Medical device system and method for using medical device system

Abstract

Provided are: a medical device system with which it is possible to insert another device in the same position as where a biopsy is performed; and a method for using the medical device system. A medical device system 10 comprises: a delivery device 20 including a long first sheath 30 inserted into biological tissue; a first medical device 60 including a biopsy needle 61 inserted into the first sheath 30; and a second medical device 70 including a long part 71 inserted into the first sheath 30. The delivery device 20 includes a hand-side part 40 provided with a first sheath-holding body 45 for holding a proximal end of the first sheath 30. The first medical device 60 has a first attachment / detachment part 66 at a proximal end section of the biopsy needle 61, and the second medical device 70 has a second attachment / detachment part 76 at a proximal end section of the long part 71. The hand-side part 40 has a fixing section 50 that enables the first attachment / detachment part 66 and the second attachment / detachment part 76 to be attached / detached, and the position of the fixing section relative to the first sheath-holding body 45 is moved and fixed. The long part 71 has an outer diameter equal to or less than the outer diameter of the biopsy needle 61.

Description

Medical device system and method of using the medical device system

[0001] The present invention relates to a medical device system capable of penetrating biological tissue to perform biopsies and other procedures, and to a method of using the medical device system.

[0002] In cancer treatment, therapeutic drugs are selected according to the mutation status through the discovery of target genes, etc. For this purpose, it is necessary to diagnose the state of the cancer histologically through biopsy, etc. Based on the histological diagnosis of the cancer through biopsy, etc., therapeutic drugs and treatment methods are selected, and treatment is carried out at a later date.

[0003] A known device for performing a biopsy is one that inserts a biopsy needle into a living body to sample tissue. An example of such a medical device for biopsy is disclosed in Patent Document 1.

[0004] Patent No. 6129932

[0005] Because the state of cancer changes daily, it is desirable to administer a selected drug to the same location as the tumor site from which tissue was extracted by biopsy. However, because biopsy medical devices cannot administer drugs, the biopsy needle is temporarily removed from the tumor site, and a drug selected based on the biopsy diagnosis is administered using an administration device separate from the biopsy device. This makes it difficult to accurately puncture the administration device at the same location as the biopsy needle.

[0006] The present invention has been made to solve the above-mentioned problems, and aims to provide a medical device system and a method of using the medical device system that allow another device to be inserted at the same position where a biopsy was performed.

[0007] (1) A medical device system according to the present invention that achieves the above-mentioned object is a medical device system comprising: a delivery device having a long first sheath to be inserted into biological tissue; a first medical device having a biopsy needle to be inserted into the first sheath; and a second medical device having a long portion to be inserted into the first sheath, wherein the delivery device has a proximal portion having a first sheath holder that holds the base end of the first sheath; the first medical device has a first detachable portion at the base end of the biopsy needle; the second medical device has a second detachable portion at the base end of the long portion; the proximal portion has a fixed portion that allows the first detachable portion and the second detachable portion to be detached and that moves and fixes the relative position with respect to the first sheath holder; and the long portion has an outer diameter that is equal to or smaller than the outer diameter of the biopsy needle.

[0008] (11) A method of using a medical device system according to the present invention that achieves the above-mentioned object is a method of using a medical device system that includes a delivery device having a first elongated sheath and a proximal portion, a first medical device having a biopsy needle inserted into the first sheath and detachable to the proximal portion, and a second medical device having a long portion inserted into the first sheath and detachable to the proximal portion, wherein the first medical device is fixed to the proximal portion, and with the tip of the biopsy needle inserted into the delivery device exposed from the tip of the first sheath, the tip of the delivery device is moved just short of a target position. a step of inserting the biopsy needle into the target position by manipulating the handheld portion to perform a biopsy; a step of determining a treatment method based on the results of the biopsy; a step of removing the first medical device from the delivery device; a step of fixing the second medical device to the handheld portion with the tip of the elongated portion inserted into the delivery device housed in the first sheath, and operating the handheld portion to perform treatment by manipulating the handheld portion to perform a treatment; and a step of removing the delivery device together with the second medical device.

[0009] In the medical device system (1) configured as described above, the first medical device for performing biopsy and the second medical device for performing treatment other than biopsy can be attached and detached to a common delivery device, so that another device can be inserted at the same position as the biopsy. Furthermore, the medical device system allows the medical device to be replaced while the first sheath is left in the body, reducing the man-hours required for the procedure and enabling treatment to be performed quickly.

[0010] (2) In the medical device system of (1), the delivery device may further include a long second sheath inserted into biological tissue, and the first sheath may be housed in the second sheath, thereby protecting the inner surface of the endoscope from the first sheath, the biopsy needle, or the long portion.

[0011] (3) In the medical device system of (1) or (2), the distal end position of the elongated section when the second detachable section is fixed to the fixed section may be the same as the distal end position of the biopsy needle when the first detachable section is fixed to the fixed section. This allows the medical device system to reliably position the distal end of the elongated section at the position where the biopsy was performed when the first medical device is replaced with a second medical device.

[0012] (4) In any of the medical device systems (1) to (3) above, the elongated portion may have a lumen for administering a drug, thereby enabling the medical device system to administer a drug using a second medical device to a site where a biopsy was performed using the first medical device.

[0013] (5) In the medical device system of (4), the elongated portion may have an opening communicating with the lumen and a cover portion that switches the opening between a closed state and an open state. This allows the medical device system to prevent fluid in the lumen from leaking into a gap between the first sheath and the elongated portion by closing the opening with the cover portion except when necessary for the elongated portion whose outer diameter is equal to or smaller than that of the biopsy needle.

[0014] (6) In any of the medical device systems (1) to (5) above, the elongated portion may have a first lumen for administering a drug and a second lumen for circulating a fluid aspirated from the opening at the distal end, thereby enabling the medical device system to simultaneously perform treatment such as aspirating a blood clot when administering a drug.

[0015] (7) In the medical device system of (4) or (5), the biopsy needle may have a biopsy lumen with an inner diameter larger than the lumen of the elongated portion, thereby enabling the medical device system to increase the amount of sample collected during biopsy while reducing the amount of drug used.

[0016] (8) In any of the medical device systems (1) to (7) above, the first medical device and the second medical device may each have a support pipe covering a proximal end of the biopsy needle or the elongated portion, thereby preventing the biopsy needle or the elongated portion from bending within the first sheath of the delivery device when the biopsy needle or the elongated portion is inserted into the delivery device.

[0017] (9) In any of the medical device systems (1) to (8) above, the elongated portion may have a cutting edge portion having a plurality of cutting surfaces in the circumferential direction, and the cutting surfaces may be formed by ridges where flat surfaces are adjacent to each other. This eliminates the need for a sharp tip of the elongated portion, and the medical device system requires a certain amount of pressure to puncture, thereby reducing the risk of unintentional perforation.

[0018] (10) In the medical device system of (9), the elongated portion may have a lumen for administering a drug and an opening communicating with the lumen, thereby enabling the medical device system to reliably administer a drug while maintaining the shape of the tip of the administration needle in a shape suitable for puncture.

[0019] The method of using the medical device system (11) configured as described above allows the first medical device to be replaced with the second medical device while the first sheath remains in the body. Therefore, when performing both a biopsy and another procedure, the method of using the medical device system can reduce the number of steps required for the procedure and perform the procedure quickly, and can also perform the other procedure at the same location as the biopsy, thereby improving the therapeutic effect.

[0020] 1 is a front view of each device constituting the medical device system of this embodiment. FIG. 1 is a cross-sectional view of a delivery device with a first medical device attached. FIG. 2 is a perspective view of needle tips, where (a) shows the tip of a biopsy needle and (b) shows the tip of an administration needle. FIG. 3 is a perspective view of the tip of an administration needle according to a modified example. FIG. 4 is a cross-sectional view of the vicinity of the base end of the delivery device and the first medical device, where (a) shows the state before the first device is inserted into the delivery device, and (b) shows the state after the first device has been inserted into the delivery device and fixed. FIG. 5 is a cross-sectional view of the vicinity of the tip of the delivery device, where (a) shows the state when the delivery device and the first medical device are inserted into the endoscope, (b) shows the state after the biopsy needle is exposed at the tip of the sheath near the surface of an organ, (c) shows the state after the biopsy needle has been moved further distally than in (b) to the vicinity of the interface where tumor cells are present, (d) shows the state after the biopsy needle has been inserted into tumor cells and is performing a biopsy, and (e) shows the state after the biopsy needle has been retracted into the sheath.

[0023] Figure 1 is a cross-sectional view of the vicinity of the proximal end of a delivery device and a second medical device, where (a) shows a state before the second device is inserted into the delivery device, and (b) shows a state after the second device has been inserted into the delivery device and secured.

[0024] Figure 2 is a cross-sectional view of the vicinity of the distal end of a delivery device, where (a) shows a state after the administration needle is housed inside the inner sheath, (b) shows a state after the administration needle is exposed at the distal end of the sheath, (c) shows a state after the administration needle has been moved further distally than in (b), and (d) shows a state after the administration needle has been housed inside the sheath.

[0025] Figure 3 is a cross-sectional view of the vicinity of the proximal end of a delivery device and a first medical device according to a modified example, where (a) shows a state before the first device is inserted into the delivery device, and (b) shows a state after the first device has been inserted into the delivery device and secured.

[0026] Figure 4 is a cross-sectional view of the vicinity of the proximal end of a delivery device and a second medical device according to a modified example, where (a) shows a state before the second device is inserted into the delivery device, and (b) shows a state after the second device has been inserted into the delivery device and secured.1A is an enlarged cross-sectional view of the vicinity of the tip of the administration needle, showing a state in which the cover sheath closes the opening, a state in which the cover sheath is pushed open and the opening is open, and a state in which the cover sheath with a short length extending toward the base end is pushed open and the opening is open. 1B is an enlarged cross-sectional view of the vicinity of the tip of the administration needle and the inner sheath, showing a state in which the administration needle is housed in the inner sheath, and a state in which the administration needle is exposed from the inner sheath and the opening is open. 1C is a cross-sectional view of an administration needle according to a modified example.

[0021] Hereinafter, embodiments of the present invention will be described with reference to the drawings. Note that the dimensional proportions in the drawings may be exaggerated for convenience of explanation and may differ from the actual proportions. In addition, in this specification, a device has an axis, and the side of the device that is inserted into biological tissue will be referred to as the "distal side" in the axial direction, and the side that is operated will be referred to as the "proximal side" in the axial direction.

[0022] The medical device system 10 of this embodiment is inserted into the forceps port of an endoscope (not shown), and the tip is delivered to the target lesion such as cancer, and is used to perform a biopsy and administer a drug.

[0023] As shown in FIG. 1 , the medical device system 10 of this embodiment is composed of a delivery device 20, a first medical device 60, and a second medical device 70. The delivery device 20 has an inner sheath 30 as an elongated first sheath to be inserted into biological tissue, an outer sheath 35 as an elongated second sheath that houses the inner sheath 30, and a proximal portion 40 provided at the proximal end of the outer sheath 35. The first medical device 60 is a biopsy device having a biopsy needle 61, and as shown in FIG. 2 , the biopsy needle 61 can be inserted into the inner sheath 30. The second medical device 70 is a drug administration device having an administration needle 71 as an elongated portion, and the administration needle 71 can be inserted into the inner sheath 30. The administration needle 71 of the second medical device 70 has an outer diameter equal to or smaller than the outer diameter of the biopsy needle 61 of the first medical device 60.

[0024] The first medical device 60 includes a first hub 65 having a first detachable portion 66 at the proximal end of the biopsy needle 61. The first detachable portion 66 has a screw shape and can be attached to and detached from the fixing portion 50 provided at the proximal end of the proximal portion 40 of the delivery device 20. The second medical device 70 includes a second hub 75 having a second detachable portion 76 at the proximal end of the administration needle 71. The second detachable portion 76 has the same screw shape as the first detachable portion 66 and can be attached to and detached from the fixing portion 50 provided at the proximal end of the proximal portion 40 of the delivery device 20.

[0025] The first medical device 60 has a support pipe 69 that covers the proximal end of the biopsy needle 61 that is exposed on the distal side from the first hub 65. The second medical device 70 has a support pipe 79 that covers the proximal end of the administration needle 71 that is exposed on the distal side from the second hub 75.

[0026] 1 and 2 , the proximal portion 40 of the delivery device 20 includes an endoscope connecting portion 41 fixed to the forceps port of the endoscope, an extension portion 41a extending from the endoscope connecting portion 41 toward the proximal end, a distal side portion 42 positioned on the proximal side of the extension portion 41a so as to cover the extension portion 41a and movable in the axial direction relative to the endoscope connecting portion 41, an intermediate portion 43 positioned on the proximal side of the distal side portion 42 so as to cover the distal side portion 42 and movable in the axial direction relative to the distal side portion 42, and a handle portion 44 positioned on the proximal side of the intermediate portion 43 so as to cover the intermediate portion 43 and movable in the axial direction relative to the intermediate portion 43. A first fixing screw 42a is provided on the outer surface of the extension portion 41a, determining the length of protrusion of the extension portion 41a toward the distal end. The first fixing screw 42a is connected to and fixed to the distal side portion 42. The distal side portion 42 has a first stopper portion 42b that protrudes like a flange near the base end of the first fixing screw 42a and is positioned (fixed) between the first fixing screw 42a and the distal side portion 42. When the second fixing screw 43a moves toward the distal side, the first stopper portion 42b prevents the second fixing screw 43a from moving toward the distal side. A second fixing screw 43a is provided on the outer surface of the distal side portion 42 to prevent the intermediate portion 43 from moving relative to the distal side portion 42. A third fixing screw 44a is provided on the outer surface of the intermediate portion 43 to prevent the handle portion 44 from moving relative to the intermediate portion 43. The intermediate portion 43 has a second stopper portion 43b that protrudes like a flange near the distal end of the intermediate portion 43. When the third fixing screw 44a moves toward the distal side, the second stopper portion 43b prevents the third fixing screw 44a from moving toward the distal side.

[0027] Inside the proximal section 40, a first proximal section internal pipe holder 45, which serves as a second sheath holder, is disposed at the proximal end of the distal side section 42, and a second proximal section internal pipe holder 46, which serves as a first sheath holder, is disposed at the proximal end of the intermediate section 43. A first proximal section internal pipe 47a is fixed to the first proximal section internal pipe holder 45, passing through a hole at the axial center of the first proximal section internal pipe holder 45. A second proximal section internal pipe 47b is fixed to the second proximal section internal pipe holder 46, passing through a hole at the axial center of the second proximal section internal pipe holder 46. The second proximal section internal pipe 47b extends proximally beyond the second proximal section internal pipe holder 46, long enough to allow the handle section 44 to abut against the second stopper section 43b of the intermediate section 43. The outer sheath 35 of the delivery device 20 is fixed to the distal end of the first proximal section internal pipe 47a. 2, the inner sheath 30 can be inserted into the outer sheath 35. The diameter of the first proximal internal pipe 47a is larger than the diameter of the outer sheath 35. The first proximal internal pipe 47a is inserted into a hole in the axial center of the first proximal internal pipe holder 45 and fixed by adhesive. Therefore, by moving the tip side portion 42 in the axial direction relative to the extension portion 41a, the outer sheath 35 can be moved in the axial direction relative to the endoscope, and the length of the outer sheath 35 protruding from the endoscope connection portion 41 can be changed.

[0028] A fixing part 50 to which the first detachable part 66 or the second detachable part 76 can be detachably attached is provided at the proximal end of the proximal section 40. The fixing part 50 is provided on the proximal end surface of the handle section 44 and has an opening to allow the first medical device 60 or the second medical device 70 to be inserted. A threaded part 51 for screwing the first detachable part 66 or the second detachable part 76 is formed on the inner surface. The handle section 44 to which the fixing part 50 is provided is movable in the axial direction relative to the distal side section 42. The proximal end of the first proximal section internal pipe 47a can be positioned near the proximal end of the distal side section 42 and is fixed to the first proximal section internal pipe holder 45. With this configuration, the fixing unit 50 can move and fix the relative positions of the first proximal section internal pipe holder 45 as the second sheath holder, the first proximal section internal pipe 47a fixed to the first proximal section internal pipe holder 45, and the outer sheath 35 fixed to the first proximal section internal pipe 47a. Therefore, when the first medical device 60 and the second medical device 70 are fixed to the fixing unit 50, the first medical device 60 and the second medical device 70 can be moved relative to the outer sheath 35.

[0029] The proximal end of the inner sheath 30, which serves as a long first sheath inserted into biological tissue, can be disposed on the distal side of the second proximal section internal pipe 47b. The diameter of the second proximal section internal pipe 47b is larger than that of the inner sheath 30, and fixes the proximal end of the inner sheath 30 on the distal side. The second proximal section internal pipe 47b passes through a hole in the axial center of the second proximal section internal pipe holder 46 and is fixed inside the second proximal section internal pipe holder 46, which is fixed to the intermediate section 43. With this configuration, the fixing section 50 can move and fix the relative positions of the second proximal section internal pipe 47b fixed to the second proximal section internal pipe holder 46, and the inner sheath 30 fixed to the second proximal section internal pipe 47b. Therefore, when the first medical device 60 and the second medical device 70 are fixed to the fixing portion 50, the first medical device 60 and the second medical device 70 are movable relative to the inner sheath 30. The inner sheath 30 of the delivery device 20 is inserted into and fixed to a second proximal section internal pipe 47b, which is fixed to a second proximal section internal pipe holder 46 provided at the base end of the intermediate section 43. The second proximal section internal pipe 47b is inserted into and fixed to a hole in the axial center of the second proximal section internal pipe holder 46. Therefore, by axially moving the intermediate section 43 having the second proximal section internal pipe holder 46 relative to the distal side section 42, the inner sheath 30 can be moved axially relative to the endoscope, and the length of the inner sheath 30 protruding from the outer sheath 35 can be changed.

[0030] The first medical device 60 and the second medical device 70 are fixed to the fixing portion 50 provided on the handle portion 44, so that the biopsy needle 61 and the administration needle 71 can be moved axially relative to the inner sheath 30 and the outer sheath 35 by moving the handle portion 44 axially relative to the intermediate portion 43. Furthermore, by moving the intermediate portion 43 axially relative to the distal end portion 42, the axial position of the inner sheath 30 relative to the biopsy needle 61, the administration needle 71, and the outer sheath 35 can be adjusted.

[0031] In the first medical device 60 with the first detachable part 66 fixed to the fixed part 50, the distal end of the support pipe 69 is located inside or outside the proximal end of the second internal proximal pipe 47b. The proximal end of the support pipe 69 is exposed on the proximal end side of the second internal proximal pipe 47b, and is positioned so that the distal end of the first hub 65 does not interfere with the second internal proximal pipe 47b when the handle part 44 moves toward the distal end. In the second medical device 70 with the second detachable part 76 fixed to the fixed part 50, the support pipe 79 is positioned in the same manner as the support pipe 69 of the first medical device 60. Note that the second internal proximal pipe 47b may be composed of multiple pipe members with different diameters.

[0032] The first hub 65 of the first medical device 60 has a device connection part 67 to which another device such as a syringe used for biopsy can be connected. The device connection part 67 communicates with the biopsy lumen 62, which is the inner cavity of the biopsy needle 61. The second hub 75 of the second medical device 70 also has a device connection part 77 to which another device used for drug administration can be connected, and communicates with the administration lumen 72, which is the inner cavity of the administration needle 71.

[0033] As shown in FIG. 3( a), the tip of the biopsy needle 61 has a sharp cutting edge 63. The biopsy needle 61 has an open distal end and communicates with the biopsy lumen 62. The shape of the tip of the biopsy needle 61 is not limited to the structure shown in FIG. 3( a). For example, the biopsy needle 61 may have a sharp cutting edge 63 and one or more side holes communicating with the biopsy lumen 62 on the outer surface of the distal end. If a side hole is provided, the distal end of the cutting edge 63 does not need to be open. As shown in FIG. 3( b), the tip of the administration needle 71 is spherical. Although the tip is spherical, the biopsy needle 61 forms a puncture route (a route formed by the passage of the biopsy needle 61) in the biological tissue, allowing it to be inserted into the biological tissue and reach the target location. An opening 73 that opens laterally in the axial direction is formed near the tip of the administration needle 71. The opening 73 communicates with the administration lumen 72 of the administration needle 71. The shape of the administration needle 71 is not limited to that shown in FIG. 3(b) and may have a sharp cutting edge similar to the biopsy needle 61. A plurality of openings 73 of the administration needle 71 may be formed on the outer surface of the administration needle 71. The size of the openings 73 is not particularly limited as long as it is large enough to allow the administration of a medicinal solution and to provide the administration needle 71 with sufficient strength.

[0034] As shown in Figure 4, the administration needle 90 has a cutting edge 91 with multiple cutting surfaces 92 in the circumferential direction, and each cutting surface 92 may be configured so that flat surfaces 93 are formed by adjacent ridges. The tip of the administration needle 90 has a spherical or elliptical spherical surface and is formed so as not to have an acute angle. This increases the force required to puncture the tip of the administration needle 90 into biological tissue compared to when the tip has a sharp cutting edge, reducing the risk of unintentional puncture of other tissue such as a blood vessel. The administration needle 90 has an opening 95 in the cutting edge 91 that communicates with the administration lumen 94 of the administration needle 90.

[0035] Next, a method of using the medical device system 10 of this embodiment will be described. Here, the medical device system 10 is used in a procedure for biopsying a tumor occurring in the pancreas and administering a drug. The location of tumor (cancer) cells and the size of the tumor are identified in advance by diagnostic imaging. Once the tumor location has been identified, an endoscope is inserted into the patient's body. The endoscope is inserted via the duodenum to the vicinity of the pancreas.

[0036] The first medical device 60 is inserted into the inner sheath 30 and combined with the delivery device 20. The delivery device 20 and the first medical device 60 are connected and fixed to the endoscope already inserted into the patient via the endoscope connecting portion 41. As shown in FIG. 5( a), the fixing portion 50 of the delivery device 20 has an opening that communicates with the interior, and the surgeon inserts the biopsy needle 61 of the first medical device 60 from the fixing portion 50 toward the distal end. As shown in FIG. 5( b), the surgeon screws the first detachable portion 66 (male thread in this embodiment) of the first medical device 60 into the threaded portion 51 (female thread in this embodiment) of the fixing portion 50, thereby fixing the first medical device 60 to the delivery device 20.

[0037] FIG. 6( a) is a cross-sectional view of the vicinity of the distal end of the delivery device 20 when the delivery device 20 and the first medical device 60 are inserted into the endoscope. FIGS. 6( b) to 6( e) are cross-sectional views of the vicinity of the distal end of the delivery device 20 when the delivery device 20 and the first medical device 60 are placed in tissue surrounding a site where tumor cells are present. When the first medical device 60 is fixed to the delivery device 20, as shown in FIG. 6( a), the handle portion 44 is moved a predetermined distance distally from a position where it is pulled as far as possible proximal to the end, so that the distal end of the biopsy needle 61 is exposed (protrudes) distally beyond the tip of the inner sheath 30, which serves as the elongated first sheath inserted into biological tissue. At this time, the distal end of the biopsy needle 61 is not exposed beyond the tip of the outer sheath 35. When the first medical device 60 is combined with the delivery device 20, a stylet 64 is inserted into the biopsy lumen 62 of the biopsy needle 61. By inserting the stylet 64 up to the base end of the cutting edge 63 , it is possible to prevent biological tissue from entering the biopsy lumen 62 through the opening or side hole at the tip of the cutting edge 63 .

[0038] As shown in Figure 6(b), after inserting the delivery device 20 and the first medical device 60 into the endoscope, the second fixing screw 43a is operated to move the intermediate section 43 and the handle section 44 a predetermined distance toward the distal end relative to the distal section 42, exposing the biopsy needle 61 and the inner sheath 30 from the outer sheath 35. This allows the sharp cutting edge 63 of the biopsy needle 61 to puncture biological tissue such as the pancreas. The delivery device 20 combined with the first medical device 60 is advanced until the distal end of the outer sheath 35 reaches near the organ surface 200. Once the outer sheath 35 has been inserted to the desired position, the first medical device 60 and the inner sheath 30 are protruded from the outer sheath 35 with the distal end of the biopsy needle 61 protruding distally beyond the forefront of the inner sheath 30.

[0039] The surgeon determines the puncture length based on the location and size of the tumor identified by diagnostic imaging and adjusts the position of the second fixing screw 43a so that the intermediate portion 43 can be moved by the determined puncture length. The surgeon then moves the intermediate portion 43 and the handle portion 44 toward the distal end relative to the distal side portion 42, thereby advancing the tip of the inner sheath 30 until it reaches the interface 210 where tumor cells are present, as shown in FIG. 6(c). Then, the surgeon adjusts the position of the third fixing screw 44a and pushes the handle portion 44 toward the distal end. This operation brings the tip of the inner sheath 30 into contact with the interface 210. Then, by pushing the handle portion 44 toward the distal end, the biopsy needle 61 moves further toward the distal end than the state in which the tip of the biopsy needle 61 protrudes distally beyond the tip of the inner sheath 30, and the biopsy needle 61 punctures the tumor tissue, as shown in FIG. 6(d).

[0040] After inserting the biopsy needle 61 into the tumor site, the surgeon pulls out the stylet 64 from the biopsy lumen 62 and connects a suction device such as a syringe to the device connection portion 67 of the first hub 65, creating a negative pressure in the biopsy lumen 62 of the biopsy needle 61. In this state, the surgeon operates the handle portion 44 to move the biopsy needle 61 back and forth within the tumor tissue to perform a biopsy. The steps from inserting the biopsy needle 61 into the tumor tissue to performing a biopsy may be repeated.

[0041] Once it is determined that the specimen has been collected, the surgeon operates the proximal portion 40 to retract the entire biopsy needle 61, including the tip of the biopsy needle 61 with the collected specimen S in the biopsy lumen 62, into the inner sheath 30, as shown in Figure 6(e). Furthermore, while maintaining the position of the inner sheath 30 with the tip of the inner sheath 30 in contact with the interface 210, the surgeon detaches the first detachable portion 66 of the first medical device 60 from the fixing portion 50, and pulls out the first medical device 60 with the biopsy needle 61 from the inner sheath 30. At this time, a puncture route R, which is a hole made by the biopsy needle 61, is formed in the area where tumor cells are present.

[0042] Next, with the delivery device 20 fixed to the endoscope (while maintaining the inner sheath 30 in a position near the site where tumor cells are present), the sample collected by the biopsy needle 61 is examined. Treatment options, such as the type and amount of medication, are determined based on the results. Once the treatment options have been determined, the second medical device 70 is prepared. An administration device, such as a syringe, is connected to the device connection portion 77 of the second medical device 70, and the medication is filled into the administration lumen 72 of the administration needle 71. Then, as shown in FIG. 7( a), the surgeon inserts the administration needle 71 from the fixed portion 50 toward the distal end. As shown in FIG. 7( b), the surgeon screws the second detachable portion 76 (male thread in this embodiment) of the second medical device 70 into the threaded portion 51 (female thread in this embodiment) of the fixed portion 50, thereby fixing the second medical device 70 to the delivery device 20.

[0043] As shown in FIG. 8( a), the second medical device 70 is fixed to the delivery device 20 with the tip of the administration needle 71 housed inside the inner sheath 30. The lengths of the biopsy needle 61 and the administration needle 71 are predetermined so that the most distal position of the administration needle 71 is the same as the most distal position of the biopsy needle 61 when the first medical device 60 and the delivery device 20 are released from each other. The tip of the inner sheath 30 is maintained in contact with the interface 210, and the puncture route R, which is a hole formed by the biopsy needle 61, is maintained to some extent at the site where tumor cells are present. After the second medical device 60 is fixed to the delivery device 20, the handle 44 is operated to expose the administration needle 71 from the inner sheath 30, as shown in FIGS. 8( b) and 8(c). This allows the exposed tip of the administration needle 71 to reach the same position as the puncture position of the biopsy needle 61. In other words, the administration needle 71 can be easily inserted into the puncture route R formed by the biopsy needle 61 and reach the target location.

[0044] The surgeon operates the syringe to administer a drug through the openings 73, 95 of the administration needles 71, 90 to the same position as the biopsy site. After administering the drug, the surgeon operates the proximal portion 40 to retract the entire administration needle 71, including the tip thereof, into the inner sheath 30, as shown in FIG. 8( d ). At this time, the tip of the inner sheath 30 is in contact with the interface 210. After retracting the administration needle 71 into the inner sheath 30, the surgeon removes the delivery device 20 together with the second medical device 70 from the endoscope.

[0045] In this way, in the medical device system 10, the first medical device 60 having the biopsy needle 61 and the second medical device 70 having the administration needle 71 can be attached and detached to the delivery device 20, so that the first medical device 60 and the second medical device 70 can be replaced while the inner sheath 30 remains indwelling in the living body. Therefore, treatment using the medical device system 10 can improve the therapeutic effect by delivering the administration needle 71 to the same position as the position where the biopsy was performed and administering the drug.

[0046] Next, a modified example of the medical device system 10 will be described. As shown in Fig. 9(a), the proximal portion 40 may include a fixed portion 100 having a support pipe 105. In this case, the fixed portion 100 has a pipe fixing portion 101 at the distal end that fixes the support pipe 105, and a receiving portion 102 at the proximal end that allows the first medical device 110 to be attached and detached. The receiving portion 102 has a tapered shape that tapers toward the distal end. The fixed portion 100 has a flange portion 103 that protrudes from the outer peripheral surface of the proximal end. The flange portion 103 has a threaded outer peripheral surface.

[0047] The first medical device 110 has a biopsy needle 111 and a first hub 115 to which the proximal end of the biopsy needle 111 is fixed. The first hub 115 is provided with a first detachable part 116 that is detachable from the fixed part 100, a device connection part 117, and an outer lock part 118 that is rotatable relative to the first detachable part 116 and has a threaded inner surface. The first detachable part 116 has a tapered outer peripheral surface that fits into the receiving part 102 of the fixed part 100. As a result, the fixed part 100 and the first hub 115 form a luer lock structure.

[0048] As shown in FIG. 9(b), the first medical device 110 can be secured to the delivery device 20 by inserting the first detachable portion 116 of the first hub 115 into the receiving portion 102 of the fixed portion 100, and rotating the outer locking portion 118 of the first hub 115 to screw it onto the flange portion 103 of the fixed portion 100.

[0049] As shown in Figure 10(a), a second medical device 120 can be attached to and detached from the fixing part 100. The second medical device 120 has an administration needle 121 and a second hub 125 to which the proximal end of the administration needle 121 is fixed. The second hub 125 is provided with a second detachable part 126 that is detachable from the fixing part 100, a device connection part 127, and an outer lock part 128 that is rotatable relative to the second detachable part 126 and has a threaded inner surface. The second detachable part 126 has a tapered outer peripheral surface that fits into the receiving part 102 of the fixing part 100. As a result, the fixing part 100 and the second hub 125 form a luer lock structure.

[0050] As shown in FIG. 10(b), the second medical device 120 can be secured to the delivery device 20 by inserting the second detachable portion 126 of the second hub 125 into the receiving portion 102 of the fixed portion 100, and rotating the outer locking portion 128 of the second hub 125 to screw it onto the flange portion 103 of the fixed portion 100.

[0051] The administration needle 71 may have a cover that switches the opening 73 between a closed state and an open state. As shown in FIG. 11( a), the administration needle 71 is covered by a cover sheath 74 made of a flexible elastomer material as a cover. The cover sheath 74 covers the opening 73 except when a drug is being administered. In this state, the administration lumen 72 of the administration needle 71 is closed (closed state). As shown in FIG. 11( b), when a drug is injected into the administration lumen 72, the internal pressure of the administration lumen 72 increases, and the flexibility of the cover sheath 74 causes it to expand outward through the opening 73. This allows the opening 73 to communicate with the outside, opening the administration lumen 72 and allowing the drug to be released (open state). Because the length of the cover sheath 74 extending distally beyond the opening 73 is short and the length of the cover sheath 74 extending proximally beyond the opening 73 is long, the portion distal to the opening 73 is expanded and communicates with the outside. Because the administration needle 71 has a smaller outer diameter than the biopsy needle 61, when the administration needle 71 is inserted into the inner sheath 30 shared with the administration needle 71, a large gap forms between the administration needle 71 and the inner wall of the inner sheath 30, which makes it easy for the drug to leak from the administration lumen 72 of the administration needle 71 into the inner sheath 30. For this reason, by closing the lumen 72 with the cover sheath 74 until the administration needle 71 reaches the target site, it is possible to prevent the drug filled in the lumen 72 of the administration needle 71 from leaking into the inner sheath 30. As shown in Figure 11 (c) , if the length of the cover sheath 74 extending proximally from the opening 73 is shortened, the entire cover sheath 74 can be pushed outward, allowing both the distal and proximal sides of the opening 73 to communicate with the outside.

[0052] The cover sheath 74 may be switched between the closed state and the open state by a reason other than an increase in internal pressure of the administration lumen 72. As shown in Figure 12(a) , the inner sheath 30 that houses the administration needle 71 has a tapered distal end portion 32 that tapers to a point at its distal end, and the distal end opening 31 is formed to be smaller than the inner diameter of the inner sheath 30. The diameter of the distal end opening 31 is set to be the same as or slightly smaller than the outer diameter of the administration needle 71. The administration needle 71 housed in the inner sheath 30 is in a closed state with the opening 73 covered by the cover sheath 74.

[0053] When the administration needle 71 is moved toward the tip, as shown in Figure 12 (b), the administration needle 71 can pass through the tip opening 31 of the inner sheath 30, but the cover sheath 74 cannot pass through the tip opening 31, so that only the tip of the administration needle 71 is exposed at the tip side of the inner sheath 30, opening the opening 73 and allowing the drug to be released from the administration lumen 72.

[0054] 13 , the administration needle 140 may have a first lumen 141 and a second lumen 144 arranged in parallel. The first lumen 141 communicates with a first opening 142 at the distal end of the administration needle 140, and the second lumen 144 communicates with a second opening 145 at the distal end of the administration needle 140. The first lumen 141 communicates with a first device connection portion 143 at the proximal end, and the second lumen 144 communicates with a second device connection portion 146 at the proximal end. The first lumen 141 can be used as a lumen for administering a drug by connecting a syringe or the like containing a drug to the first device connection portion 143. The second lumen 144 can be used as a lumen for circulating a fluid aspirated from the second opening 145 by connecting a suction device to the second device connection portion 146. In this embodiment, the first lumen 141 and the second lumen 144 are configured as a parallel, integrated tubular member from the tip of the administration needle 140 to the branched portion 147, and are configured as separate tubular members branching from the branched portion 147 to the base end of the administration needle 140. A detachable portion 148 is formed at the branched portion 147 or distal to the branched portion 147, and the administration needle 140 is fixed to the delivery device 20 by screwing the detachable portion 148 into the threaded portion 51 of the fixing portion 50 of the delivery device 20. The tip of the administration needle 140 does not need to be sharp as shown in FIG. 12 , but may have a sharp cutting edge. Although the first opening 142 and the second opening 145 open on the side of the administration needle 140, the first opening 142 and the second opening 145 may each open on the distal surface of the administration needle 140.

[0055] As described above, the (1) medical device system 10 according to this embodiment is a medical device system 10 including a delivery device 20 having an elongated inner sheath 30 to be inserted into biological tissue, a first medical device 60 having a biopsy needle 61 to be inserted into the inner sheath 30, and a second medical device 70 having an elongated portion 71 to be inserted into the inner sheath 30, and the delivery device 20 includes a first sheath 60 that holds the proximal end of the inner sheath 30. The medical device system 10 includes a proximal section 40 equipped with a second proximal section internal pipe holder 46 as a biopsy needle holder, a first medical device 60 having a first detachable section 66 at the proximal end of the biopsy needle 61, and a second medical device 70 having a second detachable section 76 at the proximal end of the elongated section 71. The proximal section 40 has a fixed section 50 that allows the first detachable section 66 and the second detachable section 76 to be detachably attached and detached and that moves and fixes the relative position of the proximal section 40 with respect to the second proximal section internal pipe holder 46, and the elongated section 71 has an outer diameter equal to or smaller than that of the biopsy needle 61. In the medical device system 10 configured in this manner, the first medical device 60 for performing a biopsy and the second medical device 70 for performing a procedure other than biopsy can be detachably attached to a common delivery device 20, allowing another device to be inserted at the same location as the biopsy. Furthermore, the medical device system 10 allows the medical device to be replaced while the inner sheath 30 remains in the body, thereby reducing the man-hours required for the procedure and enabling rapid treatment.

[0056] (2) In the medical device system described in (1) above, the delivery device 20 may further include an elongated outer sheath 35 that is inserted into biological tissue, and the inner sheath 30 may be housed in the outer sheath 35. This allows the medical device system 10 to protect the inner surface of the endoscope from the inner sheath 30, the biopsy needle, or the elongated portion.

[0057] (3) In the medical device system 10 described in (1) or (2) above, the distal end position of the elongated portion 71 when the second detachable portion 76 is fixed to the fixed portion 50 may be the same as the distal end position of the biopsy needle 61 when the first detachable portion 66 is fixed to the fixed portion 50. This allows the medical device system 10 to reliably position the distal end of the elongated portion 71 at the position where the biopsy was performed when the first medical device 60 is replaced with the second medical device 70.

[0058] (4) In any of the medical device systems 10 described above in (1) to (3), the elongated portion 71 may have a lumen 72 for administering a drug. This allows the medical device system 10 to administer a drug using the second medical device 70 to a location where a biopsy was performed using the first medical device 60.

[0059] (5) In the medical device system 10 described in (4) above, the elongated portion 71 may have an opening 73 communicating with the administration lumen 72 and a cover portion 74 that switches between a closed state and an open state of the opening 73. In this way, for the elongated portion 71 whose outer diameter is equal to or smaller than the outer diameter of the biopsy needle 61, the opening 73 is closed with the cover portion 74 except when necessary, thereby preventing fluid from leaking from the lumen 72 into the gap between the inner sheath 30 and the elongated portion 71.

[0060] (6) In any of the medical device systems 10 described above in (1) to (5), the elongated section 140 may have a first lumen 141 for administering a drug and a second lumen 144 for circulating a fluid aspirated from the opening at the distal end. This allows the medical device system 10 to simultaneously perform treatments such as aspirating a blood clot when administering a drug.

[0061] (7) In the medical device system 10 described in (4) or (5) above, the biopsy needle 61 may have a biopsy lumen 62 with an inner diameter larger than the administration lumen 72 of the long portion 71. This allows the medical device system 10 to increase the amount of sample collected during biopsy while reducing the amount of drug used.

[0062] (8) In any of the medical device systems 10 described above in (1) to (7), the first medical device 60 and the second medical device 70 may have support pipes 69, 79 that cover the proximal ends of the biopsy needle 61 or the elongated portion 71, respectively. This allows the medical device system 10 to prevent the biopsy needle 61 or the elongated portion 71 from bending within the inner sheath 30 of the delivery device 20 when the biopsy needle 61 or the elongated portion 71 is inserted into the delivery device 20.

[0063] (9) In any of the medical device systems 10 described above in (1) to (8), the long section 71 may include a cutting edge 91 having a plurality of cutting surfaces 92 in the circumferential direction, and the cutting surfaces 92 may be formed by ridges where flat surfaces are adjacent to each other. This eliminates the need for a sharp tip of the long section 71 in the medical device system 10, and the medical device system 10 only requires a certain amount of pressure to puncture, thereby reducing the risk of unintentional perforation.

[0064] (10) In the medical device system 10 described in (9) above, the elongated portion 71 may have an administration lumen 94 for administering a drug and an opening 95 communicating with the administration lumen 94. This allows the medical device system 10 to reliably administer a drug while making the tip shape of the administration needle 71 suitable for puncture.

[0065] The method of using the medical device system 10 according to this embodiment (11) is a method of using the medical device system 10 including a delivery device 20 having an elongated inner sheath 30 and a proximal portion 40, a first medical device 60 having a biopsy needle 61 inserted into the inner sheath 30 and detachable from the proximal portion 40, and a second medical device 70 having an elongated portion 71 inserted into the inner sheath 30 and detachable from the proximal portion 40, the method including fixing the first medical device 60 to the proximal portion 40, and inserting the biopsy needle 61 into the delivery device 20 with the tip of the biopsy needle 61 exposed from the tip of the inner sheath 30. the proximal section 40 to a position just before the target position, operating the proximal section 40 to make the tip of the biopsy needle 61 reach the target position and perform a biopsy, determining a treatment method based on the results of the biopsy, removing the first medical device 60 from the delivery device 20, fixing the second medical device 70 to the proximal section 40 with the tip of the elongated section 71 inserted into the delivery device 20 housed in the first sheath 30, and operating the proximal section 40 to make the tip of the elongated section 71 reach the target position and perform treatment, and removing the delivery device 20 together with the second medical device 70. A method of using the medical device system 10 configured in this manner allows the first medical device 60 to be exchanged for the second medical device 70 while the inner sheath 30 remains indwelling in the body. Therefore, when performing both a biopsy and another treatment, the method of using the medical device system 10 can reduce the man-hours required for the procedure and perform the treatment quickly, and can also perform the other treatment at the same location as the biopsy, thereby improving the therapeutic effect.

[0066] The present invention is not limited to the above-described embodiment, and various modifications may be made by those skilled in the art within the technical spirit of the present invention. In the above-described embodiment, a therapeutic agent is administered from the administration needle 71 of the second medical device 70, but the administration needle 71 may be used for other purposes. For example, the administration needle 71 may be used to fill a hemostatic agent at a biopsy site. The second medical device 70 may also be a medical device having an elongated portion other than the administration needle 71. For example, the elongated portion may be an ablation device having a cauterizing portion at the tip that cauterizes biological tissue.

[0067] This application is based on Japanese Patent Application No. 2024-050157, filed on March 26, 2024, the disclosures of which are incorporated herein by reference in their entirety.

[0068] 10 Medical device system 20 Delivery device 30 Inner sheath 40 Proximal portion 41 Endoscope connection portion 42 Distal side portion 43 Middle portion 44 Handle portion 45 First proximal portion internal pipe holder 46 Second proximal portion internal pipe holder 47a First proximal portion internal pipe 47b Second proximal portion internal pipe 47 Proximal portion internal pipe 50 Fixing portion 51 Threaded portion 60 First medical device 61 Biopsy needle 62 Biopsy lumen 65 First hub 66 First detachable portion 67 Device connection portion 69 Support pipe 70 Second medical device 71 Administration needle (long portion) 72 Lumen 73 Opening 74 Cover sheath (cover portion) 75 Second hub 76 Second detachable portion 77 Device connection portion 79 Support pipe

Claims

1. A medical device system comprising: a delivery device having a first elongated sheath to be inserted into biological tissue; a first medical device having a biopsy needle to be inserted into the first sheath; and a second medical device having a long portion to be inserted into the first sheath, wherein the delivery device has a proximal portion having a first sheath holder that holds the proximal end of the first sheath, the first medical device has a first detachable portion at the proximal end of the biopsy needle, and the second medical device has a second detachable portion at the proximal end of the long portion, the proximal portion has a fixed portion that allows the first detachable portion and second detachable portion to be detached and that moves and fixes the relative position of the proximal portion to the first sheath holder, and the long portion has an outer diameter equal to or smaller than the outer diameter of the biopsy needle.

2. The medical device system of claim 1, wherein the delivery device further comprises a second elongated sheath that is inserted into biological tissue, and the first sheath is housed within the second sheath.

3. A medical device system as described in claim 1, wherein when the state of the proximal portion is the same, the most distal position of the elongated portion when the second detachable portion is fixed to the fixed portion is the same as the most distal position of the biopsy needle when the first detachable portion is fixed to the fixed portion.

4. A medical device system according to any one of claims 1 to 3, wherein the elongated portion has a lumen for administering a drug.

5. The medical device according to claim 4, wherein the elongated portion has an opening communicating with the lumen and a cover portion that switches the opening between a closed state and an open state.

6. A medical device system according to any one of claims 1 to 3, wherein the elongated portion has a first lumen for administering a drug and a second lumen for circulating a fluid aspirated from an opening at the tip.

7. The medical device system according to claim 4, wherein the biopsy needle has a biopsy lumen with an inner diameter larger than the lumen of the elongated portion.

8. A medical device system according to any one of claims 1 to 3, wherein the first medical device and the second medical device each have a support pipe covering the base end of the biopsy needle or the long portion.

9. A medical device system according to any one of claims 1 to 3, wherein the long portion comprises a cutting edge portion having a plurality of cutting surfaces in the circumferential direction, and the cutting surfaces are formed by ridges where flat surfaces are adjacent to each other.

10. The medical device system of claim 9, wherein the elongated portion has a lumen for administering a drug and an opening communicating with the lumen.

11. A method of using a medical device system comprising: a delivery device having a first elongated sheath and a proximal portion; a first medical device having a biopsy needle inserted into the first sheath and detachable from the proximal portion; and a second medical device having a long portion inserted into the first sheath and detachable from the proximal portion, comprising the steps of: fixing the first medical device to the proximal portion, and inserting the distal end of the delivery device to a position just before a target position with the distal end of the biopsy needle inserted into the delivery device exposed from the distal end of the first sheath; operating the proximal portion to make the distal end of the biopsy needle reach the target position and perform a biopsy; determining a treatment method based on the results of the biopsy; removing the first medical device from the delivery device; and fixing the second medical device to the proximal portion with the distal end of the long portion inserted into the delivery device housed in the first sheath, and operating the proximal portion to make the distal end of the long portion reach the target position and perform treatment. and withdrawing the delivery device along with the second medical device.

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