Patent Application
20210353298
The present invention relates generally to surgical devices and, more particularly, to surgical devices suitable for arterial occlusion.
Slowing a rate of blood loss for a severely injured patient is critical in saving that patient's life. Conventionally, slowing the rate of blood loss has been accomplished by limiting (or even stopping) the flow of blood through any major blood vessel leading to the site of blood loss. For medics in a battlefield or a first responder setting, slowing the loss of blood of a patient having significant lower body injury has been achieve by aortic occlusion—using a large aortic clamp that is inserted into the chest cavity via a large incision between the ribs. The goal of the aortic clamping procedure is to keep the patient's remaining blood circulating between the heart, lungs, and brain until bleeding below the aortic clamp is controlled and systemic circulation restored. By clamping the aorta, systemic circulation is excluded, causing an ischemia. Thus, the highly invasive maneuver of aortic clamping is often a “last ditch” effort, used only for the most injured patient having lost vital signs and are considered, practically, clinically dead.
Conventional balloon catheters used in endovascular surgery have recently been repurposed to fully occlude the aorta by inflation of the balloon and as an alternative to aortic clamping. This procedure, referred to as Resuscitative Endovascular Balloon Occlusion of the Aorta (“REBOA”), has the potential to achieve effective aortic occlusion with a lower rate of morbidity. Thus it is believed that REBOA may be used earlier in the clinical course of the bleeding patient as compared to the conventional aortic clamp procedure.
Because blood flow is restricted from tissues below the aortic occlusion, tissues of that region start to die due to lack of blood flow. Therefore, as soon as is feasible after successful use of aortic occlusion (whether by clamp or balloon) and loss of blood is controlled, the patient is “weaned” from full occlusion. Unfortunately, current, FDA-approved balloon catheters suitable for REBOA are capable of achieving only complete occlusion or no occlusion. Further complicating matters is that as the REBOA balloon is deflated to initiate flow, hemodynamic collapse is a possibility. Moreover, if patient size (height, weight, aortic diameter) requires the use of multiple REBOE balloons, then the risk of hemodynamic collapse occurs with deflation of each balloon.
Accordingly, there remains a need for medical devices configured to effectively and efficiently control endovascular occlusion of arteries in both the trauma setting and the clinical setting.
The present invention overcomes the foregoing problems and other shortcomings, drawbacks, and challenges of conventional endovascular occlusion devices. While the invention will be described in connection with certain embodiments, it will be understood that the invention is not limited to these embodiments. To the contrary, this invention includes all alternatives, modifications, and equivalents as may be included within the spirit and scope of the present invention.
According to one embodiment of the present invention, an endovascular occlusion device has a balloon and a catheter. The catheter has a distal end, a proximal end, and a lumen extending therebetween. The balloon is positioned proximate to the distal end of the catheter and has a deflated state and an inflated state. The catheter further includes a plurality of ports proximate to a proximal end of the balloon. Each port extends through a wall of the catheter such that surface of the catheter is in fluid communication with the lumen of the catheter. A flow restrictor is positioned within, and is in sliding relation with, the lumen of the catheter. Movement of the flow restrictor is configured to close one or more ports of the plurality so as to limit blood flow through the lumen of the catheter.
In other embodiments of the present invention, an endovascular occlusion device includes a first balloon and a second balloon. Each of the first and second balloons has a distal end, a proximal end, and a lumen extending therebetween. The first and second balloons each also have a deflated state and an inflated state. When the second balloon is in the inflated state, blood flow through the lumen of the first balloon is restricted. When the second balloon is in the deflated state, blood may flow through the lumen of the first balloon.
Still other embodiments of the present invention include an endovascular occlusion device having a first balloon, a second balloon, and an inflatable plug. The first balloon has a distal end, a proximal end, and a lumen extending therebetween; the first balloon has a deflated state and an inflated state. The second balloon has a distal end, a proximal end, and a lumen extending therebetween; the second balloon is coaxial with the first balloon and has a deflated state and an inflated state. The inflatable plug has a distal end and a proximal end; the inflatable plug is coaxial with the first and second balloons and has a deflated state and an inflated state. When the inflatable plug is in the inflated state, the inflatable plug forms a seal with the second balloon.
Yet other embodiments of the present invention include an endovascular occlusion device having a first balloon and a second balloon. The first balloon has a distal end and a proximal end; the first balloon also has a deflated state and an inflated state. A channel extends between the distal and proximal ends of the first balloon and radially inwardly from an outer surface of the first balloon. The channel has a first side and a second side. The second balloon has a distal end and a proximal end and is in juxtaposition with the channel of the first balloon. The second balloon has a deflated state and an inflated state. When the second balloon is in the inflated state, the second balloon moves the first and second sides of the channel in opposing directions so as to open the channel.
Additional objects, advantages, and novel features of the invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art upon examination of the following or may be learned by practice of the invention. The objects and advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present invention and, together with a general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.
It should be understood that the appended drawings are not necessarily to scale, presenting a somewhat simplified representation of various features illustrative of the basic principles of the invention. The specific design features of the sequence of operations as disclosed herein, including, for example, specific dimensions, orientations, locations, and shapes of various illustrated components, will be determined in part by the particular intended application and use environment. Certain features of the illustrated embodiments have been enlarged or distorted relative to others to facilitate visualization and clear understanding. In particular, thin features may be thickened, for example, for clarity or illustration.
Referring now to the figures, and in particular to
The method begins with the surgeon making a primary incision site 102 in the patient 104 that is substantially near a superficial vein. A suitable superficial vein for the primary incision site 102 can include a peripheral vein, on either of the right or left sides of the patient 104, such as the left or right femoral artery 106, 108, or others known by one skilled in the art. Similar veins or locations on the left side of the body could also be used.
The surgeon may then direct a guidewire 110 (for example, a 0.025 in guidewire) into the primary incision site 102, within the right femoral artery 108, superiorly through the common iliac artery 112, and up the abdominal aorta 114 to a desired location and site for occlusion (hereafter, the “occlusion site”). With the guidewire 110 suitably positioned, the endovascular occlusion device 100 may be back-loaded over the guidewire 110 and advanced to the location of occlusion.
The endovascular occlusion device 100, as shown in
As shown with greater detail in
The first balloon 128 may be constructed of a compliant or noncompliant material, such as Nylon-11, Nylon-12, polyurethane, polybutylene terephthalate (“PBT”), PEBAX (a brand of thermoplastic elastomer), or polyethylene terephthalate (“PET”), such that when the first balloon 128 is fully inflated an outer surface 146 of the first balloon 128 contacts an inner wall 148 of the artery to be occluded (illustrated in FIG. abdominal aorta 114 in
The second balloon 130 may be constructed of a compliant material, such as those provided above with respect to the first balloon 128, such that when the second balloon 130 is fully inflated an outer surface 150 of the second balloon 130 contacts the lumen 136 of the first balloon 128.
The third balloon 132 may be constructed of a compliant material, such as those provided above with respect to the first balloon 128, such that when the third balloon 132 is fully inflated an outer surface 152 of the third balloon 132 contacts the lumen 134 of the second balloon 130.
In use, and with reference now to
With specific reference to
Finally, in
While not specifically illustrate, deflation and removal of the occlusion device 100 may occur in a manner that is generally the reverse of the illustrative inflation method.
Provided the three balloons 128, 130, 132 of the balloon portion 118 of the occlusion device 100, flow rate of blood along the vessel to be occluded may be controlled with particularity. For example, flow may range from full occlusion, 150 mL/min, 300 mL/min, 500 mL/min, to full flow depending on a degree of inflation of the second and third balloons 130, 132. Such finer control and management of blood flow overcomes several of the deficiencies of conventional devices that fail to offer such functionality.
Turning now to
The first and second balloons 176, 178, although not explicitly illustrated here, may be coupled together such that the second balloon 178 is secured within the lumen 180 of the first balloon 176 and such that the first and second balloons 176, 178 move in concert.
The inflatable plug 174 is configure to deflate (shown in
According to some embodiments of the present invention, the inflatable plug 174 is physically separated from the first and second balloons 176, 178 such that the inflatable plug 174 and be advanced to the occlusion site sequentially before or sequentially after advancing the first and second balloon 176, 178 to the occlusion site. Alternatively, according to other embodiments of the present invention, the inflatable plug 174 with the first and second balloons 176, 178, forming a conjoined unit that is advanced to the occlusion site as a singular device.
Turning now to
With the guidewire 110 in place, the first and second balloons 176, 178 may be advanced over the guidewire 110 to the occlusion site and inflated such that an outer surface 192 of the first balloon 176 contacts the inner wall 148 of the abdominal aorta 114, thereby securing the first and second balloons 176, 178 within the lumen 154 of the abdominal aorta 114.
While maintaining a position of the first and second balloons 176, 178, the inflatable plug 174 may be advanced over the guidewire 110 to the occlusion site but proximal to the inflated first and second balloon 176, 178. The inflatable plug 176 may then be inflated (as shown in
In
While maintaining this position of the first and second balloons 176, 178, the inflatable plug 174 may be advanced over the guidewire 110 to the occlusion site and through the lumen 188 of the second balloon 178, as represented by a direction of an arrow 200 in
Turning now to
The occluding balloon 224 includes a channel 232 extending a portion of the length thereof and radially inwardly from the outer surface 230 toward the catheter 228. Sides 234, 236 of the channel 232 may include, be constructed of, or incorporate a non-compliant material configured to provide a degree of rigidity to the channel 232.
A non-compliant balloon 238 is positioned within the channel of the occluding balloon 224. A length of the non-compliant balloon 238 may, although not required, be substantially similar to a length of the channel 232 and is configured such that an outer surface 240, with inflation, moves from a minimum diameter to a diameter sufficient to force the sides 234, 236 of the channel 232 to move in opposing directions such that the non-compliant balloon 238 operates as a wedge within the channel 232.
While not required, and not explicitly illustrated herein, the non-compliant balloon 238 may be coupled to the occluding balloon 224 such that the non-compliant balloon 238 and the occluding balloon 224 are more easily movable as a singular unit.
In use, as shown in
When blood flow is desired or necessary, as illustrated in
Turning now to
The second balloon 258 is positioned within a lumen 264 of the stent 256 and may be constructed from a non-compliant material so as to facilitate deploying of the stent 256 within the lumen 260 of the first balloon 254.
A removably coupled shaft 266, as specifically shown in
A catheter hub 268 extends proximally away from the occluding portion 250 and is configured to support an inflation line 270 for the first balloon 254, control wires 272 operably coupled to the stent 256, an inflation line 276 for the second balloon 258, and the shaft 266 for receiving the guidewire 110 (
Referring to
Referring now to
With the guidewire 110 in place, the endovascular occlusion device 252 may be back-loaded and advanced over the guidewire 110 to the occlusion site. As shown in
In
When the endovascular occlusion device of
Because of the number of catheters 254, 258, stents 256, control wires 272, and shafts 266 associated with the endovascular occlusion device 252 of
As illustrated, the hubs 286, 288 may be arranged in series to minimize an overall diameter of the control handle. More particularly, a primary port 290 may be centrally disposed and is configured to provide a primary supply of inflation fluids, for example.
Turning now to
The flow port catheter 304, proximal to the balloon 306, includes a plurality of ports 314 extending from a surface 316 to a lumen 318 of the catheter 304 to provide fluid communication therebetween. In a similar manner, the distal tip 310 of the flow port catheter 304 may include at least one port 320 that also extends from the surface 312 to the lumen 318 of the catheter 304.
While shown in
The balloon 306 may be constructed for a compliant or semi-compliant material and is configured to move from a deflated state to an inflated state. When in the inflated state, an outer surface 322 of the balloon 306 may contact an inner wall of the vascular in which it is positioned.
A flow restrictor 324 is disposed within the lumen 318 of the flow port catheter 304 and is in sliding relation thereto. The flow restrictor 324 may be constructed from a non-compliant material and has a length that is sufficient to extend over all ports 314 proximal to the balloon 306 but is also sufficiently shortened such that the flow restrictor 324 may be advance distally within the lumen of the flow port catheter 304 to expose one or more of the ports 314.
The flow restrictor 324 may include a lumen 326 configured to receive and move in sliding relation to a guidewire 110 (
In the particular illustrative embodiment of
Referring now to
With the guidewire 110 in place, the endovascular occlusion device 302 may be back-loaded and advanced over the guidewire 110 to the occlusion site. Once suitably positioned, the balloon may be inflated such that the outer surface 322 of the balloon 306 contacts the inner wall 148 of the abdominal aorta 114, thereby securing the occluding portion 300 within the lumen 154 of the abdominal aorta 114.
Use of the occluding portion 300 illustrated in
Retracting the flow restrictor 324 within the lumen 318 of the flow port catheter 304, as shown in
Use of occluding portion 300 illustrated in
When the flow restrictor 324 is advanced within the lumen of the flow port catheter 304, as shown in
During use of the occluding portion 300 illustrated in
While the laterally-deflected portion is shown to have a semi-circular shape, it would be readily understood by those having ordinary skill in the art and the benefit of the disclosure made herein that such illustrative shape need not be limiting.
Referring now to
A proximal tip 370 of the distal handle 352 is configured to receive a shaft 372, catheter, sheath, or other like device that is operably coupled to one of more surgical devices. For purposes of illustration herein, the surgical device is the occluding portion 300 of
As illustrated in
The graduated slide 380 may include indicia (illustrated as lines, with an enlarged view provided in
Further advancing of the flow restrictor 324 (
According to some embodiments, the indicia of the graduated slide 380 may indicate a distance advanced or retracted by the flow restrictor 324 (
While not specifically illustrated, one of ordinary skill in the art would understand that the threaded cap 382 and the threaded lumen 388 may be replaced with other known mechanical systems suitable for adjusting linear displacement. A suitable alternative may be, for example, a ratchet.
While not explicitly illustrated herein, one of more of the embodiments of the present invention described herein may incorporate additional tools that are conventionally used in endovascular procedures. For example, a delivery sheath may be use to enclose the endovascular occlusion device so as to facilitate delivery of the device to the occluding site. Such suitable delivery sheaths may include a 7-9 French sheath. Moreover, the guidewires may include any suitable or preferred guidewire type, whether a j-loop, coil, and so forth.
One or more pressure sensors may be used with endovascular occlusion devices according to any embodiment of the present invention described herein. The pressure sensors may be configured to communicate blood pressure, measured locally, to an external display. Such blood pressure information may assist the surgeon in making operational decisions. Additionally or alternatively, the blood pressure information may be processed by an external control devices so as to adjust flow restriction. For example, a rotary or stepper motor operably coupled to such external control devices may be operable to inflate/deflate balloons, reposition flow restrictors, advance/retract delivery sheaths, and so forth. The external control devices may also incorporate an algorithm configured to determine a physiological status of the patient given the blood pressure information with or without additional measurements.
While embodiments of the present invention were envisioned as fulfilling a need associated with the treatment of soldiers injured in the battlefield, embodiments of the present invention have applicability beyond the battlefield. Any patient having a significant risk of hemorrhage may benefit from use of an endovascular occlusion device as described according to various embodiments herein.
The following examples illustrate particular properties and advantages of some of the embodiments of the present invention. Furthermore, these are examples of reduction to practice of the present invention and confirmation that the principles described in the present invention are therefore valid but should not be construed as in any way limiting the scope of the invention.
A prototypical endovascular occlusion device similar to the embodiment illustrated in
Backpressure was evaluated using a pig model comprising a 12.7 mm ID×1.5 mm wall silicone tubing (aorta), a flow regulator downstream of the “aorta,” and two pressure gauges on opposing ends of the aorta. Table 1 summarizes measured flow measurements and backpressures:
Data of Table 1 are graphically illustrated in
The experiments were repeated with 40% glycerin and compared with the results for water. Table 2, below, summarizes the data. Data is also illustrated graphically in
As described herein, embodiments of the present invention provide endovascular occlusion while maintaining the ability to allow for controlled distal (anterograde) blood flow to varying degrees. The endovascular device described herein is configured to allow anterograde blood flow rates ranging from about 5% to about 10% of baseline blood flow, which ameliorate the deleterious effects of prolonged distal ischemia.
Endovascular occlusion devices configured to permit anterograde blood flow rates ranging from 5% to 10% of baseline blood flow are describe herein according to embodiments of the present invention. Permitting such anterograde flow during conventional endovascular occlusion procedures have been shown to ameliorate deleterious effects of prolonged distal ischemia. Such devices may provide minimally invasive procedures for treating non-compressible torso hemorrhage and shock.
While the present invention has been illustrated by a description of one or more embodiments thereof and while these embodiments have been described in considerable detail, they are not intended to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and method, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the scope of the general inventive concept.
This application is a continuation of U.S. application Ser. No. 16/305,991, filed 30 Nov. 2018, which was the U.S. National Stage Application of International Application No. PCT/US17/36023 filed Jun. 5, 2017, which claimed the benefit of and priority to prior filed co-pending Provisional Application Ser. No. 62/345,825, filed Jun. 5, 2016, and prior filed co-pending Provisional Application Ser. No. 62/365,155, filed Jul. 21, 2016. The disclosure of each of these applications is expressly incorporated herein by reference, each in its entirety.
The invention described herein may be manufactured and used by or for the Government of the United States for all governmental purposes without the payment of any royalty.
| Number | Date | Country | |
|---|---|---|---|
| 62345825 | Jun 2016 | US | |
| 62365155 | Jul 2016 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16305991 | Nov 2018 | US |
| Child | 17318549 | US |
