Aneurysm occluding device for use with coagulating agents

Devices can generally include a fan portion for occluding an aneurysm neck, a channel orifice opening in the fan portion, and an agent channel for delivering a coagulating agent through the orifice into the aneurysm. Devices can be delivered through a catheter to the aneurysm, the fan portion can expand to occlude the aneurysm neck, and coagulating agent can be injected into the aneurysm. During injection of the coagulating agent, the fan portion can inhibit the coagulating agent from exiting the aneurysm. After injection of the coagulation agent, the fan portion can collapse and the device can be extracted from the patient.

FIELD OF INVENTION

The present invention generally relates to medical instruments, and more particularly, to treatment devices for aneurysm therapy.

BACKGROUND

Aneurysms 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.

Alternatives 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 as 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. Additionally, embolic coils do not always effectively treat aneurysms as re-canalization of the aneurysm and/or coil compaction can occur over time. Many people who undergo aneurysm coil procedures also require a long period of dual antiplatelet therapy while the patient recovers post-procedure.

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, this approach also has its drawbacks, as the aneurysm does not undergo thromboses immediately, and there is still a risk of rupture post-surgery. Therefore, there is a need for a device capable of simplified and shortened implantation procedures that can quickly inhibit blood flow in an aneurysm to increase patient safety, reduce the length of the patient recovery period, and reduce the length of antiplatelet therapy administration.

It is an aim of this invention to resolve these and other issues of the art.

SUMMARY

Disclosed herein are various exemplary devices for treating an aneurysm with a coagulating agent. The devices can generally include a fan portion for occluding an aneurysm neck, a channel orifice opening in the fan portion, and an agent channel for delivering a coagulating agent through the orifice into the aneurysm. Devices can be delivered through a catheter to the aneurysm, the fan portion can expand to occlude the aneurysm neck, and the coagulating agent can be injected into the aneurysm. During injection of the coagulating agent, the fan portion can create a barrier to inhibit the coagulating agent from exiting the aneurysm. After injection of the coagulating agent, the fan portion can collapse and the device can be extracted from the patient.

An example device for occluding an aneurysm can include a fan portion that is expandable from a collapsed configuration to an occluding configuration, a channel orifice, and an agent channel. The fan portion in the occluding configuration can occlude an aneurysm neck to create a barrier between the aneurysm and a blood vessel. This barrier can prevent the coagulating agent from leaking into the blood vessel during and/or after delivery of the agent into the aneurysm sac. The fan portion can extend across and occlude at least a portion of the aneurysm neck or can completely occlude the aneurysm neck in the occluding configuration. The channel orifice can define an opening in the fan portion through which the coagulating agent can be injected. The agent channel can be in communication with the channel orifice and can deliver the coagulating agent through the channel orifice into the aneurysm sac.

The example device can be delivered to the aneurysm using a microcatheter. The fan portion can detach from its position near the aneurysm neck after the coagulating agent has been delivered to the aneurysm sac. In another example, the fan portion can be collapsed from the occluding configuration to an extraction configuration. This extraction configuration can be sized to fit inside a retrieval catheter.

The fan portion can consist of at least one elongated support. The elongated support can be connected to an occluding element. In some examples, the elongated support can have a first end and a second end. The first end of the elongated support can be positioned near the channel orifice in the fan portion. The second end of the elongated support can extend towards a wall of the aneurysm across at least a portion of the aneurysm neck to occlude the neck when the fan portion is expanded to the occluding configuration.

The fan portion can also be inflated to reach the occluding configuration. The device can include an inflation tube to inflate the fan portion to the occluding configuration. The inflation tube can have a distal end connected to the fan portion.

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 coagulating agent into the aneurysm sac. The proximal end of the agent channel can receive the coagulating 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 have 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 coagulating agent or introduce the coagulating agent into the agent channel. The trigger mechanism can facilitate delivery of the coagulating agent from the proximal end to the distal end of the agent channel, and then through the channel orifice into the aneurysm sac.

In another example, a delivery apparatus for treating an aneurysm can have an agent channel that can deliver a coagulating agent to an aneurysm sac. The agent channel can have a distal end and a proximal end. The proximal end of the agent channel can receive the coagulating agent and deliver the coagulating agent from the proximal end to the distal end of the agent channel. The distal end of the agent channel can communicate with a channel orifice in a fan portion and deliver the coagulating agent through the channel orifice into the aneurysm. The channel orifice can also be an opening in the distal end of the agent channel.

In the example apparatus, the fan portion can expand from a collapsed configuration to an occluding configuration. The fan portion in the occluding configuration can extend across and occlude a portion of an aneurysm neck to create a barrier between a blood vessel and the aneurysm. This barrier can prevent the delivered coagulating agent from entering the blood vessel and help retain the coagulating agent inside the aneurysm sac.

The fan portion can detach from its position near the aneurysm neck after the coagulating agent has been delivered to the aneurysm sac. The fan portion can collapse from the occluding configuration to an extraction configuration. This extraction configuration can be sized to fit inside a retrieval catheter.

The example apparatus can further comprise a trigger mechanism in communication with the proximal end of the agent channel for receiving the coagulating agent or introducing the coagulating agent into the agent channel.

An example method for treating an aneurysm can include providing an exemplary treatment device which can include a fan portion, a channel orifice defining an opening in the fan 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 fan portion to an occluding configuration approximate a center of an aneurysm neck wherein the expanded fan portion occludes at least a portion of the aneurysm neck; injecting a coagulating agent through the agent channel, through the channel orifice, and into the aneurysm sac to coagulate the blood present in the aneurysm; and collapsing the treatment device from the occluding configuration to an extraction configuration for extraction of the device after the injection of the coagulating agent.

The method can include the step of creating a barrier with the fan portion between a blood vessel and the aneurysm to prevent the coagulating agent from entering the blood vessel. The method can include removing the treatment device through a microcatheter or through a retrieval deployment system. The method can include treating an aneurysm with only a single implementation step.

The method can further include 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.

DETAILED DESCRIPTION

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 over the neck of an aneurysm to create a barrier between a vessel and the aneurysm. At least one coagulating agent can then delivered into the aneurysm sac. Delivery can be activated via trigger mechanism on the proximal end of the delivery system. The device can be held approximate the aneurysm neck at least until the coagulating agent is injected, and then can be retracted or detached from the aneurysm. The rapid coagulating agents can coagulate the blood in the aneurysm instantly. In some examples, the device can be removed via a microcatheter or deployed via a retrieval deployment system.

The example devices can include a fan portion that can expand from a collapsed configuration to an occluding configuration in which the fan portion in the occluding configuration is shaped to occlude an aneurysm neck from within an aneurysm sac. In the occluding configuration, the fan portion can generally have a channel orifice working in connection with an agent channel that delivers a coagulating 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.

Turning toFIG. 1, an example treatment device100is shown with the fan portion102in an occluding configuration approximate the neck12of an aneurysm10. The fan portion102can occlude the aneurysm10from inside the aneurysm sac16. The fan portion102in the occluding configuration can be sized to occlude at least a portion of the aneurysm neck12. The fan portion102in the occluding configuration can completely occlude the aneurysm neck12as depicted inFIG. 1. The fan portion102in the occluding configuration can occlude the neck12to create a barrier between a blood vessel106and the aneurysm10. The fan portion102can contain a channel orifice104. As illustrated, the channel orifice104can be located in the fan portion102such that the channel orifice104opens up to the aneurysm10. The channel orifice104can be centrally located in the fan portion102. The channel orifice can work in connection with an agent channel112.

FIGS. 2athrough 2fare illustrations of stages or steps that can occur during a treatment sequence of an exemplary treatment device100and delivery of a coagulating agent114to an aneurysm10. The coagulating agent114can be a drug based on replacement factors, vitamin K, antiplasmins or any other drugs known to those of skill in the art that can affect blood clotting. In some examples, a rapidly clotting drug can be effective. In addition, the drug needs to be deliverable through a torturous agent channel112.

FIG. 2ais an illustration of an example treatment device100wherein the fan portion102is shown in a collapsed delivery configuration inside a delivery catheter400, a channel orifice104positioned on a proximal end of the collapsed fan portion102, and an agent channel112attached to the channel orifice104. The fan portion102can be sized to fit within the lumen of a delivery catheter400when the fan portion102is in the collapsed configuration. The treatment device100in its entirety can be sized to fit within the lumen of a delivery catheter400when the fan portion102is in the collapsed configuration. When the fan portion102is in the collapsed configuration, the fan portion102can have sufficient flexibility to be delivered through the delivery catheter400, navigating torturous anatomical geometries, to be delivered to an aneurysm10(not shown). The agent channel112can have sufficient length to be accessible outside of the patient when the fan portion102reaches a treatment site. The fan portion102in the collapsed configuration can have a substantially tubular shape. The fan portion102can be comprised of at least one elongated support108. The example inFIG. 2ashows three elongated supports108comprising the fan portion102. An occluding element110can be attached to the one or more elongated supports108.

Moving on toFIG. 2b, the treatment device100can be delivered to an aneurysm10by sliding the device100distally when the fan portion102is in a collapsed configuration through a delivery catheter400. The treatment device100can be delivered to a treatment site through a blood vessel106.FIG. 2billustrates the treatment device100inside the delivery catheter400located near an aneurysm neck12.FIG. 2bfurther shows the fan portion102pushed partially out of the delivery catheter400for deployment inside the aneurysm sac16. The fan portion102can expand as it exits the delivery catheter400. The fan portion102can include a memory shape material such as Nitinol, a Nitinol alloy, a polymer memory shape material, or other memory shape material having properties for reshaping as described herein. The fan portion102can be in a deformed shape in the collapsed configuration and reshape based on a predetermined shape after exiting the delivery catheter400. As illustrated inFIG. 2b, each elongated support108of the fan portion102can have a first end108apositioned approximate the channel orifice104, and a second end108bextending from the first end108aacross at least a portion of the aneurysm neck12towards an aneurysm wall14. The second end108bcan extend towards the interior wall14of the aneurysm10upon expansion of the fan portion102. When each elongated support108expands, the elongated support108can in turn expand the connected occluding element110to occlude at least a portion of the aneurysm neck12. In another example, the occluding element110can expand upon discharge from the delivery catheter400and cause the second end108bof each connected elongated support108to move towards the aneurysm wall14.

FIG. 2cillustrates the example treatment device100wherein the fan portion102is in an occluding configuration in the aneurysm10. The fan portion102in the occluding configuration can be sized to occlude at least a portion of an aneurysm neck12. The fan portion102in the occluding configuration can completely occlude the aneurysm neck12as depicted inFIG. 2c. The fan portion102in the occluding configuration can occlude the neck12to create a barrier between a blood vessel106and the aneurysm10. As illustrated inFIG. 2c, the second end108bof the elongated support108can be in contact with the aneurysm wall14when the fan portion102is in the occluding configuration. In occluding configuration, the fan portion102can be capable of deflecting a blood flow from the aneurysm10, diverting a blood flow from the aneurysm10, slowing a blood flow into the aneurysm10, or any combination thereof.

In the occluding configuration, the fan portion102can extend to the aneurysm wall14, and the fan portion102can provide a force against the aneurysm wall14to maintain the expanded position of the fan portion102such that the treatment device100doesn't become dislodged and become ineffective at inhibiting blood flow into the aneurysm. The force of the fan portion102to the aneurysm wall14can be sufficient to maintain the position of the treatment device100within the aneurysm10. For example, the fan portion102can be made of a memory shape material having a first, predetermined shape and a second, collapsed shape in the collapsed configuration. When the fan portion102is in an occluding configuration within the aneurysm10, the fan portion102can move to a third, deployed shape that is based at least in part on the first, predetermined shape and the anatomical geometry of the aneurysm10. In the example, the first, predetermined shape can be sized larger than the wall14within the aneurysm sac16; the fan portion102can move to extend to the wall14; and the fan portion102can provide a force against the wall14as the properties of the memory shape material cause the fan portion102to attempt to open to the predetermined shape. The fan portion102in the occluding configuration can take the shape of the aneurysm neck12and/or interior walls14of the aneurysm near the aneurysm neck12.

FIG. 2dis an illustration of a cross-sectional view looking distally into the aneurysm10of an example treatment device100where the fan portion102is in the occluding configuration, such as the treatment device100depicted inFIG. 2c.

FIG. 2eillustrates the treatment device100wherein the fan portion102is in the occluding configuration. The channel orifice104in the fan portion102can work in connection with an agent channel112. The agent channel112can allow for the transfer of one or more coagulating agents114through the channel112to the channel orifice104. The coagulating agent114can include rapid coagulating agents, such as collagen, chitosan, kaolin, zeolite, or other agents having properties for coagulating as described herein. The agent channel112can have a distal end112aa proximal end (not shown). The distal end112aof the agent channel112can connect to the channel orifice104. The proximal end can receive the coagulating agent114into the agent channel112and deliver the coagulating agent114from the proximal end to the distal end112aconnected to the channel orifice104. The proximal end can be accessible outside of the patient for injection of the coagulating agent114into the patient. Coagulating agent114passing through the lumen of the agent channel112to the distal end112acan subsequently pass through the channel orifice104and into the aneurysm sac16upon reaching the distal end112aof the agent channel112. The distal end112aof the agent channel112can also be the channel orifice104of the fan portion102. The coagulating agent114can coagulate the blood inside the aneurysm10. The coagulating agent114can coagulate the blood inside the aneurysm10virtually instantaneously upon contacting the blood inside the aneurysm10according to the coagulation properties of the coagulating agent114.

As shown inFIG. 2f, once the coagulating agent114has been pumped into the aneurysm sac16, the treatment device100can be removed from the aneurysm10. The treatment device100can be removed once the coagulating agent114has coagulated the blood in the aneurysm10. The treatment device100can detach from its location approximate the aneurysm neck12after delivery of the coagulating agent114. As in the device shown inFIG. 2e, the occluding element110, the elongated supports108, or both the occluding element110and the elongated supports108can detach from their location approximate the aneurysm neck12after delivery of the coagulating agent114. In another example, the treatment device100can be removed via a retrieval deployment system. In another example, the fan portion102(not shown) can collapse from the occluding configuration to an extraction configuration after the coagulating agent114has been delivered to the aneurysm sac16. The extraction configuration can be sized to traverse through a lumen of a catheter (not shown). The aneurysm10, now filled with the coagulating agent114can now start to be reabsorbed into the blood vessel106through the body's natural healing process. This can avoid the need for permanently implanted elements in the patient.

FIGS. 3ato 3eare illustrations of stages or steps that can occur during another example implementation sequence of an exemplary treatment device100.FIG. 3aillustrates an example treatment device100comprising a fan portion102having a channel orifice104, an agent channel112connected to the channel orifice104at a distal end112aof the agent channel112, and an inflation tube118connected to the fan portion102. The fan portion102is shown in a collapsed delivery configuration inside a delivery catheter400. The fan portion102can be in connection with the inflation tube118which can inflate the fan portion102. The fan portion102can include at least one material used in neurovascular balloons, such as polyurethane or silicon. The inflation tube118can have a distal end118aconnected to the fan portion102.

FIG. 3billustrates the treatment device100inside the delivery catheter400with the fan portion102exiting the delivery catheter104for deployment inside a sac16of an aneurysm10. As shown inFIG. 3b, the fan portion102can be inflated to expand using the inflation tube118as it exits the delivery catheter400. The fan portion102can be completely removed from the delivery catheter400before inflation begins. Alternatively, inflation of the fan portion102can begin while the fan portion102is still entirely or partially inside the delivery catheter400. Inflation of the fan portion102can occur using saline or a variety of other elements known in the art with respect to inflating neurovascular balloons. As the fan portion102inflates, the outer surface of the fan portion102can expand towards the aneurysm wall14.

FIG. 3cillustrates the treatment device100wherein the fan portion102is in an occluding configuration in the aneurysm10. As illustrated inFIG. 3c, fan portion102can inflate to the extent that the fan portion102can be in contact with the aneurysm wall14when the fan portion102is in the occluding configuration.FIG. 3cillustrates the delivery of a coagulating agent114to the aneurysm sac16in the same manner as described inFIG. 2e.

FIG. 3dillustrates coagulation agent114delivered into the aneurysm sac16and a retrieval catheter500in place to extract the device100. The fan portion102can collapse from the occluding configuration to an extraction configuration after the coagulating agent114has been delivered to the aneurysm sac16. The extraction configuration can be sized to traverse through a lumen of the retrieval catheter500. The treatment device100can be extracted using the retrieval catheter500or a deployment and retrieval device. The delivery catheter400can also be the retrieval catheter500.FIG. 3eillustrates the aneurysm following extraction of the retrieval catheter500and the treatment device100. Once the coagulating agent114has been pumped into the aneurysm sac16, the fan portion102can detach from its location approximate the aneurysm neck12. The fan portion102can deflate from the occluding configuration to an extraction configuration after the coagulating agent114has been delivered to the aneurysm sac16.

FIGS. 4ato 4eare illustrations of stages or steps that can occur during another example implementation sequence of an exemplary treatment device100.FIG. 4ais an illustration of an example treatment device100including a fan portion102, a channel orifice104, an agent channel112, and a trigger mechanism116. The fan portion102is shown in a collapsed delivery configuration inside a delivery catheter400. The fan portion102can contain the channel orifice104that can be in communication with an agent channel112. The agent channel112can have a proximal end112bin communication with the trigger mechanism116. The proximal end112bof the agent channel112can receive the coagulating agent114into the agent channel112for delivery. The trigger mechanism116can facilitate the delivery of the coagulating agent to an aneurysm sac16(not shown).

FIG. 4billustrates the treatment device100inside the delivery catheter400with the fan portion102exiting the delivery catheter400for deployment inside the aneurysm sac16. As illustrated inFIGS. 4bto 4d, the treatment site can include an aneurysm10positioned adjacent bifurcated blood vessel branches and the treatment device100can be delivered to the aneurysm10through a stem branch106feeding the bifurcated blood vessel branches.

FIG. 4cillustrates the treatment device100wherein the fan portion102is in an occluding configuration in the aneurysm10. Upon the fan portion reaching the occluding configuration, the trigger mechanism116can facilitate the delivery of the coagulating agent114through the agent channel112to the aneurysm sac16. The trigger mechanism116can be operated to release the coagulating agent114by a physician, nurse, or other medical professional.FIG. 4dillustrates the delivery of a coagulating agent114to the aneurysm sac16in the same manner as described inFIG. 2e.FIG. 4eillustrates the aneurysm following extraction of the retrieval catheter500and the treatment device100.

FIG. 5is a flow diagram outlining example method steps that can be carried out during the administration of a treatment device100. The method steps can be implemented by any of the example means described herein or by any means that would be known to one of ordinary skill in the art.

Referring to a method500outlined inFIG. 5, in step510the treatment device having a fan portion, a channel orifice defining an opening in the fan portion, and an agent channel can be provided for administration to a patient. In step520, the agent channel can be joined to communicate with the channel orifice. In step530, the treatment device can be delivered to an aneurysm treatment site. In step540, the fan portion can be expanded to the occluding configuration approximate a center of an aneurysm neck. When the fan portion is expanded to the occluding configuration in step540, the fan portion can occlude at least a portion of an aneurysm neck. Step540can also create a barrier between a blood vessel and the aneurysm to prevent the coagulating agent from entering the blood vessel. In step550, the coagulating agent can be injected through the agent channel and the channel orifice into the aneurysm sac to coagulate the blood present in the aneurysm. In step560, the treatment device can be collapsed from the occluding configuration to the extraction configuration for extraction of the device after the injection of the coagulating agent. Method500can further comprise the step of treating an aneurysm with only a single implementation step.

FIG. 6is a flow diagram outlining further steps of method500. Method500can further comprise step562of removing the treatment device through a microcatheter.FIG. 7is a flow diagram outlining further steps of method500. Method500can further comprise step564of removing the treatment device through a retrieval system.FIG. 8is a flow diagram outlining further steps of method500. Method500can further comprise the steps of providing a trigger mechanism (step542) 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 (step544).

It should be apparent to those skilled in the art that the present teachings apply equally to the delivery apparatus100and treatment device100claimed herein. 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 fan 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, such as coagulating agents and deployment devices, 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.