WO2013084943A1

WO2013084943A1 - Catheter assembly

Info

Publication number: WO2013084943A1
Application number: PCT/JP2012/081513
Authority: WO
Inventors: 本間康之; 中川雄司; 畑優
Original assignee: テルモ株式会社
Priority date: 2011-12-05
Filing date: 2012-12-05
Publication date: 2013-06-13

Abstract

A catheter assembly (10) is provided with a hollow shaft (18) which has a lumen (18a), a seal mechanism (14) which is provided on the outer periphery of the vicinity of the distal end of the shaft (18) and which can be expanded and contracted, and a sheath (16) through which the shaft (18) can be inserted and which can contain the contracted seal mechanism (14). When the expanded seal mechanism (14) is pressed in a living organism against the periphery of a part to be treated (a damaged part (30) of a cartilage), the inside and outside of the part to be treated are separated by the seal mechanism (14).

Description

Catheter assembly

The present invention relates to a catheter assembly including an isolation mechanism for isolating a treatment target site and other tissues in a living body.

One method of regenerative treatment of cartilage damage sites (cartilage defects) is a method of transplanting cultured cells and bone marrow-derived cells prepared by concentrating collected bone marrow fluid under arthroscopy. For example, the following “Clinical Orthopedic Surgery” (Ichiro Sekiya, Vol. 45, No. 9, Medical School, September 25, 2010, p. 791-795) shows the following specific examples. Synovial cells collected from patients are cultured for 2 weeks, and the cartilage damage site is dissected (shaved) under arthroscopy, and then 0.1 mL of cell suspension is injected into the cartilage damage site using a needle and syringe. To do. It should be noted that when the cell suspension is transplanted to the cartilage injury site of the knee, if the intra-articular fluid is not removed sufficiently, the cells will disperse and do not stay selectively at the cartilage injury site. There is a concern that the regeneration effect cannot be obtained.

Therefore, it is necessary to suck and remove the liquid in the joint as much as possible using a needle and syringe, etc., but there is a risk of damaging not only the cartilage damaged site but also healthy cartilage by the arthroscope or needle . In addition, there is a gap for the liquid to enter in the joint, and it is difficult to completely remove the liquid. Therefore, after a certain amount of time has passed since the liquid removal operation, the liquid remaining in the joint is treated. Therefore, it was necessary to remove the liquid many times with a syringe or the like.

The present invention has been made in consideration of such a problem, and the treatment target region can be isolated from other tissues by a simple operation from outside the living body, thereby treating the treatment target region. An object of the present invention is to provide a catheter assembly capable of preventing liquid from flowing into a target site.

In order to achieve the above object, a catheter assembly according to the present invention includes a hollow shaft having a lumen, a seal mechanism provided on the outer periphery in the vicinity of the tip of the shaft and capable of contraction and expansion, and the shaft. And a sheath that can accommodate the contracted seal mechanism, and when the expanded seal mechanism is pressed around the treatment target site in a living body, The outside is separated from the outside by the sealing mechanism.

According to the above-described configuration, the treatment target region is expanded from other tissues by expanding the seal mechanism in the living body by a simple operation from outside the living body, and pressing the expanded seal mechanism around the treatment target region. It isolates and can prevent the inflow of the liquid to a treatment object site | part by this. Therefore, the treatment for the treatment target site can be performed easily and reliably without reducing the therapeutic effect.

In the above catheter assembly, the sealing mechanism may include an isolation film joined to an outer periphery of the shaft and a frame that supports the isolation film. According to this configuration, it is possible to improve the adhesion of the seal mechanism to the periphery of the treatment target site, and it is possible to more suitably prevent liquid from entering from the outside to the inside of the treatment target site.

In the above catheter assembly, the frame is a ring-shaped flexible member provided on an outer peripheral edge of the isolation membrane, and the seal mechanism is configured so that when it comes out of the sheath, the frame It is good to be a structure which self-expands by elastic restoring force. According to this configuration, the seal mechanism can be expanded by a single operation without requiring a separate expansion operation, and the operability is excellent.

In the above catheter assembly, a plurality of the frames may be provided around the shaft, and may be configured to expand radially when the seal mechanism is expanded. According to this configuration, the rigidity of the entire seal mechanism at the time of expansion can be increased, and the adhesion between the seal mechanism and the periphery of the treatment target site can be effectively increased.

In the above-described catheter assembly, the sealing mechanism may include a connecting member that is connected to the plurality of frames and that is displaceable along the shaft on the proximal end side of the shaft with respect to the isolation film. According to this configuration, a plurality of frames can be developed radially with good balance. Therefore, the adhesion between the seal mechanism and the periphery of the treatment target site can be effectively enhanced.

In the above catheter assembly, when the outer peripheral portion of the shaft is provided with a lock portion for releasably engaging the connecting member, the expanded state of the seal mechanism can be reliably maintained.

In the above catheter assembly, when a rod-like pressing device that presses the sealing mechanism is provided, the adhesion between the sealing mechanism and the periphery of the treatment target site can be suitably increased.

In the above catheter assembly, the sheath has a bent portion in the longitudinal direction, and the pressing device has flexibility to bend along the sheath, for example, a knee joint in arthroscopic surgery As in the case of transplantation of cultured cells to a cartilage injury site, a treatment in which the treatment target site is in a direction bent with respect to the insertion direction of the catheter assembly can be suitably performed.

In the above catheter assembly, if the inner peripheral surface of the lumen is hydrophobic, the cell suspension can be injected without loss.

In the above catheter assembly, when the sealing mechanism is transparent, it is possible to reliably observe the state of sucking liquid and the state of cell injection by an endoscope or an arthroscope.

In the above catheter assembly, when the seal mechanism has an annular seal member or a porous body on the side in contact with the treatment target site, the sealing performance between the seal mechanism and the treatment target site is improved, and the treatment is performed. It is possible to more reliably prevent the liquid from flowing into the target site.

In the above catheter assembly, the shaft has an imaging lumen into which the imaging means can be inserted and an illumination lumen into which the light irradiation means can be inserted, so that the catheter can be used even when an endoscope or an arthroscope is not used. The assembly can be reliably placed at the treatment target site. In addition, the state of the damaged site can be directly observed, and after confirming that the liquid has been completely removed, cells can be injected, and treatment can be performed reliably.

In the above catheter assembly, when the shaft passes through the approximate center of the isolation membrane in the expanded state, cells can be injected from the approximate center of the treatment target site.

According to the catheter assembly of the present invention, the treatment target site can be isolated from other tissues by a simple operation from outside the living body with respect to the treatment target site, thereby allowing the liquid to flow into the treatment target site. Can be prevented.

1 is a partially omitted perspective view of a catheter assembly according to a first embodiment of the present invention. 2A is a partially omitted vertical cross-sectional view of the sealing mechanism of the catheter assembly shown in FIG. 1 in a contracted state, and FIG. 2B is a diagram of an expanded state of the sealing mechanism of the catheter assembly shown in FIG. FIG. It is a perspective view of the expanded sealing mechanism. FIG. 4A is a first diagram illustrating a method of using the catheter assembly according to the first embodiment, and FIG. 4B is a second diagram illustrating a method of using the catheter assembly according to the first embodiment. FIG. 4C is a third diagram illustrating a method of using the catheter assembly according to the first embodiment, and FIG. 4D is a fourth diagram illustrating a method of using the catheter assembly according to the first embodiment. FIG. FIG. 5A is a fifth diagram illustrating a method of using the catheter assembly according to the first embodiment, and FIG. 5B is a sixth diagram illustrating a method of using the catheter assembly according to the first embodiment. FIG. 5C is a seventh diagram illustrating a method of using the catheter assembly according to the first embodiment. It is a partially-omission perspective view of the catheter assembly which concerns on 2nd Embodiment of this invention. FIG. 7A is a longitudinal sectional view in a contracted state of the sealing mechanism of the catheter assembly according to the second embodiment, and FIG. 7B is a longitudinal sectional view in an expanded state of the sealing mechanism of the catheter assembly according to the second embodiment. FIG. It is a perspective view in the expansion state of the seal mechanism in the catheter assembly concerning a 2nd embodiment. FIG. 9A is a first diagram illustrating a method for using the catheter assembly according to the second embodiment, and FIG. 9B is a second diagram illustrating a method for using the catheter assembly according to the second embodiment. FIG. 9C is a third diagram illustrating a method of using the catheter assembly according to the second embodiment, and FIG. 9D is a fourth diagram illustrating a method of using the catheter assembly according to the second embodiment. FIG. FIG. 10A is a fifth diagram for explaining how to use the catheter assembly according to the second embodiment, and FIG. 10B is a sixth diagram for explaining how to use the catheter assembly according to the second embodiment. FIG. 10C is a seventh diagram illustrating a method for using the catheter assembly according to the second embodiment, and FIG. 10D is an eighth diagram illustrating a method for using the catheter assembly according to the second embodiment. FIG. FIG. 11A is a longitudinal sectional view of a distal end portion of a catheter assembly provided with a seal mechanism according to a modification, and FIG. 11B is a longitudinal sectional view of a distal end portion of the catheter assembly provided with a shaft according to the modification. .

Hereinafter, preferred embodiments of the catheter assembly according to the present invention will be described with reference to the accompanying drawings. For convenience of explanation, the ratio of dimensions between components in each drawing and the ratio of dimensions between components in the drawings are appropriately changed and do not necessarily match the actual ratio. .

[First Embodiment]
FIG. 1 is a partially omitted perspective view of a catheter assembly 10 according to a first embodiment of the present invention. The catheter assembly 10 includes a catheter 12, a contractible and expandable seal mechanism 14 provided near the distal end of the catheter 12, and a sheath 16 through which the catheter 12 and the seal mechanism 14 can be inserted. Thus, the expanded seal mechanism 14 is pressed against the periphery of the treatment target site to isolate the inside of the treatment target site from other sites. FIG. 1 shows a state in which the seal mechanism 14 is accommodated in the sheath 16.

FIG. 2A is a partially omitted longitudinal sectional view of the catheter assembly 10 with the sealing mechanism 14 contracted, and FIG. 2B is a partially omitted longitudinal section of the catheter assembly 10 with the sealing mechanism 14 expanded. FIG. FIG. 3 is a perspective view of the seal mechanism 14 in the expanded state. As shown in FIGS. 1 to 3, the catheter 12 includes a hollow shaft 18 constituting the main body of the catheter 12 and a hollow hub 20 connected to the proximal end portion of the shaft 18. The shaft 18 is a flexible tubular member, and a lumen 18a is formed to penetrate in the axial direction.

The dimension of the shaft 18 is appropriately selected according to the living body in which the shaft 18 is used and the size of the treatment target site. In particular, when the shaft 18 is used for arthroscopic surgery at the knee joint, the outer diameter is selected. Is preferably set to about 1 to 10 mm, the inner diameter is set to about 0.5 to 9.5 mm, and the total length is set to about 20 to 300 mm.

The hub 20 connected to the base end portion of the shaft 18 has a hub lumen 20a communicating with the lumen 18a of the shaft 18 penetrating in the axial direction. The hub 20 is configured to be connectable to a suction device that generates a negative pressure for liquid suction and an injection tool for supplying a cell suspension to the catheter 12. The suction device is, for example, a mechanism including a vacuum pump and a collection container, an aspirator, a syringe, or the like. The injection tool is, for example, a syringe filled with a cell suspension.

The shaft 18 and the hub 20 constituting the catheter 12 are made of various materials such as ethylene-tetrafluoroethylene copolymer (ETFE), polyether nylon, polyamide, polyester, polyurethane, polyethylene, polypropylene, and polyvinyl chloride. The

In the present embodiment, the seal mechanism 14 includes an isolation film 22 whose inner periphery is joined to the outer periphery of the shaft 18 and a frame 24 that supports the isolation film 22, and in a expanded state, a treatment target site (for example, The site to be treated is sealed by being pressed against the cartilage injury site. The isolation film 22 is a sheet-like member having flexibility such that it can be easily folded into a size that can be accommodated in the sheath 16. The shaft 18 of the catheter 12 passes through a hole provided in the central portion of the isolation film 22, and the distal end portion of the shaft 18 protrudes from the isolation film 22 when the isolation film 22 is expanded.

The size of the isolation membrane 22 is appropriately selected according to the living body in which the isolation membrane 22 is used and the size of the treatment target site, and in particular, when used for arthroscopic surgery at the knee joint, The diameter is preferably set to about 1.5 to 40 mm.

The isolation film 22 is made of a material capable of sealing the treatment target site, and includes, for example, vinyl chloride, polyurethane elastomer, styrene-ethylene-butylene-styrene copolymer (SEBS), styrene-ethylene-propylene-styrene copolymer. It is preferable to use a thermoplastic elastomer such as (SEPS), a thermoplastic resin such as nylon or PET, or a thermosetting resin such as rubber or silicone elastomer. Moreover, it is also possible to use these in combination as appropriate. In addition, the isolation film 22 is transparent so that a state in which the liquid in the treatment target region is sucked and a state in which cells are injected can be visually confirmed with an endoscope or an arthroscope while the treatment target region is covered by the seal mechanism 14. Have

The frame 24 is provided on the outer peripheral edge portion of the isolation film 22, supports the isolation film 22, and is a ring-shaped member having flexibility. Since the seal mechanism 14 includes a flexible frame 24, the seal mechanism 14 can be inserted into the sheath 16 together with the shaft 18 by contracting due to elastic deformation of the frame 24, as shown in FIG. As shown in FIG. 2B, when the sheath 16 comes out from the distal end, it can be expanded by the elastic restoring force of the frame 24.

Such a frame 24 is only required to have elasticity that can be elastically deformed and to be elastically recoverable in shape, for example, a metal having elasticity or superelasticity such as stainless steel, tantalum, cobalt alloy, titanium alloy or the like. It is made of a material or various polymers such as polyolefin such as polyethylene, polypropylene and ethylene-vinyl acetate copolymer, polyvinyl chloride, polymethyl methacrylate, polycarbonate, polybutadiene, polyamide and polyester. In particular, it is preferable that the constituent material of the frame 24 is a superelastic alloy (shape memory alloy) such as a titanium alloy because the seal mechanism 14 can be reliably expanded when it comes out of the sheath 16.

The sheath 16 is a tubular member having a lumen 16b into which the catheter 12 and the contracted seal mechanism 14 can be inserted, and both ends are open. In the present embodiment, the sheath 16 is bent downward in the vicinity of the distal end portion, and the distal end opening 16a is directed downward. The body portion 27 constituting the proximal end side of the bending portion 26 in the sheath 16 is configured in a straight line. As shown in FIG. 2A, the catheter 12 inserted into the body portion 27 of the sheath 16 remains straight, but when the catheter 12 is further advanced within the sheath 16, the shaft 18 of the catheter 12 is forced by the curved portion 26. Elastically deformed and curved. As a result, the distal end portion of the shaft 18 of the catheter 12 protrudes from the distal end of the sheath 16 in a state of being directed in the same direction (downward) as the outlet direction of the sheath 16 (see FIG. 2B).

The sheath 16 allows the distal end portion of the catheter assembly 10 to be disposed at a treatment target site in the living body while the operator grasps and operates the proximal end side, and the shaft 18 of the catheter 12 is forcibly bent by the bending portion 26. It is only necessary to have an appropriate rigidity so that it can be made, for example, metal materials such as stainless steel, iron, iron alloy, aluminum, aluminum alloy, titanium, titanium alloy, polyethylene, polypropylene, ethylene- It is formed of various polymers such as polyolefin such as vinyl acetate copolymer, polyvinyl chloride, polymethyl methacrylate, polycarbonate, polybutadiene, polyamide, and polyester.

As shown in FIG. 3, the seal mechanism 14 (the isolation film 22 and the frame 24) in the present embodiment is formed in a circular shape. Note that the sealing mechanism 14 is not limited to a circular shape, and may have an elliptical shape, a rectangular shape, or the like. The shape of the treatment target site is various, and the catheter 12 to which the seal mechanism 14 having a shape suitable for the shape is attached can be used according to the shape of the treatment target site.

The catheter assembly 10 according to the present embodiment is basically configured as described above, and the operation and effect thereof will be described below. Hereinafter, a cultured cell transplantation to a knee joint cartilage damaged part in an arthroscopic operation which is a typical use of the catheter assembly 10 will be described as an example. The method of using the catheter assembly 10 according to this example includes the following steps (1) to (11). 4A to 5C, reference numeral 29 is cartilage, reference numeral 30 is a cartilage damage site, reference numeral 32 is an arthroscope, and reference numeral 33 is skin.

(1) Dissection of the cartilage damage site Inject a liquid such as physiological saline into the knee joint where the cartilage damage site 30 exists to secure a work space, insert a dissection device from one side of the knee joint, The arthroscope 32 is inserted from the other side. Then, using a physiological saline or the like as a cleaning solution, while carving the inside of the knee joint under arthroscopy, the cartilage damaged part 30 is dissected (shaved) with the dissector to reveal the part to be transplanted with cells. Thereafter, the dissector is removed from the knee joint.

(2) Insertion of catheter assembly The catheter 12 is inserted into the sheath 16 through the puncture cavity (skin incision part) into which the dissection device has been inserted, and the seal mechanism 14 is reduced in diameter within the sheath 16 under arthroscopy. The catheter assembly 10 is inserted.

(3) Liquid suction in the joint A suction device (syringe or the like) is connected to the hub 20 (see FIG. 1) constituting the proximal end portion of the catheter 12, and the liquid in the knee joint is used by using the suction device and the catheter assembly 10. Aspirate (cleaning solution, etc.) and remove to some extent. FIG. 4A shows a state in which a small amount of liquid 35 remains in the cartilage injury site 30 after the liquid in the knee joint has been removed to some extent. In addition, instead of using the catheter assembly 10, some removal of the liquid in the knee joint may be performed using a syringe and an injection needle before inserting the catheter assembly 10 into the knee joint.

(4) Position Adjustment As shown in FIG. 4A, the position of the sheath 16 is adjusted so that the distal end opening 16 a of the sheath 16 is directly above the cartilage damage site 30.

(5) Deployment of the sealing mechanism The catheter 12 is advanced in the sheath 16 by further pushing the catheter 12 into the sheath 16. Then, the shaft 18 of the catheter 12 is forcibly bent by the bending portion 26 of the sheath 16. When the catheter 12 is further pushed in, the distal end of the shaft 18 and the sealing mechanism 14 come out of the distal end opening of the sheath 16 (see FIG. 4B). In this case, since the shaft 18 is bent by the bending portion 26, the distal end portion of the shaft 18 is directed in the same direction as the distal end opening 16 a of the sheath 16, that is, the cartilage damage site 30. When the seal mechanism 14 exits from the distal end opening 16 a of the sheath 16, the seal mechanism 14 is self-expanded (deployed) by the elastic restoring force of the frame 24.

(6) Isolation of the cartilage damage site When the seal mechanism 14 is expanded, the seal mechanism 14 is pressed against the cartilage 29 around the cartilage damage site 30 to bring the lower surface of the seal mechanism 14 into close contact with the cartilage damage site 30. In this case, the periphery of the cartilage damage site 30 may be pressed against the seal mechanism 14 using a rod-shaped pressing device 36 (see FIG. 4C). Specifically, a pressing device 36 having a C-shaped or U-shaped pressing portion 38 at the tip and a rod-like portion 40 that supports the pressing portion 38 is inserted into the sheath 16 and pressed from the tip opening 16a. The portion 38 is pressed against the upper surface of the seal mechanism 14 in the expanded state. As a result, the lower surface of the seal mechanism 14 and the cartilage 29 around the cartilage damaged site 30 are in close contact with each other, and the cartilage damaged site 30 is isolated from other tissues (normal portions). As a result, the inflow of the liquid into the cartilage damaged part 30 from other parts, that is, the parts other than the cartilage damaged part 30 is prevented.

The rod-like portion 40 of the pressing device 36 is bent in the same manner as the sheath 16 in a natural state so that the seal mechanism 14 can be easily pressed. The pressing device 36 preferably has an appropriate rigidity so that the operating force from the operator's hand side can be suitably transmitted to the distal end side. For example, any one of the pressing devices 36 exemplified above as the constituent material of the sheath 16 is used. Or it may be composed of a plurality of materials. However, when the sealing mechanism 14 is pressed by the pressing device 36 passed through the sheath 16 as shown in FIG. 4C, the rod-shaped portion 40 is elastically deformed in order to insert the pressing device 36 having the bent rod-shaped portion 40 into the sheath 16. Therefore, the pressing device 36 is required to have a certain degree of flexibility. Instead of inserting the pressing device 36 into the sheath 16, another lumen may be provided in the sheath 16, and the pressing device 36 may be inserted into the knee joint through the other lumen to press the sealing mechanism 14. .

(7) Liquid Aspiration of Cartilage Damaged Site Under the arthroscopy, the seal mechanism 14 is pressed around the cartilage damaged site 30 to maintain the isolated state of the cartilage damaged site 30 from other tissues. The suction device connected to the hub 20 is operated to completely remove the liquid 35 remaining on the cartilage injury site 30 (see FIG. 4D). In this case, since the isolation film 22 has transparency, even when the cartilage damage site 30 is covered by the seal mechanism 14, it is possible to confirm the state of sucking the liquid in the cartilage damage site 30 with the arthroscope 32.

When the distal end of the catheter 12 does not reach the liquid 35 in a state where the seal mechanism 14 is pressed around the cartilage damage site 30, the lumen 18a of the catheter 12 has a shaft having a diameter smaller than that of the lumen 18a. Another catheter (hereinafter referred to as “aspiration catheter”) is inserted, the distal end of the aspiration catheter is protruded from the distal end of the catheter 12, and the liquid 35 on the cartilage injury site 30 is aspirated through the aspiration catheter. May be. Thereby, the suction of the liquid 35 away from the distal end of the catheter 12 can be reliably performed.

(8) Cell injection When the liquid 35 in the cartilage injury site 30 is completely removed, the suction device is detached from the hub 20 of the catheter 12 and, instead, an injection device filled with the cell suspension 42 (cultured cells) (for example, , Syringe) to the hub 20. When suction of the liquid 35 is performed using the suction catheter described above in step (7), the suction catheter is removed from the lumen of the catheter 12 and then the injection tool is connected to the hub 20 of the catheter 12. Then, by operating the injection tool connected to the catheter 12, the cell suspension 42 is caused to flow out from the distal end of the catheter 12 and injected into the cartilage damage site 30 under arthroscopy (see FIG. 5A). Since the isolation film 22 has transparency, even when the cartilage damage site 30 is covered by the sealing mechanism 14, it is possible to confirm the state in which the cell suspension 42 is injected into the cartilage damage site 30 under an arthroscopic view. . In addition, it is preferable that the inner peripheral surface of the lumen 18a of the catheter 12 or the inner peripheral surface of the lumen of the suction catheter is hydrophobic because the cell suspension 42 can be injected without loss.

(9) Standing After the cell suspension 42 is injected into the cartilage injury site 30, the plate is allowed to stand for a predetermined time (for example, 10 minutes). As described above, since the cartilage damage site 30 and other tissues are isolated from each other by the seal mechanism 14, while the cell suspension 42 is allowed to stand still, the part other than the cartilage damage site 30 is used. The liquid does not flow into the cartilage damage site 30.

(10) Release of isolation and accommodation of sealing mechanism When the predetermined time has elapsed, the catheter 12 is moved to the proximal end side to lift the sealing mechanism 14 and disengage from the periphery of the cartilage damage site 30 (see FIG. 5B). Thereby, the isolation | separation by the sealing mechanism 14 is cancelled | released. Thereafter, when the catheter 12 is further moved to the proximal end side with respect to the sheath 16, the seal mechanism 14 is contracted by being restricted by the inner peripheral surface of the sheath 16 and is accommodated in the sheath 16 (see FIG. 5C).

(11) Removal of catheter assembly and arthroscope Thereafter, the catheter assembly 10 and the arthroscope 32 in a state where the seal mechanism 14 is accommodated in the sheath 16 are removed from the knee joint.

Through the above steps (1) to (11), transplantation of the cultured cells to the cartilage damage site 30 is completed.

As will be understood from the above description, the following cell transplantation method can be performed by using the catheter assembly 10 according to the present embodiment. That is, the cell transplantation method is:
A step of preparing a catheter assembly 10 including a hollow shaft 18, a contractible and expandable seal mechanism 14 provided in the vicinity of the distal end portion of the shaft 18, and a sheath 16 that can accommodate the seal mechanism 14. When,
Inserting the catheter assembly 10 in a state where the seal mechanism 14 is accommodated in the sheath 16 into a living body where a treatment target site exists;
Extending the seal mechanism 14 out of the sheath 16 and expanding the seal mechanism 14;
Isolating the treatment target site from other tissues by pressing the expanded seal mechanism 14 around the treatment target site;
Sucking the liquid remaining on the treatment target site through the catheter 12;
And a step of injecting cells (cultured cells) into the treatment target site through the catheter 12.

As described above, according to the catheter assembly 10 according to the present embodiment, the seal mechanism 14 is expanded in vivo by a simple operation from outside the living body, and the expanded seal mechanism 14 is disposed around the treatment target site. By pressing against the treatment target region, the treatment target region can be isolated from other tissues, thereby preventing liquid from flowing into the treatment target region. Therefore, the treatment for the treatment target site can be performed easily and reliably without reducing the therapeutic effect.

In the case of the present embodiment, the seal mechanism 14 includes an isolation film 22 whose inner periphery is joined to the outer periphery of the shaft 18 and a frame 24 that supports the isolation film 22. The adhesion of the seal mechanism 14 can be improved, and the penetration of the liquid from the outside to the inside of the treatment target site can be more preferably prevented.

In the case of this embodiment, the frame 24 is a ring-shaped flexible member provided on the outer peripheral edge of the isolation film 22, and the seal mechanism 14 is elastic when it comes out of the sheath 16. Self-expand by resilience. That is, the seal mechanism 14 that moves the catheter 12 in the distal direction relative to the sheath 16 is automatically expanded. For this reason, the seal mechanism 14 can be expanded by a single operation without requiring a separate expansion operation, and the operability is excellent.

[Second Embodiment]
FIG. 6 is a partially omitted perspective view of the catheter assembly 10a according to the second embodiment of the present invention. In the catheter assembly 10a according to the second embodiment, elements having the same or similar functions and effects as those of the catheter assembly 10 according to the first embodiment are denoted by the same reference numerals, and detailed description thereof is omitted. To do.

The catheter assembly 10a according to the second embodiment is different from the catheter assembly 10 according to the first embodiment in the configuration of the seal mechanism 50. Here, FIG. 7A is a longitudinal sectional view of the sealing mechanism 50 in a contracted state, and FIG. 7B is a longitudinal sectional view of the sealing mechanism 50 in an expanded state. FIG. 8 is a perspective view of the seal mechanism 50 in an expanded state. As shown in FIGS. 6 to 8, the seal mechanism 50 includes a separation film 52 joined to the outer periphery of the shaft 18, a plurality of frames 54 that support the separation film 52, and the plurality of frames 54 connected to the shaft 18. And a slidable connecting member 56.

The isolation film 52 of the seal mechanism 50 is configured in the same manner as the isolation film 22 in the first embodiment. A plurality of the frames 54 are provided around the shaft 18 (eight in the illustrated example), and expand radially when the seal mechanism 50 is expanded (see FIGS. 7B and 8). Specifically, one end of the frame 54 is rotatably connected to the connecting member 56, and the other end is connected to the outer peripheral edge of the isolation film 52. The frame 54 preferably has an appropriate rigidity so that the isolation film 52 can be reliably deployed. For example, the frame 54 can be made of the same material as the frame 54 in the first embodiment.

The connecting member 56 is formed in a ring shape, and the shaft 18 is inserted inside the ring shape and can be displaced along the shaft 18. The frame 54 described above is rotatably connected to the outer peripheral portion of the connecting member 56. In the outer peripheral portion of the shaft 18, in the vicinity of the connecting portion between the isolation film 52 and the shaft 18, the isolation film 52 expands and a plurality of frames 54 radiate at a position closer to the proximal end of the shaft 18 than the isolation film 52. When the connecting member 56 is displaced to a position where the connecting member 56 is deployed, a lock portion 60 is provided that engages the connecting member 56 to prevent (restrict) movement of the connecting member 56 in the proximal direction. . The lock portion 60 is made of, for example, an elastic body and has a tapered surface that is inclined so that the distance (height) from the outer peripheral surface of the shaft 18 increases toward the distal end of the shaft 18.

In the state where the seal mechanism 50 is contracted (the state shown in FIG. 7A), the connecting member 56 is located away from the lock portion 60 in the proximal direction of the shaft 18. When the connecting member 56 moves in the proximal direction of the shaft 18 when the seal mechanism 50 is expanded (deployed), the connecting member 56 eventually gets over the lock portion 60 and is closer to the distal end side of the shaft 18 than the lock portion 60. Displaces up to (between the lock portion 60 and the isolation film 52) (see FIG. 7B). When the connecting member 56 gets over the lock part 60, the lock part 60 is elastically compressed and deformed. However, after the connecting member 56 gets over the lock part 60, the lock part 60 is restored to its original shape. For this reason, the connecting member 56 is locked by the end surface on the distal end side of the lock portion 60, and the connecting member 56 is in a locked state in which the connecting member 56 is prevented from moving in the proximal direction of the shaft 18.

The catheter assembly 10a according to the present embodiment is basically configured as described above, and the operation and effect thereof will be described below. In the following, referring to FIGS. 9A to 10D, an example of cultured cell transplantation into a knee joint cartilage injury site in arthroscopic surgery, which is a typical use of the catheter assembly 10a, will be described. The method of using the catheter assembly 10a according to this example includes the following steps (1a) to (11a).

(1a) Dissection of cartilage damage site As in the case of (1) in the first embodiment, the cartilage damage site 30 is dissected with a dissector, and then the dissector is removed from the knee joint.

(2a) Insertion of catheter assembly The catheter 12 is inserted into the sheath 16 through the puncture cavity (skin incision portion) into which the dissection device has been inserted under the arthroscopy, and the seal mechanism 50 is reduced in diameter in the sheath 16. The catheter assembly 10a is inserted.

(3a) Liquid suction in the joint A suction device (syringe or the like) is connected to the hub 20 constituting the proximal end portion of the catheter 12, and the liquid in the knee joint (cleaning fluid or the like) is discharged using the suction device and the catheter assembly 10a. Aspirate and remove to some extent. FIG. 9A shows a state in which a small amount of liquid 35 remains in the cartilage injury site 30 after the liquid in the knee joint has been removed to some extent. It should be noted that some removal of the liquid in the knee joint may be performed using a syringe and an injection needle before inserting the catheter assembly 10a into the knee joint, instead of using the catheter assembly 10a.

(4a) Position Adjustment As shown in FIG. 9A, the position of the sheath 16 is adjusted so that the distal end opening 16 a of the sheath 16 is directly above the cartilage damage site 30.

(5a) Deployment of seal mechanism The catheter 12 is advanced in the sheath 16 by further pushing the catheter 12 into the sheath 16. Then, the shaft 18 of the catheter 12 is forcibly bent by the bending portion 26 of the sheath 16. When the catheter 12 is further pushed in, the distal end of the shaft 18 and the sealing mechanism 50 come out from the distal end opening of the sheath 16 (see FIG. 9B). In this case, since the shaft 18 is bent by the bending portion 26, the distal end portion of the shaft 18 is directed in the same direction as the distal end opening 16 a of the sheath 16, that is, the cartilage damage site 30. Next, the pressing device 36 is inserted into the sheath 16, and the connecting member 56 or the frame 54 is pushed downward by the pressing portion 38 provided at the distal end of the pressing device 36, and the connecting member 56 gets over the lock portion 60 and locks 60. The connecting member 56 is displaced in the direction of the distal end of the shaft 18 until it is locked to the position (see FIG. 9C). At this time, as the plurality of frames 54 spread radially, the isolation film 52 is expanded, and the seal mechanism 50 is expanded as shown in FIG. 9C. Instead of inserting the pressing device 36 into the sheath 16, the above-described operation of providing another lumen in the sheath 16, inserting the pressing device 36 into the knee joint through the other lumen, and expanding the seal mechanism 50. May be performed.

(6a) Isolation of the cartilage damage site When the seal mechanism 50 is expanded, the seal mechanism 50 is pressed around the cartilage damage site 30 and the lower surface of the seal mechanism 50 is brought into close contact with the cartilage damage site 30. In this case, when the sealing mechanism 50 is pressed against the cartilage damaged site 30 using the pressing device 36 as shown in FIG. 9D, the adhesion between the lower surface of the sealing mechanism 50 and the surrounding portion of the cartilage damaged site 30 can be further improved. Yes (see FIG. 9D). As a result, the cartilage damage site 30 is isolated from other tissues (normal parts), and the inflow of liquid from the other tissues into the cartilage damage site 30 is prevented.

(7a) Liquid suction of the cartilage damage site Under the arthroscopic view, the seal mechanism 50 is pressed around the cartilage damage site 30 to maintain the isolated state between the cartilage damage site 30 and other tissues. The suction device connected to the hub 20 is operated to completely remove the liquid 35 remaining on the cartilage damage site 30 (see FIG. 10A). In the case where the distal end of the catheter 12 does not contact the liquid 35 with the sealing mechanism 50 pressed around the cartilage damage site 30, the lumen of the catheter 12 is the same as in the step (7) in the first embodiment. The suction catheter may be inserted into 18a, the tip of the suction catheter may protrude from the tip of the catheter 12, and the liquid 35 on the cartilage injury site 30 may be sucked through the suction catheter. Thereby, the suction of the liquid 35 away from the distal end of the catheter 12 can be reliably performed.

(8a) Cell Injection When the liquid in the cartilage injury site 30 is completely removed, the suction device is detached from the hub 20 of the catheter 12, and instead, an injection tool (for example, a syringe) filled with the cell suspension 42 is used as the hub. 20 is connected. When suction of the liquid 35 is performed using the suction catheter described above in the step (7a), the suction catheter is removed from the lumen of the catheter 12 and then the injection tool is connected to the hub 20 of the catheter 12. Then, by operating the injection tool connected to the catheter 12, the cell suspension 42 flows out from the distal end of the catheter 12 and is injected into the cartilage damage site 30 under arthroscopy (see FIG. 10B).

(9a) Standing After the cell suspension 42 is injected into the cartilage injury site 30, the plate is left standing for a predetermined time (for example, 10 minutes). As described above, since the cartilage damage site 30 and other tissues are isolated by the seal mechanism 50, while the cell suspension 42 is allowed to stand still, the part other than the cartilage damage site 30 is used. The liquid does not flow into the cartilage damage site 30.

(10a) Isolation release and accommodation of sealing mechanism When the predetermined time has elapsed, the catheter 12 is moved to the proximal end side to lift the sealing mechanism 50 and disengage it from the periphery of the cartilage damage site 30. Thereby, the isolation | separation by the seal mechanism 50 is cancelled | released. Thereafter, the pressing portion 38 of the pressing device 36 is brought into contact with the lock portion 60, and the locking portion 60 is elastically deformed by the pressing portion 38, thereby releasing the locking of the connecting member 56 by the locking portion 60. When the locking by the lock portion 60 is released, the connecting member 56 can move in the proximal direction of the shaft 18. Next, the sealing portion 50 is contracted as shown in FIG. 10C by hooking the pressing portion 38 on the connecting member 56 or the frame 54 and moving the connecting member 56 to the proximal end side of the shaft 18. When the sealing mechanism 50 is contracted, the catheter 12 is further moved to the proximal end side with respect to the sheath 16, and the sealing mechanism 50 is accommodated in the sheath 16 (see FIG. 10D).

(11a) Removal of catheter assembly and arthroscope Thereafter, the catheter assembly 10a and the arthroscope 32 in a state where the seal mechanism 50 is accommodated in the sheath 16 are removed from the knee joint.

Through the above steps (1a) to (11a), the transplantation of the cultured cells to the cartilage damage site 30 is completed.

As can be understood from the above description, the following cell transplantation method can be performed by using the catheter assembly 10a according to the present embodiment. That is, the cell transplantation method is:
A step of preparing a catheter assembly 10 a including a hollow shaft 18, a contractible and expandable seal mechanism 50 provided in the vicinity of the tip of the shaft 18, and a sheath 16 that can accommodate the seal mechanism 50. When,
Inserting the catheter assembly 10a in a state where the seal mechanism 50 is accommodated in the sheath 16 into a living body where a treatment target site exists;
Extending the seal mechanism 50 out of the sheath 16 to expand the seal mechanism 50;
Isolating the treatment target site from other tissues by pressing the expanded seal mechanism 50 around the treatment target site;
Sucking the liquid remaining on the treatment target site through the catheter 12;
And a step of injecting cells (cultured cells) into the treatment target site through the catheter 12.

As described above, according to the catheter assembly 10a according to the present embodiment, a plurality of frames 54 are provided around the shaft 18 and expand radially when the seal mechanism 50 is expanded. The overall rigidity can be increased, and the adhesion between the seal mechanism 50 and the periphery of the treatment target site can be effectively increased.

Further, in the case of the present embodiment, the seal mechanism 50 includes the connecting member 56 that is connected to the plurality of frames 54 and can be displaced along the shaft 18, so that the plurality of frames 54 can be radially developed with good balance. . For this reason, the adhesiveness of the seal mechanism 50 and the circumference | surroundings of a treatment object site | part can be improved effectively.

Furthermore, in the case of this embodiment, since the lock part 60 which latches the connection member 56 releasably is provided in the outer peripheral part of the said shaft 18, operation which cancels | releases the movement restriction | limiting of the connection member 56 by the lock part 60 is not performed. As long as the expansion state of the seal mechanism 50 can be reliably maintained.

In addition, in the second embodiment, for each component common to the first embodiment, it is possible to obtain the same or similar operation and effect as the operation and effect brought about by the common component in the first embodiment. Of course.

[Other variations]
As in the seal mechanism 70 according to the modification shown in FIG. 11A, an annular seal member 72 may be provided on the lower surface of the isolation film 52 (the surface on the side in contact with the treatment target site). The seal member 72 is configured by, for example, an O-ring, and is disposed along the outer peripheral edge portion of the lower surface of the isolation film 22. By providing such a seal member 72, it is possible to improve the sealing performance between the seal mechanism 70 and the periphery of the treatment target site when the seal mechanism 70 is pressed around the treatment target site. Inflow of the liquid can be more reliably prevented.

In addition, instead of the seal member 72, a flexible annular porous body may be provided on the outer peripheral edge of the lower surface of the isolation film 22. In the case of a configuration in which such a porous body is provided, the porous body can be elastically deformed so as to follow the surface shape (uneven shape, etc.) around the treatment target site, so that it can be well around the treatment target site. Since it adheres closely, the sealing performance between the sealing mechanism 70 and a treatment object site | part can be improved.

Like the shaft 80 according to the modification shown in FIG. 11B, in addition to the lumen 81 for liquid suction and cell injection, an imaging lumen 82 into which an imaging means (a small-diameter camera) can be inserted, and a light irradiation means ( An illumination lumen 83 into which an optical fiber or the like connected to a light source can be inserted may be provided. According to the shaft 80 having such a configuration, even when an endoscope or an arthroscope is not used, the imaging means is inserted into the imaging lumen 82 and the light irradiation means is inserted into the illumination lumen 83, whereby the catheter The

assemblies

10 and 10a can be reliably disposed at the treatment target site. In addition, since the inside of the treatment target site can be directly observed even in the state where the treatment target site is covered by the sealing

mechanisms

14, 50, 70, it is confirmed that the liquid in the treatment target site has been completely removed. Cell injection can be performed and treatment can be reliably performed. In the case of the configuration illustrated in FIG. 11B, the lower surface of the isolation film 22 (the surface on the side in contact with the treatment target site) may be configured with, for example, a mirror surface or white so as to easily reflect light.

In the above description, the present invention has been described with reference to preferred embodiments. However, the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the scope of the present invention. Yes. For example, in the above-described embodiment, an arthroscopic cell transplantation operation at the knee joint is given as an application of the

catheter assembly

10, 10a, but the present invention is not limited to this. That is, the

catheter assembly

10, 10a according to the present invention can be applied to any surgical method that involves draining a liquid. For example, the

catheter assemblies

10 and 10a according to the present invention can be used for endoscopic surgery such as intracerebral, intraperitoneal, carpal tunnel, shoulder joint, elbow joint, spine, etc., and drainage of pleural effusion and ascites.

Claims

A hollow shaft (18, 80) having a lumen (18a, 81);
A seal mechanism (14, 50, 70) provided on the outer periphery in the vicinity of the tip of the shaft (18, 80) and capable of contraction and expansion;
The shaft (18, 80) can be inserted, and the sheath (16) can accommodate the contracted seal mechanism (14, 50, 70).
In vivo, when the expanded seal mechanism (14, 50, 70) is pressed around the treatment target site, the inside and the outside of the treatment target site are isolated by the seal mechanism (14, 50, 70). Is configured to
A catheter assembly (10, 10a) characterized in that.
The catheter assembly (10, 10a) according to claim 1,
The sealing mechanism (14, 50, 70) includes a separation membrane (22, 52) joined to an outer periphery of the shaft (18, 80), and a frame (24, 54) that supports the separation membrane (22, 52). )
A catheter assembly (10, 10a) characterized in that.
Catheter assembly (10) according to claim 2,
The frame (24) is a ring-shaped flexible member provided on the outer peripheral edge of the isolation film (22),
The sealing mechanism (14) self-expands by the elastic restoring force of the frame (24) when exiting from the sheath (16).
A catheter assembly (10) characterized in that.
The catheter assembly (10a) according to claim 2,
A plurality of the frames (54) are provided around the shaft (18), and expand radially when the seal mechanism (50) is expanded.
A catheter assembly (10a) characterized in that
The catheter assembly (10a) according to claim 4,
The seal mechanism (50) is connected to the plurality of frames (54) and is displaceable along the shaft (18) on the proximal end side of the shaft (18) with respect to the isolation film (52). Comprising a member (56),
A catheter assembly (10a) characterized in that
Catheter assembly (10a) according to claim 5,
A lock portion (60) for releasably locking the connecting member (56) is provided on the outer peripheral portion of the shaft (18).
A catheter assembly (10a) characterized in that
The catheter assembly (10, 10a) according to any one of claims 1 to 6,
A rod-shaped pressing device (36) for pressing the sealing mechanism (14, 50, 70);
A catheter assembly (10, 10a) characterized in that.
The catheter assembly (10, 10a) according to claim 7,
The sheath (16) is bent in the middle in the longitudinal direction,
The pressing device (36) has the flexibility to bend along the sheath (16),
A catheter assembly (10, 10a) characterized in that.
The catheter assembly (10, 10a) according to any one of claims 1 to 6,
The inner peripheral surface of the lumen (18a, 81) has hydrophobicity,
A catheter assembly (10, 10a) characterized in that.
The catheter assembly (10, 10a) according to any one of claims 1 to 6,
The sealing mechanism (14, 50, 70) has transparency.
A catheter assembly (10, 10a) characterized in that.
The catheter assembly (10, 10a) according to any one of claims 1 to 6,
The seal mechanism (70) has an annular seal member (72) or a porous body on the side in contact with the treatment target site.
A catheter assembly (10, 10a) characterized in that.
The catheter assembly (10, 10a) according to any one of claims 1 to 6,
The shaft (80) has an imaging lumen (82) into which the imaging means can be inserted, and an illumination lumen (83) into which the light irradiation means can be inserted.
A catheter assembly (10, 10a) characterized in that.
The catheter assembly (10, 10a) according to any one of claims 2 to 6,
The shaft (80) penetrates substantially the center of the isolation membrane (22, 52) in the expanded state;
A catheter assembly (10, 10a) characterized in that.