Patent Application
20240341768
The present invention generally relates to implantable medical devices, and more particularly to implants to induce venous stasis.
Aneurysms can be intravascularly treated by delivering a treatment device to the aneurysm to fill the sac of the aneurysm with embolic material and/or block the neck of the aneurysm to inhibit blood flow into the aneurysm. When filling the aneurysm sac, the embolic material can promote blood clotting to create a thrombotic mass within the aneurysm. When treating the aneurysm neck without substantially filling the aneurysm sac, blood flow into the neck of the aneurysm can be inhibited to induce venous stasis in the aneurysm and facilitate natural formation of a thrombotic mass within the aneurysm.
In some current treatments, embolic coils are used to either fill the aneurysm sac or treat the entrance of the aneurysm neck. Embolic coils may be released or deployed by mechanical means with a delivery catheter and wire system. Many such catheter-based delivery systems include a wire for retention of the implant in the catheter until the time for release of the device. These systems are then actuated by retracting or pulling the wire relative to the catheter. Such a wire is sometimes referred to as a “pull wire”.
One issue with current catheter-based delivery systems is premature detachment of the implantable device. Premature detachment occurs when the implant is detached from the delivery system before reaching the treatment site. This may occur due to the tortuosity experienced by the delivery system as it passes through the vasculature of the patient, which can cause an increase in friction between the “pull wire” and the delivery system causing the pull wire to move proximally while the delivery system is moving distally.
Accordingly, there is a need for an improved implant delivery system that prevents premature detachment of the implant as it is delivered through tortuous vasculature. This disclosure is directed to this and other considerations.
In some examples, an apparatus for controlling movement of a wire configured to deploy an implant is disclosed. The apparatus can include a wire including a bump and a valve including a friction element configured to apply a friction force to the wire. The friction force can vary based on one or more of: a speed at which the wire is pulled through the friction element, a direction in which the wire is pulled through the friction element, and a contact between the bump and the friction element. The wire can be configured to deploy an implant upon a proximal retraction of the wire.
In some examples, a system for delivering an implant is disclosed. The system can include a delivery tube, a wire disposed in the delivery tube and configured to deploy an implant upon a proximal retraction of the wire, and a valve including a friction element configured to apply a friction force to the wire. The friction force can vary based on one or more of a speed at which the wire is pulled through the friction element, a direction in which the wire is pulled through the friction element, and a contact between the wire and the friction element. The delivery tube can include a distal spring portion, an intermediate flexible portion, and a proximal portion making up a majority of a length of the delivery tube.
In some examples, a method of deploying an implant is disclosed. The method can include positioning a distal end of a delivery tube while hindering a premature deployment of an implant and deploying the implant. Deploying the implant can include retracting a wire proximally by pulling the wire with a force greater than a minimum deployment force, the premature deployment of the implant being caused by proximal movement of a distal portion of the wire in relation to a delivery tube.
Other aspects and features of the present disclosure will become apparent to those skilled in the pertinent art, upon reviewing the following detailed description in conjunction with the accompanying figures.
The above and further aspects of this disclosure are further discussed with the following description of 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 disclosure. The figures depict one or more implementations of the inventive devices, by way of example only, not by way of limitation. It is expected that those of skill in the art can conceive of and combining elements from multiple figures to better suit the needs of the user.
The following detailed description is merely exemplary in nature and is not intended to limit the disclosure or the application and uses of the disclosure. Although the description of the disclosure is in many cases in the context of treatment of intracranial aneurysm, the disclosure may also be used in other body passageways as previously described.
The terms “distal” or “proximal” are used in the following description with respect to a position or direction relative to the treating physician. “Distal” or “distally” are a position distant from or in a direction away from the physician. “Proximal” or “proximally” or “proximate” are a position near or in a direction toward the physician.
As discussed herein, a “patient” or “subject” can be a human or any animal. It should be appreciated that an animal can be a variety of any applicable type, including, but not limited to, mammal, veterinarian animal, livestock animal or pet-type animal, etc. As an example, the animal can be a laboratory animal specifically selected to have certain characteristics similar to a human e.g., rat, dog, pig, monkey, or the like.
As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values±20% of the recited value, e.g., “about 90%” may refer to the range of values from 71% to 99%.
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.
By “comprising” or “containing” or “including” is meant that at least the named compound, element, particle, or method step is present in the composition or article or method, but does not exclude the presence of other compounds, materials, particles, method steps, even if the other such compounds, material, particles, method steps have the same function as what is named.
It must also be noted that, as used in the specification and the appended claims, the singular forms “a.” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Ranges can be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, other exemplary examples include from the one particular value and/or to the other particular value.
Reference is now made to
As shown in
The friction element 121 and bump 111 are sized relative to each other such that unless a deliberate proximal pull force Fp (see
The pull force Fp is also related to the compliance of friction element 121—if friction element 121 is made of a lower durometer material, the pull force Fp will be lower compared to if a higher durometer material were used.
Bump 111 can be tapered to facilitate a gradual increase in the resistance to proximally directed pulling force. Furthermore, the further that friction element 121 extends along the longitudinal axis L-L i.e. the longer friction element 121 is, the longer the user will have to apply pull force Fp over a greater distance longitudinally in order to deploy implant 200.
In any of the examples disclosed herein, wherein the friction force applied by the friction element 121 can vary based on one or more of: a speed at which the wire 110 is pulled through the friction element 121, a direction in which the wire 110 is pulled through the friction element 121, contact or lack thereof between the bump 111 and the friction element 121, and perforation design of the friction element 121.
Any of the previously described subcomponents of example apparatus 100, especially valve 120 and its constituent components and configurations, can be used in a system 300 for delivering an implant 200 as described below.
In any of the examples disclosed herein, flexible body 126 can be constructed of flexible materials such as biocompatible silicone, thermoplastic elastomers, or other flexible materials as appreciated by those skilled in the pertinent art. Flexible body 126 can include a high friction surface finish.
In some examples, a detachment feature 210 disposed on a proximal end 220 of the implantable coil 200 is configured to receive the wire 110, and the implantable coil 200 is deployed upon the proximal retraction of the wire 110 through the detachment feature 210. The implant 200 can be deployed upon proximal retraction of the wire 110 through a detachment feature 210. The detachment feature 210 can be disposed on a proximal end 220 of the implant 200 and configured to receive the wire 110.
In any of the examples described herein, valve 120 can be disposed in the delivery tube 310 proximate a proximal end 311b of the distal spring portion 311.
Additional details related to the detachment feature 210, wire 110, bump 111, and deployment of embolic coils more generally can be found in U.S. Pat. No. 11,253,265 and U.S. patent application Ser. No. 17/569,632 which are incorporated by reference as if set forth herein in entirety.
Also disclosed herein is a method 400 of deploying an implant. Generally, the method can include positioning step 402 a distal end of a delivery tube while hindering a premature deployment of an implant and deploying step 404 the implant, wherein deploying the implant can include retracting a wire proximally by pulling the wire with a force greater than a minimum deployment force, the premature deployment of the implant being caused by proximal movement of a distal portion of the wire in relation to a delivery tube.
In the example illustrated in
In some examples, applying friction can include providing via a piezoelectric element a resistance to a movement of the block from the first position to the second position, wherein the resistance hinders the movement of the block when the wire is pulled with a force less than the minimum deployment force.
In the example illustrated in
As will be appreciated, the method 400 just described can be varied in accordance with the various elements and implementations described herein. That is, methods in accordance with the disclosed technology can include all or some of the steps described above and/or can include additional steps not expressly disclosed above. Further, methods in accordance with the disclosed technology can include some, but not all, of a particular step described above. Further still, various methods described herein can be combined in full or in part. That is, methods in accordance with the disclosed technology can include at least some elements or steps of a first method and at least some elements or steps of a second method.
The disclosed technology described herein can be further understood according to the following clauses:
Clause 1: An apparatus controlling movement of a wire configured to deploy an implant, the apparatus comprising: a wire comprising a bump, wherein the wire is configured to deploy an implant upon a proximal retraction of the wire; and a valve comprising a friction element configured to apply a friction force to the wire, wherein the friction force varies based on one or more of: a speed at which the wire is pulled through the friction element, a direction in which the wire is pulled through the friction element, and a contact between the bump and the friction element.
Clause 2: The apparatus of Clause 1, and wherein the friction element comprises a block configured to move radially with respect to a longitudinal axis of the valve from a first position to a second position, wherein the block when in the first position hinders the wire from moving longitudinally in the valve, and wherein the block when in the second position allows the wire to move longitudinally in the valve.
Clause 3: The apparatus of Clause 2, wherein the friction element further comprises a piezoelectric element configured to resist a sudden movement of the block from the first position to the second position and to allow a gradual movement of the block from the first position to the second position.
Clause 4: The apparatus of Clause 2, wherein the friction element further comprises a piezoelectric element configured to allow a movement of the block from the first position to the second position when the wire is pulled with a force greater than a minimum deployment force.
Clause 5: The apparatus of Clause 1, wherein the friction element comprises a flexible body, the flexible body comprising a lumen disposed along a longitudinal axis in the valve, and wherein the lumen narrows from a proximal end to a distal end such that the bump does not engage the friction element at the proximal end and the bump does engage the friction element at the distal end.
Clause 6: The apparatus of Clause 1, wherein the implant is deployed upon the proximal retraction of the wire through a detachment feature, the detachment feature being disposed on a proximal end of the implant and configured to receive the wire.
Clause 7: The apparatus of Clause 1, wherein the friction element comprises a flexible body, the flexible body comprising a lumen disposed along a longitudinal axis of the valve, wherein the wire comprises a narrowed portion distal to the bump, and wherein the lumen is configured to allow the proximal retraction of the wire when the wire is pulled with a force greater than a minimum deployment force.
Clause 8: A system for delivering an implant, the system comprising: a delivery tube comprising: a distal spring portion; an intermediate flexible portion; and a proximal portion comprising a majority of a length of the delivery tube; a wire disposed in the delivery tube and configured to deploy an implant upon a proximal retraction of the wire; a valve comprising a friction element configured to apply a friction force to the wire, wherein the friction force varies based on one or more of: a speed at which the wire is pulled through the friction element, a direction in which the wire is pulled through the friction element, and a contact between the wire and the friction element.
Clause 9: The system of Clause 8, wherein the valve is disposed in the delivery tube proximate a proximal end of the distal spring portion.
Clause 10: The system of Clause 9, and wherein the friction element comprises a block configured to move radially with respect to a longitudinal axis of the valve from a first position to a second position, wherein the block when in the first position hinders the wire from moving longitudinally in the valve, and wherein the block when in the second position allows the wire to move longitudinally in the valve.
Clause 11: The system of Clause 10, wherein the friction element further comprises a piezoelectric element configured to resist a sudden movement of the block from the first position to the second position and to allow a gradual movement of the block from the first position to the second position.
Clause 12: The system of Clause 10, wherein the friction element further comprises a piezoelectric element configured to allow a movement of the block from the first position to the second position when the wire is pulled with a force greater than a minimum deployment force.
Clause 13: The system of Clause 9, wherein the friction element comprises a flexible body, the flexible body comprising a lumen disposed along a longitudinal axis in the valve, and wherein the lumen narrows from a proximal end to a distal end such that the wire does not engage the friction element at the proximal end and the wire does engage the friction element at the distal end.
Clause 14: The system of Clause 9, wherein the friction element comprises a flexible body, the flexible body comprising a lumen disposed along a longitudinal axis of the valve, and wherein the lumen is configured to allow the proximal retraction of the wire when the wire is pulled with a force greater than a minimum deployment force.
Clause 15: The system of Clause 8, further comprising an implantable coil disposed proximate a distal end of the distal spring portion, wherein the distal spring portion is configured to deploy the implantable coil distally upon the proximal retraction of the wire.
Clause 16: The system of Clause 15, further comprising a detachment feature disposed on a proximal end of the implantable coil and configured to receive the wire, wherein the implantable coil is deployed upon the proximal retraction of the wire through the detachment feature.
Clause 17: A method of deploying an implant, the method comprising: positioning a distal end of a delivery tube while hindering a premature deployment of an implant; and deploying the implant, wherein deploying the implant comprises retracting a wire proximally by pulling the wire with a force greater than a minimum deployment force, the premature deployment of the implant being caused by proximal movement of a distal portion of the wire in relation to a delivery tube.
Clause 18: The method of Clause 17, wherein hindering the premature deployment comprises: applying friction to the wire via a block disposed in a valve, wherein the block is configured to move radially with respect to a longitudinal axis of the delivery tube from a first position to a second position, wherein the block when in the first position hinders the wire from moving longitudinally in the delivery tube, and wherein the block when in the second position allows the wire to move longitudinally in the valve.
Clause 19: The method of Clause 18, wherein applying friction comprises providing via a piezoelectric element a resistance to a movement of the block from the first position to the second position, wherein the resistance hinders the movement of the block when the wire is pulled with a force less than the minimum deployment force.
Clause 20: The method of Clause 17, wherein hindering the premature deployment comprises: applying friction to the wire via a flexible body, wherein the wire passes through a lumen of the flexible body, the lumen configured to allow proximal retraction of the wire when the wire is pulled with a force greater than a minimum deployment force.
Other aspects and features of the present disclosure will become apparent to those of ordinary skill in the art, upon reviewing the detailed description in conjunction with the accompanying figures.
In describing examples, terminology is resorted to for the sake of clarity. It is intended that each term contemplates its broadest meaning as understood by those skilled in the art and includes all technical equivalents that operate in a similar manner to accomplish a similar purpose. It is also to be understood that the mention of one or more steps of a method does not preclude the presence of additional method steps or intervening method steps between those steps expressly identified. Steps of a method can be performed in a different order than those described herein without departing from the scope of the disclosed technology. Similarly, it is also to be understood that the mention of one or more components in a device, system, or assembly does not preclude the presence of additional components or intervening components between those components expressly identified.
The descriptions contained herein are examples of the disclosure and are not intended in any way to limit the scope of the disclosure. While particular examples of the present disclosure are described, various modifications to devices and methods can be made without departing from the scope and spirit of the disclosure. For example, while the examples described herein refer to particular components, the disclosure includes other examples utilizing various combinations of components to achieve a described functionality, utilizing alternative materials to achieve a described functionality, combining components from the various examples, combining components from the various example with known components, etc. The disclosure contemplates substitutions of component parts illustrated herein with other well-known and commercially available products. To those having ordinary skill in the art to which this disclosure relates, these modifications are often apparent and are intended to be within the scope of the claims which follow.
