WO2013081071A1 - Device for cell transplantation - Google Patents

Device for cell transplantation Download PDF

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Publication number
WO2013081071A1
WO2013081071A1 PCT/JP2012/080983 JP2012080983W WO2013081071A1 WO 2013081071 A1 WO2013081071 A1 WO 2013081071A1 JP 2012080983 W JP2012080983 W JP 2012080983W WO 2013081071 A1 WO2013081071 A1 WO 2013081071A1
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WO
WIPO (PCT)
Prior art keywords
expansion
cell transplantation
catheter
lumen
expansion means
Prior art date
Application number
PCT/JP2012/080983
Other languages
French (fr)
Japanese (ja)
Inventor
中川雄司
本間康之
畑優
Original Assignee
テルモ株式会社
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Publication of WO2013081071A1 publication Critical patent/WO2013081071A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/025—Joint distractors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/025—Joint distractors
    • A61B2017/0268—Joint distractors for the knee

Definitions

  • the present invention is a device for cell transplantation used for arthroscopic or endoscopic surgery, and includes a lumen for liquid aspiration and cell injection and a tissue between the tissues to secure a visual field of the arthroscope or endoscope. It is related with the device for cell transplantation provided with the expansion means which expands.
  • One method of regenerative treatment of cartilage damage sites is a method of transplanting cultured cells and bone marrow-derived cells prepared by concentrating collected bone marrow fluid under arthroscopy.
  • cartilage damage sites cartilage defects
  • Clinical Orthopedic Surgery Ichiro Sekiya, Vol. 45, No. 9, Medical School, September 25, 2010, p. 791-795
  • 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.
  • US Pat. No. 6,187,023 discloses a method of expanding between joints using a retractor having a blader that can be expanded into a wedge shape. Further, the US Pat. No. 6,187,023 discloses that an endoscope is inserted through a lumen of a retractor into a space formed in a tissue by expansion of a donut-shaped braider. That is, when the retractor is used, a work space such as an arthroscope and a needle can be secured even when there is no liquid in the joint.
  • the retractor has a shape suitable for knee cartilage, and the space around the cartilage damaged part cannot always be reliably expanded.
  • transplantation devices needles, catheters, etc.
  • the present invention has been made in view of such problems, and in the case of cell transplantation surgery under arthroscopy or endoscopy, cells can be reliably and easily applied to a treatment target site without damaging tissue in the living body. It aims at providing the device for cell transplantation which can be transplanted.
  • a cell transplantation device is expanded by a catheter and an expansion fluid that is provided at the distal end portion of the catheter and supplied through an expansion lumen formed in the catheter. And at least one lumen is formed in the catheter in addition to the expansion lumen, and the lumen is expanded between the tissues in the living body by expanding the expansion means. It is characterized in that the liquid on the treatment target site is sucked directly or indirectly and the cells are injected into the treatment target site.
  • the device for cell transplantation configured as described above, it is possible to expand between the tissues in the living body by the expansion means when performing the cell transplantation operation under the arthroscope or the endoscope. Can be secured and will not hurt the tissue.
  • the remaining liquid on the treatment target site is sucked through the lumen formed in the catheter and the cells are injected into the treatment target site, the cells are reliably and easily transplanted to the treatment target site. can do.
  • the catheter includes a suction lumen having a suction port for sucking a liquid on the treatment target site, and an injection lumen having a discharge port for discharging the cells. But you can.
  • the suction port may be positioned below the discharge port.
  • the suction port when sucking the remaining liquid on the treatment target site, the suction port can be preferentially infiltrated into the remaining liquid.
  • the suction port may be positioned below the lower surface of the expansion means with the expansion means expanded.
  • the residual liquid on the treatment target site can be reliably sucked.
  • the discharge port may be positioned above the lower surface of the expansion means with the expansion means expanded.
  • the discharge port is difficult to touch the injected cells.
  • a suction catheter for aspirating the liquid on the treatment target site and an injection catheter for injecting cells into the treatment target site can be selectively inserted into the catheter.
  • a guide lumen may be formed.
  • the height of the distal end portion of the suction catheter when sucking the remaining liquid on the treatment target site, and the height of the distal end portion of the injection catheter when injecting cells into the treatment target site respectively. It can be easily adjusted to a suitable position.
  • the expansion means has a plurality of expansion bodies that expand in an arc shape, and when the plurality of expansion bodies expands, the expansion means has a generally annular shape as a whole, and the distal end portion of the catheter is It is preferable that the expansion means bends at a substantially center position of a substantially annular shape when expanded and is directed downward.
  • the suction port and the discharge port are positioned at substantially the center position of the circle drawn by the plurality of expansion bodies at the time of expansion, the position of the suction port and the discharge port when the contrast medium is used as the expansion fluid It is easy to grasp the above, and it is possible to reliably suck the liquid and inject cells at the target site.
  • the expansion means has a plurality of expansion bodies that expand in a curved shape, and when the plurality of expansion bodies expands, the expansion means has a substantially annular shape as a whole. It is preferable that they are connected to each other by a connecting film and have an integral structure by the connecting film at the time of expansion.
  • the expansion means when the expansion means is expanded, the shape of the expansion means is stabilized, and a space for suction and injection is suitably provided in the inner space surrounded by the plurality of expansion bodies constituting the expansion means. Can be secured.
  • the plurality of expansion bodies may be a pair of expansion bodies each having an arc shape and being arranged on the same circle during expansion.
  • the living body can be efficiently expanded.
  • the expansion means may be provided with an opening into which the imaging means can be inserted.
  • an imaging means (arthroscope, endoscope, etc.) is inserted into the opening, and the state of sucking the remaining liquid on the treatment target site and the state of cell transplantation to the treatment target site are observed. can do.
  • the expansion means may be configured to be foldable so as to be coaxial with the catheter.
  • the incision range of the skin can be reduced when the expansion means is folded and inserted into the living body percutaneously.
  • cells can be transplanted to a site to be treated surely and easily without damaging a tissue in a living body during a cell transplantation operation under an arthroscope or an endoscope.
  • FIG. 1 is a partially omitted plan view of a device for cell transplantation according to a first embodiment of the present invention.
  • FIG. 2 is a transverse sectional view taken along the line II-II of the cell transplantation device shown in FIG. It is a side view which shows the state which expanded the expansion means of the device for cell transplantation concerning 1st Embodiment. It is a side view which shows the state which folded the expansion means of the device for cell transplantation concerning 1st Embodiment, and was inserted in the joint.
  • FIG. 5A is a plan view showing the cell transplantation device according to the first embodiment in which the expansion means is expanded in the joint
  • FIG. 5B is a cross-sectional view taken along the line VB-VB in FIG. 5A.
  • FIG. 5 is a partially omitted vertical cross-sectional view of a cell transplant device according to a second embodiment of the present invention, in a state where an aspiration catheter is inserted into the cell transplant device.
  • FIG. 6 is a partially omitted vertical cross-sectional view of a cell transplant device according to a second embodiment of the present invention, in a state where an injection catheter is inserted into the cell transplant device.
  • FIG. 1 is a partially omitted plan view of a cell transplant device 10 according to a first embodiment of the present invention.
  • This cell transplantation device 10 includes a catheter 12 and an expansion means 14 provided at the distal end of the catheter 12, and expands between tissues in the living body by the expansion means 14 and sucks the liquid remaining in the treatment target site. In addition, it is configured to inject cells into a treatment target site.
  • FIG. 1 shows a state where the expansion means 14 is expanded.
  • the catheter 12 has a catheter shaft 16 constituting the main body of the catheter 12 and a plurality of hubs 28, 30, 32 connected to the proximal end portion of the catheter shaft 16.
  • the catheter shaft 16 is a flexible tubular member.
  • the size of the catheter shaft 16 is appropriately selected according to the living body in which the catheter shaft 16 is used and the size of the treatment target site. In particular, when the catheter shaft 16 is used for arthroscopic surgery at the knee joint, The diameter is preferably set to about 1 to 10 mm and the total length to about 20 to 300 cm.
  • the catheter shaft 16 includes an expansion lumen 20 communicating with the inside of the expansion means 14, a suction lumen 22 for aspirating residual liquid from the treatment target site, and cells (cells) in the treatment target site.
  • An infusion lumen 24 for supplying (suspension) is formed in parallel along the axis of the catheter 12. Even if the catheter shaft 16 having such a plurality of lumens has a configuration in which a plurality of lumens are formed on the catheter shaft 16 itself, a plurality of tubes having the expansion lumen 20, the suction lumen 22, and the injection lumen 24 are heated.
  • the structure may be integrated with a shrink tube or the like.
  • the expansion means 14 is connected to the distal end portion of the expansion lumen 20 so that the expansion lumen 20 communicates with the inside of the expansion means 14.
  • the expansion means 14 includes a pair of expansion bodies 26, and two expansion lumens 20 are provided corresponding to the expansion bodies 26.
  • the two expansion lumens 20 are connected to each other on the base end side to become one common lumen 20a, and an inflator for supplying expansion fluid to the expansion lumen 20 is provided at the base end portion of the common lumen 20a.
  • a hub 28 is provided which can be connected to a pressure application device (not shown).
  • an expansion fluid for example, gas, liquid, air, water, physiological saline, contrast agent, gel, etc.
  • an expansion fluid for example, gas, liquid, air, water, physiological saline, contrast agent, gel, etc.
  • the tip of the suction lumen 22 is opened as a suction port 23 for sucking the liquid (residual liquid) on the treatment target site.
  • a hub 30 to which suction means (not shown) can be connected is provided at the proximal end portion of the suction lumen 22.
  • a suction means for example, a mechanism including a vacuum pump and a collection container, or a syringe can be applied.
  • the tip of the injection lumen 24 is opened as a discharge port 25 for discharging cells.
  • a hub 32 that can be connected to an injection tool (for example, a syringe 33 filled with a cell suspension) for supplying (filling) the cell suspension to the injection lumen 24 is provided at the proximal end portion of the injection lumen 24. It has been.
  • FIG. 2 is a cross-sectional view taken along line II-II in FIG.
  • the distal end portion of the suction lumen 22 and the distal end portion of the injection lumen 24 are bent and directed downward at a substantially annular center position when the two expansion bodies 26 are expanded.
  • the suction port 23 is located below the discharge port 25. With this configuration, when the remaining liquid on the treatment target site is sucked, the tip of the suction lumen 22 can be preferentially infiltrated into the remaining liquid.
  • the height from the discharge port 25 to the suction port 23 is preferably about 0.5 to 19.5 mm.
  • the catheter shaft 16 is rotated by inserting a guide wire into the injection lumen 24 that runs parallel to the suction lumen 22 and rotating it. It is possible to adjust the direction of the suction port 23 of the suction lumen 22 by elastically deforming the distal end of the suction lumen 22. Moreover, you may comprise so that the direction of the front-end
  • the direction of the distal end portion of the suction lumen 22 is adjusted by inserting a guide wire into the suction lumen 22 and rotating the suction lumen 22. It is possible to retract the distal end portion from the treatment target site.
  • the suction port 23 of the suction lumen 22 is lower than the lower surface of the expansion means 14 in a state where the expansion means 14 is expanded, as shown in FIG. Good location.
  • the protruding length of the suction port 23 from the lower surface of the expansion means 14 is preferably about 1 to 20 mm.
  • the discharge port 25 of the injection lumen 24 be positioned above the lower surface of the expansion means 14 in a state where the expansion means 14 is expanded.
  • the catheter 12 has a structure having moderate flexibility and moderate rigidity so that the operator can place the distal end portion of the cell transplant device 10 at a treatment target site in the living body while grasping and operating the proximal end side. It is preferable that Therefore, the catheter 12 is formed of various materials such as polyamide, polyester, polyurethane, polyethylene, polypropylene, and polyvinyl chloride. In particular, polyamide and polyester are preferable from the viewpoints of heat processability and pressure resistance.
  • the expansion means 14 includes a pair of expansion bodies 26 (balloons) that expand in a curved shape.
  • Each expansion body 26 is configured to be foldable (shrinkable) and expanded by supplying and discharging the expansion fluid.
  • a base end portion of each expansion body 26 is joined to the catheter shaft 16 in a fluid-tight manner, and the inside of the expansion body 26 and the expansion lumen 20 communicate with each other.
  • the expansion body 26 and the catheter shaft 16 only need to be fixed in a liquid-tight manner, and are joined by, for example, adhesion or heat fusion.
  • the pair of expansion bodies 26 are arranged so as to form a substantially annular shape as a whole when expanded, and have a one-piece structure with a coupling film 36.
  • the “substantially annular” of the expansion body 26 includes not only a shape that makes a round without a break, but also a shape that is partially opened and opened but is annular as a whole.
  • the outer peripheral edge portion of the coupling film 36 is coupled to the curved inner peripheral portion of each expansion body 26.
  • the expansion body 26 has an arc shape (so-called banana shape) at the time of expansion and is configured to have a substantially annular shape as a whole. That is, the expansion body 26 is configured to be arranged on the same circle during expansion.
  • the size of the expansion body 26 is appropriately selected according to the living body in which the expansion body 26 is used and the size of the treatment target site. In particular, when the expansion body 26 is used for arthroscopic surgery at the knee joint, the expansion body 26 is expanded.
  • the body 26 preferably has an outer diameter of 1 to 20 mm, a length of 10 to 30 mm, and a diameter of a circumscribed circle when the two expansion bodies 26 are expanded to about 10 to 50 mm.
  • expansion body 26 is not limited to the shape shown in FIG. 1 and may be configured to have an elliptical shape as a whole during expansion.
  • Such an expansion body 26 is required to have appropriate flexibility so that expansion and contraction can be performed by supplying and discharging a fluid to the inside of the expansion body 26, and also ensures a space in the living body in which a treatment target site exists.
  • the material may be the same as the constituent material of the catheter exemplified above, or may be another material.
  • an opening 34 is provided through which an arthroscope or endoscope can be inserted.
  • the opening 34 is formed by a gap between the end portions on the distal end side of the two expansion bodies 26.
  • the interval (width) of the opening 34 when the expansion body 26 is expanded is set larger than the outer diameter of the arthroscope or endoscope assumed to be inserted, For example, about 1 to 20 mm is preferable.
  • connection film 36 is provided so as to connect the two expansion bodies 26 to the inner side (annular inner side) of the expansion means 14 that has a substantially annular shape during expansion.
  • connection film 36 is an opening provided in the expansion means 14.
  • a notch 37 that communicates with the portion 34 and extends in the axial direction of the catheter 12 is provided.
  • the cutout portion 37 extends to a position closer to the base end side (rear end side) than the suction port 23 and the discharge port 25 in a plan view, and the distal end portion of the catheter shaft 16 is directed downward through the opening 34. Can be seen.
  • the cell transplant device 10 can be in a state in which the expansion means 14 is folded so as to be coaxial with the catheter 12 by winding the expansion means 14 in a spiral shape as shown in FIG.
  • the incision range of the skin can be reduced when it is inserted into the living body (in the knee joint or the like) percutaneously.
  • the cell transplant device 10 can be inserted into the lumen of a cannula or dilator and inserted into a living body (such as in a knee joint).
  • the expansion body 26 constituting the expansion means 14 and the catheter shaft 16 constituting the catheter 12 can be manufactured by an existing method.
  • the expansion body 26 can be manufactured by integral molding such as inflation molding or a method of molding two or more resin films by heat or the like.
  • the catheter shaft 16 can be produced by extrusion molding or the like.
  • the expansion body 26 and the catheter shaft 16 manufactured in this way can be connected using heat fusion, an adhesive, or the like.
  • the cell transplant device 10 is basically configured as described above, and the operation and effect thereof will be described below.
  • a cultured cell transplantation to a knee joint cartilage injury site in an arthroscopic operation which is a typical application of the cell transplantation device 10, will be described as an example.
  • the method for using the cell transplant device 10 according to this example includes the following steps (1) to (14). 4 to 7, reference numeral 39 denotes a knee joint, reference numeral 40 denotes a femur, reference numeral 42 denotes cartilage on the inner condyle surface of the femur, and reference numeral 44 denotes a cartilage damage site generated in the cartilage 42.
  • the reference numeral 46 denotes a patella, and the reference numeral 48 denotes a cartilage inside the patella 46.
  • a liquid such as physiological saline is injected into the knee joint 39 to secure a working space, a treatment tool (dissection device) is inserted from the inside of the knee joint 39, and an arthroscope 52 is inserted from the outside of the knee joint 39. To do. Then, under arthroscopic viewing, the cartilage damaged portion 44 is dissected (shaved) and then thoroughly washed with physiological saline or the like. Thereafter, the liquid in the knee joint 39 (cleaning liquid or the like) is removed to some extent using a syringe and an injection needle.
  • the expansion means 14 After inserting the cell transplant device 10 into the knee joint 39, the expansion means 14 in a state of being folded just above the cartilage damage site 44 on the inner condyle surface of the femur is observed while checking with the arthroscope 52 A cell transplant device 10 is placed.
  • An indeflator (pressure applying device) filled with a contrast agent is connected to the hub 30 (see FIG. 1) provided at the rear end of the suction lumen 22 of the cell transplant device 10.
  • the expansion fluid filled in the indeflator is not limited to the contrast agent, and may be other fluids exemplified above.
  • the inflating body 26 is filled with the contrast medium by operating the indeflator while confirming with the arthroscope 52, and the expanding body 26 is expanded.
  • the contrast medium is used as the expansion fluid
  • the expansion state of the expansion body 26 can be confirmed by X-rays if necessary.
  • 5A is a plan view of the expansion means 14 of the cell transplantation device 10 expanded on the cartilage 42
  • FIG. 5B is a cross-sectional view taken along the line VB-VB in FIG. 5A. In this way, by expanding the expansion means 14, the tissue can be expanded by an amount corresponding to the thickness of the expansion means 14.
  • FIG. 7 is a schematic cross-sectional view showing an arrangement state of the cell transplant device 10 in the knee joint 39.
  • a syringe as a suction means (not shown) is connected to the hub provided at the rear end of the suction lumen 22 of the catheter 12.
  • a syringe 33 (see FIG. 1) filled with a liquid (cell suspension) in which cultured cells are suspended in advance is connected to a hub 32 provided at the rear end portion of the injection lumen 24 of the catheter 12.
  • (11) Operate the syringe 33 while confirming with the arthroscope 52, and inject a predetermined amount (for example, about 0.1 mL) of the cell suspension into the cartilage damage site 44 through the injection lumen 24.
  • a predetermined amount for example, about 0.1 mL
  • the direction of the distal end portion of the suction lumen 22 can be adjusted by independently rotating only the suction lumen 22, when the cell suspension is injected into the cartilage damage site 44, the suction lumen 22 By inserting and rotating the guide wire 22, the distal end portion of the suction lumen 22 may be retracted from the cartilage damage site 44 as indicated by a virtual line in FIG. 5B.
  • the cell suspension may be injected using another injection tool.
  • the cell suspension After injecting a predetermined amount of the cell suspension into the cartilage damage site 44, the cell suspension is allowed to stand as it is for a predetermined time (for example, about 10 minutes).
  • the contrast medium is removed from the expansion body 26 by operating the inflator, and the expansion means 14 is contracted.
  • the following first cell transplantation method can be carried out by using the cell transplantation device 10 according to the present invention. That is, the first cell transplantation method is: A catheter 12 having a plurality of lumens, and an expansion means 14 provided at the distal end of the catheter 12 and expandable by an expansion fluid supplied through an expansion lumen 20 formed in the catheter 12.
  • Preparing a cell transplant device 10 Inserting the expansion means 14 of the cell transplant device 10 into a living body; Expanding the expansion means 14 between living tissue and disposing the expansion means 14 on a treatment target site; and A step of aspirating residual liquid of a treatment target site through a suction lumen 22 formed in the catheter 12; And a step of injecting a cell suspension into a site to be treated through an injection lumen 24 formed in the catheter 12.
  • the cell space can be expanded between the tissues in the living body by the expansion means 14 in the cell transplantation operation under the arthroscope or the endoscope. It can be secured sufficiently and does not damage the tissue.
  • the cells since the liquid remaining in the treatment target site is sucked through the suction lumen 22 formed in the catheter 12, the cells are injected into the treatment target site through the injection lumen 24. And a cell can be transplanted to a treatment object site
  • the suction port 23 is located below the discharge port 25, the tip of the suction lumen 22 can be preferentially infiltrated into the remaining liquid when the remaining liquid in the cartilage defect site is sucked. . Further, since the suction port 23 is positioned below the lower surface of the expansion means 14 in a state in which the expansion means 14 is expanded, the residual liquid in the cartilage damage site 44 can be reliably suctioned. Furthermore, since the discharge port 25 is located above the lower surface of the expansion unit 14 in a state where the expansion unit 14 is expanded, the discharge port 25 is difficult to touch the injected cell suspension.
  • the expansion means 14 has a plurality of expansion bodies 26 that expand in an arc shape, and the plurality of expansion bodies 26 expand the tip portion of the suction lumen 22 and the tip portion of the injection lumen 24.
  • the suction port 23 and the discharge port 25 are positioned substantially at the center of the circle drawn by the plurality of expansion bodies 26 at the time of expansion. To do. Therefore, when a contrast medium is used as the expansion fluid, the positions of the suction port 23 and the discharge port 25 can be easily grasped, and the liquid suction and cell injection can be reliably performed at the treatment target site.
  • the expansion means 14 includes a plurality of expansion bodies 26 that expand in a curved shape, and a connecting film 36 that connects the plurality of expansion bodies 26, and the plurality of expansion bodies 26 are expanded. In some cases, they are arranged so as to form a substantially annular shape as a whole, and the connecting film 36 forms an integral structure. Therefore, when the expansion means 14 is expanded, the shape of the expansion means 14 is stabilized, and a plurality of expansions constituting the expansion means 14 are formed. A space for performing suction and injection can be suitably secured in the inner space surrounded by the body 26. Further, since the expansion body 26 has an arc shape, the tissue can be expanded in a balanced manner.
  • the expansion means 14 is provided with an opening 34 into which the imaging means can be inserted, a state in which an arthroscope or an endoscope is inserted into the opening 34 and the residual liquid in the cartilage damage site 44 is sucked, or cartilage damage The state of injecting cells into the region 44 can be observed. Therefore, the liquid can be sucked without leaving the remaining liquid, and the cells can be accurately injected into the cell damage site.
  • the expansion means 14 of the cell transplant device 10 is configured to be foldable so as to be coaxial with the catheter 12, the expansion means 14 is folded into the knee joint 39 percutaneously. When inserting, the incision range of the skin can be reduced.
  • the catheter shaft 16 is provided with two expansion lumens 20, but the expansion means 14 is substantially a single expansion body 26 (the internal space is substantially divided without being divided into a plurality of spaces). In this case, only one dilating lumen 20 may be provided.
  • the opening 34 for inserting the arthroscope or endoscope is provided at the distal end portion of the expansion means 14, but the location near the base end of the expansion means 14 or the expansion means 14. It may be provided at any location between the distal end portion and the proximal end portion. Since the side for inserting the cell transplant device 10 and the side for inserting the arthroscope or endoscope are not always opposite to each other, the side for inserting the cell transplant device 10, What is necessary is just to select the cell transplantation device 10 in which the opening part 34 was provided in the position suitable for it according to the positional relationship with the side which inserts an endoscope.
  • FIG. 8 is a partially omitted vertical cross-sectional view of a cell transplant device 10a according to a second embodiment of the present invention. Note that in the cell transplant device 10a according to the second embodiment, elements having the same or similar functions and effects as those of the cell transplant device 10 according to the first embodiment are denoted by the same reference numerals, and are described in detail. Is omitted.
  • This cell transplant device 10a differs in the configuration of the catheter 60 from the configuration of the cell transplant device 10 according to the first embodiment.
  • the suction lumen 22 and the injection lumen 24 are individually formed.
  • the catheter 60 of the cell transplant device 10a according to the second embodiment is a suction catheter.
  • a guide lumen 61 is formed through which 66 and the injection catheter 70 can be selectively inserted.
  • the guide lumen 61 opens as a proximal end opening 63 at the proximal end portion of the catheter 60, and opens as a distal end opening 62 at the distal end portion of the catheter 60.
  • the catheter 60 is bent at a substantially center position of a circle including the arc of the expansion body 26 when the expansion means 14 is expanded, and the distal end portion is directed downward.
  • a portion bent near the distal end of the catheter 60 is referred to as a “bent portion 60a”.
  • the tip opening 62 is located above the lower surface of the expansion means 14.
  • the catheter 60 is provided with an expansion lumen similar to the expansion lumen 20 (see FIG. 1) of the cell transplant device 10 according to the first embodiment.
  • the cell transplant device 10a is placed in the knee joint 39 (see FIGS. 5A to 7).
  • the aspiration catheter 66 is inserted into the guide lumen 61 of the catheter 60, and the distal end of the aspiration catheter 66 provided with the aspiration port 67 is inserted into the catheter 60. It protrudes from the tip opening 62. At this time, the suction catheter 66 is forcibly bent downward by the bent portion 60a of the catheter 60 and directed toward the treatment target site. At this time, while confirming with an arthroscope or an endoscope, the distal end portion of the suction catheter 66 is moved from the lower surface of the expansion means 14 so that the distal end portion of the suction catheter 66 is surely infiltrated into the remaining liquid at the treatment target site.
  • a syringe suction means (not shown) is connected to the hub 68 provided at the proximal end portion of the suction catheter 66, and the syringe is operated while confirming with an arthroscope to remove the liquid present in the cartilage damage site 44. Aspirate completely. When the remaining liquid is completely sucked, the suction catheter 66 is removed from the guide lumen 61 of the catheter 60.
  • an injection catheter 70 for injecting cells is inserted into the guide lumen 61 of the catheter 60, and the distal end of the injection catheter 70 provided with the discharge port 73 is inserted into the distal end opening 62 of the catheter 60. Or slightly flush with the tip opening 62. In this case, the tip of the infusion catheter 70 may be positioned above the lower surface of the expansion means 14.
  • the syringe 33 filled with the cell suspension is connected to the hub 74 provided at the proximal end portion of the infusion catheter 70.
  • the injection catheter 70 to which the syringe 33 is connected may be inserted into the catheter 60.
  • the syringe 33 is operated to inject a predetermined amount (for example, about 0.1 mL) of the cell suspension into the cartilage damage site.
  • a predetermined amount for example, about 0.1 mL
  • the distal end of the injection catheter 70 since the distal end of the injection catheter 70 is positioned above the lower surface of the expansion means 14, the distal end of the injection catheter 70 does not touch the cell suspension injected into the cartilage damage site 44.
  • the following second cell transplantation method can be implemented by using the cell transplantation device 10a according to the present embodiment. That is, the second cell transplantation method is: A catheter 60 having a plurality of lumens, and an expansion means 14 provided at the distal end of the catheter 60 and expandable by an expansion fluid supplied through the expansion lumen 20 formed in the catheter 60.
  • Preparing a cell transplant device 10a Inserting the expansion means 14 of the cell transplant device 10a into a living body; Expanding the space between the tissues in the living body by expanding the expansion means 14 and disposing the expansion means 14 on a treatment target site; Inserting a suction catheter 66 into a guide lumen 61 formed in the catheter 60; Sucking the remaining liquid on the treatment target site through the suction catheter 66 inserted into the guide lumen 61; Removing the suction catheter 66 from the guide lumen 61; Inserting an infusion catheter 70 into the guide lumen 61; And a step of injecting a cell suspension into the treatment target site via the injection catheter 70 inserted into the guide lumen 61.
  • the suction catheter 66 is inserted into the guide lumen 61 when the residual liquid on the treatment target site is sucked, and the cell suspension is placed on the treatment target site. Since the injection catheter 70 is inserted into the guide lumen 61 when injecting the turbid liquid, the positions of the suction catheter 66 and the distal end portions of the injection catheter 70 (position with respect to the treatment target site) can be easily adjusted. That is, when the residual liquid on the treatment target site is aspirated, the distal end portion of the suction catheter 66 is positioned below the lower surface of the expansion means 14, and the suction catheter 66 is further in accordance with the depth of the treatment site.
  • the tip position can be arbitrarily adjusted, the remaining liquid on the treatment target site can be reliably sucked. Further, when injecting the cell suspension into the treatment target site, the position of the distal end portion of the injection catheter 70 can be arbitrarily adjusted at a position above the lower surface of the expansion means 14, so that a suitable position is obtained. Cell suspension can be injected.
  • 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.
  • the cell transplantation device 10 or 10a is used for the arthroscopic cell transplantation operation at the knee joint, but the present invention is not limited to this. That is, the cell transplantation device 10 or 10a according to the present invention can be applied to any surgical method that involves discharging a liquid.
  • the device for cell transplantation according to the present invention can be used for endoscopic surgery such as intracerebral, intraperitoneal, carpal tunnel, shoulder joint, elbow joint, spine, and drainage of pleural effusion and ascites.

Abstract

This device (10) for cell transplantation is provided with a catheter (12) and an expanding means (14). An expansion lumen (20), a suction lumen (22), and an injection lumen (24) are formed in parallel in the catheter (12). The expanding means (14) is provided with two circular-arc-shaped expansion bodies (26) that can be expanded by an expansion fluid such as a contrast medium. In a cell-transplantation procedure, with the space between bodily tissues expanded by expansion of the two expansion bodies (26), any liquid (residual liquid) at the target site is suctioned out via the suction lumen (22) and a cell suspension is then injected to the target set via the injection lumen (24).

Description

細胞移植用デバイスCell transplant device
　本発明は、関節鏡又は内視鏡視下手術に用いられる細胞移植用デバイスであって、液体吸引及び細胞注入のためのルーメンと、関節鏡又は内視鏡の視野を確保するために組織間を拡張する拡張手段とを備えた細胞移植用デバイスに関する。 The present invention is a device for cell transplantation used for arthroscopic or endoscopic surgery, and includes a lumen for liquid aspiration and cell injection and a tissue between the tissues to secure a visual field of the arthroscope or endoscope. It is related with the device for cell transplantation provided with the expansion means which expands.
　軟骨損傷部位（軟骨欠損部）の再生治療方法の１つとして、培養した細胞や採取した骨髄液を濃縮し調整した骨髄由来細胞を関節鏡視下で移植する方法がある。例えば、文献「臨床整形外科」（関矢一郎、Ｖｏｌ．４５、Ｎｏ．９、医学書院、２０１０年９月２５日、ｐ．７９１－７９５）には以下のような具体例が示されている。患者から採取した滑膜細胞を２週間培養し、軟骨損傷部位を関節鏡視下で郭清（シェービング）した後、針とシリンジを用いて軟骨損傷部位に０．１ｍＬの細胞懸濁液を注入する。ここで注意すべき点として、細胞懸濁液を膝の軟骨損傷部位に移植する際、関節内液を十分に除去しなければ、細胞が分散してしまい軟骨損傷部位に選択的に留まらず軟骨再生効果が得られない懸念がある。 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.
　そこで、針とシリンジなどを用いて関節内の液体を可能な限り吸引し、除去する必要があるが、吸引により関節内の空間が縮小され、関節鏡や針などの作業空間が狭くなり処置が困難になり、関節鏡や針により軟骨損傷部位だけでなく健康な軟骨まで損傷してしまう危険性がある。従って、関節内の液体を吸引、除去した状態でも、関節鏡や針などの作業空間を十分に確保することでき、更に軟骨を損傷させず容易に細胞を移植できるようなデバイスが望まれている。 Therefore, it is necessary to aspirate and remove the liquid in the joint as much as possible using a needle and a syringe, etc., but the space in the joint is reduced by the suction, and the work space such as the arthroscope and the needle becomes narrow. There is a risk that the arthroscope and the needle may damage not only the cartilage damage site but also healthy cartilage. Therefore, there is a demand for a device that can sufficiently secure a working space such as an arthroscope and a needle even when the liquid in the joint is sucked and removed, and that can easily transplant cells without damaging cartilage. .
　この解決策として、米国特許第６１８７０２３号明細書には、くさび形状に拡張可能なブレーダーを有するリトラクターを用いて関節間を拡張する方法が開示されている。更に当該米国特許第６１８７０２３号明細書には、ドーナツ状のブレーダーの拡張により組織内に形成された空間に、リトラクターのルーメンを通じて内視鏡を挿入することも開示されている。すなわち、前記リトラクターを用いると、関節内の液体がない状態でも関節鏡や針などの作業空間を確保することが可能となる。しかし、前記リトラクターは、膝軟骨に適した形状とは言い難く、軟骨損傷部周辺の空間を確実に拡張できるとは限らない。更に、細胞移植する場合は別途関節内に挿入した移植用デバイス（針、カテーテル等）を操作する必要があり、これらのデバイスで軟骨を損傷してしまう危険性は残ったままである。 As a solution to this problem, US Pat. No. 6,187,023 discloses a method of expanding between joints using a retractor having a blader that can be expanded into a wedge shape. Further, the US Pat. No. 6,187,023 discloses that an endoscope is inserted through a lumen of a retractor into a space formed in a tissue by expansion of a donut-shaped braider. That is, when the retractor is used, a work space such as an arthroscope and a needle can be secured even when there is no liquid in the joint. However, it is difficult to say that the retractor has a shape suitable for knee cartilage, and the space around the cartilage damaged part cannot always be reliably expanded. Furthermore, when transplanting cells, it is necessary to operate transplantation devices (needles, catheters, etc.) inserted into joints separately, and the risk of damaging cartilage with these devices remains.
　本発明はこのような課題を考慮してなされたものであり、関節鏡又は内視鏡視下での細胞移植手術に際し、生体内の組織を傷付けず、確実且つ容易に処置対象部位に細胞を移植することができる細胞移植用デバイスを提供することを目的とする。 The present invention has been made in view of such problems, and in the case of cell transplantation surgery under arthroscopy or endoscopy, cells can be reliably and easily applied to a treatment target site without damaging tissue in the living body. It aims at providing the device for cell transplantation which can be transplanted.
　上記の目的を達成するため、本発明に係る細胞移植用デバイスは、カテーテルと、前記カテーテルの先端部に設けられ、前記カテーテルに形成された拡張用ルーメンを介して供給される拡張用流体によって拡張可能な拡張手段とを備え、前記カテーテルには、前記拡張用ルーメン以外に、少なくとも１つのルーメンが形成され、前記拡張手段を拡張させることにより生体内の組織間を拡張させた状態で、前記ルーメンを直接的に又は間接的に介して、処置対象部位上の液体を吸引し、前記処置対象部位に細胞を注入するように構成されていることを特徴とする。 To achieve the above object, a cell transplantation device according to the present invention is expanded by a catheter and an expansion fluid that is provided at the distal end portion of the catheter and supplied through an expansion lumen formed in the catheter. And at least one lumen is formed in the catheter in addition to the expansion lumen, and the lumen is expanded between the tissues in the living body by expanding the expansion means. It is characterized in that the liquid on the treatment target site is sucked directly or indirectly and the cells are injected into the treatment target site.
　上記のように構成された細胞移植用デバイスによれば、関節鏡又は内視鏡視下での細胞移植手術に際し、拡張手段により生体内の組織間を拡張させることができるので、作業空間を十分に確保することができ、組織を傷付けることがない。また、カテーテルに形成されたルーメンを介して、処置対象部位上の残存液を吸引し、処置対象部位に細胞を注入するように構成されているので、確実且つ容易に処置対象部位に細胞を移植することができる。 According to the device for cell transplantation configured as described above, it is possible to expand between the tissues in the living body by the expansion means when performing the cell transplantation operation under the arthroscope or the endoscope. Can be secured and will not hurt the tissue. In addition, since the remaining liquid on the treatment target site is sucked through the lumen formed in the catheter and the cells are injected into the treatment target site, the cells are reliably and easily transplanted to the treatment target site. can do.
　上記の細胞移植用デバイスにおいて、前記カテーテルは、前記処置対象部位上の液体を吸引するための吸引口を有する吸引ルーメンと、前記細胞を吐出させるための吐出口を有する注入ルーメンとを備えた構成でもよい。 In the above-described cell transplantation device, the catheter includes a suction lumen having a suction port for sucking a liquid on the treatment target site, and an injection lumen having a discharge port for discharging the cells. But you can.
　このように吸引ルーメンと注入ルーメンとが個別に形成された場合、吸引ルーメンと注入ルーメンに対応したデバイス（吸引手段、細胞懸濁液が充填されたシリンジ）をそれぞれ接続し、当該デバイスを操作することで、液体の吸引と細胞の注入を容易に実施することができる。 When the suction lumen and the injection lumen are individually formed in this way, devices corresponding to the suction lumen and the injection lumen (aspiration means, syringe filled with cell suspension) are connected and the devices are operated. As a result, liquid aspiration and cell injection can be easily performed.
　上記の細胞移植用デバイスにおいて、前記吸引口は、前記吐出口よりも下方に位置するとよい。 In the above-described cell transplantation device, the suction port may be positioned below the discharge port.
　このような構造によれば、処置対象部位上の残存液を吸引するときに、吸引口を優先的に残存液に浸入させることができる。 According to such a structure, when sucking the remaining liquid on the treatment target site, the suction port can be preferentially infiltrated into the remaining liquid.
　上記の細胞移植用デバイスにおいて、前記拡張手段が拡張した状態で、前記吸引口は、前記拡張手段の下面よりも下方に位置するとよい。 In the above-described cell transplantation device, the suction port may be positioned below the lower surface of the expansion means with the expansion means expanded.
　上記の構成によれば、処置対象部位上の残存液を確実に吸引することができる。 According to the above configuration, the residual liquid on the treatment target site can be reliably sucked.
　上記の細胞移植用デバイスにおいて、前記拡張手段が拡張した状態で、前記吐出口は、前記拡張手段の下面よりも上方に位置するとよい。 In the above-described cell transplantation device, the discharge port may be positioned above the lower surface of the expansion means with the expansion means expanded.
　上記の構成によれば、吐出口が、注入した細胞に触れにくい。 According to the above configuration, the discharge port is difficult to touch the injected cells.
　上記の細胞移植用デバイスにおいて、前記カテーテルには、前記処置対象部位上の液体を吸引するための吸引カテーテルと、前記処置対象部位に細胞を注入するための注入カテーテルとを選択的に挿入可能なガイドルーメンが形成されていてもよい。 In the above-described cell transplantation device, a suction catheter for aspirating the liquid on the treatment target site and an injection catheter for injecting cells into the treatment target site can be selectively inserted into the catheter. A guide lumen may be formed.
　上記の構成によれば、処置対象部位上の残存液を吸引する際における吸引カテーテルの先端部の高さと、処置対象部位に細胞を注入する際における注入カテーテルの先端部の高さを、それぞれに適した位置に簡単に調整することができる。 According to the above configuration, the height of the distal end portion of the suction catheter when sucking the remaining liquid on the treatment target site, and the height of the distal end portion of the injection catheter when injecting cells into the treatment target site, respectively. It can be easily adjusted to a suitable position.
　上記の細胞移植用デバイスにおいて、前記拡張手段は、円弧状に拡張する複数の拡張体を有し、当該複数の拡張体が拡張したときに全体として略円環状をなし、前記カテーテルの先端部は、前記拡張手段が拡張した際の略円環状の略中心位置で屈曲して下方に指向するとよい。 In the above-described cell transplantation device, the expansion means has a plurality of expansion bodies that expand in an arc shape, and when the plurality of expansion bodies expands, the expansion means has a generally annular shape as a whole, and the distal end portion of the catheter is It is preferable that the expansion means bends at a substantially center position of a substantially annular shape when expanded and is directed downward.
　上記の構成によれば、拡張時の複数の拡張体が描く円の略中心位置に吸引口と吐出口が位置するので、拡張用流体として造影剤を用いた場合に吸引口と吐出口の位置を把握しやすく、目的部位での液体の吸引と細胞の注入を確実に行うことができる。 According to the above configuration, since the suction port and the discharge port are positioned at substantially the center position of the circle drawn by the plurality of expansion bodies at the time of expansion, the position of the suction port and the discharge port when the contrast medium is used as the expansion fluid It is easy to grasp the above, and it is possible to reliably suck the liquid and inject cells at the target site.
　上記の細胞移植用デバイスにおいて、前記拡張手段は、湾曲状に拡張する複数の拡張体を有し、当該複数の拡張体が拡張したときに全体として略環状をなし、前記複数の拡張体は、連結膜により相互に連結され、拡張時に前記連結膜により一体構造をなすとよい。 In the above-described cell transplantation device, the expansion means has a plurality of expansion bodies that expand in a curved shape, and when the plurality of expansion bodies expands, the expansion means has a substantially annular shape as a whole. It is preferable that they are connected to each other by a connecting film and have an integral structure by the connecting film at the time of expansion.
　上記の構成によれば、拡張手段が拡張した際に、拡張手段の形状が安定し、拡張手段を構成する複数の拡張体で囲まれた内側の空間に、吸引及び注入を行う空間を好適に確保することができる。 According to the above configuration, when the expansion means is expanded, the shape of the expansion means is stabilized, and a space for suction and injection is suitably provided in the inner space surrounded by the plurality of expansion bodies constituting the expansion means. Can be secured.
　上記の細胞移植用デバイスにおいて、前記複数の拡張体は、拡張時にそれぞれ円弧状をなすとともに同一円上に配置される一対の拡張体であるとよい。 In the above-described cell transplantation device, the plurality of expansion bodies may be a pair of expansion bodies each having an arc shape and being arranged on the same circle during expansion.
　上記の構成によれば、生体内を効率的に拡張することができる。 According to the above configuration, the living body can be efficiently expanded.
　上記の細胞移植用デバイスにおいて、前記拡張手段には、撮像手段を挿入可能な開口部が設けられるとよい。 In the above-described cell transplantation device, the expansion means may be provided with an opening into which the imaging means can be inserted.
　上記の構成によれば、当該開口部に撮像手段（関節鏡、内視鏡等）を挿入し、処置対象部位上の残存液を吸引する様子や、処置対象部位への細胞移植の様子を観察することができる。 According to the above configuration, an imaging means (arthroscope, endoscope, etc.) is inserted into the opening, and the state of sucking the remaining liquid on the treatment target site and the state of cell transplantation to the treatment target site are observed. can do.
　上記の細胞移植用デバイスにおいて、前記拡張手段は、前記カテーテルと同軸状の形態となるように折り畳み可能に構成されるとよい。 In the above-described cell transplantation device, the expansion means may be configured to be foldable so as to be coaxial with the catheter.
　上記の構成によれば、拡張手段を折り畳むことにより、経皮的に生体内に挿入する場合に皮膚の切開範囲を小さくすることができる。 According to the above configuration, the incision range of the skin can be reduced when the expansion means is folded and inserted into the living body percutaneously.
　本発明の細胞移植用デバイスによれば、関節鏡又は内視鏡視下での細胞移植手術に際し、生体内の組織を傷付けず、確実且つ容易に処置対象部位に細胞を移植することができる。 According to the device for cell transplantation of the present invention, cells can be transplanted to a site to be treated surely and easily without damaging a tissue in a living body during a cell transplantation operation under an arthroscope or an endoscope.
本発明の第１実施形態に係る細胞移植用デバイスの一部省略平面図である。1 is a partially omitted plan view of a device for cell transplantation according to a first embodiment of the present invention. 図１に示した細胞移植用デバイスのＩＩ－ＩＩ線に沿った横断面図である。FIG. 2 is a transverse sectional view taken along the line II-II of the cell transplantation device shown in FIG. 第１実施形態に係る細胞移植用デバイスの拡張手段を折り畳んだ状態を示す側面図である。It is a side view which shows the state which expanded the expansion means of the device for cell transplantation concerning 1st Embodiment. 第１実施形態に係る細胞移植用デバイスの拡張手段を折り畳んで関節内に挿入した状態を示す側面図である。It is a side view which shows the state which folded the expansion means of the device for cell transplantation concerning 1st Embodiment, and was inserted in the joint. 図５Ａは、関節内で拡張手段を拡張させた第１実施形態に係る細胞移植用デバイスを示す平面図であり、図５Ｂは、図５ＡにおけるＶＢ－ＶＢ線に沿った横断面図である。FIG. 5A is a plan view showing the cell transplantation device according to the first embodiment in which the expansion means is expanded in the joint, and FIG. 5B is a cross-sectional view taken along the line VB-VB in FIG. 5A. 第１実施形態に係る細胞移植用デバイスの拡張手段に設けられた開口に関節鏡を挿入した状態を示す平面図である。It is a top view which shows the state which inserted the arthroscope in the opening provided in the expansion means of the device for cell transplantation concerning 1st Embodiment. 膝関節内に配置された第１実施形態に係る細胞移植用デバイスを示す断面図である。It is sectional drawing which shows the device for cell transplantation concerning 1st Embodiment arrange | positioned in a knee joint. 本発明の第２実施形態に係る細胞移植用デバイスの一部省略縦断面図であって、細胞移植用デバイスに吸引カテーテルを挿入した状態の図である。FIG. 5 is a partially omitted vertical cross-sectional view of a cell transplant device according to a second embodiment of the present invention, in a state where an aspiration catheter is inserted into the cell transplant device. 本発明の第２実施形態に係る細胞移植用デバイスの一部省略縦断面図であって、細胞移植用デバイスに注入カテーテルを挿入した状態の図である。FIG. 6 is a partially omitted vertical cross-sectional view of a cell transplant device according to a second embodiment of the present invention, in a state where an injection catheter is inserted into the cell transplant device.
　以下、本発明に係る細胞移植用デバイスについて好適な実施形態を挙げ、添付の図面を参照しながら説明する。なお、説明の都合上、個々の図面における構成要素同士寸法の比率、及び複数の図面における同一の構成要素同士の寸法の比率は適宜変更されており必ずしも現実の比率とは一致しないものとする。 Hereinafter, preferred embodiments of the device for cell transplantation 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 individual drawings and the ratio of dimensions between identical components in a plurality of drawings are appropriately changed and do not necessarily match the actual ratio.
［第１実施形態］
　図１は、本発明の第１実施形態に係る細胞移植用デバイス１０の一部省略平面図である。この細胞移植用デバイス１０は、カテーテル１２と、カテーテル１２の先端部に設けられた拡張手段１４とを備え、拡張手段１４により生体内の組織間を拡張し、処置対象部位に残存した液体を吸引するとともに、処置対象部位に細胞を注入するように構成されている。図１では、拡張手段１４が拡張した状態が示されている。 [First Embodiment]
FIG. 1 is a partially omitted plan view of a cell transplant device 10 according to a first embodiment of the present invention. This cell transplantation device 10 includes a catheter 12 and an expansion means 14 provided at the distal end of the catheter 12, and expands between tissues in the living body by the expansion means 14 and sucks the liquid remaining in the treatment target site. In addition, it is configured to inject cells into a treatment target site. FIG. 1 shows a state where the expansion means 14 is expanded.
　カテーテル１２は、カテーテル１２の本体を構成するカテーテルシャフト１６と、カテーテルシャフト１６の基端部に接続された複数のハブ２８、３０、３２とを有する。カテーテルシャフト１６は、可撓性有する管状部材である。カテーテルシャフト１６の寸法は、それが使用される生体内及び処置対象部位の大きさに応じて適宜選択されるが、特に、膝関節での関節鏡視下手術に使用される場合には、外径が１～１０ｍｍ程度、全長が２０～３００ｃｍ程度に設定されるのが好ましい。 The catheter 12 has a catheter shaft 16 constituting the main body of the catheter 12 and a plurality of hubs 28, 30, 32 connected to the proximal end portion of the catheter shaft 16. The catheter shaft 16 is a flexible tubular member. The size of the catheter shaft 16 is appropriately selected according to the living body in which the catheter shaft 16 is used and the size of the treatment target site. In particular, when the catheter shaft 16 is used for arthroscopic surgery at the knee joint, The diameter is preferably set to about 1 to 10 mm and the total length to about 20 to 300 cm.
　図１に示すように、カテーテルシャフト１６には、拡張手段１４の内部に連通する拡張用ルーメン２０と、処置対象部位の残存液を吸引するための吸引ルーメン２２と、処置対象部位に細胞（細胞懸濁液）を供給するための注入ルーメン２４とが、カテーテル１２の軸線に沿って並列に形成されている。このような複数のルーメンを有するカテーテルシャフト１６は、カテーテルシャフト１６自体に複数のルーメンが形成された構成であっても、拡張用ルーメン２０、吸引ルーメン２２及び注入ルーメン２４をもつ複数のチューブを熱収縮チューブ等で一体化した構成であってもよい。 As shown in FIG. 1, the catheter shaft 16 includes an expansion lumen 20 communicating with the inside of the expansion means 14, a suction lumen 22 for aspirating residual liquid from the treatment target site, and cells (cells) in the treatment target site. An infusion lumen 24 for supplying (suspension) is formed in parallel along the axis of the catheter 12. Even if the catheter shaft 16 having such a plurality of lumens has a configuration in which a plurality of lumens are formed on the catheter shaft 16 itself, a plurality of tubes having the expansion lumen 20, the suction lumen 22, and the injection lumen 24 are heated. The structure may be integrated with a shrink tube or the like.
　拡張用ルーメン２０の先端部には拡張手段１４が接続され、拡張用ルーメン２０と拡張手段１４の内部とが連通している。具体的には、後述するように拡張手段１４は一対の拡張体２６からなり、各拡張体２６に対応して２つの拡張用ルーメン２０が設けられている。２つの拡張用ルーメン２０は、基端側で互いに結合して１つの共通ルーメン２０ａとなり、当該共通ルーメン２０ａの基端部には、拡張用ルーメン２０に拡張用流体を供給するためのインデフレーター等の圧力印加装置（図示せず）に接続可能なハブ２８が設けられている。 The expansion means 14 is connected to the distal end portion of the expansion lumen 20 so that the expansion lumen 20 communicates with the inside of the expansion means 14. Specifically, as will be described later, the expansion means 14 includes a pair of expansion bodies 26, and two expansion lumens 20 are provided corresponding to the expansion bodies 26. The two expansion lumens 20 are connected to each other on the base end side to become one common lumen 20a, and an inflator for supplying expansion fluid to the expansion lumen 20 is provided at the base end portion of the common lumen 20a. A hub 28 is provided which can be connected to a pressure application device (not shown).
　ハブ２８に前記圧力印加装置を接続し、当該圧力印加装置を作動させることで、当該圧力印加装置から拡張用流体（例えば、気体、液体、空気、水、生理食塩水、造影剤、ゲル等）をハブ２８及び拡張用ルーメン２０を介して拡張体２６まで送液可能となっている。 By connecting the pressure application device to the hub 28 and operating the pressure application device, an expansion fluid (for example, gas, liquid, air, water, physiological saline, contrast agent, gel, etc.) is generated from the pressure application device. Can be fed to the expansion body 26 via the hub 28 and the expansion lumen 20.
　吸引ルーメン２２の先端は、処置対象部位上の液体（残存液）を吸引するための吸引口２３として開口している。吸引ルーメン２２の基端部には、吸引手段（図示せず）が接続可能なハブ３０が設けられている。吸引手段としては、例えば、真空ポンプと回収容器を備えた機構や、シリンジを適用することができる。 The tip of the suction lumen 22 is opened as a suction port 23 for sucking the liquid (residual liquid) on the treatment target site. A hub 30 to which suction means (not shown) can be connected is provided at the proximal end portion of the suction lumen 22. As a suction means, for example, a mechanism including a vacuum pump and a collection container, or a syringe can be applied.
　注入ルーメン２４の先端は、細胞を吐出するための吐出口２５として開口している。注入ルーメン２４の基端部には、注入ルーメン２４に細胞懸濁液を供給（充填）するための注入具（例えば、細胞懸濁液が充填されたシリンジ３３）に接続可能なハブ３２が設けられている。 The tip of the injection lumen 24 is opened as a discharge port 25 for discharging cells. A hub 32 that can be connected to an injection tool (for example, a syringe 33 filled with a cell suspension) for supplying (filling) the cell suspension to the injection lumen 24 is provided at the proximal end portion of the injection lumen 24. It has been.
　図２は、図１におけるＩＩ－ＩＩ線に沿った横断面図である。図１及び図２に示すように、吸引ルーメン２２の先端部と注入ルーメン２４の先端部は、２つの拡張体２６が拡張した際の略円環状の略中心位置で屈曲して下方に指向するとともに、吸引口２３は吐出口２５よりも下方に位置している。この構成により、処置対象部位上の残存液を吸引するときに、吸引ルーメン２２の先端を優先的に残存液に浸入させることができる。吐出口２５から吸引口２３までの高さは、０．５～１９．５ｍｍ程度であるのが好ましい。 FIG. 2 is a cross-sectional view taken along line II-II in FIG. As shown in FIGS. 1 and 2, the distal end portion of the suction lumen 22 and the distal end portion of the injection lumen 24 are bent and directed downward at a substantially annular center position when the two expansion bodies 26 are expanded. In addition, the suction port 23 is located below the discharge port 25. With this configuration, when the remaining liquid on the treatment target site is sucked, the tip of the suction lumen 22 can be preferentially infiltrated into the remaining liquid. The height from the discharge port 25 to the suction port 23 is preferably about 0.5 to 19.5 mm.
　また、処置対象部位上の残存液に吸引ルーメン２２の吸引口２３を確実に浸入させるために、吸引ルーメン２２に並走する注入ルーメン２４にガイドワイヤーを挿入して回転させることにより、カテーテルシャフト１６の先端部を弾性変形させ、吸引ルーメン２２の吸引口２３の方向を調整することが可能である。また、吸引ルーメン２２のみを独立して回転させることで吸引ルーメン２２の先端部の方向を調整できるように構成してもよい。このように構成した場合、処置対象部位に細胞懸濁液を注入する際に、吸引ルーメン２２にガイドワイヤーを挿入して回転させることにより吸引ルーメン２２の先端部の方向を調整し、吸引ルーメン２２の先端部を処置対象部位内から退避させることが可能である。 Further, in order to ensure that the suction port 23 of the suction lumen 22 enters the remaining liquid on the treatment target site, the catheter shaft 16 is rotated by inserting a guide wire into the injection lumen 24 that runs parallel to the suction lumen 22 and rotating it. It is possible to adjust the direction of the suction port 23 of the suction lumen 22 by elastically deforming the distal end of the suction lumen 22. Moreover, you may comprise so that the direction of the front-end | tip part of the suction lumen 22 can be adjusted by rotating only the suction lumen 22 independently. When configured in this way, when injecting a cell suspension into a treatment target site, the direction of the distal end portion of the suction lumen 22 is adjusted by inserting a guide wire into the suction lumen 22 and rotating the suction lumen 22. It is possible to retract the distal end portion from the treatment target site.
　処置対象部位上の残存液を確実に吸引し易くするために、図２に示すように、拡張手段１４が拡張した状態で、吸引ルーメン２２の吸引口２３は、拡張手段１４の下面よりも下方に位置するのがよい。拡張手段１４の下面からの吸引口２３の突出長さは、１～２０ｍｍ程度であるのがよい。また、拡張手段１４が拡張した状態で、注入ルーメン２４の吐出口２５は、拡張手段１４の下面よりも上方に位置するのがよい。この構成により、細胞懸濁液を処置対象部位に注入する際に、吐出口２５が、注入された細胞懸濁液に触れることを防止できる。 As shown in FIG. 2, the suction port 23 of the suction lumen 22 is lower than the lower surface of the expansion means 14 in a state where the expansion means 14 is expanded, as shown in FIG. Good location. The protruding length of the suction port 23 from the lower surface of the expansion means 14 is preferably about 1 to 20 mm. Further, it is preferable that the discharge port 25 of the injection lumen 24 be positioned above the lower surface of the expansion means 14 in a state where the expansion means 14 is expanded. With this configuration, when the cell suspension is injected into the treatment target site, the discharge port 25 can be prevented from touching the injected cell suspension.
　カテーテル１２は、操作者が基端側を把持及び操作しながら、生体内の処置対象部位に細胞移植用デバイス１０の先端部を配置できるように、適度な可撓性と適度な剛性を有する構造であることが好ましい。そこで、カテーテル１２は、ポリアミド、ポリエステル、ポリウレタン、ポリエチレン、ポリプロピレン、ポリ塩化ビニル等の各種材料で形成される。特に、熱加工性および耐圧性の観点から、ポリアミド、ポリエステルが好ましい。 The catheter 12 has a structure having moderate flexibility and moderate rigidity so that the operator can place the distal end portion of the cell transplant device 10 at a treatment target site in the living body while grasping and operating the proximal end side. It is preferable that Therefore, the catheter 12 is formed of various materials such as polyamide, polyester, polyurethane, polyethylene, polypropylene, and polyvinyl chloride. In particular, polyamide and polyester are preferable from the viewpoints of heat processability and pressure resistance.
　本実施形態において、拡張手段１４は、湾曲状に拡張する一対の拡張体２６（バルーン）により構成されている。各拡張体２６は、拡張用流体の給排により折り畳み（収縮）及び拡張が可能に構成されている。各拡張体２６の基端部は、カテーテルシャフト１６に液密に接合されており、拡張体２６の内部と拡張用ルーメン２０とが連通している。拡張体２６とカテーテルシャフト１６とは、液密に固着されればよく、例えば接着や熱融着によって接合される。 In the present embodiment, the expansion means 14 includes a pair of expansion bodies 26 (balloons) that expand in a curved shape. Each expansion body 26 is configured to be foldable (shrinkable) and expanded by supplying and discharging the expansion fluid. A base end portion of each expansion body 26 is joined to the catheter shaft 16 in a fluid-tight manner, and the inside of the expansion body 26 and the expansion lumen 20 communicate with each other. The expansion body 26 and the catheter shaft 16 only need to be fixed in a liquid-tight manner, and are joined by, for example, adhesion or heat fusion.
　一対の拡張体２６は、拡張時に全体として略環状をなすように配置され、連結膜３６により一体構造をなすようになっている。ここで、拡張体２６について「略環状」とは、切れ目無く一周する形状だけでなく、一部が分断して開口するが全体としては環状である形状も含まれる。連結膜３６の外周縁部は、各拡張体２６の湾曲形状の内周部に結合されている。 The pair of expansion bodies 26 are arranged so as to form a substantially annular shape as a whole when expanded, and have a one-piece structure with a coupling film 36. Here, the “substantially annular” of the expansion body 26 includes not only a shape that makes a round without a break, but also a shape that is partially opened and opened but is annular as a whole. The outer peripheral edge portion of the coupling film 36 is coupled to the curved inner peripheral portion of each expansion body 26.
　本実施形態では、拡張体２６は、拡張時において円弧状（いわゆるバナナ状）であり全体として略円環状をなすように構成されている。すなわち、拡張体２６は、拡張時において同一円上に配置されるように構成されている。拡張体２６の寸法は、それが使用される生体内及び処置対象部位の大きさに応じて適宜選択されるが、特に、膝関節での関節鏡視下手術に使用される場合には、拡張体２６は外径が１～２０ｍｍ、長さが１０～３０ｍｍ、２つの拡張体２６の拡張時における外接円の直径が１０～５０ｍｍ程度とするのが好ましい。 In the present embodiment, the expansion body 26 has an arc shape (so-called banana shape) at the time of expansion and is configured to have a substantially annular shape as a whole. That is, the expansion body 26 is configured to be arranged on the same circle during expansion. The size of the expansion body 26 is appropriately selected according to the living body in which the expansion body 26 is used and the size of the treatment target site. In particular, when the expansion body 26 is used for arthroscopic surgery at the knee joint, the expansion body 26 is expanded. The body 26 preferably has an outer diameter of 1 to 20 mm, a length of 10 to 30 mm, and a diameter of a circumscribed circle when the two expansion bodies 26 are expanded to about 10 to 50 mm.
　なお、拡張体２６は図１に示した形状に限らず、拡張時において全体として楕円状をなすように構成されてもよい。 It should be noted that the expansion body 26 is not limited to the shape shown in FIG. 1 and may be configured to have an elliptical shape as a whole during expansion.
　このような拡張体２６は、その内部への流体の供給及び排出により拡張及び収縮が可能であるように適度の柔軟性が必要とされるとともに、処置対象部位が存在する生体内の空間を確実に押し広げることができる程度の強度が必要であり、その材質は、例えば、上記にて例示したカテーテルの構成材料と同一でよく、或いは他の材質であってもよい。 Such an expansion body 26 is required to have appropriate flexibility so that expansion and contraction can be performed by supplying and discharging a fluid to the inside of the expansion body 26, and also ensures a space in the living body in which a treatment target site exists. For example, the material may be the same as the constituent material of the catheter exemplified above, or may be another material.
　処置対象部位上の残存液の吸引の様子や、処置対象部位への細胞移植の様子を観察することができるように、拡張手段１４の先端部（カテーテル１２が接続された側とは反対側の端部）には、関節鏡又は内視鏡を挿入することが可能な開口部３４が設けられている。具体的には、２つの拡張体２６の先端側の端部同士の間の隙間によって前記開口部３４が形成されている。関節鏡又は内視鏡を挿入する目的から、拡張体２６の拡張時における当該開口部３４の間隔（幅）は、挿入が想定される関節鏡又は内視鏡の外径よりも大きく設定され、例えば、１～２０ｍｍ程度が好ましい。 The distal end portion of the expansion means 14 (on the side opposite to the side to which the catheter 12 is connected) so that the state of suction of the residual liquid on the treatment target site and the state of cell transplantation to the treatment target site can be observed. At the end, an opening 34 is provided through which an arthroscope or endoscope can be inserted. Specifically, the opening 34 is formed by a gap between the end portions on the distal end side of the two expansion bodies 26. For the purpose of inserting the arthroscope or endoscope, the interval (width) of the opening 34 when the expansion body 26 is expanded is set larger than the outer diameter of the arthroscope or endoscope assumed to be inserted, For example, about 1 to 20 mm is preferable.
　２つの円弧状の拡張体２６は、拡張時において、同一円上に、カテーテル１２の軸線に対して左右対称に位置し、連結膜３６により連結した一体構造を形成する。連結膜３６は、拡張時において略環状をなす拡張手段１４の内側（環状の内側）に、２つの拡張体２６を連結するように設けられ、本実施形態では、拡張手段１４に設けられた開口部３４と連通し且つカテーテル１２の軸線方向に延在する切欠部３７が設けられている。切欠部３７は、平面視で、吸引口２３及び吐出口２５よりも基端側（後端側）の位置まで延在しており、開口部３４を通して、下方に指向したカテーテルシャフト１６の先端部が見えるようになっている。 The two arc-shaped expansion bodies 26 are positioned symmetrically with respect to the axis of the catheter 12 on the same circle at the time of expansion, and form an integral structure connected by the connection film 36. The connecting film 36 is provided so as to connect the two expansion bodies 26 to the inner side (annular inner side) of the expansion means 14 that has a substantially annular shape during expansion. In this embodiment, the connection film 36 is an opening provided in the expansion means 14. A notch 37 that communicates with the portion 34 and extends in the axial direction of the catheter 12 is provided. The cutout portion 37 extends to a position closer to the base end side (rear end side) than the suction port 23 and the discharge port 25 in a plan view, and the distal end portion of the catheter shaft 16 is directed downward through the opening 34. Can be seen.
　細胞移植用デバイス１０は、図３のように、拡張手段１４を螺旋状に巻くことにより、カテーテル１２と同軸状の形態となるように拡張手段１４を折り畳んだ状態にすることができる。拡張手段１４を折り畳むことにより、経皮的に生体内（膝関節内等）に挿入する場合に皮膚の切開範囲を小さくすることができる。また、細胞移植用デバイス１０をカヌラやダイレーターの内腔に挿入し生体内（膝関節内等）に挿入することもできる。 The cell transplant device 10 can be in a state in which the expansion means 14 is folded so as to be coaxial with the catheter 12 by winding the expansion means 14 in a spiral shape as shown in FIG. By folding the expansion means 14, the incision range of the skin can be reduced when it is inserted into the living body (in the knee joint or the like) percutaneously. Alternatively, the cell transplant device 10 can be inserted into the lumen of a cannula or dilator and inserted into a living body (such as in a knee joint).
　拡張手段１４を構成する拡張体２６及びカテーテル１２を構成するカテーテルシャフト１６は既存の方法で製造することができる。例えば、拡張体２６はインフレーション成形などの一体成形や、２枚以上の樹脂製フィルムを熱等で融着して成形する方法などで作製できる。また、カテーテルシャフト１６は押出成形などにより作製できる。このように作製された拡張体２６とカテーテルシャフト１６は、熱融着や接着剤などを用いて接続することができる。 The expansion body 26 constituting the expansion means 14 and the catheter shaft 16 constituting the catheter 12 can be manufactured by an existing method. For example, the expansion body 26 can be manufactured by integral molding such as inflation molding or a method of molding two or more resin films by heat or the like. The catheter shaft 16 can be produced by extrusion molding or the like. The expansion body 26 and the catheter shaft 16 manufactured in this way can be connected using heat fusion, an adhesive, or the like.
　本実施形態に係る細胞移植用デバイス１０は、基本的には以上のように構成されるものであり、以下、その作用及び効果について説明する。以下では、細胞移植用デバイス１０の代表的な用途である関節鏡視下手術での膝関節軟骨損傷部への培養細胞移植を例に挙げて説明する。本例による細胞移植用デバイス１０の使用方法は、以下の工程（１）～（１４）からなる。なお、図４～図７において、符号３９は膝関節であり、符号４０は大腿骨であり、符号４２は大腿骨内側顆表面の軟骨であり、符号４４は軟骨４２に発生した軟骨損傷部位であり、符号４６は膝蓋骨であり、符号４８は膝蓋骨４６の内側の軟骨である。 The cell transplant device 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 injury site in an arthroscopic operation, which is a typical application of the cell transplantation device 10, will be described as an example. The method for using the cell transplant device 10 according to this example includes the following steps (1) to (14). 4 to 7, reference numeral 39 denotes a knee joint, reference numeral 40 denotes a femur, reference numeral 42 denotes cartilage on the inner condyle surface of the femur, and reference numeral 44 denotes a cartilage damage site generated in the cartilage 42. The reference numeral 46 denotes a patella, and the reference numeral 48 denotes a cartilage inside the patella 46.
　（１）　軟骨損傷部位４４がある大腿骨内側顆が上向きとなるように膝を屈曲した状態で固定し（図７参照）、膝関節３９の内側と外側の２箇所の皮膚を１０ｍｍ程切開する。 (1) Fix with the knee flexed so that the femoral medial condyle with the cartilage damage site 44 is facing upward (see FIG. 7), and cut about 10 mm in the skin on the inside and outside of the knee joint 39 .
　（２）　膝関節３９内に生理食塩水等の液体を注入して作業空間を確保し、膝関節３９の内側から処置具（郭清器）を挿入し、膝関節３９の外側から関節鏡５２を挿入する。そして、関節鏡視下で、軟骨損傷部位４４を郭清（シェービング）した後、生理食塩水等で十分に洗浄する。その後、膝関節３９内の液体（洗浄液等）をシリンジと注射針を用いてある程度除去する。 (2) A liquid such as physiological saline is injected into the knee joint 39 to secure a working space, a treatment tool (dissection device) is inserted from the inside of the knee joint 39, and an arthroscope 52 is inserted from the outside of the knee joint 39. To do. Then, under arthroscopic viewing, the cartilage damaged portion 44 is dissected (shaved) and then thoroughly washed with physiological saline or the like. Thereafter, the liquid in the knee joint 39 (cleaning liquid or the like) is removed to some extent using a syringe and an injection needle.
　（３）　処置具を抜去し、抜去した内側の切開傷から、シース５０等を介して、拡張手段１４を折り畳んだ状態の細胞移植用デバイス１０を挿入する（図４参照）。このように拡張手段１４を折り畳んだ状態で細胞移植用デバイス１０を挿入することができるため、皮膚の切開範囲を小さくすることができる。 (3) The treatment tool is removed, and the cell transplantation device 10 in which the expansion means 14 is folded is inserted through the sheath 50 and the like from the removed inner incision wound (see FIG. 4). Since the cell transplant device 10 can be inserted with the expansion means 14 folded as described above, the incision range of the skin can be reduced.
　（４）　細胞移植用デバイス１０を膝関節３９内に挿入したら、関節鏡５２で確認しながら、大腿骨内側顆表面の軟骨損傷部位４４の真上に折り畳んだ状態の拡張手段１４が来るように細胞移植用デバイス１０を配置する。 (4) After inserting the cell transplant device 10 into the knee joint 39, the expansion means 14 in a state of being folded just above the cartilage damage site 44 on the inner condyle surface of the femur is observed while checking with the arthroscope 52 A cell transplant device 10 is placed.
　（５）　細胞移植用デバイス１０の吸引ルーメン２２の後端部に設けられたハブ３０（図１参照）に、造影剤が充填されたインデフレーター（圧力印加装置）を接続する。なお、インデフレーターに充填される拡張用流体は、造影剤に限らず、上記に例示した他の流体であってもよい。 (5) An indeflator (pressure applying device) filled with a contrast agent is connected to the hub 30 (see FIG. 1) provided at the rear end of the suction lumen 22 of the cell transplant device 10. The expansion fluid filled in the indeflator is not limited to the contrast agent, and may be other fluids exemplified above.
　（６）　関節鏡５２で確認しながらインデフレーターを操作して造影剤を拡張体２６に充填し、拡張体２６を拡張させる。本例では、拡張用流体として造影剤を用いているので、必要があれば、Ｘ線によっても拡張体２６の拡張状態を確認することができる。図５Ａは、軟骨４２上で拡張した状態の細胞移植用デバイス１０の拡張手段１４の平面図であり、図５Ｂは、図５ＡにおけるＶＢ－ＶＢ線に沿った断面図である。このように、拡張手段１４を拡張させることにより、拡張手段１４の厚さに相当する分だけ、組織間を拡張させることができる。 (6) The inflating body 26 is filled with the contrast medium by operating the indeflator while confirming with the arthroscope 52, and the expanding body 26 is expanded. In this example, since the contrast medium is used as the expansion fluid, the expansion state of the expansion body 26 can be confirmed by X-rays if necessary. 5A is a plan view of the expansion means 14 of the cell transplantation device 10 expanded on the cartilage 42, and FIG. 5B is a cross-sectional view taken along the line VB-VB in FIG. 5A. In this way, by expanding the expansion means 14, the tissue can be expanded by an amount corresponding to the thickness of the expansion means 14.
　（７）　拡張体２６を拡張させた状態で、関節鏡５２を拡張手段１４の開口部３４から拡張手段１４内に挿入し、カテーテル１２の先端部（吸引ルーメン２２の先端部）が軟骨損傷部位４４内に進入していることを確認する（図６参照）。なお、図７は、細胞移植用デバイス１０の膝関節３９内での配置状態を示す概略断面図である。 (7) With the expansion body 26 expanded, the arthroscope 52 is inserted into the expansion means 14 from the opening 34 of the expansion means 14, and the distal end portion of the catheter 12 (the distal end portion of the suction lumen 22) is the cartilage damage site. It is confirmed that the vehicle has entered 44 (see FIG. 6). FIG. 7 is a schematic cross-sectional view showing an arrangement state of the cell transplant device 10 in the knee joint 39.
　（８）　カテーテル１２の吸引ルーメン２２の後端部に設けられたハブに、図示しない吸引手段としてのシリンジを接続する。 (8) A syringe as a suction means (not shown) is connected to the hub provided at the rear end of the suction lumen 22 of the catheter 12.
　（９）　関節鏡５２で確認しながら前記シリンジを操作し、吸引ルーメン２２を介して、軟骨損傷部位４４に残存する液体を完全に吸引する。なお、前記シリンジの代わりに他の吸引手段を用いて軟骨損傷部位４４の残存液を吸引してもよい。 (9) The syringe is operated while confirming with the arthroscope 52, and the liquid remaining in the cartilage damage site 44 is completely sucked through the suction lumen 22. In addition, you may suck | suck the residual liquid of the cartilage damage site | part 44 using another suction means instead of the said syringe.
　（１０）　カテーテル１２の注入ルーメン２４の後端部に設けられたハブ３２に、あらかじめ培養細胞を懸濁した液（細胞懸濁液）が充填されたシリンジ３３（図１参照）を接続する。 (10) A syringe 33 (see FIG. 1) filled with a liquid (cell suspension) in which cultured cells are suspended in advance is connected to a hub 32 provided at the rear end portion of the injection lumen 24 of the catheter 12.
　（１１）　関節鏡５２で確認しながらシリンジ３３を操作し、注入ルーメン２４を介して、軟骨損傷部位４４内に細胞懸濁液を所定量（例えば、０．１ｍＬ程度）注入する。吸引ルーメン２２のみを独立して回転させることで吸引ルーメン２２の先端部の方向を調整できるように構成されている場合には、軟骨損傷部位４４に細胞懸濁液を注入する際に、吸引ルーメン２２にガイドワイヤーを挿入して回転させることにより、図５Ｂにおいて仮想線で示すように、吸引ルーメン２２の先端部を軟骨損傷部位４４内から退避させてもよい。なお、前記シリンジの代わりに、他の注入具を用いて細胞懸濁液を注入してもよい。 (11) Operate the syringe 33 while confirming with the arthroscope 52, and inject a predetermined amount (for example, about 0.1 mL) of the cell suspension into the cartilage damage site 44 through the injection lumen 24. In the case where the direction of the distal end portion of the suction lumen 22 can be adjusted by independently rotating only the suction lumen 22, when the cell suspension is injected into the cartilage damage site 44, the suction lumen 22 By inserting and rotating the guide wire 22, the distal end portion of the suction lumen 22 may be retracted from the cartilage damage site 44 as indicated by a virtual line in FIG. 5B. Instead of the syringe, the cell suspension may be injected using another injection tool.
　（１２）　細胞懸濁液を軟骨損傷部位４４に所定量だけ注入した後、そのまま所定時間（例えば、１０分間程度）静置する。 (12) After injecting a predetermined amount of the cell suspension into the cartilage damage site 44, the cell suspension is allowed to stand as it is for a predetermined time (for example, about 10 minutes).
　（１３）　インデフレーターを操作して造影剤を拡張体２６から抜去し、拡張手段１４を収縮させる。 (13) The contrast medium is removed from the expansion body 26 by operating the inflator, and the expansion means 14 is contracted.
　（１４）　膝関節３９内から細胞移植用デバイス１０と関節鏡５２を抜去する。 (14) The cell transplant device 10 and the arthroscope 52 are removed from the knee joint 39.
　以上の説明から了解されるように、本発明に係る細胞移植用デバイス１０を用いれば、次のような第１の細胞移植方法を実施することができる。すなわち、当該第１の細胞移植方法は、
　複数のルーメンを有するカテーテル１２と、前記カテーテル１２の先端部に設けられ、前記カテーテル１２に形成された拡張用ルーメン２０を介して供給される拡張用流体によって拡張可能な拡張手段１４とを備えた細胞移植用デバイス１０を用意する工程と、
　前記細胞移植用デバイス１０の前記拡張手段１４を生体内に挿入する工程と、
　前記拡張手段１４を拡張させることにより生体の組織間を拡張させるとともに拡張手段１４を処置対象部位上に配置する工程と、
　前記カテーテル１２に形成された吸引ルーメン２２を介して処置対象部位の残存液を吸引する工程と、
　前記カテーテル１２に形成された注入ルーメン２４を介して処置対象部位に細胞懸濁液を注入する工程とを含むことを特徴とする。 As will be understood from the above description, the following first cell transplantation method can be carried out by using the cell transplantation device 10 according to the present invention. That is, the first cell transplantation method is:
A catheter 12 having a plurality of lumens, and an expansion means 14 provided at the distal end of the catheter 12 and expandable by an expansion fluid supplied through an expansion lumen 20 formed in the catheter 12. Preparing a cell transplant device 10;
Inserting the expansion means 14 of the cell transplant device 10 into a living body;
Expanding the expansion means 14 between living tissue and disposing the expansion means 14 on a treatment target site; and
A step of aspirating residual liquid of a treatment target site through a suction lumen 22 formed in the catheter 12;
And a step of injecting a cell suspension into a site to be treated through an injection lumen 24 formed in the catheter 12.
　以上説明したように、細胞移植用デバイス１０によれば、関節鏡又は内視鏡視下での細胞移植手術に際し、拡張手段１４により生体内の組織間を拡張させることができるので、作業空間を十分に確保することができ、組織を傷付けることがない。また、カテーテル１２に形成された吸引ルーメン２２を介して、処置対象部位の残存液を吸引した後、注入ルーメン２４を介して、処置対象部位に細胞を注入するように構成されているので、確実且つ容易に処置対象部位に細胞を移植することができる。 As described above, according to the cell transplantation device 10, the cell space can be expanded between the tissues in the living body by the expansion means 14 in the cell transplantation operation under the arthroscope or the endoscope. It can be secured sufficiently and does not damage the tissue. In addition, since the liquid remaining in the treatment target site is sucked through the suction lumen 22 formed in the catheter 12, the cells are injected into the treatment target site through the injection lumen 24. And a cell can be transplanted to a treatment object site | part easily.
　本実施形態の場合、吸引口２３が吐出口２５よりも下方に位置するので、軟骨欠損部位の残存液を吸引するときに、吸引ルーメン２２の先端を優先的に残存液に浸入させることができる。また、拡張手段１４が拡張した状態で、吸引口２３は拡張手段１４の下面よりも下方に位置するので、軟骨損傷部位４４の残存液を確実に吸引することができる。更に、拡張手段１４が拡張した状態で、吐出口２５は拡張手段１４の下面よりも上方に位置するので、吐出口２５が、注入した細胞懸濁液に触れにくい。 In the case of the present embodiment, since the suction port 23 is located below the discharge port 25, the tip of the suction lumen 22 can be preferentially infiltrated into the remaining liquid when the remaining liquid in the cartilage defect site is sucked. . Further, since the suction port 23 is positioned below the lower surface of the expansion means 14 in a state in which the expansion means 14 is expanded, the residual liquid in the cartilage damage site 44 can be reliably suctioned. Furthermore, since the discharge port 25 is located above the lower surface of the expansion unit 14 in a state where the expansion unit 14 is expanded, the discharge port 25 is difficult to touch the injected cell suspension.
　また、本実施形態の場合、拡張手段１４は、円弧状に拡張する複数の拡張体２６を有し、吸引ルーメン２２の先端部と注入ルーメン２４の先端部は、複数の拡張体２６が拡張した際の略円環状の略中心位置で屈曲して下方に指向する（図２参照）ことから、拡張時の複数の拡張体２６が描く円の略中心位置に吸引口２３と吐出口２５が位置する。このため、拡張用流体として造影剤を用いた場合に吸引口２３と吐出口２５の位置を把握しやすく、処置対象部位での液体の吸引と細胞の注入を確実に行うことができる。 In the case of this embodiment, the expansion means 14 has a plurality of expansion bodies 26 that expand in an arc shape, and the plurality of expansion bodies 26 expand the tip portion of the suction lumen 22 and the tip portion of the injection lumen 24. In this case, the suction port 23 and the discharge port 25 are positioned substantially at the center of the circle drawn by the plurality of expansion bodies 26 at the time of expansion. To do. Therefore, when a contrast medium is used as the expansion fluid, the positions of the suction port 23 and the discharge port 25 can be easily grasped, and the liquid suction and cell injection can be reliably performed at the treatment target site.
　更に、本実施形態の場合、拡張手段１４は、湾曲状に拡張する複数の拡張体２６と、前記複数の拡張体２６を連結する連結膜３６とを備え、前記複数の拡張体２６は、拡張時に全体として略環状をなすように配置され、前記連結膜３６により一体構造をなすので、拡張手段１４が拡張した際に、拡張手段１４の形状が安定し、拡張手段１４を構成する複数の拡張体２６で囲まれた内側の空間に、吸引及び注入を行う空間を好適に確保することができる。また、拡張体２６が円弧状であることで、組織間をバランスよく拡張することができる。 Further, in the case of the present embodiment, the expansion means 14 includes a plurality of expansion bodies 26 that expand in a curved shape, and a connecting film 36 that connects the plurality of expansion bodies 26, and the plurality of expansion bodies 26 are expanded. In some cases, they are arranged so as to form a substantially annular shape as a whole, and the connecting film 36 forms an integral structure. Therefore, when the expansion means 14 is expanded, the shape of the expansion means 14 is stabilized, and a plurality of expansions constituting the expansion means 14 are formed. A space for performing suction and injection can be suitably secured in the inner space surrounded by the body 26. Further, since the expansion body 26 has an arc shape, the tissue can be expanded in a balanced manner.
　拡張手段１４には、撮像手段を挿入可能な開口部３４が設けられるので、当該開口部３４に関節鏡又は内視鏡を挿入し、軟骨損傷部位４４の残存液を吸引する様子や、軟骨損傷部位４４へ細胞を注入する様子を観察することができる。よって、残存液を残さずに吸引することができるとともに、細胞を細胞損傷部位へと正確に注入することができる。 Since the expansion means 14 is provided with an opening 34 into which the imaging means can be inserted, a state in which an arthroscope or an endoscope is inserted into the opening 34 and the residual liquid in the cartilage damage site 44 is sucked, or cartilage damage The state of injecting cells into the region 44 can be observed. Therefore, the liquid can be sucked without leaving the remaining liquid, and the cells can be accurately injected into the cell damage site.
　本実施形態に係る細胞移植用デバイス１０の拡張手段１４は、カテーテル１２と同軸となるように折り畳み可能に構成されているので、拡張手段１４を折り畳むことにより、経皮的に膝関節３９内に挿入する場合に皮膚の切開範囲を小さくすることができる。 Since the expansion means 14 of the cell transplant device 10 according to the present embodiment is configured to be foldable so as to be coaxial with the catheter 12, the expansion means 14 is folded into the knee joint 39 percutaneously. When inserting, the incision range of the skin can be reduced.
　なお、上述した本実施形態では、カテーテルシャフト１６には２つの拡張用ルーメン２０が設けられているが、拡張手段１４が単一の拡張体２６（内部空間が複数に分割されることなく実質的に単一であるバルーン）により構成される場合には、拡張用ルーメン２０は１つだけ設けられてもよい。 In the present embodiment described above, the catheter shaft 16 is provided with two expansion lumens 20, but the expansion means 14 is substantially a single expansion body 26 (the internal space is substantially divided without being divided into a plurality of spaces). In this case, only one dilating lumen 20 may be provided.
　上述した本実施形態では、関節鏡又は内視鏡を挿入するための開口部３４は、拡張手段１４の先端部に設けられているが、拡張手段１４の基端寄りの箇所、又は拡張手段１４の先端部と基端部との間のいずれかの箇所に設けられてもよい。細胞移植用デバイス１０を挿入する側と、関節鏡又は内視鏡を挿入する側とは、常に互いに反対側であるとは限らないため、細胞移植用デバイス１０を挿入する側と、関節鏡又は内視鏡を挿入する側との位置関係に応じて、それに適した位置に開口部３４が設けられた細胞移植用デバイス１０を選択すればよい。 In the present embodiment described above, the opening 34 for inserting the arthroscope or endoscope is provided at the distal end portion of the expansion means 14, but the location near the base end of the expansion means 14 or the expansion means 14. It may be provided at any location between the distal end portion and the proximal end portion. Since the side for inserting the cell transplant device 10 and the side for inserting the arthroscope or endoscope are not always opposite to each other, the side for inserting the cell transplant device 10, What is necessary is just to select the cell transplantation device 10 in which the opening part 34 was provided in the position suitable for it according to the positional relationship with the side which inserts an endoscope.
［第２実施形態］
　図８は、本発明の第２実施形態に係る細胞移植用デバイス１０ａの一部省略縦断面図である。なお、第２実施形態に係る細胞移植用デバイス１０ａにおいて、第１実施形態に係る細胞移植用デバイス１０と同一又は同様な機能及び効果を奏する要素には同一の参照符号を付し、詳細な説明を省略する。 [Second Embodiment]
FIG. 8 is a partially omitted vertical cross-sectional view of a cell transplant device 10a according to a second embodiment of the present invention. Note that in the cell transplant device 10a according to the second embodiment, elements having the same or similar functions and effects as those of the cell transplant device 10 according to the first embodiment are denoted by the same reference numerals, and are described in detail. Is omitted.
　この細胞移植用デバイス１０ａは、カテーテル６０の構成において、第１実施形態に係る細胞移植用デバイス１０の構成と異なる。第１実施形態に係る細胞移植用デバイス１０のカテーテル１２では、吸引ルーメン２２と注入ルーメン２４が個別に形成されているが、第２実施形態に係る細胞移植用デバイス１０ａのカテーテル６０は、吸引カテーテル６６と注入カテーテル７０を選択的に挿入可能なガイドルーメン６１が形成されている。ガイドルーメン６１は、カテーテル６０の基端部にて基端開口６３として開口し、カテーテル６０の先端部にて先端開口６２として開口している。また、カテーテル６０は、拡張手段１４が拡張した際の、拡張体２６の円弧を含む円の略中心位置で屈曲して先端部が下方に指向している。以下、カテーテル６０の先端近傍で屈曲した部分を「屈曲部６０ａ」という。先端開口６２は、拡張手段１４の下面よりも上方に位置する。 This cell transplant device 10a differs in the configuration of the catheter 60 from the configuration of the cell transplant device 10 according to the first embodiment. In the catheter 12 of the cell transplant device 10 according to the first embodiment, the suction lumen 22 and the injection lumen 24 are individually formed. However, the catheter 60 of the cell transplant device 10a according to the second embodiment is a suction catheter. A guide lumen 61 is formed through which 66 and the injection catheter 70 can be selectively inserted. The guide lumen 61 opens as a proximal end opening 63 at the proximal end portion of the catheter 60, and opens as a distal end opening 62 at the distal end portion of the catheter 60. Further, the catheter 60 is bent at a substantially center position of a circle including the arc of the expansion body 26 when the expansion means 14 is expanded, and the distal end portion is directed downward. Hereinafter, a portion bent near the distal end of the catheter 60 is referred to as a “bent portion 60a”. The tip opening 62 is located above the lower surface of the expansion means 14.
　なお、図８には図示していないが、カテーテル６０には、第１実施形態に係る細胞移植用デバイス１０の拡張用ルーメン２０（図１参照）と同様の拡張用ルーメンが設けられている。 Although not shown in FIG. 8, the catheter 60 is provided with an expansion lumen similar to the expansion lumen 20 (see FIG. 1) of the cell transplant device 10 according to the first embodiment.
　次に、上記のように構成された細胞移植用デバイス１０ａの使用方法について、細胞移植用デバイス１０と異なる部分を主として説明する。 Next, with respect to the method of using the cell transplant device 10a configured as described above, the differences from the cell transplant device 10 will be mainly described.
　細胞移植用デバイス１０の上記（１）～（７）の工程と同様に、細胞移植用デバイス１０ａを膝関節３９内に配置する（図５Ａ～図７参照）。 In the same manner as the above steps (1) to (7) of the cell transplant device 10, the cell transplant device 10a is placed in the knee joint 39 (see FIGS. 5A to 7).
　軟骨損傷部位４４の残存液を吸引するには、図８に示すように、吸引カテーテル６６をカテーテル６０のガイドルーメン６１に挿入し、吸引口６７が設けられた吸引カテーテル６６の先端を、カテーテル６０の先端開口６２から突出させる。このとき、吸引カテーテル６６は、カテーテル６０の屈曲部６０ａによって強制的に下方に曲げられ、処置対象部位側を指向する。またこのとき、関節鏡又は内視鏡で確認しながら、吸引カテーテル６６の先端部を処置対象部位の残存液に確実に浸入させるように、吸引カテーテル６６の先端部を、拡張手段１４の下面よりも下方に位置させる。次に、吸引カテーテル６６の基端部に設けられたハブ６８に図示しないシリンジ（吸引手段）を接続し、関節鏡で確認しながら前記シリンジを操作して軟骨損傷部位４４内に存在する液体を完全に吸引する。残存液を完全に吸引したら、カテーテル６０のガイドルーメン６１から吸引カテーテル６６を抜去する。 In order to aspirate the remaining liquid in the cartilage damaged region 44, as shown in FIG. 8, the aspiration catheter 66 is inserted into the guide lumen 61 of the catheter 60, and the distal end of the aspiration catheter 66 provided with the aspiration port 67 is inserted into the catheter 60. It protrudes from the tip opening 62. At this time, the suction catheter 66 is forcibly bent downward by the bent portion 60a of the catheter 60 and directed toward the treatment target site. At this time, while confirming with an arthroscope or an endoscope, the distal end portion of the suction catheter 66 is moved from the lower surface of the expansion means 14 so that the distal end portion of the suction catheter 66 is surely infiltrated into the remaining liquid at the treatment target site. Is also positioned below. Next, a syringe (suction means) (not shown) is connected to the hub 68 provided at the proximal end portion of the suction catheter 66, and the syringe is operated while confirming with an arthroscope to remove the liquid present in the cartilage damage site 44. Aspirate completely. When the remaining liquid is completely sucked, the suction catheter 66 is removed from the guide lumen 61 of the catheter 60.
　次に、図９に示すように、細胞を注入するための注入カテーテル７０をカテーテル６０のガイドルーメン６１に挿入し、吐出口７３が設けられた注入カテーテル７０の先端を、カテーテル６０の先端開口６２から僅かに突出させるか、先端開口６２と略面一とする。この場合、注入カテーテル７０の先端は、拡張手段１４の下面よりも上方に位置させるのがよい。次に、注入カテーテル７０の基端部に設けられたハブ７４に、細胞懸濁液が充填されたシリンジ３３を接続する。なお、注入カテーテル７０のハブ７４に細胞懸濁液が充填されたシリンジ３３を接続した後に、当該シリンジ３３が接続された注入カテーテル７０をカテーテル６０に挿入してもよい。次に、関節鏡で確認しながらシリンジ３３を操作して軟骨損傷部位内に細胞懸濁液を所定量（例えば、０．１ｍＬ程度）注入する。この場合、注入カテーテル７０の先端は、拡張手段１４の下面よりも上方に位置させているので、注入カテーテル７０の先端が、軟骨損傷部位４４に注入された細胞懸濁液に触れることがない。 Next, as shown in FIG. 9, an injection catheter 70 for injecting cells is inserted into the guide lumen 61 of the catheter 60, and the distal end of the injection catheter 70 provided with the discharge port 73 is inserted into the distal end opening 62 of the catheter 60. Or slightly flush with the tip opening 62. In this case, the tip of the infusion catheter 70 may be positioned above the lower surface of the expansion means 14. Next, the syringe 33 filled with the cell suspension is connected to the hub 74 provided at the proximal end portion of the infusion catheter 70. In addition, after connecting the syringe 33 filled with the cell suspension to the hub 74 of the injection catheter 70, the injection catheter 70 to which the syringe 33 is connected may be inserted into the catheter 60. Next, while confirming with an arthroscope, the syringe 33 is operated to inject a predetermined amount (for example, about 0.1 mL) of the cell suspension into the cartilage damage site. In this case, since the distal end of the injection catheter 70 is positioned above the lower surface of the expansion means 14, the distal end of the injection catheter 70 does not touch the cell suspension injected into the cartilage damage site 44.
　これ以降は、上記（１２）～（１４）と同様の工程を実施することにより、軟骨損傷部位４４への細胞移植が完了する。 Thereafter, by performing the same steps as in the above (12) to (14), the cell transplantation to the cartilage damage site 44 is completed.
　以上の説明から了解されるように、本実施形態に係る細胞移植用デバイス１０ａを用いれば、次のような第２の細胞移植方法を実施することができる。すなわち、当該第２の細胞移植方法は、
　複数のルーメンを有するカテーテル６０と、前記カテーテル６０の先端部に設けられ、前記カテーテル６０に形成された拡張用ルーメン２０を介して供給される拡張用流体によって拡張可能な拡張手段１４とを備えた細胞移植用デバイス１０ａを用意する工程と、
　前記細胞移植用デバイス１０ａの前記拡張手段１４を生体内に挿入する工程と、
　前記拡張手段１４を拡張させることにより前記生体内の組織間を拡張させるとともに前記拡張手段１４を処置対象部位上に配置する工程と、
　前記カテーテル６０に形成されたガイドルーメン６１に吸引カテーテル６６を挿入する工程と、
　前記ガイドルーメン６１に挿入された前記吸引カテーテル６６を介して前記処置対象部位上の残存液を吸引する工程と、
　前記ガイドルーメン６１から吸引カテーテル６６を抜去する工程と、
　前記ガイドルーメン６１に注入カテーテル７０を挿入する工程と、
　前記ガイドルーメン６１に挿入された前記注入カテーテル７０を介して前記処置対象部位に細胞懸濁液を注入する工程とを含むことを特徴とする。 As can be understood from the above description, the following second cell transplantation method can be implemented by using the cell transplantation device 10a according to the present embodiment. That is, the second cell transplantation method is:
A catheter 60 having a plurality of lumens, and an expansion means 14 provided at the distal end of the catheter 60 and expandable by an expansion fluid supplied through the expansion lumen 20 formed in the catheter 60. Preparing a cell transplant device 10a;
Inserting the expansion means 14 of the cell transplant device 10a into a living body;
Expanding the space between the tissues in the living body by expanding the expansion means 14 and disposing the expansion means 14 on a treatment target site;
Inserting a suction catheter 66 into a guide lumen 61 formed in the catheter 60;
Sucking the remaining liquid on the treatment target site through the suction catheter 66 inserted into the guide lumen 61;
Removing the suction catheter 66 from the guide lumen 61;
Inserting an infusion catheter 70 into the guide lumen 61;
And a step of injecting a cell suspension into the treatment target site via the injection catheter 70 inserted into the guide lumen 61.
　以上説明したように本実施形態に係る細胞移植用デバイス１０ａによれば、処置対象部位上の残存液を吸引する際にはガイドルーメン６１に吸引カテーテル６６を挿入し、処置対象部位上に細胞懸濁液を注入する際にはガイドルーメン６１に注入カテーテル７０を挿入するので、吸引カテーテル６６と注入カテーテル７０の先端部の位置（処置対象部位に対する位置）を簡単に調整することができる。すなわち、処置対象部位上の残存液を吸引する際には、吸引カテーテル６６の先端部を、拡張手段１４の下面よりも下方に位置させ、更に処置対処部位の深さに応じて吸引カテーテル６６の先端位置を任意に調整することができるので、処置対象部位上の残存液を確実に吸引することができる。また、処置対象部位に細胞懸濁液を注入する際には、注入カテーテル７０の先端部の位置を、拡張手段１４の下面よりも上方の位置で任意に調整することができるので、好適な位置から細胞懸濁液の注入を行うことができる。 As described above, according to the cell transplant device 10a according to the present embodiment, the suction catheter 66 is inserted into the guide lumen 61 when the residual liquid on the treatment target site is sucked, and the cell suspension is placed on the treatment target site. Since the injection catheter 70 is inserted into the guide lumen 61 when injecting the turbid liquid, the positions of the suction catheter 66 and the distal end portions of the injection catheter 70 (position with respect to the treatment target site) can be easily adjusted. That is, when the residual liquid on the treatment target site is aspirated, the distal end portion of the suction catheter 66 is positioned below the lower surface of the expansion means 14, and the suction catheter 66 is further in accordance with the depth of the treatment site. Since the tip position can be arbitrarily adjusted, the remaining liquid on the treatment target site can be reliably sucked. Further, when injecting the cell suspension into the treatment target site, the position of the distal end portion of the injection catheter 70 can be arbitrarily adjusted at a position above the lower surface of the expansion means 14, so that a suitable position is obtained. Cell suspension can be injected.
　なお、第２実施形態において、第１実施形態と共通する各構成部分については、第１実施形態における当該共通の各構成部分がもたらす作用及び効果と同一又は同様の作用及び効果が得られることは勿論である。また、第１実施形態の変形例として説明した構成は、第２実施形態においても同様に適用することが可能である。 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. Moreover, the structure demonstrated as a modification of 1st Embodiment is applicable similarly in 2nd Embodiment.
　上記において、本発明について好適な実施形態を挙げて説明したが、本発明は前記実施形態に限定されるものではなく、本発明の要旨を逸脱しない範囲において、種々の改変が可能なことは言うまでもない。例えば、上記実施形態では細胞移植用デバイス１０、１０ａの用途として膝関節での関節鏡視下細胞移植手術を挙げたが、本発明はこれに限定されるものではない。すなわち、本発明に係る細胞移植用デバイス１０、１０ａは、液体を排出することを伴う手術方法であればいかなるものにも適用することができる。例えば、本発明に係る細胞移植用デバイスは、脳内、腹腔内、手根管、肩関節、肘関節、脊椎などの内視鏡手術や胸水、腹水の水抜に使用することができる。 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, the cell transplantation device 10 or 10a is used for the arthroscopic cell transplantation operation at the knee joint, but the present invention is not limited to this. That is, the cell transplantation device 10 or 10a according to the present invention can be applied to any surgical method that involves discharging a liquid. For example, the device for cell transplantation according to the present invention can be used for endoscopic surgery such as intracerebral, intraperitoneal, carpal tunnel, shoulder joint, elbow joint, spine, and drainage of pleural effusion and ascites.
　上記において、本発明について好適な実施形態を挙げて説明したが、本発明は前記実施形態に限定されるものではなく、本発明の要旨を逸脱しない範囲において、種々の改変が可能なことは言うまでもない。 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.

Claims (11)

  1. 　カテーテル（１２、６０）と、
    　前記カテーテル（１２、６０）の先端部に設けられ、前記カテーテル（１２、６０）に形成された拡張用ルーメン（２０）を介して供給される拡張用流体によって拡張可能な拡張手段（１４）とを備え、
    　前記カテーテル（１２、６０）には、前記拡張用ルーメン（２０）以外に、少なくとも１つのルーメンが形成され、
    　前記拡張手段（１４）を拡張させることにより生体内の組織間を拡張させた状態で、前記ルーメンを直接的に又は間接的に介して、処置対象部位上の液体を吸引し、前記処置対象部位に細胞を注入するように構成されている、
    　ことを特徴とする細胞移植用デバイス（１０、１０ａ）。     A catheter (12, 60);
    Expansion means (14) provided at the distal end of the catheter (12, 60) and expandable by an expansion fluid supplied through an expansion lumen (20) formed in the catheter (12, 60); With
    In addition to the expansion lumen (20), at least one lumen is formed in the catheter (12, 60),
    In a state where the tissue in the living body is expanded by expanding the expansion means (14), the liquid on the treatment target site is sucked directly or indirectly through the lumen, and the treatment target site Configured to inject cells into the
    A device for cell transplantation (10, 10a).
  2. 　請求項１記載の細胞移植用デバイス（１０）において、
    　前記カテーテル（１２）は、前記処置対象部位上の液体を吸引するための吸引口（２３）を有する吸引ルーメン（２２）と、前記細胞を吐出させるための吐出口（２５）を有する注入ルーメン（２４）とを備える、
    　ことを特徴とする細胞移植用デバイス（１０）。     The device for cell transplantation (10) according to claim 1,
    The catheter (12) includes a suction lumen (22) having a suction port (23) for sucking a liquid on the treatment target site, and an injection lumen (25) having a discharge port (25) for discharging the cells. 24)
    A device for cell transplantation (10) characterized by the above.
  3. 　請求項２記載の細胞移植用デバイス（１０）において、
    　前記吸引口（２３）は、前記吐出口（２５）よりも下方に位置する、
    　ことを特徴とする細胞移植用デバイス（１０）。     The cell transplantation device (10) according to claim 2,
    The suction port (23) is located below the discharge port (25).
    A device for cell transplantation (10) characterized by the above.
  4. 　請求項２記載の細胞移植用デバイス（１０）において、
    　前記拡張手段（１４）が拡張した状態で、前記吸引口（２３）は、前記拡張手段（１４）の下面よりも下方に位置する、
    　ことを特徴とする細胞移植用デバイス（１０）。     The cell transplantation device (10) according to claim 2,
    With the expansion means (14) expanded, the suction port (23) is positioned below the lower surface of the expansion means (14).
    A device for cell transplantation (10) characterized by the above.
  5. 　請求項２記載の細胞移植用デバイス（１０）において、
    　前記拡張手段（１４）が拡張した状態で、前記吐出口（２５）は、前記拡張手段（１４）の下面よりも上方に位置する、
    　ことを特徴とする細胞移植用デバイス（１０）。     The cell transplantation device (10) according to claim 2,
    In the state where the expansion means (14) is expanded, the discharge port (25) is located above the lower surface of the expansion means (14).
    A device for cell transplantation (10) characterized by the above.
  6. 　請求項１記載の細胞移植用デバイス（１０ａ）において、
    　前記カテーテル（６０）には、前記処置対象部位上の液体を吸引するための吸引カテーテル（６６）と、前記処置対象部位に細胞を注入するための注入カテーテル（７０）とを選択的に挿入可能なガイドルーメン（６１）が形成されている、
    　ことを特徴とする細胞移植用デバイス（１０ａ）。     The cell transplantation device (10a) according to claim 1,
    The catheter (60) can be selectively inserted with an aspiration catheter (66) for aspirating the liquid on the treatment target site and an injection catheter (70) for injecting cells into the treatment target site. A guide lumen (61) is formed,
    A device for cell transplantation (10a).
  7. 　請求項１～６のいずれか１項に記載の細胞移植用デバイス（１０、１０ａ）において、
    　前記拡張手段（１４）は、円弧状に拡張する複数の拡張体（２６）を有し、当該複数の拡張体（２６）が拡張したときに全体として略円環状をなし、
    　前記カテーテル（１２、６０）の先端部は、前記拡張手段（１４）が拡張した際の略円環状の略中心位置で屈曲して下方に指向する、
    　ことを特徴とする細胞移植用デバイス（１０、１０ａ）。     The cell transplantation device (10, 10a) according to any one of claims 1 to 6,
    The expansion means (14) has a plurality of expansion bodies (26) that expand in an arc shape, and has a substantially annular shape as a whole when the plurality of expansion bodies (26) expands,
    The distal end portion of the catheter (12, 60) bends at a substantially annular center position when the expansion means (14) is expanded and is directed downward.
    A device for cell transplantation (10, 10a).
  8. 　請求項１～６のいずれか１項に記載の細胞移植用デバイス（１０、１０ａ）において、
    　前記拡張手段（１４）は、湾曲状に拡張する複数の拡張体（２６）を有し、当該複数の拡張体（２６）が拡張したときに全体として略環状をなし、
    　前記複数の拡張体（２６）は、連結膜（３６）により相互に連結され、拡張時に前記連結膜（３６）により一体構造をなす、
    　ことを特徴とする細胞移植用デバイス（１０、１０ａ）。     The cell transplantation device (10, 10a) according to any one of claims 1 to 6,
    The expansion means (14) has a plurality of expansion bodies (26) that expand in a curved shape, and when the plurality of expansion bodies (26) expands, the expansion means (14) has a substantially annular shape as a whole,
    The plurality of expansion bodies (26) are connected to each other by a connection film (36), and form an integral structure by the connection film (36) during expansion.
    A device for cell transplantation (10, 10a).
  9. 　請求項８記載の細胞移植用デバイス（１０、１０ａ）において、
    　前記複数の拡張体（２６）は、拡張時にそれぞれ円弧状をなすとともに同一円上に配置される一対の拡張体（２６）である、
    　ことを特徴とする細胞移植用デバイス（１０、１０ａ）。     The device for cell transplantation (10, 10a) according to claim 8,
    The plurality of expansion bodies (26) are a pair of expansion bodies (26) each having an arc shape when being expanded and arranged on the same circle.
    A device for cell transplantation (10, 10a).
  10. 　請求項１～６のいずれか１項に記載の細胞移植用デバイス（１０、１０ａ）において、
    　前記拡張手段（１４）には、撮像手段を挿入可能な開口部（３４）が設けられる、
    　ことを特徴とする細胞移植用デバイス（１０、１０ａ）。     The cell transplantation device (10, 10a) according to any one of claims 1 to 6,
    The expansion means (14) is provided with an opening (34) into which the imaging means can be inserted.
    A device for cell transplantation (10, 10a).
  11. 　請求項１～６のいずれか１項に記載の細胞移植用デバイス（１０、１０ａ）において、
    　前記拡張手段（１４）は、前記カテーテル（１２、６０）と同軸状の形態となるように折り畳み可能に構成される、
    　ことを特徴とする細胞移植用デバイス（１０、１０ａ）。     The cell transplantation device (10, 10a) according to any one of claims 1 to 6,
    The expansion means (14) is configured to be foldable so as to be coaxial with the catheter (12, 60).
    A device for cell transplantation (10, 10a).
PCT/JP2012/080983 2011-12-02 2012-11-29 Device for cell transplantation WO2013081071A1 (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005514160A (en) * 2002-01-11 2005-05-19 カイフォン インコーポレイテッド Device and method for cancellous bone compression using an expandable body with internal restraint
JP2007296371A (en) * 1996-08-30 2007-11-15 Verigen Ag Method, instrument and kit for autologous transplantation

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007296371A (en) * 1996-08-30 2007-11-15 Verigen Ag Method, instrument and kit for autologous transplantation
JP2005514160A (en) * 2002-01-11 2005-05-19 カイフォン インコーポレイテッド Device and method for cancellous bone compression using an expandable body with internal restraint

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