Vascular occlusion catheter for partial occlusion or full occlusion

Abstract

A vascular occlusion catheter system includes a single-use occlusion catheter and a remote and reusable electronic module. The catheter includes a proximal catheter shaft, a distal catheter shaft and an occlusion balloon interposed between the proximal and distal catheter shafts. A proximal catheter sensor is located on a proximal side of the occlusion balloon. A distal catheter sensor is located on a distal side of the occlusion balloon. An electronic proximal hub, having an electrical connector, is attached to, and in fluid communication with, a proximal end of the proximal catheter shaft. An inflation hub is in fluid communication with the proximal hub. The remote and reusable electronic module includes a display, a battery and a PCB, and is releasably electrically connectable to the proximal hub via the electrical connector.

Description

TITLE OF THE DISCLOSUREVASCULAR OCCLUSION CATHETER FOR PARTIAL OCCLUSION ORFULL OCCLUSIONCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority from similarly-titled U.S. Provisional Patent Application No. 63 / 610,449, filed on December 15, 2023, the entire contents of which are incorporated by reference herein.BACKGROUND OF THE DISCLOSURE

[0002] This disclosure relates to vascular occlusion catheters and, more particularly, to vascular occlusion catheters capable of performing both partial and full vascular occlusion.

[0003] Vascular occlusion may be indicated in either the venous system and / or the arterial system. Endoarterial occlusion, such as, resuscitative endovascular balloon occlusion of the aorta (“REBOA”), is a procedure in which a blood vessel is at least partially occluded in order to restrict blood flow upstream or downstream of the occlusion site for purposes of a vascular procedure or repair. Partial occlusion of the aorta is beneficial to mitigate the risk of ischemia below the site of the occlusion to limit or eliminate lack of blood flow to organs and tissue below the occlusion location. That is, partial perfusion past the occlusion balloon can provide the benefits of focusing or directing a majority of blood flow to the brain, heart and lungs or other upstream portions of the patient, but also potentially increasing the amount of time the occlusion balloon can be implanted in the patient, by providing at least partial blood flow to the patient’s organs downstream of the occlusion member, such as to the patient’s liver, digestive tract, kidneys and legs.

[0004] It would, therefore, be desirable to design, develop and implement a vascular occlusion catheter configured to perform partial and full occlusion.BRIEF SUMMARY OF THE DISCLOSURE

[0005] Briefly stated, one aspect of the present disclosure is directed to a vascular occlusion catheter system. The system includes a single-use occlusion catheter and a remote and reusable electronic module. The catheter includes a proximal catheter shaft, a distal catheter shaft and an occlusion balloon interposed between the proximal and distal catheter shafts. A proximal cathetersensor is located on a proximal side of the occlusion balloon. A distal catheter sensor is located on a distal side of the occlusion balloon. An electronic proximal hub, having an electrical connector, is attached to, and in fluid communication with, a proximal end of the proximal catheter shaft. An inflation hub is in fluid communication with the proximal hub. The remote and reusable electronic module includes a display, a battery and a PCB, and is releasably electrically connectable to the proximal hub via the electrical connector.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0006] The following description of embodiments of the disclosure will be better understood when read in conjunction with the appended drawings. It should be understood, however, that the disclosure is not limited to the precise arrangements and instrumentalities shown. In the drawings:

[0007] Fig. l is a partial, perspective view of a vascular occlusion catheter according to a first embodiment of the present disclosure;

[0008] Fig. 2 is another partial, perspective view of the occlusion catheter of Fig. 1;

[0009] Fig. 3 is an expanded, partial perspective view of the occlusion catheter of Fig. 2;

[0010] Fig. 4 is an expanded, partial perspective view of an alternative configuration of the occlusion catheter of Fig. 2;

[0011] Fig. 5 A is a schematic view of the occlusion catheter of Fig. 1, upon initial inflation in a target blood vessel;

[0012] Fig. 5B is a schematic view of the occlusion catheter of Fig. 1, when permitting a bolus volume of blood to flow past the catheter;

[0013] Fig. 6 is a partial, perspective view of a vascular occlusion catheter according to a second embodiment of the present disclosure;

[0014] Fig. 7 is another partial, perspective view of the occlusion catheter of Fig. 6;

[0015] Fig. 8A is a schematic view of the occlusion catheter of Fig. 6, upon initial inflation in a target blood vessel;

[0016] Fig. 8B is a schematic view of the occlusion catheter of Fig. 6, when permitting a bolus volume of blood to flow past the catheter;

[0017] Fig. 9 is a partial, elevational view of a vascular occlusion catheter according to a third embodiment of the present disclosure;

[0018] Fig. 10 is a partial, perspective view of the occlusion catheter of Fig. 9;

[0019] Fig. 11 is a partial, elevational view of an alternative configuration of the vascular occlusion catheter of Fig. 9;

[0020] Fig. 12 is a partial, perspective view of the occlusion catheter of Fig. 11;

[0021] Fig. 13 is a partial, elevational view of a vascular occlusion catheter according to a fourth embodiment of the present disclosure;

[0022] Fig. 14 is a partial, perspective view of a vascular occlusion catheter according to a fifth embodiment of the present disclosure;

[0023] Fig. 15 is a partial, cross-sectional view of the occlusion catheter of Fig. 14, taken along sectional line 15-15;

[0024] Fig. 16 is a partial, perspective view of an alternative configuration of the occlusion catheter of Fig. 14;

[0025] Fig. 17 is a partial, cross-sectional view of the occlusion catheter of Fig. 16, taken along sectional line 17-17;

[0026] Fig. 18 is a partial, perspective view of an alternative configuration of the occlusion catheter of Fig. 9;

[0027] Fig. 19 is a partial, perspective view of a vascular occlusion catheter according to a sixth embodiment of the present disclosure;

[0028] Fig. 20 is a partial, cross-sectional view of the occlusion catheter of Fig. 19, taken along sectional line 20-20;

[0029] Fig. 21 is a perspective view of an alternative configuration of an expandable member of the occlusion catheter of Fig. 19;

[0030] Fig. 22 is a schematic, elevational view of a vascular occlusion catheter according to a seventh embodiment of the present disclosure, in a tensioned state of the expandable member;

[0031] Fig. 23 is a schematic, elevational view of the occlusion catheter of Fig. 22, in a relaxed state of the expandable member;

[0032] Fig. 24 is a schematic, elevational view of a vascular occlusion catheter according to an eighth embodiment of the present disclosure, in a twisted, tensioned state of the expandable member;

[0033] Fig. 25 is a schematic, elevational view of a vascular occlusion catheter according to ninth embodiment of the present disclosure, the occlusion catheter being electrically connected with an external, electronic module;

[0034] Fig. 26 is a schematic, elevational view of an alternative configuration of the occlusion catheter of Fig. 25, the occlusion catheter being electrically connected with an external, controller;

[0035] Fig. 27 is a schematic, elevational view of a vascular occlusion catheter and an introducer sheath according to a tenth embodiment of the present disclosure;

[0036] Fig. 28, is an enlarged, partial elevational view of the occlusion catheter of Fig. 27 advanced through the accompanying introducer sheath of Fig. 27; and

[0037] Fig. 29 is a partial cross-sectional view of the occlusion catheter and introducer sheath of Fig. 28, taken along sections line 29-29 of Fig. 28.DETAILED DESCRIPTION OF THE DISCLOSURE

[0038] Certain terminology is used in the following description for convenience only and is not limiting. The terms “lower,” “bottom,” “upper”, “top”, “above” and “below” describe the orientation, or relative orientation, of various elements as they appear in the drawings to which reference is made. The terms “inwardly,” “outwardly,” “upwardly” and “downwardly” refer to directions toward and away from, respectively, the geometric center of the occlusion balloon catheter, and designated parts thereof, in accordance with the present disclosure. In describing the occlusion balloon catheter, the term proximal is used in relation to the end of the catheter closer to the user and the term distal is used in relation to the end of the device further from the user. Unless specifically set forth herein, the terms “a,” “an” and “the” are not limited to one element, but instead should be read as meaning “at least one.” The terminology includes the words noted above, derivatives thereof and words of similar import.

[0039] The term “coupled” and variations thereof, as used herein, means the joining of two members directly or indirectly to one another. Such joining may be stationary (e.g., permanent or fixed) or moveable (e.g., removable or releasable). Such joining may be achieved with the two members coupled directly to each other or with the two members coupled to each other using at least one intervening member, unless otherwise indicated. As one example, if the term “coupled” or variations thereof are modified by an additional term (e.g., directly coupled), the aforementioned, generic definition of “coupled” is modified by the plain language meaning of the additional term (e.g., “directly coupled” means the joining of two members without any separate intervening member) Such coupling may be mechanical, electrical, fluidic a combination thereof, or the like, unless otherwise indicated.

[0040] The term “or,” as used herein, is used in its inclusive sense (and not in its exclusive sense) so that when used to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is understood to convey that an element may be either X; Y; Z; X and Y; X and Z; Y and Z; or X, Y, and Z (i.e., any combination of X, Y, and Z including just one of them). Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y, and at least one of Z to each be present, unless otherwise indicated.

[0041] It should also be understood that the terms “about,” “approximately,” “generally,” “substantially” and like terms, used herein when referring to a dimension or characteristic of a component of the disclosure, indicate that the described dimension / characteristic is not a strict boundary or parameter and does not exclude insubstantial or inconsequential modification or alterations therefrom that are functionally similar, e.g., + / — 10%. At a minimum, such references that include a numerical parameter would include variations that, using mathematical and industrial principles accepted in the art e.g., rounding, measurement or other systematic errors, manufacturing tolerances, etc.), would not vary the least significant digit.

[0042] Referring to the drawings in detail, wherein like numerals indicate like elements throughout, there is shown in Figs. 1-5B an occlusion catheter, generally designated 10, in accordance with a first embodiment of the present disclosure. As shown, the catheter 10 includes a plurality of expandable members, such as occlusion balloons, positioned in series along the catheter 10. In the illustrated embodiment, the expandable member(s) takes the form of occlusion balloon(s), but the disclosure is not so limited. In the illustrated embodiment, the catheter 10 includes two occlusion balloons: a first occlusion balloon 12 and a distal occlusion balloon 14, but the disclosure is not so limited, as the catheter may include more than two balloons. The first occlusion balloon 12 is mounted between a proximal catheter shaft 16 and an intermediate catheter shaft 18. The second occlusion balloon 14 is mounted between the intermediate catheter shaft 18 and a distal catheter shaft 20.

[0043] As one non-limiting example, a proximal neck portion 12a of the first occlusion balloon 12 may be sealingly mounted (in a manner understood, e.g., bonding, welding, a combination thereof or the like) to the proximal catheter shaft 16. Similarly, a distal neck portion 12b of the first occlusion balloon 12 may be sealingly mounted (in a manner understood, e.g., bonding,welding, a combination thereof or the like) to the intermediate catheter shaft 18. Likewise, a proximal neck portion 14a of the second occlusion balloon 14 may be sealingly mounted to the intermediate catheter shaft 18, and a distal neck portion 14b of the second occlusion balloon 14 may be sealingly mounted to the distal catheter shaft 20. The distal catheter shaft 20 distally terminates in an atraumatic tip or a P-tip 22. In one configuration, the proximal, intermediate and distal catheter shafts 16, 18, 20 may be constructed of medical grade, biocompatible polymers, such as, for example, without limitation, silicone, nylon, polyurethane, PETE, latex, thermoplastic elastomers, poly ether block amides (e.g., PEBAX, Arkema, Paris, France), a combination thereof, or the like.

[0044] In one configuration, one, some or all of the occlusion balloons 12, 14 may take the form of compliant balloon(s). In the context of the present disclosure, a compliant balloon may have growth of approximately greater than twenty percent (20%+) within the working range (balloon pressure) when inflated, reaching up to approximately one hundred to three hundred percent (100-300%) within the working range when inflated. Conversely, a non-compliant or substantially non-compliant balloon generally has growth of approximately two to seven percent (2-7%) within the working range (balloon pressure) when inflated. A semi-compliant balloon has growth of approximately seven to twenty percent (7-20%) within the working range (balloon pressure) when inflated.

[0045] A central catheter shaft 24, i.e., a hypotube, extends through the proximal catheter shaft 16, the first occlusion balloon 12, the intermediate catheter shaft 18, the second occlusion balloon 14 and terminates in the distal catheter shaft 20 (as will be described in further detail below). The proximal catheter shaft 16 and the hypotube 24 may be secured at the respective proximal ends thereof to a proximal hub (not shown), e.g., to an internal frame thereof, such as, for example, as described in International Patent Application Publication No. WO 2022 / 197895 (“the ‘895 publication”), the entire contents of which are incorporated by reference herein in their entirety. The hypotube 24 forms the structural backbone / chassis of the catheter 10. Stated differently, the hypotube 24 forms the primary load-bearing framework of the catheter 10, advantageously eliminating the necessity for a separate guidewire to provide such load bearing stability. The hypotube 24 may be constructed of a metal, a metal alloy, a polymer, a combination thereof, e.g., composite braided shafts, or the like. Non-limiting examples of the hypotube 24 material include stainless steel, nitinol, plastic reinforced with fiberglass, Kevlar® owned by E.I. Du Pont DeNemours and Company, and / or nylon. Generally, the hypotube 24 forms the most elastic shaftcomponent of the occlusion catheter 10, such that the hypotube 24 substantially returns to its initial configuration after a load is applied thereon and subsequently withdrawn. Optionally, the hypotube 24 may be constructed of a super-elastic material (e.g., such as nitinol).

[0046] The proximal catheter shaft 16 includes an internal proximal shaft lumen 16a extending therethrough, in fluid communication with the inflation hub (not shown) on a proximal side thereof. The proximal shaft lumen 16a is in fluid communication with the first occlusion balloon 12 on a distal side of the lumen. As shown in Figs. 3 and 4, the proximal shaft lumen 16a may optionally bifurcate into multiple, e.g. two or more, lumens 16a at the distal end thereof, but the disclosure is not so limited, i.e., the proximal shaft lumen 16a may not bifurcate. The proximal shaft lumen 16a operates as an inflation lumen for the first balloon 12. In the configuration of Fig. 3, the first balloon 12 and the second balloon 14 are fluidly connected via at least one intermediate lumen 18a extending through the intermediate catheter shaft 18, i.e., fluidly connected with the first balloon 12 at a proximal end thereof and fluidly connected with the second balloon 14 at a distal end thereof. Accordingly, the proximal shaft lumen 16a is in fluid communication with both the first and second balloons 12, 14, thereby operating as the inflation lumen for both balloons 12, 14.

[0047] Alternatively, as shown in the configuration of Fig. 4, the first and second occlusion balloons 12, 14 are not in fluid communication with one another, i.e. fluidly disconnected. Rather, an auxiliary inflation shaft 19, also in fluid communication with the inflation hub (not shown) on a proximal side thereof, may extend through the proximal catheter shaft 16 and the first occlusion balloon 12 and into fluid communication with the at least one intermediate lumen 18a, thereby fluidly communicating with the second balloon 14. Accordingly, the first and second balloons 12, 14 are independently inflatable, the proximal shaft lumen 16a operating as the inflation lumen for the first balloon 12 and the auxiliary inflation shaft 19 operating as the inflation lumen for the second balloon 14. As should be understood, however, the balloons 12, 14 in the configuration of Fig. 3 may also be independently inflated. For example, without limitation, a tubular inflation member (not shown) may be reciprocally movable through the proximal shaft lumen 16a and into selective communication with and / or through the intermediate lumen 18a. The tubular inflation member may include side port(s) or openings for advancement and withdrawal of inflation mediumtherethrough, thereby permitting fluid flow independently or concurrently into each of the plurality ofballoons 12, 14.

[0048] In operation, the plurality of balloons 12, 14 enable partial or intermittent occlusion of a target blood vessel 1, e.g., the aorta, by permitting periodic bolus volumes of blood to flow downstream past the balloons 12, 14. In the configuration of Fig. 3, for example, inflation media is advanced into the balloons 12, 14, whereby the upstream blood pressure see Fig. 5A: Region 1) causes the first (or proximal) balloon 12 to inflate faster than the second (or distal) balloon 14. Accordingly, as shown in Fig. 5A, the first balloon 12 may initially be inflated into substantially full apposition with the blood vessel 1, e.g., fully inflated, while the second balloon 14 is initially only partially inflated, i.e., not in full apposition with the blood vessel 1. Accordingly, blood may flow downstream beyond the second balloon 14 from region 1 into region 2, i.e., the region between the first and second balloons 12, 14. As the blood pressure in region 2 exceeds the internal balloon pressure of the first balloon 12, some inflation media transfers from the first balloon 12 to the second balloon 14 (with an inflation valve of the catheter 10 in a closed state), autonomously deflating the first balloon 12 out of apposition with the blood vessel 1 and inflating the second balloon 14 into substantially full apposition with the blood vessel 1 (Fig. 5B), thereby permitting a bolus volume of blood, i.e., the volume of blood within region 2, to flow beyond the first balloon 12 and into region 3, i.e., downstream past both balloons 12, 14 of the catheter 10. Subsequently, the blood pressure in region 1 will increase again to a pressure greater than the pressure within the second balloon 14, thereby autonomously transferring some inflation media back to the first balloon 12 and restarting the oscillating balloon inflation cycle between the first and second balloons 12, 14 (Fig. 5A).

[0049] Additionally, or alternatively, the proximal shaft lumen(s) 16a and the intermediate lumen(s) 18a may define differing lumen sizes. For example, the cross-sectional area of the proximal shaft lumen(s) 16a may be larger than the cross-sectional area of the intermediate lumen(s) 18a, which would at least contribute to inflation of the first (or proximal) balloon 12 faster than the second (or distal) balloon 14. Further additionally, or alternatively, the balloons 12, 14 may define one or more of different geometries (e.g., wall thickness, balloon shape, balloon length, a combination thereof, or the like) and different balloon compliances. As should be understood by those of ordinary skill, for example, a thicker wall thickness or a lower compliance balloon will inflate less at a given pressure than a thinner wall thickness or a higher complianceballoon. Advantageously, the periodic transfer of inflation media between the first and second balloons 12, 14, as previously described, autonomously transpires based on pressure differentials without requiring user inteij ection or modulation.

[0050] In the configuration of Fig. 4, the catheter 10 may be operatively connected to a control hub (not shown), such as, for example, as described in International Application Publication No. WO 2023 / 225110, the entire contents of which are incorporated by reference herein in their entirety. The control hub may be configured to automate the oscillating balloon inflation cycle between the first and second balloons 12, 14 via independent inflation and deflation of each of the balloons 12, 14. For example, without limitation, the control hub may be configured to independently inflate and partially deflate each of the balloons 12, 14 on a predetermined time cycle. In one configuration, both balloons 12, 14 may be inflated into substantially full apposition with the blood vessel 1. Thereafter, with the first balloon 12 in apposition with the blood vessel 1, the second balloon 14 may be partially deflated (Fig. 5A) to allow a bolus volume of blood to flow from region 1 into region 2, and subsequently re-inflated into apposition with the blood vessel 1. Afterwards, the first balloon 12 may be partially deflated (Fig. 5B) to allow the bolus volume of blood to flow beyond the first balloon 12 and into region 3, downstream past both balloons 12, 14 of the catheter 10. The first balloon 12 may then be reinflated into apposition with the blood vessel. The net effect of the aforementioned oscillating effects of the balloons 12, 14 is intermittent or partial blood vessel occlusion.

[0051] To provide feedback to the control hub and / or user, at least for inflation and deflation purposes, a proximal sensor 26 (Figs. 1, 2), e.g., a pressure sensor, may be included in the occlusion catheter 10, proximal to the first balloon 12 and positioned within a window / opening formed in the sidewall of the proximal catheter shaft 16. The proximal sensor 26 may be positioned within the proximal window, such as described, for example, in the ‘895 publication, and electrically connected with the proximal hub. Turning to the distal side of the second balloon 14, as also shown in Figs. 1 and 2, a distal sensor 28, e.g., a pressure sensor, may, in one configuration, also be employed in the occlusion catheter 10. The distal sensor 28 may be positioned within a window / opening formed in the sidewall of the distal catheter shaft 20, such as described, for example, in the ‘895 publication, and electrically connected with the proximal hub. An intermediate sensor (not shown) may similarly be positioned in a window in the intermediate catheter shaft 18 and electrically connected with the proximal hub. The catheter 10 may alsoinclude intra-balloon pressure sensors electrically connected with the proximal hub. The sensors may take the form of Micro Electro-Mechanical System (“MEMS”) sensors, but the disclosure is not so limited.

[0052] In one configuration, the catheter 10, i.e., the proximal catheter shaft 16, the first balloon 12, the intermediate catheter shaft 18, the second balloon 14 and the distal catheter shaft 20, is dimensioned to be less than 7 Fr, e.g., 6 Fr, 5 Fr or 4 Fr in cross-section, with the balloons 12, 14 deflated. As should be understood by ordinary skill in the art, the narrower the catheter 10, the narrower the required introducer sheath, which, in turn, requires a smaller access site incision in the patient’s body. Advantageously, the smaller the access site incision, the shorter amount of time is required to close the incision after completion of the procedure. For example, the catheter 10 may be dimensioned to pass through a 7 Fr introducer sheath at the outset of the REBOA procedure and return to substantially the same dimensions (or at least sufficient dimensions) to withdraw in like manner, i.e., without increased difficulty, from the 7 Fr introducer sheath upon completion of the REBOA procedure.

[0053] Figs. 6-8B illustrate a second embodiment of the occlusion catheter 110. The reference numerals of the present embodiment are distinguishable from those of the above-described embodiment by a factor of one-hundred (100), but otherwise indicate the same elements as indicated above, except as otherwise specified. The occlusion catheter 110 of the present embodiment is similar to that of the previous embodiment. Therefore, the description of certain similarities between the embodiments may be omitted herein for the sake of brevity and convenience, and, therefore, is not limiting.

[0054] A primary difference between the occlusion catheter 110 and the occlusion catheter 10 is that the catheter 110 includes one expandable member, e.g., one occlusion balloon 112, configured to permit regions thereof to oscillate into and out of apposition with the blood vessel wall 1. For example, in one state, as shown in Figs. 6-8A, the occlusion balloon 112 may be at least partially inflated, whereby upstream blood pressure causes a proximal region 113a of the occlusion balloon 112 to inflate faster than a distal region 113b of the occlusion balloon 112. Additionally, or alternatively, the occlusion balloon 112 may be constructed to have a preferred shape in the partially inflated state, i.e., a thicker wall in the distal region 113, and / or may be individually blown to different diameters between the proximal region 113a and the distal region 113b. Accordingly, the proximal region 113a may be inflated into substantially full appositionwith the blood vessel wall 1 before the distal region 113b of the occlusion balloon 112 conies into apposition, or at least into full apposition, with the blood vessel wall 1. Accordingly, as shown in Fig. 8A, blood may flow around the distal region 113b of the occlusion balloon 112. As the upstream blood pressure continues to build and ultimately exceeds the internal pressure of the proximal region 113a of the occlusion balloon 112, some inflation media autonomously transfers from the proximal region 113a to the distal region 113b (with an inflation valve of the catheter 110 in a closed state), deflating the proximal region 113a out of apposition with the blood vessel 1 and inflating distal region 113b into substantially full apposition with the blood vessel 1 (Fig. 8B), thereby permitting a bolus volume of blood to flow beyond the proximal region 113a and downstream past the catheter 110. Thus, the net effect of this oscillating effect of the occlusion balloon 112 is intermittent or partial occlusion. As previously explained, the periodic transfer of inflation media between regions of the occlusion balloon 112 autonomously transpires based on pressure differentials without requiring user interjection or modulation.

[0055] Figs. 9-21 illustrate third through sixth embodiments (as well as alternative configurations) of the occlusion catheter 210, 310, 410, 510, 610, and 710, respectively. The reference numerals of the present embodiments are distinguishable from those of the abovedescribed embodiment(s) by factor of one-hundred (100), but otherwise indicate the same elements as indicated above, except as otherwise specified. The occlusion catheters 210, 310, 410, 510, 610, and 710 are similar to that of the previous embodiments. The balloon(s) of any of the catheters 210, 310, 410, 510, 610 and 710 may be employed with any of the previous embodiments, i.e., replacing or supplementing the balloon(s) of the previous embodiments. Therefore, the description of certain similarities between the embodiments may be omitted herein for the sake of brevity and convenience, and, therefore, is not limiting.

[0056] A primary difference between the occlusion catheters 210, 310, 410, 510, 610, and 710 and the previous embodiments is that the respective occlusion balloons may be manipulated to exhibit, or formed with, surface features that provide an extended, e.g., tortuous, blood flow path which permits the flow of blood past the balloon when inserted into the vessel 1 and at least partially inflated. As one non-limiting example, the occlusion balloon(s) of a third embodiment may be manipulated to form at least one generally spiral flow path along the exterior surface thereof. In one configuration, as shown in Figs. 9 and 10, the occlusion balloon 212 of the occlusion catheter 210 may be molded straight and then twisted prior to mounting to the proximaland distal catheter shafts 216, 220, thereby creating a generally spiral flow channel 213 along the exterior surface of the occlusion balloon 212.

[0057] In an alternative configuration, the occlusion balloon 212 may be molded with at least one spiral channel 213. Accordingly, the occlusion balloon 212 may be inflated, e.g. partially, into apposition with the vessel wall, whereby blood may flow past the balloon 212 along the spiral flow channel 213. The spiral flow channel 213 creates more resistance than an axial flow channel, thereby providing additional control for partial occlusion of the blood vessel, increasing stability of the occlusion balloon 212 inside the blood vessel and mitigating against vibration, rubbing or shifting of the occlusion balloon 212, which may otherwise damage the blood vessel. The occlusion balloon 212 may be further inflated to seal off the spiral flow channel 213, against itself and / or against the vessel wall, thereby fully occluding the blood vessel. As shown in Figs. 11 and 12, the occlusion balloon 212 may include opposing spiral flow channels 213, 213' to further increase rate of fluid flow across the balloon 212.

[0058] As should be understood by those of ordinary skill in the art, the molded channel is not limited to a spiral channel 213. As one example, as shown in Fig. 18, an occlusion balloon 612 of an occlusion catheter 610 may include a plurality of circuitous channels 613 extending between a proximal side of the balloon 612 and a distal side of the balloon 612. Similarly to the spiral flow channel(s) 213, the circuitous channels 613 provide flow channels that are longer in length than a straight channel, thereby creating more resistance to flow for improved flow control. In the illustrated embodiment, the circuitous channels 613 have a “zig zag” pattern, creating folds that are both partially axial in extent and partially radial in extent, for improved axial and radial folding, to maintain the low profile of the occlusion catheter 612.

[0059] In a fourth embodiment, as shown in Fig. 13, the occlusion catheter 310 may include an occlusion balloon 312 having a plurality of nodes 315 formed along the exterior surface thereof. In the illustrated embodiment, the nodes 315 are generally bulbous or spherically shaped, but the disclosure is not so limited, as the nodes 315 may take the form of other shapes, or combination of shapes, and sizes capable of performing the function(s) of the nodes 315 described herein. The nodes 315 create flow channels 313 in the valleys therebetween. The occlusion balloon 312 may be inflated, e.g. partially, into apposition with the vessel wall, whereby blood may flow past the balloon 312 along the tortuous flow channels 313 formed between the nodes. The occlusionballoon 312 may be further inflated to seal off the flow channels 313 against themselves and / or against the vessel wall, thereby fully occluding the blood vessel.

[0060] In a fifth embodiment, as shown in Figs. 14-17, the occlusion catheter may include an occlusion balloon having a textured surface. As shown in Figs. 14 and 15, the occlusion catheter 410 may include an occlusion balloon 412 having a plurality of dimples 415, i.e., depressions, formed along the exterior surface thereof. In the illustrated embodiment, the dimples 415 are generally spherically shaped, but the disclosure is not so limited, as the dimples 415 may take the form of other shapes, or combination of shapes, and sizes capable of performing the function(s) of the dimples 415 described herein. The dimples 415 create flow channels 413 therebetween. The occlusion balloon 412 may be inflated, e.g. partially, into apposition with the vessel wall, whereby blood may flow past the balloon 412 along the tortuous flow channels 413 formed between the dimples 415. The occlusion balloon 412 may be further inflated to seal off the flow channels 413 against themselves and / or against the vessel wall, thereby fully occluding the vessel. Additionally, or alternatively, as shown in Figs. 16 and 17, the occlusion catheter 510 may include a plurality of protrusions formed along the exterior surface thereof. In the illustrated embodiment, the protrusions 515 are generally hexagonally shaped, but the disclosure is not so limited, as the protrusions 515 may take the form of other shapes or combination of shapes and sizes. The protrusions 515 create flow channels 513 therebetween. The occlusion balloon 512 may be inflated, e.g. partially, into apposition with the vessel wall, whereby blood may flow past the balloon 512 along the tortuous flow channels 513 formed between the protrusions 515. The occlusion balloon 512 may be further inflated to seal off the flow channels 513 against themselves and / or against the vessel wall, thereby fully occluding the vessel.

[0061] In a sixth embodiment, as shown in Figs. 19 and 20, the occlusion catheter 710 may include an occlusion balloon 712 having at least one pleat 715. The pleat(s) 715 form flow channels 713 therebetween. The depth of the pleat(s) 715 may be increased or decreased for intended flow purposes. In the illustrated embodiment of Fig. 20, the depth of the pleats 715 does not reach the central axis of the occlusion balloon 712, but the disclosure is not so limited. The occlusion balloon 712 may be inflated, e.g. partially, into apposition with the vessel wall, whereby blood may flow past the balloon 712 along the flow channels 713 formed between the pleats 715. The occlusion balloon 712 may be further inflated to seal off the pleats 715 against themselves and / or against the vessel wall, thereby fully occluding the blood vessel. As shown in theconfiguration of Fig. 21, the pleats 715' may be radially and / or axially curvilinear. Advantageously, such configuration assists in the predictability of balloon folding prior to removal from the blood vessel.

[0062] Figs. 22 and 23 illustrate a seventh embodiment of the occlusion catheter 810. The reference numerals of the present embodiment are distinguishable from those of the abovedescribed embodiment(s) by a factor of one-hundred (100), but otherwise indicate the same elements as indicated above, except as otherwise specified. The occlusion catheter 810 of the present embodiment is similar to that of the previous embodiments. Therefore, the description of certain similarities between the embodiments may be omitted herein for the sake of brevity and convenience, and, therefore, is not limiting.

[0063] A primary difference between the occlusion catheter 810 and the previous embodiments is the ability to adjust the tension / slack in the balloon 812. As shown in Figs. 22 and 23, the hypotube 824 (which may be a solid or hollow wire, a braided shaft or the like) takes the form of a plunger, sealingly and slidably engaged with the proximal hub 830 and extended through the proximal shaft lumen 816a, through the occlusion balloon 812 and terminates within the distal catheter shaft 820. A distal portion of hypotube 824 is adjoined to the distal catheter shaft 820. The hypotube 824 may be adjoined to the distal catheter shaft 820 via welding, bonding (e.g., thermally bonded), molding, a combination thereof or the like. At least a segment of the distal neck portion 812b of the occlusion balloon 812 is also adjoined (in like manner as aforementioned) to the hypotube 824. Optionally, and alternatively, at least a segment of the distal neck portion 812b of the occlusion balloon 812 may also be adjoined (in like manner as aforementioned) to the distal catheter shaft 820. In such a configuration, the attachment between the distal catheter shaft 820 and the hypotube 824 and the attachment between the distal neck portion 812b and the distal catheter shaft 820 may at least partially, radially overlap along the axial axis of the catheter 810, thereby forming a three-component-attachment. The hypotube 824 is selectively, reciprocally slidable through the proximal hub 830. As shown, the head / handle 824a of the hypotube 824 is located proximal to proximal hub 830 and sealingly engaged with the proximal hub 830 via sealing member 831, e.g., O-rings or the like, to prevent inflation media leakage out of the proximal hub 830.

[0064] As shown in Fig. 22, the hypotube 824, connected to the distal neck portion 812b of the occlusion balloon 812, is initially, distally advanced, thereby elongating the occlusion balloon812 from the distal end relative to the proximal end thereof, i.e., the occlusion balloon 812 is tensioned. Advantageously, therefore, the outer radial profile of the catheter 810 is reduced in the uninflated state for streamlined insertion into, and subsequent removal from, the introducer sheath (not shown) during insertion or withdrawal of the catheter 810. Subsequently, as shown in Fig. 23, the hypotube 824 may be proximally retracted, thereby shortening and relaxing the occlusion balloon 812, thereby providing the occlusion balloon 812 with increased slack and preparing the occlusion balloon 812 for inflation for partial or full occlusion of the target blood vessel. The occlusion balloon 812 may be inflated with inflation media via an inflation port 830a of the proximal hub 830 in a manner well understood by those of ordinary skill in the art.

[0065] Optionally, as shown in Fig. 22, a biasing member 827 (e.g., a spring or the like) may be placed relative to the head 824a of the hypotube 824 and configured to bias the hypotube 824 into the distally advanced position. In such a configuration for example, as shown in Fig. 22, a frame 825 may be secured about the head 824a of the hypotube 824, defining a stop surface 825a proximal of the head 824a, and the biasing member 827 may be placed between the head 824a and the stop surface 825a. The biasing force of the biasing member 827 axially biases the hypotube into the distally advanced position absent a countering force. Inflation of the balloon 812, which shortens the balloon 812, imposes a proximally directed axial force on the hypotube 824, countering the biasing force of the biasing member 827. For example, where the biasing member 827 takes the form of a spring, a spring constant is selected whereby inflation of the balloon 812 imposes a proximally directed axial force which overcomes the spring force and proximally retracts the hypotube 824 (Fig. 23). Subsequently deflation of the balloon 812 alleviates the proximally directed axial force, resulting in the hypotube 824 resuming the distally advanced position thereof.

[0066] The occlusion balloon 812 may be constructed of a semi-compliant or substantially non-compliant material. In the shortened state of Fig. 23, the occlusion balloon 812 may exhibit a large / oversized blown diameter. The occlusion balloon 812 may be “oversized”, i.e., define a blown diameter D that is larger than a diameter of the target, i.e., destination, blood vessel (not shown) into which the occlusion balloon 812 is inserted and inflated for occlusion. In one configuration, the occlusion balloon 812 (without being tensioned by the hypotube 824) may define a blown diameter D between approximately twenty and approximately thirty-five millimeters (-20-35mm), which is configured to be between approximately ten percent andapproximately sixty percent (10-60%) larger than the diameter of the target vessel, e.g., the aorta, in a normotensive state of the vessel. The occlusion balloon 812 may, therefore, only require partial inflation for the outer surface thereof to come into full diametric contact / apposition with the inside wall of the target vessel, whereby folds (not shown) remain at the peripheral surface of the occlusion balloon 812. The open / un-collapsed folds of the balloon 812, in combination with the opposing inner wall of the vessel or with radially overlying portions of the outer surface of the occlusion balloon 812, results in flow channels extending along the length of the occlusion balloon 812 that allow partial perfusion or blood flow past the occlusion balloon 812 under the blood pressure within the vessel. Advantageously, movement of the hypotube 824 may further assist in formation and / or adjustment of the flow channels for improved partial occlusion properties.

[0067] The occlusion balloon 812 may also be thin-walled and otherwise dimensioned as described, for example, in International Patent Application Publication No. WO / 2024 / 030319 (“the ‘319 publication”), the entire contents of which are incorporated by reference herein in their entirety. In the shortened / slack state of Fig. 23, and upon partial inflation, the occlusion balloon 812 is able to conform to the dynamically changing diameter of the surrounding blood vessel and maintain partial or full occlusion, such as described in the ‘319 publication.

[0068] Fig. 24 illustrates an eighth embodiment of the occlusion catheter 910. The reference numerals of the present embodiment are distinguishable from those of the above-described embodiment(s) by a factor of one-hundred (100), but otherwise indicate the same elements as indicated above, except as otherwise specified. The occlusion catheter 910 of the present embodiment is similar to that of the previous embodiments. Therefore, the description of certain similarities between the embodiments may be omitted herein for the sake of brevity and convenience, and, therefore, is not limiting.

[0069] A primary difference between the occlusion catheter 910 and the occlusion catheter 810 pertains to the hypotube 924, which is rotatable relative to the occlusion catheter 910 rather than reciprocally slidable relative thereto. As should be understood by those of ordinary skill in the art, however, the hypotube 824, 924 may be both reciprocally slidably attached and rotatably attached to the proximal hub 830, 930. Rotation of the hypotube 924 in one rotational direction, e g., clockwise, causes the distal catheter shaft 920, and, in turn, the distal end of the occlusion balloon 912, to rotate therewith, thereby twisting the occlusion balloon 912 into a spiral shape. Twisting of the balloon 912 results in both tensioning of the balloon 912 as well as the creation ofspiral fluid flow channels 913 along the exterior of the balloon. The occlusion catheter 910 may be inserted into, and subsequently removed from, the introducer sheath (not shown) in the tensioned state during insertion or withdrawal of the catheter 910. Rotation of the hypotube 924 in the opposite rotational direction, e.g., counterclockwise, at least partially unwinds / releases the spiral twist of the occlusion balloon 912, providing the occlusion balloon 912 with more slack for inflation. The occlusion balloon 912 may be maintained in a partially twisted configuration to maintain the spiral fluid flow channels 913 for partial occlusion.

[0070] Figs. 25 and 26 illustrate a ninth embodiment of the occlusion catheter 1010. The reference numerals of the present embodiment are distinguishable from those of the abovedescribed embodiment(s) by a factor of one-hundred (100), but otherwise indicate the same elements as indicated above, except as otherwise specified. The occlusion catheter 1010 of the present embodiment is similar to that of the previous embodiments. Therefore, the description of certain similarities between the embodiments may be omitted herein for the sake of brevity and convenience, and, therefore, is not limiting.

[0071] As shown, the occlusion catheter 1010 includes a proximal catheter shaft 1016 and a distal catheter shaft 1020 with the occlusion balloon 1012 interposed therebetween. A proximal catheter sensor 1032 may be employed on a proximal side of the occlusion balloon 1012 and a distal catheter sensor 1034 may be employed on a distal side of the occlusion balloon 1012. The proximal hub 1030 is attached to, and in fluid communication with, the proximal end of the proximal catheter shaft 1016, and is in fluid communication with an inflation hub 1036. The proximal hub 1030 includes at least an electrical connector 1031 connectable to an external module (as will be described below). Optionally, the proximal hub 1030 may have a display (not shown), a battery (not shown), a printed circuit board or board assembly (collectively, PCB) (not shown), a combination thereof or the like.

[0072] The proximal hub 1030 may be selectively and releasably electrically connected, e.g., via the electrical connector 1031, to a reusable electronic module or dongle 1038, e.g., through a cable connection. The electronic module / dongle 1038 may include a display (not shown), a battery (not shown), a PCB (not shown), a combination thereof or the like, in addition to, or instead of, the proximal hub 1030, thereby simplifying and reducing cost of the disposable occlusion catheter 1010. The electronic module 1038 may further operate as a connector to selectively and releasably electrically connect the occlusion catheter 1010 to a vital sign monitor 1040. The module mayalso be configured to electrically convert an analog signal to a digital signal and / or vice versa, as well as allow the user to properly zero / calibrate the signal for each sensor 1032, 1034 for accurate display of the signal(s) on the vital sign monitor. The electronic module 1038 may also be configured to properly zero the vital sign monitor for each sensor 1032, 1034.

[0073] In an alternative configuration, as shown in Fig. 26, the electronic module 1038 may be substituted with a reusable controller 1042, such as, for example, as described in International Patent Application Publication No. WO / 2023 / 225110 (“the ‘ 110 publication”), the entire contents of which are incorporated by reference herein in their entirety. The controller 1042 may be selectively and releasably, electrically connected with the proximal hub 1030 and may be selectively and releasably in fluid communication with the inflation hub 1036 with an intervening fluid reservoir 1043, e.g., syringe or piston, storing inflation media therein. As described in the ‘ 110 publication, the controller 1042 may be configured to modulate the volume of the balloon 1012, i.e., automate at least one of inflation and deflation of the occlusion balloon 1012 based on criteria, such as, for example, without limitation sensor feedback (via the connection with the proximal hub 1030).

[0074] Figs. 27-29 illustrate a tenth embodiment of the occlusion catheter 1110. The reference numerals of the present embodiment are distinguishable from those of the above-described embodiment(s) by a factor of one-hundred (100), but otherwise indicate the same elements as indicated above, except as otherwise specified. The occlusion catheter 1110 of the present embodiment is similar to that of the previous embodiments. Therefore, the description of certain similarities between the embodiments may be omitted herein for the sake of brevity and convenience, and, therefore, is not limiting.

[0075] A primary difference between the occlusion catheter 1110 and the occlusion catheter 1010 is the placement of the proximal sensor 1132. As should be understood, an introducer sheath 1150 is inserted into the blood vessel prior to insertion of the occlusion catheter. As shown in Fig. 27, the occlusion catheter 1110 maintains the distal sensor 1134. Conversely, the proximal sensor 1132 is located in the introducer sheath 1150. The introducer sheath 1150 may include a proximal hub 1151 with an electrical connector 1152 (configured for data transfer) also configured for connection with an electronic module 1038 or a controller 1042.

[0076] Advantageously, placing the proximal sensor 1132 in the introducer sheath 1150 assists a user in determining the blood pressure within the blood vessel prior to inserting the occlusioncatheter 1110. Direct and unimpeded measurement of central vessel pressure is advantageous due to the accuracy and immediacy of the measurement. Therefore, employing the proximal sensor 1132 in the introducer sheath 1150, rather than, for example, employing a fluid column, provides improved efficiency, accuracy and reliability in determining and monitoring if and when REBOA is required prior to inserting the occlusion catheter 1110. For example, a blood pressure of 90 mmHg or less generally warrants REBOA. Further advantageously, employing the proximal sensor 1132 in the introducer sheath 1150 rather than in the occlusion catheter 1110 reduces the catheter 1110 profile.

[0077] As shown in Figs. 28 and 29, the proximal sensor 1132 may be embedded in a window / opening 1154 formed in the sidewall of the introducer sheath 1150. The window provides access for direct fluid, e.g., blood, contact with the sensor 1132 for pressure measurements. The proximal sensor 1132 also includes a proximal sensor signal wire 1132a extending proximally therefrom to the proximal hub 1151 of the introducer sheath 1150. The introducer sheath 1150 may include a sensor lumen 1156 formed in the sidewall thereof fortravel of the sensor signal wire 1132a therethrough, as well as a main, catheter lumen 1158 for passage of the occlusion catheter 1110 therethrough.

[0078] It will be appreciated by those skilled in the art that changes could be made to the embodiment(s) described above without departing from the broad inventive concept thereof. It is understood, therefore, that this disclosure is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present disclosure as defined by the present description, as set forth in the appended claims.

Claims

CLAIMSI / We claim:

1. A vascular occlusion catheter system comprising: a single-use occlusion catheter comprising: a proximal catheter shaft; a distal catheter shaft; an occlusion balloon interposed between the proximal and distal catheter shafts; a proximal catheter sensor on a proximal side of the occlusion balloon; a distal catheter sensor on a distal side of the occlusion balloon an electronic proximal hub attached to, and in fluid communication with, a proximal end of the proximal catheter shaft, the proximal hub having an electrical connector; and an inflation hub in fluid communication with the proximal hub; and a remote and reusable electronic module comprising a display, a battery and a PCB, the electronic module being releasably electrically connectable to the proximal hub via the electrical connector.

2. The vascular occlusion catheter system of claim 1, wherein the electronic module is electrically connectable with the proximal hub via an input connector, the electronic module further comprising at least one output connector for selectively and releasably electrically connecting with a vital sign monitor.

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