PATCH DEPLOYMENT DEVICE
20220346805 · 2022-11-03
Inventors
- Alejandro Aranda Gil (Barcelona, ES)
- Andres-Amador Garcia Granada (Barcelona, ES)
- Jordi Martorell Lopez (Barcelona, ES)
- Vicente Riambau Alonso (Barcelona, ES)
Cpc classification
A61B17/0057
HUMAN NECESSITIES
A61F2/0063
HUMAN NECESSITIES
A61B2017/0053
HUMAN NECESSITIES
A61B2017/0061
HUMAN NECESSITIES
International classification
A61B17/12
HUMAN NECESSITIES
A61F2/00
HUMAN NECESSITIES
Abstract
The present invention provides a patch deployment device, the device comprising a pusher wire having a proximal end and a distal end; a plurality of deployment wires, wherein each deployment wire: has a first end and a second end, and the first end and the second end are connected to the distal end of the pusher wire; and is configured to be in an unexpanded state when positioned and constrained within a catheter, and configured to self-expand into an expanded state when positioned beyond a distal end of the catheter and not constrained, wherein in the expanded state at least a portion of the wire is positioned substantially within a plane that is substantially perpendicular to the longitudinal axis of the pusher wire and has an asymmetric form when viewed along a direction parallel to the longitudinal axis of the pusher wire.
Claims
1-41. (canceled)
42. A patch deployment device, the device comprising: a pusher wire having a proximal end and a distal end; a plurality of deployment wires, wherein each deployment wire: (i) has a first end and a second end, and the first end and the second end are connected to the distal end of the pusher wire; and (ii) is configured to be in an unexpanded state when positioned and constrained within a catheter, and configured to self-expand into an expanded state when positioned beyond a distal end of the catheter and not constrained, wherein in the expanded state at least a portion of the wire is positioned substantially within a plane that is substantially perpendicular to the longitudinal axis of the pusher wire and has an asymmetric form when viewed along a direction parallel to the longitudinal axis of the pusher wire.
43. The patch deployment device of claim 42, wherein the portion of the wire having an asymmetric form comprises a first curved portion and a second curved portion, wherein the first curved portion overlaps the second curved portion in a circumferential direction around the longitudinal axis of the pusher wire, and the first curved portion is convex and the second curved portion is concave, the first curved portion and the second curved portion being connected via a connecting portion.
44. The patch deployment device of claim 43, wherein the first curved portion comprises a minimum radius of curvature that is less than the minimum radius of curvature of the second curved portion.
45. The patch deployment device of claim 43, wherein the first curved portion comprises a minimum radius of curvature that is more than the minimum radius of curvature of the second curved portion.
46. The patch deployment device of claim 43, wherein each deployment wire of the plurality of deployment wires is arranged such that the first curved portion of the deployment wire overlaps the second curved portion of an adjacent deployment wire in a direction substantially parallel to the longitudinal axis of the pusher wire.
47. The patch deployment device of claim 42, wherein the at least a portion of each of the plurality of wires collectively form a patch applicator, wherein along a first direction that extends across the patch applicator when the plurality of deployment wires are in the expanded state, the distance of the patch applicator from a reference plane is substantially constant; and along a second direction that extends across the patch applicator when the plurality of deployment wires are in the expanded state, the distance of the patch applicator from the reference plane varies.
48. The patch deployment device of claim 47, wherein the reference plane is the plane perpendicular to the longitudinal axis of the pusher wire.
49. A patch deployment device, the device comprising: a pusher wire having a proximal end and a distal end; a plurality of deployment wires, wherein each deployment wire: (i) has a first end and a second end, and the first end and the second end are connected to the distal end of the pusher wire; and (ii) is configured to be in an unexpanded state when positioned and constrained within a catheter, and configured to self-expand into an expanded state when positioned beyond a distal end of the catheter and not constrained; wherein at least a portion of each of the plurality of wires collectively form a patch applicator, wherein along a first direction that extends across the patch applicator when the plurality of deployment wires are in the expanded state, the distance of the patch applicator from a reference plane, which is perpendicular to the longitudinal axis of the pusher wire, is substantially constant; and along a second direction that extends across the patch applicator when the plurality of deployment wires are in the expanded state, the distance of the patch applicator from the reference plane varies.
50. The patch deployment device of claim 49, wherein, in the expanded state, at least a portion of each of the plurality of wires has an asymmetric form when viewed along a direction parallel to the longitudinal axis of the pusher wire.
51. The patch deployment device of claim 49, wherein the first direction is perpendicular to the second direction.
52. The patch deployment device of claim 49, wherein, along the second direction, the distance of the patch applicator from the reference plane when the plurality of deployment wires are in the expanded state increases with increasing distance from the longitudinal axis of the pusher wire.
53. The patch deployment device of claim 49, wherein, when the plurality of deployment wires are in the expanded state, the patch applicator has a concave shape with respect to a point distal of the patch applicator.
54. The patch deployment device of claim 49, wherein when the plurality of deployment wires are in the expanded state, the patch applicator has a maximum diameter, D, and along the second direction, the distance of the patch applicator from the reference plane varies by more than 0.05 D.
55. The patch deployment device of claim 49, wherein when the plurality of deployment wires are in the expanded state, the patch applicator has a maximum diameter, D, and along the second direction, the distance of the patch applicator from the reference plane varies by less than 0.3 D.
56. The patch deployment device of claim 49, wherein the plurality of deployment wires when in the expanded state are arranged such that they collectively form a ring.
57. The patch deployment device of claim 56, wherein the plurality of wires when in the expanded state are arranged such that they collectively form a further ring, wherein the ring and the further ring are substantially concentric.
58. The patch deployment device of claim 49, wherein the plurality of deployment wires is movable from the unexpanded state within a catheter to the expanded state beyond the distal end of the catheter by moving the pusher wire.
59. The patch deployment device of claim 49, wherein each deployment wire of the plurality of deployment wires has the same form in the expanded state.
60. The patch deployment device of claim 49, wherein the plurality of deployment wires are arranged so as to be evenly distributed around the longitudinal axis of the pusher wire when in the expanded state.
61. The patch deployment device of claim 49, wherein the plurality of deployment wires comprises Nitinol.
62. The patch deployment device of claim 61, wherein the Nitinol has an austenite finish temperature of 28° C. or less.
63. The patch deployment device of claim 49, wherein the plurality of deployment wires comprises 20 deployment wires or fewer.
64. The patch deployment device of claim 49, wherein the plurality of deployment wires comprises 2 deployment wires or more.
65. The patch deployment device of claim 49, wherein the plurality of deployment wires comprises 8 deployment wires.
66. The patch deployment device of claim 49, wherein the plurality of deployment wires have a diameter of 0.127 mm or more.
67. The patch deployment device of claim 49, wherein the plurality of deployment wires have a diameter of 0.508 mm or less.
68. The patch deployment device of claim 49, wherein the plurality of deployment wires has a maximum diameter of 70 mm or less, when each deployment wire of the plurality of deployment wires is in the expanded state.
69. The patch deployment device of claim 49, wherein a further portion of each of the plurality of deployment wires is arranged along the longitudinal axis of the pusher wire such that at least 30% of the length of each of the plurality of deployment wires is arranged along the projection of the longitudinal axis of the pusher wire beyond the distal end of the pusher wire.
70. The patch deployment device of claim 49, wherein the catheter has a size of 30 Fr or less.
71. The patch deployment device of claim 49, wherein the catheter has a size of 6 Fr or greater.
72. The patch deployment device of claim 49, further comprising a patch releasably attached to the plurality of deployment wires.
73. The patch deployment device of claim 72, wherein the patch is attached to the plurality of deployment wires by a single thread, wherein the single thread is threaded through a plurality of loops associated with the patch.
74. The patch deployment device of claim 72, wherein the patch is bioabsorbable.
75. The patch deployment of claim 72, wherein the patch further comprises a bioabsorbable adhesive.
76. A patch deployment system, the system comprising: a pusher wire having a proximal end and a distal end; a plurality of deployment wires, wherein each deployment wire: (i) has a first end and a second end, and the first end and the second end are connected to the distal end of the pusher wire; and (ii) is configured to be in an unexpanded state when positioned and constrained within a catheter, and configured to self-expand into an expanded state when positioned beyond a distal end of the catheter and not constrained; a patch releasably attached to the plurality of deployment wires; wherein at least a portion of each of the plurality of wires collectively form a patch applicator, wherein along a first direction that extends across the patch applicator when the plurality of deployment wires are in the expanded state, the distance of the patch applicator from a reference plane, which is perpendicular to the longitudinal axis of the pusher wire, is substantially constant; and along a second direction that extends across the patch applicator when the plurality of deployment wires are in the expanded state, the distance of the patch applicator from the reference plane varies.
77. The patch deployment system of claim 76, wherein the pusher wire can be movably positioned within the catheter.
78. The patch deployment system of claim 77, further comprising a funnel for use when drawing the plurality of deployment wires into the catheter from the expanded state into the unexpanded state.
79. A method of applying a patch comprising the following steps: (i) providing the patch deployment device with the plurality of deployment wires in the unexpanded state within the catheter; (ii) inserting the catheter into a patient so as to position the distal end of the catheter at a patch application site; (iii) moving the pusher wire to move the plurality of deployment wires from the unexpanded state within the catheter to the expanded state beyond the distal end of the catheter; (iv) applying a patch to the patch application site; (v) releasing the patch from the plurality of deployment wires; (vi) moving the pusher wire to move the plurality of deployment wires from the expanded state to the unexpanded state; and (vii) removing the catheter from the patient; and wherein the patch deployment device comprises: a pusher wire having a proximal end and a distal end; a plurality of deployment wires, wherein each deployment wire: a) has a first end and a second end, and the first end and the second end are connected to the distal end of the pusher wire; b) is configured to be in an unexpanded state when positioned and constrained within a catheter, and configured to self-expand into an expanded state when positioned beyond a distal end of the catheter and not constrained; and c) the patch releasably attached to the plurality of deployment wires; wherein at least a portion of each of the plurality of wires collectively form a patch applicator, wherein along a first direction that extends across the patch applicator when the plurality of deployment wires are in the expanded state, the distance of the patch applicator from a reference plane, which is perpendicular to the longitudinal axis of the pusher wire, is substantially constant; and along a second direction that extends across the patch applicator when the plurality of deployment wires are in the expanded state, the distance of the patch applicator from the reference plane varies.
Description
[0078] The present invention will now be described with reference to the following figures.
[0079]
[0080]
[0081]
[0082]
[0083]
[0084]
[0085]
[0086]
[0087]
[0088]
[0089]
[0090]
[0091]
[0092]
[0093]
[0094]
[0095]
[0096]
[0097]
[0098]
[0099]
[0100]
[0101]
[0102] The expanded configuration of the deployment wires 8 is shown in greater detail in
[0103]
[0104]
[0105]
[0106] A procedure utilising the patch deployment device will now be described in relation to
[0107]
[0108]
[0109]
[0110]
[0111] The outer circle is a wire ring that has been collectively formed by plurality of deployment wires, specifically it has been formed collectively by the first curved portion 48 of each deployment wire. In addition, there is an inner wire ring that is collectively formed by the second curved portion 50 of each of the plurality of deployment wires. In this way, the overall arrangement provides two rings that can provide a continuous circumferential support. A patch can then be applied using the inner ring to support the outer periphery of a circular patch, while the outer ring can apply continuous pressure to the area around the patch application site, to hold the site in position during the application process and so improve the adhesion of the patch.
[0112]
[0113] An experiment was conducted to assess the effect of the patch applicator of
[0114] The present invention has been described with reference to specific embodiments. However, the invention is not limited by these specific embodiments and encompasses any subject matter within the scope of the following claims.
[0115] The following list of embodiments forms part of the description. [0116] 1. A patch deployment device, the device comprising [0117] a pusher wire having a proximal end and a distal end; [0118] a plurality of deployment wires, wherein each deployment wire: [0119] (i) has a first end and a second end, and the first end and the second end are connected to the distal end of the pusher wire; and [0120] (ii) is configured to be in an unexpanded state when positioned and constrained within a catheter, and configured to self-expand into an expanded state when positioned beyond a distal end of the catheter and not constrained, wherein in the expanded state at least a portion of the wire is positioned substantially within a plane that is substantially perpendicular to the longitudinal axis of the pusher wire and has an asymmetric form when viewed along a direction parallel to the longitudinal axis of the pusher wire. [0121] 2. The patch deployment device of embodiment 1, wherein the plurality of deployment wires is movable from the unexpanded state within a catheter to the expanded state beyond the distal end of the catheter by moving the pusher wire. [0122] 3. The patch deployment device of any preceding embodiment, wherein each deployment wire of the plurality of deployment wires has the same form in the expanded state. [0123] 4. The patch deployment device of any preceding embodiment, wherein the plurality of deployment wires are arranged so as to be evenly distributed around the longitudinal axis of the pusher wire when in the expanded state. [0124] 5. The patch deployment device of any preceding embodiment, wherein the portion of the wire having an asymmetric form comprises a first curved portion and a second curved portion, wherein the first curved portion overlaps the second curved portion in a circumferential direction around the longitudinal axis of the pusher wire, and the first curved portion is convex and the second curved portion is concave, the first curved portion and the second curved portion being connected via a connecting portion. [0125] 6. The patch deployment device of embodiment 5, wherein the first curved portion comprises a minimum radius of curvature that is less than the minimum radius of curvature of the second curved portion. [0126] 7. The patch deployment device of embodiment 5, wherein the first curved portion comprises a minimum radius of curvature that is more than the minimum radius of curvature of the second curved portion. [0127] 8. The patch deployment device of any one of embodiments 5 to 7, wherein each deployment wire of the plurality of deployment wires is arranged such that the first curved portion of the deployment wire overlaps the second curved portion of an adjacent deployment wire in a direction substantially parallel to the longitudinal axis of the pusher wire. [0128] 9. The patch deployment device of any preceding embodiment, wherein the plurality of deployment wires comprises Nitinol. [0129] 10. The patch deployment device of embodiment 9, wherein the Nitinol has an austenite finish temperature of 28° C. or less. [0130] 11. The patch deployment device of any preceding embodiment, wherein the plurality of deployment wires comprises 20 deployment wires or fewer. [0131] 12. The patch deployment device of any preceding embodiment, wherein the plurality of deployment wires comprises 2 deployment wires or more. [0132] 13. The patch deployment device of any preceding embodiment, wherein the plurality of deployment wires comprises 8 deployment wires. [0133] 14. The patch deployment device of any preceding embodiment, wherein the plurality of deployment wires have a diameter of 0.127 mm or more. [0134] 15. The patch deployment device of any preceding embodiment, wherein the plurality of deployment wires have a diameter of 0.508 mm or less. [0135] 16. The patch deployment device of any preceding embodiment, wherein the plurality of deployment wires has a maximum diameter of 35 mm or less, when each deployment wire of the plurality of deployment wires is in the expanded state. [0136] 17. The patch deployment device of any preceding embodiment, further comprising a patch releasably attached to the plurality of deployment wires. [0137] 18. The patch deployment device of embodiment 17, wherein the patch is attached to the plurality of deployment wires by a single thread, wherein the single thread is threaded through a plurality of loops associated with the patch. [0138] 19. The patch deployment device of any preceding embodiment, wherein the catheter has a size of 18 Fr or less. [0139] 20. The patch deployment device of any preceding embodiment, wherein the catheter has a size of 12 Fr or greater. [0140] 21. A patch deployment system, wherein the patch deployment system comprises [0141] the patch deployment device of any one of embodiments 1 to 16, or embodiments 19 or 20 when dependent on any one of embodiments 1 to 16; and [0142] a patch, wherein the patch is attachable to the patch deployment device. [0143] 22. The patch deployment system of embodiment 21, further comprising the catheter, wherein the pusher wire can be movably positioned within the catheter [0144] 23. A patch deployment system, the patch deployment system comprising [0145] the patch deployment device of embodiments 17 or 18, or embodiments 19 or 20 when dependent on embodiment 17 or 18; and [0146] the catheter, wherein the pusher wire can be movably positioned within the catheter. [0147] 24. A patch deployment system, the patch deployment system comprising [0148] the patch deployment device of any one of embodiments 1 to 16, or embodiments 19 or 20 when dependent on any one of embodiments 1 to 16; and [0149] the catheter, wherein the pusher wire can be movably positioned within the catheter. [0150] 25. The patch deployment system of embodiment 24, further comprising a patch, wherein the patch is attachable to the patch deployment device. [0151] 26. The patch deployment system of any one of embodiments 21 to 25, further comprising a funnel for use when drawing the plurality of deployment wires into the catheter from the expanded state into the unexpanded state. [0152] 27. The patch deployment device of embodiment 17 or 18, or embodiments 19 or 20 when dependent on embodiments 17 or 18, or the patch deployment system of any one of embodiments 21, 22, 23, or 25, or embodiment 26 when dependent on any one of embodiments 21, 22, 23, or 25, wherein the patch is bioabsorbable. [0153] 28. The patch deployment of embodiment 17, 18 or 27, or embodiments 19 or 20 when dependent on embodiments 17 or 18, or the patch deployment system of any one of embodiments 21, 22, 23, 25, or 27, or embodiment 26 when dependent on any one of embodiments 21, 22, 23, or 25, wherein the patch further comprises a bioabsorbable adhesive. [0154] 29. A method of applying a patch comprising the following steps: [0155] (i) providing the patch deployment device of embodiment 17 with the plurality of deployment wires in the unexpanded state within the catheter; [0156] (ii) inserting the catheter into a patient so as to position the distal end of the catheter at a patch application site; [0157] (iii) moving the pusher wire to move the plurality of deployment wires from the unexpanded state within the catheter to the expanded state beyond the distal end of the catheter; [0158] (iv) applying the patch to the patch application site; [0159] (v) releasing the patch from the plurality of deployment wires; [0160] (vi) moving the pusher wire to move the plurality of deployment wires from the expanded state to the unexpanded state; and removing the catheter from the patient.
[0161] A further list of embodiments that forms part of the description is given below [0162] 1. A patch deployment device, the device comprising [0163] a pusher wire having a proximal end and a distal end; [0164] a plurality of deployment wires, wherein each deployment wire: [0165] (i) has a first end and a second end, and the first end and the second end are connected to the distal end of the pusher wire; and [0166] (ii) is configured to be in an unexpanded state when positioned and constrained within a catheter, and configured to self-expand into an expanded state when positioned beyond a distal end of the catheter and not constrained, wherein in the expanded state at least a portion of the wire is positioned substantially within a plane that is substantially perpendicular to the longitudinal axis of the pusher wire and has an asymmetric form when viewed along a direction parallel to the longitudinal axis of the pusher wire. [0167] 2. The patch deployment device of embodiment 1, wherein the plurality of deployment wires is movable from the unexpanded state within a catheter to the expanded state beyond the distal end of the catheter by moving the pusher wire. [0168] 3. The patch deployment device of any preceding embodiment, wherein each deployment wire of the plurality of deployment wires has the same form in the expanded state. [0169] 4. The patch deployment device of any preceding embodiment, wherein the plurality of deployment wires are arranged so as to be evenly distributed around the longitudinal axis of the pusher wire when in the expanded state. [0170] 5. The patch deployment device of any preceding embodiment, wherein the portion of the wire having an asymmetric form comprises a first curved portion and a second curved portion, wherein the first curved portion overlaps the second curved portion in a circumferential direction around the longitudinal axis of the pusher wire, and the first curved portion is convex and the second curved portion is concave, the first curved portion and the second curved portion being connected via a connecting portion. [0171] 6. The patch deployment device of embodiment 5, wherein the first curved portion comprises a minimum radius of curvature that is less than the minimum radius of curvature of the second curved portion, or wherein the first curved portion comprises a minimum radius of curvature that is more than the minimum radius of curvature of the second curved portion. [0172] 7. The patch deployment device of embodiment 5 or embodiment 6, wherein each deployment wire of the plurality of deployment wires is arranged such that the first curved portion of the deployment wire overlaps the second curved portion of an adjacent deployment wire in a direction substantially parallel to the longitudinal axis of the pusher wire. [0173] 8. The patch deployment device of any preceding embodiment, wherein the plurality of deployment wires comprises Nitinol. [0174] 9. The patch deployment device of any preceding embodiment, wherein the plurality of deployment wires comprises 8 deployment wires. [0175] 10. The patch deployment device of any preceding embodiment, wherein the plurality of deployment wires have a diameter of from 0.127 mm to 0.508 mm. [0176] 11. The patch deployment device of any preceding embodiment, wherein the plurality of deployment wires has a maximum diameter of 35 mm or less when each deployment wire of the plurality of deployment wires is in the expanded state. [0177] 12. The patch deployment device of any preceding embodiment, further comprising a patch releasably attached to the plurality of deployment wires. [0178] 13. The patch deployment device of any preceding embodiment, wherein the catheter has a size of 18 Fr or less. [0179] 14. A patch deployment system, the patch deployment system comprising [0180] the patch deployment device of any preceding embodiment; and [0181] the catheter, wherein the pusher wire can be movably positioned within the catheter. [0182] 15. The patch deployment system of embodiment 14, further comprising a funnel for use when drawing the plurality of deployment wires into the catheter from the expanded state into the unexpanded state.