Composite guidewire
Abstract
An alternative design, material and manufacturing method for guide wires. Some embodiments are couplers that are adapted and configured to permanently join the proximal area (14) and the distal area (16) and the proximal area (14) to the distal area (16). 18) and related to composite guide wires. In some embodiments, at least one area (16) is formed from a linear elastic nickel-titanium alloy. Several alternative guidewire tip designs with coiled safety / shaping structures are also disclosed.

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83 claims: 17 independent, 66 dependent
- 1ガイドワイヤであって、 先端を有する基端区域と、 線形弾性ニッケルチタン合金からなる先端区域であって、基端を有する前記先端区域と、 前記基端区域の前記先端及び前記先端区域の前記基端に隣接して配置されている連結器とを備えており、前記連結器は前記基端区域を前記先端区域に恒久的に接合するように適合され構成されている、ガイドワイヤ。
- 2前記基端区域が第1の柔軟性を備えており、前記先端区域が第2の柔軟性を備えており、前記基端区域の前記先端と前記先端区域の前記基端とが重なって、前記第1の柔軟性から前記第2の柔軟性に移行する領域を画定する請求項1に記載のガイドワイヤ。
- 3前記基端区域の前記先端の寸法が縮小されており、かつ前記先端区域の前記基端の寸法も縮小されている、請求項1に記載のガイドワイヤ。
- 4前記縮小寸法部分は均一な外形を有する請求項3に記載のガイドワイヤ。
- 5前記縮小寸法部分はテーパー状である請求項3に記載のガイドワイヤ。
- 6前記縮小寸法部分がインターロック形状である請求項3に記載のガイドワイヤ。
- 7前記基端区域の前記先端及び前記先端区域の前記基端が接合されて突合せ接合を画定している請求項1に記載のガイドワイヤ。
- 8前記基端区域の前記先端がテーパー状部分を画定しており、かつ前記先端区域の前記基端もテーパー状部分を画定しており、前記テーパー状部分は少なくとも部分的に互いに重なっている請求項1に記載のガイドワイヤ。
- 9前記連結器が、前記テーパー状部分同士の間に配置された連結物質を含む請求項8に記載のガイドワイヤ。
- 10前記基端区域が金属または合金からなる請求項1に記載のガイドワイヤ。
- 11前記金属または合金が、ステンレス鋼、ニッケルチタン合金、ニッケルクロム合金、ニッケルクロム鉄合金、コバルト合金、およびこれらの組み合わせのうちいずれかを含む請求項10に記載のガイドワイヤ。
- 12前記基端区域がステンレス鋼からなる請求項11に記載のガイドワイヤ。
- 13前記ガイドワイヤが、前記先端区域の少なくとも一部の周囲に配置された外部構造を更に備えている請求項1に記載のガイドワイヤ。
- 14前記外部構造がポリマースリーブを備える請求項13に記載のガイドワイヤ。
- 15前記ガイドワイヤが、前記先端区域に取り付けられた平らなリボンを更に備えている請求項14に記載のガイドワイヤ。
- 16前記ガイドワイヤが、前記先端区域の一部の周囲に配置されたコイルを更に備えており、前記コイルは前記先端区域の先端方向に延びる先端部分を有する、請求項14に記載のガイドワイヤ。
- 17前記外部構造が前記先端区域の一部の周囲に配置された第1のコイルを備える請求項13に記載のガイドワイヤ。
- 18前記ガイドワイヤが、前記先端区域の一部の周囲で少なくとも部分的に前記第1のコイル内部に配置された内側コイルを更に備えており、前記内側コイルは前記先端区域の先端方向に延びる先端部分を有する、請求項17に記載のガイドワイヤ。
- 19前記内側コイルが安全構造となるように適合され構成されている請求項18に記載のガイドワイヤ。
- 20前記ガイドワイヤが、前記先端区域に取り付けられた平らなリボンを更に備えている請求項17に記載のガイドワイヤ。
- 21前記連結器が金属または合金からなる請求項1に記載のガイドワイヤ。
- 22前記金属または合金が、ステンレス鋼、ニッケルチタン合金、ニッケルクロム合金、ニッケルクロム鉄合金、コバルト合金、ニッケル、およびこれらの組み合わせのうちいずれかを含む請求項21に記載のガイドワイヤ。
- 23前記連結器がニッケルクロム鉄合金からなる請求項22に記載のガイドワイヤ。
- 24前記連結器がポリマーまたは金属とポリマーとの複合材料からなる請求項1に記載のガイドワイヤ。
- 25前記連結器が、前記基端区域の前記先端及び前記先端区域の前記基端の周囲に配置されたチューブ状部材を備える請求項1に記載のガイドワイヤ。
- 26ガイドワイヤであって、 先端を有する基端区域と、前記基端区域の前記先端は柔軟性移行領域を有することと、 線形弾性ニッケルチタン合金からなる先端区域と、前記先端区域は基端を有し、前記先端区域の前記基端は柔軟性移行領域を有することと、 前記基端区域の前記先端及び前記先端区域の前記基端に隣接して配置されている連結器とを備えており、前記連結器は前記基端区域を前記先端区域に接合するように適合され構成されている、ガイドワイヤ。
- 27前記基端区域が第1の柔軟性を備えており、前記先端区域が第2の柔軟性を備えており、前記柔軟性移行領域同士が重なって、前記第1の柔軟性から前記第2の柔軟性に移行する領域を画定する請求項26に記載のガイドワイヤ。
- 28前記基端区域がステンレス鋼から構成されている請求項26に記載のガイドワイヤ。
- 29前記ガイドワイヤが、前記先端区域の一部の周囲に配置されたポリマースリーブを更に備えている請求項26に記載のガイドワイヤ。
- 30前記ガイドワイヤが、前記先端区域の一部の周囲に配置されたコイルを更に備えており、前記コイルは前記先端区域の先端方向に延びる先端部分を有する請求項29に記載のガイドワイヤ。
- 31前記ガイドワイヤが、前記先端区域の一部の周囲に配置された第1のコイルを更に備えている請求項26に記載のガイドワイヤ。
- 32前記ガイドワイヤが、前記先端区域の一部の周囲で少なくとも部分的に前記第1のコイル内部に配置された内側コイルを更に備えており、前記内側コイルは前記先端区域の先端方向に延びる先端部分を有する請求項31に記載のガイドワイヤ。
- 33前記内側コイルが安全構造となるように適合され構成されている請求項32に記載のガイドワイヤ。
- 34前記連結器がニッケルクロム鉄合金チューブを備える請求項26に記載のガイドワイヤ。
- 35前記連結器の少なくとも一部が前記柔軟性移行領域同士の間に配置される請求項26に記載のガイドワイヤ。
- 36ガイドワイヤの製造方法であって、 先端を有する基端区域を設ける工程と、 線形弾性ニッケルチタン合金からなる先端区域を設ける工程であって、前記先端区域は基端を有する、工程と、 前記基端区域を前記先端区域に恒久的に接合するように適合され構成されている連結器を用いて、前記基端区域の前記先端と前記先端区域の前記基端とを連結する工程とを有している方法。
- 37前記基端区域の前記先端及び前記先端区域の前記基端に柔軟性移行領域を形成する工程を更に有している請求項36に記載の方法。
- 38前記柔軟性移行領域を形成する前記工程が、前記基端及び前記先端の寸法を縮小する工程を有している請求項37に記載の方法。
- 39前記基端区域の前記先端と前記先端区域の前記基端とを連結する工程が、前記基端と前記先端とを重ねる工程を有している請求項37に記載の方法。
- 40ガイドワイヤの製造方法であって、 先端を有する基端区域を設け、更に前記先端に柔軟性移行領域を設ける工程と、 線形弾性ニッケルチタン合金からなる先端区域を設け、前記先端区域は基端を有し、更に前記基端に柔軟性移行領域を設ける工程と、 前記柔軟性移行領域同士を接合する工程とを有している方法。
- 41ガイドワイヤであって、 基端区域と、 線形弾性ニッケルチタン合金からなる先端区域と、 前記基端区域を前記先端区域と接合する手段とを備えているガイドワイヤ。
- 42前記基端区域が第1の柔軟性を備えており、前記先端区域が第2の柔軟性を備えており、前記接合する手段が、前記第1の柔軟性から前記第2の柔軟性に移行するように前記基端区域を前記先端区域と接合する手段を備えている、請求項41に記載のガイドワイヤ。
- 43ガイドワイヤであって、 ステンレス鋼からなる基端区域と、 線形弾性ニッケルチタン合金からなる先端区域と、 ニッケルクロム鉄合金を含み、前記基端区域と前記先端区域とを連結している連結器とを備えているガイドワイヤ。
- 44ガイドワイヤであって、 基端部分および先端部分を有する心線と、 基端領域および先端領域を有するコイルと、前記コイルの前記基端領域は前記心線の前記先端部分に連結されており、前記コイルの前記先端領域は前記心線の前記先端部分を越えて先端方向に延びていることと、 前記心線及び前記コイルの少なくとも一部の周囲に配置されたポリマーシースとを備えており、前記ポリマーシースは前記心線の前記先端部分及び前記コイルの前記先端領域を越えて先端方向に延びてチップを形成しているガイドワイヤ。
- 45前記コイルが安全構造となるように適合され構成されている請求項44に記載のガイドワイヤ。
- 46前記コイルが平角線のコイルである請求項44に記載のガイドワイヤ。
- 47前記コイルの前記先端領域が第1の外径を備えており、前記コイルの前記基端領域が前記第1の外径とは異なった第2の外径を備えている請求項44に記載のガイドワイヤ。
- 48ガイドワイヤであって、 ニッケルチタン合金からなるコア構造と、前記コア構造は先端部分を有することと、 基端領域および先端領域を有する平角線のコイルと、前記コイルの前記基端領域は前記心線の前記先端部分に連結されており、前記コイルの前記先端領域は前記心線の前記先端部分を越えて先端方向に延びることと、 前記コアの前記先端部分及び前記平角線のコイルの少なくとも一部の周囲に配置された外部構造とを備えているガイドワイヤ。
- 49前記外部構造がポリマーシースである請求項48に記載のガイドワイヤ。
- 50前記外部構造が外側コイルである請求項48に記載のガイドワイヤ。
- 51前記外側コイルが丸線のコイルである請求項50に記載のガイドワイヤ。
- 52前記コア構造が線形弾性ニッケルチタン合金からなる請求項48に記載のガイドワイヤ。
- 53前記コイルの前記先端領域が第1の外径を備えており、前記コイルの前記基端領域が前記第1の外径とは異なった第2の外径を備えている請求項48に記載のガイドワイヤ。
- 54前記コイルが先端方向に延びるにつれ細くなるようにテーパー状になった外径を有する請求項53に記載のガイドワイヤ。
- 55ガイドワイヤであって、 先端を備えた基端区域と、基端及び先端を備えた先端区域とを有する心線と、 前記基端区域の前記先端及び前記先端区域の前記基端に隣接して配置されている連結器と、前記連結器は前記基端区域を前記先端区域に恒久的に接合するように適合され構成されていることと、 基端領域および先端領域を備えた内側コイルと、前記コイルの前記基端領域は前記先端区域の前記先端に連結されており、前記コイルの前記先端領域は前記先端区域の前記先端を越えて先端方向に延びていることと、 前記先端区域及び前記内側コイルの少なくとも一部の周囲に配置された外部構造とを備えているガイドワイヤ。
- 56前記外部構造がポリマーシースである請求項55に記載のガイドワイヤ。
- 57前記ポリマーシースが前記コイルの前記先端領域を越えて先端方向に延びてチップを形成している請求項56に記載のガイドワイヤ。
- 58前記外部構造が外側コイルである請求項55に記載のガイドワイヤ。
- 59前記内側コイルが平角線のコイルである請求項55に記載のガイドワイヤ。
- 60ガイドワイヤであって、 先端を有する基端区域と、前記基端区域の前記先端の寸法は縮小されていることと、 基端を有する先端区域と、前記先端区域の前記基端の寸法は縮小されており、前記先端区域の前記基端は前記基端区域の前記先端に重なっていることと、 前記基端区域の前記先端及び前記先端区域の前記基端に隣接して配置されている連結器とを備えており、前記連結器は前記基端区域を前記先端区域に恒久的に接合するように適合され構成されている、ガイドワイヤ。
- 61前記基端区域が第1の柔軟性を備えており、前記先端区域が第2の柔軟性を備えており、前記基端区域の前記先端と前記先端区域の前記基端とが重なって、前記第1の柔軟性から前記第2の柔軟性に移行する領域を画定する請求項60に記載のガイドワイヤ。
- 62前記縮小寸法部分が均一な外形を有する請求項60に記載のガイドワイヤ。
- 63前記縮小寸法部分がテーパー状になっている請求項60に記載のガイドワイヤ。
- 64前記縮小寸法部分がインターロック形状を有する請求項60に記載のガイドワイヤ。
- 65前記基端区域がステンレス鋼から構成されている請求項61に記載のガイドワイヤ。
- 66前記先端区域がニッケルチタン合金から構成されている請求項65に記載のガイドワイヤ。
- 67前記連結器がニッケルクロム鉄合金から構成されている請求項66に記載のガイドワイヤ。
- 68前記連結器が、前記基端区域の前記先端及び前記先端区域の前記基端の周囲に配置されたチューブ状部材を備える請求項60に記載のガイドワイヤ。
- 69前記チューブ状連結器の外径は、前記基端区域の外径と同一である請求項68に記載のガイドワイヤ。
- 70前記チューブ状連結器の外径は、前記先端区域の外径と同一である請求項69に記載のガイドワイヤ。
- 71前記連結器の少なくとも一部が前記基端区域のテーパー状の先端と前記先端区域のテーパー状の基端との間に配置されている請求項60に記載のガイドワイヤ。
- 72ガイドワイヤであって、 先端を有する基端区域と、前記基端区域の前記先端は柔軟性移行領域を有することと、 基端を有する先端区域と、前記先端区域の前記基端は柔軟性移行領域を有することと、 前記基端区域の前記先端及び前記先端区域の前記基端に隣接して配置されている連結器とを備えており、前記連結器は前記基端区域を前記先端区域に接合するように適合され構成されている、ガイドワイヤ。
- 73前記基端区域が第1の柔軟性を備えており、前記先端区域が第2の柔軟性を備えており、前記柔軟性移行領域同士が重なって、前記第1の柔軟性から前記第2の柔軟性に移行する領域を画定する、請求項72に記載のガイドワイヤ。
- 74前記基端区域がステンレス鋼から構成されている請求項73に記載のガイドワイヤ。
- 75前記先端区域がニッケルチタン合金から構成されている請求項74に記載のガイドワイヤ。
- 76前記連結器がニッケルクロム鉄合金チューブを備える請求項75に記載のガイドワイヤ。
- 77前記連結器の少なくとも一部が前記柔軟性移行領域同士の間に配置される請求項72に記載のガイドワイヤ。
- 78ガイドワイヤの製造方法であって、 先端を有する基端区域を設け、更に前記先端に柔軟性移行領域を設ける工程と、 基端を有する先端区域を設け、更に前記基端に柔軟性移行領域を設ける工程と、 前記柔軟性移行領域同士を接合する工程とを有している方法。
- 79前記柔軟性移行領域を形成する工程を更に有している請求項78に記載の方法。
- 80前記柔軟性移行領域を形成する工程が、前記基端及び前記先端の寸法を縮小する工程を有している請求項78に記載の方法。
- 81前記柔軟性移行領域を接合する工程が、前記基端と前記先端とを重ねる工程を有している請求項79に記載の方法。
- 82ガイドワイヤであって、 第1の柔軟性を備えている基端区域と、 第2の柔軟性を備えている先端区域と、 前記第1の柔軟性から前記第2の柔軟性に移行するように前記基端区域を前記先端区域と接合する手段とを備えているガイドワイヤ。
- 83ガイドワイヤであって、 ステンレス鋼からなる基端区域と、 ニッケルチタン合金からなる先端区域と、 ニッケルクロム鉄合金からなり、前記基端区域と前記先端区域とを連結している連結器とを備えているガイドワイヤ。
Independent claims83
84 paragraphs, as filed
Related Applications This application is a partial continuation of US Simultaneous Application No. 09 / 972,276 (submitted October 5, 2001), which is incorporated herein by reference. Fields of the Invention The present invention generally relates to guide wires in blood vessels.
Various guide wires have been developed for use in blood vessels. Intravascular guide wires are commonly used with intravascular devices such as catheters to facilitate navigation through the patient's vascular structure. Since the patient's vascular structure can be very winding, it is desirable to combine a number of performance features in the guidewire. For example, in some cases it is desirable for the guide wire to have a relatively high level of pushability and torqueability, especially near the proximal end. In some cases, it is desirable that the guide wire be relatively flexible, especially near the tip. A number of different guidewire structures and assemblies are known, each with certain advantages and disadvantages. However, there is still a need to provide alternative guidewire structures and assemblies.
The present invention provides several alternative shapes, materials, and methods for manufacturing alternative guidewire structures and assemblies.
The following description should be understood with reference to the drawings, in which the same reference numbers indicate the same elements throughout several figures. The detailed description and drawings are not intended to be limiting and provide examples of various embodiments of the claimed invention.
Here, with reference to FIGS. 1 to 5, these figures show a partial cross-sectional view of a guide wire 10 having a connecting portion 20 that joins the proximal guide wire zone 14 and the distal guide wire zone 16. FIG. 1 illustrates the guide wire 10 and the connecting portion 20 before the final grinding process, and FIG. 2 illustrates the guide wire 10 and the connecting portion 20 after the final grinding process, and this process smoothes the external shape. In the embodiments of FIGS. 1 and 2, the overlapping tapered joint 12 and the tubular coupler 18 are used.
The embodiment of FIG. 3 is very similar to the embodiment of FIGS. 1 and 2, but the connecting portion 20 between the base end guide wire area 14 and the tip end guide wire area 16 does not use the connecting tube 18 and uses the connecting material 19. I am using it. The embodiment of FIG. 4 is very similar to the embodiment of FIGS. 1 and 2, but the connecting portion 20 between the base end guide wire area 14 and the tip end guide wire area 16 does not use the overlapping joint 12 but the butt joint 13 is formed. I am using it. The embodiment of FIG. 5 is also very similar to the embodiments of FIGS. 1 and 2, but the connecting portion 20 between the proximal guide wire area 14 and the distal guide wire area 16 uses a non-tapered overlapping joint 12. ..
The material, structure and size of the proximal / distal guidewire area 14/16 are determined primarily by the desired properties and function of the final guidewire, but any wide range of materials, structures and sizes are available. Those skilled in the art recognize that it can be used.
For example, the proximal and distal guide wire sections 14/16 may have a solid or hollow cross section as shown, and may further depend on the desired properties of the guide wire. It may be formed from any material suitable for use. Examples of suitable materials include metals, alloys and polymers. In some embodiments, it is desirable to use a metal or alloy suitable for metal joining techniques such as welding, soldering, brazing, crimping, friction adjustment, bonding and the like. As used herein, the proximal area 14 and the distal area 16 collectively refer to any two adjacent guidewire areas along any portion of the guidewire. Although described with reference to a specific guide wire, the present invention can be applied to almost all intravascular devices. For example, the present invention may also be applied to a partially tubular shaft of an intravascular catheter (eg, high-speed exchange balloon catheter, stent delivery catheter, etc.) or a drive shaft of an intravascular rotating device (such as an atherectomy catheter or IVUS catheter). Applicable.
In some embodiments, the proximal guide wire segment 14 may be formed of a relatively rigid material such as straightened 304v stainless steel wire. Alternatively, the base end portion 14 may be composed of a metal or alloy, such as nickel titanium alloys, nickel chrome alloys, nickel chrome iron alloys, cobalt alloys, or other suitable materials. .. In general, the material used in the construction of the proximal portion 14 will be selected to be relatively stiff for pushability and torque.
In some embodiments, the tip guide wire area 16 is a relatively flexible material, such as a wire of straightened superelastic alloy or linear elastic alloy (eg, nickel titanium), or, as an alternative, a high performance polymer, etc. May be made of polymer material. Alternatively, the tip portion 16 may be composed of a metal or alloy, such as stainless steel, nickel-chromium alloys, nickel-chromium iron alloys, cobalt alloys, or other suitable materials. In general, the material used to construct the tip portion 16 can be selected to be relatively flexible for trackability.
In certain embodiments, the tip zone 16 is a linear elastic nickel-titanium alloy, such as a linear elastic nitinol. The term nitinol was coined by a group of researchers at the Naval Ordinance Laboratory (NOL) of the US Department of Defense, who first observed the shape memory properties of this material. The term nitinol is an acronym that includes the chemical symbol for nickel (Ni), the chemical symbol for titanium (Ti), and the acronym (NOL) that identifies the Navy Weapons Institute of the Department of Defense.
Commercially available nitinol alloy systems have a category called "linear elastic," which is chemically similar to that of the traditional shape memory and hyperelastic types, but with different usefulness. Shows mechanical properties. Due to the expertise of cold working, directional stress and heat treatment, the wire has a "superelastic plateau" or "flag" in the stress / strain curve of the wire. Manufactured so as not to indicate "region)". Rather, as the recoverable strain increases, the stress continues to increase in an essentially linear relationship until plastic deformation begins. In some embodiments, the linear elastic nickel-titanium alloy is an alloy that exhibits no martensite / austenite phase change, which can be detected over a wide temperature range by DSC and DMTA analysis. For example, in some embodiments, there is no martensite / austenite phase change that can be detected by DSC and DMTA analysis in the range of -60 ° C to 120 ° C. Therefore, the mechanical bending properties of such materials are generally inert to the effects of temperature over this very wide temperature range. In certain embodiments, the mechanical properties of the alloy at ambient temperature or room temperature are approximately identical to those at body temperature. In some embodiments, the use of a linear elastic nickel-titanium alloy for the tip portion 16 allows the guidewire to exhibit excellent "pushability" around the meandering anatomical tissue.
In some embodiments, the linear elastic nickel-titanium alloy is composed of nickel in the range of about 50% to about 60% by weight, the rest being essentially titanium. In certain embodiments, the composition may be composed of nickel in the range of about 54% to about 57% by weight. An example of a suitable nickel-titanium alloy is an FHP-NT alloy commercially available from Furukawa Techno Material Co., located in Kanagawa Prefecture, Japan.
In certain embodiments, the proximal guide wire area 14 is made of stainless steel wire, the diameter of which the stainless steel wire ranges from 0.0254 cm (0.01 inch) to 0.0508 cm (0.02 inch), and this stainless steel. Wire lengths range from about 127 centimeters (about 50 inches) to about 279.4 centimeters (about 110 inches). The tip guide wire area 16 is made of linear elastic nitinol wire, and the diameter of this linear elastic nitinol wire ranges from a diameter matching the diameter of the proximal guide wire area 14 to about 0.00508 centimeters (0.002 inches). The length of this linear elastic nitinol wire ranges from 7.62 centimeters (3 inches) to 38.1 centimeters (15 inches).
The tip 24 of the base end portion 14 and the base end 26 (that is, the joint end) of the tip end portion 16 may form an overlapping tapered joint 12 as shown in FIGS. 1 to 3. Alternatively, the joint ends 24/26 may form a butt joint 13 as shown in FIG. As a further alternative, the joint ends 24/26 may form overlapping joints 12 that are not tapered, as shown in FIG. The non-tapered ends 24/26 have a uniform outer shape (diameter) 23 as shown in FIG. 6A, a spherical portion 25 for mechanical interlocking as shown in FIG. 6B, and FIG. 6C. A spiral shape 27 may be provided for the purpose of mechanical interlocking as shown in. In each of the embodiments illustrated in FIGS. 1 to 3 and 5, the ends 24/26 overlap to form an overlapping joint 12. The overlap joint 12 shifts from the rigidity of the base end portion 14 to the rigidity of the tip portion 16 by combining the characteristics of each end area 24/26 forming the cross section of the overlap joint 12. Thus, the junction 12 forms a flexibility transition region with relative flexibility between the flexibility of the proximal portion 14 and the flexibility of the distal portion 16.
In the tapered embodiment shown in FIGS. 1 to 3, the ends 24/26 may be tapered or formed so as to have a fitting shape in which the cross-sectional area gradually decreases toward the center of the connecting portion 20. May be good. The tapered overlap 12 defines a uniform or non-uniform transition in area 24/26 depending on the desired transition characteristics. For example, the edge area 24/26 may be linearly tapered, curved, or stepped as shown. When the taper is linearly tapered as shown in the figure, the taper angle may vary. Using the vertical central axis of the guide wire 10 as a reference, the taper angle is an acute angle (ie, less than 90 degrees) when measured from the end of the end area 24/26, for example in the range of 5 degrees to 45 degrees. .. By changing the angle of the tapered end 24/26, the length of the overlapping joint 12 also changes according to the principle of geometry. The length of the overlap joint 12 may be selected to increase (extend the length) or reduce (shorten the length) the gradual transition of stiffness.
As mentioned above, the proximal guide wire compartment 14 and the distal guide wire segment 16 are made of different materials (ie, materials with different elastic moduli) and therefore have different flexibility. For example, if the base end guide wire area 14 is formed of stainless steel wire and the tip end guide wire area 16 is made of nickel titanium alloy wire and both are of the same size, there is a 3: 1 difference in elastic modulus. Due to such a difference in elastic modulus (that is, flexibility), a stress concentration point is generated during bending and / or twisting, and the stress concentration point tends to be twisted (kink) or broken. .. Due to the gradual transition of stiffness provided by the overlap portion 12, the stress is distributed along the entire length of the connecting portion 20 so that the guide wire 10 is less likely to twist at the junction.
The stepwise shift in rigidity also makes it possible to install the connecting portion 20 further on the tip side. According to this embodiment, the tip portion 16 can be manufactured to be shorter than the base end portion 14. Having a relatively long proximal region 14 is advantageous because the torque and pushability of the guide wire 10 is enhanced. Although only one connecting part 20 is shown, additional connecting parts 20 may be used to connect other guidewire areas of varying stiffness.
The coupler 18 may consist of a tubular structure, eg, a hypotube or coiled wire as shown. The coupler 18 has an inner diameter appropriately sized to accommodate the ends 24/26 of the base end portion 14 and the tip end portion 16 and an outer diameter large enough to accommodate the final grinding procedure. In some embodiments, the inner diameter of the coupler 18 can range from about 0.0127 centimeters (about 0.005 inches) to about 0.0508 centimeters (about 0.02 inches). The outer diameter of the coupler 18 may range from about 0.0254 centimeters (about 0.01 inches) to about 0.0635 centimeters (about 0.025 inches). In certain embodiments, the inner diameter of the coupler 18 may be about 0.02540 centimeters (about 0.010 inches) and the outer diameter of the coupler 18 may be about 0.03556 centimeters (about 0.014 inches). The final diameter of the guide wire 10 and the coupler 18 may range, for example, from 0.02540 centimeters (0.010 inches) to 0.04572 centimeters (0.018 inches). As an example, not a limitation, if the overlap 12 is about 0.635 centimeters (about 0.25 inches) to about 6.35 centimeters (about 2.5 inches), the length of the coupler 18 is about 2.540 centimeters (about 1.0 inches) ~ about. It is 7.620 centimeters (about 3.0 inches). However, in other embodiments, this type of configuration can also be applied to larger diameter wires, for example for peripheral intervention. The diameter of such wires can be as large as 0.035 centimeters (about 0.025 inches), thus extending the length of the coupler and correspondingly increasing the overlap area.
The coupler 18 may be made of a metal or alloy and may be a radiation opaque material. Suitable metals and alloys include stainless steel, nickel-titanium alloys (eg, nitinol), nickel-chromium alloys, nickel-chromium iron alloys, cobalt alloys, nickel and other suitable materials. Alternatively, the coupler 18 may be composed of a polymer such as a radiation opaque filler or a metal-polymer composite material.
Certain alloys are particularly suitable for couplers 18 for connecting a base end area 14 of a stainless steel and a tip area 16 of a nickel titanium alloy, or for connecting each area where the materials are reversed. One example is a nickel-chromium ferroalloy called UNS N06625, which is commercially available under the trade name INCONEL® 625. This is advantageous for welding both stainless steel and nickel titanium alloys. INCONEL® 625 Wire can be purchased from the California Fine Wire Company in Grover Beach, California, and its typical composition is as follows:
<tables num="1"><img file="JP2005528126A_D0001.tif" /></tables> Another example of an alloy suitable for welding to both stainless steel and nickel-titanium alloys is called UNS 10276, Fort Wayne Metals Research, Fort Wayne, Indiana. It is commercially available from Products Corporation) under the trade name ALLOY C276, and its typical composition is as follows.
<tables num="2"><img file="JP2005528126A_D0002.tif" /></tables> Another example of an alloy suitable for welding to both stainless steel and nickel titanium alloys is the Hastelloy system. An example is commercially available from Fort Wayne Metals Research Products Corporation in Fort Wayne, Indiana under the trade name ALLOY B2, the typical composition of which is:
<tables num="3"><img file="JP2005528126A_D0003.tif" /></tables> To manufacture the connecting portion 20 of the guide wire 10, the ends 24/26 of the base and tip guide wire areas 14/16 have the desired shape (eg, uniform diameter 23) to accommodate the overlap joint 12. , Spherical portion 25, spiral 27, taper, etc.) may be ground. If the butt joint 13 is used, it is not necessary to grind into such a shape. Indented steps in the base and tip guide wire areas 14/16 may be ground to accommodate the connecting tube 18. When the connecting tube 18 is not used, it is not necessary to grind this recessed step.
In the embodiment utilizing the connecting tube 18, the connecting tube 18 is located on one of the base end and the end 24/26 of the tip guide wire area 14/16. The tip 24 of the base portion 14 and the base end 26 of the tip portion 16 are arranged adjacent to each other in an array of 12 overlapping or 13 arrays of end-to-end contacts. Base and tip guide wire sections 14/16 and connecting tubes 18 are suitable techniques for bonding, welding (eg, resistance welding or laser welding), soldering, brazing, or depending on the material of each element selected. Can be connected by. Alternatively, the ends 24/26 and the connecting tube 18 may be crimped together or may be sized to establish a frictional fit between them. If the connecting tube 18 is not used, the ends 24/26 are glued, welded (eg, resistance welded or laser welded), soldered, brazed, or connected using connecting material 19. It is done. The coupler 19 may be the same as or similar to the material of the coupler 18. In all cases, it is desirable to use a permanent connection (as opposed to an open connection), as the connection 20 is inside the catheter lumen during use.
It should be recognized that various welding methods are available without departing from the spirit and scope of the invention. Examples of welding methods suitable for some applications include laser welding, resistance welding, TIG welding, microplasma welding, electron beam, friction welding or inertia welding. Laser welders suitable for several applications are commercially available from Unitek Miyachi in Monrovia, California and Rofin-Sinar Incorporated in Plymouth, Michigan. Resistance welding equipment suitable for several applications is commercially available from Palomar Products Incorporated in Carlsbad, California and Polaris Electronics in Olathe, Kansas. TIG welding equipment suitable for several applications is Weldlogic in Newbury Park, California. It is commercially available from Weldlogic Incorporated. Microplasma welding equipment suitable for several applications is commercially available from Process Welding Systems Incorporated in Smyrna, Tennessee.
Once connected, the connecting tube 18 and the base end and tip guide wire areas 14/16 are centerlessly ground to provide a smooth and uniform profile throughout the connecting portion 20 and the base end and tip. A slight misalignment between the tip guide wire areas 14/16 is corrected. Other parts of the guide wire 10 are similarly ground to provide the desired taper shape and diameter changes. For example, one or both of the proximal and distal guidewire areas 14/16 may be continuously tapered, may have tapered areas, or may have a large number or series of tapers of different diameters. It may have an area or it may have a constant diameter. In some embodiments, the area 14/16 may be formed to be tapered so that the cross-sectional area decreases toward the tip of the area 14/16. If tapered, the area 14/16 has a uniform or non-uniform migration of the area, depending on the desired migration characteristics. For example, one or both of the areas 14/16 may be linearly tapered, curved so as to be tapered, or tapered stepwise. Such taper angles may vary depending on the desired flexibility characteristics. The taper length may be selected to extend (extend the length) or reduce (shorten the length) the gradual transition of stiffness. When finally ground, in some embodiments, a flexible coil tip (optionally covering the connection 20) and / or a polymer jacket tip (jacket). tip) and combinations thereof and other such structures, such as radiation opaque markers, safety and / or molded ribbons (coiled or unwound), may be placed on the guide wire 10. Further, in some embodiments, coatings, such as smooth (eg, hydrophilic) or other types of coatings, may be utilized on all or part of the guide wire. Separate coatings may be utilized for different areas of the guide wire. Examples of this coating and material and the methods used to form this coating include US Pat. Nos. 6,139,510 and 5,772,609, which are incorporated herein by reference.
The centerless grinding technique may utilize an indexing method that uses sensors (eg, light / reflection sensors, magnetic sensors) to prevent excessive grinding of the connection 20. In some embodiments, the presence of dissimilar materials in the composition affects the grinding techniques and tools used to uniformly remove the materials, provide a smooth transition and fill the gaps between adjacent elements. Can be done. In addition, the heartless grinding technique may utilize a CBN or diamond abrasive grinding wheel, which is well formed and reworked to prevent the coupler 20 from squeaking during the grinding process.
Here, with reference to FIG. 7, a partial cross-sectional view of a guide wire 110 provided with a connecting portion 120 similar to the connecting portion 20 shown in the embodiment of FIG. 1 is shown. The connecting portion 120 joins the base end guide wire area 114 and the tip end guide wire area 116 by using the overlapping tapered joint 112 and the tubular coupler 118. The proximal / distal guidewire areas 114/116, connecting 120, tapered joint 112, and tubular coupler 118 shown in the embodiment of FIG. 7 are described above with respect to the same elements of the embodiments of FIGS. 1-6C. There may be the same overall configuration, structure, material, and construction method as the one used.
The embodiment of FIG. 7 further shows an example of the tip tip portion 130 of the guide wire 110 arranged at the tip portion 134 of the tip guide wire area 116. The tip portion 134 has two tapered regions 142,146 and two constant diameter regions 150,154, so that the end portion 134 has a shape in which the cross-sectional area decreases toward its tip. In some embodiments, these tapers 142/146 and constant diameter regions 150/154 are adapted and configured to shift stiffness and provide the desired flexibility properties.
The wire or ribbon 158 is attached adjacent to the tip 160 of the tip 134 and extends towards the tip of the tip 134. In some embodiments, the wire or ribbon 158 may be manufactured or formed into a wire structure. This wire structure is, for example, the coiled wire shown in the embodiments described in more detail below. In the illustrated embodiment, the ribbon 158 is a substantially straight wire that overlaps a region 154 of constant diameter and is attached to the attachment point 164. In some embodiments, the ribbon 158 overlaps a constant diameter area 154 with a length ranging from about 0.127 centimeters (0.05 inches) to about 2.540 centimeters (1.0 inches), but in other embodiments. Then, the overlapping length may be longer or shorter.
Ribbon 158 may be constructed from any suitable material and may be formed in a suitable size to provide desired properties such as strength and flexibility properties. Examples of suitable materials include metals, alloys and polymers. In some embodiments, the ribbon 158 is made of metal or alloy. Such alloys include, for example, stainless steel, nickel-chromium alloys, nickel-chromium iron alloys, cobalt alloys, and nickel-titanium alloys such as straightened superelastic or linear elastic alloy (eg, nickel-titanium) wires. Ribbon 158 can be attached using any suitable attachment technique. Examples of mounting techniques include soldering, brazing, welding, gluing, crimping and the like. In some embodiments, the ribbon or wire 158 acts as a shaped or safety structure.
An outer sleeve 168 is arranged around the tip portion 134 of the tip guide wire area 116. In the illustrated embodiment, the sleeve 168 extends from the tapered region 142 at the proximal end beyond the most tip portion of the ribbon 158 to form a round tip portion 169. In other embodiments, the sleeve 158 may extend further towards the proximal end and, in some cases, beyond the connecting portion 120 or the proximal guide wire area 114. In yet another embodiment, the sleeve 168 may start at the tip of the tapered region 142.
Suitable materials for use as the outer sleeve 168 include any material that provides the desired strength or flexibility or other desired properties. Suitable materials include polymers and similar materials. Examples of suitable polymer materials are any polymer of a wide variety generally known for use as a guidewire polymer sleeve. The use of polymer on the outer sleeve 168 serves several functions. By using the polymer sleeve, the flexibility property of the tip portion 134 is improved. The choice of polymer for sleeve 168 varies in flexibility. For example, durometers or low hardness polymers form very flexible or flexible chips. On the contrary, polymers with high durometer form stiff chips. By using a polymer for the sleeve, the guide wire is provided with a more non-traumatic tip. Non-traumatic tips are better suited for passage through fragile body tubes. Finally, the polymer can act as a fixative for the radiation opaque material, as described in more detail below.
In some embodiments, the polymeric material used is a thermoplastic polymeric material. Examples of some suitable materials include polyurethanes, elastomeric polyamides, block polyamides / ethers (such as Pebax), silicones, copolymers and the like. The sleeve may be a single polymer, multiple layers, a mixture of polymers, and the like. With careful selection of materials and treatment techniques, thermoplastic variants, solvent-soluble variants, and thermosetting variants of these materials can be used to obtain the desired results.
The sleeve 168 is placed around the guide wire 110 and can be attached to the guide wire 110 using any technique suitable for the particular material used. In some embodiments, the sleeve 168 is attached by heating a sleeve of polymeric material to a certain temperature until the sleeve is deformed around the tip guide wire area 116 and the ribbon 158. In other embodiments, the sleeve 168 may be attached using heat shrinkage techniques. The sleeve 168 may be finished, for example, by centerless grinding or other methods to provide the desired diameter and smooth outer surface.
In some embodiments, the sleeve 168 or part thereof is radiopaque in order to make the sleeve 168 or part thereof more clearly visible when certain contrast techniques, such as fluorescence fluoroscopy techniques, are used. It may contain material or be doped with a radiation opaque material. Any suitable radiation opaque material known in the art can be used. Examples include precious metals, tungsten, barium carbonate powder and the like, as well as mixtures thereof. In some embodiments, the sleeve 168 may be provided with separate areas, each with a different filling amount of the radiation opaque material. For example, in FIG. 7, the sleeve 168 has a tip area 170 and a base area 172, and the level of filling of the radiation opaque material in the tip area 170 is higher than that of the base area 172. In some embodiments, a stand-alone radiation-impermeable member or series of radiation-impermeable members, such as radiation-impermeable coils, bands, tubes, or other such structures, guidewire 110. It can be attached to the core wire or incorporated into the core wire by plating, drawing, forging, or ion implantation technology.
In addition, in some embodiments, coatings, such as smooth (eg, hydrophilic) or other types of coatings, are utilized on all or part of the sleeve, or on other parts of the guidewire 110. May be good. Hydrophobic coatings such as fluoropolymers provide dry lubricity, which improves guidewire handling and equipment replacement. The smooth coating improves maneuverability and the ability to traverse lesions. Suitable smooth polymers are well known in the art and are hydrophilic polymers such as polyarylene oxide, polyvinylpyrolidone, polyvinyl alcohol, hydroxyalkyl cellulose derivatives. Cellulosic), algin, sugars, caprolactone, and mixtures and combinations thereof. Hydrophilic polymers may be mixed with each other to obtain a coating with suitable lubricity, adhesion and solubility, or in a dosage of water-insoluble compounds (some polymers). May be mixed with). Other examples of this coating and material, and the methods used to form this coating, include US Pat. Nos. 6,139,510 and 5,772,609, which are incorporated herein by reference. In some embodiments, the further tip portion of the guidewire may be covered with the hydrophilic polymer described above, and the proximal end portion may be further covered with a fluoropolymer such as polytetrafluroethylene (PTFE). is there.
Those skilled in the art will recognize that a wide range of materials, sizes, and structures can be used to construct suitable embodiments, depending on the desired properties. The following examples of the size of the tip configuration are not intended to be limited and are provided merely as an example. In certain embodiments, the guidewire has the overall structure described in FIG. 7, and the length of the tip guidewire area 116 ranges from approximately 25.4 cm (10 inches) to 50.8 cm (20 inches). .. The outer diameter of the main part of the tip guide wire area 116 ranges from 0.03302 cm (0.013 inch) to about 0.03683 cm (0.0145 inch), and the outer diameters of the two constant diameter areas 150 and 154 are about 0.023876 cm, respectively. It ranges from (0.0094 inches) to about 0.024638 centimeters (0.0097 inches) and from 0.00254 centimeters (0.001 inches) to about 0.003556 centimeters (0.0014 inches). The lengths of the two constant diameter areas 150,154 range from about 10.16 centimeters (4 inches) to about 38.1 centimeters (15 inches) and from about 1.27 centimeters (0.5 inches) to about 10.16 centimeters (4 inches), respectively. Is the range of. The lengths of the two tapered regions 142,146 range from about 1.27 cm (0.5 inch) to about 5.08 cm (2 inch) and from about 1.27 cm (0.5 inch) to about 5.08 cm (2 inch), respectively. The range. The outer diameter of the polymer sleeve 168 is sized to fit the outer diameter of the main portion of the tip guide wire area 116, ranging from, for example, 0.03302 centimeters (0.013 inches) to about 0.03683 centimeters (0.0145 inches). The length of the polymer sleeve tip area 170, which is filled with a radiation opaque material, ranges from about 2.54 centimeters (1 inch) to about 7. It has a range of 62 centimeters (3 inches). The length of the ribbon 158 ranges from about 2.032 centimeters (0.8 inches) to about 5.08 centimeters (2 inches), and in some embodiments about 0.508 centimeters (0.2 inches) to about 2.54 centimeters toward the tip of the core. It may extend by a meter (1 inch).
FIG. 8 shows a guide wire 110 that closely resembles the guide wire shown in FIG. The same reference numbers indicate a similar structure as described above. The proximal / tip guide wire area 114/116, the coupling 120, the tapered coupling 112, and the tubular coupler 118, as shown in the embodiment of FIG. 8, are described above with respect to the same elements of the embodiments of FIGS. 1-7. It may have the same overall construction, structure, material, and method of construction as the one used.
The tip tip portion 130 of the guide wire 110 of FIG. 8 is also very similar to the tip tip portion shown in FIG. 7, and the same reference figures show a similar structure. However, in the embodiment shown in FIG. 8, the ribbon 158 extends further in the proximal direction so as to overlap the tapered region 146, and the ribbon 158 is attached at two attachment points 164,165.
Here, with reference to FIG. 9, a cross-sectional view of a portion of another embodiment of the guide wire 210 with a connecting portion 220 similar to the guide wire shown in the embodiments of FIGS. 7 and 8 is shown. The proximal / distal guidewire area 214/216, coupling 220, tapered joint 212, and tubular coupler 218, shown in the embodiment of FIG. 9, have been described above with respect to the same elements of the embodiments of FIGS. 1-8. It may have the same overall construction, structure, material, and method of construction as the one.
In the embodiment of FIG. 9, another example of the tip tip portion 230 of the guide wire 210 located at the tip portion 234 of the tip guide wire area 216 is shown. As in the embodiment of FIG. 7, the tip portion 234 has two tapered regions 242,246 and two constant diameter regions 250,254 so that the end portion 234 has a geometry whose cross-sectional area decreases toward its tip. Has a shape. Further, the tip tip portion 230 has a wire or ribbon 258, which is adjacent to the tip 260 of the tip portion 234 and at attachment point 264 in a manner similar to that described above in the embodiment of FIG. It is attached.
However, in FIG. 9, the tip tip portion 230 is provided with a combination of a sleeve 268 and a coil 280 arranged around the tip portion 234 of the tip guide wire area 216. The sleeve 268 extends from the tapered region 242 of the proximal end to the proximal point of the tip of the guidewire area 216. In the illustrated embodiment, the sleeve 268 extends from the tapered region 242 to near the middle of the tapered portion 246. In other embodiments, the sleeve 268 may extend further towards the proximal end and, in some cases, beyond the connecting portion 220 or the proximal end guide wire area 214. In yet another embodiment, the sleeve 268 may start at a point at the tip of the tapered region 242.
The sleeve 268 may or may be formed of the same material, structure, radiation impermeable filler, coating, and the same methods described with respect to the embodiments shown in FIGS. 1-8. Obtained according to. In the illustrated embodiment, the adhesive material or filling resin 279 is located at the tip 265 of the sleeve 268 around the tip guide wire area 216. However, there are other embodiments that do not use the adhesive material or the filling resin 279.
The coil 280 extends beyond the tip of the ribbon 258 from the adhesive material 279 adjacent to the tip 265 of the sleeve 268. The coil 280 is attached to the tip guide wire area 216 at attachment point 283 of the base end 281 of the coil 280 using any suitable attachment technique, such as soldering, brazing, welding, gluing, crimping, etc. .. The tip 285 of the coil 280 is attached to the ribbon 258 via a round tip portion 269. The round chip portion 269 can be formed of any suitable material, such as a solder chip or a polymer chip.
The coil 280 can be made of various materials such as metals, alloys and polymers. Examples of materials used for coils include stainless steel, nickel chrome alloys, nickel chrome iron alloys, cobalt alloys, or other suitable materials. Further examples of suitable materials include linear superelastic or linear elastic alloy (eg, nickel titanium) wires, or, as an alternative, polymeric materials such as high performance polymers. In some embodiments, the coil 280 may be made of a radiation opaque material such as gold, platinum, tungsten, etc., or alloys thereof. The coil 280 may be formed from a round or flat ribbon sized to achieve the desired flexibility. In some embodiments, the coil 280 may be a round ribbon, the diameter of which ranges from about 0.00254 cm (0.001 inch) to 0.0381 cm (0.015 inch), and the length of the coil 280 is about 5.08. It may range from centimeters (2 inches) to about 10.16 centimeters (4 inches).
The coil 280 is spirally wound by a conventional winding technique. The pitch of adjacent turns of the coil 280 may be tightly wound so that each turn can contact subsequent turns, or the pitch may be set so that the coil 280 opens. .. In the illustrated embodiment, the coil 280 is wound so that the winding of the coil 280 opens at the proximal end 281 and is tightly wound at the portion adjacent to the tip 269.
Further, in some embodiments, a portion or whole of the sleeve 268 and coil 280, or other portion of the guide wire 210, is coated with a coating similar to that described above, eg, smooth (eg, hydrophilic) or Other types of coatings may be utilized.
Those skilled in the art will recognize that a wide range of materials, sizes and structures can be used depending on the desired properties to construct a suitable embodiment. The size example for tip configuration in the references in FIG. 7 is also suitable for the embodiment shown in FIG.
FIG. 10 shows a guidewire 210 that closely resembles the guidewire shown in FIG. 9, with the same reference numerals indicating a similar structure. The proximal / distal guidewire area 214/216, coupling 220, tapered joint 212, and tubular coupler 218, shown in the embodiment of FIG. 10, have been described above with respect to the same elements of the embodiments of FIGS. 1-9. It may have the same overall composition, structure, material, and method of construction as the one.
The tip tip portion 230 of the guide wire 210 in FIG. 10 is also very similar to the tip tip portion shown in FIG. 9, and the same reference figures show a similar structure. However, in the embodiment shown in FIG. 10, the ribbon 258 extends further in the proximal direction so as to overlap the tapered region 246 and is attached at two attachment points 264,283.
Here, with reference to FIG. 11, a cross-sectional view of a part of another embodiment of the guide wire 310 having a connecting portion 320 similar to the guide wire shown in the embodiments of FIGS. 7 to 10 is shown. The proximal / distal guidewire area 314/316, coupling 320, tapered joint 312, and tubular coupler 318, shown in the embodiment of FIG. 11, have been described above with respect to the same elements of the embodiments of FIGS. 1-10. It may have the same overall composition, structure, material, and method of construction as the one.
The embodiment of FIG. 11 shows another example of the tip tip portion 330 of the guide wire 310 located at the tip portion 334 of the tip guide wire area 316. As in the embodiments of FIGS. 1-7, the tip 334 has two tapered regions 342,346 and two constant diameter regions 350,354 so that the end 334 has a smaller cross-sectional area towards its tip. Has a shape. Further, the tip tip portion 330 comprises a wire or ribbon 358 and is mounted adjacent to the tip 360 of the tip portion 334 at attachment point 364 in a manner similar to that described above in embodiments of FIGS. 7 and 9.
However, in FIG. 11, the tip tip portion 330 has a dual coil tip configuration in which the outer coil 380 and the inner coil 390 are located around the tip portion 334 of the tip guide wire area 316. And have.
In the illustrated embodiment, the outer coil 380 extends from the tapered region 342 around the tip guide wire area 316 beyond the most tip portion of the ribbon 358. The outer coil 380 is attached to the tip guide wire area 316 at the attachment point 383 of the base end 381 of the coil 380 using any suitable attachment technique, such as soldering, brazing, welding, gluing, crimping, etc. There is. The tip 383 of the coil 380 is attached to the ribbon 358 via a round tip portion 369. The round tip portion 369 can be formed of any suitable material, such as a solder tip or a polymer tip. The outer coil 380 may be made of the same material as the coil 280 described above in the embodiments of FIGS. 9 and 10, and may further have the same overall configuration and pitch spacing as the coil 280. In some embodiments, the outer coil 280 may extend beyond the attachment point 393 in the distal direction by a range of about 2 to about 4 centimeters in length.
In the illustrated embodiment, the inner coil 390 is located around the tip guide wire area 316 from the tapered region 346 to the spacer element 395 adjacent to the tip portion 369. However, in other embodiments, the spacer element is not required. The coil 390 is attached to the tip guide wire area 316 at attachment point 393 at the base end 391 using any suitable attachment technique, such as soldering, brazing, welding, gluing, crimping, and the like. The tip 397 of the coil 390 is attached to the spacer element 395. The spacer element 395 is placed around the ribbon 358 and can be made of any suitable material such as metal, alloy, polymer and the like. In some embodiments, the spacer may also be made of a polymer such as polytetrafluroethylene (PTFE).
The inner coil 390 may be made of the same material as described above for the coil 280 of the embodiments of FIGS. 9 and 10, and may also have the same overall configuration and pitch spacing. In some embodiments, the inner coil 390 is formed of a radiation opaque wire with a diameter less than the diameter of the wire used to make the outer coil 380.
Those skilled in the art will recognize that a wide range of materials, sizes and structures can be used depending on the desired properties to construct a suitable embodiment. The size example for tip configuration in the references in FIG. 7 is also suitable for the embodiments shown in FIGS. 9 and 11.
FIG. 12 shows a guidewire 310 that closely resembles the guidewire shown in FIG. 11, with the same reference numerals indicating a similar structure. The proximal / distal guidewire area 314/316, coupling 320, tapered joint 312, and tubular coupler 318, shown in the embodiment of FIG. 12, have been described above with respect to the same elements of the embodiments of FIGS. 1-11. It may have the same overall composition, structure, material, and method of construction as the one.
The tip tip portion 330 of the guide wire 310 in FIG. 12 is also very similar to the tip tip portion shown in FIG. 11, and shows the same structure with the same reference figures. However, in the embodiment shown in FIG. 12, the ribbon 358 extends further in the proximal direction so as to overlap the tapered region 346 and is attached at two attachment points 364,393.
References herein to FIGS. 13-21 show a series of alternative chip designs for use with guide wires, which include wires or ribbons for use as a safety and / or shaped structure. There are parts formed in a coil or spiral shape. These chip designs, which use a coiled or spirally formed safety or shaped structure, can be used for a wide range of guidewire structures. For example, these chip designs may be used in combination with other structures disclosed in the present application, such as the connection structures described above, or in other guide wire configurations, such as guide wires that do not have these connection structures. May be done.
Here, with reference to FIG. 13, one embodiment of a guide wire 410 with a coiled safety and / or shaped structure 458 is shown. The guide wire 410 has a core member 413 with a tip portion 416. The core member 413 and the tip portion 416 of the core member 413 may have the structure disclosed above for a portion of the guide wire, or may have other structures commonly known in the art used in the guide wire. You may. Further, the core member 413 and the tip portion 416 of the core member 413 may be formed using any suitable material described above used in forming the guide wire member or the guide wire area, or the guide wire. Other materials commonly known in the art used in the art may be included. In the illustrated embodiment, the tip portion 416 of the core member 413 is a solid wire. The wire comprises a tip portion 434 with three constant diameter portions 450,452,454 and two tapered portions 442,446.
Arranged around a portion of the core wire 413 is a coiled safety and / or shaped structure 458, such as a coiled ribbon, a coiled wire, or other such coiled structure. In the illustrated embodiment, the coiled structure 458 is a coiled ribbon that overlaps or surrounds, or surrounds, a portion of the most tipped tapered portion 446 and a portion of the most tipped constant diameter portion 454. It extends from the tip 460 of the core wire 413 toward the tip.
The coil 458 can be constructed of any suitable material and formed to a suitable size in order to provide the desired properties such as strength and flexibility properties. In some embodiments, the attachment of the coil 458 to the core wire 413 may affect the characteristics of the core wire 413 where the coil 458 overlaps.
Examples of materials used for coil 458 include stainless steel, nickel-chromium alloys, nickel-chromium iron alloys, cobalt alloys, nickel-titanium alloys, or other suitable materials. Further examples of suitable materials include linear superelastic or linear elastic alloys (eg, nickel titanium), or, as an alternative, polymeric materials such as high performance polymers. In some embodiments, the coil 458 may be made of a radiation opaque material such as gold, platinum, tungsten, or alloys thereof. The coil 458 may be formed of a round or flat ribbon sized to achieve the desired flexibility. In some embodiments, the coil 458 may be a round ribbon, the diameter of which ranges from about 0.00254 cm (0.001 inch) to 0.0381 cm (0.015 inch). In other embodiments, the coil may be formed of a flat or rectangular ribbon, the width of which ribbon ranges from about 0.00508 cm (0.002 inch) to about 0.0508 cm (0.02 inch). , The thickness of this ribbon ranges from about 0.00127 centimeters (0.0005 inches) to about 0.0508 centimeters (0.02 inches).
The coil 458 may be attached to the core wire 413 using any suitable attachment technique. Examples of mounting techniques include soldering, brazing, welding, gluing, crimping and the like. In the illustrated embodiment, the coil 458 is mounted at two attachment points 464 and 465.
The coil 458 is spirally wound by a conventional winding technique. The coil 458 may be wound tightly at the pitch of adjacent turns such that each turn contacts a subsequent turn, or the pitch is set so that the coil 458 opens. You may be. In some embodiments, the coil pitch is up to about 1.016 centimeters (0.4 inches), in some embodiments the pitch is up to about 0.2032 centimeters (0.08 inches), and in some embodiments the pitch range is up to about 0.2032 centimeters (0.08 inches). It ranges from about 0.0254 centimeters (0.01 inches) to about 0.2032 centimeters (0.08 inches). The pitch may be constant throughout the length of the coil 458 or may vary depending on desired properties such as flexibility. In some embodiments, the pitch of the coil portion 458 overlapping the core wire 413 is narrow and the pitch of the coil portion not overlapping the core wire 413 is wide. For example, in some embodiments, the pitch of the coil portion overlapping the core wire 413 ranges from about 0.0254 centimeters (0.01 inches) to about 0.2032 centimeters (0.08 inches), eg 0.1016 centimeters (0.04 inches). ), And the pitch of the coil part that does not overlap with the core wire 413 is up to about 0.2032 cm (0.08 inch). These changes in coil pitch may be achieved during the initial winding of the wire, or by manipulating the coil after the wire has been wound or attached to the guide wire. For example, in some embodiments, a wide pitch may be achieved at the tip of the coil by simply pulling the coil after attaching the coil 458 to the guide wire.
It is desirable that the diameter of the coil 458 is sized to fit around the tip of the core wire 413 and combine with the tip to provide the desired properties. The diameter of the coil 458 may be constant or tapered. In some embodiments, the coil 458 is tapered to connect to the tapered area of the core wire 413. The diameter of the coil 458 may optionally have a tapered portion ahead of the tip of the core wire 413.
An outer sleeve 468 is arranged around the tip portion 416 of the guide wire 410. In the illustrated embodiment, the sleeve 468 extends beyond the most tip portion of the coiled ribbon 458 to form a round tip portion 469. The sleeve 468 may have the above-mentioned structure with respect to the sleeve structure, or may be formed by the above-mentioned materials and methods with respect to the sleeve structure.
Those skilled in the art will recognize that a wide range of materials, sizes, and structures can be used to construct suitable embodiments, depending on the desired properties. The following examples are provided as examples without any limitation. In certain embodiments, the guidewire has the overall structure described in FIG. 13, where core wire 413 is the tip of a core wire made of linear elastic nickel titanium alloy, with constant diameter portions 450,452,454. The diameters are about 0.024638 centimeters (0.0097 inches), about 0.01524 centimeters (0.006 inches), and about 0.00762 centimeters (0.003 inches), respectively. In addition, the lengths of the constant diameter portions 452 and 454 are about 2.54 centimeters (1 inch) and about 1.27 centimeters (0.5 inch), respectively. The tapered portions 442,446 are about 2.54 centimeters (1 inch) and about 3.81 centimeters (1.5 inches), respectively. The coil 458 is about 3.81 centimeters (1.5 inches) long and is made of flat stainless steel wire, which measures about 0.0127 centimeters wide and about 0.00254 centimeters thick (about 0.00254 centimeters thick). 0.001 inch). The diameter of the coil 458 tapers from about 0.024638 cm (0.0097 inches) at the base of the coil 458 to about 0.00762 cm (0.003 inches) at the tip of the coil 458, where the coil 458 attaches to the core 413 at attachment points 464,465. It is attached using solder. The coil 458 overlaps the core wire 413 at about 2.794 centimeters (1.1 inches), and extends from the core wire 413 toward the tip at about 1.016 centimeters (0.4 inches). The pitch of the coil part that overlaps the core wire is about 0.1016 cm (0.04 inch), and the pitch of the coil part that extends toward the tip of the core wire is about 0.2032 cm (0. 08 inches). In such an embodiment, the guide wire at the portion where the coil 458 overlaps the core wire 413 by about 2.794 centimeters (1.1 inches) is plated, for example, tin-plated. The sleeve 468 is a polyurethane sleeve attached around the core wire 413 and the coil 458. The sleeve 468 has a hydrophilic coating.
Here, referring to FIG. 14, a guide wire 410 having a chip configuration similar to the chip configuration shown in FIG. 13 is shown, and the same reference numerals indicate a similar structure. However, the tip portion 434 of the core wire 413 of the embodiment of FIG. 13 has one constant diameter portion 450 and one tapered portion 442, and the coiled ribbon 458 surrounds a part of the tapered portion 442. It is attached. Other aspects and components of the embodiment shown in FIG. 14 may have the same overall structure and material as described above with respect to FIG.
In certain embodiments, the guide wire 413 has the overall structure described in FIG. The core wire 413 is the tip portion of the core wire formed of a linearly elastic nickel-titanium alloy. The constant diameter part 450 has a diameter of about 0.024638 cm (0.0097 inches), the tapered part 442 has a length of about 7.62 cm (3 inches), and a tapered part with a diameter of about 0.00762 cm (0.003 inches). Terminate at the tip of portion 442. The coil 458 is about 3.81 centimeters (1.5 inches) long and is made of flat stainless steel wire, which measures about 0.0127 centimeters wide and about 0.00254 centimeters thick (about 0.00254 centimeters thick). 0.001 inch). The diameter of the coil 458 tapers from about 0.024638 cm (0.0097 inches) at the base of the coil 458 to about 0.00762 cm (0.003 inches) at the tip of the coil 458. The coil 458 is attached to the core wire 413 using solder at attachment points 464,465. The coil 458 overlaps the core wire 413 at about 2.794 centimeters (1.1 inches), and extends from the core wire 413 toward the tip at about 1.016 centimeters (0.4 inches). The pitch of the coil portion overlapping the core wire is about 0.1016 cm (0.04 inch), and the pitch of the coil portion extending toward the tip of the core wire is about 0.2032 cm (0.08 inch). In such an embodiment, the guide wire at the portion where the coil 458 overlaps the core wire 413 by about 2.794 centimeters (1.1 inches) may be plated, for example, tin-plated. The sleeve 468 is a polyurethane sleeve attached around the core wire 413 and the coil 458. The sleeve 468 has a hydrophilic coating.
Here, referring to FIG. 15, a guide wire 410 having a chip configuration similar to the chip configuration shown in FIG. 13 is shown, and the same reference numerals indicate a similar structure. However, the tip portion 434 of the core wire 413 of the embodiment of FIG. 15 has two constant diameter portions 450,454 and one tapered portion 442. The coil 458 is mounted around a portion 454 of constant diameter. In FIG. 15, the coil 458 is mounted around a constant diameter portion 454 with two attachment points 464,465, which are not tapered and there is no substantial pitch change along the length of the coil 458. Other aspects and components of the embodiment shown in FIG. 15 may have the same overall structure and material as described above with respect to FIG.
Here, referring to FIG. 16, a guide wire 410 having a chip configuration similar to the chip configuration shown in FIG. 15 is shown, and the same reference numerals indicate a similar structure. However, in the embodiment of FIG. 16, the pitch of the coil 458 on the tip side of the attachment point 464 is longer than the pitch of the coil 458 on the base end side of the attachment point 464. Other aspects and components of the embodiment shown in FIG. 16 may have the same overall structure and material as described above with respect to FIG.
Here, referring to FIG. 17, a guide wire 410 having a chip configuration similar to the chip configuration shown in FIG. 16 is shown, and the same reference numerals indicate a similar structure. However, in the embodiment of FIG. 17, only the attachment point 464 near the tip of the core wire 413 is used. Other aspects and components of the embodiment shown in FIG. 17 may have the same overall structure and material as described above with respect to FIG.
Here, referring to FIG. 18, a guide wire 410 having a chip configuration similar to that shown in FIG. 16 is shown, and the same reference numerals indicate a similar structure. However, in the embodiment of FIG. 18, only the attachment point 465 on the most proximal side is used. Other aspects and components of the embodiment shown in FIG. 18 may have the same overall structure and material as described above with respect to FIG.
Here, referring to FIG. 19, a guide wire 410 having a chip configuration similar to the chip configuration shown in FIG. 16 is shown, and the same reference numerals indicate a similar structure. However, in the embodiment of FIG. 19, the safety and / or shaped structure 458 comprises a coiled portion 490 wound around a constant diameter portion 454 and a non-coiled portion extending from the tip of the core wire 413 toward the tip. It is transformed into 492. Other aspects and components of the embodiment shown in FIG. 18 may have the same overall structure and material as described above with respect to FIG.
Here, with reference to FIG. 20, a guide wire 410 having a chip configuration similar to that shown in FIG. 19 is shown, and the same reference numerals indicate a similar structure. However, in the embodiment of FIG. 20, the safety and / or shaped structure 458 has two independent parts. These two independent parts overlap with a constant diameter portion 454, a generally straight portion 492 extending from the tip of the core wire 413 toward the tip, and a straight ribbon portion 492 to attach the straight portion 492 to the constant diameter portion 454. And a coiled portion 490 wound around both sides of a constant diameter portion 454. Other aspects and components of the embodiment shown in FIG. 18 may have the same overall structure and material as described above with respect to FIG.
Referring here to FIG. 21, FIG. 21 is a partial cross-sectional view of the chip configuration of the guide wire 410 similar to the chip configuration shown in FIG. 19, with the same reference numerals indicating a similar structure. Similar to the embodiment of FIG. 19, the embodiment shown in FIG. 21 also has a safety and / or shaped structure 458, which structure has a coiled portion 490 wound around a constant diameter portion 454. Further, the safety and / or shaping structure 458 is deformed from the tip of the core wire 413 to a non-coiled portion 492 extending toward the tip. However, in FIG. 21, the non-coiled portion 492 is twisted to form a spiral wire. Other aspects and components of the embodiment shown in FIG. 21 may have the same overall structure and material as described above with respect to FIG.
Referring here to FIG. 22, FIG. 22 is a partial cross-sectional view of a guide wire 410 having a tip configuration similar to the tip tip portion 230 of the guide wire 210 shown in FIGS. 9 and 10, with the same reference numerals being similar. Shows the structure. However, in the embodiment of FIG. 22, it is not the non-coiled ribbon 258 shown in FIGS. 9 and 10 but the coiled safety and / or shaped structure 458 provided in the chip configuration. The coil is attached to the guide wire at two attachment points 464,465, for example by soldering. Other aspects and components of the embodiments shown in FIG. 21 may have the same overall structure and material as described above with respect to FIGS. 9 and 10 and / or 13.
Referring here to FIG. 23, FIG. 23 is a partial cross-sectional view of a guide wire 410 having a tip configuration similar to the tip tip portion 230 of the guide wire 210 shown in FIGS. 11 and 12, with the same reference numerals being similar. Shows the structure. However, in the embodiment of FIG. 23, the chip configuration is provided with a coiled safety and / or shaped structure 458 rather than the non-coiled structure 258 shown in FIGS. 11 and 12. The coil is attached to the guide wire at two attachment points 464,465, for example by soldering. Further, the embodiment of FIG. 21 does not have the inner coil 390 and spacer 395 shown in FIGS. 11 and 12. Other aspects and components of the embodiments shown in FIG. 21 may have the same overall structure and material as described above with respect to FIGS. 11 and 12 and / or 13.
It should be understood that this disclosure is, in many respects, merely an example. The details, in particular the shape, dimensions, and arrangement of steps, may be modified without departing from the scope of the invention. For example, an alternative structure may be used to connect the proximal and distal areas of the guide wire. In addition, alternative insert configurations, such as flexible insert inserts, polymer insert inserts, inserts with coiled safety and / or molded wires, and combinations thereof, and other such structures can be added to the guide wire. It may be arranged. The scope of the present invention is, of course, defined by the wording indicating the scope of the appended claims.
<figref num="1">Partial sectional view of a guide wire (before grinding) including a connecting portion using an overlapping tapered joint for joining the base end portion and the tip end portion of the guide wire and a tubular coupler.</figref><figref num="2">Partial sectional view of the guide wire (after grinding) of FIG.</figref><figref num="3">Partial sectional view of a guide wire (after grinding) including a connecting portion using an overlapping joint (without a tubular coupler) for joining the base end portion and the tip end portion of the guide wire.</figref><figref num="4">Partial sectional view of an alternative guide wire (after grinding) comprising a butt joint for joining the base end and the tip of the guide wire and a coupling using a tubular coupler.</figref><figref num="5">Partial sectional view of an alternative guide wire (after grinding) comprising an overlapping tapered joint for joining the base end and the tip of the guide wire and a coupling using a tubular coupler.</figref><figref num="6A">FIG. 5 is a partial cross-sectional view of an end portion used with the guide wire embodiment of FIG.</figref><figref num="6B">FIG. 5 is a partial cross-sectional view of an end portion used with the guide wire embodiment of FIG.</figref><figref num="6C">FIG. 5 is a partial cross-sectional view of an end portion used with the guide wire embodiment of FIG.</figref><figref num="7">An alternative guidewire configuration and tip with a coupling similar to the guidewire configuration shown in FIG. 2 with overlapping tapered joints and tubular couplers that join the base and tip of the guidewire. Partial cross-sectional view of the chip configuration of.</figref><figref num="8">A partial cross-sectional view of another alternative guidewire configuration similar to the guidewire configuration of FIG. 7, but with an alternative chip configuration.</figref><figref num="9">A partial cross-sectional view of another alternative guidewire configuration similar to the guidewire configuration of FIG. 7, but with another alternative chip configuration.</figref><figref num="10">A partial cross-sectional view of another alternative guidewire configuration similar to the guidewire configuration of FIG. 7, but with another alternative chip configuration.</figref><figref num="11">A partial cross-sectional view of another alternative guidewire configuration similar to the guidewire configuration of FIG. 7, but with another alternative chip configuration.</figref><figref num="12">A partial cross-sectional view of another alternative guidewire configuration similar to the guidewire configuration of FIG. 7, but with another alternative chip configuration.</figref><figref num="13">Partial sectional view of another embodiment of a guide wire comprising an alternative chip configuration.</figref><figref num="14">Partial sectional view of another embodiment of a guide wire having another alternative chip configuration.</figref><figref num="15">Partial sectional view of another embodiment of a guide wire having another alternative chip configuration.</figref><figref num="16">Partial sectional view of another embodiment of a guide wire having another alternative chip configuration.</figref><figref num="17">Partial sectional view of another embodiment of a guide wire having another alternative chip configuration.</figref><figref num="18">Partial sectional view of another embodiment of a guide wire having another alternative chip configuration.</figref><figref num="19">Partial sectional view of another embodiment of a guide wire having another alternative chip configuration.</figref><figref num="20">Partial sectional view of another embodiment of a guide wire having another alternative chip configuration.</figref><figref num="21">Partial sectional view of another embodiment of a guide wire having another alternative chip configuration.</figref><figref num="22">Partial sectional view of another embodiment of a guide wire having another alternative chip configuration.</figref><figref num="23">Partial sectional view of another embodiment of a guide wire having another alternative chip configuration.</figref>
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- Application, EPODOC
- JP20030534012
Titles2
- Japanese
- 複合ガイドワイヤ
- English
- Composite guide wire
Classification
- CPC, 5
- A61M25/0905
- A61L31/022
- A61M25/09
- A61M2025/09141
- A61M2025/09175
- IPC, 2
- A61M25 01
- A61L31 02
Designated states4
- Regional, 4
- Zimbabwe
- Turkmenistan
- Türkiye
- Togo