WO2014128881A1 - Appareil médical - Google Patents

Appareil médical Download PDF

Info

Publication number
WO2014128881A1
WO2014128881A1 PCT/JP2013/054338 JP2013054338W WO2014128881A1 WO 2014128881 A1 WO2014128881 A1 WO 2014128881A1 JP 2013054338 W JP2013054338 W JP 2013054338W WO 2014128881 A1 WO2014128881 A1 WO 2014128881A1
Authority
WO
WIPO (PCT)
Prior art keywords
expansion
catheter
tubular portion
lumen
substance
Prior art date
Application number
PCT/JP2013/054338
Other languages
English (en)
Japanese (ja)
Inventor
栗田朋香
谷田部輝幸
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to PCT/JP2013/054338 priority Critical patent/WO2014128881A1/fr
Publication of WO2014128881A1 publication Critical patent/WO2014128881A1/fr

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M2025/0024—Expandable catheters or sheaths
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/0039—Multi-lumen catheters with stationary elements characterized by lumina being arranged coaxially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M2025/0042—Microcatheters, cannula or the like having outside diameters around 1 mm or less
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0693—Brain, cerebrum

Definitions

  • the present invention relates to a medical device used for continuous convection-enhanced delivery of a substance into a living tissue, particularly for continuous administration of a therapeutic substance into the brain parenchyma.
  • Non-patent Document 1 glioblastoma, anaplastic astrocytoma, etc.
  • various therapies such as chemotherapy, immunotherapy, gene therapy, molecular target therapy, etc.
  • Attempts have been made to improve the outcome of malignant brain tumors, including glioma.
  • the most malignant glioblastoma has a low 5-year survival rate of about 7%, and still has the poorest prognosis among all cancers (Non-patent Document 1).
  • BBB blood brain barrier
  • a convection-enhanced delivery (CED) method has been devised as a new drug administration method for overcoming the problems of chemotherapy for malignant glioma as described above (see, for example, Patent Document 1). ).
  • the CED method is local chemotherapy in which a drug is actively infused from a catheter placed stereotaxically in the brain parenchyma using a microinfusion pump.
  • the distribution of the drug depends on the diffusion of the substance, whether it is intracavitary administration to the tumor excision cavity or a local chemotherapeutic agent placed in the brain.
  • the diffusion of substances is defined by concentration gradients and tissue properties, and even a low-molecular compound with good diffusivity is considered to have a range of only a few millimeters due to absorption and metabolism in capillaries. This is inadequate for 80-90% of recurrences of malignant gliomas occurring at sites within 2 cm from the initial lesion (see Non-Patent Document 2).
  • the pressure gradient during the injection is maintained to induce a bulk flow between the cerebral layers to enhance the diffusion of the injected substance. Therefore, compared with the conventional local administration method, the drug can be distributed more uniformly and at a high concentration over a wide range.
  • the distribution of the drug in the brain can be controlled by the injection volume and the injection speed, and it is possible to reduce the dose compared to the systemic administration by vein, so that systemic side effects can be suppressed to a level where there is no problem. Is possible.
  • drugs that can be administered by the CED method, and various drugs have been tried in rat brain tumor transplantation models, and their effectiveness has been reported. Because of these advantages, the CED method is expected as a treatment method for not only brain tumors but also Parkinson's disease, Alzheimer's disease and epilepsy.
  • Patent Document 1 discloses a cannula having a step structure with an outer diameter changing near the end and a drug delivery system as a catheter for preventing a drug backflow.
  • a drug having a substantially constant inner diameter is provided with a multi-stage structure in which the outer diameter decreases from the proximal end to the distal end, thereby preventing backflow of the drug.
  • the present invention solves the above-mentioned problems, and damages the living tissue as much as possible by causing the backflow of the material along the outer surface of the catheter to be passed through the non-lumen region of the living tissue and delivering the material into the living tissue. It is an object of the present invention to provide a highly safe medical device that can be suppressed without any movement, and that suppresses the movement and removal of the catheter.
  • a medical instrument according to the present invention that achieves the above object is a medical instrument for inserting a substance into a non-luminal region of a living tissue and delivering a substance into the living tissue, and a tubular portion extending in a long length, and The diameter of the tubular portion is formed on the outer periphery of the tubular portion so as to extend from the distal end portion to the proximal end side with a length that is 30% or more of the length of the tubular portion that can be inserted into the living tissue.
  • An extension portion that expands outward in the direction is formed, and a delivery lumen for delivering the substance and an extension lumen for flowing a fluid for expanding the extension portion into the extension portion are formed.
  • the medical device configured as described above can increase the outer diameter by expanding the expansion portion in a wide region including the distal end portion of the catheter at the time of administration / delivery of the substance. While suppressing the damage of the living tissue as much as possible without increasing the gap between the catheter and the living tissue after insertion of the catheter, the gap between the catheter and the living tissue is eliminated by expanding the expanded portion, and the catheter is brought into close contact with the tissue in a wide range. The backflow of the delivered substance can be suppressed. Furthermore, the close contact of the catheter with the living tissue also exhibits the effect of preventing the catheter from moving or coming off that may occur during a long indwelling period.
  • the catheter can be in contact with the living tissue over a wide area, the load on the living tissue due to expansion can be dispersed, and the effect of preventing the removal can be further enhanced. , Safety can be improved.
  • the expansion part is formed on the entire circumference of the tubular part, the effect of suppressing the back flow of the substance, the effect of preventing the movement and removal of the catheter, and the load on the living tissue due to the expansion are distributed.
  • the effect of making it possible can be further enhanced.
  • the expansion portion is formed with a length that is 100% of the insertion length of the tubular portion into the living tissue, the effect of preventing the catheter from moving or coming out can be further enhanced.
  • the expansion portion is provided on the outer periphery of the tubular portion, and the tubular portion is provided by a fluid flowing in by being provided on the distal end side of the first expansion portion or on the outer periphery of the first expansion portion. If it has the 2nd expansion part which can be expanded to the diameter direction outside, the effect which controls backflow of a substance by the 1st expansion part and the 2nd expansion part, and the movement and removal of a catheter are prevented. The effect of distributing the load on the living tissue due to expansion can be arbitrarily adjusted.
  • the second expansion portion expands larger than the first expansion portion outward in the radial direction of the tubular portion at the time of expansion, the backflow of the substance can be effectively suppressed by the second expansion portion.
  • FIG. 3 is a cross-sectional view taken along line 3-3 in FIG. It is the schematic which shows the time of administering a therapeutic substance in brain parenchyma with the medical device which concerns on 1st Embodiment. It is sectional drawing which shows the catheter of the medical device which concerns on 2nd Embodiment, (A) is before expanding an expansion part, (B) shows the time of expanding an expansion part.
  • FIG. 8 is a cross-sectional view taken along line 8-8 in FIG. It is sectional drawing which shows the other modification of a catheter. It is sectional drawing which shows the other modification of a catheter. It is sectional drawing which shows the other modification of a catheter. It is sectional drawing which shows the other modification of a catheter. It is sectional drawing which shows the other modification of a catheter. It is sectional drawing which shows the other modification of a catheter. It is sectional drawing which shows the other modification of a catheter.
  • proximal end side the proximal side of the catheter
  • distal end side the inserted side
  • catheter represents one including a tube used for medical purposes.
  • the catheter is not limited to treatment, and may be for examination, for example.
  • the medical device 1 is used in a convection-enhanced delivery (CED) method for delivering a therapeutic substance to, for example, a brain tumor in the brain.
  • CED convection-enhanced delivery
  • the CED method is a method in which a therapeutic substance (drug) is injected in small amounts in a stereotaxic manner in the brain parenchyma while being actively and continuously pressurized, thereby maintaining a pressure gradient and convection. It is a local chemotherapy that uses the resulting flow to distribute and distribute a therapeutic substance in a wide and high concentration in the tissue gap.
  • the medical instrument 1 has a tubular catheter 10 that is inserted into the brain parenchyma to deliver a therapeutic substance.
  • the catheter 10 has a tubular portion 20 in which a delivery lumen 21 for delivering a therapeutic substance is formed, and a tubular shape disposed on the outer peripheral surface of the tubular portion 20 so as to form a tubular portion 20 and a double tube.
  • the hub 40 fixed to the proximal end of the tubular portion 20.
  • the tubular portion 20 is made of a flexible material, and for example, a polyurethane elastomer, a polyamide elastomer, a polyester elastomer, a polyvinyl chloride, a silicone elastomer, or the like can be suitably applied thereto, but is not limited thereto.
  • the extended portion 30 has a distal end portion joined to the distal end of the tubular portion 20 and a proximal end portion joined to the distal end of the hub 40.
  • An expansion lumen 22 is formed between the expansion portion 30 and the tubular portion 20.
  • the expansion portion 30 is brought into close contact with the tubular portion 20 as shown in FIG. 2 (A) and from the distal end portion to the proximal end portion as shown in FIG. 2 (B).
  • the entire span extends radially outward.
  • the length L of the region of the tubular portion 20 that can be inserted into the living tissue is preferably 40 to 200 mm, but is not limited thereto.
  • the extended portion 30 is arranged on the entire circumference so as to surround the outer periphery of the tubular portion 20 over substantially the entire region from the distal end portion to the proximal end portion of the tubular portion 20.
  • an elastically deformable material for example, silicone, thermoplastic elastomer, rubber, or the like can be suitably applied.
  • the expansion portion 30 is formed with a length that is approximately 100% of the length L that the tubular portion 20 can be inserted into the living tissue from the distal end portion to the proximal end side of the tubular portion 20. In addition, the length of the expansion part 30 may not be substantially 100% of the insertion length L.
  • the extended portion 30 is provided at least at the distal end portion of the tubular portion 20, and is preferably formed with a length of 30% or more of the insertable length L, more preferably 50% or more of the insertable length L, and more The length is preferably 70% or more of the insertable length L, and most preferably 100% of the insertable length L.
  • tip part of the expansion part 30 does not necessarily need to be provided from the strict tip part of the tubular part 20.
  • the base end portion of the extension portion 30 may be joined to the tubular portion 20 instead of the hub 40.
  • the hub 40 has a delivery opening 41 that communicates with the delivery lumen 21 and an expansion opening 42 that communicates with the expansion lumen 22.
  • a connecting pipe 46A provided at an end of a liquid feeding tube 46 extending from a syringe 45 filled with a therapeutic substance can be inserted.
  • the syringe 45 is attached to a microinjection pump 48 (see FIG. 4) or the like, and can supply a therapeutic substance at a predetermined injection amount and injection rate.
  • the delivery opening 41 has a structure in which the connection pipe 46A is directly fitted, but a three-way stopcock or a check valve may be provided between the delivery opening 41 and the connection pipe 46A.
  • the expansion opening 42 is connected to an expansion tube 44 in which a three-way stopcock 43 is disposed at the end.
  • the three-way cock 43 is for sealing the fluid supplied into the expansion lumen 22 for an arbitrary time. If the fluid can be sealed, the three-way stopcock 43 is not necessarily provided, and for example, a check valve may be provided.
  • the three-way stopcock 43 can be connected to a fluid supply tube 49 connected to an indeflator 47 (see FIG. 4) that can supply an expansion fluid.
  • the outer diameter D (see FIG. 1) of the portion that is inserted into the living tissue of the catheter 10 before the expansion portion 30 is expanded is preferably 0.1 to 50 mm, but is not limited thereto.
  • the amount of expansion of the catheter 10 in the radial direction (the amount of increase in the radius of the catheter 10) when the expansion unit 30 is expanded is several ⁇ m to several mm, but is not limited thereto.
  • the fluid injected into the expansion lumen 22 is not particularly limited as long as it is a fluid that can expand the expansion portion 30, and is preferably sterilized water, physiological saline, various contrast agents for MRI imaging or X-ray imaging, and the like. Applicable.
  • the catheter 10 can be visually recognized by an image diagnostic apparatus such as MRI, X-ray fluoroscopy apparatus, or X-ray CT, so that the insertion position of the catheter 10 can be confirmed. This not only prevents damage to the brain tissue due to movement of the catheter 10, administration to unnecessary sites, infections, etc., but also enables use in combination with real-time monitoring technology for insertion of the catheter 10 and administration of therapeutic substances. It is also very useful from the point of. Real-time monitoring technology is an important technology for accurately and safely implementing the CED method.
  • the therapeutic substance is, for example, an anticancer agent, more specifically, an alkylating agent such as nimustine, ranimustine, and temozolomide, a platinum preparation such as cisplatin, oxaliplatin, and dahaplatin, sulfazine, methotrexate, fluorouracil, fructocin, azathioprine, pentostatin, etc.
  • an anticancer agent more specifically, an alkylating agent such as nimustine, ranimustine, and temozolomide
  • a platinum preparation such as cisplatin, oxaliplatin, and dahaplatin
  • sulfazine such as cisplatin, oxaliplatin, and dahaplatin
  • methotrexate fluorouracil
  • fructocin fructocin
  • azathioprine pentostatin
  • connection pipe 46A of the liquid feeding tube 46 connected to the syringe 45 filled with the therapeutic substance is fitted into the delivery opening 41 of the hub 40 and connected. Thereafter, the catheter 10 is grasped, and the catheter 10 is inserted into the brain parenchyma until the tip reaches the brain tumor in the brain parenchyma or the vicinity of the brain tumor.
  • a fluid supply tube 49 is connected to the three-way cock 43, and fluid is supplied into the expansion lumen 22 by the indeflator 47 or the like.
  • the outer diameter of the catheter 10 increases within the brain parenchyma in the range of the insertion length L from the distal end portion of the catheter 10 toward the proximal end side.
  • the three-way stopcock 43 is closed, the fluid injected into the expansion lumen 22 is sealed, and the state where the outer diameter of the catheter 10 is increased is maintained. Even if a check valve is provided instead of the three-way stopcock 43, the state in which the outer diameter of the catheter 10 is increased can be maintained. The state in which the outer diameter of the catheter 10 is increased is continued until the delivery of the therapeutic substance is completed.
  • a therapeutic substance is supplied from the syringe 45 to the delivery lumen 21 using a microinfusion pump 48 or the like.
  • the connection of the liquid feeding tube 46 to the hub 40 may be performed after the catheter 10 is inserted into the brain parenchyma.
  • the three-way stopcock 43 is opened, the fluid injected into the expansion lumen 22 is withdrawn, and the expansion portion 30 is elastically contracted by its own elastic force, thereby the outer diameter of the catheter 10 After the decrease, the catheter 10 is removed.
  • the medical device 1 is for delivering a therapeutic substance (substance) into the brain parenchyma, which is a non-luminal region of a living tissue, and is a tubular tube extending in a long length.
  • the portion 20 and the outer circumference of the tubular portion 20 are formed to extend from the distal end portion to the proximal end side with a length of 30% or more of the length L that can be inserted, and outward in the radial direction of the tubular portion 20.
  • a delivery lumen 21 for delivering a therapeutic substance, and an extension lumen 22 for flowing a fluid for expanding the extension 30 into the extension 30 are formed.
  • the outer diameter can be increased in a wide region including the distal end portion of the catheter 10 at the time of administration / delivery of the therapeutic substance, damage to the living tissue is minimized without increasing the outer diameter when the catheter 10 is inserted. While suppressing, the gap between the catheter 10 and the living tissue generated after the insertion of the catheter 10 is eliminated by the expansion of the expansion portion 30, and the catheter 10 is brought into close contact with the tissue in a wide range, thereby allowing the therapeutic substance delivered into the brain parenchyma. Backflow can be suppressed. Furthermore, the close contact of the catheter 10 with the living tissue also exhibits an effect of preventing the catheter 10 from moving or coming off that may occur in a long-term indwelling period.
  • the catheter 10 can be in contact with the living tissue over a wide area, the load on the living tissue due to expansion can be dispersed, and the effect of preventing the disconnection can be further enhanced. Therefore, safety can be improved.
  • the backflow of the therapeutic substance from the catheter 10 is mainly performed in the CED method of the therapeutic substance into the living tissue, particularly the brain parenchyma. Because it can prevent leakage to the brain surface, cerebral sulcus, excision space, etc., the distribution efficiency of therapeutic substances is reduced, side effects due to unnecessary administration of medication, brain tissue damage, infection The possibility of the occurrence of complications such as these can be reduced, and it can contribute to the realization of a more accurate, safe and effective CED method.
  • the medical device 1 since the medical device 1 according to the present embodiment has a structure capable of increasing the outer diameter of the catheter 10 only at the time of administration / delivery of the therapeutic substance, the insertion or removal of the catheter 10 from or into the brain parenchyma. Sometimes brain tissue damage can be minimized. This is very effective in minimizing functional complications in brain tissue that performs different functions depending on the site.
  • the expansion part 30 is formed in the outer periphery of the tubular part 20 all over, the effect which suppresses the back flow of the therapeutic substance mentioned above, the effect which prevents the movement of the catheter 10, and omission, the expansion of the expansion part 30 It is possible to further enhance the effect of dispersing the load on the living tissue.
  • the expansion part 30 is formed with a length that is 100% of the insertion length L of the tubular part 20 into the living tissue, the effect of preventing the catheter 10 from moving or coming out can be further enhanced.
  • the catheter 10 is used for convection increased delivery of the therapeutic substance to the tumor, it becomes possible to effectively deliver the therapeutic substance to the tumor.
  • the medical device 50 according to the second embodiment is different from the medical device 1 according to the first embodiment in that the catheter 60 has two expansion portions.
  • the part which has the same function as 1st Embodiment attaches
  • the catheter 60 includes a tubular portion 70 in which a delivery lumen 71 for delivering a therapeutic substance and an expansion lumen 72 into which an expansion fluid flows are formed, and an outer peripheral surface of the tubular portion 70.
  • the tubular portion 70 and the tubular first extending portion 81 and the second extending portion 82 arranged so as to constitute a double tube, and the hub 40 fixed to the proximal end of the tubular portion 70 are provided. .
  • the second expansion portion 82 is a region on the distal end side of the tubular portion 70, and a distal end portion and a proximal end portion are joined to the outer peripheral surface of the tubular portion 70.
  • the first extension portion 81 has a distal end portion joined to the tubular portion 70 on the proximal end side of the second extension portion 82, and a proximal end portion joined to the distal end of the hub 40.
  • a space between the first expansion portion 81 and the tubular portion 70 communicates with the expansion lumen 72 through a first through hole 73 formed in the tubular portion 70, and between the second expansion portion 82 and the tubular portion 70. This space communicates with the expansion lumen 72 through a second through hole 74 formed in the tubular portion 70.
  • the second expansion portion 82 expands larger than the first expansion portion 81 outward in the radial direction of the tubular portion 70 during expansion.
  • the second expansion portion 82 preferably has an outer diameter of 100.1 to 1000% as compared with the outer diameter of the expanded first expansion portion 81 when expanded.
  • the second expansion portion 82 is preferably provided at a position of 0 to 10 mm from the most distal end of the catheter 60 (tubular body 70), but is not limited thereto.
  • the expansion portion 80 is divided into the two first expansion portions 81 and the second expansion portion 82, and extends over the substantially entire region from the distal end portion to the proximal end portion of the tubular portion 70. Be placed.
  • the 2nd expansion part 82 is formed separately from the 1st expansion part 81, you may form integrally.
  • the 1st expansion part 81 and the 2nd expansion part 82 expand with the fluid from the same expansion lumen 72, a different expansion lumen may be provided and each may be expandable independently.
  • the catheter 60 has a second expansion portion 82 that can be expanded radially outward of the tubular portion 70 when fluid flows into the distal end side of the first expansion portion 81. Therefore, the first expansion portion 81 and the second expansion portion 82 have the effect of suppressing the backflow of the therapeutic substance, the effect of preventing the movement and removal of the catheter 60, and the expansion portion (the first expansion portion 81 and the second expansion portion). The effect of distributing the load on the living tissue due to the expansion of the expansion unit 82) can be arbitrarily adjusted.
  • the second expansion portion 82 expands larger than the first expansion portion 81 radially outward of the tubular portion 70 during expansion, the backflow of the therapeutic substance can be effectively suppressed by the second expansion portion 82. .
  • the second expansion portion 82 is positioned on the distal end side with respect to the first expansion portion 81, the backflow of the therapeutic substance is effectively performed by the second expansion portion 82 upstream of the first expansion portion 81. Can be suppressed.
  • the amount of expansion is reduced in the first expansion unit 81 on the downstream side of the second expansion unit 82, it is possible to reduce the load on the living tissue while exhibiting a predetermined backflow suppressing effect.
  • the delivery lumen 71 and the expansion lumen 72 are formed inside one tubular portion 70, but the delivery lumen 71 and the expansion lumen 72 may be formed in different tubular bodies.
  • the medical instrument 90 according to the third embodiment is different from the medical instrument 1 according to the first embodiment in that the catheter 100 has two expansion portions.
  • the part which has the same function as 1st Embodiment attaches
  • the catheter 100 forms a tubular portion 110 in which a delivery lumen 111 for delivering a therapeutic substance is formed, and a tubular portion 110 and a double tube on the outer peripheral surface of the tubular portion 110.
  • a cylindrical first extension part 121 arranged as described above, and a cylindrical second extension part 122 arranged on the outer peripheral surface of the first extension part 121 so as to form a double pipe with the first extension part 121
  • a hub 40 fixed to the proximal end of the tubular portion 110.
  • the first extended portion 121 has a distal end portion joined to the distal end of the tubular portion 110 and a proximal end portion joined to the distal end of the hub 40.
  • An expansion lumen 112 is formed between the first expansion portion 121 and the tubular portion 110.
  • the second extended portion 122 is a region on the distal end side of the first expanded portion 121, and a distal end portion and a proximal end portion are joined to the outer peripheral surface of the first expanded portion 121.
  • the expansion lumen 112 between the first expansion portion 121 and the tubular portion 110 communicates with the expansion opening 42 of the hub 40, and the space between the second expansion portion 122 and the first expansion portion 121 is the first. It communicates with the expansion lumen 112 through a through hole 113 formed in the expansion portion 121.
  • the first expansion portion 121 and the second expansion portion 122 are in close contact with the tubular portion 110 as shown in FIG. From the state where the portion 122 is in close contact with the first expansion portion 121, the first expansion portion 121 and the second expansion portion 122 expand radially outward as shown in FIG. 6B. Since the second expansion portion 122 is disposed on the outer peripheral surface of the first expansion portion 121, the second expansion portion 122 expands larger than the first expansion portion 121 radially outward of the tubular portion 110 during expansion.
  • the second expansion portion 122 preferably has an outer diameter of 100.1 to 1000% as compared with the outer diameter of the expanded first expansion portion 121 at the time of expansion, but is not limited thereto.
  • the second expansion portion 122 is preferably provided at a position of 0 to 10 mm from the most distal end of the catheter 100 (tubular body 110), but is not limited thereto.
  • the expansion portion 120 is divided into the two first expansion portions 121 and the second expansion portion 122, and extends over the entire area from the distal end portion of the tubular portion 110 to the proximal end portion. Be placed.
  • the 2nd expansion part 122 is formed separately from the 1st expansion part 121, you may form integrally.
  • the 1st expansion part 121 and the 2nd expansion part 122 expand with the fluid from the same expansion lumen 112, a different expansion lumen may be provided and each may be expandable independently.
  • a plurality of second expansion portions 122 may be provided on the outer periphery of the first expansion portion 121.
  • the catheter 100 is provided on the outer periphery of the first expansion portion 121 and can be expanded radially outward of the tubular portion 110 when fluid is introduced.
  • the first dilating portion 121 and the second dilating portion 122 have the effect of suppressing the backflow of the therapeutic substance, the effect of preventing the catheter 100 from moving and coming off, and the dilating portion (the first dilating portion 121 and the first dilating portion 121). 2)
  • the effect of distributing the load on the living tissue due to the expansion of the expansion unit 122) can be arbitrarily adjusted.
  • the 2nd expansion part 122 expands larger than the 1st expansion part 121 to the radial direction outward of the tubular part 110 at the time of expansion, the backflow of a therapeutic substance can be effectively suppressed by the 2nd expansion part 122. . Since the 2nd expansion part 122 is located in the outer periphery of the front-end
  • the present invention is not limited to the above-described embodiment, and various modifications can be made by those skilled in the art within the technical idea of the present invention.
  • the first expansion portion 131 provided between the second expansion portion 132 and the tubular portion 20 can be partially provided without providing the entire circumference.
  • the second extension part 132 provided on the outer periphery of the first extension part 131 may be provided partially rather than on the entire periphery.
  • the second expansion portion 142 provided on the outer peripheral surface of the first expansion portion 141 may be provided on the proximal side with respect to the distal end portion of the catheter.
  • the 2nd expansion part 152 provided in the outer peripheral surface of the 1st expansion part 151 may be a disk shape (disk shape).
  • the extended portion may be formed so as to have an elliptical shape instead of a circular shape when viewed from the central axis direction.
  • the tubular portion 170 of the catheter 160 may have a tapered portion 171 whose outer diameter gradually decreases toward the distal end side between the distal end portion 172 and the proximal end portion 173. .
  • the distal end 172 of the tubular portion 170 has a smaller outer diameter than the proximal end 173.
  • the outer diameter of the tapered portion 171 preferably decreases gradually at an angle of 2 ° to 60 ° with respect to the central axis of the catheter 160, more preferably decreases gradually at an angle of 2 ° to 45 °. Formed. If the angle of the taper portion 171 is too large, damage to the brain parenchyma will increase, and if the angle of the taper portion 171 is too small, the effect of backflow in the taper portion 171 will decrease. Instead of the tapered portion 171, a step portion whose outer diameter decreases in a direction perpendicular to the central axis of the catheter may be provided.
  • a stylet 190 (core that can be inserted into the catheter 10 so as to penetrate the delivery lumen 21 of the catheter 10 is provided. Material part) may be provided.
  • the stylet 190 is pulled out after the catheter 10 is placed in the living tissue.
  • the catheter 10 may be provided with another lumen different from the delivery lumen 21 and the expansion lumen 22 and the stylet 190 may be inserted therethrough.
  • a plurality of lumens different from the delivery lumen 21 and the expansion lumen 22 may be provided.
  • the catheter 10 can be inserted along the guide wire.
  • a separate tube body that can be inserted through the catheter 10 may be used.
  • the distal end portion and the proximal end portion of the expansion portion 210 provided on the catheter 200 are joined to the outer peripheral surface of the tubular portion 220, and an expansion lumen 222 is formed between the expansion portion 210 and the tubular portion 220. It may be formed.
  • the expansion lumen 222 communicates with the delivery lumen 221 through a through hole 223 formed in the tubular portion 220. In this way, by connecting the expansion lumen 222 to the delivery lumen 221, the positive pressure is obtained by utilizing the characteristic that a continuous positive pressure acts on the therapeutic substance when the therapeutic substance is delivered by the delivery lumen 221.
  • the expansion part 210 can be expanded, and the backflow of the therapeutic substance along the outer surface of the catheter 200 can be suppressed.
  • the expansion portion 210 expands with a higher positive pressure, and the backflow suppression effect increases.
  • the extended part 210 can set a position and the length of a central-axis direction suitably like the extended part in the above-mentioned various embodiment.
  • the medical devices according to the various embodiments described above deliver a therapeutic substance to a brain tumor, but the delivery site is not limited to the tumor, and for example, the liver, pancreas, kidney, gallbladder, breast, It may be a living tissue other than the brain, such as the uterus. Medical devices can be inserted into non-luminal regions that are not biological lumens (blood vessels, vessels, ureters, etc.) and deliver various substances into the non-luminal regions of biological tissue.
  • 1,50,90 medical instruments 10, 60, 100, 160, 200 catheter, 20, 70, 110, 170, 220 tubular section, 21, 71, 111, 221 delivery lumen, 22, 72, 112, 222 Extended lumen, 30, 80, 120, 180, 210 extension, 81, 121, 131, 141, 151 first extension, 82, 122, 132, 142, 152 second extension, 190 Stylet (core material part), L Length that can be inserted.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un appareil médical très sûr ayant un cathéter qui doit être introduit dans une zone sans lumière de tissu biologique de façon à administrer une substance dans le tissu biologique, de telle sorte qu'un reflux de la substance le long de la surface externe du cathéter est éliminé avec le moins de lésion possible du tissu biologique, et le déplacement et le glissement du cathéter sont éliminés. L'appareil médical (1) est introduit dans une zone sans lumière de tissu biologique de façon à administrer une substance dans le tissu biologique, et comprend un cathéter (10). Le cathéter a une partie tube s'étendant longitudinalement (20) et une partie extension (30) pouvant s'étendre vers l'extérieur dans une direction radiale de la partie tube (20), la partie extension (30) étant formée sur la surface externe de la partie tube (20) et s'étendant de l'extrémité avant de la partie tube (20) vers l'extrémité de base de celle-ci à une longueur de 30 % ou plus de la longueur d'introduction (L) de la partie tube (20) par rapport au tissu biologique. Dans le cathéter, une lumière d'administration (21) pour administrer la substance et une lumière d'extension (22) pour permettre l'écoulement d'un fluide, pour étendre la partie extension (30) vers l'intérieur de la partie extension (30), sont formées.
PCT/JP2013/054338 2013-02-21 2013-02-21 Appareil médical WO2014128881A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/JP2013/054338 WO2014128881A1 (fr) 2013-02-21 2013-02-21 Appareil médical

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2013/054338 WO2014128881A1 (fr) 2013-02-21 2013-02-21 Appareil médical

Publications (1)

Publication Number Publication Date
WO2014128881A1 true WO2014128881A1 (fr) 2014-08-28

Family

ID=51390711

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2013/054338 WO2014128881A1 (fr) 2013-02-21 2013-02-21 Appareil médical

Country Status (1)

Country Link
WO (1) WO2014128881A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2020189008A (ja) * 2019-05-24 2020-11-26 国立大学法人東北大学 対流強化薬剤送達法用カテーテル
US11298043B2 (en) 2016-08-30 2022-04-12 The Regents Of The University Of California Methods for biomedical targeting and delivery and devices and systems for practicing the same
US11497576B2 (en) 2017-07-17 2022-11-15 Voyager Therapeutics, Inc. Trajectory array guide system

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010533558A (ja) * 2007-07-17 2010-10-28 ノースバウンド メディカル，インコーポレイティッド アクセスを維持するための方法及び装置
JP2010540200A (ja) * 2007-10-08 2010-12-24 レニショウ （アイルランド） リミテッド カテーテル

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010533558A (ja) * 2007-07-17 2010-10-28 ノースバウンド メディカル，インコーポレイティッド アクセスを維持するための方法及び装置
JP2010540200A (ja) * 2007-10-08 2010-12-24 レニショウ （アイルランド） リミテッド カテーテル

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11298043B2 (en) 2016-08-30 2022-04-12 The Regents Of The University Of California Methods for biomedical targeting and delivery and devices and systems for practicing the same
US11298041B2 (en) 2016-08-30 2022-04-12 The Regents Of The University Of California Methods for biomedical targeting and delivery and devices and systems for practicing the same
US11497576B2 (en) 2017-07-17 2022-11-15 Voyager Therapeutics, Inc. Trajectory array guide system
JP2020189008A (ja) * 2019-05-24 2020-11-26 国立大学法人東北大学 対流強化薬剤送達法用カテーテル

Similar Documents

Publication Publication Date Title
JP5666102B2 (ja) 治療薬の標的組織への送達における逆流を減少させるカテーテル
US7621895B2 (en) Needle array devices and methods
ES2872274T3 (es) Sistema para aumentar la rigidez y la resistencia a enganche de una punta de catéter
US9402974B2 (en) Optimized intracranial catheters for convection-enhanced delivery of therapeutics
EP3532140B1 (fr) Cathéter à demeure à lumières multiples
US20110313399A1 (en) Intravenous cannula
US11364370B2 (en) Multi-purpose balloon catheter for intra cavity radiation delivery
US20110106009A1 (en) Device and method for delivering therapeutic agents to an area of the body
US20150038902A1 (en) Infusion therapy device
WO2014128881A1 (fr) Appareil médical
JP2015015988A (ja) 医療用器具
CN118178841A (zh) 利用球囊实现药物输送的装置、给药装置及微创医学系统
WO2014128824A1 (fr) Instrument pour traitement médical
WO2014128875A1 (fr) Instrument pour traitement médical
WO2015093274A1 (fr) Catheter d'administration de substances
JP2015015989A (ja) 医療用器具
US9737690B2 (en) Dual purpose balloon catheters
JP2020189008A (ja) 対流強化薬剤送達法用カテーテル
PL224676B1 (pl) Mikrocewnik wewnątrznaczyniowy do dostarczania substancji aktywnych
JP2024095707A (ja) 多管腔留置カテーテル

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 13875768

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 13875768

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: JP