WO1997035629A1 - Catheter a double lumiere - Google Patents

Catheter a double lumiere Download PDF

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Publication number
WO1997035629A1
WO1997035629A1 PCT/US1997/004885 US9704885W WO9735629A1 WO 1997035629 A1 WO1997035629 A1 WO 1997035629A1 US 9704885 W US9704885 W US 9704885W WO 9735629 A1 WO9735629 A1 WO 9735629A1
Authority
WO
WIPO (PCT)
Prior art keywords
blood
lumen
tube
inner tube
tip
Prior art date
Application number
PCT/US1997/004885
Other languages
English (en)
Other versions
WO1997035629A9 (fr
Inventor
Yosuke Okada
Shigeaki Funamura
Original Assignee
Sherwood Medical Company
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 Sherwood Medical Company filed Critical Sherwood Medical Company
Priority to AU25475/97A priority Critical patent/AU2547597A/en
Publication of WO1997035629A1 publication Critical patent/WO1997035629A1/fr
Publication of WO1997035629A9 publication Critical patent/WO1997035629A9/fr

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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
    • 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
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • 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
    • A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
    • A61M2025/0031—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment

Definitions

  • This invention has to do with double lumen (double tube-shaped) catheters used for dialysis treatment, etc., and, more particularly has to do with a structure for double lumen catheters that is particularly effective when a heparin lock is maintained within the blood vessel while dialysis is not being performed.
  • the invention disclosed in patent disclosure Hei 1-303159, shown in Figure 11 is an example of a double lumen catheter for circulation of blood outside of the body, where the catheter remains within the blood vessel.
  • the double lumen catheter disclosed in patent disclosure Hei 1-303159 is structured, as shown in Figure 11 (a), from a No. 1 inner lumen that has multiple side holes 51a in the tip part, and which is formed in the vicinity of the tip part from the base part of a catheter 50, a No. 2 inner lumen 52 that has multiple side holes 52a in its tip part and that passes through from the base of catheter 50 through to the tip part, and a connection tube that is equipped at the base (not shown).
  • the No. 1 inner catheter 51 is formed in a shape that, in cross section, is nearly semicircular
  • No. 2 inner catheter 52 is formed in a shape that, in cross- section, is nearly semicircular meeting with the part that is formed by No. 1 inner catheter 51 , so that the tip part side forms a part that, in cross-section, is circular.
  • the tube that connects to the No. 1 inner lumen 51 is connected to the blood removal-side of the dialysis circuit, and the tube that is connected to the No. 2 inner lumen 52 is connected to the blood delivery-side of the dialysis circuit to begin circulation outside of the body, at which time the blood flows from the side holes 51a of the No. 1 inner lumen 51 into the inside of No. 1 inner lumen 51 , and is sent to the dialysis circuit, and the blood from the dialysis circuit is sent through No. 2 inner lumen 52 into the blood vessel from side holes 52a.
  • both inner lumens 51 and 52 are flushed with a sanitary saline solution to which heparin is added to perform a heparin lock so that blood clots will not form where the blood flows within said No. 1 inner lumen 51 and said No. 2 inner lumen 52.
  • Figure 12 is a structural cross-sectional diagram of required parts for another conventional double lumen catheter and a n-n cross-sectional diagram thereof, where this double lumen catheter 53 (Conventional Example 2) is structured from an integrated outer catheter 54 having side holes 54a at its tip, and inner catheter 55 that passes through the inside of outer catheter 54 where its tip part extends from the tip of outer catheter 54, where the connecting tubes (not shown) of both catheters 54 and 55 are integrated together.
  • this double lumen catheter 53 (Conventional Example 2) is structured from an integrated outer catheter 54 having side holes 54a at its tip, and inner catheter 55 that passes through the inside of outer catheter 54 where its tip part extends from the tip of outer catheter 54, where the connecting tubes (not shown) of both catheters 54 and 55 are integrated together.
  • the double lumen catheter 50 is similar to the double lumen catheter 53 having this structure, in that it is secured within a blood vessel and the respective connecting tubes are connected to a dialysis circuit to perform circulation outside of the body, moreover, after the circulation outside of the body is complete, the insides of both catheters 54 and 55 are flushed with a sanitary saline solution to which has been added heparin to perform a heparin lock.
  • a structure has been conceived of to solve the problems described above with a separate double lumen catheter outer catheter and inner catheter, where the inner catheter is withdrawn from the outer catheter during non-dialysis times and the inside of the outer catheter is flushed with the sanitary saline heparin solution, so that the inside of the outer catheter is filled with either a hollow or solid obturator where the side wall of this obturator blocks the holes in the outer catheter, thus preventing the formation of blood clots within the outer catheter.
  • This invention solves the problems described above, by maintaining for extended periods of time the heparin lock that solidly prevents the flow of blood from the blood vessel into the catheter during the time of the heparin lock, for the purposes of providing a double lumen catheter that is economical and easy to use and that reduces the load on both the patient and the doctor.
  • the double lumen catheter in this invention is equipped with at least a double lumen formed from a blood removal lumen, which is a lumen that is formed between an outer tube, wherein the tip part outer radius is reduced, and an inner tube, wherein the outer diameter of the inner tube is smaller than the inner diameter of the aforementioned outer tube, and where the tip portion of the inner tube is equipped with a wide diameter part wherein the outer diameter of the tip part of the inner tube is nearly the same as the inner diameter of the tip part of the outer tube, and a blood delivery lumen, which is the inner lumen of the inner tube, where the blood removal lumen is equipped with a blood removal tube that extends in a branch from the blood removal lumen near the base of the outer tube, and equipped with a seal valve unit that seals the blood removal lumen at the base side near the branch part of the outer tube and that can cause the inner tube to slide freely.
  • a blood removal lumen which is a lumen that is formed between an outer tube, wherein the tip part outer radius is reduced, and an inner
  • the double lumen catheter of this invention is equipped with a freely constricting sleeve that tightly covers and seals the inner tube and which is located within the position securing means between base part side of the position securing means and the base of the position determination part along with having a position securing means that is nearly tube shaped and which is equipped with connect stop parts in at least 2 locations on the inner peripheral surface which are formed as a single unit at one end of a blood delivery-side connector where the blood delivery-side connector is equipped at the base part of the inner tube, and a position determination part that slides freely within the position-securing means and which can slide freely into the inner tube, and which is equipped with a connection part stopped by the connection stop part of the position securing means at the outer peripheral surface.
  • the double lumen catheter of this invention is structured so that not only is a blood removal lumen tip opening part formed between the inner tube and the outer tube tip part by the wide diameter part extending out from the outer tube when the connection part position determination part is stopped at the connection stop part equipped on the base side of the position securing part, but also that the wide diameter part blocks the blood removal lumen tip part opening by being placed in the outer tube when the position determination part of the connection part is stopped at the connection stop part that is equipped at the opening part side at the other end of the position securing part.
  • the double lumen catheter of this invention is structured with the side wall of the tip part of the outer tube and/or the side wall of the wide diameter part being equipped with at least one side hole, and structured so that when the wide diameter part is positioned within the outer tube, the side holes in the outer tube tip part and/or the side holes in the wide diameter part are positioned so that the side wall of the outer tube and/or the side wall of the wide diameter part block the side holes, and structured so that when the connector part of the position determination part is positioned at the stop part at the base side of the position securing means, then the wide diameter part extends from the outer tube and a blood removal tip opening is formed between the inner tube and the outer tube tip part, or the wide diameter part opens the outer tube tip part side holes and wide diameter part high side holes without extending out of the outer tube, and when the position determination means connection part is stopped at the stop part equipped on the opening side of the position securing means, the wide diameter part blocks the outer tube side holes and the wide diameter part side holes and the blood removal lumen tip opening part.
  • the double lumen catheter of this invention is equipped with a stylet, which is equipped with a plunger at its base, that can easily fit into the blood delivery lumen of the inner tube so that the tip part extends from the tip part of the outer tube and its outer wall forms a tight seal with at least the inner wall of the tip part of the inner tube.
  • the double lumen catheter of this invention is structured so that the inner diameter of the tip part of the outer tube is of an smaller diameter, or so that the reduced diameter part is made from elastic materials.
  • the double lumen catheter of this invention is such that the inner walls of the inner tube being structured from materials that are hard while along with the outer wall of the inner tube being structured from materials that have relatively good compatibility with the wide diameter part where the inner tube is structured in an outer wall and inner wall double-layer structure such that the large diameter part is made from a soft material, metal wires being embedded within the inner wall of the inner tube, and/or the wide diameter part being structured from an elastic material.
  • the double lumen catheter of this invention is equipped with a slit at the tip of the inner tube, where the tip of the inner tube is structured in a form where the most leading edge of the tip is blocked.
  • the inner tube which is equipped with a wide diameter part at its tip end in this way, it is possible to place the wide diameter part within the outer tube to close the blood removal lumen tip opening, the side openings within the wide diameter part, and the side openings within the outer tube tip part, blocking them with the side wall of the outer tube and with the side wall of the wide diameter part, thereby preventing blood from flowing into the blood removal lumen and the blood delivery lumen during heparin lock.
  • Figure 1 is a structural diagram showing the first form of embodiment of this invention.
  • Figure 2 is an operational diagram showing the first form of embodiment of this invention.
  • Figure 3 is a structural diagram showing the second form of embodiment of this invention and an operational explanation diagram of the important parts.
  • Figure 4 is a structural diagram showing the third form of embodiment of this invention.
  • Figure 5 is a structural diagram showing the fourth form of embodiment of this invention.
  • Figure 6 is a structural diagram showing the fifth form of embodiment of this invention.
  • Figure 7 is an expanded cross-sectional diagram showing the important parts of the sixth form of embodiment of this invention.
  • Figure 8 is an expanded cross-sectional diagram of an example where the inner tube is changed in the sixth form of embodiment of this invention.
  • Figure 9 is an expanded cross-sectional diagram showing the important parts of the seventh form of embodiment of this invention.
  • Figure 10 is an expanded cross-sectional diagram of the outer tube related to the first form of embodiment of this invention, and a cross-sectional diagram of a modified example thereof.
  • Figure 11 is a structural diagram and an n-n cross-sectional diagram of the structure of a conventional double lumen catheter
  • Figure 12 is a structural cross-sectional diagram and an n-n cross- sectional diagram showing the important parts of another conventional double lumen catheter.
  • Embodiment Form 1 Figure 1 is a structural diagram of the first form of embodiment of this invention.
  • 1 is the outer tube wherein the outer diameter of the tip part of the tube is reduced
  • 2 is the inner tube which has an outer diameter that is less than the inner diameter of outer tube 1
  • the inner tube is equipped with a wide diameter part 2a that has an increased outer diameter so that it is about the same as the inner diameter of outer tube 1 at its tip part and which also has a reduced outer diameter at its leading side
  • blood removal lumen 21 is a lumen which is formed between outer tube 1 and inner tube 2 and which passes through the inside of outer tube 1
  • blood supply lumen 22 is the inner lumen of the inner tube to form a double lumen structure.
  • a support tube where the tip thereof is rigidly fixed to the base of outer tube 1 where inner lumen 3a passes through blood removal lumen 21, a concave part 4 is equipped on the center part of the base side, and connecting concave part 3 is equipped on the outer peripheral surface of the base part.
  • a blood removal-side connector 5a where blood removal tube 3c to which is connected blood removal-side tube 5 which is connected to inner lumen 3a is branched.
  • connection concave part 8a of outer wall 6a is stopped by connection concave part 3b of support tube 3 to connect the position determination means 6 to the base of support tube 3.
  • ring-shaped seal valve which seals the blood removal lumen 21 that is attached to the lower part of concave part 4 of the support tube 3 and in which its inner periphery is in sliding contact with the outer periphery of inner tube 2, and which is fastened by inner wall 6b of position determination means 6 that is inserted into the concave part 4 of support tube 3, structured, for example, of a silicone rubber or another elastic material.
  • a position fastening means that is tube shaped and that has blood delivery-side connector 11 on one end and that is open on the other end, where the base part of inner tube 2 is fastened at the tip part of blood delivery-side connector 11 , where this inner tube 2 and the position securing means 10 are fabricated as a single unit.
  • the inner wall of the opening side of this position securing method 10 is equipped with a stop connection convex part 10a that stops at the connection concave part 8b equipped on the outer peripheral surface of outer wall 6a or position determination material 6, where, similarly, the base side is also equipped with connection stop convex part 10b, and where the side wall on the opening part side (or in this case, the top portion of the side wall) is equipped with a nearly U shaped guide hole 12 that guides blood removal tube 3c of support tube 3.
  • 13 is a sterile support sleeve that can be freely extended and retracted and that tightly covers inner tube 2 positioned at location securing means 10, and which is equipped between the base of the position determination part 6 and the inside of the base of position determination part 10, made from, for example, a thin transparent film such as polyethylene.
  • outer tube 1, inner tube 2, support tube 3, blood removal-side tube 5, position determination part 6, and position securing part 10 are all made, for example, from a synthetic resin material such as polyurethane to form the double lumen catheter "A" that will be used in circulation outside of the body.
  • the double lumen catheter A is inserted into a blood vessel using a guide wire, etc., and is fastened there when it is in a state where the connection stop convex part 10a of the opening side of the position securing means 10 is stopped at the connection concave part 8b of the position determination part 6, or in other words, is in a state where the wide diameter part 2a of the inner tube 2 is positioned inside of outer tube 1. Consequently, blood removal-side tube 5 is connected to the blood removal-side of the dialysis circuit through connector 5a, and position securing means 10 [SIC?] is connected to the blood supply-side of the dialysis circuit through connector 11.
  • connection stop convex part 10a of the open part side of position securing means 10 and the connection concave part 8b of position determination part 6 is released, position securing means 10 is slid in the forward direction (in the direction marked with arrow Z shown in Figure 1 ), and connection stop convex part 10b of the base side of position securing means 10 is stopped at the connection concave part 8b of position determination part 6.
  • the inner tube 2 also moves in the forward direction, and as shown in Figure 2, the wide diameter part 2a of inner tube a extends out from the tip part of outer tube 1a to create a blood removal lumen tip opening part 21a between inner tube 2 and the tip part of outer tube 1.
  • the sterile support sleeve 13 is compressed by the movement of the position determination part 6, and is maintained in that state within the inside of position securing means 10.
  • the blood within the blood vessel flows into blood removal lumen 21 from blood removal lumen tip opening 21 a formed between inner tube 2 and the tip part of outer tube 1 , as shown by the arrow labeled X in Figure 2, and is sent to the dialysis circuit through inner lumen 3a of support tube 3, blood removal tube 3c, and blood removal-side tube 5.
  • the blood from the dialysis circuit is delivered to the blood vessel from the tip part of inner tube 2 (blood delivery lumen 22) through blood delivery lumen 22 which is the inner lumen of inner tube 2.
  • the dialysis circuit is removed from blood removal-side connector 5a and blood delivery-side connector 11 , and blood supply lumen 22 of inner tube 2 is flushed with a sanitary saline heparin solution from the blood supply-side connector 11. Then the blood removal lumen 21 is flushed with the sanitary saline heparin solution through blood removal- side tube 5, etc., from the blood removal-side connector 5a side, to perform a heparin lock on blood removal " lumen 21 and blood supply lumen 22. Moreover, after the blood supply-side connector 11 is blocked by inserting a rubber stopper, etc.
  • connection stop convex part 10b of the base side of position securing means 10 and the connection concave part 8b of position determination part 6 is released, the position securing means 10 is slid in the backwards direction (the direction opposite to the direction shown by the arrow labeled Z in Figure 1 ), and connection stop convex part 10a of the opening part side of connection securing means 10 is stopped at the connection concave part 8b of the position determination part 6.
  • the inner tube 2 is also moved in the backwards direction, so as shown in Figure 1 the blood removal lumen tip opening part 21a is closed by the wide diameter part 2a being positioned inside of outer tube 1 , which prevents the sanitary saline heparin solution within blood removal lumen 21 from escaping into the blood vessel side from blood removal lumen tip opening part 21a.
  • the sterile maintenance sleeve 13 extends with the sliding movement of the position determination part 6 to return to the form shown in Figure 1.
  • the inner diameter of the tip part or in other words the lumen diameter of blood delivery lumen 22, is fabricated with a size that makes it difficult for the sanitary saline heparin solution to escape, and thus most of the sanitary saline heparin solution does not escape into the blood vessel side, and so there is no danger of the blood supply lumen 22 becoming blocked by blood clots.
  • the position securing means 10 is slid in the forward direction, the connection stop convex part 10b of the base side of position securing means 10 is stopped at the connection concave part 8b of position determination part 6, and the wide diameter part 2a of the inner tube 2 extends out from the tip part of outer tube 1.
  • blood removal lumen 21 and the blood supply lumen 22 are flushed with the sanitary saline heparin solution, blood removal-side connector 5a and blood supply-side connector 11a are connected to their respective dialysis circuit connections, and circulation outside of the body resumes.
  • connection stop convex parts 10a and 10b of position securing means 10 and connection concave part 8b of position determination part 6 to easily and certainly extend and retract wide diameter part 2a, thus making it possible to support a heparin lock of blood removal lumen 21 for an extended time period while double lumen catheter A is secured within the blood vessel, thus preventing the inadequate blood removal flow and preventing situations where circulation is not possible when circulation outside of the body is restarted because obstructing blood clots in blood removal lumen 21.
  • the load on both the patient and the doctor is lightened, making it possible to obtain the easily used double lumen catheter A.
  • FIG. 3 shows a structural diagram of the second form of embodiment of this invention along with an operational explanation diagram of its important parts.
  • This form of embodiment has multiple side holes 1a for blood removal connected to blood removal lumen 21 at the tip part of outer tube 1 found in the first form of embodiment.
  • the operation is the same as was explained in the first form of embodiment in that the double lumen catheter B is inserted into the blood vessel using a guide wire, etc., and then is secured there (see Figure 3(a)) when it is in a state where connection stop convex part 10a of the opening part side of position securing means 10 is stopped at the connection concave part 8b of position determination part 6.
  • the blood flows into blood removal lumen 21 from side holes 1a of outer tube 1 and is delivered to the dialysis circuit, and blood from the dialysis circuit is delivered to the blood vessel through blood delivery lumen 22 from its tip part.
  • the blood removal-side connector 5a and blood supply-side connector 11 are removed from the dialysis circuit, blood removal lumen 21 and blood supply lumen 22 are flushed with the sanitary saline heparin solution, and a heparin lock is performed.
  • connection stop convex part 10a of the opening part side of position securing means 10 is slid in the backwards direction to cause the connection stop convex part 10a of the opening part side of position securing means 10 to stop at the connection concave part 8b of the position determination part 6, causing, as is shown in Figure 3 (a) the wide diameter part 2a of inner tube 2 to be positioned within outer tube 1 , blocking side holes 1a of outer tube 1 with the side wall of wide diameter part 2a.
  • Figure 4 shows a structural diagram of the third form of embodiment of this invention, where multiple side holes 2b blood supply through blood supply lumen 22 are equipped at in the side wall of the wide diameter part 2a of inner tube 2 of the first form of embodiment of this invention.
  • the inner diameter of the tip part of inner tube 2 (the lumen diameter of blood supply lumen 22) is structured in this form of embodiment with a size that is such that most of the sanitary saline heparin solution does not escape.
  • connection stop convex part 10a of the opening part side of position securing means 10 is stopped at the connection concave part 8b of position determination part 6.
  • position securing means 10 is slid in the forward direction to cause the connection stop convex part 10b of the base part side of position securing means 10 to stop at the connection concave part 8b of position determination part 6, causing the wide diameter part 2a of inner tube 2 to extend out from the tip part of outer tube 1a to form a blood removal lumen tip opening part 21a between the inner tube 2 and the tip part of outer tube 1.
  • blood flows into blood removal lumen 21 through this blood removal lumen tip opening part 21a and is delivered to the dialysis circuit while the blood from the dialysis circuit is delivered into the blood vessel through blood supply lumen 22 and its tip part and the side holes 2b.
  • the blood removal-side connector 5a and blood supply-side connector 11 are removed from the dialysis circuit, blood removal lumen 21 and blood supply lumen 22 are flushed with the sanitary saline heparin solution, and a heparin lock is performed.
  • the position securing means 10 is slid in the backwards direction to cause the connection stop convex part 10a of the opening part side of position securing means 10 to stop at the connection concave part 8b of the position determination part 6, causing, as is shown in Figure 4, the wide diameter part 2a of inner tube 2 to be positioned within outer tube 1 , blocking the blood removal lumen tip opening part 21a, and blocking side holes 1a of outer tube 1 with the side wall of wide diameter part 2a.
  • Form of Embodiment 4 Figure 5 shows a structural diagram of the 4th form of embodiment of this invention, where this form of embodiment not only has multiple side holes 1a for blood removal through blood removal 31 equipped in the tip part of outer tube 1 , but also has multiple side holes 2b for blood supply through blood supply lumen 22 equipped in the side wall of wide diameter part 2a of inner tube 2.
  • connection stop convex part 10b of the base part side of connection securing means 10 is slid in the forward direction to cause connection stop convex part 10b of the base part side of connection securing means 10 to stop at the connection concave part 8b of the position determination part 6, causing the wide diameter part 2a of inner tube 2 to protrude from the tip part of outer tube 1.
  • the wide diameter part 2a of inner tube 2 does not protrude completely out of the tip part of outer tube 1, but rather the blood removal lumen tip opening part 21a is blocked by the wide diameter part 2a of inner tube 2 and the blood is removed only through the side holes 1a in outer tube 1.
  • blood flows into blood removal lumen 21 through the side holes 1a in outer tube 1 and is sent to the dialysis circuit while blood from the dialysis circuit is delivered to the blood vessel through blood supply lumen 22 and from its tip part and from side holes 2b.
  • blood removal-side connector 5a and blood supply-side connector 11 are removed from the dialysis circuits, blood removal lumen and blood supply lumen 22 are flushed with sanitary saline heparin solution, and a heparin lock is performed.
  • position securing means 10 is slid in the backwards direction to cause the connection stop convex part 10a of the opening part side of position determination means 10 to stop at the connection concave part 8b of the position determination part 6, and as shown in Figure 5, the wide diameter part 2a of inner tube 2 is caused to be positioned inside of outer tube 1 causing side holes 1a in outer tube 1 to be blocked by the side walls of the wide diameter part 2a, and causing side holes 2b in inner tube 2 to be blocked by the side walls of the tip portion of outer tube 1.
  • 15 is a stylet that can be inserted into or removed from the blood supply lumen 22 of the inner tube 2 in the first form of embodiment of this invention, fitting in such a way as to cause a tight seal with at least the inner wall of the tip part of inner tube 2, where the outer diameter of this stylet is approximately the same as the inner diameter of tube 2 (the lumen diameter of blood supply lumen 22) where this inner diameter is approximately the same as the outer parameter of a guide wire 16 that is used when inserting the catheter into the blood vessel, and where the device is equipped with tubular main unit 15a the tip of which having a length that protrudes from the tip part of inner tube 2 and which has an outer diameter that is smaller at the tip, and has a connector 16c at one end, where plunger part 15b is equipped with a concave part 15b that fits into the base part of the blood supply-side connector 11 and is equipped with a connection stop part 15a that stops at flange part 11a of the blood supply-side connector at the inner peripheral surface at the other end, where
  • the inner diameter of the tip part of inner tube 2 in this form of embodiment is constructed to be larger than the outer diameter if guide wire 16, where stylet 15 is fit into blood removal lumen 22 of inner tube 2 so as to block the gap between the inner wall of inner tube 2 and the outer wall of guide wire 16 that passes through blood supply lumen 22, not only preventing the stripping of the tip part of inner tube 2 when it is inserted into the blood vessel by eliminating the gap that appears between the tip portion of inner tube 2 and the guide wire 16, but reinforcing the hardness of the inner tube 2 and the entire double lumen catheter A.
  • the tip part of the main unit 15a of stylet 15 extends out of the tip part of inner tube 2, and the main unit 15 forms a tight seal with at least the inside wall of the tip part of inner tube 2.
  • guide wire 16, etc. is used to insert this double lumen catheter A into the blood vessel, where it is secured.
  • the double lumen catheter A is inserted smoothly into the blood vessel with stylet 15 without the tip part of inner tube 2 being stripped.
  • stylet 15 is removed from double lumen catheter A, and blood removal-side connector 5a and blood supply connector 11 are connected to their respective dialysis circuits.
  • Next position securing means 10 is slid, the wide diameter part 2a of inner tube 2 is caused to extend out of the tip part of outer tube 1 , and the blood removal lumen tip opening part 21 a is formed between the inner tube 2 and the tip portion of outer tube 1. Moreover, when the circulation outside of the body is started, blood flows into the blood removal lumen 21 from the blood removal lumen tip opening part 21a and is delivered to the dialysis circuit, while blood from the dialysis circuit is delivered into the blood vessel through blood supply lumen 22 from its tip part.
  • the blood removal side connector 5a and the blood supply side connector 11 are removed from the dialysis circuits, and a heparin lock is performed by flushing blood removal lumen 21 and blood supply lumen 22 with the sanitary saline heparin solution. Then the position securing means 10 is slid, the wide diameter part 2a of inner tube 2 is moved into outer tube 1 , and the blood removal lumen tip opening part 21a is blocked by the wide diameter part 2a.
  • double lumen catheter A which has an inner tube 2 with an inner diameter that is bigger than the outer diameter of guide wire 16
  • stylet 15 is inserted into blood removal lumen 22 of inner tube 2 in order to block the gap between the inner wall of inner tube 2 and the outer wall of guide wire 16 and to cause the tip part of stylet 15 to protrude from the tip part of inner tube 2, and thus it is possible to insert the double lumen catheter A into the blood vessel smoothly, making it possible to reduce the damage to the patient.
  • stylet 15 reinforces the strength of double lumen catheter A as a whole, it is possible to insert double lumen catheter A with ease, without placing a strong force on the wall of the blood vessel by making it possible to follow a curved blood vessel, making it possible to obtain a double lumen catheter A with superior usability.
  • FIG. 7 is an expanded cross-sectional diagram of the important parts of the sixth form of enablement of this invention, where this form of enablement is one wherein the inner tube 2 of the first firm of enablement of this invention is formed from a 2-layer structure that has a material with hardness, such as polyimide, for example, with a surface 2c having a adhesive material, where the wide diameter part 2a is formed from a material with softness, such as, for example, a polyimide-system elastomer, where the tip part of this inner tube 2 is secured in the base part of the wide diameter part 2a so as to form a single unit.
  • the material that has the adhesive properties of the surface 2c has a compatibility with the material from which is constructed the wide diameter part 2a that is of superior adhesiveness.
  • wide diameter part 2a should be made from an elastic material.
  • the inner tube 2 is formed from a material with hardness, it is possible to maintain the transmission of torque while suppressing the bending hardness of inner tube 2 even when the thickness of the side walls of inner tube 2 is made thinner through fabricating inner tube 2 with a large inner diameter in order to support a greater volume of blood flow through blood supply lumen 22, thus making it possible to obtain a double lumen catheter A with excellent usability.
  • inner tube 2 can, for example, be made from materials that are relatively soft and thus are compatible with the large diameter part 2a and then, as shown in Figure 8, be strengthened by embedding into the walls of inner tube 2 a material such as, for example, the stainless steel wire web 17. Even in this case, the same results would be obtained.
  • this is shown in this particular embodiment of this invention using the inner tube 2 that is formed as found in the first example of embodiment of this invention, it may also be applied to the forms of embodiment of this invention found in the second through fifth examples described above, and in the seventh form of embodiment of this invention to be described below, and in these cases the results would be the same.
  • Figure 9 shows a magnified cross-sectional diagram of the important parts of the seventh form of enablement of this invention.
  • the tip-most part 18 of the tip inner tube 2 i.e. the tip part of the wide diameter part 2a
  • side holes 2b as found in the third form of enablement of this invention
  • tip-most part 18 of inner tube 2 is fabricated so that it is closed, because slit 19 is provided, guide wire 19, which is used when equipping double lumen catheter C into the blood vessel, can be received easily, and by closing the tip-most part 18 it is possible to maintain a heparin lock while preventing blood from flowing into blood removal lumen 22 and preventing the sanitary saline heparin solution from escaping from the tip of blood removal lumen 22.
  • the outer radius of the tip part R1 of outer tube 1 was shown with a reduced radius ( ), however, as shown in Figure 10 (b) the inner radius R2 may also be set at a reduced radius (r2) to insure a firm contact with the side walls of wide diameter part 2a of inner tube 2, and, as shown in Figure 10 ⁇ the tip portion may be made from an elastic material 20, and the outer diameter and inner diameter may be reduced to insure a solid seal with the wide diameter portion 2a of inner tube 2.
  • this invention may be applied to not only the first form of embodiment of this invention, but to the second to seventh forms of embodiment of this invention as well, with equal effectiveness in these cases.
  • the double lumen catheter of this invention is equipped with a double lumen catheter characterized by at least a double lumen formed from a blood removal lumen, which is a lumen that is formed between an outer tube, wherein the tip part outer radius is reduced, and an inner tube, wherein the outer diameter of the inner tube is smaller than the inner diameter of the aforementioned outer tube, and where the tip portion of the inner tube is equipped with a wide diameter part wherein the outer diameter of the tip part of the inner tube is nearly the same as the inner diameter of the tip part of the outer tube, and a blood delivery lumen, which is the inner lumen of the inner tube, where the blood removal lumen is equipped with a blood removal tube that extends in a branch from the blood removal lumen near the base of the outer tube, and equipped with a seal valve unit that seals the
  • the double lumen catheter of this invention is one wherein the side wall of the tip part of the outer tube and/or the side wall of the wide diameter part being equipped with at least one side hole, and structured so that when the wide diameter part is positioned within the outer tube, the side holes in the outer tube tip part and/or the side holes in the wide diameter part are positioned so that the side wall of the outer tube and/or the side wall of the wide diameter part block the side holes, and structured so that when the connector part of the position determination part is positioned at the stop part at the base side of the position securing means, then the wide diameter part extends from the outer tube and a blood removal tip opening is formed between the inner tube and the outer tube tip part, or the wide diameter part opens the outer tube tip part side holes and wide diameter part high side holes without extending out of the outer tube, and when the position determination means connection part is stopped at the stop part equipped on the opening side of the position securing means, the wide diameter part blocks the outer tube side holes and the wide diameter part side holes and the blood removal lumen tip opening
  • the double lumen catheter of this invention is equipped with a stylet, which is equipped with a plunger at its base, which can easily fit into the blood delivery lumen of the inner tube so that the tip part extends from the tip part of the outer tube and its outer wall forms a tight seal with at least the inner wall of the tip part of the inner tube, making it not only possible to prevent peeling during the insertion into the blood vessel of the tip part of the inner tube when the inner tube has a large inner diameter in its tip part, but it also makes it possible to reinforce the strength of the double lumen catheter as a whole to facilitate smooth insertion into the blood vessel, thus making it possible to obtain a double lumen catheter with superior ease of use that reduces the load on both the doctor and the patient.
  • the double lumen catheter of this invention is one which is structured so that the inner diameter of the tip part of the outer tube is of an smaller diameter, or so that the reduced diameter part is made from elastic materials, making it possible to increase the seal with the wide diameter part of the inner tube, making it possible to prevent with certainty problems with inadequate blood removal flow or the inability to circulate the blood due to blood clots.
  • the double lumen catheter of this invention is one which wherein the inner walls of the inner tube being structured from materials that are hard while along with the outer wall of the inner tube being structured from materials that have relatively good compatibility with the wide diameter part where the inner tube is structured in an outer wall and inner wall double-layer structure such that the large diameter part is made from a soft material, or structured with metal wires being embedded within the inner wall of the inner tube, or structured with the wide diameter part being structured from an elastic material, making it possible to not only reduce the risk of damaging the walls of the blood vessel, etc., through the protrusion of the wide diameter part from the outer tube, but also to reduce the hardness of the of the inner tube while yet maintaining its ability to transmit torque, thus making it possible to obtain a high-reliability double lumen catheter with superior ease of use.
  • the double lumen catheter of this invention is equipped with a slit at the tip of the inner tube, where the tip of the inner tube is structured in a form where the most leading edge of the tip is blocked, thus making it possible to prevent with certainty the flow of blood into the blood removal lumen, and to prevent with certainty the escape of the sanitary saline heparin solution from the blood removal lumen without interfering the operation involved in placing the catheter into the blood vessel.

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  • 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)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un cathéter à double lumière, qui comprend une lumière (21) servant à extraire du sang, située entre le tube extérieur (1) et le tube intérieur (2) dont l'extrémité avant est élargie, et une lumière (22) servant à injecter du sang, qui est la lumière intérieure du tube intérieur (2). Une lumière en embranchement, servant à extraire du sang (3c) s'étend à proximité de la base du tube extérieur (1), et un clapet d'obturation (9) est placé sur le côté de la base du tube extérieur (1) adjacent à l'embranchement. Le clapet d'obturation (9) ferme hermétiquement la lumière (21) servant à extraire du sang tout en permettant au tube intérieur (2) d'y glisser librement. Un connecteur injecteur de sang (11) est installé à la base du tube intérieur (2). Un élément de retenue (10) presque cylindrique, muni de butées (10a et 10b) sur sa circonférence intérieure est placé à une extrémité du connecteur injecteur de sang (11). Lorsque la pièce d'engagement (8b) du positionneur (6) est engagée avec la butée (10b) installée sur le côté de la base de l'élément de retenue (10), l'extrémité allongée (2a) est poussée hors du tube extérieur (1) et l'ouverture (21a) de la lumière servant à extraire du sang se forme entre le tube intérieur (2) et l'extrémité avant du tube extérieur (1). A l'opposé, lorsque la pièce d'engagement (8b) est engagée avec la butée (10a) installée sur le côté ouverture, l'extrémité allongée (2a) se retire dans le tube extérieur (2) et ferme l'ouverture arrière (21a) de la lumière servant à extraire du sang.
PCT/US1997/004885 1996-03-26 1997-03-26 Catheter a double lumiere WO1997035629A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU25475/97A AU2547597A (en) 1996-03-26 1997-03-26 Double lumen catheter

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP06956296A JP3409270B2 (ja) 1996-03-26 1996-03-26 ダブルルーメンカテーテル
JP8/69562 1996-03-26

Publications (2)

Publication Number Publication Date
WO1997035629A1 true WO1997035629A1 (fr) 1997-10-02
WO1997035629A9 WO1997035629A9 (fr) 1998-02-12

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1997/004885 WO1997035629A1 (fr) 1996-03-26 1997-03-26 Catheter a double lumiere

Country Status (3)

Country Link
JP (1) JP3409270B2 (fr)
AU (1) AU2547597A (fr)
WO (1) WO1997035629A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
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EP1287844A1 (fr) * 2001-08-16 2003-03-05 REHAU AG + Co Systéme de catheter pour drainage et Lyse
EP1321163A1 (fr) * 2001-12-19 2003-06-25 C-I-Medic Co., Ltd. Ensemble cathéter
EP1670523A2 (fr) * 2003-10-08 2006-06-21 Medical Components, Inc. Catheter coaxial effile
US7282041B2 (en) 2002-06-27 2007-10-16 Nipro Corporation Multi lumen catheter
CN107096085A (zh) * 2017-03-19 2017-08-29 陈菁 一种支气管肺泡灌洗导管

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CA2302720C (fr) * 1999-03-29 2009-07-14 Ed Geistlich Sohne Ag Fur Chemische Industrie Compositions sterilisantes avec anticoagulant et methodes connexes
JP4567847B2 (ja) * 2000-05-30 2010-10-20 ユニチカ株式会社 ダブルルーメンカテーテル
US7001369B2 (en) 2003-03-27 2006-02-21 Scimed Life Systems, Inc. Medical device
JP2006149442A (ja) * 2004-11-25 2006-06-15 Piolax Medical Device:Kk カテーテル
WO2006090707A1 (fr) * 2005-02-22 2006-08-31 Kaneka Corporation Catheter
JP4790366B2 (ja) * 2005-10-13 2011-10-12 株式会社カネカ 体外循環用カテーテル
US8048059B2 (en) * 2005-05-09 2011-11-01 Medical Components, Inc. Security tip for vascular catheter and method of using same
JP2007037971A (ja) * 2005-07-05 2007-02-15 Ookiddo:Kk カテーテル組立体とシース引裂補助具
US20070260173A1 (en) * 2006-05-05 2007-11-08 Alcon, Inc. Irrigation/aspiration tip
CA2688825C (fr) * 2007-05-17 2016-06-28 Medgenesis Therapeutix Inc. Catheter porteur ameliore par convection avec element raidisseur amovible et mode d'utilisation de celui-ci
US20200359995A1 (en) * 2019-05-17 2020-11-19 Boston Scientific Scimed, Inc. Apparatus to provide an adjustable mechanism for radial ultrasound port and flush port
CN216629383U (zh) * 2020-09-29 2022-05-31 巴德阿克塞斯系统股份有限公司 多内腔导管和导管系统

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US4004588A (en) * 1975-05-21 1977-01-25 Wrightson Nma Limited Apparatus for flushing ova from cows or mares
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Publication number Priority date Publication date Assignee Title
US1494344A (en) * 1923-04-09 1924-05-20 Joseph W Deben Syringe
US2148541A (en) * 1935-12-10 1939-02-28 Hugh E Dierker Colon therapy device and applicator therefor
US4004588A (en) * 1975-05-21 1977-01-25 Wrightson Nma Limited Apparatus for flushing ova from cows or mares
US4014333A (en) * 1975-09-22 1977-03-29 Mcintyre David J Instrument for aspirating and irrigating during ophthalmic surgery
US4648865A (en) * 1984-01-12 1987-03-10 Karl Aigner Device for in vivo purification of blood
US5176660A (en) * 1989-10-23 1993-01-05 Cordis Corporation Catheter having reinforcing strands
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US5437673A (en) * 1993-02-04 1995-08-01 Cryomedical Sciences, Inc. Closed circulation tissue warming apparatus and method of using the same in prostate surgery

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1287844A1 (fr) * 2001-08-16 2003-03-05 REHAU AG + Co Systéme de catheter pour drainage et Lyse
EP1321163A1 (fr) * 2001-12-19 2003-06-25 C-I-Medic Co., Ltd. Ensemble cathéter
US7282041B2 (en) 2002-06-27 2007-10-16 Nipro Corporation Multi lumen catheter
US7846127B2 (en) 2002-06-27 2010-12-07 Nipro Corporation Multi lumen catheter
EP1670523A2 (fr) * 2003-10-08 2006-06-21 Medical Components, Inc. Catheter coaxial effile
EP1670523A4 (fr) * 2003-10-08 2007-10-03 Medical Components Inc Catheter coaxial effile
US8226633B2 (en) 2003-10-08 2012-07-24 Medical Components, Inc. Method of making a co-axial catheter
US8241245B2 (en) 2003-10-08 2012-08-14 Medical Components, Inc. Co-axial catheter
CN107096085A (zh) * 2017-03-19 2017-08-29 陈菁 一种支气管肺泡灌洗导管

Also Published As

Publication number Publication date
JPH09253214A (ja) 1997-09-30
AU2547597A (en) 1997-10-17
JP3409270B2 (ja) 2003-05-26

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