JP2019154926A - Medical device and puncture state determination method - Google Patents

Abstract

To provide a medical device capable of determining a puncture state of a puncture member to a biological tissue, and holding a state in which the biological tissue is being punctured by the puncture member.SOLUTION: A medical device comprises a long puncture member having a blade surface inclined to an axial direction and capable of puncturing the biological tissue. The puncture member partitions an administration lumen communicated to outside through an administration hole formed on the blade surface, one or more suction lumens communicated to outside through one or more suction holes formed on a side surface, and the suction hole provided closest to a tip side out of the one or more suction holes communicates to outside on a position opposite to the region where the blade surface is positioned, in a circumferential direction.SELECTED DRAWING: Figure 2

Description

  The present disclosure relates to a medical instrument and a puncture state determination method.

  In recent years, a puncture member of a medical device that divides an administration lumen into a living tissue such as the inner wall of the left ventricle of the heart is punctured, and an administration target such as a cell is administered to the living tissue through the administration lumen. Treatment of lesions such as heart failure has been studied. In such a case, it is required to puncture the living tissue appropriately with the puncture member.

  Patent Document 1 discloses a needle as a long puncture member that can puncture a living tissue, and a detection unit that can be wound around the needle and detect the contact state with the living tissue by detecting impedance. And an electrode as a medical device.

JP-T-2015-5294487

  According to the medical instrument described in Patent Literature 1, when the electrode detects contact with a living tissue, it can be determined that the probability that the needle is punctured into the living tissue is high.

  However, the medical device described in Patent Document 1 has room for improvement in maintaining the state where the needle is punctured into the living tissue.

  In view of the above problems, an object of the present disclosure is to provide a medical instrument and a puncture state determination method capable of determining a puncture state of a puncture member into a living tissue and maintaining a state where the puncture member is punctured into a living tissue. It is to be.

  A medical instrument according to an aspect of the present invention includes a long puncture member that has a blade surface that is inclined with respect to an axial direction at a distal end, and is capable of puncturing a living tissue, and the puncture member includes the blade surface Partitioning a dosing lumen that communicates with the outside through a dosing hole formed on the side and one or more suction lumens that respectively communicate with the outside through one or more suction holes formed on the side surface, Of the two or more suction holes, the suction hole located on the most distal end side communicates with the outside at a position opposite to the region where the blade surface is located in the circumferential direction.

  In the medical instrument as an embodiment of the present invention, the side surface of the puncture member includes a recessed portion that is recessed from the periphery, and at least one suction hole of the one or more suction holes is located in the recessed portion. .

  In the medical instrument as an embodiment of the present invention, the concave portion is a reduced diameter portion extending in the circumferential direction.

  In the medical device according to an embodiment of the present invention, a cross-sectional area of each of the one or more suction lumens is smaller than a cross-sectional area of the administration lumen.

  In the medical instrument as one embodiment of the present invention, the one or more suction holes include a plurality of suction holes arranged at different positions in the circumferential direction.

  In the medical device as one embodiment of the present invention, the one or more suction holes include a plurality of suction holes arranged at different positions in the axial direction.

  In the medical instrument as one embodiment of the present invention, the one or more suction holes are located at a distance of 8 mm or less from the needle tip of the puncture member along the axial direction.

  The puncture state determination method included as one aspect of the present invention includes a puncture step of puncturing a living tissue with a puncture member that divides a suction lumen communicating with the outside through a suction hole, and generating negative pressure in the suction lumen A suction step for generating a suction force from the suction hole to the suction lumen, and a determination step for determining a puncture state of the puncture member into the living tissue based on a result of the suction step. Including.

  According to the present disclosure, it is possible to provide a medical instrument and a puncture state determination method capable of determining a puncture state of a puncture member into a biological tissue and capable of holding the state where the puncture member is punctured into the biological tissue.

It is a figure which shows the medical device as a 1st aspect of this indication. It is a longitudinal cross-sectional view which shows a part including the front-end | tip part 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 sectional drawing which follows the VV line of FIG. It is the figure which looked at the puncture member of the medical instrument of FIG. 1 along the axial direction from the front-end | tip. It is a figure which shows the 1st example of the puncture state to the biological tissue of the puncture member of the medical instrument of FIG. 1, or the medical instrument of FIG. It is a figure which shows the 2nd example of the puncture state to the biological tissue of the puncture member of the medical instrument of FIG. 1, or the medical instrument of FIG. It is a figure which shows the 1st modification of the puncture member of the medical device of FIG. It is a figure which shows the 2nd modification of the puncture member of the medical instrument of FIG. It is a figure which shows the extracorporeal arrangement | positioning part of the puncture member of the medical instrument of FIG. It is a flowchart which shows the puncture state determination method performed using the medical device of FIG. It is a longitudinal cross-sectional view which shows a part including the front-end | tip part of the medical device as a 2nd aspect of this indication. It is sectional drawing which follows the XIV-XIV line | wire of FIG. It is sectional drawing which follows the XV-XV line | wire of FIG. It is sectional drawing which follows the XVI-XVI line of FIG. It is a longitudinal cross-sectional view which shows a part including the front-end | tip part of the modification of the medical device of FIG. It is sectional drawing which follows the XVIII-XVIII line of FIG. It is sectional drawing which follows the XIX-XIX line | wire of FIG. It is sectional drawing which follows the XX-XX line of FIG. It is a flowchart which shows the puncture state determination method performed using the medical device of FIG. It is a figure which shows the 3rd example of the puncture state to the biological tissue of the puncture member of the medical instrument of FIG. 1, or the medical instrument of FIG.

  Hereinafter, each aspect of the present disclosure will be described with reference to the drawings. In each figure, the same code | symbol is attached | subjected to the common element.

(First aspect)
FIG. 1 is a diagram illustrating a medical device 1 as a first aspect of the present disclosure. As shown in FIG. 1, the medical instrument 1 is elongate, for example. FIG. 1 shows a state in which the medical device 1 extends from outside the subject's body to the left ventricle LV of the heart lumen through a tubular catheter 200. Specifically, the catheter 200 is inserted into the body of the subject from the femoral artery FA, and extends into the left ventricle LV through the aorta AO and the aortic valve AV. And the front-end | tip part 8 of the medical device 1 is delivered to the left ventricle LV through the catheter 200 in a state where a part of the proximal end side of the medical device 1 is located outside the body of the subject. The catheter 200 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 longitudinal sectional view showing a part including the distal end portion 8 of the medical instrument 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. FIG. 5 is a cross-sectional view taken along line VV in FIG.

  As shown in FIGS. 2 to 5, the medical device 1 includes a puncture member 10. As shown in FIG. 2, the distal end portion of the puncture member 10 constitutes the distal end portion 8 of the medical instrument 1. Hereinafter, the distal end portion 8 of the medical instrument 1 is referred to as “the distal end portion 8” without being distinguished from the distal end portion of the puncture member 10. The puncture member 10 is a long member that can puncture a living tissue such as the inner wall of the left ventricle LV (see FIG. 1) from the distal end portion 8.

  As shown in FIG. 2, the distal end portion 8 of the puncture member 10 includes a blade surface 16 that is inclined with respect to a direction along the central axis O of the puncture member 10 (hereinafter simply referred to as “axial direction”). As shown in FIGS. 2 to 5, the puncture member 10 defines an administration lumen 30. In this example, the puncture member 10 partitions the administration lumen 30 with the inner peripheral surface 12 of the peripheral wall 11 of the puncture member 10. As shown in FIG. 2, the administration lumen 30 communicates with the outside through the administration hole 31. The administration hole 31 is formed in the blade surface 16. As shown in FIGS. 2, 4, and 5, the puncture member 10 defines a suction lumen 40. In this example, the puncture member 10 partitions the suction lumen 40 at a position between the inner peripheral surface 12 and the outer peripheral surface 13 of the peripheral wall 11 of the puncture member 10. As shown in FIG. 2, the suction lumen 40 communicates with the outside through a suction hole 41. The suction hole 41 is formed in the outer peripheral surface 13 (hereinafter also simply referred to as “side surface 13”) of the peripheral wall 11 of the puncture member 10. In other words, the suction lumen 40 of this example extends in the peripheral wall 11 along the axial direction, and communicates with the outside at the position of the suction hole 41.

  As shown in FIGS. 2, 4, and 5, in this embodiment, the suction lumen 40 is partitioned into a cylindrical shape that communicates in the circumferential direction on the radially outer side of the administration lumen 30 and extends in the axial direction. Has been. In the present example, a first suction hole 42, a second suction hole 43, and a third suction hole 44 as three suction holes 41 are partitioned and all communicate with one suction lumen 40. The second suction hole 43 is located at a position different from the first suction hole 42 in the circumferential direction and is located closer to the base end side than the first suction hole 42. The third suction hole 44 is located at the same position in the circumferential direction as the first suction hole 42 and is located closer to the base end side than the first suction hole 42 and the second suction hole 43. Although the case where there are three suction holes 41 is illustrated in FIG. 2, the number is not limited to three, and may be one, two, or four or more.

  The administration lumen 30 may communicate with the outside on the proximal end side of the puncture member 10. Specifically, the proximal end side of the puncture member 10 extends to a position outside the body of the subject shown in FIG. 1, for example, and the administration lumen 30 is connected to the outside at the first proximal end opening of the puncture member 10. Communicate. From the first proximal end opening of the puncture member 10, the administration lumen 30 can be supplied with a fluid as an administration substance to be administered to the living tissue. The fluid as the administration object supplied from the first proximal end opening is administered to the living tissue through the administration hole 31 of the administration lumen 30 located at the distal end portion 8 of the puncture member 10. The fluid supplied to the administration lumen 30 is, for example, a cell, an extracellular matrix having a function of adhering the cell to living tissue, a growth factor such as a fibroblast growth factor (bFGF) preparation, a contrast agent, and a biocompatible material. One or more of the sexual 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 target includes non-cellular components present in each tissue and organ, such as the heart, 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.

  The suction lumen 40 may communicate with the outside on the proximal end side of the puncture member 10. Specifically, the proximal end side of the puncture member 10 extends to a position outside the body of the subject shown in FIG. 1, for example, and the suction lumen 40 is connected to the outside through the second proximal end opening of the puncture member 10. Communicate. By generating a negative pressure inside the suction lumen 40 through the second proximal end opening of the puncture member 10, a suction force from the suction hole 41 into the suction lumen 40 can be generated.

  As shown in FIGS. 4 and 5, the cross-sectional area of the suction lumen 40 is preferably smaller than the cross-sectional area of the administration lumen 30 in a cross-sectional view orthogonal to the axial direction. Specifically, the sectional area of the suction lumen 40 is preferably ½ or less of the sectional area of the administration lumen 30 in a cross-sectional view orthogonal to the axial direction. Thereby, it can suppress that the to-be-administered substance administered to the biological tissue through the administration lumen 30 is sucked in through the suction lumen 40.

  As shown in FIG. 2, the arrangement range L of all the suction holes 41 from the needle tip 17 can be set as appropriate according to the puncture site. For example, when the liver is a puncture target, the arrangement range L is 300 mm or less. It is preferably 100 mm or less when the kidney is a puncture target, preferably 20 mm or less when the heart wall of the heart is a puncture target, and 8 mm when the heart wall of a heart failure state is a puncture target. The following is more preferable. In other words, the suction hole 41 is preferably located at a distance within 300 mm from the needle tip 17 along the axial direction, and more preferably at a distance within 8 mm.

  Since the puncture member 10 is punctured into the living tissue at a depth of more than 8 mm from the needle tip 17 in the state of being properly punctured into the living tissue, the puncture member can be formed by setting the arrangement range L to 8 mm or less. When 10 is properly punctured into a living tissue, all the suction holes 41 can be positioned inside the living tissue. Therefore, the operator of the medical instrument 1 such as a medical worker determines that the puncture member 10 is properly punctured into the living tissue when all the suction holes 41 are located inside the living tissue. Can do. Details of the determination of the puncture state using the suction hole 41 will be described later (see FIGS. 7 and 8).

  FIG. 6 is a view of the puncture member 10 of the medical device 1 viewed from the tip along the axial direction. As shown in FIGS. 2 and 6, among the three suction holes 41, the first suction hole 42, which is the suction hole located on the most distal side, is on the opposite side to the region where the blade surface 16 is located in the circumferential direction. It communicates with the outside at the position. Here, the region where the blade surface 16 is located in the circumferential direction is a region on the proximal end 18 side of the blade surface 16. Therefore, in the circumferential direction, the position opposite to the region where the blade surface 16 is located is a plane X including the needle tip 17 and the central axis O, that is, a plane including the longitudinal section shown in FIG. Position. More specifically, the first suction hole 42 is formed in a region including at least a part of the intersection line Y where the above-described plane X intersects on the needle tip 17 side in the side surface 13 of the puncture member 10. As shown in FIG. 6, in this example, the needle tip 17 constitutes one point on the intersection line Y. In other words, as shown in FIG. 6, the first suction hole 42 is located in a region including the needle tip 17 when viewed from the distal end of the puncture member 10 along the axial direction. Thereby, since the 1st suction hole 42 is arrange | positioned in the position where the to-be-administered substance administered to the biological tissue through the administration lumen 30 cannot reach | attain, it can suppress that a to-be-administered object is sucked from the 1st suction hole 42. .

  FIG. 7 is a diagram illustrating a first example of a puncture state of the puncture member 10 of the medical instrument 1 into the living tissue 300. In the example shown in FIG. 7, all the suction holes 41, that is, the first suction hole 42, the second suction hole 43, and the third suction hole 44 are located outside the living tissue 300. At this time, if a negative pressure is generated inside the suction lumen 40 (see FIG. 2 and the like), the negative pressure is present outside the living tissue 300 through the first suction hole 42, the second suction hole 43, and the third suction hole 44. Body fluid such as blood is sucked into the suction lumen 40. An operator of the medical instrument 1 such as a medical worker can determine that the puncture member 10 is not properly punctured into the living tissue 300 based on the fact that the body fluid has been sucked into the suction lumen 40. . A method for determining whether or not the body fluid has been sucked into the suction lumen 40 will be described later.

  FIG. 8 is a diagram illustrating a second example of the puncture state of the puncture member 10 of the medical instrument 1 into the living tissue 300. In the example shown in FIG. 8, all the suction holes 41, that is, the first suction hole 42, the second suction hole 43, and the third suction hole 44 are located inside the living tissue 300. At this time, when a negative pressure is generated inside the suction lumen 40 (see FIG. 2 and the like), a part of the living tissue 300 is drawn into the first suction hole 42, the second suction hole 43, and the third suction hole 44. Therefore, the puncture member 10 is fixed to the living tissue 300. Further, since the side surface 13 of the puncture member 10 is in close contact with the biological tissue 300, when the administration subject is administered to the biological tissue 300 through the administration lumen 30 (see FIG. 2 and the like), the administered administration subject is the puncture member. It is possible to suppress the flow from the surface 301 of the living tissue 300 to the outside along the side surface 13 of 10. The operator of the medical instrument 1 can determine that the puncture member 10 has been properly punctured into the living tissue 300 based on the fact that the body fluid is not sucked into the suction lumen 40.

  As described above, the first suction hole 42 and the second suction hole 43 are arranged at different positions in the circumferential direction. Similarly, the second suction hole 43 and the third suction hole 44 are arranged at different positions in the circumferential direction. Thus, since the medical instrument 1 of this aspect includes the plurality of suction holes 41 arranged at different positions in the circumferential direction, the living tissue 300 is in close contact at the plurality of positions in the circumferential direction, and the puncture member 10 is the living body. It is more stably fixed to the tissue 300.

  7 shows an example in which all the suction holes 41 are located outside the living tissue 300, and FIG. 8 shows an example in which all the suction holes 41 are located inside the living tissue 300. FIG. 22 is a diagram illustrating a third example of a puncture state of the puncture member 10 of the medical instrument 1 into the living tissue 300. FIG. As shown in FIG. 22, in the medical device 1 of this aspect, at least one suction hole 41 (third suction hole 44 in the example shown in FIG. 22) among the plurality of suction holes 41 is located outside the living tissue 300. In this case, body fluid is sucked into the suction lumen 40 through the one suction hole 41. Therefore, the operator of the medical instrument 1 determines that the puncture member 10 is not properly punctured into the living tissue 300 except when all the suction holes 41 are located inside the living tissue 300. Can do.

  FIG. 9 is a view showing a puncture member 10 a as a first modification of the puncture member 10 of the medical instrument 1. The side surface 13 of the puncture member 10a is provided with a recess that is recessed from the periphery. In detail, as shown in FIG. 9, the recessed part with which the side surface 13 of the puncture member 10a is equipped is the reduced diameter part 14 extended over the circumferential direction. At least one of the one or more suction holes 41 a is located in the reduced diameter portion 14. In the example shown in FIG. 9, the puncture member 10a includes a first reduced diameter portion 14a, a second reduced diameter portion 14b, and a third reduced diameter portion as the reduced diameter portion 14 in order from the distal end side toward the proximal end side. 14c. The first suction hole 42a is located in the first reduced diameter portion 14a, the second suction hole 43a is located in the second reduced diameter portion 14b, and the third suction hole 44a is located in the third reduced diameter portion 14c. Since the puncture member 10a is the same as the puncture member 10 described above except for the points described above, the description thereof is omitted here. As described above, in the puncture member 10a, at least one of the suction holes 41a is located in the reduced diameter portion 14 as the concave portion, and therefore the suction lumen 40 (see FIG. 2 and the like) with the puncture member 10a being punctured into the living tissue. When a negative pressure is generated inside the body tissue, the living tissue is pulled inwardly in the radial direction of the puncture member 10a at the position of the reduced diameter portion 14 by the suction force from the suction hole 40a. Therefore, the puncture member 10 can be more firmly fixed to the living tissue.

  FIG. 10 is a view showing a puncture member 10 b as a second modification of the puncture member 10 of the medical instrument 1. As shown in FIG. 10, the puncture member 10b defines a plurality of suction holes 41b. The plurality of suction holes 41b include a plurality of suction holes arranged at the same position in the axial direction and at different positions in the circumferential direction. In the example shown in FIG. 10, the plurality of first suction holes 42b are arranged at the same position in the axial direction and at different positions in the circumferential direction. The plurality of second suction holes 43b are arranged at the same position in the axial direction and at different positions in the circumferential direction. The plurality of third suction holes 44b are arranged at the same position in the axial direction and at different positions in the circumferential direction. Since the puncture member 10b is the same as the puncture member 10 described above except for the points described above, the description thereof is omitted here. Thus, since the puncture member 10b includes a plurality of suction holes arranged at the same position in the axial direction and at different positions in the circumferential direction, the puncture member 10b is more stable with respect to the living tissue. Fixed.

  Here, a method for determining whether body fluid has been sucked into the suction lumen 40 will be described. As shown in FIG. 2, the medical device 1 may include a detection unit 60 that can detect a substance in the suction lumen 40. The detection unit 60 is configured by a sensor that can detect a body fluid such as blood as a substance, and can perform potential measurement, absorbance measurement, color measurement, and the like. Based on whether or not the detection unit 60 has detected body fluid inside the suction lumen 40, it can be determined whether or not body fluid has been sucked into the suction lumen 40. Although FIG. 2 shows an example in which the detection unit 60 is arranged inside the suction lumen 40, the position where the detection unit 60 is arranged is not limited to the inside of the suction lumen 40.

  Although the example which divides | segments the cylindrical one suction lumen 40 was shown as the medical device 1 of this aspect, you may divide the some suction lumen 40. FIG. As an example in which the medical instrument 1 divides the plurality of suction lumens 40, there is a configuration of the medical instrument 100 or the medical instrument 101 according to a second aspect described later.

  FIG. 11 is a diagram showing the extracorporeal arrangement portion 50 of the puncture member 10 of the medical instrument 1. As shown in FIG. 11, the puncture member 10 may include an extracorporeal arrangement portion 50 located outside the living body in a state where the distal end portion 8 (see FIG. 2 and the like) is punctured into the living tissue. The extracorporeal arrangement unit 50 may include a transmission part 51 made of a member that is permeable so that the suction lumen 40 can be visually recognized from the outside. The operator of the medical instrument 1 can visually recognize whether or not a body fluid such as blood exists in the suction lumen 40 through the transmission part 51. Therefore, the operator of the medical instrument 1 can determine whether or not the body fluid has been sucked into the suction lumen 40 by the transmission unit 51.

  FIG. 12 is a flowchart showing a puncture state determination method executed using the medical instrument 1. As shown in FIG. 12, the puncture state determination method performed using the medical instrument 1 includes a puncture step S11, a suction step S12, and a determination step S13.

  In the puncturing step S11, the puncture member 10 that divides the suction lumen 40 communicating with the outside through the suction hole 41 is punctured into the living tissue. Specifically, for example, as shown in FIG. 1, the distal end portion 8 of the puncture member 10 of the medical device 1 delivered to the left ventricle LV through the catheter 200 is protruded from the catheter 200 and left as a living tissue. The inner wall of the ventricle 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 the suction step S <b> 12, a suction force from the suction hole 41 to the suction lumen 40 is generated by generating a negative pressure in the suction lumen 40. Thereby, when all the suction holes 41 are located in the living tissue, the body fluid is not sucked into the suction lumen 40 and the puncture member 10 is fixed to the living tissue. On the other hand, when at least one suction hole 41 is located outside the living tissue, the body fluid is sucked into the suction lumen 40.

  In the determination step S13, the puncture state of the puncture member 10 into the living tissue is determined based on the result of the suction step S12. Specifically, when the body fluid is not sucked into the suction lumen 40, the operator of the medical instrument 1 determines that the puncture member 10 is properly punctured into the living tissue. On the other hand, when the body fluid is sucked into the suction lumen 40, the operator of the medical instrument 1 determines that the puncture member 10 is not properly punctured into the living tissue.

  In the determination step S13, when it is determined that the puncture member 10 has been properly punctured into the living tissue, the operator of the medical device 1 can, for example, add cells or the like to the administration lumen 30 of the puncture member 10 of the medical device 1. A fluid as an administration target is supplied, and the fluid is administered to a living tissue. On the other hand, if it is determined in the determination step S13 that the puncture member 10 is not properly punctured into the biological tissue, the operator of the medical instrument 1 returns to the puncture step S11, for example, and the biological tissue of the puncture member 10 Repeat the puncture.

(Second aspect)
FIG. 13 is a longitudinal sectional view showing a part including the distal end portion 8 of the medical device 100 as the second aspect of the present disclosure. 14 is a cross-sectional view taken along line XIV-XIV in FIG. 15 is a cross-sectional view taken along line XV-XV in FIG. 16 is a cross-sectional view taken along line XVI-XVI in FIG. The medical device 100 is, for example, a long shape, 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 cylindrical catheter 200, and the heart lumen It can be used in such a state that the distal end portion 8 is positioned in the left ventricle LV.

  As shown in FIGS. 13 to 16, the medical device 100 includes a puncture member 110. As shown in FIG. 13, the distal end portion of the puncture member 110 constitutes the distal end portion 8 of the medical instrument 100. Hereinafter, the distal end portion 8 of the medical device 100 is referred to as “the distal end portion 8” without being distinguished from the distal end portion of the puncture member 110. The puncture member 110 is a long member that can puncture a living tissue such as the inner wall of the left ventricle LV (see FIG. 1) from the distal end portion 8.

  In the example illustrated in FIG. 13, the distal end portion 8 of the puncture member 110 includes a blade surface 116 that is inclined with respect to the axial direction. As shown in FIGS. 13 to 16, the puncture member 110 defines an administration lumen 130. In this example, the puncture member 110 divides the administration lumen 130 with the inner peripheral surface 112 of the peripheral wall 111 of the puncture member 110. As shown in FIG. 13, the administration lumen 130 communicates with the outside through the administration hole 131. In the example shown in FIG. 13, the administration hole 131 is formed in the blade surface 116.

  As shown in FIGS. 13, 15, and 16, the puncture member 110 defines a plurality of suction lumens 140. In this example, the puncture member 110 places the first suction lumen 140a and the second suction lumen 140b as the plurality of suction lumens 140 at positions between the inner peripheral surface 112 and the outer peripheral surface 113 of the peripheral wall 111 of the puncture member 110. Partition. As shown in FIGS. 13, 15, and 16, the first suction lumen 140a and the second suction lumen 140b as the plurality of suction lumens 140 are not in communication with each other.

  As shown in FIG. 13, each of the plurality of suction lumens 140 communicates with the outside through the suction holes 141. In the example shown in FIG. 13, a plurality of suction holes 141 are formed in the outer peripheral surface 113 (hereinafter also simply referred to as “side surface 113”) of the peripheral wall 111 of the puncture member 110. As shown in FIG. 13, each of the plurality of suction holes 141 is located on the proximal end side with respect to the administration hole 131.

  As shown in FIGS. 13, 15, and 16, in this aspect, the first suction lumen 140 a and the second suction lumen 140 b as the plurality of suction lumens 140 are respectively circumferentially outward of the administration lumen 130 in the radial direction. Are divided into columnar shapes extending in the axial direction. In this example, a first suction hole 142, a second suction hole 143, and a third suction hole 144 as three suction holes 141 are defined, and the first suction lumen 140a is a first suction hole 142 and a third suction hole 144. The second suction lumen 140 b communicates with the outside through the second suction hole 143. The second suction hole 143 is located at a position different from the first suction hole 142 in the circumferential direction, and is located closer to the base end side than the first suction hole 142. The third suction hole 144 is located at the same position in the circumferential direction as the first suction hole 142 and is located closer to the base end side than the first suction hole 142 and the second suction hole 143. FIG. 13 illustrates the case where there are three suction holes 141, but the number is not limited to three, and may be one, two, or four or more.

  Similarly to the administration lumen 30 of the first aspect, the administration lumen 130 may be in communication with the outside on the proximal end side of the puncture member 110 and supplies a fluid as an administration object to be administered to the living tissue. be able to. The fluid as the administration object supplied to the administration lumen 130 is administered to the living tissue through the administration hole 131 of the administration lumen 130 located at the distal end portion 8 of the puncture member 110. The fluid supplied to the administration lumen 130 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 a biocompatible material. One or more of the sexual materials. The cells, extracellular matrix, and biocompatible material as the administration target are the same as those exemplified in the first embodiment.

  Each of the plurality of suction lumens 140 may communicate with the outside on the proximal end side of the puncture member 110 in the same manner as the suction lumen 40 of the first aspect. Each of the plurality of suction lumens 140 generates a suction force from the suction hole 141 into the suction lumen 140 by generating a negative pressure inside the suction lumen 140, similarly to the suction lumen 40 of the first aspect. Can do.

  As shown in FIGS. 15 and 16, the cross-sectional area of each of the plurality of suction lumens 140 is preferably smaller than the cross-sectional area of the administration lumen 130 in a cross-sectional view orthogonal to the axial direction. Specifically, the cross-sectional area of each of the plurality of suction lumens 140 is preferably ½ or less of the cross-sectional area of the administration lumen 130 in a cross-sectional view orthogonal to the axial direction. As a result, it is possible to prevent the administration target administered to the living tissue through the administration lumen 130 from being aspirated through the suction lumen 140.

  As shown in FIG. 13, the arrangement range L of all the suction holes 141 from the needle tip 117 can be appropriately set according to the puncture site. For example, when the liver is a puncture target, it is 300 mm or less. It is preferably 100 mm or less when the kidney is a puncture target, preferably 20 mm or less when the heart wall of the heart is a puncture target, and 8 mm when the heart wall of a heart failure state is a puncture target. The following is more preferable. In other words, the suction hole 141 is preferably located at a distance within 300 mm from the needle tip 117 along the axial direction, and more preferably at a distance within 8 mm.

  Since the puncture member 110 is punctured into the living tissue at a depth of more than 8 mm from the needle tip 117 in a state where the puncturing member 110 is punctured at a sufficient depth, the arrangement range L is set to 8 mm or less. When the puncture member 110 is punctured into the living tissue at a sufficient depth, all the suction holes 141 can be positioned inside the living tissue. Therefore, when the operator of the medical instrument 1 such as a medical worker has all the suction holes 141 located inside the living tissue, the puncture member 110 is pierced with a sufficient depth into the living tissue. Can be determined. Details of the determination of the puncture state using the suction hole 141 will be described later.

  As shown in FIG. 13, among the plurality of suction holes 141, the first suction hole 142, which is the suction hole located on the most distal side, is externally positioned at a position opposite to the region where the blade surface 116 is located in the circumferential direction. Communicating with More specifically, as shown with reference to FIG. 6 in the first mode, the first suction hole 142 is such that the plane X (see FIG. 6) of the side surface 113 of the puncture member 110 is on the needle tip 117 side. It is formed in a region including at least a part of the intersecting intersection line Y. In other words, the first suction hole 142 is located in a region including the needle tip 117 when viewed along the axial direction from the distal end of the puncture member 110.

  FIG. 7 is a diagram illustrating a first example of a puncture state of the puncture member 110 of the medical device 100 into the living tissue 300. FIG. In the example illustrated in FIG. 7, the medical device 100 includes all the suction holes 141, that is, the first suction hole 142, the second suction hole 143, and the third suction hole 144, similarly to the medical device 1 of the first aspect. Is located outside the living tissue 300. At this time, if negative pressure is generated inside the first suction lumen 140a (see FIG. 13 and the like) and the second suction lumen 140b (see FIG. 13 and the like), the first suction hole 142, the second suction hole 143, and the Through the three suction holes 144, body fluid such as blood existing outside the living tissue 300 is sucked into the first suction lumen 140a and the second suction lumen 140b. The operator of the medical instrument 100 such as a medical worker can determine the puncture depth of the puncture member 110 into the living tissue 300 based on the fact that body fluid has been sucked into all the suction lumens 140 (see FIG. 13 and the like). It can be determined that it is not sufficient or likely not enough.

  FIG. 8 is a diagram illustrating a second example of a puncture state of the puncture member 110 of the medical device 100 into the living tissue 300. In the example illustrated in FIG. 8, the medical device 100 includes all the suction holes 141, that is, the first suction hole 142, the second suction hole 143, and the third suction hole 144, similarly to the medical device 1 of the first aspect. Is located inside the living tissue 300. At this time, if negative pressure is generated inside the first suction lumen 140a (see FIG. 13 and the like) and the second suction lumen 140b (see FIG. 13 and the like), the first suction hole 142, the second suction hole 143, and the A part of the living tissue 300 is drawn into and in close contact with the three suction holes 144. Therefore, the puncture member 110 is fixed to the living tissue 300. Further, since the side surface 113 of the puncture member 110 is in intimate contact with the living tissue 300, when the administration target is administered to the living tissue 300 through the administration lumen 130 (see FIG. 13 and the like), the administered subject is the puncture member. It is possible to suppress the flow from the surface 301 of the living tissue 300 to the outside along the side surface 113 of 110. The operator of the medical device 100 determines that the puncture member 110 has been punctured into the living tissue 300 at a sufficient depth based on the fact that body fluid is not sucked into the first suction lumen 140a and the second suction lumen 140b. can do.

  FIG. 22 is a diagram illustrating a third example of a puncture state of the puncture member 110 of the medical device 100 into the living tissue 300. FIG. In the example illustrated in FIG. 22, the medical device 100 includes a first suction hole 142 and a second suction hole 143 that are located inside the living tissue 300 and a third suction hole 144 that is located outside the living tissue 300. Yes. At this time, if a negative pressure is generated inside the first suction lumen 140a (see FIG. 13 and the like) and the second suction lumen 140b (see FIG. 13 and the like), a living body is placed in the second suction hole 143 of the second suction lumen 140b. A part of the tissue 300 is drawn into close contact. On the other hand, body fluid such as blood is sucked into the first suction lumen 140a through the third suction hole 144. The operator of the medical instrument 100 moves the puncture member 110 into the living tissue 300 based on the fact that the body fluid is sucked into the first suction lumen 140a and the body fluid is not sucked into the second suction lumen 140b. Although it is not punctured at an excessive depth, it can be determined that it has been punctured to a sufficient depth.

  As described above, the medical device 100 includes the elongated puncture member 110 that can puncture a living tissue, and the puncture member 110 has an administration lumen 130 that communicates with the outside through the administration hole 131, and a proximal end than the administration hole 131. A plurality of suction lumens 140 communicating with the outside through the suction holes 141 located on the side and not communicating with each other are defined. Therefore, the puncture state of the puncture member 110 into the living tissue can be determined depending on whether the plurality of suction holes 141 are positioned inside or outside the living tissue.

  Furthermore, in the medical device 100, the first suction hole 142, the second suction hole 143, and the third suction hole 144 as the at least two suction holes 141 of the plurality of suction holes 141 are at different positions in the axial direction. To position. Therefore, the puncture depth of the puncture member 110 into the living tissue can be determined.

  The medical device 100 may be provided with a concave portion in which the side surface 113 of the puncture member 110 is recessed from the surroundings in the same manner as described for the medical device 1 of the first aspect with reference to FIG. And at least 1 of the several suction holes 141 may be located in the said recessed part. Thereby, the same effect as described above can be obtained.

  In the medical device 100, as described for the medical device 1 of the first aspect with reference to FIG. 10, the plurality of suction holes 141 of the puncture member 110 are in the same position in the axial direction and in the circumferential direction. You may include the some suction hole arrange | positioned in a mutually different position. Thereby, the same effect as described above can be obtained.

  As illustrated in FIG. 13, the medical device 100 may include a detection unit 60 that can detect a substance inside each of the plurality of suction lumens 140. The details of the detection unit 60 are as described in the first aspect. Although FIG. 13 shows an example in which the detection unit 60 is arranged inside each of the plurality of suction lumens 140, the position where the detection unit 60 is arranged is not limited to the inside of the suction lumen 140.

  The medical device 100 is located outside the living body in a state where the distal end portion 8 is punctured into the living tissue, as described for the medical device 1 of the first aspect with reference to FIG. You may provide an external arrangement | positioning part. The extracorporeal arrangement portion may include a transmission portion made of a member that is permeable to the extent that the suction lumen 140 is visible from the outside.

  FIG. 17 is a longitudinal sectional view showing a part including a distal end portion 8 of a medical instrument 101 as a modified example of the medical instrument 100. 18 is a cross-sectional view taken along line XVIII-XVIII in FIG. 19 is a cross-sectional view taken along line XIX-XIX in FIG. 20 is a cross-sectional view taken along line XX-XX in FIG.

  As shown in FIGS. 17, 19 and 20, the puncture member 110a of the medical device 101 includes a first suction lumen section 21 and a second suction lumen section as a plurality of suction lumen section sections 20 in addition to the peripheral wall 111a. The unit 22 is provided. Each of the plurality of suction lumen partition sections 20 extends in the axial direction along the inner peripheral surface 112a of the peripheral wall 111a, and is configured in a cylindrical shape that partitions the suction lumen 140 therein. The first suction lumen section 21 partitions the first suction lumen 140a. The second suction lumen section 22 partitions the second suction lumen 140b. Each suction lumen 140 penetrates the suction lumen partitioning section 20 and penetrates from the inner peripheral surface 112a to the outer peripheral surface 113a of the peripheral wall 111a and communicates with the outside. In other words, each suction lumen 140 communicates with the outside through the suction holes 141 defined in the outer peripheral surface 113a. The medical instrument 101 is the same as the above-described medical instrument 100 in points other than those described above, and thus description thereof is omitted here.

  FIG. 21 is a flowchart illustrating a puncture state determination method performed using the medical instrument 100. The puncture state determination method executed using the medical instrument 100 includes a puncture step S21, a suction step S22, and a determination step S23.

  In the puncturing step S21, puncture members 110 (see FIG. 13) that communicate with the outside through the respective suction holes 141 and define a plurality of suction lumens 140 that are not in communication with each other are punctured into the living tissue. Specifically, for example, as shown in FIG. 1, the distal end portion 8 of the puncture member 110 of the medical device 100 (see FIG. 13) delivered to the left ventricle LV through the catheter 200 is protruded from the catheter 200. The inner wall of the left ventricle LV as a living tissue is punctured. The operation of the medical instrument 100 can be performed by an operator such as a medical worker operating a part of the proximal end side of the medical instrument 100 located outside the body of the subject.

  In the suction step S <b> 22, a negative pressure is generated inside each of the plurality of suction lumens 140 (see FIG. 13), thereby generating a suction force from each of the plurality of suction holes 141 (see FIG. 13) to the suction lumen 140. Thereby, when all the suction holes 141 are located inside the living tissue, the body fluid is not sucked into any of the suction lumens 140, and the puncture member 110 is sucked from the suction holes 141 so that the puncture member 110 is Fixed against. On the other hand, when all the suction holes 141 are located outside the living tissue, the body fluid is sucked into all the suction lumens 140. Furthermore, when the suction holes 141 of a part of the suction lumens 140 among the plurality of suction lumens 140 are located inside the living tissue, and the suction holes 141 of the remaining suction lumens 140 are located outside the living tissue, Body fluid is not sucked into the part of the suction lumens 140, and body fluid is sucked into the remaining suction lumens 140.

  In the determination step S23, the puncture depth of the puncture member 110 into the living tissue is determined based on the result of the suction step S22. Specifically, when the body fluid is not sucked into any of the suction lumens 140, the operator of the medical device 100 determines that the puncture member 110 has been punctured at a sufficient depth into the living tissue. On the other hand, when the body fluid is sucked into all the suction lumens 140, the operator of the medical instrument 100 determines that the puncture depth of the puncture member 110 into the living tissue is insufficient. Furthermore, when the bodily fluid is sucked into some of the suction lumens 140, the operator of the medical instrument 100 is informed that the puncture depth of the puncture member 110 into the living tissue is not sufficient, Depending on the procedure, it can be determined as appropriate.

  In the determination step S23, when it is determined that the puncture member 110 has been punctured into the living tissue at a sufficient depth, the operator of the medical instrument 100, for example, the administration lumen 130 ( In FIG. 13), a fluid as an administration target such as a cell is supplied, and the fluid is administered to a living tissue. On the other hand, when it is determined in the determination step S23 that the puncture depth of the puncture member 110 into the living tissue is not sufficient, the operator of the medical instrument 100 returns to the puncture step S21, for example, Puncture the living tissue again.

  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 a medical instrument and a puncture state determination method.

DESCRIPTION OF SYMBOLS 1, 100, 101: Medical instrument 8: The front-end | tip part 10, 10a, 10b, 110, 110a of medical instrument: Puncture member 11, 111, 111a: Peripheral wall 12, 112, 112a of a puncture member: Inner periphery of the peripheral wall of a puncture member Surfaces 13, 113, 113a: outer peripheral surface of peripheral wall of puncture member (side surface of puncture member)
14: reduced diameter portion 14a: first reduced diameter portion 14b: second reduced diameter portion 14c: third reduced diameter portion 16, 116: blade surface 17, 117: needle tip 18, 118: proximal end 20 of the blade surface: suction Lumen compartment 21: first suction lumen compartment 22: second suction lumen compartment 30, 130: administration lumen 31, 131: administration hole 40, 140: suction lumen 140a: first suction lumen 140b: second suction lumen 41 41a, 41b, 141: suction holes 42, 42a, 42b, 142: first suction holes 43, 43a, 43b, 143: second suction holes 44, 44a, 44b, 144: third suction holes 50: extracorporeal arrangement part 51: Transmission unit 60: Detection unit 200: Catheter 300: Living tissue 301: Surface of living tissue AO: Aorta AV: Aortic valve FA: Femoral artery LV: Left ventricle L: Arrangement range O from the needle tip of the suction hole Central axis X: plane Y: line of intersection

Claims (8)

A long puncture member having a blade surface inclined with respect to the axial direction at the distal end and capable of puncturing a living tissue,
The puncture member is
An administration lumen communicating with the outside through an administration hole formed in the blade surface;
One or more suction lumens each communicating with the outside through one or more suction holes formed on the side surfaces;
The suction hole located on the most distal side among the one or more suction holes communicates with the outside at a position opposite to a region where the blade surface is located in the circumferential direction. The side surface of the puncture member comprises a recess recessed from the surroundings,
The medical device according to claim 1, wherein at least one suction hole among the one or more suction holes is located in the recess.   The medical device according to claim 2, wherein the concave portion is a reduced diameter portion extending in a circumferential direction.   The medical device according to any one of claims 1 to 3, wherein a cross-sectional area of each of the one or more suction lumens is smaller than a cross-sectional area of the dosing lumen.   The medical instrument according to any one of claims 1 to 4, wherein the one or more suction holes include a plurality of suction holes arranged at different positions in the circumferential direction.   The medical device according to any one of claims 1 to 5, wherein the one or more suction holes include a plurality of suction holes arranged at different positions in the axial direction.   The medical device according to any one of claims 1 to 6, wherein the one or more suction holes are located at a distance within 8 mm from the needle tip of the puncture member along the axial direction. A puncturing step for puncturing a living tissue with a puncture member that defines a suction lumen communicating with the outside through a suction hole;
A suction step of generating a suction force from the suction hole to the suction lumen by generating a negative pressure in the suction lumen;
And a determination step of determining a puncture state of the puncture member to the living tissue based on a result of the suction step.

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