IMPLANT DELIVERY SYSTEM WITH BRAID CUP FORMATION
20220304699 · 2022-09-29
Assignee
Inventors
Cpc classification
A61B2017/12054
HUMAN NECESSITIES
A61B2090/3966
HUMAN NECESSITIES
International classification
Abstract
An implant system presented herein includes an engagement wire, a pull wire, and a braided implant having a distal ring thereon. The engagement wire has an elongated member with a radially extending engagement feature at its distal end. The braid can be moved from a delivery shape sized to traverse a catheter to an implanted shape sized to occlude an aneurysm neck. When the braid is in the delivery shape, the pull wire and the elongated member extend through the distal ring and the engagement feature is in a distal direction in relation to the distal ring. Once at least a portion of the braid is positioned in the aneurysm, the pull wire and the elongated member can be moved in a proximal direction to engage the engagement feature to the distal ring and move the distal ring proximally, thereby reshaping the braid within the aneurysm.
Claims
1. A method for configuring an implant comprising a distal ring and a tubular braid for delivery, the method comprising: positioning the distal ring of approximate a distal end of the tubular braid; positioning an engagement feature to extend radially from a distal end of an elongated member; extending the elongated member though a lumen of the tubular braid and a lumen of the distal ring; extending a pull wire through the lumen of the tubular braid and the lumen of the distal ring such that the pull wire inhibits the engagement feature from passing through the lumen of the distal ring; retracting the engagement feature in a proximal direction to secure the implant within an aneurysm; retracting the pull wire in a proximal direction from the implant; retracting the engagement feature in a proximal direction from the implant such that the implant is disengaged from at least the pull wire and the engagement feature; and disengaging the implant from a delivery tube.
2. The method of claim 1, further comprising: positioning the implant with the elongated member and the pull wire therethrough within a delivery catheter such that the engagement feature is positioned in a distal direction in relation to the distal ring.
3. The method of claim 1, further comprising: attaching a proximal ring to a proximal end of the tubular braid; and extending the elongated member and the pull wire through a lumen of the proximal ring.
4. The method of claim 3, further comprising: attaching a detachment feature to the proximal ring; and detachably attaching the detachment feature to a delivery tube.
5. The method of claim 4, further comprising: positioning the detachment feature in a notch at a distal end of the delivery tube.
6. The method of claim 4, the method further comprising: attaching a loop wire to the delivery tube; extending the loop wire through an opening of the detachment feature; and extending at least the pull wire or an elongated member through an aperture of the loop wire.
7. The method of claim 3, further comprising: engaging a distal end of a hollow push rod to the proximal ring such that the hollow push rod is configured to disengage the proximal ring during treatment.
8. A method for positioning an implant, the method comprising: positioning the implant comprising a distal ring thereon within a delivery catheter; positioning a pull wire and an elongated member with an engagement feature thereon through a lumen of the distal ring such that the engagement feature is positioned in a distal direction in relation to the distal ring and such that the pull wire inhibits the engagement feature from passing through the lumen of the distal ring; extending the implant through a neck of an aneurysm; reshaping the implant within the aneurysm by retracting the elongated member while the pull wire is extended through the distal ring, causing the engagement feature to engage the distal ring and move the distal ring proximally; retracting the pull wire in a proximal direction from the implant; retracting the engagement feature in a proximal direction from the implant such that the implant is disengaged from at least the pull wire and the engagement feature; and disengaging the implant from a delivery tube.
9. The method of claim 8, further comprising: securing the implant within the aneurysm.
10. The method of claim 8, further comprising: engaging the delivery tube to the implant; positioning the delivery tube, the implant, the pull wire, and the elongated member within the delivery catheter; and moving the implant distally through the delivery catheter by pushing the delivery tube distally.
11. The method of claim 10, further comprising: disengaging the delivery tube from the implant by first retracting the pull wire and then the elongated member from an opening in a loop wire attached to the delivery tube thereby allowing the loop wire to disengage the implant.
12. The method of claim 8, further comprising: positioning the delivery tube in a proximal direction in relation to a proximal ring, the proximal ring disposed approximate a proximal end of the implant, wherein the delivery tube is a hollow push rod; positioning the pull wire and the elongated member within a lumen of the hollow push rod and within a lumen of the proximal ring; pushing the hollow push rod in a distal direction against the proximal ring, thereby moving the implant distally through the delivery catheter; maintaining the proximal ring within the delivery catheter while the implant is extended through the neck of the aneurysm and while the implant is reshaped by retracting the elongated member while the pull wire is extended through the distal ring; engaging the hollow push rod to the proximal ring while the implant is reshaped by retracting the elongated member while the pull wire is extended through the distal ring; retracting the pull wire in the proximal direction from the distal ring to remove the pull wire from the lumen of the distal ring; retracting the engagement feature in the proximal direction through the distal ring while the pull wire is removed from the distal ring; retracting the pull wire in the proximal direction through the proximal ring; retracting the engagement feature in the proximal direction through the proximal ring; and retracting the hollow push rod in the proximal direction, thereby disengaging the hollow push rod from the proximal ring.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] The above and further aspects of this invention are further discussed with reference to the following description in conjunction with the accompanying drawings, in which like numerals indicate like structural elements and features in various figures. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating principles of the invention. The figures depict one or more implementations of the inventive devices, by way of example only, not by way of limitation.
[0020]
[0021]
[0022]
[0023]
[0024]
[0025]
[0026]
[0027]
[0028]
DETAILED DESCRIPTION
[0029] In general, example systems described herein can include an implant having an expandable body with a distal ring thereon and a delivery system configured to position and shape the implant in an aneurysm. The implant can be a braid expandable from a deformed configuration in which the implant is shaped to be delivered through a microcatheter to an aneurysm treatment site to a deployed configuration in which the implant is shaped to occlude an aneurysm from within an aneurysm sac. The delivery system can include a pull wire and an engagement wire configured to pass though the lumen of the distal ring and the lumen of the braid. The pull wire and the engagement wire can be retracted in tandem to move the braid to a cup-shaped deployed configuration, thereby providing a mechanical means to adjust the implant within the sac. The engagement wire can have a bead or other such engagement feature at its distal end sized to pass through the collar, and the pull wire can be sized such that when both the pull wire and engagement wire are positioned through the lumen of the distal ring, the engagement feature is inhibited from passing through the distal ring. The system can also be configured such that the pull wire and/or engagement wire functions to mechanically release the implant from the delivery system.
[0030]
[0031] The braid 110 can be constructed from a shape memory alloy, for example, Nitinol or other suitable memory shape material. The braid 110 can have a pre-determined configuration, a deformed configuration, and a deployed configuration. The pre-determined configuration of the braid 110 is the configuration the braid 110 is trained to remember using, for example, via heat treatment. The pre-determined configuration can be a cup-like or a bowl-like shape. The deformed configuration of the braid 110 is the configuration the of the braid 110 while the braid 110 is within the guide catheter 310. In the deformed configuration, the braid 110 can be stretched into an elongated tube-like shape. The braid 110 can be moved from the pre-determined configuration to the deformed configuration so that the braid 110 is sized to traverse the catheter 310 to the aneurysm 10. The deployed configuration of the braid 110 can be based on the pre-determined configuration or a variant of the pre-determined configuration, for example, an asymmetric cup-like configuration. The deployed configuration can be a mutation of the pre-determined configuration, meaning as the braid 110 moves to return to the pre-determined configuration while within an aneurysm 10, it can contact and be constrained by a wall 14 of the aneurysm 10, thereby causing deviations in the pre-determined configuration and yielding the deployed configuration.
[0032] The delivery system 200, can have a delivery tube 210, a pull wire 220, and an engagement wire 230. The delivery system 200 can be used to position and deploy the implant 100 within an aneurysm 10. A guide catheter 310 can be used to provide a means to deliver the implant 100 to the aneurysm 10 and/or to assist in the positioning and deployment of the implant 100 within the aneurysm 10.
[0033]
[0034]
[0035]
[0036]
[0037] Referring collectively to
[0038] As illustrated in
[0039] The delivery tube 210 can be made of a biocompatible material, such as stainless steel. The tube 210 can be suitably sized for delivering and deploying the implant 100 to an aneurysm 10 as described herein.
[0040] As illustrated in
[0041] The loop wire 218 can be relatively small, having the thickness of a hair in some examples, so it can be preferred for the loop wire to be entirely shielded within the delivery tube 210 to prevent damage from accidental contact. The loop wire 218 can be an elongated wire that is bent to form an opening. Alternatively, the loop wire 218 can be a single elongated wire with an opening. The loop wire 218 can be formed from any number of materials, including nitinol and stainless steel.
[0042]
[0043]
[0044] As illustrated in
[0045] As illustrated in
[0046] The braid 110 can be include a memory shape material and can be heat-set or otherwise set to form the pre-determined shape. When deformed, the braid 110 can be activated to move to the pre-determined shape due to heat from contact blood or other bodily fluid. Alternatively, the braid 110 need not include memory shape material, and a delivery system 200 such as illustrated and described herein can be sufficient to move the braid 110 from the deformed shape as illustrated in
[0047] As illustrated in
[0048]
[0049] As illustrated in
[0050] As illustrated in
[0051]
[0052] As illustrated in
[0053] As illustrated in
[0054] Illustrations in the above-described figures depict generally hollow or delivery tubes 210 according to the present invention. When used herein, the terms “tubular” and “tube” are to be construed broadly and are not limited to a structure that is a right cylinder or strictly circumferential in cross-section or of a uniform cross-section throughout its length. For example, the tubular structure or system is generally illustrated as a substantially right cylindrical structure. However, the tubular system may have a tapered or curved outer surface without departing from the scope of the present invention.
[0055]
[0056] At block 802, an implant having a distal band can be positioned within a guide catheter. The distal band and guide catheter can be a distal band 124 and guide catheter 310 as presented herein, a variation thereof, or an alternative thereof as would otherwise be appreciated and understood by a person of ordinary skill in the art. In some examples, a delivery tube can also be positioned within the guide catheter, proximal to the implant. The delivery tube can be a delivery tube 210 as presented herein, a variation thereof, or alternative thereof as would be appreciated and understood by a person of ordinary skill in the art. The delivery tube, guide catheter, and implant can be positioned as presented herein or as otherwise would be appreciated and understood by a person of ordinary skill in the art. Additionally, or alternatively, the delivery tube can be a hollow push rod 320 as presented herein, a variation thereof, or an alternative as would be appreciated and understood by a person of ordinary skill in the art. In such an example, the hollow push rod can be positioned within the guide catheter, proximal to the implant as presented herein or otherwise positioned as would be appreciated and understood by a person of ordinary skill in the art.
[0057] At block 804 a pull wire and an engagement wire are extended through the aperture of the loop wire and the lumen of the proximal ring. The pull wire, engagement wire, loop wire, and proximal ring can each respectively be a pull wire 220, engagement wire 230, loop wire 218, and proximal ring 122 as presented herein, a variation thereof, or an alternative thereof as would be appreciated and understood by a person of ordinary skill in the art. In some examples, the engagement wire 230 can be extended through the aperture 218a of the loop wire 218 before the pull wire 220 can be extended through the aperture 218a of the loop wire 218. Alternatively, the engagement wire 230 can be extended through the lumen 126 of the proximal ring 122 before the pull wire 220 can be extended through the lumen 126 of the proximal ring 122. In some examples, the engagement wire 230 need not be extended through the aperture 218a of the loop wire 218. In some examples, the pull wire 220 need not be extended though the aperture 218a of the loop wire 218. In some examples, neither the pull wire 220 nor the engagement wire 230 is extended through aperture 218a of the loop wire 218 and the detachment feature 123 need not be present. The pull wire 220 and the engagement wire 230 can be extended through the lumen 125 of the braid 110. In some examples, the engagement wire 230 can be extended though the lumen 125 of the braid 110 before the pull wire 220 can be extended through the lumen 125 of the braid 110. The pull wire 220 and the engagement wire 230 are extended through the lumen 128 of the distal band 124. In some examples, the engagement wire 230 can be extended though the lumen 128 of the distal band 124 before the pull wire 220 can be extended through the lumen 128 of the distal band 124. The implant 100 with the pull wire 220 and the engagement wire 230 therethrough can be positioned within a delivery catheter 310 such that the engagement feature 238 can be positioned in the distal direction in relation to the distal band 124.
[0058] At block 806, the implant 100 can pass though the neck 16 of the aneurysm 10, to enter the aneurysm's sac 12 by pushing the implant 100 using either a hollow push rod 320 or a delivery tube 210. In some examples, the distal end of the hollow push rod 320 can engage the proximal band 122 of the implant 100 permitting the hollow push rod 320 to push the implant 100 into the sac 12 of the aneurysm 10. In some examples, the detachment feature 123 can be secured to the notch 216 of the delivery tube 210 via the loop wire 218, allowing the delivery tube 210 to push the implant 100 into the sac 12 of the aneurysm 10.
[0059] At block 808, the implant 100 can be reshaped within the sac 12 by retracting the engagement wire 230 in a proximal direction while the pull wire 220 remains extended though the lumen 128 of the distal band 124. This causes the distal band 124 to move in a proximal direction, thereby reshaping the braid 110.
[0060] At block 810, the pull wire 220 can be retracted through the lumen 128 of the distal ring 124, the lumen 125 of the braid 110, and the lumen 126 of the proximal band 122 in a proximal direction. In some examples the pull wire 220 can be retracted through the aperture 218a of the loop wire 218.
[0061] At block 812, the engagement wire 230 can be retracted through the lumen 128 of the distal band 124, the lumen 125 of the braid 110, and the lumen 126 of the proximal band 122 in a proximal direction. In some examples the engagement wire 230 can be retracted through the aperture 218a of the loop wire 218.
[0062] At block 814, the implant 100 can be disengaged from the delivery system 200 via the retraction of the delivery tube 210, resulting in loop wire 218 to fall out of the opening 123a of the detachment feature 123, and thus allowing the detachment feature 123 to detach from the notch 216 of the delivery tube 210. Alternatively, the hollow push rod 320 pushes the implant 100 out of the guide catheter 310 and into the sac 12 without the use of the detachment feature 123 or the loop wire 218.
[0063]
[0064] At block 902, a distal ring can be positioned along a central axis approximate the distal end of a tubular braid. The distal ring and tubular braid can each respectively be a distal ring 124 and tubular braid 110 as presented herein, a variation thereof, or an alternative thereof as would be appreciated and understood by a person of ordinary skill in the art. The distal ring 124 can be attached to the distal end 114 of the tubular braid 110.
[0065] At block 904, the delivery system can include an engagement wire comprising an engagement feature and elongated member, and the engagement feature can be positioned at the distal end of the elongated member. The engagement wire can be an engagement wire 230 as presented herein, a variation thereof, or an alternative thereof as would be appreciated and understood by a person of ordinary skill in the art. The engagement feature 238 can extend radially from a distal end 234 of the elongated member 236. The engagement feature can be formed by grinding, welding, gluing, or other means as would be appreciated and understood by a person of ordinary skill in the art. For instance, polymer or metal sleeves can be affixed to a portion of the core wire, the core wire can form the elongated member of the engagement wire, and the sleeves can be ground down to the desired shape to form the engagement feature. Alternatively, the engagement feature can be formed by creating a weld bead on the end of a core wire, the core wire forming the elongated member of the engagement wire.
[0066] At block 906, a proximal ring can be positioned at the proximal end of the braid. The proximal ring can be a proximal ring 122 as presented herein, a variation thereof, or an alternative thereof as would be appreciated and understood by a person of ordinary skill in the art. The proximal ring 122 can be attached to the proximal end 112 of the tubular braid 110. In some examples, a detachment feature such as a detachment feature 123 presented herein, variation thereof, or alternative thereof can be attached to the proximal ring 122.
[0067] At block 908, a pull wire 220 and the engagement wire 230 are extended through the aperture 218a of a loop wire 218 and the lumen 126 of the proximal ring 122. The pull wire and loop wire can each respectively be a pull wire 220 and loop wire 218 as presented herein, a variation thereof, or an alternative thereof as would be appreciated and understood by a person of ordinary skill in the art. The loop wire 218 can be affixed to a delivery tube such as a delivery tube 210 presented herein, variation thereof, or alternative thereof as would be appreciated and understood by a person of ordinary skill in the art. Extension of the loop wire 218 and/or pull wire 220 through the aperture 218a of the loop wire 218 can serve to releasably secure the implant 100 to the delivery tube 210. In an exemplary system, the engagement wire 230 can be extended through the aperture 218a of the loop wire 218 before the pull wire 220 can be extended through the aperture 218a of the loop wire 218. In another exemplary system, the engagement wire 230 can be extended through the lumen 126 of the proximal ring 122 before the pull wire 220 can be extended through the lumen 126 of the proximal ring 122. In yet another exemplary system, the engagement wire 230 need not extend through the aperture 218a of the loop wire 218. In still another exemplary system, the pull wire 220 need not extend though the aperture 218a of the loop wire 218. In still yet another exemplary system, neither the pull wire 220 nor the engagement wire 230 extend through aperture 218a of the loop wire 218 and the detachment feature 123 need not be present.
[0068] At block 910, the pull wire 220 and the engagement wire 230 are extended through the lumen 125 of the tubular braid 110. In an exemplary system, the engagement wire 230 can be extended though the lumen 125 of the tubular braid 110 before the pull wire 220 can be extended through the lumen 125 of the tubular braid 110.
[0069] At block 912, the pull wire 220 and the engagement wire 230 are extended through the lumen 128 of the distal ring 124. In an exemplary system, the engagement wire 230 can be extended though the lumen 128 of the distal ring 124 before the pull wire 220 can be extended through the lumen 128 of the distal ring 124.
[0070] At block 914, the implant 100 with the pull wire 220 and the engagement wire 230 therethrough can be positioned within a delivery catheter 310 such that the engagement feature 238 is positioned in the distal direction in relation to the distal ring 124.
[0071] At block 916, the implant 100 can be disengaged from the delivery system 200 via the retraction of the pull wire 220 and the engagement wire 230 from the lumen 128 of the distal ring 124, the lumen 125 of the tubular braid 110, and the lumen 126 of the proximal ring 122. In an exemplary system, at least one of the pull wire 220 or the engagement wire 230 can be retracted from the aperture 218a of the loop wire 218.
[0072] The descriptions contained herein are examples of embodiments of the invention and are not intended in any way to limit the scope of the invention. As described herein, the invention contemplates many variations and modifications of the implant system, including alternative geometries of elements and components described herein, alternative braid shapes, utilizing one or more of several means for braiding, knitting, weaving, or otherwise forming the braid, utilizing alternative materials for each component or element (e.g. radiopaque materials, memory shape materials, polymers, metals, etc.), utilizing additional components to perform functions described herein or not described herein. These modifications would be apparent to those having ordinary skill in the art to which this invention relates and are intended to be within the scope of the claims which follow.