CN1222062A - Lead wires for mixing tubes for catheters - Google Patents

Abstract

A hybrid tubular guidewire (320) has first and second elongate tubular bodies (340, 344) fitted end-to-end, and a catheter threadably coupled thereto for being guided to a target location within a vasculature passageway of a human body. The first elongated body (340) has a greater rotational stiffness than the second elongated body (344), which in turn has greater lateral flexibility. A plurality of cuts (362) are made at spaced apart locations along the length of the second elongated body (344) by sawing, laser cutting or etching to increase the lateral flexibility of the second elongated body (344). At least some of the slits extend through the tubular body into the interior cavity to permit drainage of fluid flowing within the cavity.

Description

Lead wires for mixing tubes for catheters

Background of the invention

FIELD OF THE INVENTION This invention relates to catheter systems and, more particularly, to a hybrid catheter guidewire device having improved twisting and bending properties.

Catheter guidewires have been used for many years to "guide" or "guide" a catheter to a desired target location within the body's vasculature. Typical leads are approximately 135cm to 195cm long and are constructed of two main components - a solid stainless steel wire, and a platinum alloy coil spring. The solid wire is tapered at its distal end to increase its flexibility. Coil springs are typically brazed to the distal end of the solid wire at the point where the inner diameter of the coil spring mates with the outer diameter of the solid wire. Therefore, platinum is selected as the helical spring because platinum can provide radiation opacity to X-rays when the wire is navigating in the human body and is observed with X-rays, and platinum is biocompatible. The coil spring also provides flexibility to the tip of the wire to reduce the possibility of tissue puncture.

Navigation through human tissue is accomplished using X-ray fluoroscopy to see how the wires are inside the body. Inserting the wire into a catheter so that the wire protrudes from the end of the tube, then inserting the wire and catheter into and moving through the vessel or duct until the tip of the wire reaches the desired branch of the vessel or duct, then Turn or twist the proximal end of the lead so that the bent tip points into the desired branch before proceeding. The catheter then follows or traces the wire on the outside of the wire to advance to the desired location and provides additional support for the wire. Once the catheter is in place, the wire can then be withdrawn through it depending on the treatment to be performed. But often, as in the case of balloon angioplasty, the guide wire is left in place during the procedure and can be used to replace the catheter.

As the lead enters the tissue, internal resistance from typically many turns of surface contact reduces the ability of the lead to continue advancing, which in turn can lead to a more difficult and protracted process, or worse, not approaching the desired organization, becomes a failed process. Of course, a wire that combines flexibility with good torsional properties (torsional stiffness) will help overcome problems due to internal resistance.

Summary of the invention

It is an object of the present invention to provide an improved catheter guide device.

Another object of the present invention is to provide such an instrument that combines torsional stiffness, bending flexibility and longitudinal strength.

Yet another object of the invention is to provide such an instrument which is simple in design and construction.

These and other objects of the present invention are achieved in a specific exemplary embodiment of a catheter guidewire. The catheter wire consists of a first thin-walled, elongated, hollow tubular body made of a first material and a thin-walled, elongated, hollow tubular body made of a second material that is collinearly joined to the first tubular body. Consists of a hollow tubular body. The first material has greater torsional stiffness and less lateral yield than the second material, but the tubular structure still provides considerable torsional stiffness to the second tubular body. In this embodiment, the wire is hollow and acts as a conduit itself.

Brief description of the drawings

After reading the following detailed description in conjunction with the accompanying drawings, when you can have a clear understanding of the above-mentioned and other objects, characteristics and advantages, in the accompanying drawings:

Fig. 1 is according to the side of the lead wire of mixing tube of the present invention, partial cut-away view;

Fig. 2 is according to the side of another embodiment of the lead wire of mixing tube of the present invention, partial cutaway view;

Fig. 3 is a side, partial, partly sectional view of yet another embodiment of the wire of the mixing tube according to the present invention.

Detailed description

Fig. 1 is a side, partial, partial cross-sectional view of a wire 320 of a mixing tube made in accordance with the present invention. A pin clamp type twist collet 324 is attached to the proximal end 328 in the usual manner. The collet 324 also has an opening, hole or Luer adapter 332 for introducing a medical fluid or other treatment agent into the tubular lead 320 . (Collet 324 can be positioned further distally, and can also be separated from the Luer adapter.)

The wire 320 of the mixing tube is made of two parts 340 and 344, wherein the part 344 has a smaller outer diameter than the part 340 and is inserted and attached into the distal end of the part 340 with adhesive or other fastening mechanism. A smooth tubular sleeve 346 may also fit over portion 344 to abut the distal end of portion 340 to form a substantially smooth joint. Alternatively, a smooth coating or film may optionally be applied to the outside of portions 340 and 344.

A tapered spool 333 can be inserted into the lumen of the tubular guidewire 320, which can be made of a material that is radiopaque to fluoroscopy, or if magnetic resonance imaging (MRI) is used, the spool 333 can be detected by MRI. Active materials are made such as gadolinium, gadolinium compounds, gadolinium capsules, dysprosium, dysprosium compounds, or dysprosium capsules. Alternatively, a radiopaque solution may be introduced into the interior of the tubular guidewire 320, or an MRI visible solution may be used if MRI rather than fluoroscopy is employed. Of course, the lead 320 may be radiation opaque or MRI detectable, and a suitable solution may be introduced into the lead to enhance visibility. Of course, the purpose of such a spool or solution is to enable the position and/or movement of the guidewire 320 to be tracked as it is threaded into the vasculature or body cavity.

The spool 333 can also be used to change the curvature of the tubular wire 320 according to the needs of the user. For example, a portion of the tubular wire 320 can be made curved or angled, and then a straight spool 333 can be inserted into the wire to straighten it, and this spool can be removed to allow the wire to straighten when desired. The wire returns to the arc. Alternatively, the tubular wire 320 can be made to bend in a straight line, and the spool 333 can be made into an arc selected so that when the spool is inserted into the tubular wire, the spool can cause the wire to have the same arc, and when the spool is bent As the wire is withdrawn or advanced beyond the arc of the spool, the leading end of the wire can straighten again. In this way, depending on the initial shape of the spool 333 and/or tubular lead 320, the shape of the lead may be controlled to some extent when the lead is placed within the vasculature or body cavity.

The spool 333 can also be used to vary the flexibility of the lead 320 - varying the slope or diameter of the spool 333 can provide different stiffness to the lead.

Preferably, portion 340 of tubular wire 320 is made of stainless steel and portion 344 is made of Nitinol. Portion 340 of tubular lead 320 may also be made of a polymer or other flexible material of suitable strength. Sleeve 346 may be made from a smooth polymer such as polyethylene or film coated urethane.

Preferably, portion 340 may have an outer diameter of 0.018 inches (or 0.036 inches), an inner diameter of 0.012 inches (or 0.030 inches), and portion 344 may have an outer diameter of about 0.014 inches (or 0.032 inches). The hollow portion of the distal end of portion 340 is drilled to snugly receive and grip the proximal end of portion 344 . Glue or other adhesives may also be used to maintain the collinear telescoping in a fixed connection. Preferably, the length of portion 344 may be about 35 cm, while the length of portion 340 makes up the remainder of the standard length of the wire. Sleeve 346 is preferably selected to have such a thickness that when mounted on portion 344, the combined diameter is substantially the same as the diameter of portion 340, thereby presenting a smooth, unbroken length of wire.

Slits, grooves, gaps or openings can be made anisotropically along the length of the portion 344 of the tubular wire 320 to provide lateral flexibility of the portion 344, either by sawing (e.g., buried Semiconductor cutting blades with diamond grains), electrical discharge machining, laser cutting or etching (for example, using the etching method described in US Patent No. 5,106,455). The cuts are generally perpendicular to or across the length dimension of the wire and are alternately placed around the wire. However, the incision can also be oblique in order to obtain a longer incision. The bend shape of the tubular wire can be easily selected by controlling and varying both the spacing and depth of the notches, the smaller the spacing and the greater the depth of the notches, the more flexible the wire will be obtained, and vice versa.

The distal end 348 of the wire is preferably rounded in order to minimize the chance of injury through bodily tissue. Radiopaque or MRI detectable markers or cuffs 349 may also be made on the distal end 340 . Cuff 349 may be gold or platinum alloy (suitable for fluoroscopy) or gadolinium, dysprosium and their compounds (suitable for MRI), and may be deposited, coiled or utilized shape memory alloy ( NiTi) effect to "lock" the cuff around the end and so on. Alternatively, a radiopaque plug (or MRI marker) may also be placed in the lumen of the distal end 340 .

Figure 2 is a partial side view of another embodiment of a wire 350 for a mixing tube made in accordance with the present invention. Conductor 350 is formed of two sections 354 and 358 like the conductor in FIG. 1 . Portion 354 is preferably made of stainless steel and is sized to receive proximal end 358a of portion 358 within the cavity at distal end 354a. Preferably, portion 358 is made of Nitinol for greater lateral flexibility than portion 354. The outer surface of distal end 354a of portion 354 is tapered to present a tapered joint between portion 354 and portion 358 so as not to damage the channel wall of the vasculature into which it is inserted. Portion 358 may be held in place within the cavity of portion 354 with a press fit, a suitable adhesive, and/or using the shape memory effect.

The slits 362 shown in the portion 358 are made at spaced locations on the top, bottom, and sides of the portion to increase the portion's lateral flexibility while maintaining a suitable degree of flexibility. torsional stiffness. A plug 364, which may be made of a radiopaque material or an MRI sensitive material or a combination of both, is provided at the distal end of portion 358 to enhance visibility of the guide wire and is rounded to This reduces the possibility of trauma and damage to the vasculature channels. Radiopaque or MRI sensitive can of course also be used to track motion and/or view the lead 350 within the vasculature.

The spool 368 shown in the cavity of the guide wire 350 has a bend 372 so that when the spool is inserted into the guide wire 350, the wire will have the same curved shape, and when the spool is withdrawn, the wire will re-form. Straighten. The bend 372 is generally on the far side of the spool. A stop 376 is attached to the proximal end of the spool 368 to prevent the spool from being inserted into the lead beyond a certain point. The stopper can also be just a section of auxiliary pipe arranged on the proximal end of the spool.

Figure 3 shows another embodiment of a wire 380 for a mixing tube made in accordance with the present invention. Lead 380 , like the other leads, is made up of two sections 384 and 388 , the proximal end of section 388 being fitted within the distal end of section 384 . A sleeve 392 is fitted over a portion of portion 388 but still leaves the distal end of portion 388 protruding therefrom. Slits 394 are made in the distal end of portion 388 to allow solution introduced into the proximal end of portion 384 to drain laterally (also for bendability, etc.), as discussed above in the embodiment of FIG. 2 . In this example, the ends of portion 388 are flexible and may be used as the desired type of wire. Section 384 could be made of stainless steel, section 388 could be made of Nitinol, and sleeve 392 should be made of a smooth material.

Using the lead wire of the hybrid tube of the present invention, a relatively high torsional rigidity can be obtained on the stainless steel part, and then due to the distal part of the nickel-titanium alloy is also included, and a large lateral bendability can be obtained, so that the lead wire can be screwed into into the channels of the vasculature. Appropriate rotational rigidity can also be obtained due to the tubular structure of the nickel-titanium alloy part and microfabrication. This makes it possible to obtain both rotational stiffness and lateral bending properties on the leading or distal end of the wire.

The wires of the mixing tubes disclosed herein can be used with catheters that are threaded on the outside of the wires in a conventional manner, or can be used to deliver medical fluids to target sites in a similar manner to catheters. Due to the incision made over at least a portion of the length of the tubular guidewire, medical fluid is allowed to leak from the hole in the guidewire into the passageway of the vasculature. Of course, the position at which the liquid medicine is discharged from the tubular wire can be controlled by controlling the depth of the incision and its position. Alternatively, a polymeric sleeve may be inserted into the flow channel or bore of the tubular lead and/or positioned on the outside thereof to seal and prevent the flow or discharge of medical fluid from the lead flow channel. Controlling the length of the sleeve over the lead can control the discharge point of the liquid medicine from the lead. Slits can also be made in the sleeve to provide other discharge points.

Alternatively, a reinforced bobbin may be inserted into the bore or channel of the tubular wire as described above, and such bobbin may be bent at selected locations. As in FIG. 2 the bobbin 368 is bent at position 372 so that the tubular wire is bent correspondingly. Alternatively, the tubular wire can be formed with one or more bends and then a substantially straight spool inserted into the lumen of the wire to straighten the wire if desired. Also, the spool can be made from a material that is visible to fluoroscopy or MRI depending on the method used to view the clinical diagnostic procedure.

In the lead embodiments described above, the lead can be made "flow directable" by providing a highly flexible distal end. The so-called "flow directability" means that the distal end of the wire can "flow" with the arc and bend of the blood around the channel of the vasculature. To reduce the resistance of the lead to movement within the vasculature channel, the surface of the lead can be electropolished, blasted (with sand, glass beads, sodium carbonate, etc.), or otherwise treated to increase its smoothness. Alternatively, a smooth coating can be applied to the surface of the wire - such a coating can for example comprise silicone-based oils and/or polymers or hydrophilic polymers. Alternatively, a smooth sleeve, for example made of a hydrophilic polymer, may also be used to fit around the wire.

It should be understood that the configurations described above are merely exemplary applications of the principles of the present invention. Many modifications and alternative configurations of the present invention will be apparent to those skilled in the art without departing from the spirit and scope of the invention and the appended claims, and the present invention is intended to cover such modifications and alternative configurations.

Claims (28)

1. one kind is used for being incorporated in vascular or the pipeline so that when needed catheter is directed into the lead of the mixing tube in precalculated position, this lead is made of the first thin-wall long and thin tube portion and the second thin-wall long and thin tube portion, the tube wall of first tube portion forms a runner, and be to make by material with predetermined torsional rigidity and lateral thrust performance, and second tube portion has than less torsional rigidity of first tube portion and bigger lateral thrust performance, and said second tube portion is attached on first tube portion in the mode of conllinear.

2. according to the lead of claim 1, it is characterized by, the outer surface of second tube portion is provided with a plurality of isolated otch at least a portion length of second tube portion as a means of improving its lateral thrust performance.

3. according to the lead of claim 2, it is characterized by, said otch is made with sawing.

4. according to the lead of claim 2, it is characterized by, said otch is made with cut.

5. according to the lead of claim 2, it is characterized by, said otch is made with etching.

6. according to the lead of claim 2, it is characterized by, said otch is processed into discharge.

7. according to the lead of claim 1, it is characterized by, second tube portion has a near-end and a far-end, and lead also is provided with one to radiopaque element on the far-end of pipe two parts.

8. according to the lead of claim 1, it is characterized by, second tube portion has a near-end and a far-end, and lead also is provided with an element that can be detected by MRI on the far-end of second tube portion.

9. according to the lead of claim 1, it is characterized by, the size of first tube portion and second tube portion is formulated like this, and an end of second tube portion can be inserted in the runner of first tube portion, and second tube portion is fixing within it.

10. according to the lead of claim 9, it is characterized by, the overall diameter of first tube portion is from about 0.010 to 0.038 inch, and the diameter of runner is from about 0.006 to 0.030 inch, at the overall diameter of second tube portion from about 0.008 to 0.032 inch.

11. the lead according to claim 10 is characterized by, the overall diameter of first tube portion is about 0.018 inch, and the diameter of runner is 0.012 inch, and the overall diameter of second tube portion is about 0.014 inch.

12. the lead according to claim 1 is characterized by, first tube portion is made by rustless steel, and second tube portion is made by Nitinol.

13. the lead according to claim 1 also comprises an elongated line, this line can be arranged in the runner of first tube portion and in the cavity of second tube portion and can slide so that reinforce that segment length part that is occupied by this line selectively within it.

14. the lead according to claim 13 is characterized by, said slender threads comprise the stopping device of making within it in case be used for preventing exceeding when this line is in being inserted into runner and cavity certain a bit outside.

15. the lead according to claim 13 is characterized by, said slender threads comprises one or more bendings, when making in it is set at two-part runner and cavity, two parts can be crooked and with slender threads in crooked consistent.

16. lead according to claim 13, it is characterized by, two elongated portions are made by preform has one or more bendings, and slender threads is pre-formed into straight condition basically, when slender threads was set in the runner of two parts and the bending in the cavity, slender threads can make two parts become straight basically like this.

17. the lead according to claim 13 is characterized by, slender threads is by radiopaque material is made.

18. the lead according to claim 13 is characterized by, slender threads is by being made by the material that MRI detects.

19. the lead according to claim 13 is characterized by, slender threads has gradient at least on the one partial-length, so its far-end is thinner than near-end.

20. the lead according to claim 1 also comprises a tubular sleeve, is slidably disposed on the outside of second tube portion, docks with the termination of first tube portion, therefore the overall diameter of first tube portion and tubular sleeve is substantially the same.

21. the lead according to claim 20 is characterized by, tubular sleeve is made by a kind of material of choosing from the cohort that comprises lactoprene, polyurethane, polyethylene and polytetrafluoroethylene.

22. the lead according to claim 20 is characterized by, tubular sleeve and the general adjacency of second tube portion.

23. the lead according to claim 20 is characterized by, the far-end of second tube portion reaches outside the tubular sleeve.

24. the lead according to claim 20 is characterized by, tubular sleeve is covered by one deck lubricious material.

25. compound catheter/catheter lead has first elongate body, its pipe sidewall forms a central flow channel, with second elongate body, its pipe sidewall also forms a central flow channel, said second tubular body has the lateral thrust performance bigger than first tubular body, said second tubular body is linked on first tubular body end-to-end, on the length of the said sidewall of second tubular body, be shaped on groove so that improve the lateral thrust performance of this tubular body, at least some extend through sidewall up to runner in the said groove, make in runner flowing liquid be able to discharge by this route.

26. the catheter/catheter lead according to claim 25 is characterized by, said first tubular body is made by rustless steel, and said second tubular body is made by Nitinol.

27. the catheter/catheter lead according to claim 25 is characterized by, the near-end of said second tubular body is fitted in the runner of far-end of first tubular body.

28. the catheter/catheter lead according to claim 25 also comprises a stopper that is located at the far-end of second tubular body, said stopper is to be made by a kind of material of choosing from comprise the cohort to the radiopaque material and the material that can be detected by MRI.

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