Source: http://www.google.com/patents/US20040116833?dq=%223do%22+dna
Timestamp: 2017-08-22 14:18:10
Document Index: 615403085

Matched Legal Cases: ['Application No. 2000', 'Application No. 10', 'Application No. 11', 'Application No. 11', 'Application No. 7', 'Application No. 10']

Patent US20040116833 - Wire-stranded hollow coil body, a medical equipment made therefrom and a ... - Google Patents
A wire-stranded hollow coil body (1) has a multitude of coil line elements (2) stranded along a predetermined circular line to form a flexible wire tube having a central axial hollow portion (3), the flexible wire tube is stranded under a strand-turn resistant load and heat treated to remove a residual...http://www.google.com/patents/US20040116833?utm_source=gb-gplus-sharePatent US20040116833 - Wire-stranded hollow coil body, a medical equipment made therefrom and a method of making the same
Publication number US20040116833 A1
Application number US 10/611,664
Also published as CN1506022A, CN100399976C, CN101238968A, EP1428547A2, EP1428547A3, EP1428547B1, US7117703, US20060014418
Publication number 10611664, 611664, US 2004/0116833 A1, US 2004/116833 A1, US 20040116833 A1, US 20040116833A1, US 2004116833 A1, US 2004116833A1, US-A1-20040116833, US-A1-2004116833, US2004/0116833A1, US2004/116833A1, US20040116833 A1, US20040116833A1, US2004116833 A1, US2004116833A1
Inventors Tomihisa Kato, Kenji Miyata
Original Assignee Asahi Intecc Co., Ltd.
Patent Citations (9), Referenced by (36), Classifications (27), Legal Events (3)
US 20040116833 A1
1. A wire-stranded hollow coil body comprising a multitude of coil line elements stranded along a predetermined circular line to form a flexible linear tube having a central axial hollow portion, whereby said flexible linear tube is stranded under a strand-turn resistant load and heat treated to remove a residual stress upon formation so as to provide a high rotation-following capability and a high straightness.
2. A wire-stranded hollow coil body according to claim 1, wherein said flexible linear tube is lengthwisely divided into pluralistic sections, each of which has different number of strand turns.
3. A wire-stranded hollow coil body according to claim 1, wherein said flexible linear tube is lengthwisely divided into pluralistic sections, each of which has residual stresses removed in different degrees.
4. A wire-stranded hollow coil body according to claims 1 to 3, wherein an outer surface of said flexible linear tube is ground in concentric relationship with said predetermined circular line.
5. A wire-stranded hollow coil body according to claim 1, wherein an outer surface of said flexible linear tube is ground by an electrolytic polishing in concentric relationship with said predetermined circular line.
6. A wire-stranded hollow coil body according to claim 1, wherein said coil line elements are austenitic stainless steel.
7. A medical endscope having an cloak tube constituted by said wire-stranded hollow coil body according to claim 1.
8. A medical endscope treating tool having a coil sheath constituted by said wire-stranded hollow coil body according to claim 1.
9. A medical endscope treating tool having a manipulating sheath portion constituted by said wire-stranded hollow coil body according to claim 1.
10. A medical guide wire having a main wire body constituted by said wire-stranded hollow coil body according to claim 1.
11. A pressure sensor type medical guide wire having a main wire component constituted by said wire-stranded hollow coil body according to claim 1.
12. A method of making a wire-stranded hollow coil body comprising a multitude of coil line elements stranded along a predetermined circular line to form a flexible linear tube having a central axial hollow portion,
clamping one end of a primary forming flexible linear tube by means of a rotationally active chuck, and arranging the other end of said primary forming flexible linear tube to be slidable in its lengthwise direction, and clamping said other end by a fixture chuck to impart a tensile force with said primary forming flexible linear tube;
actuating said rotationally active chuck to strand said primary forming flexible linear tube, and concurrently or thereafter heat treating said primary forming flexible linear tube to remove a residual stress upon forming said coil line elements by electrically conducting between said rotationally active chuck and said fixture chuck.
13. A method of making a wire-stranded hollow coil body comprising a multitude of coil line elements stranded along a predetermined circular line to form a flexible linear tube having a central axial hollow portion,
clamping one end of a primary forming flexible linear tube by means of a rotationally active chuck, and clamping halfway middle portions of said primary forming flexible linear tube by means of middle clamp portions, and stranding said primary forming flexible linear tube in different strand turns depending on spans between said rotationally active chuck and each of said middle clamp portions.
14. A method of making a wire-stranded hollow coil body comprising a multitude of coil line elements stranded along a predetermined circular line to form a flexible linear tube having a central axial hollow portion,
concurrently or after stranding a primary forming flexible linear tube, accommodating lengthwisely divided sections of a primary forming flexible linear tube into heating devices, each of which has different heating condition depending on said lengthwisely divided sections, so as to heat treat said pluralistically divided sections individually to have residual stresses removed in different degrees.
In a catheter and a catheter guide wire which introduce a leading distal end into a diseased area through a twisted and turned vascular system, a leading distal end of the catheter or the catheter guide wire is inserted into the blood vessel or the somatic cavity by a “push-pull and turn” manipulation at a hand access portion located ouside a subject patient upon treating the diseased area. In an endscope treating tool which is inserted through a somatic cavity to reach the diseased area, a leading end of the endscope treating tool is manipulated in the same manner as mentioned above.
In the references of Laid-open Japanese Patent Application Nos. 2002-275774 and 4-309371 (referred in turn to as “first and second reference” hereinafter), a wire-stranded hollow coil body is disclosed which have a multitude of coil line elements stranded along a predetermined circular line to form a rope-like flexible linear tube having a central axial hollow portion. In the domestic publication of Japanese Patent Application No. 2000-512691 (referred to as “third reference” hereinafter), a solid thin wire made from an elastic shape-memory alloy is stranded under a tensile load. The solid thin wire thus stranded is subjected to a stress-removing heat-treatment procedure under the condition of approx. 280° C.×30 min.−300° C.×30 min. so as to provide a flexible solid wire body used for medical devices.
The reference of Laid-open Japanese Patent Application No. 10-165361 (referred to as “fourth reference” hereinafter) discloses a helical hollow pipe to produce a sheath from an elongated hollow thin wire used for an endscope treating tool. An outer surface of the helical hollow pipe is partly ground to form a diameter-reduced portion, or partly replaced by a thin wire to provide a good bending capability with the sheath.
The reference of Laid-open Japanese Patent Application No. 11-104071 (referred to as “fifth reference” hereinafter) discloses a flexible wire sheath made from a multi-wound helical coil body used for an endscope treating tool. Into the flexible wire sheath, a manipulation wire is inserted so as to be rotatable with a biopsy end portion in unison.
The reference of Laid-open Japanese Patent Application No. 11-33004 (referred to as “sixth reference” hereinafter) discloses a pressure-sensor type guide wire in which a guide wire sensor portion is made from a stainless steel cloak tube having a platinum helical wire tube and a stainless steel helical wire tube concentrically placed to enclose a piezoelectric elongation plate. The reference of Laid-open Japanese Patent Application No. 7-213481 (referred to as “seventh reference” hereinafter) discloses a flexible endscope in which a manipulation wire is placed within a cloak tube having four flexible helical wires juxtaposed,each of which is wound to have a different helical pitch. The reference of Laid-open Japanese Patent Application No. 10-290803 (referred to as “eighth reference” hereinafter) discloses an endscope treating tool in which a flexible wire coil sheath constitutes a main structure.
Upon stranding the group of the coil line elements, the flexible linear tube generally generates rolls or swells transmitting in the lengthwise direction due to a contractile stress produced between the neighboring coil line elements tightly arranged and due to a tensile and shearing stress appeared between the coil line elements. In contrast to the above situation, the hollow wire coil configuration according to the invention is stranded under the torsion-resistant load, and heat treated to remove the residual stress. This obviates a chance to occur the detrimental roll or swell phenomenon produced due to the complicated stresses combined, thus providing the wire-stranded hollow configuration with a good straightness. This also achieves a good rotation-following capability in which the leading distal end staunchly follows the rotational manipulation of the hand access portion. The related art wire-stranded hollow coil body disclosed by the first and second references intermittently generates “strand stuck portions”, a part of which is rapidly released with an excessive times of turning operation so as to roll in the stick slip manner. This produces a zigzag curve represented by broken lines in Table 1 which indicates that the rotational manipulation of the hand access portion at an angle (θ2) results in twisting the leading distal end by an angle (θ1). On the contrary, the wire-stranded hollow coil body according to the invnetion is stranded under the torsion-resistant load to eliminate the unfavorable “strand stuck portions” so as to present the high rotation-following capability and high straightness as shown by a linear relationship represented by the solid line in Table 1.
[0027]FIG. 1 is an exploded plan view of a wire-stranded hollow coil body according to a first embodiment of the invention;
[0028]FIG. 2 is a latitudinal cross sectional view taken along the line II-II of FIG. 1;
[0029]FIG. 3 is a plan view of a medical guide wire into which the wire-stranded hollow coil body is incorporated but partly sectioned;
[0030]FIG. 4 is an explanatory view showing how the wire-stranded hollow coil body is manufactured;
[0031]FIG. 5 is a latitudinal cross sectional view taken along the line V-V of FIG. 4;
[0032]FIG. 6 is a plan view of a wire-stranded hollow coil body according to a second embodiment of the invention;
[0033]FIG. 7 is an explanatory view showing how the wire-stranded hollow coil body is manufactured;
[0034]FIG. 8 is a perspective view of a clamp portion;
[0035]FIG. 9 is a characteristic curve of the wire-stranded hollow coil body;
[0036]FIG. 10 is a wire-stranded hollow coil body according to a third embodiment of the invention;
[0037]FIG. 11 is an explanatory view showing how the wire-stranded hollow coil body is manufactured;
[0038]FIG. 12 is a characteristic curve of the wire-stranded hollow coil body;
[0039]FIG. 13 is a latitudinal cross sectional view taken along the line XIII-XIII of FIG. 16 according to a fourth embodiment of the invention;
[0040]FIG. 14 is a latitudinal cross sectional view taken along the line XIV-XIV of FIG. 16;
[0041]FIG. 15 is a latitudinal cross sectional view taken along the line XV-XV of FIG. 16;
[0042]FIG. 16 is a plan view of a wire-stranded hollow coil body;
[0043]FIG. 17 is a plan view of a modified wire-stranded hollow coil body;
[0044]FIG. 18 is a plan view of a flexible endscope;
[0045]FIG. 19 is a latitudinal cross sectional view taken along the line XIX-XIX of FIG. 18;
[0046]FIG. 20 is an explanatory view of a related art flexible endscope shown for comparison;
[0047]FIG. 21 is an explanatory view of the flexible endscope;
[0048]FIG. 22 is another explanatory view of the flexible endscope shown how a cloak tube stretches when subjected to a bending deformation;
[0049]FIG. 23 is a graphical representation showing a relationship between a total bending angle (θ) and an extension length (L);
[0050]FIG. 24 is a plan view of a related art cloak tube but partly sectioned;
[0051]FIG. 25 is a plan view of a cloak tube but partly sectioned;
[0052]FIG. 26 is a plan view of a endscope treating tool but partly sectioned;
[0053]FIG. 27 is a plan view of another endscope treating tool but partly sectioned;
[0054]FIG. 28 is a plan view of a related art multi-wound coil sheath;
[0055]FIG. 29 is a plan view of a pressure sensor type guide wire; and
[0056]FIG. 30 is an explanatory view of the pressure sensor type guide wire.
Referring to FIGS. 1 through 5, with the use of a first method of making a wire-stranded hollow coil body 1, the wire-stranded hollow coil body 1 according to a first embodiment of the invention is described. In order to use an elongated thin flexible wire to a medical guide wire, a multitude of austenitic stainless steel coil line elements 2 are stranded along a predetermined circular line to form a flexible linear tube, a space of which serves as a central axial hollow portion 3. An entire length (Lt) of the flexible linear tube measures approx. 1.000-1.500 mm.
The wire-stranded hollow coil body 1 is formed in accordance with the following first method (see FIG. 4). Namely, with the use of an ordinary wire rope stranding machine, a primary forming flexible linear tube R (referred simply to as “primary approximation R”) is formed as a normal wire rope structure having a predetermined length. One end of the primary approximation R is set at a rotationally active chuck 11 of a stranding machine 10. The other end of the primary approximation R is arranged to be slidable along its lengthwise direction, and clamped by a slide type fixture chuck 12 loaded with a static weight W. The torsion-resistant load under the tensile stress W is added to the primary approximation R set between the rotationally active chuck 11 and the slide type fixture chuck 12. Then, a conductor line 15 extended from an electric power generator 14 is connected between the rotationally active chuck 11 and the slide type fixture chuck 12, so as to apply an electric current to the primary approximation R to prepare for heat treatment of the primary approximation R.
The primary approximation R set under the torsion-resistant load and the heat treatment is turned 300 times in the stranding direction and unwound 100 times in the reverse direction (stranded 200 (300−100) times resultantly) as shown at (A) in Table 2. At the time of stranding the primary approximation R or after stranded the primary approximation R, the primary approximation R is heat treated due to its own electric resistor energized. After heat treating the primary approximation R, an elongated core 4 is withdrawn from the primary approximation R to provide the axial hollow portion 3 so as to produce the wire-stranded hollow coil body 1.
dimension 18 coil line elements 8 coil line elements
(line diameter: 0.55 mm) (line diameter: 0.22 mm)
entire length: 4.500 mm entire length: 4.500 mm
outer diameter of coil: outer diameter of coil:
0.415 mm 0.865 mm
inner diameter of coil: inner diameter of coil:
0.305 mm 0.425 mm
stranded stranded 300 times but stranded 350 times but
times unwound 100 times unwound 120 times
resistance 2.8 Amp × 60 sec 6.0 Amp × 60 sec
heating heating temp.: approx. heating temp.: approx.
400-500° C. 400-500° C.
static load 3.6 kg 13.6 kg
With the coil line elements 2 made from the austenitic stainless steel (having a high coefficient of thermal expansion) and its outer surface electrolytically polished, secondary advantages are ensured. Namely, it is possible to provide the primary approximation R with a good drawability and heat-releasable capability at the time of thermally bonding bulge portion 6, so as to alleviate the residual stress in the primary approximation R to help stabilize the main advantages. Due to the electrolytically polishedsurface, it is possible to ensure a smooth and erosion-resistant surface to stabilize an improved performance as a main wire component of the medical equipment.
[0068]FIGS. 10 through 12 show a third embodiment of the invention in which the individually divided sections X, Y and Z are placed respectively at three heating devices 16A, 16B and 16C each having different heating condition. The primary approximation R is heat treated by energizing the devices 16A, 16B and 16C concurrently at the time of stranding the primary approximation R or after the primary approximation R is stranded, so as to remove the residual stress upon formation by a third method of making the wire-stranded hollow coil body 1. Depending on the heating condition of the heating devices 16A, 16B and 16C, the sections X, Y and Z are heat treated differently to have the residual stresses removed in different degrees. This provides the wire-stranded hollow coil body 1 with the functionally gradient “tensile strength” and “bending rigidity (R2)” each gradually shifting in the lengthwise direction (L) so as to produce a high quality flexible linear tube as shown in FIG. 12.
[0069]FIGS. 13 through 17 show a fourth embodiment of the invention in which an outer surface of the group of the coil line elements 2 is ground in concentric relationship with the central axial hollow portion 3 to reduce an original outer diameter (DL) into a reduced outer diameter (DS). As shown at diametrical dimensions DS, D2 and D3 in FIG. 16, it is possible to diametrically reduce the wire-stranded hollow coil body 1 progressively in a stepwise fashion from the hand access portion 8 to the leading distal end 7 in accordance with the lengthwisely divided sections. As an alternative, the wire-stranded hollow coil body 1 may be progressively decreased at its diametrical dimension in a cone-shaped fashion from the hand access portion 8 to the leading distal end 7 as shown at diametrical dimensions DS and D3 in FIG. 17. From this stand of view, “the flexible wire tube being soft at the front end and rigid at the rear end portion” is attained as a requirement for the medical equipment. This realizes a functionally gradient structure which enables the manipulator to feel a smooth shift from the front soft property to the rear rigid property in proportion with a distance from the hand access portion 8.
[0071]FIG. 18 shows a medical equipment in which the wire-stranded hollow coil body 1 is used as the flexible wire tube. FIGS. 18, 19, 21, 22 and 25 show a flexible endscope 20 in which the wire-stranded hollow coil body 1 is used as a cloak tube 23. As shown in FIG. 19, the endscope 20 has four elongated flexible cloak tubes 23 arranged between a front angle manipulator 21 and a rear manipulator 22 in a manner distinguishable from the first reference. Each of the cloak tubes 23 has a manipulator wire 24 surrounded by a flexible outer tube 25.
[0075]FIG. 23 shows a relationship between a total bending angle (θ) and an extension length (L) of the manipulator wire 24. It is found from a solid line in FIG. 23 that the flexible linear tube structure makes it possible to render the extension length (L) significantly small as compared to the related art extension length (Lp) (seventh reference) depicted by broken lines.
[0078]FIG. 26 shows an endscope treating tool 30 in which a coil sheath 31 is arranged between a rear manipulator 33 and a front detain loop 34. The coil sheath 31 acts as the wire-stranded hollow coil body 1 which has a central hollow area, through which manipulator rope 32 is inserted. In addition to the main advantages, the endscope treating tool 30 provides the following advantages.
It is to be noted that since the endscope treating tool 30 requires a stronger torsional torque when clutching the lesion tissue, the manipulation is further improved by using the structure (FIGS. 13-17) in which the outer surface of the group of the coil line elements 2 is ground. For the same purpose, the structure (FIG. 25) may be used in which the cloak tube 23 and the manipulator wire 24 are reversely stranded each other.
[0085]FIGS. 29 and 30 show a pressure sensor type guide wire 45 in which a pressure sensor 48 is provided at a front distal end of a flexible hollow tube wire 46 to measure a blood pressure or to monitor a blood pressure wave through a lead line 47 in a manner distinguishable from the sixth reference. With the flexible hollow tube wire 46 into which the wire-stranded hollow coil body 1 is incoporated, the pressure sensor type guide wire 45 provides the following advantages in addition the main advantages.
By applying the structure of FIGS. 13-17 to the flexible hollow tube wire 46 to represent the ground outer surface of the coil line elements, it is possible to define a smooth outer surface of the flexible hollow tube wire 46 to reduce the fluid friction resistance against the blood stream so as to suppress a laminar stream resistance at a boundary layer as shown at a parabolic velocity distribution 49 in FIG. 30. This makes it possible to achieve a necessary amount of the precisely measurable blood stream with a least amount of thrombi deposited on the outer surface of the coil line elements.
With the austenitic stainless steel applied to the wire-stranded hollow coil body 1 and the medical equipment, the description continues with respect to the structure represented by an “austenitic stainless steel” and the “electrolytically polished outer surface of the coil line elements”. By way of illustration, the martensitic stainless steel tends to harden with the heat treatment so as to likely stiffen the stranded coil section near the bulge portion 6 under the thermal influence produced at the time of soldering the bulge portion 6, thereby resultantly depriving the stranded coil section of the favorable flexibility. On the other hand, the ferritic stainless steel has the property referred to as “475° C. fragility” and having the property called as “sigma fragility” occurred when heated to approx. 600-800° C. for an extended period of time. Especially, the ferritic stainless steel grows the crystallized particles to reveal “fragility in high temperature” when heated to 950° C. or more, thereby unfavorably deteriorating the quality as a catheter or catheter guide wire due to the thermal influence brought by thermally bonding the bulge portion 6.
However, since the austenitic stainless steel is less subjected to the texture transformation when heated, it is less affected by the heat generated when thermally bonding the bulge portion 6. In addition, the austenitic stainless steel has a relatively small thermal conductivity and a greater coefficient of thermal expansion which is approx. 1.5-1.6 times as great as that of the general stainless steel. This means that the thermal expansion and the thermal stress produced on the wire-stranded hollow coil body 1 by thermally bonding the bulge portion 6 are absorbed by a restricted portion of the wire-stranded hollow coil body 1 near the bulge portion 6. This alleviates the residual stress produced by thermally bonding the bulge portion 6, and thereby providing a good linearity and favorable flexibility with the restricted portion of the wire-stranded hollow coil body 1 near the bulge portion 6.
While the martensitic stainless steel has a quench hardening property by which a tensile strength is augmented, the austenitic stainless steel increases its strength when drawn (work hardening) to be well-suited to the coil line elements of the wire-stranded hollow coil body 1. Since an electric resistance of the austenitic stainless steel is approx. five times as great as that of the carbon steel, and is approx. 1.6 times as great as that of the martensitic stainless steel. This decreases an intensity of the electric current necessary to thermally bond the bulge portion 6, whereby limiting the thermally bonding heat to a necessary minimum so as to lessen a twisting and torsional deformation under the influence of the heat generated by thermally bonding the bulge portion 6.
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U.S. Classification 600/585, 140/71.00R
International Classification A61F2/958, A61B1/005, D07B1/12, D07B3/00, A61B1/00, A61M25/09, A61M25/01, A61M25/16
Cooperative Classification D07B1/12, A61M2025/09191, A61M2025/09108, A61M25/09, A61B5/6851, A61B5/417, A61B1/005, A61B1/00071, D07B3/00, D07B5/005
European Classification A61B1/00E4, A61B5/68D1F, A61B5/41J6, A61B1/005, D07B3/00, A61M25/09, D07B1/12
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:KATO, TOMIHISA;MIYATA, KENJI;REEL/FRAME:017504/0223