JP2007007042A - Multi-guide hole catheter, multi-guide hole catheter assembly , and method for operating the assembly - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a multi-guide hole catheter which does not make a fracture at a tube wall. <P>SOLUTION: A first guide hole 11 is formed of the lower part of a main body and a common partition 19. Its cross section is shifted from a nearly D-shape to a proximal end 12 through a shifting part 20 to be a nearly circular cross section, and connected to a first distal end opening 51. This three-dimensional shape prevents vortex of blood and prevents blood clot. A second guide hole 13 includes a second opening 55 extended obliquely from the common partition 19 toward the first distal end opening 51. A guide wire 61 is made pass through the second guide hole 13 on the upper side of the common partition 19 of a main body 18 from the proximal end 12, goes out onto the main body 18 from a second guide wire opening 56, passes through over the distal end of a second distal end 17, enters inside of the first guide hole 11 from a second opening 52 toward a distal end 14. The guide wire 61 presses the top of the distal end of the elastic second distal end 17 to squash it downward to bend it to prevent the second distal end 17 from being caught by a blood vessel wall. When the guide wire 61 is pulled out, the distal end of the second distal end 17 is returned to an upper position of a front side by elasticity, and a cavity 60 is opened to make flowing blood flow into the second guide hole 13 easily. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a multi-hole catheter assembly (acembrie) used to simultaneously drain and inject fluid from the body, such as during hemodialysis.

Catheters for fluid injection or drainage are placed in various venous locations and cavities throughout the body for fluid injection or drainage.
Such catheterization can be performed using a single catheter assembly with multiple lumens.

  A typical example of a multi-lead catheter assembly is a dual guide catheter where one guide hole injects fluid and the other guide hole drains fluid. Such multi-lead catheter assemblies are known as SPRIT STREAM® catheters and are manufactured and sold by Medical Components, Inc. of Harleysville, Pa.

  In general, when any catheter is inserted into a blood vessel, the blood vessel is identified by aspiration through a long hollow needle according to the well-known Seldinger method. When blood enters the syringe barrel attached to the needle, it indicates that a blood vessel has been found, at which time a thin guidewire is introduced, and a stenotic needle or other introducer is generally introduced into the vessel lumen Is done.

  The introducer is then removed leaving the guide wire in the blood vessel. The guide wire is placed protruding from the skin surface. At this point, the physician has several options for catheter insertion. The simplest is to pass the catheter through the blood vessel directly through the guide wire.

  Thereafter, the guide wire is removed by placing the catheter at a predetermined position in the blood vessel. However, this technique is only applicable when the catheter is made of a relatively small diameter, stiff material, and not much larger than a guide wire for insertion of a small diameter dual guide catheter.

  When the inserted catheter is significantly larger than the guidewire, the dilator is passed over the guidewire and removed to enlarge the vessel opening diameter. The catheter is then passed over the guide wire, and then the guide wire is removed by placing the catheter in the blood vessel.

  During hemodialysis, two lead holes, arterial and venous lead holes, are connected to the hemodialyzer, each of which removes toxic blood from the patient for hemodialysis, It is also used to return dialyzed blood to the patient.

  However, the aspiration of toxic blood into the arterial lead pulls the distal end opening of the arterial lead into the arterial wall into which the lead is inserted, reducing or blocking the blood flow through the arterial lead, Decrease dialysis blood volume.

  This reduction in blood flow will result in an increase in dialysis time or will reduce the dialysis volume of the patient's blood. It would be beneficial to provide a catheter that reduces the retraction of the arterial lead to the vessel wall.

  Patent Literature 1 and Patent Literature 2 disclose a dual lead catheter having an arterial guide hole including an overhanging lip or a shield for reducing the phenomenon of the arterial guide hole being drawn into the blood vessel wall.

  However, both of the above prior arts have a structure for an insertion method in which a hard lip that protrudes during catheter insertion has the potential to tear the vessel wall and minimize the possibility of such tearing. Or, no method is disclosed. It would be beneficial to provide a catheter with an overhanging lip and a method for inserting the catheter without incurring such a laceration.

US Pat. No. 5,405,320 US Pat. No. 6,280,423 B1

  The present invention provides an improved multi-hole catheter assembly having an overhanging lip to reduce the pull-in phenomenon of the arterial lead to the vessel wall so that the lip does not risk laceration of the vessel wall. And

  In summary, the present invention provides a multi-guide hole catheter assembly. The assembly comprises an elongated tubular body having a proximal end and a distal end. The first guide hole extends between the proximal end and the transition portion with a substantially D-shaped cross section formed by the main body and the common partition. The transition portion causes the first guide hole to transition from a substantially D-shaped cross-sectional shape to a substantially circular cross-sectional shape. The transition portion has an upper surface of a curved surface having an arc-shaped cross section that substantially extends with a vertex in the direction of the near end. The transition part is a triangle whose planar shape has a vertex toward the near end. This shape prevents blood vortex and prevents clotting. The far end of the main body extends to the far end side of the transition portion, and the cross-sectional shape is substantially circular at the far end. A first far end opening is provided at the far end of the body.

  A first substantially oval guide wire opening is provided in the same plane as the common partition near the far end. The second guide hole communicates with the common partition wall and extends between the second far end and the near end near the far end. The second guide hole includes a second opening below the second far end extending obliquely from the common partition toward the first opening. The second opening is provided below the second far end made of a resilient material, and the second far end can be elastically deformed toward the upper surface of the transition portion. A second substantially oval guidewire opening is provided on a surface substantially parallel to the common partition near the second opening.

The invention according to claim 1 is:
Having an elongated body (18) having a proximal end (12) and a distal end (14);
A common bulkhead (19) extending between the near end (12) and the far end (14),
A first far end opening (51) disposed at the far end (14);
A first guide hole (11) having a first guide wire opening (52) disposed adjacent to the far end (14) and coplanar with the common partition wall (19) having the following: :
A substantially D-shaped cross section formed by the main body (18) and the common partition (19) extending between the proximal end (12) and the transition part (20), provided that the transition part (20) is the first. The lead hole (11) transitions from its substantially D-shaped cross section to a substantially circular cross section, and its transition (20) is a generally expanded arched upper surface at its apex (20b) and near end. Including (20a),
The far end (14) extending to the far end of the transition (20) and having a substantially circular cross-section,
A first far end opening (51) disposed at the far end (14); and
Having a generally elongated first guidewire opening (52) near its distal end (14) and disposed coplanar with the common septum (19);
And a second guide hole (13) connected to the common bulkhead (19) and extending between the near end (12) and the second far end (17) closer to the far end (14). Including the following:
The second far end (17) above the second opening (55) extending obliquely from the common partition wall (19) toward the first far end (15), and the second far end on the second opening (55). The far end (17) can be elastically crushed toward the transition part (20); and is arranged in a plane substantially parallel to the common bulkhead (19) adjacent to the second opening (55) A generally elongated second guidewire opening (56);
A multi-lead catheter assembly.
The invention according to claim 2 is the invention according to claim 1, and
A multi-hole catheter assembly further comprising a hub (16) connected to the proximal end (12) of the body (18).
The invention according to claim 3 is the invention according to claim 1, and
The multi-guide catheter assembly further includes at least one opening in which the first guide hole (11) is disposed closer to the side near the far end (14).
The invention according to claim 4 is the invention according to claim 1, further comprising:
A multi-hole catheter assembly in which the first distal end opening is disposed in a plane substantially perpendicular to the plane of the common septum (19).
The invention according to claim 5 is the invention according to claim 1, and
A multi-hole catheter assembly in which the first distal end opening is substantially circular.
The invention described in claim 6 is the invention described in claim 1, further comprising:
The multi-hole catheter assembly has a first D-hole (11) having a substantially D-shaped cross section in the vicinity of the second opening (55).
The invention according to claim 7 is the invention according to claim 1, further comprising:
The second guide hole (13) is a multi-lead catheter assembly having a substantially D-shaped cross section.
The invention according to claim 8 is the invention according to claim 1, further comprising:
A multi-hole catheter assembly in which the body (18) has a substantially circular cross section.
The invention described in claim 9 is the invention described in claim 1, further comprising:
A multi-hole catheter assembly in which the second opening (55) is tapered.
The invention described in claim 10 is the invention described in claim 1, further comprising:
A multi-guide catheter assembly in which the first guidewire opening (52) is substantially oval.
The invention according to claim 11 is the invention according to claim 1, further comprising:
The multi-guide catheter assembly in which the second guidewire opening (56) is substantially oval.
The invention according to claim 12 is:
A method of operating a multi-hole catheter assembly (10) comprising the following steps:
An elongated body (18) having a proximal end (12) and a distal end (14) inserted into the blood vessel;
A common bulkhead (19) extending between the near and far ends,
A first far end opening (51) disposed at the far end (14);
A first guide hole (11) having a first guide wire opening (52) disposed adjacent to the far end (14) and coplanar with the common partition wall (19) having the following: :
A substantially D-shaped cross section formed by the main body (18) and the common partition (19) extending between the proximal end (12) and the transition part (20), provided that the transition part (20) is the first. The lead hole (11) transitions from its substantially D-shaped cross section to a substantially circular cross section, and its transition (20) is a generally expanded arched upper surface at its apex (20b) and near end. Including (20a),
The far end (14) extending to the far end of the transition (20) and having a substantially circular cross-section,
A first far end opening (51) disposed at the far end (14); and
A generally elongate first guidewire opening (52) disposed near its distal end (14) and coplanar with the common septum (19);
And a second guide hole (13) connected to the common bulkhead (19) and extending between the near end (12) and the second far end (17) closer to the far end (14). Including the following:
The second far end (17) above the second opening (55) extending obliquely from the common partition wall (19) toward the first far end (15), and the second far end on the second opening (55). The far end (17) is arranged in a plane that can be elastically crushed toward the transition part (20) and in a plane substantially parallel to the common partition wall (19) in the vicinity of the second opening (55). A generally elongated second guidewire opening (56);
Providing a multi-lead catheter assembly;
Providing a catheter guide wire (61) having a proximal end (12) and a distal end (14);
Inserting the proximal end of the guide wire into the first guide hole (11) through the first far end opening (51);
The proximal end of the guide wire (61) is led out of the body (18) from the first guide hole (11) through the first guide wire opening (52);
The proximal end of the guide wire (61) is pulled along the outside of the first guide hole (11) toward the proximal end (12) of the main body (18) and passes through the second guide wire opening (56) to the main body (18). The second far end (17) is pushed into the second partition hole (13) by the guide wire (61), and the second far end (17) is pushed toward the common partition wall (19) by a force that overcomes its elasticity. The step of being bent and crushed by elasticity;
The proximal end of the guide wire is pulled through the second guiding hole (13) from the opening at the proximal end of the second guiding hole (13);
The proximal end of the guide wire (61) is inserted through the first distal end opening (51) of the catheter assembly (10), and the catheter assembly (10) is advanced over the distal end along the guide wire (61). And being sent out from the first far end opening (51) of the body (18) inserted through the blood vessel;
A method of operating a catheter assembly.
The invention of claim 13 is the invention of claim 12, further comprising:
After the proximal end of the guide wire (61) is inserted into the second guide hole (13) through the second guide wire opening (56), the second guide hole (61) is pulled by a tension tension by pulling the guide wire (61) tightly. The method of operating an assembly, wherein the second far end (17) of (13) is compressed and bent by a guide wire (61) elastically toward the common partition wall (19).
The invention described in claim 14 is the invention described in claim 12, further comprising:
After pulling the proximal end of the guide wire from the proximal end (12) of the second guide hole (13), the distal end (14) of the catheter is located at the site to be catheterized. The method of operation of the assembly.
The invention described in claim 15 is the invention described in claim 14, further comprising:
After the distal end (14) of the catheter is located at the site to be catheterized, the proximal end of the guide wire is further withdrawn from the proximal end (12) of the catheter and the guide wire is removed from the catheter assembly (10). The method of operating an assembly further comprising the steps of:

  The multi-guide hole assembly of the present invention has an overhanging lip to reduce the retraction of the arterial hole into the vessel wall, and the lip is elastically crushed by a guidewire pulled between the two openings in the body. It has the effect that there is no risk of tearing the blood vessel wall.

  In the drawings, identical or similar numerals indicate similar elements to the end. Certain terminology used below is for convenience only and should not be taken as a limitation on the present invention. The terms “near” and “far” respectively refer to the direction away from or near the insertion tip of the catheter according to the present invention. The terminology specifically includes the above terms, their derivatives, and similar meanings. In the following, preferred embodiments of the invention will be described.

FIG. 1 shows a side view of a catheter assembly 10 according to a preferred embodiment of the present invention. Catheter assembly 10 includes a proximal end 12, a distal end 14, and a hub 16 connecting the proximal end 12 and the distal end 14. An elongated body 18 extends between the hub 16 and the distal end 14. The elongate body 18 is preferably also known as the venous lead, also known as the first catheter lead 11 and the arterial lead shown in the lower half of FIG. 2, the upper half of FIG. The second catheter guide hole 13 shown in FIG. Although only two catheter lead holes 11 and 13 are shown, those skilled in the art will appreciate that the catheter assembly 10 can include more than two lead holes 11 and 13 or more. You will understand.
The first guide hole 11 extends over the entire length between the hub 16 and the far end 14 and ends at the first far end 14. On the other hand, the second guide hole 13 starts from the hub 16, but ends at the tip of the second far end 17, that is, before the far end 14. FIG. 2 shows an enlarged cross-sectional view of the first and second guide holes 11 and 13 in the vicinity of the second far end 17. The common partition wall 19 shown in FIG. 2 extends from the hub 16 shown in FIG. FIG. 3 is an enlarged cross-sectional view of the first guide hole 11 at a portion farther from the second far end 17.

  As shown in FIG. 2, the catheter body 18 has a first guide hole 11 and a second guide hole 13 each having a substantially “D-shaped” cross section, which are parallel to each other and are partitioned by a common partition wall 19. . Preferably, at this position, the first guide hole and the second guide holes 11, 13 each have a first cross-sectional area. Although the cross section of the body 18 is preferably circular, those skilled in the art will appreciate that the cross section of the body 18 may be other shapes, such as an oval. The cross-sectional shape of the body 18 is preferably a generally smooth curve that facilitates sealing of the patient's skin around the body 18 at the incision site and minimizes bleeding at the entrance to the blood vessel. On the far end side from the second far end 17, the first guide hole 11 preferably has a substantially circular cross section. In this position, the first guide hole 11 preferably has a second cross-sectional area that is at least slightly larger than the first cross-sectional area described above.

  4, 5 and 6 show an enlarged perspective view, an enlarged plan view and an enlarged side view of the distal end 14 of the catheter assembly 10, respectively. The transition portion 20 of the first guide hole 11 provided between the distal end portion of the first far end 15 and the second far end 17 shows a cross section of the first guide hole 11 from the D-shape shown in FIG. Transition to the substantially circular cross section shown in FIG. As seen in FIG. 5, the inner diameter of the first guide hole 11 decreases in the direction from the hub 16 toward the far end 14 at the transition portion 20. However, the change in shape from the D-shaped cross section to the circular cross section slightly increases the cross-sectional area of the first guide hole 11. Further, the transition portion 20 has an upper surface 20a having an apex 20b of the upper surface 20a toward the second far end 17 and extending substantially in an arch shape, and a base portion 20c of the upper surface 20a extending toward the first far end 15, Is included. The plan view of the transition portion 20 has a substantially triangular shape. The surface of the transition portion 20 includes a series of arcs extending from the vertex 20b toward the base portion 20c in each plane orthogonal to the plane including the common partition wall 19. The inventors believe that this shape of the upper surface 20a can improve the flow of blood flow around the first far end 15 but not sucked into the second guide hole 13. Further, as seen in FIG. 6, the apex 20b of this shape starts from a position away from the second far end 17 downward.

Accordingly, the second far end 17 is always obliquely separated from the upper surface of the common partition wall 19 on the same surface as the vertex 20b (when stress is not applied).
With the above-described structure, the blood flow flowing into the second guide hole 13 through the second opening 55 provided below the transition portion 20 and the second far end 17 returns upward elastically after the guide wire 61 is removed. The second opening 55 below the second far end 17 is wide open. With the aid of this configuration and the three-dimensional configuration of the smooth transition portion 20, the generation of blood flow vortices in the vicinity of the second opening 55 is prevented, and as a result, the generation of thrombus due to blood clots is prevented.
The body 18 is preferably such as CARBOTHANE® containing about 20% barium sulfate to assist in ultrasound and fluoroscopy positioning of the body 18 in the patient's blood vessel after insertion. Made of polymer or elastomer. However, those skilled in the art will appreciate that other biocompatible materials can be used for the body 18. The body 18 preferably has a hardness of approximately 80-A on the Shore hardness scale. However, those skilled in the art will appreciate that the body 18 can be stiffer or softer.

  As shown again in FIG. 1, the hub 16 preferably includes a suture wing 21 that extends generally laterally of the body 18. The suture wing 21 preferably includes at least one, and more preferably at least two suture holes 22. The suture hole 22 is for preventing the catheter assembly 10 from moving from its insertion position in the patient, and the inserted doctor sutures the hub 16 to the outer skin of the patient into which the catheter assembly 10 has been inserted. It is possible to do. The suture wing 21 may be fixedly connected to the hub 16 or the hub of the suture wing 21 to allow the catheterization physician additional freedom in the position of the hub 16 relative to the patient's skin. It may be pivotally connected to the hub 16 to allow rotation about 16.

  Preferably, the catheter tissue implantation cuff 24 is disposed along the exterior of the body 18 between the second distal end 17 and the hub 16. The catheter tissue implantation cuff 24 is used for long-term catheter insertion intended for long-term patient insertion of the catheter assembly 10 over several months. Catheter tissue implantation cuff 24 is placed in a subcutaneous tunnel according to methods known to anyone skilled in the art. Catheter tissue implant cuff 24 is made of polyester or dacron (DACRON) so that the inwardly extending subcutaneous / skin tissue can be bonded to the material and the catheter tissue implant cuff 24 can be secured to the subcutaneous / skin tissue. (Registered trademark) It is preferable that the material is generally composed of a rough material. For emergency catheterization, the catheter assembly 10 need not be in a subcutaneous tunnel, and the catheter tissue implantation cuff 24 may be omitted.

  The proximal end 12 of the catheter assembly 10 includes a first extension tube 30 that is in fluid communication with the first guide hole 11 at the distal end 32 of the first extension tube 30 through a first hub conduit 33. Yes. The first hub conduit 33 transitions from a substantially circular cross section in the first extension tube 30 to a substantially D-shaped cross section in the first guide hole 11. The proximal end 12 of the catheter assembly 10 also has a second extension tube 40 in fluid communication with the second lead 13 at the distal end 42 of the second extension tube 40 through the second hub conduit 43. Contains. The second hub conduit 43 transitions from a substantially circular cross section in the second extension tube 40 to a substantially D-shaped cross section in the second guide hole 13. Each of the first and second extension tubes 30, 40 can be extended at any angle as will be appreciated by anyone skilled in the art, but preferably the first extension. The tube 30 may extend substantially coaxially with the first guide hole 11, and the second extension tube 40 may extend at an angle of about 20 degrees with respect to the length direction of the second guide hole 13. One skilled in the art will appreciate that other materials may be used for each of the first and second extension tubes 30, 40, but preferably perethein (pellethane®). )) (Resilient resin known as). The proximal end 34 of the first extension tube 30 is preferably terminated with a first connector 36, such as a standard luer lock, as is well known in the art. The first connector 36 is preferably colored with a blue color coded to indicate connection with the venous lead hole (first lead hole) 11. Also, the proximal end 44 of the second extension tube 40 is preferably terminated with a second connector 46, such as a standard luer lock, as is well known in the art. The second connector 46 is preferably colored in red coded to indicate connection with the arterial lead hole (second lead hole) 13.

  A first clamp 38, such as a Roberts clamp, is preferably placed on the first extension tube 30 between the proximal end 34 and the distal end 32 of the first extension tube 30, and the second clamp 48 is preferably first. Between the proximal end 44 and the distal end 42 of the second extension tube 40 is placed on the second extension tube 40. When each clamp 38, 48 is in a closed position, the first and second clamps 38, 48 ensure that each of the first and second extension tubes 30, 40 is openable, It serves to stop fluid flow through each of the first and second extension tubes 30,40.

  An information display ring 39, 49 is provided in each clamp 38, 48. Indicia, manufacturer's logo, guide hole fill volume, warning, or other indicia can be printed on each information display ring 39,49.

  Referring again to FIGS. 4-6, the distal end 14 of the catheter assembly 10 will be described in more detail. The first guide hole 11 preferably includes a substantially circular first far end opening 51 disposed at the first far end 15 and a first guide wire opening 52 disposed in the vicinity of the first far end 15. . Preferably, the first guidewire opening 52 has a substantially oval or oval shape with the major axis of the first guidewire opening 52 parallel to the main axis direction of the body 18. The first guide wire opening 52 is preferably substantially parallel to the plane of the common septum 19. Further, the first guide hole 11 preferably includes at least one, and more preferably, a plurality of first side ports 54, each of which is disposed in a plane substantially orthogonal to the plane of the common partition wall 19. The Each of the multiple first side ports 54 may be of any other shape, as can be understood by anyone skilled in the art, but is preferably substantially circular. In order to provide a smooth shape change between the tip of the first distal end 15 of the first guide hole 11 and the main body 18, and reduce the risk of the tip of the first distal end 15 damaging the blood vessel wall during insertion. Therefore, the tip of the first far end 15 preferably has a substantially circular slope (bevel surface).

  The second far end 17 of the second guide hole 13 has a substantially parabolic shape in plan view, and thus extends obliquely from the common partition wall 19 toward the first far end opening 51. The substantially parabolic shape of the tip of the second far end 17 is in the form of an overhanging lip, as can be seen in FIGS. The tip of the second distal end 17 of the second guide hole 13 with respect to the plane of the common partition wall 19 preferably extends at an angle β1 of about 37.5 degrees in the case of FIG. Those skilled in the art will understand that it can be other than 37.5 degrees.

  With reference to FIGS. 4 and 6, the distal end of the second distal end 17 preferably includes a second opening 55 and a second guidewire opening 56 disposed proximate to the second opening 55. Preferably, the second guidewire opening 56 is rectangular or oval with a major axis extending substantially parallel to the main axis direction of the body 18.

  A cavity 60 is formed between the arcuate surface 20 a of the transition 20 and the tip of the second far end 17. Since the transition part 20 is provided away from the tip of the second far end 17, the size of the cavity 60 can be increased, thereby increasing the blood flow flowing into the second guide hole 13. . The inclined shape of the cavity 60 and the second far end 17 helps to keep a large blood flow rate through the second opening 55 and into the second guide hole 13 during dialysis.

  In order to insert the catheter assembly 10 into a patient, an incision is first made near the insertion site on the patient's skin. The incision is for aspiration using a syringe or other introduction device near or closest to the area where the catheter is attached. If this catheter assembly 10 is used for hemodialysis and the catheter insertion area is the internal jugular vein, the incision is made in the triangular region of the clavicle. The exact location of the incision can be changed by the physician. According to the Seldinger technique, a hollow needle is inserted into the vein through the incision and the vein is aspirated. Next, the guide wire 61 is passed through the needle, and the needle is removed. Then, the catheter assembly 10 is inserted along the guide wire 61 into the place where the soft tissue and the phlebotomy site are expanded. This insertion technique greatly reduces the risk of air embolism because it eliminates the need for a prior art sheath to be inserted over the guidewire.

  Prior to insertion of the catheter assembly 10 into the patient, the catheter assembly 10 of FIG. 1 is inserted (over) over the proximal end of the guidewire as described below. The proximal end 62 of the guide wire 61 shown in FIG. 7 is inserted into the first distal end opening 51 and pushed through the first guide hole 11 to the first guide wire opening 52. Next, the proximal end 62 of the guide wire 61 is fed out of the catheter body 18 through the first guide wire opening 52. The proximal end 62 of the guide wire 61 then extends along the exterior of the first guide hole 11 and over the distal end of the second distal end 17 from the second guide wire opening 56 into the body 18. Pulled in the direction. The proximal end 62 of the guide wire 61 is guided into the second guide hole 13 through the second guide wire opening 56. The proximal end 62 of the guide wire 61 is inserted through the second guide hole 13 toward the proximal end 12 of the body 18 and the second end is guided until the proximal end 62 of the guide wire 61 exits the proximal end 12 of the catheter assembly 10. Pushed through hole 13.

  As the guide wire 61 is pulled through both the first guide wire opening 52 and the second guide wire opening 56, the guide wire 61 between the first guide wire opening 52 and the second guide wire opening 56 is shown in FIG. As shown, the tip of the second far end 17 engages with the tip of the second far end 17, and the tip of the second far end 17 is bent in the direction of the transition portion 20 so as to close the cavity 60. In this way, the distal end portion of the second far end 17 is bent in the direction of the axial center of the catheter body 18 so that the distal end portion of the second far end 17 is not caught on the blood vessel wall surface or damages the blood vessel wall. The distal end 14 of the assembly 10 can be smoothly inserted into the blood vessel. The distal end 14 of the catheter assembly 10 is inserted and secured into the blood vessel to the location desired by the physician and to a location that can be confirmed by fluoroscopy. When the distal end 14 of the catheter assembly 10 is in its required position, the guidewire 61 is pulled through the proximal end 12 of the catheter assembly 10 and removed. When the guide wire 61 is removed, the distal end of the second far end 17 returns to its original position as shown in FIGS. 1, 4, 6, etc., and blood flows into the second guide hole 13. The cavity 60 opens so that it can. Next, the incision is closed and the hub 16 is secured to the patient's skin by stitching the suture wing 21 to the patient's skin. The open ends of the first and second connectors 36, 46 are connected to fluid inlets and outlets of a hemodialysis unit (not shown) or other fluid transfer devices (not shown) during fluid transmission. ), And dialysis is started.

  After the dialysis machine is connected to the catheter assembly 10 and energized, the dialysis machine aspirates blood from the blood vessel through the second guide hole 13 during use. Generally, a pressure drop in the blood vessel caused by blood being sucked into the second guide hole 13 presses the blood vessel wall toward the second opening 55. As a result, the blood vessel wall may completely block the second opening 55, thereby closing the blood flow through the second guide hole 13. However, in the catheter assembly 10 according to the present invention, since the overhanging lip of the second far end 17 is provided, the second far end 17 moves away from the common septum 19 in the operating state. Therefore, a wide blood flow path is secured to prevent the blood flow from being closed.

  The blood sucked into the second guide hole 13 is flowed to the hemodialyzer, where the blood is purified and processed. The blood is then pumped through the first guide hole 11 to be released back into the blood vessel. The first far end opening 51 and the first side port 54 provide a discharge port for blood discharged from the first guide hole 11.

  Those skilled in the art will appreciate that the embodiments described above can be modified in some way without departing from the broad concept of the invention. Accordingly, the invention is not limited to the specific embodiments disclosed, but is intended to cover modifications within the spirit and scope of the invention as defined by the appended claims. Should be understood to be.

  According to the structure of the multi-guide hole catheter of the present invention, a safe catheter assembly that does not cause laceration in the blood vessel wall can be manufactured with a plus-tip molded product, and can be used in the medical component manufacturing industry.

1 is a side view of an entire catheter assembly according to a preferred embodiment of the present invention. FIG. 2 is an enlarged cross-sectional view of the catheter guide hole shown in FIG. 1 taken along line 2-2 of FIG. FIG. 3 is an enlarged cross-sectional view of the catheter guide hole shown in FIG. 1 taken along line 3-3 in FIG. 1. FIG. 2 is an enlarged perspective view of a distal end portion of the catheter assembly shown in FIG. 1. FIG. 2 is an enlarged plan view of a distal end portion of the catheter assembly shown in FIG. 1. FIG. 2 is an enlarged side view of the distal end of the catheter assembly shown in FIG. 1. The enlarged side view of the far end part of the catheter assembly which showed the state in the middle of the operation | movement step of the far end part of the catheter assembly shown by FIG. 1 with the guide wire. FIG. 2 is an enlarged side view of the distal end portion of the catheter assembly, showing the state of the catheter assembly shown in FIG. 1 in the middle of another operation step of the distal end portion of the catheter assembly together with a guide wire.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Catheter assembly 11 1st guide hole 12 Near end 13 2nd guide hole 14 Far end 15 1st far end 16 Hub 17 2nd far end 18 Main body 19 Common partition 20 Transition part 20a Arch-shaped upper surface 20b Vertex 20c Base 21 Suture wing 22 suture hole 24 catheter tissue implantation cuff 30 first extension tube 32 distal end 33 of first extension tube 30 first hub conduit 34 proximal end 36 of first extension tube 30 first connector 38 first 1 clamp 39 first information display ring 40 second extension tube 42 far end 43 of second extension tube 40 second hub conduit 44 proximal end 46 of second extension tube 40 second connector 48 second Clamp 49 second information display ring 51 first far end opening 52 first guide wire opening 54 first side port 55 second opening 56 second guide wire opening 60 cavity 61 guide wire 62 guide wire 6 Near end

Claims (15)

An elongated body having a proximal end and a distal end;
A common bulkhead extending between the near end and the far end,
A first far end opening disposed at the far end;
A first guide hole disposed adjacent to the far end and having a first guide wire opening that is coplanar with the common bulkhead and has the following:
A substantially D-shaped cross section formed by the main body and a common partition extending between the near end and the transition part, wherein the transition part has a substantially circular cross section from the substantially D-shaped cross section to the first guide hole. And the transition includes a generally expanded arched top surface that is approximately triangular in plane and on the apex and near end sides,
Having a substantially circular cross section at the far end extending to the far end of the transition,
A first far end aperture disposed at the far end; and
A generally elongate first guidewire opening disposed near its distal end and coplanar with the common septum;
And a second guide hole connected to the common bulkhead and extending between the near end and a second far end closer to the far end, including:
The second far end on the second opening extending obliquely from the common partition toward the first far end opening, and the second far end on the second opening is crushed elastically toward the transition portion. And a generally elongated second guidewire opening disposed in a plane generally parallel to the common septum proximate to the second opening;
Multi-lead catheter assembly.   The multi-lead catheter assembly according to claim 1, further comprising a hub connected to the proximal end of the body.   The multi-guide catheter assembly according to claim 1, wherein the first guide hole further includes at least one opening disposed on a side closer to the far end.   2. A multi-hole catheter assembly according to claim 1, wherein the first distal opening is disposed in a plane substantially perpendicular to the plane of the common septum.   The multi-hole catheter assembly according to claim 1, wherein the first distal opening is substantially circular.   The multi-hole catheter assembly according to claim 1, wherein the first hole has a substantially D-shaped cross section in the vicinity of the second opening.   2. A multi-hole catheter assembly according to claim 1, wherein the second hole has a substantially D-shaped cross section.   2. A multi-hole catheter assembly according to claim 1 wherein the body has a generally circular cross section.   The multi-hole catheter assembly according to claim 1, wherein the second opening is tapered.   The multi-hole catheter assembly according to claim 1, wherein the first guide wire opening is substantially oval.   The multi-hole catheter assembly according to claim 1, wherein the second guidewire opening is substantially oval. A method of operating a catheter assembly for inserting a catheter into a blood vessel comprising the following steps:
An elongated body having a proximal end and a distal end inserted into the blood vessel;
A common bulkhead extending between the near end and the far end,
A first far end opening disposed at the far end;
A first guide hole disposed adjacent to the far end and having a first guide wire opening that is coplanar with the common bulkhead and has the following:
A substantially D-shaped cross section formed by the main body and a common partition extending between the near end and the transition part, wherein the transition part has a substantially circular cross section from the substantially D-shaped cross section to the first guide hole. And the transition includes a generally expanded arched top surface that is approximately triangular in plane and on the apex and near end sides,
Having a substantially circular cross section at the far end extending to the far end of the transition,
A first far end aperture disposed at the far end; and
A generally elongate first guidewire opening disposed near its distal end and coplanar with the common septum;
And a second guide hole connected to the common bulkhead and extending between the near end and a second far end closer to the far end, including:
The second far end on the second opening extending obliquely from the common partition toward the first far end opening, and the second far end on the second opening is crushed elastically toward the transition portion. And a generally elongated second guidewire opening disposed in a plane generally parallel to the common septum proximate to the second opening;
Providing a multi-lead catheter assembly;
Providing a catheter guide wire having a proximal end and a distal end;
Inserting the proximal end of the guide wire into the first guide hole through the first remote opening;
The proximal end of the guide wire is led out of the body from the first guide hole through the first guide wire opening;
The proximal end of the guide wire is drawn in the direction of the proximal end of the main body along the outside of the first guide hole, and is introduced into the second guide hole in the main body through the second guide wire opening. A step in which the far end is pushed and bent toward the common partition wall by a force that overcomes its elasticity and is crushed by the elasticity;
The proximal end of the guide wire is pulled through the second guide hole from the opening at the near end of the second guide hole;
The proximal end of the guide wire is inserted through the distal end opening of the catheter assembly, and the catheter assembly is advanced along the guide wire beyond the distal end and out of the distal end opening of the body inserted through the blood vessel. Sent out step;
A method of operating a catheter assembly.   After the proximal end of the guide wire is inserted into the second guide hole through the second guide wire opening, the second distal end of the second guide hole is elastically directed toward the common partition wall by a tensile tension by pulling the guide wire tightly. 13. The method according to claim 12, wherein the assembly is compressed and bent by a guide wire.   13. The method of operating an assembly according to claim 12, wherein after pulling the proximal end of the guide wire from the proximal end of the second guide hole, the distal end of the catheter is positioned at the site to be catheterized. . 15. The assembly according to claim 14, further comprising the step of further pulling the proximal end of the guide wire from the proximal end of the catheter and removing the guide wire from the catheter after the distal end of the catheter is positioned at the site to be catheterized. Operating method.

Images