US20030233115A1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Expandable guide sheath and apparatus and methods using such sheaths
Assignee: Leland Stanford Junior University
•
Filing: 2003-04-24
•
Granted: —
•
Expires: 2023-04-24
Abstract
Abstract Apparatus and methods are provided for accessing body lumens and/or for delivering instruments into body lumens, e.g., vessels within a patient's vasculature. A flexible sheath is provided that is expandable from a contracted condition to an enlarged condition wherein the sheath at least partially defines a lumen therein. The sheath is lubricious and has a relatively thin wall, thereby providing a collapsible/expandable guide for delivering fluids and/or instruments through tortuous anatomy and/or into relatively narrow passages. The sheath is advanced from an entry site to a body lumen in the contracted condition. Once the sheath reaches a target body lumen, the sheath is expanded to the enlarged condition, thereby defining a lumen within the sheath, and fluids and/or instruments are introduced into the body lumen via the sheath lumen. Upon completing the procedure, the sheath is removed from the body lumen.
Inventors
- 👤 Christian Eversull
- 👤 Nicholas Mourlas
- 👤 Stephen Leeflang
- 👤 Asha Nayak
- 👤 David Miller
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 05:15
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/10; A61M25/1027; A61B; A61B17/00; A61B17/34; A61B17/3417; A61B17/3421; A61B17/3431; A61B17/3439; A61M25/01; A61M25/06; A61M25/0662; A61M25/1002; A61M25/104; A61F; A61F2/00; A61F2/01; A61F2/011; A61F2/95; A61F2002/9505; A61F2002/9511; A61M2025/0177; A61M2025/0681; A61M2025/1004; A61M2025/1043; A61M2025/1088; A61M29/00; A61M29/02; A61M2029/025; A61M25/0668
Claims Analysis
Total Claims: 87
Claim 1
Independent Claim
104 words
1 . An apparatus for providing access to a body lumen of a patient, comprising: a flexible stiffening member having a proximal end and a distal end having a size and shape for insertion into a body lumen; and an expandable sheath extending between the proximal and distal ends of the stiffening member, the sheath being expandable from a contracted condition to minimize a profile of the sheath to allow insertion along with the stiffening member into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen extending between the proximal and distal ends of the stiffening member.
Claim 2
Dependent Claim
104 words
1 . An apparatus for providing access to a body lumen of a patient, comprising: a flexible stiffening member having a proximal end and a distal end having a size and shape for insertion into a body lumen; and an expandable sheath extending between the proximal and distal ends of the stiffening member, the sheath being expandable from a contracted condition to minimize a profile of the sheath to allow insertion along with the stiffening member into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen extending between the proximal and distal ends of the stiffening member.
Claim 3
Dependent Claim
15 words
2 . The apparatus of claim 1 , wherein the sheath comprises a lubricious material.
Claim 4
Dependent Claim
14 words
3 . The apparatus of claim 1 , wherein the sheath comprises a polymer.
Claim 5
Dependent Claim
24 words
4 . The apparatus of claim 3 , wherein the polymer comprises at least one of PTFE, EPTFE, FEP, PET, urethane, olefin, and PE.
Claim 6
Dependent Claim
15 words
5 . The apparatus of claim 1 , wherein the sheath comprises an elastomeric material.
Claim 7
Dependent Claim
22 words
6 . The apparatus of claim 5 , wherein the elastomeric material comprises at least one of silicone, latex, isoprene, and chronoprene.
Claim 8
Dependent Claim
37 words
7 . The apparatus of claim 1 , wherein the sheath comprises a tubular member that is attached to the stiffening member at one or more locations between the proximal and distal ends of the stiffening member.
Claim 9
Dependent Claim
21 words
8 . The apparatus of claim 7 , wherein the stiffening member comprises one or more strands extending along the sheath.
Claim 10
Dependent Claim
26 words
9 . The apparatus of claim 8 , wherein the one or more strands extend along the sheath at least one of axially, helically, and circumferentially.
Claim 11
Dependent Claim
36 words
10 . The apparatus of claim 1 , wherein the sheath comprises a sheet of material whose edges are attached to the stiffening member such that the sheet and the stiffening member together define the lumen.
Claim 12
Dependent Claim
40 words
11 . The apparatus of claim 1 , wherein the sheath comprises a distal end having an opening communicating with the lumen such that an instrument inserted through the lumen may be advanced from the opening into a body lumen.
Claim 13
Dependent Claim
43 words
12 . The apparatus of claim 1 , wherein the sheath comprises a substantially closed distal end comprising a break-away portion for creating an opening such that an instrument inserted through the lumen may be advanced from the opening into a body lumen.
Claim 14
Dependent Claim
22 words
13 . The apparatus of claim 12 , wherein the break-away portion comprises a weakened region of a material comprising the sheath.
Claim 15
Dependent Claim
60 words
14 . The apparatus of claim 1 , wherein the sheath comprises a substantially closed distal end attached to the distal end of the stiffening member, the distal end of the sheath being separable from the stiffening member to create an opening such that an instrument inserted through the lumen may be advanced from the opening into a body lumen.
Claim 16
Dependent Claim
30 words
15 . The apparatus of claim 1 , wherein the sheath is configured to split such that the sheath may be removed from around an instrument disposed within the lumen.
Claim 17
Dependent Claim
24 words
16 . The apparatus of claim 15 , wherein the sheath comprises a weakened region extending between proximal and distal ends of the sheath.
Claim 18
Dependent Claim
23 words
17 . The apparatus of claim 1 , wherein the sheath comprises a wall thickness not more than about 0.01 inch (0.25 mm).
Claim 19
Dependent Claim
39 words
18 . The apparatus of claim 1 , wherein the stiffening member has sufficient column strength that the distal end may be advanced through a body lumen by pushing the proximal end without substantial risk of kinking or buckling.
Claim 20
Dependent Claim
15 words
19 . The apparatus of claim 1 , wherein the stiffening member comprises a guidewire.
Claim 21
Dependent Claim
49 words
20 . The apparatus of claim 1 , wherein the stiffening member comprises an arcuate cross-section, thereby defining a groove extending between the proximal and distal ends within which the sheath may be at least partially disposed in the contracted condition to minimize a cross-sectional profile of the apparatus.
Claim 22
Dependent Claim
26 words
21 . The apparatus of claim 1 , wherein the stiffening member comprises an elongate member extending substantially parallel to a longitudinal axis of the sheath.
Claim 23
Dependent Claim
22 words
22 . The apparatus of claim 1 , wherein the sheath is attached to the stiffening member at one or more locations.
Claim 24
Dependent Claim
27 words
23 . The apparatus of claim 21 , wherein the sheath is attached to the stiffening member at the proximal and distal ends of the stiffening member.
Claim 25
Dependent Claim
29 words
24 . The apparatus of claim 21 , wherein the sheath is attached substantially continuously to the stiffening member between the proximal and distal ends of the stiffening member.
Claim 26
Dependent Claim
18 words
25 . The apparatus of claim 21 , wherein the sheath is detachably secured to the stiffening member.
Claim 27
Dependent Claim
28 words
26 . The apparatus of claim 1 , wherein the stiffening member comprises a plurality of elongate members extending substantially parallel to a longitudinal axis of the sheath.
Claim 28
Dependent Claim
21 words
27 . The apparatus of claim 1 , further comprising a constraint for selectively maintaining the sheath in the contracted condition.
Claim 29
Dependent Claim
28 words
28 . The apparatus of claim 27 , wherein the constraint comprises a tubular member comprising a lumen within which the stiffening member and sheath may be disposed.
Claim 30
Dependent Claim
45 words
29 . The apparatus of claim 27 , wherein the constraint comprises an outer sheath that surrounds the sheath in the contracted condition, the outer sheath comprises one or more weakened regions that are separable to allow the sheath to expand to the enlarged condition.
Claim 31
Dependent Claim
33 words
30 . The apparatus of claim 29 , wherein the outer sheath is attached to the stiffening member at one or more locations between the proximal and distal ends of the stiffening member.
Claim 32
Dependent Claim
48 words
31 . The apparatus of claim 29 , wherein the outer sheath comprises a lumen within which the sheath may be disposed in the contracted condition, the lumen configured for receiving a fluid therein such that fluid pressure may cause the one or more weakened regions to separate.
Claim 33
Dependent Claim
21 words
32 . The apparatus of claim 27 , wherein the constraint comprises one or more strands disposed around the expandable member.
Claim 34
Dependent Claim
23 words
33 . The apparatus of claim 27 , wherein the constraint comprises at least one of an adhesive and a bioabsorbable encapsulating material.
Claim 35
Dependent Claim
28 words
34 . The apparatus of claim 1 , wherein the sheath comprises a plurality of lumens that extend between the proximal and distal ends in the enlarged condition.
Claim 36
Dependent Claim
29 words
35 . The apparatus of claim 34 , wherein each of the plurality of lumens is configured for at least one of the following: infusion, aspiration, perfusion, and agitation.
Claim 37
Dependent Claim
56 words
36 . A method for accessing a body lumen of a patient, the method comprising: advancing an expandable sheath from an entry site to a body lumen with the sheath in a contracted condition; expanding the sheath to an enlarged condition, thereby defining a lumen within the sheath; and removing the sheath from the body lumen.
Claim 38
Dependent Claim
56 words
36 . A method for accessing a body lumen of a patient, the method comprising: advancing an expandable sheath from an entry site to a body lumen with the sheath in a contracted condition; expanding the sheath to an enlarged condition, thereby defining a lumen within the sheath; and removing the sheath from the body lumen.
Claim 39
Dependent Claim
30 words
37 . The method of claim 36 , further comprising performing at least one of diagnostic and therapeutic procedure within the body lumen via the lumen defined by the sheath.
Claim 40
Dependent Claim
42 words
38 . The method of claim 36 , wherein the sheath is advanced from the entry site until a distal end of the sheath is disposed within the body lumen while a proximal end of the sheath remains outside the entry site.
Claim 41
Dependent Claim
24 words
39 . The method of claim 36 , wherein the lumen defined by the sheath extends from the entry site to the body lumen.
Claim 42
Dependent Claim
31 words
40 . The method of claim 36 , wherein the entry site comprises a percutaneous site communicating with the patient's vasculature, and wherein the body lumen comprises a target blood vessel.
Claim 43
Dependent Claim
26 words
41 . The method of claim 40 , wherein the target blood vessel comprises a vessel within one of the patient's coronary, peripheral, and neuro vasculature.
Claim 44
Dependent Claim
25 words
42 . The method of claim 40 , further comprising introducing an instrument through the lumen defined by the sheath into the target blood vessel.
Claim 45
Dependent Claim
36 words
43 . The method of claim 42 , wherein the instrument comprises at least one of a catheter, a guidewire, a balloon, a stent, a filter, a pacing lead, an atherectomy device, and a thrombectomy device.
Claim 46
Dependent Claim
25 words
44 . The method of claim 42 , wherein the target blood vessel comprises a coronary vein, and wherein the instrument comprises an electrical lead.
Claim 47
Dependent Claim
35 words
45 . The method of claim 42 , wherein the target blood vessel comprises an occlusion or stenosis, and wherein the instrument comprises at least one of a dilation balloon, a filter, and a stent.
Claim 48
Dependent Claim
28 words
46 . The method of claim 42 , wherein the sheath comprises lubricious material for facilitating advancing the instrument through narrow or tortuous regions of the patient's vasculature.
Claim 49
Dependent Claim
39 words
47 . The method of claim 36 , further comprising advancing an elongate rail from the entry site to the body lumen, and wherein the sheath is advanced from the entry site to the body lumen over the rail.
Claim 50
Dependent Claim
28 words
48 . The method of claim 36 , wherein the sheath is expanded to the enlarged condition by introducing a fluid into the lumen defined by the sheath.
Claim 51
Dependent Claim
13 words
49 . The method of claim 48 , wherein the fluid comprises contrast.
Claim 52
Dependent Claim
38 words
50 . The method of claim 49 , wherein the sheath comprises one or more openings in the distal end for delivering the contrast into the blood vessel, the method further comprising imaging the vessel using the contrast.
Claim 53
Dependent Claim
28 words
51 . The method of claim 36 , wherein the sheath is expanded to the enlarged condition by introducing an instrument into the lumen defined by the sheath.
Claim 54
Dependent Claim
28 words
52 . The method of claim 36 , wherein the sheath is expanded to the enlarged condition by introducing a fluid into the lumen defined by the sheath.
Claim 55
Dependent Claim
28 words
53 . The method of claim 36 , wherein the body lumen is part of the patient's urogenital tract, respiratory tract, gastrointestinal tract, lymphatic system, or vascular system.
Claim 56
Dependent Claim
29 words
54 . The method of claim 36 , wherein the entry site is a surgically created opening, and wherein the body lumen comprises a passageway created within the patient.
Claim 57
Dependent Claim
28 words
55 . The method of claim 36 , further comprising collapsing the sheath at least partially from the enlarged condition before removing the sheath from the body lumen.
Claim 58
Dependent Claim
54 words
56 . The method of claim 36 , wherein the sheath comprises a stiffening member and an expandable membrane attached to the stiffening member, the method further comprising separating at least a distal end of the expandable membrane from the stiffening member to create an opening communicating with the lumen defined by the sheath.
Claim 59
Dependent Claim
26 words
57 . The method of claim 36 , wherein the step of removing the sheath from the body lumen comprises at least partially splitting the sheath.
Claim 60
Dependent Claim
41 words
58 . The method of claim 36 , wherein the sheath is maintained in the contracted condition by a constraint, and wherein the constraint is at least partially removed from the sheath before the sheath is expanded to the enlarged condition.
Claim 61
Dependent Claim
90 words
59 . An apparatus for providing access to a body lumen of a patient, comprising an expandable flimsy sheath comprising a proximal end, a distal end, and a length sufficient for the sheath to extend between an entry site into a patient's body and a target body lumen, the sheath being expandable from a contracted condition to minimize a profile of the sheath to allow insertion into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen extending between the proximal and distal ends.
Claim 62
Dependent Claim
90 words
59 . An apparatus for providing access to a body lumen of a patient, comprising an expandable flimsy sheath comprising a proximal end, a distal end, and a length sufficient for the sheath to extend between an entry site into a patient's body and a target body lumen, the sheath being expandable from a contracted condition to minimize a profile of the sheath to allow insertion into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen extending between the proximal and distal ends.
Claim 63
Dependent Claim
15 words
60 . The apparatus of claim 59 , wherein the sheath comprises a lubricious material.
Claim 64
Dependent Claim
14 words
61 . The apparatus of claim 59 , wherein the sheath comprises a polymer.
Claim 65
Dependent Claim
15 words
62 . The apparatus of claim 59 , wherein the sheath comprises an elastomeric material.
Claim 66
Dependent Claim
15 words
63 . The apparatus of claim 59 , wherein the sheath comprises a tubular member.
Claim 67
Dependent Claim
19 words
64 . The apparatus of claim 59 , further comprising one or more reinforcing members extending along the sheath.
Claim 68
Dependent Claim
27 words
65 . The apparatus of claim 64 , wherein the one or more reinforcing members extend along the sheath at least one of axially, helically, and circumferentially.
Claim 69
Dependent Claim
43 words
66 . The apparatus of claim 59 , further comprising an elongate stiffening member, and wherein the sheath comprises a sheet of material whose edges are attached to the stiffening member such that the sheet and the stiffening member together define the lumen.
Claim 70
Dependent Claim
40 words
67 . The apparatus of claim 59 , wherein the sheath comprises a distal end having an opening communicating with the lumen such that an instrument inserted through the lumen may be advanced from the opening into a body lumen.
Claim 71
Dependent Claim
43 words
68 . The apparatus of claim 59 , wherein the sheath comprises a substantially closed distal end comprising a break-away portion for creating an opening such that an instrument inserted through the lumen may be advanced from the opening into a body lumen.
Claim 72
Dependent Claim
30 words
69 . The apparatus of claim 59 , wherein the sheath is configured to split such that the sheath may be removed from around an instrument disposed within the lumen.
Claim 73
Dependent Claim
23 words
70 . The apparatus of claim 59 , wherein the sheath comprises a wall thickness not more than about 0.01 inch (0.25 mm).
Claim 74
Dependent Claim
21 words
71 . The apparatus of claim 59 , further comprising a constraint for selectively maintaining the sheath in the contracted condition.
Claim 75
Dependent Claim
21 words
72 . The apparatus of claim 59 , further comprising one or more instruments insertable through the lumen of the sheath.
Claim 76
Dependent Claim
85 words
73 . An apparatus for delivery into a body lumen of a patient, comprising: a flexible catheter comprising proximal and distal ends; an expandable sheath attached to an outer surface of the catheter and comprising a lumen extending between proximal and distal ends of the sheath, the sheath being expandable from a contracted condition to minimize a profile of the sheath, and an enlarged condition wherein the sheath at least partially defines an accessory lumen extending between the proximal and distal ends of the sheath.
Claim 77
Dependent Claim
85 words
73 . An apparatus for delivery into a body lumen of a patient, comprising: a flexible catheter comprising proximal and distal ends; an expandable sheath attached to an outer surface of the catheter and comprising a lumen extending between proximal and distal ends of the sheath, the sheath being expandable from a contracted condition to minimize a profile of the sheath, and an enlarged condition wherein the sheath at least partially defines an accessory lumen extending between the proximal and distal ends of the sheath.
Claim 78
Dependent Claim
15 words
74 . The apparatus of claim 73 , wherein the sheath comprises a lubricious material.
Claim 79
Dependent Claim
15 words
75 . The apparatus of claim 73 , wherein the sheath comprises a flimsy material.
Claim 80
Dependent Claim
43 words
76 . The apparatus of claim 73 , wherein the sheath comprises a substantially closed distal end comprising a break-away portion for creating an opening such that an instrument inserted through the lumen may be advanced from the opening into a body lumen.
Claim 81
Dependent Claim
23 words
77 . The apparatus of claim 73 , wherein the sheath comprises a wall thickness not more than about 0.01 inch (0.25 mm).
Claim 82
Dependent Claim
21 words
78 . The apparatus of claim 73 , further comprising a constraint for selectively maintaining the sheath in the contracted condition.
Claim 83
Dependent Claim
107 words
79 . A method for delivering an instrument through an occlusion in a body lumen using a catheter comprising an expandable sheath extending along an outer surface of the catheter, comprising: introducing a distal end of the catheter into the body lumen proximal to the occlusion with the sheath in a contracted condition; advancing the distal end of the catheter through the occlusion until a distal end of the sheath is disposed distal to the occlusion; advancing an elongate member through the sheath until a distal end of the elongate member is disposed distal to the occlusion; and withdrawing the catheter and sheath from the body lumen.
Claim 84
Dependent Claim
107 words
79 . A method for delivering an instrument through an occlusion in a body lumen using a catheter comprising an expandable sheath extending along an outer surface of the catheter, comprising: introducing a distal end of the catheter into the body lumen proximal to the occlusion with the sheath in a contracted condition; advancing the distal end of the catheter through the occlusion until a distal end of the sheath is disposed distal to the occlusion; advancing an elongate member through the sheath until a distal end of the elongate member is disposed distal to the occlusion; and withdrawing the catheter and sheath from the body lumen.
Claim 85
Dependent Claim
35 words
80 . The method of claim 79 , wherein the elongate member comprises a guidewire, and wherein one or more instruments are advanced over the guidewire after the catheter is withdrawn to treat the occlusion.
Claim 86
Dependent Claim
29 words
81 . The method of claim 79 , wherein the distal end of the catheter comprises one or more elements for facilitating advancing the distal end through the occlusion.
Claim 87
Dependent Claim
29 words
82 . The method of claim 81 , wherein the one or more elements comprises at least one of an imaging element, a dissection element, and a steering element.
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