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US20060074442A1 Expired / Lapsed US ⏱️ 0.0 years remaining

Guidewire for crossing occlusions or stenoses

Assignee: Boston Scientific Scimed Inc
•
Filing: 2005-09-26
•
Granted: —
•
Expires: 2025-09-26
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Abstract

Abstract A deflectable and torqueable hollow guidewire device is disclosed for removing occlusive material and passing through occlusions, stenosis, thrombus, plaque, calcified material, and other materials in a body lumen, such as a coronary artery. The hollow guidewire generally comprises an elongate, tubular guidewire body that has an axial lumen. A mechanically moving core element is positioned at or near a distal end of the tubular guidewire body and extends through the axial lumen. Actuation of the core element (e.g., oscillation, reciprocation, and/or rotation) creates a passage through the occlusive or stenotic material in the body lumen.

Inventors

  • 👤 Gerardo Noriega
  • 👤 Victor Chechelski
  • 👤 Rudolfo Sudaria
  • 👤 Michael Carley
  • 👤 Nestor Aganon
  • 👤 Eric Coblin

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 05:18
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/01; A61M25/09; A61B; A61B17/00; A61B17/32; A61B17/320016; A61B17/32002; A61B17/3205; A61B17/3207; A61B17/320758; A61M25/09016; A61M25/09025; A61B17/22; A61B17/22004; A61B17/22012; A61B17/320725; A61B17/320783; A61B2017/22038; A61B2017/22042; A61B2017/22044; A61B2017/22094; A61B2017/320004; A61B2017/320733; A61B2017/320741; A61M25/0021; A61M2025/0042; A61M25/0194; A61M2025/0197; A61M2025/09175; A61M2025/09183

Claims Analysis

Total Claims: 65
Claim 1
Independent Claim 53 words
1 . A deflectable hollow guidewire device for crossing an occlusion or stenosis within a body lumen, the device comprising: an elongate hollow guidewire body having a proximal end, a deflectable distal end, and an axial lumen therebetween; and a mechanically moving core element extending through the axial lumen of the guidewire body.
Claim 2
Dependent Claim 53 words
1 . A deflectable hollow guidewire device for crossing an occlusion or stenosis within a body lumen, the device comprising: an elongate hollow guidewire body having a proximal end, a deflectable distal end, and an axial lumen therebetween; and a mechanically moving core element extending through the axial lumen of the guidewire body.
Claim 3
Dependent Claim 23 words
2 . The device of claim 1 , wherein the elongate hollow guidewire body comprises a unitary structure having a plurality of sections.
Claim 4
Dependent Claim 18 words
3 . The device of claim 2 , wherein at least one section comprises an interrupted helical pattern.
Claim 5
Dependent Claim 26 words
4 . The device of claim 3 , wherein the interrupted helical pattern comprises laser edged helical windings at 180 degrees interrupted by 30 degree segments.
Claim 6
Dependent Claim 17 words
5 . The device of claim 2 , wherein at least one section comprises a ribbed pattern.
Claim 7
Dependent Claim 27 words
6 . The device of claim 2 , wherein at least a first section comprises an interrupted helical pattern and a second section comprises a ribbed pattern.
Claim 8
Dependent Claim 29 words
7 . The device of claim 1 , further comprising a pull tube extending through the axial lumen and coupled to the distal end portion of the guidewire body.
Claim 9
Dependent Claim 24 words
8 . The device of claim 7 , wherein actuation of the pull tube deflects or bends the distal end of the guidewire body.
Claim 10
Dependent Claim 15 words
9 . The device of claim 7 , wherein the pull tube is distally tapered.
Claim 11
Dependent Claim 17 words
10 . The device of claim 7 , wherein the pull tube is formed from nickel titanium.
Claim 12
Dependent Claim 24 words
11 . The device of claim 1 , further comprising a radiopaque coil disposed over at least a distal portion of the core element.
Claim 13
Dependent Claim 28 words
12 . The device of claim 11 , wherein the coil separates a pull tube extending through the axial lumen of the guidewire body from the core element.
Claim 14
Dependent Claim 45 words
13 . The device of claim 1 , wherein a distal tip of the core element extends distally of the distal end of the guidewire body and upon activation creates a passageway or enlarges a passageway through the occlusion or stenosis within the body lumen.
Claim 15
Dependent Claim 19 words
14 . The device of claim 13 , wherein the mechanically moving core element comprises an oscillatory drive shaft.
Claim 16
Dependent Claim 23 words
15 . The device of claim 13 , wherein the mechanically moving core element comprises an axially translatable drive shaft for reciprocation movement.
Claim 17
Dependent Claim 23 words
16 . The device of claim 13 , wherein the distal tip comprises a bullet, fluted bullet, flat spatula, drill, or football shape.
Claim 18
Dependent Claim 16 words
17 . The device of claim 13 , wherein the distal tip is deflected or shaped.
Claim 19
Dependent Claim 15 words
18 . The device of claim 13 , wherein the distal tip comprises laser edgings.
Claim 20
Dependent Claim 33 words
19 . The device of claim 13 , further comprising a locking mechanism coupled to the distal end of the guidewire body which prevents inadvertent release of distal tip into the body lumen.
Claim 21
Dependent Claim 21 words
20 . The device of claim 1 , further comprising a handle coupled to the proximal end of the guidewire body.
Claim 22
Dependent Claim 18 words
21 . The device of claim 20 , wherein the handle is fixedly coupled to the guidewire body.
Claim 23
Dependent Claim 30 words
22 . The device of claim 21 , wherein the handle allows for torque transmission of the guidewire body independent of deflection of the distal end of the guidewire body.
Claim 24
Dependent Claim 18 words
23 . The device of claim 20 , wherein the handle is removably coupled to the guidewire body.
Claim 25
Dependent Claim 18 words
24 . The device of claim 20 , further comprising circuitry within the handle which provides feedback control.
Claim 26
Dependent Claim 39 words
25 . A non-deflectable, hollow guidewire device comprising: an elongate hollow guidewire body having a proximal end, a pre-shaped distal end, and an axial lumen therebetween; and a drive shaft extending through the axial lumen of the guidewire body.
Claim 27
Dependent Claim 39 words
25 . A non-deflectable, hollow guidewire device comprising: an elongate hollow guidewire body having a proximal end, a pre-shaped distal end, and an axial lumen therebetween; and a drive shaft extending through the axial lumen of the guidewire body.
Claim 28
Dependent Claim 67 words
26 . A deflectable hollow guidewire device for crossing an occlusion or stenosis within a body lumen, the device comprising: an elongate hollow guidewire body having a proximal end, a deflectable distal end, an axial lumen therethrough, and a plurality of sections therebetween, wherein at least one section comprises an interrupted helical pattern; and an oscillatory drive shaft extending through the axial lumen of the guidewire body.
Claim 29
Dependent Claim 67 words
26 . A deflectable hollow guidewire device for crossing an occlusion or stenosis within a body lumen, the device comprising: an elongate hollow guidewire body having a proximal end, a deflectable distal end, an axial lumen therethrough, and a plurality of sections therebetween, wherein at least one section comprises an interrupted helical pattern; and an oscillatory drive shaft extending through the axial lumen of the guidewire body.
Claim 30
Dependent Claim 26 words
27 . The device of claim 26 , wherein the interrupted helical pattern comprises laser edged helical windings at 180 degrees interrupted by 30 degree segments.
Claim 31
Dependent Claim 16 words
28 . The device of claim 26 , further comprising another section comprising a ribbed pattern.
Claim 32
Dependent Claim 17 words
29 . The device of claim 26 , further comprising another section comprising a solid-walled tubular member.
Claim 33
Dependent Claim 71 words
30 . A steerable hollow guidewire device comprising: an elongate hollow guidewire body having a proximal end, a distal end, and an axial lumen therebetween; a drive shaft extending through the axial lumen of the guidewire body; and a pull tube extending through the axial lumen and coupled to the distal end portion of the guidewire body, wherein actuation of the pull tube deflects the distal end of the guidewire body.
Claim 34
Dependent Claim 71 words
30 . A steerable hollow guidewire device comprising: an elongate hollow guidewire body having a proximal end, a distal end, and an axial lumen therebetween; a drive shaft extending through the axial lumen of the guidewire body; and a pull tube extending through the axial lumen and coupled to the distal end portion of the guidewire body, wherein actuation of the pull tube deflects the distal end of the guidewire body.
Claim 35
Dependent Claim 22 words
31 . The device of claim 31 , further comprising a radiopaque coil disposed between the pull tube and the drive shaft.
Claim 36
Dependent Claim 81 words
32 . A method of crossing an occlusion or stenosis within a body lumen comprising: positioning a hollow guidewire into the body lumen adjacent the occlusion or stenosis: oscillating a drive shaft within an inner lumen of the hollow guidewire, wherein a distal tip of the drive shaft extends distally beyond the hollow guidewire; and advancing the distal tip of the drive shaft into the occlusion or stenosis in the body lumen to create a path in the occlusion or stenosis.
Claim 37
Dependent Claim 81 words
32 . A method of crossing an occlusion or stenosis within a body lumen comprising: positioning a hollow guidewire into the body lumen adjacent the occlusion or stenosis: oscillating a drive shaft within an inner lumen of the hollow guidewire, wherein a distal tip of the drive shaft extends distally beyond the hollow guidewire; and advancing the distal tip of the drive shaft into the occlusion or stenosis in the body lumen to create a path in the occlusion or stenosis.
Claim 38
Dependent Claim 21 words
33 . The method of claim 32 , wherein oscillating the drive shaft comprises changing polarity after a period of time.
Claim 39
Dependent Claim 24 words
34 . The method of claim 33 , wherein the period of time is in a range from about 0.3 seconds to 1.2 seconds.
Claim 40
Dependent Claim 23 words
35 . The method of claim 32 , wherein advancing further comprises reciprocating axial translation of the distal tip of the drive shaft.
Claim 41
Dependent Claim 20 words
36 . The method of claim 35 , wherein oscillation and reciprocation of the drive shaft are carried out sequentially.
Claim 42
Dependent Claim 21 words
37 . The method of claim 35 , wherein oscillation and reciprocation movement of the drive shaft are carried out simultaneously.
Claim 43
Dependent Claim 28 words
38 . The method of claim 35 , wherein oscillation or reciprocation movement of the drive shaft are carried out by a drive motor or by manual operation.
Claim 44
Dependent Claim 24 words
39 . The method of claim 32 , wherein advancing further comprises extending the drive shaft from a retracted configuration to an extended configuration.
Claim 45
Dependent Claim 19 words
40 . The method of claim 39 , wherein the drive shaft is simultaneously or sequentially extended and oscillated.
Claim 46
Dependent Claim 23 words
41 . The method of claim 32 , wherein positioning the hollow guidewire is carried out without the use of a separate guidewire.
Claim 47
Dependent Claim 20 words
42 . The method of claim 32 , further comprising viewing a distal end of the hollow guidewire under fluoroscopy.
Claim 48
Dependent Claim 23 words
43 . The method of claim 32 , further comprising deflecting a distal end of the hollow guidewire by actuating a pull tube.
Claim 49
Dependent Claim 23 words
44 . The method of claim 32 , further comprising measuring resistance encountered during advancement of the distal tip in the body lumen.
Claim 50
Dependent Claim 19 words
45 . The method of claim 44 , automatically adjusting a torque speed in response to the measured resistance.
Claim 51
Dependent Claim 26 words
46 . The method of claim 32 , further comprising measuring a level of load encountered during advancement of the distal tip in the body lumen.
Claim 52
Dependent Claim 27 words
47 . The method of claim 46 , further comprising signaling a visual or audio alarm if the measured load is above or below a threshold value.
Claim 53
Dependent Claim 14 words
48 . The method of claim 46 , further comprising automatically disabling the device.
Claim 54
Dependent Claim 25 words
49 . The method of claim 32 , further comprising measuring a use of the device based on time or number of revolutions or oscillations.
Claim 55
Dependent Claim 27 words
50 . The method of claim 49 , further comprising automatically and permanently disabling the device if the measured time or number is above a threshold value.
Claim 56
Dependent Claim 36 words
51 . The method of claim 32 , further comprising preventing inadvertent release of the distal tip of the drive shaft into the body lumen by locking it to a distal end of the hollow guidewire.
Claim 57
Dependent Claim 26 words
52 . The method of claim 32 , further comprising transmitting torque to the hollow guidewire independently of deflecting a distal end of the hollow guidewire.
Claim 58
Dependent Claim 30 words
53 . The method of claim 32 , wherein the drive shaft creates a path at least as large as a perimeter of a distal end of the hollow guidewire.
Claim 59
Dependent Claim 28 words
54 . The method of claim 32 , further comprising maintaining a position of the hollow guidewire during the advancing of the distal tip of the drive shaft.
Claim 60
Dependent Claim 40 words
55 . The method of claim 32 , further comprising positioning a support system in the body lumen adjacent the occlusion or stenosis, wherein the hollow guidewire is sized to be received within an inner lumen of the support system.
Claim 61
Dependent Claim 48 words
56 . The method of claim 55 , wherein positioning the support system comprises: advancing a guidewire through the body lumen to the occlusion or stenosis; advancing the support system over the guidewire; removing the guidewire from the body lumen; advancing the hollow guidewire through the support system.
Claim 62
Dependent Claim 17 words
57 . The method of claim 56 , further comprising exchanging the hollow guidewire with the guidewire.
Claim 63
Dependent Claim 34 words
58 . The method of claim 32 , further comprising turning a knob on a handle coupled to a proximal end of the hollow guidewire to effect torque transmission of the entire hollow guidewire.
Claim 64
Dependent Claim 36 words
59 . The method of claim 32 , further comprising turning a wheel on a handle coupled to a proximal end of the hollow guidewire to effect deflection of a distal end of the hollow guidewire.
Claim 65
Dependent Claim 51 words
60 . The method of claim 32 , further comprising turning a knob on a handle coupled to a proximal end of the hollow guidewire to effect torque transmission of the hollow guidewire and turning a wheel on the handle to effect deflection of the hollow guidewire either sequentially or simultaneously.

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