ADHESIVE COVER OCCLUDING DEVICE FOR ANEURYSM TREATMENT
The device includes a net portion for occluding an aneurysm neck and an adhesive to secure the net portion. The device can further include a channel orifice opening in the net portion, and an agent channel for delivering a rapid-curing agent through the orifice into the aneurysm. Devices can be delivered through a catheter to the aneurysm, the net can expand to occlude the aneurysm neck, and the net can be adhered to the aneurysm neck. In devices including a channel orifice and agent channel, the rapid-curing agent can be injected into the aneurysm. During injection of the rapid-curing agent, the net portion can create a barrier to inhibit the rapid-curing agent from exiting the aneurysm. After injection of the coagulation agent, portions of the treatment device, excluding the net portion, can be extracted from the patient.
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The present application is a continuation application of U.S. patent application Ser. No. 16/269,209 filed Feb. 6, 2019, the entire contents of which are hereby incorporated by reference.
FIELD OF INVENTIONThe present invention generally relates to medical instruments, and more particularly, to treatment devices for aneurysm therapy.
BACKGROUNDAneurysms can be complicated and difficult to treat. For example, treatment access can be limited or unavailable when an aneurysm is located proximate critical tissues. Such factors are of particular concern with cranial aneurysms due to the brain tissue surrounding cranial vessels and the corresponding limited treatment access.
Prior solutions have included endovascular treatment access whereby an internal volume of the aneurysm sac is removed or excluded from arterial blood pressure and flow. In this respect, because the interior walls of the aneurysm can continue being subjected to flow of blood and related pressure, aneurysm rupture remains possible.
Alternative to endovascular or other surgical approaches can include occlusive devices. Such devices have typically incorporated multiple embolic coils that are delivered to the vasculature using microcatheter delivery systems. For example, when treating cranial aneurysms, a delivery catheter with embolic coils is typically first inserted into non-cranial vasculature through a femoral artery in the hip or groin area. Thereafter, the catheter is guided to a location of interest within the cranium. The sac of the aneurysm can then be filled with the embolic material to create a thrombotic mass that protects the arterial walls from blood flow and related pressure. However, such occlusive devices do have certain shortcomings, including mass effect, which can cause compression on the brain and its nerves. Obtaining an embolic coil packing density sufficient to either occlude the aneurysm neck or fill the aneurysm sac is difficult and time consuming. Further, aneurysm morphology (e.g. wide neck, bifurcation, etc.) can require ancillary devices such a stents or balloons to support the coil mass and obtain the desired packing density. The coils and accompanying ancillary devices can remain in patients for their entire lives, and can apply damaging stressing forces to the aneurysm. Current embolic coil approaches can also involve the delivery of various coils into a coil mass. With each coil inserted, there is an increased risk for an adverse event. Therefore, there is an advantage to creating a system that does not require multiple products or coils to be inserted during one procedure. Additionally, embolic coils do not always effectively treat aneurysms as re-canalization of the aneurysm and/or coil compaction can occur over time.
One particular type of occlusive approach endeavors to deliver and treat the entrance or “neck” of the aneurysm as opposed to the volume of the aneurysm by implanting a device in the parent vessel of the aneurysm. In such “neck” approaches, by minimizing blood flow across the neck, a cessation of flow into the aneurysm can be achieved. In turn, a thrombotic mass can naturally form without having to deliver embolic materials into the aneurysm sac, as previously described. However, neck-occlusive approaches, such as implanting a flow impeding device in the parent vessel, are not without drawbacks. This type of approach can impede blood flow into peripheral blood vessels while blocking the aneurysm neck in the parent vessel. Impeding flow to the peripheral blood vessel can unintentionally lead to severe damage if the openings of the vessels are blocked.
Another type of occlusive approach is to use glues, adhesives, or other similar products (e.g., NBCA (N-butyl cyanoacrylate)) to obstruct blood flow to areas of the brain. However, these products, when inserted into cranial vessels alone, can move downstream and cause embolization in areas that are not desirable. It is therefore desirable to have a device which easily, accurately, and safely occludes a neck of an aneurysm or other arterio-venous malformation in a parent vessel and can maintain the placement of any glues or adhesives used without requiring the insertion of multiple products or blocking flow into peripheral vessels communicating with the parent vessel while minimizing applied forces to the aneurysm.
It is an aim of this invention to resolve these and other issues of the art.
SUMMARYDisclosed herein are various exemplary devices for treating an aneurysm with an adhesive cover treatment device. The devices can generally include a net portion for occluding an aneurysm neck and an adhesive to secure the net portion. The devices can further include a channel orifice opening in the net portion, and an agent channel for delivering a rapid-curing agent through the orifice into the aneurysm. Devices can be delivered through a catheter to the aneurysm, the net can expand to occlude the aneurysm neck, the net can be adhered to the aneurysm neck. In devices including a channel orifice and agent channel, the rapid-curing agent can be injected into the aneurysm. During injection of the rapid-curing agent, the net portion can create a barrier to inhibit the rapid-curing agent from exiting the aneurysm. After injection of the coagulation agent, portions of the treatment device, excluding the net portion, can be extracted from the patient.
An example treatment device for occluding an aneurysm can include a net portion that is expandable from a collapsed configuration to an occluding configuration and an adhesive for securing the net portion. The net portion in the occluding configuration can occlude an aneurysm neck to create a barrier between the aneurysm and a blood vessel. The adhesive can secure the net portion in its position in the occluding configuration near the aneurysm neck to prevent the net portion from dislodging and disrupting the barrier between the aneurysm and the blood vessel. When the barrier formed by the net portion is adhered in place, the aneurysm can self-embolize. The example device can be delivered to the aneurysm using a microcatheter.
The adhesive can be activated prior to or subsequent to the net portion reaching the occluding configuration, such as prior to delivery of the net portion to the aneurysm, upon delivery of the net portion to the aneurysm, when the net portion reaches the occluding configuration, or after the net portion reaches the occluding configuration.
An example device for occluding an aneurysm can further include a hypotube spanning at least a portion of the perimeter of the net portion that contains the adhesive in an uncured state. The hypotube can contain at least one hypotube orifice that exposes at least some of the adhesive in the uncured state to an environment outside the net portion. A curing channel can deliver a curing agent to the net portion to activate the adhesive from the uncured state. The adhesive can then adhere the net portion in the occluding configuration in its position occluding the aneurysm neck.
An example device can further include a delivery channel for delivering the adhesive to the net portion. The delivery channel can have a distal end connected to the net portion. The adhesive can be delivered to the net portion prior to or subsequent to the net portion reaching the occluding configuration, such as prior to delivery of the net portion to the aneurysm, upon delivery of the net portion to the aneurysm, when the net portion reaches the occluding configuration, or after the net portion reaches the occluding configuration.
An example device for occluding an aneurysm can further include a channel orifice and an agent channel. The channel orifice can define an opening in the net portion through which the rapid-curing agent can be injected. The channel orifice can open towards the aneurysm when the net portion is in the occluding configuration. The agent channel can be in communication with the channel orifice and can deliver the rapid-curing agent through the channel orifice into the aneurysm sac.
The agent channel can have a proximal end and a distal end. The distal end of the agent channel can communicate with the channel orifice to transfer the rapid-curing agent into the aneurysm sac. The proximal end of the agent channel can receive the rapid-curing agent. The channel orifice can also be an opening in the distal end of the agent channel, whereby a single opening functions as both the channel orifice and the distal end of the agent channel.
The example device can further include a trigger mechanism in communication with the proximal end of the agent channel. The trigger mechanism can communicate with the proximal end of the agent channel to receive the rapid-curing agent or introduce the rapid-curing agent into the agent channel. The trigger mechanism can facilitate delivery of the rapid-curing agent from the proximal end to the distal end of the agent channel, and then through the channel orifice into the aneurysm sac.
An example method for treating an aneurysm can include providing an exemplary treatment device which can include a net portion and an adhesive; delivering the exemplary treatment device to an aneurysm treatment site; expanding the net portion to an occluding configuration at an aneurysm neck to occlude at least a portion of the aneurysm neck to create a barrier between a blood vessel and the aneurysm; and adhering the net portion approximate to the aneurysm neck.
The method can further include inserting the adhesive in an uncured state into a hypotube spanning at least a portion of the perimeter of the net portion, where the hypotube contains at least one hypotube orifice exposing at least some of adhesive the environment outside the net portion; and delivering a curing agent to the net portion via a curing channel to activate the adhesive.
Another example method for treating an aneurysm can include providing an exemplary treatment device which can include a net portion, an adhesive, a channel orifice defining an opening in the net portion, and an agent channel; joining the agent channel to the channel orifice; delivering the exemplary treatment device to an aneurysm treatment site; expanding the net portion to an occluding configuration at an aneurysm neck to occlude at least a portion of the aneurysm neck to create a barrier between a blood vessel and the aneurysm to prevent a rapid-curing agent from entering the blood vessel; adhering the net portion approximate to the aneurysm neck; and delivering the rapid-curing agent through the agent channel, through the channel orifice, and into the aneurysm sac to coagulate the blood present in the aneurysm.
The method can further include providing a trigger mechanism; triggering the delivery of the agent by activating the trigger mechanism at a proximal end of the agent channel; and delivering the agent from the proximal end of the agent channel to a distal end of the agent channel.
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.
The descriptions contained herein are examples of the invention and are not intended in any way to limit the scope of the invention. In general, example devices described herein describe a treatment device that can be placed and adhered over the neck of an aneurysm to create a barrier between the vessel and the aneurysm. At least one rapid-curing agent can then be delivered into the aneurysm sac. The rapid-curing agent can coagulate the blood in the aneurysm instantly.
The example devices can include a net portion that can expand from a collapsed configuration to an occluding configuration in which the net portion in the occluding configuration is shaped to occlude an aneurysm neck. The net portion can be adhered in position to occlude the aneurysm neck. In the occluding configuration, the net portion can generally have a channel orifice working in connection with an agent channel that delivers a rapid-curing agent through the channel orifice and into the aneurysm sac.
It must 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. By “comprising” or “containing” or “including” it 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.
In describing examples, terminology will be 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 or system does not preclude the presence of additional components or intervening components between those components expressly identified.
Moving on to
In the occluding configuration, the net portion 102 can extend to the aneurysm wall 14, and the adhesive agent 108 can hold the net portion 102 in its position relative to the aneurysm wall 14 and aneurysm neck 12 such that the treatment device 100 doesn't become dislodged and therefore ineffective at inhibiting blood flow into the aneurysm 10. The net portion 102 can also provide a force against the aneurysm wall 14 to help maintain the occluding configuration of the net portion 102 and assist the adhesive agent 108 in adhering to the aneurysm wall 14. For example, the net portion 102 can be made of a memory shape material having a first, predetermined shape and a second, collapsed shape in the collapsed configuration. When the net portion 102 is in an occluding configuration within the aneurysm 10, the net portion 102 can move to a third, deployed shape that is based at least in part on the first, predetermined shape and the anatomical geometry of the aneurysm 10. In the example, the first, predetermined shape can be sized larger than the wall 14 within the aneurysm sac 16; the net portion 102 can move to extend to the wall 14; and the net portion 102 can provide a force against the wall 14 as the properties of the memory shape material cause the net portion 102 to attempt to open to the predetermined shape. This force can help the adhesive agent 108 adhere to the wall to maintain the position of the net portion 102. The net portion 102 in the occluding configuration can take the shape of the aneurysm neck 12 and/or interior walls 14 of the aneurysm near the aneurysm neck 12.
As shown in
As in
The device 100 can further have a curing channel 126 that can work in communication with the net portion 102. The curing channel 126 can have a distal end 126a in connection with net portion 102. The curing channel 126 can deliver a curing agent (as discussed above) to the net portion 102 of the device 100. The curing agent 126 can activate the uncured adhesive 108 in the net portion 102. The treatment device 100 in its entirety can be sized to fit within the lumen of a delivery catheter 400 when the net portion 102 is in the collapsed configuration.
Similar to
As in
Referring to a method 700 outlined in
Method 700 can further comprise the steps of inserting the adhesive in an uncured state into a hypotube spanning at least a portion of the perimeter of the net portion, wherein the hypotube comprises at least one hypotube orifice exposing a portion of the adhesive in the uncured state to the environment outside the net portion, and delivering a curing agent to the net portion via a curing channel to activate the adhesive.
Referring to a method 800 outlined in
Method 800 can further comprise the steps of providing a trigger mechanism and triggering the delivery of the agent by activating the trigger mechanism at a proximal end of the agent channel to deliver the agent from the proximal end of the agent channel to a distal end of the agent channel.
It should be apparent to those skilled in the art that the present teachings cover devices with any possible combination of a net portion, adhesive, channel orifice, agent channel, hypotube, delivery channel, curing channel, and/or trigger mechanism. The descriptions contained herein are examples 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 device for occluding an aneurysm, including alternative geometries of elements and components described herein, utilizing any number of known means for braiding, knitting, weaving, or otherwise forming the net portion as is known in the art, utilizing any of numerous materials for each component or element (e.g. radiopaque materials, memory shape materials, etc.), utilizing additional components including components to deliver a treatment device to an aneurysm or eject an treatment device from a delivery catheter, or utilizing additional components to perform functions not described herein, for example. 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.
Claims
1. A treatment device for treating an aneurysm comprising:
- a net portion expandable from a collapsed configuration to an occluding configuration, the occluding configuration sized to extend across and occlude at least a portion of a neck of the aneurysm to create a barrier between a blood vessel and the aneurysm; and
- an adhesive circumscribing at least a portion of a perimeter of the net portion when the net portion is in the occluding configuration, the adhesive being positioned to contact with tissue approximate the aneurysm neck thereby securing the net portion in a position approximate the aneurysm neck; and
- an adhesive barrier configured to be removed to expose the adhesive agent.
2. The treatment device of claim 1, wherein the net portion in the collapsed configuration is sized to traverse through a lumen of a delivery catheter.
3. The treatment device of claim 1, wherein the adhesive barrier is removed to expose the adhesive agent located on at least a portion of the perimeter of the net portion subsequent to the net portion reaching the occluding configuration.
4. The treatment device of claim 1, wherein the adhesive barrier is removed to expose the adhesive agent located on at least a portion of the perimeter of the net portion prior to the net portion reaching the occluding configuration.
5. The treatment device of claim 1, wherein the adhesive barrier is removed to expose the adhesive agent located on at least a portion of the perimeter of the net portion upon delivery of the net portion to the aneurysm.
6. The treatment device of claim 2, wherein the adhesive barrier is removed to expose the adhesive agent located on at least a portion of the perimeter of the net portion upon exiting the delivery catheter.
7. The treatment device of claim 1 further comprising:
- a channel orifice defining an opening in the net portion, wherein in the occluding configuration the channel orifice is open to the aneurysm; and
- an agent channel in communication with the channel orifice delivering a rapid-curing agent to an aneurysm sac through the channel orifice.
8. The treatment device of claim 7 further comprising:
- a trigger mechanism for introducing the rapid-curing agent into the agent channel; wherein the agent channel comprises a proximal end in communication with the trigger mechanism to receive the rapid-curing agent into the agent channel and a distal end in communication with the channel orifice; and wherein the agent channel delivers the rapid-curing agent from the proximal end to the distal end and through the channel orifice into the sac of the aneurysm.
9. A method for treating an aneurysm comprising:
- providing a treatment device comprising a net portion, an adhesive circumscribing at least a portion of a perimeter of the net portion, and a removable adhesive barrier covering at least a portion of the adhesive;
- delivering the treatment device to an aneurysm treatment site;
- expanding the net portion to an occluding configuration approximate a center of an aneurysm neck, wherein the expanded net portion occludes at least a portion of the aneurysm neck to create a barrier between a blood vessel and the aneurysm;
- removing the adhesive barrier to expose a portion of the adhesive to tissue approximate the aneurysm neck prior to, during, or after the expansion step; and
- adhering the net portion approximate to the aneurysm neck by the adhesive.
10. The method of claim 9, wherein the net portion in the collapsed configuration is sized to traverse through a lumen of a delivery catheter.
11. The method of claim 9, wherein the adhesive barrier is removed to expose the adhesive agent located on at least a portion of the perimeter of the net portion subsequent to the net portion reaching the occluding configuration.
12. The method of claim 9, wherein the adhesive barrier is removed to expose the adhesive agent located on at least a portion of the perimeter of the net portion prior to the net portion reaching the occluding configuration.
13. The method of claim 9, wherein the adhesive barrier is removed to expose the adhesive agent located on at least a portion of the perimeter of the net portion upon delivery of the net portion to the aneurysm.
14. The method of claim 10, wherein the adhesive barrier is removed to expose the adhesive agent located on at least a portion of the perimeter of the net portion upon exiting the delivery catheter.
15. The method of claim 10 further comprising:
- introducing a rapid-curing agent through an agent channel to the aneurysm sac, the agent channel in communication with a channel orifice defining an opening in the net portion,
- wherein in the occluding configuration the channel orifice is open to the aneurysm.
16. The method of claim 15, wherein the treatment device further comprises:
- a trigger mechanism for introducing the rapid-curing agent into the agent channel; wherein the agent channel comprises a proximal end in communication with the trigger mechanism to receive the rapid-curing agent into the agent channel and a distal end in communication with the channel orifice; and wherein the agent channel delivers the rapid-curing agent from the proximal end to the distal end and through the channel orifice into the sac of the aneurysm.
17. A method for treating an aneurysm comprising:
- providing a treatment device comprising a net portion, an adhesive circumscribing at least a portion of a perimeter of the net portion when the net portion is in an occluding configuration, a removable adhesive barrier covering at least a portion of the adhesive, a channel orifice defining an opening in the net portion, and an agent channel;
- joining the agent channel with the channel orifice;
- delivering the treatment device to an aneurysm treatment site via a delivery catheter;
- expanding the net portion to the occluding configuration approximate a center of an aneurysm neck, wherein the expanded net portion occludes at least a portion of the aneurysm neck to create a barrier between a blood vessel and the aneurysm to prevent a rapid-curing agent from entering the blood vessel;
- adhering the net portion approximate to the aneurysm neck by removing the adhesive barrier such that the adhesive contacts tissue approximate the aneurysm neck prior to, during, or after the expansion step; and
- delivering the rapid-curing agent through the agent channel and the channel orifice into the aneurysm sac to coagulate the blood present in the aneurysm.
18. The method of claim 17, wherein the adhesive barrier is removed to expose the adhesive agent located on at least a portion of the perimeter of the net portion subsequent to the net portion reaching the occluding configuration.
19. The method of claim 17, wherein the adhesive barrier is removed to expose the adhesive agent located on at least a portion of the perimeter of the net portion prior to the net portion reaching the occluding configuration.
20. The method of claim 17, wherein the adhesive barrier is removed to expose the adhesive agent located on at least a portion of the perimeter of the net portion upon exiting the delivery catheter.
Type: Application
Filed: Sep 13, 2021
Publication Date: Dec 30, 2021
Applicant: DePuy Synthes Products, Inc. (Raynham, MA)
Inventor: Daniel SOLAUN (Miami, FL)
Application Number: 17/473,230