JP2019154916A - Medical device and administration method - Google Patents

Abstract

To provide a medical device capable of partitioning a plurality of lumens extending in an axial direction and reducing puncture resistance.SOLUTION: The medical device is a long medical device and comprises: a body part for partitioning a plurality of lumens extending in an axial direction; and a puncture part communicated to the plurality of lumens and communicated to outside at a tip end, and partitions the single lumen. An outer diameter of the puncture part gradually decreases toward the tip end side.SELECTED DRAWING: Figure 2

Description

  The present disclosure relates to medical devices and administration methods.

  In recent years, as a treatment for heart failure or the like, it has been studied to administer a plurality of types of administration substances such as cells and extracellular matrix to the same part of a living tissue such as the inner wall of the left ventricle of the heart. In such a case, a lumen, which is a hollow portion extending in the axial direction, is partitioned, and an administration target is administered to the living tissue through the lumen using a long medical instrument that can puncture the living tissue at the tip. It is possible. In order to administer a plurality of types of administration objects, it is preferable that a number of lumens corresponding to the number of types of administration objects are partitioned in the medical device. In this case, the outer diameter of the medical device tends to increase and the puncture resistance tends to increase.

  Patent Document 1 describes a medical instrument in which a plurality of lumens extending in the axial direction and a mixing region communicating with the plurality of lumens are partitioned and the mixing region communicates from the tip to the outside.

JP2015-15959A

  According to the medical instrument described in Patent Document 1, the outer diameter of the tip can be reduced. However, the medical device described in Patent Document 1 has room for improvement in reducing puncture resistance.

  In view of the above problems, an object of the present disclosure is to provide a medical device and an administration method that can reduce puncture resistance while partitioning a plurality of lumens extending in the axial direction.

  A medical instrument according to an aspect of the present invention is an elongated medical instrument, and includes a main body section that defines a plurality of lumens extending in the axial direction, communicates with the plurality of lumens, and is external at a distal end. And a puncture portion that defines a single lumen, and the outer diameter of the puncture portion gradually decreases toward the distal end side.

  In the medical instrument as one embodiment of the present invention, the inner surface of the puncture portion is inclined most at a position different from the distal end and the proximal end of the puncture portion with respect to the axial direction.

  In the medical device according to the embodiment of the present invention, the plurality of lumens of the main body include an inner lumen and an outer lumen surrounding the inner lumen in a cross-sectional view orthogonal to the axial direction.

  The medical device as one embodiment of the present invention further includes a check valve at the tip of the inner lumen that inhibits fluid from entering the inner lumen.

  In the medical instrument as an embodiment of the present invention, the main body portion is composed of an outer cylinder member and an inner cylinder member, the inner lumen is partitioned by an inner surface of the inner cylinder member, and the outer lumen is And an inner surface of the outer cylinder member and an outer surface of the inner cylinder member.

  The medical instrument as one embodiment of the present invention further includes a support member that supports the inner cylinder member in a hollow portion of the outer cylinder member.

  In the medical instrument as an embodiment of the present invention, the outer surface of the puncture unit is inclined most at a position different from the distal end and the base end of the puncture unit with respect to the axial direction.

  The administration method as one aspect of the present invention includes a puncturing step of puncturing a living tissue from the tip with a puncture section that defines a lumen communicating with the outside at the tip, and a first method of administering cells to the living tissue through the lumen. An administration step; and a second administration step of administering an extracellular matrix to the living tissue through the lumen after the first administration step.

  According to the present disclosure, it is possible to provide a medical device and an administration method that can reduce puncture resistance while partitioning a plurality of lumens extending in the axial direction.

It is a figure which shows the medical device as 1st Embodiment of this invention. It is a partial longitudinal cross-sectional view including the front-end | tip of the medical device of FIG. It is sectional drawing which follows the III-III line of FIG. It is sectional drawing which follows the IV-IV line of FIG. It is a flowchart which shows the administration method performed using the medical device of FIG. It is a partial longitudinal cross-sectional view containing the front-end | tip of the medical device as 2nd Embodiment of this invention. It is sectional drawing which follows the VII-VII line of FIG. It is a partial longitudinal cross-sectional view containing the front-end | tip of the medical device as 3rd Embodiment of this invention. It is sectional drawing which follows the IX-IX line of FIG.

  Hereinafter, an embodiment of the present invention will be described with reference to the drawings. In each figure, the same code | symbol is attached | subjected to the common member.

(First embodiment)
FIG. 1 is a diagram showing a medical instrument 1 as a first embodiment of the present invention. As shown in FIG. 1, the medical instrument 1 has a long shape. FIG. 1 shows a state in which the medical instrument 1 extends from outside the subject's body to the left ventricle LV in the heart lumen through the tubular catheter 100. Specifically, the catheter 100 is inserted into the subject's body from the femoral artery FA and extends into the left ventricle LV through the aorta AO and the aortic valve AV. The distal end 8 of the medical device 1 is delivered to the left ventricle LV through the catheter 100 while a part of the proximal end side of the medical device 1 is located outside the body of the subject. The catheter 100 may be inserted into the body of the subject from the radial artery of the wrist, for example, instead of the femoral artery FA.

  FIG. 2 is a partial longitudinal sectional view including the distal end 8 of the medical device 1. 3 is a cross-sectional view taken along line III-III in FIG. 4 is a cross-sectional view taken along line IV-IV in FIG. As shown in FIG. 2, the medical instrument 1 includes a main body portion 10 and a puncture portion 30. The puncture unit 30 includes the distal end 8, and can puncture a living tissue such as an inner wall of the left ventricle LV (see FIG. 1) from the distal end 8. The main body portion 10 is located on the proximal end side with respect to the puncture portion 30. In the present embodiment, the main body portion 10 and the puncture portion 30 are adjacent to each other in a direction along the central axis O (hereinafter referred to as “axial direction”). In FIG. 2, in addition to the medical device 1, a part including the distal end 101 of the catheter 100 that houses the medical device 1 is also illustrated. 3 and 4, the illustration of the catheter 100 is omitted.

  The main body 10 of the medical device 1 defines a plurality of lumens extending in the axial direction. As shown in FIGS. 2 and 3, in this embodiment, an inner lumen 11 and an outer lumen 16 are partitioned as a plurality of lumens. As shown in FIG. 3, the outer lumen 16 surrounds the inner lumen 11 in a cross-sectional view orthogonal to the axial direction. In other words, the outer lumen 16 is located outside the inner lumen 11 over more than half of the circumferential direction of the inner lumen 11. In the example shown in FIG. 3, the outer lumen 16 completely surrounds the inner lumen 11 in a cross-sectional view orthogonal to the axial direction. In other words, the outer lumen 16 is located outside the inner lumen 11 over the entire circumferential direction of the inner lumen 11.

  The inner lumen 11 communicates with the outside on the proximal end side of the medical device 1. The inner lumen 11 can be supplied with a fluid as an administration object to be administered to the living tissue from the proximal end side. The outer lumen 16 communicates with the outside on the proximal end side of the medical device 1. The outer lumen 16 can be supplied with a fluid as an administration target to be administered to the living tissue from the proximal end side. The fluid supplied to the inner lumen 11 and the outer lumen 16 is, for example, a cell, an extracellular matrix having a function of adhering the cell to a living tissue, a growth factor such as a fibroblast growth factor (bFGF) preparation, a contrast agent, And one or more of the biocompatible materials.

  The cells as the administration target include, for example, adherent cells (adherent cells). Adherent cells include, for example, adherent somatic cells (eg, cardiomyocytes, fibroblasts, epithelial cells, endothelial cells, hepatocytes, pancreatic cells, kidney cells, adrenal cells, periodontal cells, gingival cells, periosteum cells, skin Cells, synovial cells, chondrocytes, etc.) and stem cells (eg, tissue stem cells such as myoblasts, cardiac stem cells, embryonic stem cells, pluripotent stem cells such as induced pluripotent stem (iPS) cells, mesenchymal stem cells, etc.) Etc. Somatic cells may be differentiated from stem cells, particularly iPS cells. Non-limiting examples of cells to be administered include, for example, myoblasts (for example, skeletal myoblasts), mesenchymal stem cells (for example, bone marrow, adipose tissue, peripheral blood, skin, hair root, muscle tissue, Endometrium, placenta, umbilical cord blood, etc.), cardiomyocytes, fibroblasts, cardiac stem cells, embryonic stem cells, iPS cells, synovial cells, chondrocytes, epithelial cells (eg, oral mucosal epithelial cells, retinal pigments) Epithelial cells, nasal mucosal epithelial cells, etc.), endothelial cells (eg, vascular endothelial cells, etc.), hepatocytes (eg, liver parenchymal cells, etc.), pancreatic cells (eg, islet cells, etc.), kidney cells, adrenal cells, periodontal ligament Examples include cells, gingival cells, periosteum cells, skin cells and the like.

  The extracellular matrix as the administration subject includes, for example, non-cellular components present in each tissue and organ such as myocardium, kidney, bladder, and cartilage. The extracellular matrix can be extracted, for example, by homogenizing organs such as heart muscle and cartilage. The composition of the extracellular matrix is mainly composed of fibrous proteins, structural proteins, glycosaminoglycans, etc., and all types of collagen: fibrils (type I, type II, type III, V Type, type XI); factit (type IX, type XII, type XIV); short chain (type VIII, type X), basement membrane (type IV), and others (type VI, type VII, type XIII), Elastin, fibronectin, fibrinogen, fibulin, cadherin, laminin, agrin, entactin, tenascin, link protein, proteoglycan, aggrecan, perlecan, versican, neurocan, brevican, decorin, biglycan, serglycin, syndecan, glypican, lumican, chondrocan Proteoglycan sulfate, hyaluronic acid, key Emissions, and the like. In addition, the ratio of the individual composition of the extracellular matrix depends on the ratio of the composition constituting the tissue.

  Examples of biocompatible materials for administration include polyacrylamide gel, polyvinylpyrrolidone gel, gelatin gel, β-glucan gel, agarose gel, carboxymethylcellulose gel, ethylene vinyl alcohol, zirconium, hydroxyapatite, polydimethylsiloxane, and dextranomer. , Silicon, glycols and mixtures thereof, and particles selected from them, porous particles, fibers, porous fibers, sheets, porous sheets and combinations thereof.

  As shown in FIGS. 2 and 3, the main body 10 of the present embodiment includes a cylindrical outer cylinder member 60 and a cylindrical inner cylinder member 70. The outer diameter of the inner cylinder member 70 is smaller than the inner diameter of the outer cylinder member 60, and the inner cylinder member 70 is located in the hollow portion of the outer cylinder member 60. Specifically, the inner cylinder member 70 is held in a hollow portion of the outer cylinder member 60 so that the outer surface 72 of the inner cylinder member 70 does not contact the inner surface 61 of the outer cylinder member 60.

  As shown in FIGS. 2 and 3, the inner lumen 11 is a columnar hollow portion defined by the inner surface 71 of the inner cylinder member 70. The inner cylinder member 70 defines a tip opening 73 that is one end of the inner lumen 11 at the tip of the main body 10. The inner lumen 11 communicates with a single lumen 31 described later at the position of the distal end opening 73 of the inner cylinder member 70. The outer lumen 16 is a cylindrical hollow portion defined by the inner surface 61 of the outer cylinder member 60 and the outer surface 72 of the inner cylinder member 70. In the present embodiment, the outer diameter of the outer cylinder member 60, the inner diameter of the outer cylinder member 60, the outer diameter of the inner cylinder member 70, and the inner diameter of the inner cylinder member 70 are substantially constant along the axial direction. That is, the cross-sectional areas of the inner lumen 11 and the outer lumen 16 are substantially constant along the axial direction.

  As shown in FIG. 2, the puncture unit 30 is constituted by a hollow needle-like member, and defines a single lumen 31 with an inner surface 33. The single lumen 31 communicates with the inner lumen 11 and the outer lumen 16 as a plurality of lumens on the proximal end side, and is a distal end opening 32 which is one end of the single lumen 31 and is defined at the distal end 8. Communicate. In the present embodiment, the inner surface 33 of the puncture unit 30 and the inner surface 61 of the outer cylinder member 60 of the main body unit 10 are flush with each other in a longitudinal sectional view shown in FIG. Moreover, the outer surface 34 of the puncture part 30 and the outer surface 62 of the outer cylinder member 60 of the main-body part 10 have a flush relationship. The puncture unit 30 is fixed to the outer cylinder member 60 and may be formed integrally with the outer cylinder member 60. Alternatively, the outer cylinder member 60 may protrude from the inner cylinder member 70 toward the distal end side, and the puncture portion 30 may be configured by the protruding portion.

  As shown in FIG. 2, the outer diameter of the puncture unit 30 is gradually reduced toward the distal end side. In other words, the outer surface 34 of the puncture unit 30 is axially arranged so that the outer diameter of the distal end of the puncture unit 30 (that is, the distal end 8 of the medical instrument 1) is smaller than the outer diameter of the proximal end 35 of the puncture unit 30. It is inclined with respect to it.

  In the present embodiment, the outer surface 34 of the puncture unit 30 is most inclined at a first position 36 that is a position different from the distal end 8 and the proximal end 35 with respect to the axial direction. Specifically, the inclination angle of the outer surface 34 of the puncture unit 30 with respect to the axial direction gradually increases from the proximal end 35 side to the distal end 8 side, reaches a maximum at the first position 36, and then gradually decreases. Specifically, the outer surface 34 of the puncture unit 30 has a curvature that is convex on the proximal end 35 side of the first position 36 along the axial direction, and is concave on the distal end 8 side of the first position 36. The taper shape has a curvature of As a result, the outer diameter in the vicinity of the distal end 8 of the puncture unit 30 has a small change along the axial direction and can have a small absolute value. The puncture resistance during the period can be reduced.

  As shown in FIG. 2, in this embodiment, the inner diameter of the puncture unit 30 is gradually reduced toward the distal end side. In other words, the inner surface 33 of the puncture unit 30 is inclined with respect to the axial direction so that the inner diameter of the distal end 8 is smaller than the inner diameter of the proximal end 35 of the puncture unit 30.

  In the present embodiment, the inner surface 33 of the puncture unit 30 is most inclined at a second position 37 that is a position different from the distal end 8 and the proximal end 35 with respect to the axial direction. Specifically, the inclination angle of the inner surface 33 of the puncture portion 30 with respect to the axial direction gradually increases from the proximal end 35 side to the distal end 8 side and becomes maximum, and then gradually decreases. Specifically, the inner surface 33 of the puncture unit 30 has a curvature that is convex on the proximal end 35 side of the second position 37 along the axial direction, and is concave on the distal end 8 side of the second position 37. The taper shape has a curvature of Thereby, since the inner surface 33 of the puncture part 30 is smoothly connected from the proximal end 35 side to the distal end 8 side having a smaller inner diameter than the proximal end 35 side, the puncture part 30 is punctured into the living tissue. The injection resistance when fluid is injected into the living tissue through the single lumen 31 can be reduced.

  As shown in FIG. 2, the medical instrument 1 can project a part of the distal end side of the puncture unit 30 from the distal end 101 of the catheter 100 to the outside. By the way, as shown in FIG. 2, the inner diameter near the distal end 101 of the catheter 100 is smaller than the outer diameter near the proximal end 35 of the puncture portion 30 of the medical instrument 1. In the example shown in FIG. 2, the inner diameter of the catheter 100 is gradually reduced toward the distal end 101 side. Thus, since the inner diameter near the distal end 101 of the catheter 100 is smaller than the outer diameter near the proximal end 35 of the puncture part 30 of the medical device 1, the outer surface 34 of the puncture part 30 abuts on the inner surface 102 of the catheter 100. The protruding length of the medical device 1 with respect to the catheter 100 is defined to be a predetermined length or less. Thereby, when puncturing the puncture unit 30, the catheter 100 suppresses deformation of the puncture unit 30. As a result, the puncture unit 30 can be easily punctured into the living tissue.

  The plurality of lumens defined by the main body 10 may include two lumens having different areas in a cross section perpendicular to the axial direction (hereinafter also simply referred to as “cross-sectional area”). As shown in FIG. 3, in this embodiment, the cross-sectional area of the outer lumen 16 is larger than the cross-sectional area of the inner lumen 11. With this configuration, a highly viscous fluid such as a cell is supplied through the outer lumen 16 having a larger cross-sectional area, and a lower viscous fluid such as an extracellular matrix is supplied to the inner lumen 11 having a smaller cross-sectional area. Can be used to supply through. As a result, the flow rate that is the velocity of the fluid flowing through both lumens can be made uniform, and the injection resistance that is the pipe frictional resistance of the fluid can be made uniform.

  When the plurality of lumens defined by the main body 10 include two lumens having different cross-sectional areas, the cross-sectional area of the lumen having the smaller cross-sectional area and the minimum cross-sectional area of the single lumen 31, that is, the tip opening 32 The cross-sectional area may be substantially equal. In the present embodiment, the cross-sectional area of the inner lumen 11 having a smaller cross-sectional area than the outer lumen 16 and the cross-sectional area at the distal end opening 32 of the single lumen 31 are substantially equal. With this configuration, the cross-sectional area of the tip opening 32 of the single lumen 31 can be reduced within a range that does not hinder the flow of fluid from the inner lumen 11 having a small cross-sectional area. The puncture resistance can be reduced by reducing the outer diameter of one lumen 31.

  As shown in FIGS. 2 and 4, the medical device 1 of the present embodiment further includes a check valve 13 that is provided at the distal end 12 of the inner lumen 11 and inhibits the intrusion of fluid into the inner lumen 11. Good. In this example, the check valve 13 is provided so as to cover the tip opening 73 of the inner cylinder member 70. By providing such a check valve 13, the fluid is prevented from flowing from the tip 12 through the inner lumen 11, and is prevented from flowing into the inner lumen 11 from the tip 12. Thereby, for example, when the fluid is administered to the living tissue through the outer lumen 16 in a state where the puncture unit 30 is pierced into the living tissue, the fluid from the outer lumen 16 flows into the inner side via the single lumen 31 due to the injection resistance. Inflow into the lumen 11 can be suppressed. The medical device 1 may include a check valve that suppresses the entry of fluid into the outer lumen 16 at the tip of the outer lumen 16 in addition to or instead of the check valve 13.

  As shown in FIGS. 2 and 4, the medical device 1 of the present embodiment further includes a support member 79 that supports the inner cylinder member 70 in the hollow portion of the outer cylinder member 60. In this example, the support member 79 is interposed between the outer surface 72 of the inner cylinder member 70 and the inner surface 61 of the outer cylinder member 60 in the vicinity of the tip of the inner cylinder member 70, and is provided at a plurality of positions in the circumferential direction. It is comprised with the some wire which supports the cylinder member 70 with tension | tensile_strength. The support member 79 is installed so as not to block the fluid flow in the outer lumen 16. The support member 79 is not limited to the above-described wire, and may be a member having liquid permeability disposed, for example, in the vicinity of the distal end of the inner cylindrical member 70 and over the entire predetermined cross section of the outer lumen 16. . And the inner cylinder member 70 and the outer cylinder member 60 may be mutually fixed by the base end side in the state by which the outer lumen | rumen 16 was maintained. With this configuration, when at least the central axis O of the medical instrument 1 is located on a straight line, the outer surface 72 of the inner cylinder member 70 can be held so as not to contact the inner surface 61 of the outer cylinder member 60. it can. When the central axis O of the medical instrument 1 is curved, the outer surface 72 of the inner cylinder member 70 may contact the inner surface 61 of the outer cylinder member 60. Further, the support member 79 supports the tip of the inner cylinder member 70 at a position that does not reach the hollow portion of the puncture portion 30.

  As a forming material of the main body part 10, the puncture part 30, and the catheter 100 of the medical instrument 1, those having a certain degree of flexibility are preferable, and examples thereof include metals and resins. Examples of the metal include pseudo-elastic alloys (including superelastic alloys) such as Ni-Ti alloys, stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, SUS430F, SUS302, etc., all types of SUS), cobalt-based alloys, noble metals such as gold and platinum, tungsten-based alloys, carbon-based materials (including piano wires), and the like. Examples of the resin include polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyvinyl chloride, polyamide, polyamide. Examples thereof include polymer materials such as elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, polyimides, fluororesins, mixtures thereof, and the above two or more polymer materials. Furthermore, engineering plastics represented by polyetheretherketone can be mentioned. Moreover, it can also be comprised with the multilayer tube etc. which consist of a composite formed from these metals and resin.

  FIG. 5 is a flowchart showing an administration method executed using the medical device 1. As shown in FIG. 5, the administration method executed using the medical device 1 includes a puncturing step S1, a first administration step S2, and a second administration step S3.

  In the puncturing step S1, as described above, the puncture portion 30 that divides the single lumen 31 as a hollow portion communicating with the outside at the tip 8 is punctured from the tip 8 into the living tissue. Specifically, for example, as shown in FIG. 1, the distal end 8 of the puncture portion 30 of the medical device 1 delivered to the left ventricle LV through the catheter 100 is protruded from the catheter 100, and the left ventricle as a living tissue The inner wall of the LV is punctured. The medical instrument 1 can be operated by an operator such as a medical worker operating a part of the proximal end side of the medical instrument 1 located outside the body of the subject.

  In 1st administration process S2, a cell is administered to a biological tissue through the single lumen 31 as a hollow part of the medical device 1. FIG. Specifically, for example, cells are supplied from the proximal end side of the medical device 1 through either the inner lumen 11 or the outer lumen 16. Then, the cells are administered to the living tissue via the single lumen 31.

  In the second administration step S3, the extracellular matrix is administered to the living tissue through the single lumen 31 as the hollow portion of the medical device 1 after the first administration step S2. Specifically, for example, the extracellular matrix is supplied from the proximal end side of the medical device 1 through the lumen of the inner lumen 11 or the outer lumen 16 to which cells are not supplied in the first administration step S2. Then, the extracellular matrix is administered to the living tissue via the single lumen 31.

  As described above, after the cells are administered to the biological tissue in the first administration step S2, the extracellular matrix administered to the biological tissue is gelled by the body temperature by administering the extracellular matrix to the biological tissue in the second administration step S3. Since the viscosity increases due to the increase of the viscosity, it is possible to suppress leakage of the previously administered cells due to a heartbeat or the like.

  By the way, in addition to each said process, the administration method performed using the medical device 1 is through the single lumen 31 as a hollow part of the medical device 1 after the puncture step S1 and before the first administration step S2. And a step of administering an extracellular matrix to a living tissue. Specifically, for example, the extracellular matrix is supplied from the proximal end side of the medical device 1 through the lumen that supplies the extracellular matrix in the second administration step S3 in the inner lumen 11 or the outer lumen 16. Thereby, it is possible to prepare in advance an environment in which cells are easily engrafted in living tissue. However, it is preferable not to include the said process from a viewpoint of the simplicity of operation.

  The cells may be administered through the inner lumen 11 of the medical device 1 in the first administration step S2, and the extracellular matrix may be administered through the outer lumen 16 of the medical device 1 in the second administration step S3. Thereby, since the cells that are more fragile than the extracellular matrix are supplied not to the outer lumen 16 that is the cylindrical hollow portion but into the inner lumen 11 that is the columnar hollow portion, the possibility of the cells being broken can be reduced. . Moreover, since the extracellular matrix supplied from the outer lumen 16 pushes out the cells remaining in the single lumen 31 from the outside in the radial direction after the cells are supplied, the leakage of the cells can be further suppressed.

  The cells may be administered through the outer lumen 16 of the medical device 1 in the first administration step S2, and the extracellular matrix may be administered through the inner lumen 11 of the medical device 1 in the second administration step S3. Accordingly, the body temperature is more easily transmitted to the outer lumen 16 than the inner lumen 11, so that the cell activity can be maintained in the medical device 1 before the cells are administered, and the inner lumen 11 has the outer lumen. Since body temperature is less likely to be transmitted than 16, it is possible to suppress gelation in the medical device 1 before the extracellular matrix is administered.

(Second Embodiment)
FIG. 6 is a partial longitudinal sectional view including the distal end of the medical device 2 as the second embodiment of the present invention. 7 is a cross-sectional view taken along line VII-VII in FIG. The medical device 2 is long like the medical device 1 shown with reference to FIG. 1, and the proximal end is located outside the body of the subject through the tubular catheter 100, and the left side of the heart lumen. It can be used in a state of extending so that the tip 8 is positioned in the ventricle LV. As shown in FIG. 6, the medical instrument 2 includes a main body portion 10a, a puncture portion 30, and a check valve 13. Since the puncture part 30 of this embodiment is the same as the puncture part 30 of 1st Embodiment mentioned above, description is abbreviate | omitted. Since the configuration of the check valve 13 itself of the present embodiment is the same as the configuration of the first embodiment described above, description thereof is omitted.

  The main body 10a of the medical device 2 defines a plurality of lumens extending in the axial direction. As shown in FIGS. 6 and 7, in this embodiment, an inner lumen 11a and an outer lumen 16a are partitioned as a plurality of lumens. As shown in FIG. 7, the outer lumen 16a surrounds the inner lumen 11a in a cross-sectional view orthogonal to the axial direction. In other words, the outer lumen 16a is located outside the inner lumen 11a over more than half of the circumferential direction of the inner lumen 11a. In the example shown in FIG. 7, the outer lumen 16a is located outside the inner lumen 11a, except for a part of the inner lumen 11a in the circumferential direction (the lower end in FIG. 7).

  The inner lumen 11 a communicates with the outside on the proximal end side of the medical device 2. The inner lumen 11a can be supplied with a fluid as a substance to be administered to the living tissue from the proximal end side. The outer lumen 16 a communicates with the outside on the proximal end side of the medical device 2. The outer lumen 16a can be supplied with a fluid as an administration object to be administered to the living tissue from the proximal end side. The fluid supplied to the inner lumen 11a and the outer lumen 16a includes, for example, a cell and an extracellular matrix having a function of adhering the cell to a living tissue.

  As shown in FIG.6 and FIG.7, the main-body part 10a of this embodiment is comprised by the cylindrical outer cylinder member 60a and the cylindrical inner cylinder member 70a. The outer diameter of the inner cylinder member 70a is smaller than the inner diameter of the outer cylinder member 60, and the inner cylinder member 70a is located in the hollow portion of the outer cylinder member 60a. Specifically, the inner cylinder member 70a is a hollow portion of the outer cylinder member 60a, and a part along the axial direction of the outer surface 72 of the inner cylinder member 70a contacts a part along the axial direction of the inner surface 61 of the outer cylinder member 60a. In this state, it is fixed to the outer cylinder member 60a. The inner cylinder member 70a may be formed integrally with the outer cylinder member 60a.

  The inner lumen 11a is a columnar hollow portion defined by the inner surface 71 of the inner cylinder member 70a. The inner cylinder member 70a defines a distal end opening 73 that is one end of the inner lumen 11a at the distal end of the main body 10a. The inner lumen 11a communicates with the single lumen 31 of the puncture unit 30 at the position of the distal end opening 73 of the inner cylinder member 70a. The outer lumen 16a is a hollow portion defined by the inner surface 61 of the outer cylinder member 60a and the outer surface 72 of the inner cylinder member 70a. In the present embodiment, the outer diameter of the outer cylinder member 60a, the inner diameter of the outer cylinder member 60a, the outer diameter of the inner cylinder member 70a, and the inner diameter of the inner cylinder member 70a are substantially constant along the axial direction. That is, the cross-sectional areas of the inner lumen 11a and the outer lumen 16a are substantially constant along the axial direction.

  The single lumen 31 defined by the puncture unit 30 of the present embodiment communicates with the inner lumen 11a and the outer lumen 16a as a plurality of lumens on the proximal end side. In this embodiment, the inner surface 33 of the puncture part 30 and the inner surface 61 of the outer cylinder member 60a of the main body part 10a are flush with each other in the longitudinal sectional view shown in FIG. Moreover, the outer surface 34 of the puncture part 30 and the outer surface 62 of the outer cylinder member 60a of the main-body part 10a have a flush relationship. The puncture unit 30 is fixed to the outer cylinder member 60a and may be formed integrally with the outer cylinder member 60a. Alternatively, the outer cylinder member 60a may protrude toward the distal end side relative to the inner cylinder member 70a, and the puncture portion 30 may be configured by the protruding portion.

  In this embodiment, the cross-sectional area of the outer lumen 16a is larger than the cross-sectional area of the inner lumen 11a. Further, the cross-sectional area of the inner lumen 11 a having a smaller cross-sectional area than the outer lumen 16 a is substantially equal to the cross-sectional area at the distal end opening 32 of the single lumen 31. The effects of these configurations are the same as the effects described above for the first embodiment.

  The forming material of the main body 10a of the medical device 2 can be the same as the forming material of the main body 10 of the medical device 1 described above. The administration method similar to the administration method performed using the above-described medical device 1 can be performed using the medical device 2.

(Third embodiment)
FIG. 8 is a partial longitudinal sectional view including the distal end of the medical device 3 as the third embodiment of the present invention. 9 is a cross-sectional view taken along line IX-IX in FIG. The medical device 3 is long like the medical device 1 shown with reference to FIG. 1, and the proximal end is located outside the body of the subject through the tubular catheter 100, and the left side of the heart lumen. It can be used in a state of extending so that the tip 8 is positioned in the ventricle LV. As shown in FIG. 8, the medical instrument 3 includes a main body portion 10b, a puncture portion 30, and a check valve 13. Since the puncture unit 30 of the present embodiment is the same as the puncture unit 30 of the first embodiment and the second embodiment described above, description thereof is omitted. Since the configuration of the check valve 13 itself of this embodiment is the same as that of the first embodiment and the second embodiment described above, the description thereof is omitted.

  The main body 10b of the medical device 3 defines a plurality of lumens extending in the axial direction. As shown in FIGS. 8 and 9, in this embodiment, a small lumen 11b and a large lumen 16b having a larger diameter than the small lumen 11b are partitioned as a plurality of lumens. As shown in FIGS. 8 and 9, the small lumen 11b and the large lumen 16b are parallel to each other along the axial direction.

  The small lumen 11 b communicates with the outside on the proximal end side of the medical device 3. The small lumen 11b can be supplied with a fluid as an administration object to be administered to the living tissue from the proximal end side. The large lumen 16 b communicates with the outside on the proximal end side of the medical device 3. The large lumen 16b can be supplied with a fluid as an administration object to be administered to the living tissue from the proximal end side. The fluid supplied to the small lumen 11b and the large lumen 16b includes, for example, a cell and an extracellular matrix having a function of adhering the cell to a living tissue.

  As shown in FIGS. 8 and 9, the main body portion 10 b of this embodiment includes a cylindrical outer cylinder member 60 b and an internal member 90. The outer diameter of the inner member 90 is smaller than the inner diameter of the outer cylinder member 60b, and the inner member 90 is disposed without a gap in the hollow portion of the outer cylinder member 60b. Specifically, the inner member 90 is a hollow portion of the outer cylinder member 60b, and is fixed to the outer cylinder member 60b in a state where the outer surface 91 of the inner member 90 is in contact with the inner surface 61 of the outer cylinder member 60b without a gap. Yes. The inner member 90 may be formed integrally with the outer cylinder member 60b.

  The small lumen 11 b is a columnar hollow portion defined by the first inner surface 92 of the internal member 90. The small lumen 11 b communicates with the single lumen 31 of the puncture unit 30 at the position of the first distal end opening 94 that is one end of the small lumen 11 b, which is defined at the distal end of the internal member 90. The large lumen 16 b is a columnar hollow portion defined by the second inner surface 93 of the internal member 90. The large lumen 16 b communicates with the single lumen 31 of the puncture unit 30 at the position of the second tip opening 95 that is one end of the large lumen 16 b, which is defined at the tip of the internal member 90. In the present embodiment, the inner diameter of the first inner surface 92 and the inner diameter of the second inner surface 93 of the internal member 90 are substantially constant along the axial direction. That is, the cross-sectional areas of the small lumen 11b and the large lumen 16b are substantially constant along the axial direction.

  The single lumen 31 defined by the puncture unit 30 of the present embodiment communicates with the small lumen 11b and the large lumen 16b as a plurality of lumens on the proximal end side. In this embodiment, the outer surface 34 of the puncture part 30 and the outer surface 62 of the outer cylinder member 60b of the main-body part 10b have the same relationship in the longitudinal cross-sectional view shown in FIG. The first inner surface 92 and the second inner surface 93 of the internal member 90 are smoothly connected to the inner surface 33 of the puncture unit 30, that is, the inner diameter is directed toward the distal end side toward the distal end side so as to be flush with the inner surface. A taper-shaped inner surface of the tip that gradually increases may be provided. The puncture unit 30 is fixed to the outer cylinder member 60b and may be formed integrally with the outer cylinder member 60b. Alternatively, the outer cylindrical member 60b may protrude from the inner member 90 toward the distal end side, and the puncture portion 30 may be configured by the protruding portion.

  In this embodiment, the cross-sectional area of the large lumen 16b is larger than the cross-sectional area of the small lumen 11b. Further, the cross-sectional area of the small lumen 11b having a smaller cross-sectional area than the large lumen 16b and the cross-sectional area at the distal end opening 32 of the single lumen 31 are substantially equal. The effects of these configurations are the same as the effects described above for the first embodiment.

  The forming material of the main body 10b of the medical device 3 can be the same as the forming material of the main body 10 of the medical device 1 described above. The administration method similar to the administration method performed using the above-described medical device 1 can be performed using the medical device 3.

  The present invention is not limited to the configuration specified in each of the above-described embodiments, and various modifications can be made without departing from the contents described in the claims.

  The present disclosure relates to medical devices and administration methods.

1, 2, 3: Medical device 8: Medical device tip 10, 10a, 10b: Main body 11, 11a: Inner lumen 11b: Small lumen 12: Inner lumen tip 12b: Small lumen tip 13: Check valve 16 16a: outer lumen 16b: large lumen 30: puncture section 31: single lumen 32: distal opening of the puncture section 33: inner surface of the puncture section 34: outer surface 35 of the puncture section: proximal end 36 of the puncture section: first position 37 : Second position 60, 60a, 60b: outer cylinder member 61: inner surface 62 of outer cylinder member: outer surface 70 of outer cylinder member, 70a: inner cylinder member 71: inner surface 72 of inner cylinder member: outer surface 73 of inner cylinder member: Inner cylinder member distal end opening 79: support member 90: inner member 91: inner member outer surface 92: inner member first inner surface 93: inner member second inner surface 94: first tip opening 95: second tip opening 100: Catheter 101: catheter Tel tip 102: the inner surface of the catheter AO: aorta AV: aortic valve FA: femoral artery LV: left ventricular O: center axis

Claims (8)

A long medical device,
A main body section defining a plurality of lumens extending in the axial direction;
A puncture portion that communicates with the plurality of lumens and that communicates with the outside at a distal end to define a single lumen; and
A medical instrument in which an outer diameter of the puncture portion gradually decreases toward the distal end side.   The medical instrument according to claim 1, wherein an inner surface of the puncture portion is inclined most at a position different from a distal end and a proximal end of the puncture portion with respect to the axial direction. The plurality of lumens of the body portion are
The inner lumen,
The medical device according to claim 1, further comprising: an outer lumen surrounding the inner lumen in a cross-sectional view orthogonal to the axial direction.   The medical device according to claim 3, further comprising a check valve at a distal end of the inner lumen, the check valve inhibiting the entry of fluid into the inner lumen. The main body is composed of an outer cylinder member and an inner cylinder member,
The inner lumen is defined by an inner surface of the inner cylinder member;
The medical device according to claim 3 or 4, wherein the outer lumen is partitioned by an inner surface of the outer cylinder member and an outer surface of the inner cylinder member.   The medical device according to claim 5, further comprising a support member that supports the inner cylinder member in a hollow portion of the outer cylinder member.   The medical instrument according to any one of claims 1 to 6, wherein an outer surface of the puncture unit is inclined most at a position different from a distal end and a base end of the puncture unit with respect to the axial direction. A puncturing step for puncturing a living tissue from the tip, which punctures a lumen communicating with the outside at the tip;
A first administration step of administering cells to the living tissue through the lumen;
And a second administration step of administering an extracellular matrix to the living tissue through the lumen after the first administration step.

Images