericardium L2. On the other hand, the surgeon can use the switching unit 710 to restrict the fluid communication between the second lumen 220 of the puncture unit 200 and the second detection space 521, thereby fluidly connecting the entire second lumen 220 at positions distal and proximal to the position where the switching unit 710 is disposed, thereby enabling the supply of the drug d from the drug supply unit 600 connected to the hub unit 130 to the needle portion 230.

[0052] The switching unit 710 can be configured, for example, to have an operating lever that allows the surgeon to easily operate the switching unit 710 from outside the hub unit 130, or can be configured with known components such as a three-way stopcock or one-way valve that allows the flow direction of the fluid to be controlled.

[0053] (Puncture section 200) As shown in Figures 7 and 9, the puncture section 200 includes a second lumen 220 through which the drug d to be administered into the pericardial cavity S between the epicardium L1 and the pericardium L2 can flow, and a needle section 230 that is inserted into the pericardium L2 held by the holding section 110.

[0054] The needle portion 230 is formed at the tip of the puncturing portion 200. The needle portion 230 forms a needle tip that enables puncturing and penetrating the pericardium L2. The needle portion 230 is formed with a tip opening 231 that communicates with the second lumen 220. As shown in Fig. 9 , when the needle portion 230 has penetrated the pericardium L2 and is positioned in the pericardial cavity S, the drug d can be supplied from the drug supply unit 600, thereby locally administering the drug d into the pericardial cavity S through the tip opening 231 of the needle portion 230.

[0055] In a natural state in which no external force is applied, the puncturing unit 200 extends in a substantially straight line from the tip, where the needle 230 is located, to the base end. As described above, the puncturing unit 200 is configured to be movable along the axial direction of the sheath unit 100 by the moving mechanism 720. From a state in which the needle 230 has not yet penetrated the pericardium L2 as shown in Fig. 7 , the surgeon can penetrate the needle 230 into the pericardium L2 by operating the moving mechanism 720 to advance the puncturing unit 200 toward the pericardium L2 as shown in Fig. 8 .

[0056] The puncture section 200 can be made of, for example, a metal material or a hard resin material that has a predetermined rigidity.

[0057] (First detection unit 310, first notification unit 410) The first detection unit 310 detects that the holding unit 110 has held a part of the pericardium L2. The first notification unit 410 notifies the detection result of the first detection unit 310. In this embodiment, as will be described later, the first detection unit 310 is configured to also function as the first notification unit 410.

[0058] The first detection unit 310 is configured to detect the holding state of the pericardium L2 by the holding unit 110 based on changes in the fluid flow state inside and outside the storage unit 111 through the opening 113 of the holding unit 110.

[0059] As described above, the first detection section 310 is disposed within the first detection space 511 of the first installation section 510, which is provided so as to communicate with the first region 131 of the hub section 130 (see Figures 2, 4, and 6).

[0060] The first detection unit 310 is configured to detect the holding state of the pericardium L2 by fluid flowing into the first detection space 511 through the first lumen 120 of the sheath unit 100 when the flow of fluid between the inside of the accommodating unit 111 of the holding unit 110 and the outside of the accommodating unit 111 of the holding unit 110 is not obstructed by a part of the pericardium L2.

[0061] Specifically, as shown in FIG. 3, when a portion of the pericardium L2 is not being held by the holding unit 110, the first detection unit 310 detects that the pericardium L2 is not being held by the holding unit 110 if a fluid (e.g., atmosphere) flows into the first detection space 511 through the opening 113, the storage unit 111, and the first lumen 120 when the suction mechanism 800 connected to the first installation unit 510 is operated to perform suction.

[0062] 4 , in this embodiment, the first detection unit 310 is configured as a fluid-driven indicator that vibrates due to the fluid flowing through the first detection space 511 and outputs sound to the surroundings. Therefore, the first detection unit 310 functions both as a detection unit that detects the holding of a part of the pericardium L2 by the holding unit 110 based on the fluid flow state, such as the presence or absence of fluid flow within the first detection space 511, and as a first notification unit 410 that notifies the surroundings of the detection result.

[0063] As shown in Fig. 5 , a portion of the pericardium L2 to be held is held within the holding portion 111 by suction by the suction mechanism 800, and when the portion of the pericardium L2 blocks fluid communication between the first lumen 120 and the outside of the holding portion 111, fluid no longer flows into the first detection space 511. This causes the alarm operation (sounding) of the first detection unit 310 disposed within the first detection space 511 to stop, as shown in Fig. 6 . By recognizing that the alarm operation of the first detection unit 310 has stopped, the surgeon can easily confirm that the pericardium L2 is being held by the holding portion 110.

[0064] In a state in which a portion of the pericardium L2 is held by the holding unit 110, the suction operation by the suction mechanism 800 can be continued to hold the pericardium L2 by the holding unit 110. By continuing the suction by the suction mechanism 800 as described above, after holding by the holding unit 110, the inside of the second detection space 521, which is in fluid communication with the inside of the first detection space 511 via the first lumen 120, the second lumen 220, and the communication passage 523, is maintained at a negative pressure.

[0065] When the suction mechanism 800 is operated to start holding by the holding part 110, the switching part 710 is operated to switch the state in which the second lumen 220 and the communication passage 523 are connected (see Figure 11).

[0066] (Second detection unit 320, second notification unit 420) The second detection unit 320 detects that the needle 230 of the puncture unit 200 has penetrated the pericardium L2 held by the holding unit 110. The second notification unit 420 notifies the detection result of the second detection unit 320. In the present embodiment, as will be described later, the second detection unit 320 is configured to also function as the second notification unit 420.

[0067] The second detection unit 320 is configured to detect the state of penetration of the pericardium L2 by the needle portion 230 based on a change in pressure within the second lumen 220 of the puncture unit 200.

[0068] As described above, second detection unit 320 is disposed in second detection space 521 of second installation unit 520 that is provided so as to communicate with second lumen 220 of puncture unit 200 .

[0069] The second detection unit 320 is configured to detect the penetration state of the needle portion 230 into the pericardium L2 based on a change in pressure in the second detection space 521 before and after the needle portion 230 penetrates the pericardium L2 held by the holding unit 110 while the inside of the second lumen 220 of the puncture unit 200 is suctioned. This will be described in detail below.

[0070] As shown in Figures 7 and 8, when a portion of the pericardium L2 is held by the holding portion 110 and the needle portion 230 of the puncture portion 200 is not punctured into the pericardium L2, while suction is being performed by the suction mechanism 800 attached to the first installation portion 510, the area of ​​the second detection space 521 upstream of the second detection portion 320 (upstream in the direction of fluid flow during suction, on the side where the communicating passage 523 communicating with the second lumen 220 is located) is maintained in a negative pressure state.

[0071] The second detection section 320 can be constructed of a gasket (elastic member, etc.) arranged to prevent inadvertent movement within the second detection space 521 when the upstream region within the second detection space 521 is maintained at negative pressure as described above.

[0072] 9 , when the needle 230 of the puncture unit 200 punctures the pericardium L2 while a portion of the pericardium L2 is held by the holding unit 110, and the needle 230 penetrates the pericardium L2 and reaches the pericardial cavity S, the pressure in the second lumen 220 changes to a pressure similar to that in the pericardial cavity S. As a result, the pressure in the second lumen 220 changes from negative to positive (positive pressure), and the upstream region of the second detection space 521, which communicates with the second lumen 220 via the communication path 523, also changes to a positive pressure. When the pressure (back pressure) in the downstream region as viewed from the second detection unit 320 becomes equal to or smaller than the pressure in the upstream region of the second detection space 521, the second detection unit 320 moves downstream within the second detection space 521. In this way, the second detection unit 320 detects the penetration state of the needle 230 into the pericardium L2 based on the change in pressure in the second detection space 521.

[0073] As described above, in this embodiment, second detection unit 320 is configured as a fluid-driven indicator that moves due to the fluid flowing through second detection space 521 and notifies those around it of this movement. Therefore, second detection unit 320 functions both as a detection unit that detects the state of penetration of pericardium L2 by needle 230 based on pressure changes in second detection space 521 and as second notification unit 420 that notifies those around it of the detection result.

[0074] The surgeon can easily confirm whether the needle 230 has penetrated the pericardium L2 by visually checking whether the second detection unit 320 (second notification unit 420) has moved within the second detection space 521. When the notification operation (movement) of the second notification unit 420 is configured to be visually confirmable as in this embodiment, it is preferable that a portion of the second installation unit 520 is transparent or semi-transparent so that the interior of the second detection space 521 can be visually observed from the outside. Furthermore, scales or various marks can be added to the second installation unit 520 so that changes in the amount of movement of the second notification unit 420 can be easily recognized.

[0075] 9 , the surgeon penetrates the needle portion 230 through the pericardium L2 held by the holding portion 110, and then operates the switching portion 710 to connect the portion of the second lumen 220 distal to the communication path 523 with the portion proximal to the communication path 523 (see FIG. 12 ). After operating the switching portion 710 as described above, the surgeon operates the drug supply portion 600 to supply the drug d into the second lumen 220 while maintaining the holding of the pericardium L2 by the holding portion 110, thereby enabling the drug d to be appropriately administered locally into the pericardial cavity S via the second lumen 220 and the distal opening 231 of the needle portion 230.

[0076] Next, an example of the overall procedure flow using the pericardial puncture device 10 will be described.

[0077] Prior to performing the procedure using the pericardial puncture device 10, the surgeon will confirm whether the patient is one to whom drug d cannot be administered due to adhesions or fat on the surface of the pericardium, or the absence of a pericardium, based on a preliminary examination using CT or MRI, medical history, surgical history, etc.

[0078] To start a procedure using the pericardial puncture device 10, the surgeon places the patient in a supine position on a bed. The surgeon makes an approximately 3 mm skin incision around the xiphoid process or between the ribs of the patient using a scalpel or the like.

[0079] The surgeon will insert a trocar catheter as needed. The surgeon will then insert an endoscope into the patient's body through the trocar catheter and confirm that the approach site is free of fat that may interfere with the procedure. Note that if the approximate approach site has been determined through a prior CT or MRI scan, the above steps can be omitted as appropriate.

[0080] The surgeon connects the suction mechanism 800 to the pericardial puncture device 10. The surgeon operates the suction mechanism 800 to start suctioning the holding portion 110, the first lumen 120, and the first detection space 511.

[0081] The surgeon uses an echography device or an X-ray device to confirm the position of the tip of the pericardial puncture device 10 and aligns it with the approach site.

[0082] The surgeon holds the pericardium L2 with the holding unit 110. The surgeon checks the holding state of the pericardium L2 with the first notification unit 410.

[0083] The surgeon punctures the pericardium L2 with the needle 230 of the puncture unit 200 while maintaining the position of the tip of the pericardial puncture device 10. The surgeon checks the second notification unit 420 to see if the needle 230 has penetrated the pericardium L2.

[0084] If necessary, the surgeon connects foamed saline or contrast medium to the puncture part 200 and checks whether liquid can be administered into the pericardial cavity S through the second lumen 220 of the puncture part 200.

[0085] The surgeon connects the drug supply unit 600 to the puncture unit 200 and locally administers the drug d into the pericardial cavity S via the second lumen 220 of the puncture unit 200. The drug supply unit 600 may be connected to the same location (port) as the liquid supply tool for supplying the confirmation liquid, or may be connected to a dedicated port individually provided on the pericardial puncture device 10. Alternatively, the surgeon may connect the liquid supply tool to the port and perform priming before starting the administration operation. At this time, the switching unit 710 can be switched between a fluid-communicated state and a fluid-restricted state before and after priming.

[0086] After the administration of the drug d into the pericardial cavity S is completed, the surgeon pulls out the puncture part 200 from the pericardial cavity S. If the needle diameter of the puncture part 200 is small, sealing of the puncture site is not necessary, but a biological adhesive, an adhesion inhibitor, or the like may be administered via the second lumen 220 of the puncture part 200 as needed.

[0087] The surgeon stops the suction operation of the suction mechanism 800 and releases the holding portion 110 from holding the pericardium L2. The surgeon then removes the pericardial puncture device 10 from the patient's thoracic cavity. The surgeon then sutures the insertion site of the pericardial puncture device 10 formed in the patient's thoracic wall.

[0088] As described above, the pericardial puncture device 10 of this embodiment includes a sheath portion 100 having a holding portion 110 configured to hold a portion of the pericardium L2 so as to separate it from the epicardium L1, a first lumen 120 extending from the holding portion 110 toward the base end and communicating with the inside of the holding portion 110, a second lumen 220 through which a drug d to be administered into the pericardial cavity S between the epicardium L1 and the pericardium L2 can flow, and a needle portion 230 that punctures the pericardium L2 held by the holding portion 110, a puncture portion 200 arranged within the sheath portion 100, a first detection portion 310 that detects that the holding portion 110 has held the pericardium L2, a second detection portion 320 that detects that the needle portion 230 has penetrated the pericardium L2, a first notification portion 410 that notifies the detection result of the first detection portion 310, and a second notification portion 420 that notifies the detection result of the second detection portion 320.

[0089] According to the pericardial puncture device 10 of this embodiment, the state of holding of the pericardium L2 by the holding unit 110 can be easily confirmed based on the first notification unit 410. Furthermore, the state of penetration of the needle portion 230 of the puncture unit 200 into the pericardium L2 can be easily confirmed based on the second notification unit 420. Therefore, the pericardial puncture device 10 can realize a smooth procedure and can appropriately locally administer the drug d into the pericardial cavity S.

[0090] Furthermore, in the pericardial puncture device 10, each of the notification units 410, 420 has a simple configuration that is integral with any part of the pericardial puncture device 10. This eliminates the need for an imaging means that allows the surgeon to check the state of holding the pericardium L2 by the holding unit 110 and the state of penetration of the needle portion 230 of the puncture unit 200 into the pericardium L2, or a large monitor for displaying images acquired by the imaging means. This prevents the device configuration of the pericardial puncture device 10 from becoming too complicated or too large, and prevents an increase in manufacturing costs, etc.

[0091] Next, a modified example of the pericardial puncture device 10 according to the embodiment described above will be described. In the description of the modified example, the description of the content that overlaps with the content already described will be omitted. Furthermore, the same elements as those described in the embodiment described above will be described with the same reference numerals.

[0092] The pericardial puncture device of the present invention can be modified or changed in any way as described below, as long as it can detect the holding of the pericardium by the holding portion and notify the detection result, and detect the penetration state of the needle portion of the puncture portion into the pericardium and notify the detection result.

[0093] <Modification 1> FIGS. 13 and 14 show a first detection unit 310 (first notification unit 410) according to Modification 1. FIG.

[0094] Similar to the above-described embodiment, the first detection unit 310 according to the first modification is configured to detect the state of holding of the pericardium L2 by the holding unit 110 based on a change in the state of fluid flow inside and outside the accommodation unit 111 via the opening 113 of the holding unit 110. The first detection unit 310 is also configured to function as a first notification unit 410.

[0095] 13 , before the holding unit 110 holds a portion of the pericardium L2 (a state in which fluid is flowing into the first detection space 511), the first detection unit 310 is configured to rotate (for example, comprised of a wing-shaped member attached to an axis) due to the fluid that has flowed into the first detection space 511. By visually checking that the first detection unit 310 is rotating, the surgeon can easily confirm that the holding unit 110 is in a state in which it has not yet held a portion of the pericardium L2.

[0096] 14 , when the holding unit 110 holds a portion of the pericardium L2, fluid no longer flows into the first detection space 511, and therefore the rotation of the first detection unit 310 stops. The surgeon can easily confirm that a portion of the pericardium L2 is being held by the holding unit 110 by visually confirming that the first detection unit 310 is not rotating.

[0097] In addition, when the alarm operation (rotation) of the first alarm unit 410 is configured to be visually confirmable as in this modified example, it is preferable that a portion of the first installation unit 510 is transparent or translucent so that the inside of the first detection space 511 can be visually observed from the outside.

[0098] <Modification 2> FIGS. 15 to 18 show a first detection unit 310 and a first notification unit 410 according to Modification 2. FIG.

[0099] The first detection unit 310 according to the second modification is configured to detect the holding state of the pericardium L2 by the holding unit 110 based on the contact state of the pericardium L2 with the accommodation portion 111 of the holding unit 110.

[0100] 15 and 16, the first detection unit 310 is disposed at a predetermined position on the inner surface 111a of the housing 111. The first detection unit 310 may be configured, for example, with a sensor capable of detecting the contact / non-contact state of the pericardium L2. As the sensor, for example, a known sensor capable of detecting a change in temperature, a change in electrical resistance, or a change in contact pressure of the pericardium L2 against the inner surface 111a may be used.

[0101] The first notification unit 410 may be configured, for example, with a light that operates based on the detection result of the first detection unit 310. The first notification unit 410 may be configured to have a first light 410a that notifies that the pericardium L2 is not being held, and a second light 410b that notifies that the pericardium L2 is being held. The lights 410a and 410b may be connected to the first detection unit 310 via a signal line 311 that transmits the detection result of the first notification unit 410.

[0102] The first notification section 410 can be disposed, for example, at any position of the sheath section 100 (such as the hub section 130).

[0103] 15 and 16, when a portion of the pericardium L2 is not being held by the holding unit 110, the first light 410a lights up or flashes to notify the surgeon. Also, as shown in FIGS. 17 and 18, when a portion of the pericardium L2 is held by the holding unit 110 and the pericardium L2 comes into contact with the first detection unit 310 disposed on the inner surface 111a of the housing unit 111, the second light 410b lights up or flashes to notify the surgeon. Alternatively, the first detection unit 310 may be configured as a sensor capable of recognizing the shape of an object using light such as a laser or infrared light, thereby detecting a change in the shape of the pericardium L2 and notifying the surgeon of the holding state of the pericardium L2 based on the detection result.

[0104] In this modified example, an example in which the first notification unit 410 is configured as a light has been described, but the first notification unit 410 can also be configured as something other than a light, and for example, it is possible to use known means that enable information to be transmitted in a form that can be sensed by the surgeon, such as sound, voice, vibration, or other form around the device.

[0105] <Modification 3> FIGS. 19 and 20 show a second detection unit 320 (second notification unit 420) according to Modification 3. FIG.

[0106] Similar to the above-described embodiment, the second detection unit 320 according to the third modification is configured to detect the state of the pericardium L2 being held by the needle 230 based on a change in pressure within the second lumen 220 of the puncture unit 200. The second detection unit 320 is also configured to function as a second notification unit 420.

[0107] In the above-described embodiment, the second detection unit 320 is configured to move when the state transitions from a state in which the needle 230 of the puncturing unit 200 has not punctured the pericardium L2 (a state in which the region upstream of the second detection unit 320 in the second detection space 521 is under negative pressure) to a state in which the needle 230 of the puncturing unit 200 has penetrated the pericardium L2 (a state in which the region upstream of the second detection unit 320 in the second detection space 521 is under positive pressure) (see FIGS. 8 and 10 ). In this modification, the second detection unit 320 is configured as a flexible bag-like member (e.g., a balloon-like member) that can deform so as to contract and expand within the second detection space 521 in response to the above-described pressure changes.

[0108] As shown in Fig. 19 , before the needle 230 penetrates the pericardium L2, the upstream region within the second detection space 521 is maintained at a negative pressure. In this state, the second detection unit 320 maintains an expanded state. As shown in Fig. 20 , when the needle 230 penetrates the pericardium L2, the upstream region within the second detection space 521 changes to a positive pressure. Then, when the internal pressure of the second detection unit 320 becomes equal to or smaller than the pressure in the upstream region within the second detection space 521, the second detection unit 320 contracts within the second detection space 521. The surgeon can easily confirm that the needle 230 has penetrated the pericardium L2 by visually confirming that the second detection unit 320 has contracted.

[0109] <Modification 4> FIGS. 21 to 23 show a second detector 320 according to Modification 4. FIG.

[0110] The second detection unit 320 in variant example 4 is configured to detect the state of penetration of the pericardium L2 by the needle portion 230 based on the contact state between the pericardium L2 and the needle portion 230 before and after the needle portion 230 penetrates the pericardium L2.

[0111] 21 to 23, second detection unit 320 is disposed at a predetermined position on inner surface 111a of housing unit 111. Second detection unit 320 can be configured, for example, with a known sensor capable of detecting the energized state based on a change in electrical resistance value before and after contact with pericardium L2.

[0112] The second notification unit 420 (not shown) can be configured, for example, with the various components (components that provide notification using lights, sounds, etc.) described above in Modification Example 2. Furthermore, the second notification unit 420 can be disposed, for example, at any position in the sheath unit 100 (for example, the hub unit 130, etc.). The second detection unit 320 and the second notification unit 420 can be connected via a signal line 321 that transmits the detection result of the second detection unit 320.

[0113] 21, before the needle 230 punctures the pericardium L2, the pericardium L2 and the second detection unit 320 remain in contact with each other, so that the second detection unit 320 detects the energized state.

[0114] 22, when needle 230 comes into contact with pericardium L2 and begins puncturing, there is no contact between pericardium L2 and second detection unit 320. This increases the electrical resistance value detected by second detection unit 320, causing second detection unit 320 to detect a non-energized state.

[0115] 23, when the needle portion 230 penetrates the pericardium L2, the pericardium L2 and the second detection unit 320 come into contact again, whereby the second detection unit 320 detects the energized state.

[0116] As described above, the second detection unit 320 according to the fourth modification can detect changes in three states in more detail: before the needle 230 punctures the pericardium L2, when puncture has started, and after the needle 230 has penetrated the pericardium L2. By reporting each of the above states via the second reporting unit 420, the surgeon can grasp the puncture state of the needle 230 in more detail, which allows the surgeon to proceed with the procedure more safely and quickly.

[0117] <Modification 5> FIG. 24 shows a second detector 320 according to Modification 5. As shown in FIG.

[0118] The second detection unit 320 according to the fourth modification can also be disposed on the needle portion 230, for example, as shown in Fig. 24. Even when the second detection unit 320 is disposed on the needle portion 230, the second detection unit 320 can detect non-contact between the second detection unit 320 and the pericardium L2 before puncture begins, contact between the second detection unit 320 and the pericardium L2 after puncture begins, and non-contact between the second detection unit 320 and the pericardium L2 after the needle portion 230 has penetrated the pericardium L2, thereby achieving the same effect as in the fourth modification. Note that when the second detection unit 320 is disposed on the needle portion 230 as shown in the fifth modification, the second detection unit 320 can also be configured as, for example, a pressure sensor that detects the above three state changes based on the contact pressure with the pericardium L2.

[0119] <Sixth Modification> FIG. 25 shows a second detector 320 according to a sixth modification.

[0120] The second detection unit 320 can also be configured, for example, as a temperature sensor that detects the state of the needle portion 230 relative to the pericardial L2 based on the difference between the temperature inside the first lumen 120 of the sheath portion 100 located outside the pericardial cavity S and the temperature inside the pericardial cavity S.

[0121] As shown in FIG. 25 , the second detection unit 320, which is configured as a temperature sensor, can be disposed on the needle portion 230. Before the needle portion 230 penetrates the pericardium L2, the second detection unit 320 detects the temperature (e.g., room temperature, approximately 25°C) inside the first lumen 120 of the sheath portion 100. After the needle portion 230 penetrates the pericardium L2, the second detection unit 320 detects the temperature (e.g., body temperature, approximately 37°C) inside the pericardial cavity S. The second detection unit 320 transmits information regarding the temperature change to the second notification unit 420 via a signal line 321. The second notification unit 420 notifies the penetration state of the needle portion 230 based on the detection result of the second detection unit 320. By checking the notification result of the second notification unit 420, the surgeon can easily confirm whether the needle portion 230 has penetrated the pericardium L2.

[0122] <Modification 7> Fig. 26 shows a pericardial puncture device 10A according to Modification 7. Fig. 26 is a view corresponding to the top view shown in Fig. 2.

[0123] In the embodiment described above, an example was shown in which the first detection unit 310 (first notification unit 410) was disposed in the first detection space 511 of the first installation unit 510 provided so as to extend from the hub unit 130 included in the sheath unit 100 (see FIG. 2). For example, the first detection space 511 can also be provided in the hub unit 130 as shown in FIG. 26.

[0124] In this modification, a first detection space 511 is defined in the first region 131 of the hub portion 130, and the first detection unit 310 (first notification unit 410) is disposed within the first detection space 511. Even when the first detection unit 310 is disposed in this manner, by operating the suction mechanism 800, negative pressure can be generated in the accommodation portion 111 of the holding portion 110 via the first lumen 120, the internal space of the hub portion 130, and the cavity of the first installation portion 510. Furthermore, the first detection unit 310 (first notification unit 410) disposed in the first detection space 511 provided in the hub portion 130 can detect and notify the holding state of the pericardium L2 by the holding portion 110.

[0125] Furthermore, in this modification, the second detection unit 320 (second notification unit 420) is disposed in the second detection space 521 of the second installation unit 520 extending from the hub unit 130. Even when the second detection unit 320 is disposed in this manner, it is possible to detect and notify the penetration state of the needle portion 230 into the pericardium L2 based on the pressure change in the second detection space 521.

[0126] As described above, in the pericardial puncture device 10 according to the present invention, there are no particular limitations on the placement of the first detection unit 310 (first notification unit 410) and the second detection unit 320 (second notification unit 420) as long as their respective functions can be performed. For example, both the first detection unit 310 (first notification unit 410) and the second detection unit 320 (second notification unit 420) may be placed in the respective installation units 510 and 520, or both may be placed in the respective spaces 511 and 521 integrally formed in the hub unit 130.

[0127] <Modification 8> FIG. 27 shows a puncturing unit 200 according to Modification 8.

[0128] As shown in FIG. 27 , the puncture section 200 can be configured to have a straight section 240 that extends in an approximately straight line along the axial direction of the sheath section 100, a curved section 250 that is curved relative to the straight section 240 in a direction that protrudes outside the holding section 110 (the direction in which the opening 113 is located), and a needle section 230 that is located on the tip side of the curved section 250.

[0129] As shown in this modification, when the tip of the puncture unit 200 has a shape that curves toward the outside of the holding unit 110, the suction mechanism 800 can be operated to draw a part of the pericardium L2 into the storage unit 111, and at the same time, the needle unit 230 can pierce the pericardium L2. This can simplify the procedure using the pericardial puncture device 10.

[0130] There are no particular limitations on the angle at which curved portion 250 is curved relative to straight portion 240, the length of needle portion 230 located on the distal end side of curved portion 250, or the like.

[0131] The pericardial puncture device according to the present invention has been described above through the embodiments and modifications thereof, but the present invention can be modified or changed as appropriate based on the claims.

[0132] For example, the first detection unit and the first notification unit may be any combination of the configurations described in the embodiment and each modified example. Similarly, the second detection unit and the second notification unit may be any combination of the configurations described in the embodiment and each modified example. Furthermore, it is also possible to provide a single pericardial puncture device with a plurality of first detection units and first notification units and a plurality of second detection units and second notification units.

[0133] This application is based on Japanese Patent Application No. 2023-099001, filed on June 16, 2023, the disclosure of which is incorporated herein by reference in its entirety.

[0134] 10 Pericardiocentesis device 10A Pericardiocentesis device 100 Sheath portion 101 Main body portion of sheath portion 110 Holding portion 111 Storage portion 111a Inner surface of storage portion 113 Opening portion 120 First lumen 130 Hub portion 131 First region 132 Second region 140 Connection portion 200 Puncture portion 220 Second lumen 230 Needle portion 231 Tip opening of needle portion 240 Straight portion 250 Curved portion 310 First detection portion 320 Second detection portion 410 First notification portion 420 Second notification portion 421 First detection space 510 First installation portion 511 First detection space 520 Second installation portion 521 Second detection space 523 Communication path 600 Drug supply portion 710 Switching portion 720: Moving mechanism 730: Sealing member 800: Suction mechanism L1: Epicardium L2: Pericardium S: Pericardial cavity d: Drug

Claims

1. A pericardial puncture device comprising: a sheath portion having a holding portion configured to hold a portion of the pericardium so as to move it away from the epicardium, and a first lumen extending baseward from the holding portion and communicating with the inside of the holding portion; a puncture portion disposed within the sheath portion, the sheath portion having a second lumen through which a drug to be administered into the pericardial cavity between the epicardium and the pericardium can flow, and a needle portion which punctures the pericardium held by the holding portion; a first detection portion which detects that the holding portion has held the pericardium; a second detection portion which detects that the needle portion has penetrated the pericardium; a first notification portion for notifying the detection result of the first detection portion; and a second notification portion for notifying the detection result of the second detection portion.

2. The pericardial puncture device of claim 1, wherein the holding portion has a storage portion capable of storing a portion of the pericardium and an opening that allows the pericardium to move inside and outside of the storage portion, and the holding portion is configured to store a portion of the pericardium within the storage portion and hold the portion of the pericardium when the inside of the first lumen is suctioned and the inside of the storage portion becomes negative pressure.

3. The pericardial puncture device described in claim 2, wherein the first detection unit is configured to detect the holding state of the pericardium by the holding unit based on at least one of a change in the fluid flow state inside and outside the accommodating unit via the opening, a contact state of the pericardium with respect to the accommodating unit, and a change in shape of the pericardium, and the second detection unit is configured to detect the penetration state of the pericardium by the needle unit based on a pressure change in the second lumen and / or a contact state between the pericardium and the needle unit before and after the needle unit penetrates the pericardium.

4. A pericardial puncture device as described in claim 3, having a first detection space communicating with the first lumen and the storage section, the first detection section being disposed in the first detection space, the first detection section being configured to detect the retention state of the pericardium based on the flow state of fluid flowing into the first detection space via the first lumen when the flow of fluid between the inside of the storage section and the outside of the storage section is not blocked by a part of the pericardium, and the first detection section being configured to function as the first notification section.

5. A pericardial puncture device as described in claim 3, wherein the first detection unit is arranged in the accommodating portion so as to detect a contact state between the accommodating portion and the pericardium and / or a change in shape of the pericardium.

6. A pericardial puncture device as described in any one of claims 3 to 5, having a second detection space communicating with the second lumen and the storage section, the second detection section being disposed in the second detection space, the second detection section being configured to detect the penetration state of the needle section into the pericardium based on a change in pressure in the second detection space before and after the needle section penetrates the pericardium held by the holding section when the inside of the second lumen is in a suctioned state, and the second detection section being configured to function as the second notification section.

7. The pericardial puncture device according to claim 6, wherein the sheath portion has a switching portion capable of selectively switching between a state in which fluid communication is established between the second lumen and the second detection space and a state in which fluid communication is restricted.

8. A pericardial puncture device according to any one of claims 3 to 5, wherein the second detection unit is disposed in the needle portion or the accommodating portion.

9. The pericardial puncture device according to claim 1, wherein the puncture portion extends in an approximately straight line from the tip where the needle portion is located to the base end, and the sheath portion has a moving mechanism that enables the puncture portion to move along the axial direction of the sheath portion.

10. The pericardial puncture device according to claim 1, wherein the puncture portion has a straight portion extending in an approximately straight line along the axial direction of the sheath portion, a curved portion curved relative to the straight portion in a direction protruding outside the holding portion, and the needle portion located on the tip side of the curved portion.

Images