WO1997041914A1 - Appareil d'insertion a fil d'acier a ressort, et procede d'insertion de dispositifs medicaux tubulaires dans le corps - Google Patents

Appareil d'insertion a fil d'acier a ressort, et procede d'insertion de dispositifs medicaux tubulaires dans le corps Download PDF

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Publication number
WO1997041914A1
WO1997041914A1 PCT/US1997/007807 US9707807W WO9741914A1 WO 1997041914 A1 WO1997041914 A1 WO 1997041914A1 US 9707807 W US9707807 W US 9707807W WO 9741914 A1 WO9741914 A1 WO 9741914A1
Authority
WO
WIPO (PCT)
Prior art keywords
spring wire
wire insert
catheter
tubular
spring
Prior art date
Application number
PCT/US1997/007807
Other languages
English (en)
Inventor
Matt D. Pursley
Joe E. Brown
Original Assignee
Pursley Matt D
Brown Joe E
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 Pursley Matt D, Brown Joe E filed Critical Pursley Matt D
Priority to AU30616/97A priority Critical patent/AU3061697A/en
Publication of WO1997041914A1 publication Critical patent/WO1997041914A1/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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • 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
    • A61M2025/0098—Catheters; Hollow probes having a strain relief at the proximal end, e.g. sleeve

Definitions

  • the present invention relates generally to an apparatus and method for inserting tubular medical devices into the body and, in particular, to a single helix spring wire insert with a hub fitting at a proximal end for preventing kinking in tubular medical devices, such as guide catheters, during insertion and manipula ⁇ tion of the tubular device in a patient's body.
  • Medical catheters generally comprise elongated tube-like members that are inserted into the body, either percutaneously or via a body orifice, for any of a wide variety of diagnostic and therapeutic purposes. Such medical applications generally require the use of a catheter having the ability to turn corners, such as in ocular irrigation and aspiration applications, or to negotiate twists and turns, such as in certain cardio ⁇ vascular applications.
  • percutaneous transluminal coronary angioplasty requires manipulation of a catheter from a proximal position outside the patient's body through branched and tortuous portions of the patient's arterial system for the purpose of allevi ⁇ ating an obstruction by inflating a balloon.
  • This par- ticular procedure has been performed with increasing
  • a tubular device • frequency in recent years as an alternative to open heart bypass surgery.
  • a variety of other medical applications also require insertion of a tubular device into the body.
  • a tubular device such as a vascular guiding catheter
  • the device When inserting a tubular device, such as a vascular guiding catheter, into the body, the device is typically straightened, torqued, pushed and pulled at the proximal end to position the device at a desired loca ⁇ tion. After the tubular device is in position, thera- Probeic or diagnostic devices and/or agents are then "delivered" through the tube. It is therefore desirable to have these tubular devices with as thin a wall as possible so that the penetration point into the body is minimized, while the lumen through which various devices or fluids are passed or injected is maximized.
  • tubular device Unfortunately, the tortuous path these tubular devices must pass will frequently result in kinking of the tubular device, which renders the device useless. If a tubular device kinks, the physician must remove the kinked device and try to traverse the path with another tubular device until he or she is successful. Complicat ⁇ ing this, the tubul3r devices are often preshaped, as is the case with a guiding catheter, and must be straight- ened prior to insertion into the body. This straighten ⁇ ing allows stress to be concentrated and makes kinking of the tubular device even more likely. Generally, the thinner the wall of the tubular device, the more suscep ⁇ tible the tubular device is to kinking during insertion.
  • a typical guide catheter for coronary angio ⁇ plasty has an inside diameter (ID) of approximately 0.087 inches and an outside diameter (OD) of approximately 0.105 inches.
  • ID inside diameter
  • OD outside diameter
  • the guide catheter is typically inserted into the body over a guide wire that is first positioned in the body.
  • the guide catheter often has a preshaped curve in it.
  • the preshaped curve in the catheter may be straightened out in the physician's hand and then slid over the guide wire to position the catheter within the patient's artery.
  • An introducer for the guide catheter may be positioned in a hole in the femoral artery in the leg, and often the path that the guide catheter is required to traverse is a very tortuous, tight twist path.
  • a physician or intern will kink the catheter trying to introduce it into the patient's body.
  • the physician then moves the catheter up through the patient's aorta around to the heart and positions it again.
  • the catheter is also susceptible to kinking at that time.
  • limitations on lumen diameter and wall thickness in such a guide catheter are governed by its kink resistance.
  • An object of the present invention is to solve the problems associated with the prior art systems for inserting and positioning tubular devices in the body. It is a further object of the present invention to provide a single helix spring wire insert for prevent ⁇ ing kinking in tubular devices, such as guide catheters, during insertion and manipulation of the tubular device in the body. It is a further object of the present invention to provide a single helix spring wire insert having a hub fitting at a proximal end to facilitate connection with a guide catheter.
  • the invention comprises an apparatus for preventing kinking in a thin- walled tubular medical device, comprising a hub for con ⁇ necting to a tubular medical device, and a coil spring having a proximal end fixed to the hub, the coil spring having a low bending resistance and a high circumferen ⁇ tial rigidity, the coil spring having an outside diameter that is slightly smaller than an inside diameter of the tubular medical device into which the coil spring is to be inserted, and the coil spring being freely slidable into and out of the tubular device.
  • the hub of the spring wire insert apparatus preferably includes a threaded portion having female threads for engaging corresponding male threads of a tubular device.
  • the coil spring comprises a lumen defin ⁇ ing an inside diameter of the apparatus for allowing the apparatus to slide over a guide wire.
  • An optional polymer liner may be provided within the lumen of the coil spring to facilitate insertion of the coil spring over a guide wire.
  • a method of inserting a tubular medi ⁇ cal device into a patient's body comprising the steps of providing a tubular member having an inner diameter defining a lumen, and a spring wire insert having an outer diameter, the outer diameter of the spring wire insert being slightly less than the inner diameter of the tubular member, placing a length of the spring wire insert into the lumen of the tubular member, introducing the tubular member and the spring wire insert into the patient's body and manipulating the tubular member into a desired location, and removing the spring wire insert from the tubular member.
  • the removing step of this method preferably comprises grasping the spring wire insert and pulling the spring wire insert from the tubular member while the tubular member remains at the desired location in the patient's body.
  • a hub is preferably provided at a proximal end of the spring wire insert and a hub is provided at a proximal end of the tubular member.
  • the two hubs are secured together after the spring wire insert is placed into the lumen of the tubular member.
  • a tubular catheter assembly having a high resistance to kinking comprising a tubular catheter having a proximal end and a lumen, the lumen defining an inside diameter of the catheter, and a spring wire insert comprising a coil spring having a proximal end, the coil spring having an outside diameter that is smaller than the inside diameter of the catheter, and the spring wire insert being freely slidable within the lumen of the tubular catheter.
  • the catheter assembly preferably comprises means for selectively securing the proximal end of the spring wire insert to the proximal end of the catheter.
  • the securing means preferably comprises a first hub fixed to the proximal end of the spring wire insert and a second hub fixed to the proximal end of the catheter, and means for selectively securing the first and second hubs together.
  • the first hub comprises a first threaded portion and the second hub comprises a second threaded portion, the first and second threaded portions being in threaded engagement when the spring wire insert is fully inserted within the catheter.
  • the spring wire insert preferably has a low bending rigidity so that it takes the shape of any preshaped curve of the catheter when the spring wire insert is inserted into the catheter.
  • Fig. 1 is a perspective view of a spring wire insert with a hub fitting according the present inven ⁇ tion.
  • Fig. 2 is a perspective view of a guide cathe ⁇ ter having a preshaped curve at a distal end.
  • Fig. 3 is a perspective view of the guide catheter of Fig. 2 with the spring wire insert positioned within the guide catheter.
  • Fig. 4 is a perspective view of the guide catheter of Fig. 3 after it is straightened or bent with the spring wire insert in place to prevent kinking.
  • Fig. 5 is an enlarged cross-sectional view of the proximal end of the spring wire insert and hub with a polymer lining.
  • the main components of the present invention are a spring wire insert 10 and a hub 12 fixed at a proximal end of the spring wire insert 10.
  • the spring wire insert 10 is a single helix spring coil that can be inserted into a tubular device, such as a guide catheter 14 as shown in Fig. 2, prior to insertion of the guide catheter 14 into the body.
  • the spring wire insert 10 has an outside diameter that is slightly smaller than the inner diameter of the guide catheter 14. Thus, the spring wire insert 10 will slide easily into the guide catheter 14 and track any preset curvature of the guide catheter 14, as shown in Fig. 3.
  • the spring wire insert 10 is held in place in the guide catheter 14 by locking the hub 12 of the spring wire insert 10 onto the hub 16 of the guide catheter 14.
  • the hub 12 of the spring wire insert 10 preferably has female threads 18 that engage corresponding male threads on the hub 16 of the guide catheter 14.
  • Other suitable means for interlocking the hub 12 with the hub 16 can also be used.
  • a spring detent, a snap ring, or a friction lock can be provided between the hub 12 of the spring wire insert and the hub 16 of the guide catheter to hold the spring wire insert 10 in place within the guide catheter 1 .
  • the spring wire insert 10 will not signifi ⁇ cantly increase the torquing ability of the guide catheter 14, but the insert will make the guide catheter 14 virtually unkinkable. As shown in Fig.
  • a preset bend in the guide catheter 14 can be straightened or bent severely without kinking the walls of the guide catheter 14.
  • the spring wire insert 10 and its hub 12 are hollow so that the guide catheter 14 with the spring wire insert 10 secured in place can still be inserted over guide wires and the like (not shown) .
  • the spring wire insert 10 can be removed easily my disengaging the hub 12 from the hub 16 and pulling the spring wire insert 10 from the guide catheter 14. After removing the spring wire insert 10, the guide catheter 14 can be used as originally intended. Thus, the spring wire insert 10 is left in place within the guide catheter 14 during the tortuous insertion and positioning of the guide catheter 14 in the body, but is removed from the body once the guide catheter 14 is in proper position within the body.
  • the spring wire insert 10 permits thinner walled guide catheters or other tubular devices than are currently possible without kinking the tubular devices during insertion and maneuvering.
  • the spring wire insert 10 can be provided with a polymer liner 20, as shown in Fig.
  • the poly ⁇ mer liner 20 can be secured to the hub end of the spring wire insert 10 in a known manner and to the distal end of the spring wire insert 10 by heat consolidation or the like. As shown in Fig. 5, the polymer liner 20 is folded over the distal tip of the spring wire insert 10 and heat consolidated to provide a soft and smooth covering over the distal tip.
  • the spring wire insert 10 can also be coated with silicone or thrombosis reducing compounds to improve lubricity and reduce blood adhesion during use. Example
  • the present invention can be used, for example, with a typical guide catheter having an inside diameter (ID) of approximately 0.087 inches and an outside diameter (OD) of approximately 0.105 inches.
  • the spring wire insert 10 can be a tightly wound spring (e.g. , the OD of the spring is about 0.084 inches and the ID of the spring is about 0.054 inches) slid down the throat of the guide catheter. This arrangement will greatly increase the kink resistance of the guide catheter assembly.
  • the spring wire insert 10 is flexible enough that it takes the curve shape of the guide catheter.
  • the guide catheter can be twisted, cranked, and knotted without kinking the catheter. This is because the guide catheter at that point has a very circumferentially rigid spring inside that prevents the thin walls of the catheter from collapsing in a kinking manner.
  • the spring wire insert will flex and bend in virtually any direction, but it is very difficult to crush or kink.
  • the catheter can be bent enough to "cold set” a curve in the catheter for allowing a physician to alter the curve shape of the catheter as required for a particular proce ⁇ dure.
  • the catheter can be constructed of a polymer, such as nylon, that will facilitate such "cold” setting.
  • a cold setting is accomplished by "overbending" the cathe ⁇ ter to set a desired curve in the catheter by exceeding the Youngs Modulus of the catheter's polymer.
  • the present invention provides a full length spring wire insert 10 with a locking hub 12 on the proximal end, as shown in Fig. 1. Before a physician begins the guide catheter insertion procedure, he or she slides the spring wire insert 10 into the guide catheter
  • the physician With the spring wire insert of the present invention in place, the physician has a catheter which, from a kink resistance standpoint, is unsurpassed. Moreover, from an ID standpoint, even with the spring wire insert posi ⁇ tioned in the guide catheter, the guide catheter can still be inserted over guide wires or the like. With the spring wire insert 10 positioned in the guide catheter 14, the guide catheter is not accept ⁇ able for putting balloons through because the ID is too small. However, once the physician positions the guide catheter 14 into place and has completed all of the difficult manipulation of the guide catheter, the spring wire insert 10 can be easily slid right back out of the guide catheter 1 . Therapeutic devices can then be put through the catheter in a conventional manner.
  • the present invention comprises a tightly wound spring wire insert, which is slightly shorter than the guide catheter and smaller in diameter than the catheter so that the spring wire insert can slide into the catheter without extending out of the distal end of the catheter.
  • the spring wire insert is locked in place on a hub of the catheter, and all the tortuous bending and positioning can be done without kinking the catheter. After the tortuous bending and positioning are complete, the spring wire insert can be easily removed from the catheter so that it does not interfere with the operation of the catheter.

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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)

Abstract

Cette invention se rapporte à un procédé et à un appareil qui permettent d'éviter l'entortillement d'un dispositif médical tubulaire à paroi mince, lors de son insertion et de sa manipulation dans le corps d'un patient. Cet appareil comprend un élément d'insertion unique (10) à fil d'acier à ressort hélicoïdal pourvu d'un raccord à moyeu (12) au niveau d'une extrémité proximale qui s'enclenche dans un moyeu à l'extrémité proximale du dispositif tubulaire. Cet élément d'insertion à fil d'acier à ressort est un ressort à boudin présentant une faible résistance à la flexion et une grande rigidité circonférentielle. Après avoir positionné le dispositif tubulaire dans le corps du patient, l'élément d'insertion à fil d'acier à ressort peut être sorti du dispositif tubulaire par coulissement de sorte qu'il n'interfère pas avec les fonctions normales du dispositif tubulaire. L'élément d'insertion à fil d'acier à ressort comprend également une lumière qui permet de faire glisser l'appareil sur un fil de guidage existant dans le corps du patient, ainsi qu'un revêtement polymère (20) qui facilite son insertion sur ce fil de guidage.
PCT/US1997/007807 1996-05-08 1997-05-08 Appareil d'insertion a fil d'acier a ressort, et procede d'insertion de dispositifs medicaux tubulaires dans le corps WO1997041914A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU30616/97A AU3061697A (en) 1996-05-08 1997-05-08 Spring wire insert apparatus and method for inserting tubular medical devices into the body

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US1741196P 1996-05-08 1996-05-08
US60/017,411 1996-05-08
US85195697A 1997-05-06 1997-05-06
US08/851,956 1997-05-06

Publications (1)

Publication Number Publication Date
WO1997041914A1 true WO1997041914A1 (fr) 1997-11-13

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1997/007807 WO1997041914A1 (fr) 1996-05-08 1997-05-08 Appareil d'insertion a fil d'acier a ressort, et procede d'insertion de dispositifs medicaux tubulaires dans le corps

Country Status (2)

Country Link
AU (1) AU3061697A (fr)
WO (1) WO1997041914A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4020829A (en) * 1975-10-23 1977-05-03 Willson James K V Spring guide wire with torque control for catheterization of blood vessels and method of using same
US4676249A (en) * 1986-05-19 1987-06-30 Cordis Corporation Multi-mode guidewire
US5228452A (en) * 1992-02-19 1993-07-20 Target Therapeutics Inc. Proximal end fitting with an improved seal for use in a catheter guidewire assembly
US5573520A (en) * 1991-09-05 1996-11-12 Mayo Foundation For Medical Education And Research Flexible tubular device for use in medical applications

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4020829A (en) * 1975-10-23 1977-05-03 Willson James K V Spring guide wire with torque control for catheterization of blood vessels and method of using same
US4676249A (en) * 1986-05-19 1987-06-30 Cordis Corporation Multi-mode guidewire
US5573520A (en) * 1991-09-05 1996-11-12 Mayo Foundation For Medical Education And Research Flexible tubular device for use in medical applications
US5228452A (en) * 1992-02-19 1993-07-20 Target Therapeutics Inc. Proximal end fitting with an improved seal for use in a catheter guidewire assembly

Also Published As

Publication number Publication date
AU3061697A (en) 1997-11-26

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