JP2007029674A - Vascular guide wire for venous valvular angioplasty - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a vascular guide wire for use in angioplasty for recovering the function of a vein valve, which expands a vein from inside to be observed and analyzed. <P>SOLUTION: This vascular guide wire for intravascular use includes a tip segment 1, an intermediate segment 2 and a caudal segment 3, in succession to each other. The intermediate segment includes two curvilinear wires which are joined to each other by their extremities in extremal commissures 6, 7 and finally connected by one or more intermediate commissures 8<SB>1</SB>. The wires have coplanar relationship in the resting condition, so that the wires are bent in each space between the commissures connected to one or more consecutive bell-like ansae 4<SB>1</SB>, 4<SB>2</SB>, 5<SB>1</SB>, 5<SB>2</SB>to project the ansae on the same side in one wire, and project the same on the opposite side in the other wire. Thus, they are bent to form an eyelet. The guide wire is applied to angioplasty for recovering the function of the venous valves. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to the field of instruments for vascular surgery.

  In particular, the present invention relates to a blood vessel guide device used in a blood vessel, ie, a guide wire.

  Instruments for use in blood vessels, including an outer jacket or catheter and a moving core or guide wire that slides within it, are now commercially available, such as William Cook Europe A / S. In COOK-Producti per Radiologia Diagnostica ed Interventica. Such guidewires provided in disposable sterilization packages can be used, for example, in catheters, stents, filters, in surgery and in fluoroscopy, especially in angiography (ie, observation of blood vessels by X-rays). Used as a guide device for another subsequently used instrument such as an inflatable balloon.

  On the other hand, such guidewires are also used in urological surgery, bile duct surgery for percutaneous bile drainage, general surgery for abscess removal, and above all, percutaneous intervention procedures into the cardiovascular system (Percutaneous interventional treatment) in cardiovascular surgery.

  Such a guidewire is a flexible core wire that is gradually tapered to a very flexible distal tip and is wound longitudinally with an easily sliding outer spiral. Consists of internal wires. The gap between the core wire and the outer spiral body is filled with an adhesive, while the outer surface of the spiral body can be coated with various polymeric materials. In particular, the guide wire is hydrophobic, or conversely hydrophilic, i.e. the outer spiral is wettable so that water adheres to it and makes the guide wire itself slippery. . Typical display dimensions for such guide wires are 100 to 260 centimeters (39.37-102.36 inches) in length and 0.36 to 0.97 millimeters (0.014 to 0.038 inches) in diameter. is there.

  Useful for expanding, observing, and measuring venous valves in vascular surgery, and monitoring venous valvuloplasty in combination with angioplasty, fluoroscopy, or ultrasonography There is a keen need for an intravascular means suitable for use for that purpose. Monitoring valvuloplasty as described above has not been easy so far as means for dilating veins are still not available today.

  The urgent need for being able to expand the vein in a lateral-lateral direction was filed on February 6, 2004, “For functional recovery by traction between their commissural walls to the venous valve” Inventor Sante Camiri (Sant), an inventor of the present invention, entitled "External Support for Restoring Competence to Venous Valves by Traction of The Inter Interstitial Walls". It is particularly painful to use an external support for venous valve function recovery as taught in US Pat. No. 4,442,074.4. In fact, it is important to set which is the optimal size of the external support itself to achieve the best desired result.

  Accordingly, it is an object of the present invention to provide an instrument that allows a vein to be expanded from the inside so that the vein can be observed and analyzed by blood vessel microscopy, fluoroscopy, or ultrasound.

  Such an object is achieved by a guide wire for use in a blood vessel as claimed in claim 1.

  Preferred embodiments are set forth in the dependent claims.

  The invention will be more fully understood on the basis of the following detailed disclosure of a preferred embodiment of the invention, given by way of example only and not by way of limitation, with reference to the accompanying drawings, in which:

  Referring to FIG. 1, a guide wire according to the present invention includes three segments that are spliced together. According to the first embodiment, the first and third endmost segments, i.e. the tip segment 1 and the back end segment 3, are constructed according to the traditional technique of angiographic guide wires, i.e. as described above. They are particularly wettable, i.e. coated with an easily slidable spiral of hydrophilic material, and finally coated with a material such as Teflon, i.e. heparin. Flexible core wire, while the second, or middle, segment is preceptive. As is known in the art of angiographic guidewire, the tip segment 1 can be terminated with a J-shaped tip 1 'and the trailing segment 3 can be terminated with a straight tip 3'. it can.

  In the middle segment 2, the guide wire is made of two bends made of a highly flexible material such as a superelastic alloy, for example Nitinol®, ie a medical grade steel. Flexible wires 4 and 5. As shown in FIG. 2C, the two bent flexible wires 4 and 5 have a substantially semicircular cross section, and the diameter portions of the semicircles facing each other are tip commissures (tips) at their extreme ends. communisure 6 and posterior commissure 7 are joined to the tip segment and posterior segment 1, 3. The two bent flexible wires 4 and 5 are both folded into one or more continuous bell-like answers (annae) in the same plane in the resting state. The convex shape of each wire is directed to the same side, while the convex shape of the other wire is directed to the opposite side. The two flexible wires 4, 5 are firmly connected to each other at the joint between subsequent answers by intermediate commissures to form one or more continuous eyelets, each having a spread.

The two answers 4 ₁ , 4 ₂ ; 5 ₁ , 5 ₂ are firmly connected via the intermediate commissure 8 ₁ , so that the two eyelets 45 ₁ , 45 ₂ are individually created. The degree of protrusion of the answer, that is, the spread of the eyelet, sequentially increases in the rear end direction. Thus, the middle leading segment 2 is characterized by a protruding shape for flexibility, but because of its flexibility, it can be easily pushed, retracted, or straightened inside a small diameter linear catheter. It is possible to fold the two bent flexible wires in the longitudinal direction in the reciprocating direction.

  Referring to FIGS. 2A to 2E, the structure of the guide wire according to the present invention is shown sequentially in a typical cross section from the leading edge 1 ′ to the rearmost end 3 ′. Referring to FIGS. 2A and 2E, the front end segment 1 and the rear end segment 3 may be conventional, i.e. include an inner core wire 10 around which a spiral body 11 is wound, for example, in a ribbon shape. The winding is shaped as shown in FIG. According to the embodiment considered in the present invention, the spiral body 11 is double wound, i.e. two spiral bodies are evenly wound. However, the spiral body is not limited to a double wire, and may be a single wire.

Referring to Figure 2C, the intermediate commissure ₈₁ is shown between the two wires of the leading intermediate segment 2. The two wires face each other at their diameter and are clamped at an intermediate commissure 8 by, for example, a metal, banded band 9.

The length of the guide wire is irrelevant for the purposes of the present invention with respect to the leading and trailing segments, while for the middle leading segment in the embodiment with two eyelets shown in FIG. The thickness is preferably 30 to 40 millimeters (1.18 to 1.57 inches). The width between the answer vertices of the middle leading segment, i.e. the spread of the eyelet, is 8 to 10 millimeters and 12 for the first and second eyelets 45 ₁ and 45 ₂ in the rearward direction in the resting state. To 15 millimeters is preferred. It is also possible for a third eyelet with a spread of 15 to 20 millimeters to be present in the rear end direction. In any case, other dimensions can be used for the planar width of the intermediate segment for a particular use. The middle segment wire may be 1 millimeter wide and 0.5 millimeter thick. The length of the crimped band 9 can be 1 to 3 millimeters. The maximum diameter of the guide wire is such that it can be easily introduced and manipulated inside the working channel of the angioscope, for example, 0.97 millimeters (0.038 inches).

  Referring to FIGS. 2B and 2D, an example of connection between the intermediate segment 2 and the tip segment 1 and the trailing segment 3 respectively is shown. A cylindrical core wire 10 is tapered to be an attack band 12 and is limited to a width smaller than the diameter of the curved flexible wires 4, 5. The attack band is inserted between these wires, tightened between the diameters of the wires, leaving a diametrical gap opposite each other between the facing wires themselves. The attack band may have a thickness of 0.2 millimeters and an insertion depth of 5 to 10 millimeters. The heads 11A and 11B of the double-wire spiral body 11 are inserted into these remaining gaps, for example welding or injected into the remaining gap between the two wires 4 and 5 Is connected securely. Alternatively, or in addition, the endmost segment of the guidewire can be securely connected to the middle segment by conventional mechanical attachment means. It is clear that modifications can be made from the connection configuration disclosed in the case of a single wire wound spiral, but in this case a single spiral head is inserted into the connection.

  Alternatively, the connecting means includes tubular mechanical engagement means that bite into the head of the tip segment or the head of the trailing segment on one side and the tip segment on the other side. The tube-like mechanical engagement means and the front end, the rear end and the head of the intermediate segment are provided with fitting means for mating. The wire heads that make up the segment can be knurled or threaded.

  Referring to FIGS. 3A and 3E, in an alternative embodiment, the configuration of the middle lead segment with double wires can also be done by means of leading and trailing segment prosecution, i.e. these segments. The inner core wire can be composed of two wires 10A and 10B which are combined in their diameter portions with a substantially semicircular cross section. The intermediate segment 4,5 of the double wire seen from FIG. 3C, showing a cross-sectional view of the intermediate commissure of the intermediate segment, is shown in FIGS. 3B and 3D, as shown in FIGS. 3B and 3D. Are connected by bringing the extreme ends 11A, 11B of the windings around the core wires 10A, 10B and inserting them between the extreme ends of the wires 4, 5 of the intermediate segment. The commissure thus formed is firmly connected by embedding it in the adhesive 13, as can be seen from FIGS. 3B and 3D. Alternatively or additionally, it is possible to connect securely by mechanical engagement means.

  Advantageously, the middle leading segment can be provided with markers useful for monitoring.

  Having disclosed the configuration of the guide wire according to the present invention, it is clear that its use is to dilate the blood vessel in order to select the correct size of the aforementioned external support.

  The guide wire according to the invention is introduced into the working channel of the angioscope in order to introduce the intermediate leading segment 2 therein. An angioscopy assembly loaded with a guide wire according to the present invention is pushed into the blood stream in the vein to the venous valve to restore its function. Once the non-functional examination of the venous valve is completed, the guide wire is pushed in, so that the intermediate segment 2 is exited from the working channel of the angioscope and expanded toward its resting state, making itself a valvular valve. (bulb). During observation with a blood vessel microscope, fluoroscopy, or ultrasonography, the plane of the intermediate segment is oriented parallel to the intercommissural diameter of the venous valves. The diameter between the commissures of the venous valves is then expanded by the pressure applied by the middle leading segment bell-shaped answer until the valve function is restored. This can be checked immediately by slight fluctuations in the hydrostatic pressure gradient, for example Valsalva's manoeuvre. Until the blood flow returns, the venous valve is not possible. When the blood return stops, the valve restores function. If the first eyelet does not expand sufficiently, the wider subsequent eyelet is pushed.

  Once fully expanded, the optimal intercommissural diameter can be measured externally by percutaneous ultrasonography or fluoroscopy. Thus, the optimal diameter of the external support can be selected to be applied to restore venous valve function as described above.

  At this point, the location of the vein to be treated is surgically revealed and the external support is latched to the vein wall by two pairs of sutures on both sides, one pair being located at the level of commissure diameter. Applied by doing.

  Although the present invention has been disclosed and described with reference to specific embodiments thereof, modifications, additions and / or changes can be made without departing from the relevant scope of protection limited only by the claims. It should be clearly understood what is possible.

Reference COOK-Producti per Radiologia Diagnostica ed Interventica, William Cook Europe A / S

Fig. 2 shows a front view of a guide wire according to the invention in which an intermediate leading segment is formed in an embodiment of the invention with two eyelets. AE sequentially shows a typical cross section of a guide wire according to an embodiment of the invention from the forefront to the end, from top to bottom. AE sequentially shows the cross-section of the guide wire from top to bottom according to another embodiment of the present invention from top to bottom.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Cutting edge segment 2 Middle segment 3 Last segment 4 Curved guide wire 5 Curved guide wire
6 Front end commissure 7 Rear end commissure 8 Intermediate commissure 9 Band 10 Core wire 11 Spiral body 12 Attack band 13 Bonding material 45 Eyelet

Claims (9)

In an intravascular guide wire used in a blood vessel,
A front end segment (1), an intermediate segment (2), and a rear end segment (3) are sequentially combined with each other, and the front end segment (1) and the rear end segment (3) are spiral. It includes a curved inner flexible core wire means (10, 10A, 10B) wound by a winding means (11), the intermediate segment (2) having a front end commissure (6) and a rear end commissure (7) And finally between the commissures, two curved flexible wires (4, 5, 5) joined together by their extreme ends in one or more intermediate commissures (8 ₁ ) 10A, 10B), while in their resting state, one or more continuous bell-shaped answers (4 ₁ , 4 ₂ ; 5; each answer being between successive commissures (6, 8 ₁ , 7); folding _{1, 5 2)} and so as coplanar The answer has a convex portion on each wire facing the same side, while the other wire has a convex portion on the opposite side with respect to the bell-shaped answer, so one or more continuous An intravascular guide wire characterized by forming an eyelet.   The intravascular guide wire according to claim 1, wherein the spread of the eyelet increases in the rear end direction.   The tip (1), middle (2), and rear end (3) segments are separate, the tip and rear end segments each including an inner core wire (10), the tip and rear end segments 3. An intravascular guidewire according to claim 1 or 2, characterized in that means are included for splicing to the intermediate segment.   The splicing means is at the extreme end of the core wire and has a tapered attack band inserted between the two bent flexible wires; and a flexible wire head; Including a head portion of the spiral wrapping means inserted in a remaining gap between the end of the core wire attack band and a means for securely connecting the formed seam. The intravascular guide wire according to any one of claims 1 to 3, characterized in that:   The means for securely connecting is, for example, a weld such as micro (ultra-high frequency) welding, or an adhesive, and / or a notch provided at the extreme end of the core wire attack band. Item 5. The intravascular guide wire according to Item 4.   The splicing means includes tube-like mechanical engagement means for biting the leading or trailing segment on one side at their heads and biting the intermediate segment on the other side; The blood vessel according to claim 3, wherein a mating engagement means such as a knurled line, a screw, and a notch is provided on the engaging means and the head of the front end, the rear end, and the intermediate segment. Inner guide wire.   The leading segment (1) and trailing segment (3) comprise a core wire (10A, 10B) of a double wire, the two wires being the curved flexible wire (10A, The intravascular guide wire according to claim 1 or 2, which is continuous with 10B).   The heads (11A, 11B) of the spiral wrapping means of the front and rear end segments can be injected inside the bifurcated portion between two wires corresponding to the extreme ends of the front and rear ends of the intermediate segment. 8. The intravascular guide wire according to claim 7, wherein the guide wire is embedded and fixed in a firm connection means.   The intravascular guide wire according to any one of claims 1 to 8, wherein marker means for monitoring is added to the intermediate segment.

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