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WO2016152497A1 - Corps flexible à usage médical - Google Patents

Corps flexible à usage médical Download PDF

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Publication number
WO2016152497A1
WO2016152497A1 PCT/JP2016/057100 JP2016057100W WO2016152497A1 WO 2016152497 A1 WO2016152497 A1 WO 2016152497A1 JP 2016057100 W JP2016057100 W JP 2016057100W WO 2016152497 A1 WO2016152497 A1 WO 2016152497A1
Authority
WO
WIPO (PCT)
Prior art keywords
groove
needle
flexible
flexible body
spiral
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2016/057100
Other languages
English (en)
Japanese (ja)
Inventor
中島　弘明
保臣 田中
英昭 請関
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medikit Co Ltd
Original Assignee
Medikit Co Ltd
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 Medikit Co Ltd filed Critical Medikit Co Ltd
Priority to JP2017508178A priority Critical patent/JPWO2016152497A1/ja
Publication of WO2016152497A1 publication Critical patent/WO2016152497A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • 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
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires

Definitions

  • the present invention relates to a medical flexible body, and more particularly to a flexible body that can be inserted deep inside a patient's body along a meandering blood vessel.
  • a flexible tube called a catheter may be introduced into a patient's blood vessel.
  • the catheter is put on the needle of the needle assembly, punctured into the patient's body together with the needle, and the catheter is left in the blood vessel by removing only the needle.
  • angiography it is used in combination with an introduction needle, a dilator or a sheath.
  • the catheter is guided by the sheath, introduced into the blood vessel, and inserted deep inside the patient's body.
  • a catheter is introduced, for example, from an artery in the patient's buttocks and reaches the heart and brain.
  • a similar procedure may be used to insert deep wires into the patient's body.
  • Patent Documents 1 and 2 disclose related techniques related to a needle assembly used for introducing a catheter.
  • a needle In order to insert the needle, catheter, or wire of the above-described needle assembly deep inside the patient's body, they need to be flexibly deformed along the meandering blood vessel. Otherwise, a needle, for example, can penetrate the blood vessel and pierce an unintended part of the patient's body tissue. In the case of an angiography catheter or wire, the tip cannot be extended to a distant site such as the heart or brain.
  • hollow needles and catheters are hollow so that a chemical solution can pass through them. If a hollow needle or catheter is to be made flexible, the internal cavity tends to collapse when bent. A collapsed needle or catheter becomes extremely difficult to pass a chemical solution and cannot achieve its original purpose.
  • the present invention has been made in view of these problems, and an object thereof is to provide a medical flexible body that flexes flexibly along a meandering blood vessel.
  • the flexible body has a pointed needle-like or rounded head, a main body having a cylindrical, elliptical, or polygonal surface, and the surface continues for one or more rounds. And a plurality of discontinuous spirals that circulate around the surface or a plurality of arc-shaped grooves that circulate around the surface.
  • FIG. 1 is a perspective view of a needle assembly including a flexible needle according to one embodiment.
  • FIG. 2A is an elevational view of a flexible needle according to one embodiment.
  • FIG. 2B is an elevation view of a flexible needle according to another embodiment.
  • FIG. 2C is an elevational view of a flexible needle according to yet another embodiment.
  • FIG. 3A is an elevational view of a flexible needle according to a different embodiment.
  • FIG. 3B is an elevational view of a flexible needle according to yet another embodiment.
  • FIG. 4A is an elevation view illustrating a process of manufacturing a flexible needle according to one embodiment.
  • FIG. 4B is an elevational view illustrating a process for manufacturing a flexible needle according to another embodiment.
  • FIG. 4C is an elevational view illustrating a process for manufacturing a flexible needle according to yet another embodiment.
  • FIG. 5A is an elevation view illustrating a spiral state when the flexible needle is bent.
  • FIG. 5B is an elevation view illustrating a state where the flexible needle is bent in the flexible needle according to another embodiment.
  • FIG. 6 is a schematic cross-sectional view showing how a catheter is guided into a blood vessel, and is a case where a rigid needle is used.
  • FIG. 7 is a schematic cross-sectional view showing how a catheter is guided into a blood vessel, and is a case using a flexible tube.
  • FIG. 8 is an elevation view of a flexible catheter according to one embodiment, showing an example of an angiographic catheter.
  • FIG. 9 is a schematic cross-sectional view showing an example of introducing an angiographic catheter into a blood vessel.
  • the medical flexible body according to the embodiment of the present invention is used as the flexible needle 9 of the needle assembly 1 shown in FIG.
  • the needle assembly 1 generally comprises a handle 3 and a flexible needle 9 for puncture extending forward from the handle 3.
  • the catheter 7 is put on the flexible needle 9 and introduced into the blood vessel by being punctured with the flexible needle 9 into the patient's body.
  • the flexible needle 9 can be retracted by a spring mechanism after use, and the button 5 for operating the spring mechanism has its head looked into the side surface of the handle 3.
  • the flexible needle 9 can be used for a manual retraction type or a fixed needle assembly.
  • the flexible needle 9 is made of an appropriate metal such as stainless steel.
  • the metal may be coated with a resin such as polytetrafluoroethylene. Such coatings improve lubricity and other properties.
  • an appropriate elastic material including a resin may be used instead of the metal. Examples of such a resin include polyether ketone (PEEK), polycarbonate (PC), polyphenylene sulfide (PPS), and a liquid crystal polymer.
  • the entire flexible needle 9 has a smooth and elongated cylindrical shape, and the tip of the needle is sharply pointed so that it can be used for puncture. Its interior can be hollow, i.e. generally tubular. When a coating is applied, the coating typically covers the outer surface of the tube, but instead or in addition, the inner surface may be coated.
  • the catheter 7 is guided by being slidably fitted to the tube portion. The cavity inside the tube portion communicates with the needle tip and penetrates the entire tube portion, and acts as a flow path for flowing reverse blood when the needle tip catches a blood vessel. Alternatively, a part or the whole of the flexible needle 9 may be solid.
  • the surface of the tube portion of the flexible needle 9 includes a spiral groove 9S that goes around the surface one or more times.
  • the groove 9S may reach the needle tip at the front and may reach the rear end at the rear.
  • the groove 9S may draw a spiral with an equal pitch throughout the groove 9S, or may draw a spiral with a pitch different from that of the other part in a specific part 9P as referred to by reference numeral 9S ′ in FIG. 2B. .
  • the pitch may change continuously.
  • the pitch of the grooves 9S ' may be shorter or longer than the others.
  • the groove 9S may be limited to a specific portion 9P '.
  • the groove 9S is discontinuous and may be composed of a plurality of small spiral portions.
  • FIG. 3A is an example thereof, and each spiral portion ends around the flexible needle 9 in one round.
  • Each spiral portion may of course have one or more rounds or less than one round.
  • the groove 9S is not a spiral, but may be an arc of less than one round surrounding the flexible needle 9, as illustrated in FIG. 3B.
  • Each arc may be deviated in the circumferential direction with respect to the adjacent arc. In the example of FIG. 3B, each arc is deviated by 90 degrees, but the deviation may be an arbitrary angle.
  • the groove 9S is a portion that is easily deformed, the flexible needle 9 is urged to bend flexibly. If the groove 9S extends over the entire flexible needle 9 as shown in FIG. Will not concentrate.
  • Flexibility depends on the pitch of the spiral, and the narrower the pitch, the easier it is to flex. Therefore, the ease of bending can be adjusted by the pitch of the spiral.
  • the pitch can be changed at the specific part or the groove can be limited to the specific part as shown in FIGS. 2B and 2C.
  • the groove 9S may be a groove that does not penetrate toward the inside of the flexible needle, but may be a penetration groove.
  • a through-groove may be always open, or may be normally closed and open only when the pipe portion is bent, and the surface thereof communicates with the internal flow path. In the latter case, the bending of the flexible needle is absorbed exclusively by the opening and closing of the through-groove, and the space between the spirals hardly needs to be deformed.
  • the groove 9S as described above can be formed by utilizing machining, laser processing, water jet processing, etching, or the like.
  • rotation R and translational motion F are given to the flexible needle 9 while irradiating the flexible needle 9 with the laser beam L.
  • a groove is formed at the irradiation point S, and the irradiation point S advances spirally on the surface of the flexible needle 9, so that a spiral groove 9S can be formed.
  • a tension T may be applied to the flexible needle 9 as shown in FIG. 4B.
  • the flexible needle 9 tends to shrink like a spring, so that the open groove 9S is closed, so that the groove 9S can be formed only when the flexible needle 9 is bent.
  • a similar structure can be formed by winding the steel strip 19 in a spiral shape.
  • coating may be applied to the entire flexible needle 9 or limited to the groove 9S.
  • the open groove 9S it can be closed with a coating and can be opened only when the flexible needle 9 is bent.
  • a coating may be applied for lubrication or other purposes.
  • the flexible needle 9 may be made of a shape memory alloy or a shape memory resin.
  • the groove 9S can be closed or opened by the shape memory effect.
  • the groove 9S narrows on the inner periphery side of the bend, and the groove 9S expands or opens on the outer periphery side of the bend. Accordingly, the groove 9S prompts the flexible needle 9 to bend flexibly. Furthermore, since the bending is absorbed exclusively by the groove 9S, the other portions can easily maintain their shapes. This prevents the flexible needle 9 from being crushed in the radial direction, thereby preventing the internal cavity from becoming narrow.
  • the groove 9AS generally has a spiral shape, but may partially include an S-shaped or N-shaped structure 9AC.
  • the structure 9AC engages with each other when the groove 9AS is about to spread and prevents the part from spreading.
  • the catheter 7 is used by being put on the needle 9.
  • the medical staff operates the needle assembly 1 with the finger 11 to puncture the needle 9 into the patient's body (arm) 13 and attempt to guide the needle tip into the blood vessel 15. If the medical staff is immature and the needle 9 is rigid, the needle tip may penetrate the blood vessel 15 and reach deeper into the patient's body 13.
  • the flexible needle 9 after puncturing, the flexible needle 9 is easily bent along the blood vessel 15, thereby preventing the needle tip from penetrating the blood vessel.
  • the spiral groove 9 ⁇ / b> S prompts the flexible needle 9 to bend flexibly, and prevents the internal flow path from becoming narrow. It is confirmed that the needle tip is caught in the blood vessel by being drawn out to an appropriate part of the needle assembly 1 without being blocked by the reverse blood passing through the flexible needle 9 or by seeping out from the groove 9S. To help.
  • the medical flexible body can be used as, for example, an angiography catheter shown in FIG.
  • the angiography catheter 9 ⁇ / b> L has a considerable length so as to reach the heart or brain tissue 21 from the artery in the groin of the patient, for example.
  • the catheter 9L is used in combination with a sheath 17 for introducing it into the blood vessel.
  • an appropriate auxiliary tool such as an introduction needle, a dilator, or a syringe is used.
  • the catheter 9L is made of an appropriate metal, a metal coated with a resin, or an appropriate elastic material containing a resin.
  • the surface is cylindrical, elliptical, or polygonal, and includes a spiral groove that circulates around the surface. Unlike the case where it is used as a needle, its head 9T is not sharp and may be appropriately rounded so as not to pierce the patient's tissue.
  • the helical pitch may be uniform throughout the catheter 9L as in the above-described embodiment, but the pitch may be different from other parts in a specific part.
  • the vicinity of the head 9T of the catheter 9L must be flexibly bent along the meandering blood vessel 23, but the catheter 9L should be relatively rigid in the vicinity of the hand of the medical technician. Therefore, the pitch may be narrowed near the head 9T, or the pitch may be widened near the hand.
  • the diameter of the catheter 9L may be uniform over its entire length or may be non-uniform. For example, the diameter may be gradually reduced toward the head 9T. Further, the diameter may be smoothly reduced, or the diameter may be reduced stepwise. This increases the flexibility of the catheter 9L, particularly near the head 9T, and promotes flexible bending along the meandering blood vessel 23.
  • the medical flexible body can be hollow.
  • the internal cavity can be used to allow the drug solution to pass through, that is, the medical flexible body can be used as a catheter.
  • the spiral grooves that circulate around the surface are preferably not penetrating, but may be penetrating. Even in that case, contrary to expectation, leakage of the chemical solution is not a problem. On the contrary, as described above, since the cavity is prevented from being crushed by the groove, it is more advantageous to have the groove for allowing the chemical solution to pass therethrough.
  • the inner surface of the cavity can also be cylindrical, elliptical, or polygonal.
  • the grooves may be formed on the inner surface instead of or in addition to being formed on the surface.
  • the cavity in the catheter 9L opens at the head 9T, but instead of or in addition to this, it may open at the side of the catheter 9L.
  • the medical flexible body may be solid or solid. In the case of a solid, it cannot be used for passing a chemical solution, but it can be used as a medical wire.
  • the head 9T When used as a medical wire, the head 9T may be bent into a bowl shape.
  • the saddle shape can have various forms such as an L shape, a U shape, or a C shape.
  • the whole medical flexible body may be a single body, but may be a composite body composed of a plurality of members.
  • a skin material may cover the core.
  • the core and the skin material may be the same material or different materials.
  • a metal can be applied to the core and a resin can be applied to the skin material.
  • the core may be a resin and the skin material may be a metal.
  • the core and the skin material may be bonded, or may not be bonded.
  • the core may be solid or a hollow tube.
  • the core and the skin material may be in close contact with each other, but a certain gap may be defined between the core and the skin material. Such a gap contributes to the soft deformation of the medical flexible body and can be used for the distribution of the chemical solution.
  • the core may be provided with a groove. All impart flexibility to the medical flexible body.
  • the portion with the groove is exclusively flexible, and the portion without the groove is exclusively useful for transmitting thrust force and torque. Further, since the chemical solution can flow along the groove, the groove is also useful for the distribution of the chemical solution.
  • a relatively rigid material can be applied to the medical flexible body according to each of the above-described embodiments, so that the medical flexible body can proceed deeply in the blood vessel without buckling. Further, such a medical flexible body appropriately transmits a thrust force and torque according to the procedure of a medical engineer. On the other hand, since it can bend flexibly by providing the groove, even if the blood vessel is meandering in a complicated manner, it can be flexibly deformed along this. Moreover, as already stated, even if it is a pipe
  • a flexible body for medical use that is easy to bend is provided.

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

Abstract

Un corps flexible à usage médical est pourvu d'une partie tête en forme d'aiguille pointue ou qui est arrondie ; une partie corps principal à surface cylindrique, elliptique ou polygonale ; et une rainure en forme de spirale qui s'enroule autour de la surface en au moins une boucle continue, une pluralité de rainures en forme de spirale qui s'enroulent autour de la surface et qui sont discontinues, ou une pluralité de rainures en arc qui s'enroulent autour de la surface sans l'entourer complètement.
PCT/JP2016/057100 2015-03-23 2016-03-08 Corps flexible à usage médical Ceased WO2016152497A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2017508178A JPWO2016152497A1 (ja) 2015-03-23 2016-03-08 医療用可撓体

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2015059412 2015-03-23
JP2015-059412 2015-03-23

Publications (1)

Publication Number Publication Date
WO2016152497A1 true WO2016152497A1 (fr) 2016-09-29

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PCT/JP2016/057097 Ceased WO2016152496A1 (fr) 2015-03-23 2016-03-08 Aiguille flexible à usage médical
PCT/JP2016/057100 Ceased WO2016152497A1 (fr) 2015-03-23 2016-03-08 Corps flexible à usage médical

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Application Number Title Priority Date Filing Date
PCT/JP2016/057097 Ceased WO2016152496A1 (fr) 2015-03-23 2016-03-08 Aiguille flexible à usage médical

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JP (2) JPWO2016152497A1 (fr)
WO (2) WO2016152496A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019070076A1 (fr) * 2017-10-06 2019-04-11 株式会社アルチザンラボ Aiguille à demeure et méthode d'utilisation d'une aiguille à demeure

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023010404A (ja) * 2021-07-09 2023-01-20 株式会社狭山金型製作所 注射針
JP2023010403A (ja) * 2021-07-09 2023-01-20 株式会社狭山金型製作所 注射針

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005329062A (ja) * 2004-05-20 2005-12-02 Terumo Corp イントロデューサーシース
JP2011078525A (ja) * 2009-10-06 2011-04-21 Olympus Corp ガイド装置
JP2011125632A (ja) * 2009-12-21 2011-06-30 Terumo Corp 超音波ガイド穿刺針及び留置針
JP2011125389A (ja) * 2009-12-15 2011-06-30 Terumo Corp 留置針
JP2011255099A (ja) * 2010-06-11 2011-12-22 Asahi Intecc Co Ltd 医療用ガイドワイヤ
JP2012515016A (ja) * 2009-01-12 2012-07-05 ベクトン・ディキンソン・アンド・カンパニー 柔軟な特徴部を備える内在の硬いカテーテル及び／又は柔軟なカテーテルアタッチメントの少なくとも１つを有する輸液セット及び／又はパッチポンプ
JP2013503693A (ja) * 2009-09-02 2013-02-04 サーキュライト・インコーポレーテッド 同軸経中隔ガイドワイヤおよび針アセンブリ
JP2013176559A (ja) * 2012-02-28 2013-09-09 Spiration Inc 肺生検針
JP2014200551A (ja) * 2013-04-08 2014-10-27 オリンパス株式会社 穿刺針

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005329062A (ja) * 2004-05-20 2005-12-02 Terumo Corp イントロデューサーシース
JP2012515016A (ja) * 2009-01-12 2012-07-05 ベクトン・ディキンソン・アンド・カンパニー 柔軟な特徴部を備える内在の硬いカテーテル及び／又は柔軟なカテーテルアタッチメントの少なくとも１つを有する輸液セット及び／又はパッチポンプ
JP2013503693A (ja) * 2009-09-02 2013-02-04 サーキュライト・インコーポレーテッド 同軸経中隔ガイドワイヤおよび針アセンブリ
JP2011078525A (ja) * 2009-10-06 2011-04-21 Olympus Corp ガイド装置
JP2011125389A (ja) * 2009-12-15 2011-06-30 Terumo Corp 留置針
JP2011125632A (ja) * 2009-12-21 2011-06-30 Terumo Corp 超音波ガイド穿刺針及び留置針
JP2011255099A (ja) * 2010-06-11 2011-12-22 Asahi Intecc Co Ltd 医療用ガイドワイヤ
JP2013176559A (ja) * 2012-02-28 2013-09-09 Spiration Inc 肺生検針
JP2014200551A (ja) * 2013-04-08 2014-10-27 オリンパス株式会社 穿刺針

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019070076A1 (fr) * 2017-10-06 2019-04-11 株式会社アルチザンラボ Aiguille à demeure et méthode d'utilisation d'une aiguille à demeure
JPWO2019070076A1 (ja) * 2017-10-06 2021-01-07 株式会社アルチザンラボ 留置針、及び留置針の使用方法
JP7021751B2 (ja) 2017-10-06 2022-02-17 株式会社アルチザンラボ 留置針

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JPWO2016152497A1 (ja) 2018-01-11
JPWO2016152496A1 (ja) 2018-01-18
WO2016152496A1 (fr) 2016-09-29

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