Grooved balloons and catheters

Abstract

Described herein are apparatuses, assemblies, devices, methods, and systems of and for grooved balloons and / or catheters. The embodiments herein can be used in one or more tubular organ or hollow area of the body of a human or other living being, or in other settings.

Description

[0001] PCT / US24 / 59104 09 December 2024 (09.12.2024)

[0002] TITLE: Grooved Balloons and Catheters

[0003] INVENTOR: lyunni, Venkata Sesha Sayi Nath

[0004] FIELD OF THE INVENTION

[0005]

[0001] Described herein are invention embodiments for grooved balloons and / or catheters.

[0006] BACKGROUND OF THE INVENTION

[0007]

[0002] Minimally invasive procedures may be performed through variably flexible catheters, which may be directed with guiding wires. Catheters and wires may have a range of sizes (e.g., in length or diameter) and shapes (particularly their tip shapes), as well as material characteristics, like stiffness or pliability, recoil or memory, degree of hydrophilic nature, etc. Minimally invasive instruments may involve a balloon. An annular balloon disposed around a catheter may preserve the internal channel of the catheter. Such balloons may be used in direct treatment, such as angioplasty, or other dilation (e.g. of a narrowing, occlusion, stenosis, or stricture). A balloon may be coated with and / or administer a drug or other clinical agent. Patent Cooperation Treaty (PCT) Application No. W02023113800A1 to

[0008] Nath discloses balloons capable of depth- selective tissue applications, including tissue sampling (i.e., biopsy), administration of a clinical agent, or direct treatment like stricture dilation, etc. U.S. Pat. No. 11,369,547 to Nath discloses balloon valves for catheters.

[0009]

[0003] Current balloons can be generally uniform in their maximal diameter and wall thickness circumferentially at a given cross section. When such balloons are inflated within a vessel or other tubular structure, they can be generally occlusive of the lumen of said vessel or tubular structure. For example, in blood vessels, this occlusion can limit or preclude blood flow across the inflated balloon, which may result in ischemia, infarct, necrosis, or other tissue damage (e.g. distal to a balloon inflated in an artery).

[0010] Page 1 of 23

[0011] 136989352.7 PCT / US24 / 59104 09 December 2024 (09.12.2024)

[0012]

[0004] Balloons may also be used for direct extraction, such as in the removal of a stone from the biliary or urinary systems. Such balloons can be placed, e.g., deeper to the location of a stone, then inflated and retracted such that the stone is pushed more peripherally (and ideally, e.g., the stone is freed or removed from the tract). Such maneuvers, if the balloon is occlusive of the tubular structure, can create a suction vacuum effect with balloon retraction. Suction pressure in and of itself may harm epithelial lining or cause other tissue damage, whether directly or indirectly from the dragging of the balloon. Moreover, the vacuum can be such that when fluid communication is reestablished with the tubular structure deep to where the balloon had been (e.g., when the balloon is deflated or reaches a wider area), there is an influx (and / or reflux) of fluid deeper into the tubular structure. In cases of infection where microorganisms or other pathogens had occupied a tract (e.g., urinary tract infection, cholangitis, etc.), the sudden release of vacuum pressure can propel unwanted microorganisms deeper into a tract (e.g., ascending toward the kidney or liver) and cause further pathology.

[0013]

[0005] Balloons may also be used as anchoring mechanisms, such as with indwelling catheters (e.g., a Foley catheter, suprapubic catheter, etc.). With balloons of generally uniform diameter, they may be occlusive of a normal outlet for fluid (for instance, the bladder outlet at the bladder neck and proximal urethra). Blockage of fluid, and resulting stagnant fluid, can be a nidus for infection. For example, iatrogenic urinary stasis can cause a cystitis and / or urinary tract infection, which could spread (e.g. ascending pyelonephritis) and / or even result in bacteremia, fungemia, sepsis, septic shock, and / or systemic inflammatory response syndrome.

[0014]

[0006] The embodiments described herein address shortcomings in the prior art and current technologies described above.

[0015] SUMMARY OF THE INVENTION

[0016] Page 2 of 23

[0017] 136989352.7 PCT / US24 / 59104 09 December 2024 (09.12.2024)

[0018]

[0007] The embodiments described herein overcome particular problems in the prior art related to balloon and catheter devices.

[0019]

[0008] In certain embodiments, a catheter may comprise a balloon having an outer surface with one or more grooves forming a grooved surface area versus a non-grooved surface area, the grooved surface area inflatable to at least one core diameter and the nongrooved surface area inflatable to at least one outer diameter, at least one outer diameter being greater than at least one core diameter. A balloon may be annular and / or generally spherical or cylindrical. At least one groove may be generally linear.

[0020]

[0009] In certain catheters, a balloon may comprise a long axis that is parallel to the catheter and a short axis that is perpendicular to the long axis, wherein the long axis corresponds to a length of the balloon and the short axis corresponds to a cross sectional perimeter of the balloon, further wherein at least one generally linear groove is generally aligned with at least one axis. At least one groove may be generally aligned with the long axis, and at least one long axis groove may generally extend along the full length of the balloon. At least one groove may be generally aligned with the short axis, and at least one short axis groove may generally extend along the full perimeter of the balloon. At least one groove may be generally aligned with the long axis and at least one groove may be generally aligned with the short axis. Further, at least one groove may be generally helical.

[0021]

[0010] In certain catheters, a balloon may comprise a long axis that is parallel to the catheter and a short axis that is perpendicular to the long axis, wherein the long axis corresponds to a length of the balloon and the short axis corresponds to a cross sectional perimeter of the balloon, further wherein the grooved surface area generally spirals around the perimeter along the length of the balloon.

[0022] Page 3 of 23

[0023] 136989352.7 PCT / US24 / 59104 09 December 2024 (09.12.2024)

[0024] [Oi l] In certain catheters, the balloon outer surface may be at least partially less compliant along at least one groove relative to the non-grooved surface area. An outer surface may comprise a plurality of wall thicknesses, wherein grooved surface area wall thickness is at least partially greater than non-grooved surface area wall thickness. A grooved surface area may be at least partially attached to the catheter, and may be via one or more stitches. At least one groove may comprise one or more plications.

[0025]

[0012] Certain catheters may further comprise at least one side port opening operable to fluidically communicate with at least one inner channel. At least one side port opening may be positioned along the balloon outer surface. At least one side port opening may be positioned along at least one groove.

[0026]

[0013] In certain embodiments, a balloon may have an outer surface with one or more grooves forming grooved versus non-grooved surface areas, the grooved surface area inflatable to at least one core diameter and the non-grooved surface area inflatable to at least one outer diameter, whereby at least one outer diameter is greater than at least one core diameter. A balloon may be generally spherical or cylindrical or otherwise. At least one groove may be generally linear.

[0027]

[0014] Certain balloons may comprise a long axis and a short axis that is perpendicular to the long axis, wherein the long axis corresponds to a length of the balloon and the short axis corresponds to a cross sectional perimeter of the balloon, further wherein at least one generally linear groove is generally aligned with at least one axis. At least one groove may be generally aligned with the long axis, and at least one long axis groove may generally extend along the full length of the balloon. At least one groove may be generally aligned with the short axis, and at least one short axis groove may generally extend along the full perimeter of the balloon. At least one groove may be generally aligned with the long axis and at least one groove

[0028] Page 4 of 23

[0029] 136989352.7 PCT / US24 / 59104 09 December 2024 (09.12.2024) may be generally aligned with the short axis. Further, at least one groove may be generally helical.

[0030]

[0015] Certain balloons may comprise a long axis and a short axis that is perpendicular to the long axis, wherein the long axis corresponds to a length of the balloon and the short axis corresponds to a cross sectional perimeter of the balloon, further wherein the grooved surface area generally spirals around the perimeter along the length of the balloon.

[0031]

[0016] In certain balloons, an outer surface may be at least partially less compliant along at least one groove relative to the non-grooved surface area. An outer surface may comprise a plurality of wall thicknesses, wherein grooved surface area wall thickness is at least partially greater than non-grooved surface area wall thickness. A grooved surface area may be at least partially attached to an internal support, and may be via one or more stitches. In certain balloons, at least one groove may comprise one or more plications.

[0032]

[0017] In certain embodiments, a method of using a balloon and catheter may comprise: (i) directing a catheter comprising a balloon having an outer surface with one or more grooves forming a grooved surface area versus a non-grooved surface area, the grooved surface area inflatable to at least one core diameter and the non-grooved surface area inflatable to at least one outer diameter, at least one outer diameter being greater than at least one core diameter; (ii) navigating the catheter wherein the balloon is positioned at a target area of treatment within a tubular structure or cavity; and (iii) selectively inflating the balloon wherein the outer diameter therapeutically engages the target area of treatment and the core diameter does not, wherein fluid communication is maintained across the balloon over at least one part of the grooved surface area.

[0033]

[0018] In certain embodiments, a method of using a balloon may comprise: (i) directing a balloon having an outer surface with one or more grooves forming grooved versus

[0034] Page 5 of 23

[0035] 136989352.7 PCT / US24 / 59104 09 December 2024 (09.12.2024) non-grooved surface areas, the grooved surface area inflatable to at least one core diameter and the non-grooved surface area inflatable to at least one outer diameter, whereby at least one outer diameter is greater than at least one core diameter; (ii) navigating the balloon to a target area of treatment; and (iii) deploying the balloon wherein at least one part of the outer diameter therapeutically engages the target area of treatment.

[0036] BRIEF DESCRIPTION OF THE DRAWINGS

[0037]

[0019] Other features of embodiments disclosed herein will become apparent from the attached drawings. The following drawings are illustrative examples and do not further limit any claims that may eventually issue. For purposes of explanation, several embodiments are set forth in the following figures, wherein:

[0038]

[0020] FIG. 1 illustrates a long axis side view of a partially inflated grooved balloon on a catheter;

[0039]

[0021] FIG. 2 illustrates a short axis cross sectional view of a catheter balloon with two grooves;

[0040]

[0022] FIG. 3 illustrates a long axis side view of an inflated partially grooved balloon on a catheter;

[0041]

[0023] FIG. 4 illustrates a long axis side view of an inflated catheter balloon with extended longitudinal grooves;

[0042]

[0024] FIG. 5 illustrates a short axis cross sectional view of a catheter balloon with four grooves;

[0043]

[0025] FIG. 6 illustrates a long axis side view of a catheter balloon circumferentially grooved along its short axis;

[0044]

[0026] FIG. 7A illustrates a catheter balloon with plications in long axis;

[0045]

[0027] FIG. 7B illustrates a catheter balloon with plications in short axis;

[0046] Page 6 of 23

[0047] 136989352.7 PCT / US24 / 59104 09 December 2024 (09.12.2024)

[0048]

[0028] FIG. 7C illustrates a catheter balloon with attachments in long axis;

[0049]

[0029] FIG. 7D illustrates a catheter balloon with attachments in short axis;

[0050]

[0030] FIG. 8A illustrates a long axis side view of a catheter balloon with a plurality of wall thicknesses;

[0051]

[0031] FIG. 8B illustrates a short axis cross sectional view of a catheter balloon with a plurality of wall thicknesses;

[0052]

[0032] FIG. 8C illustrates a magnified view of a thickened groove of a balloon;

[0053]

[0033] FIG. 9 illustrates a long axis side view of a catheter and grooved balloon with at least one side port;

[0054]

[0034] FIG. 10 illustrates a catheter balloon with helical grooving; and

[0055]

[0035] FIG. 11 illustrates an isolated balloon with longitudinal and cross sectional grooving.

[0056] DETAILED DESCRIPTION

[0057]

[0036] In certain embodiments, a catheter may include any cannula, shunt, stent, trocar, tube, or tubular structure. Examples include, but are not limited to, cystostomy tube, chest tube, pleural drainage catheter, gastrostomy tube, gastrojejunostomy tube, gastroenteric tube, nasogastric tube, orogastric tube, nasojejunal tube, feeding tube, enteric tube, biliary tube, biliary drainage catheter, nephrostomy tube, nephroureteral stent, ventriculoperitoneal shunt, etc.

[0058]

[0037] In certain embodiments, a clinical agent may include any radiotracer, pharmaceutical, medicine, medicament, medication, dye, drug, contrast, diagnostic agent, imaging agent, staining agent, visualization agent, detection agent, treatment agent, cytotoxic agent, immunological agent, antimicrobial agent, radioactive agent, tissue-bulking agent, sclerosing agent, acidic agent, timed-release agent, stimulant agent, fibrosis-inducing agent,

[0059] Page 7 of 23

[0060] 136989352.7 PCT / US24 / 59104 09 December 2024 (09.12.2024) anti-platelet agent, chemical agent, chemotherapeutic agent, radiotherapeutic agent, or marking agent, etc., or any combination thereof.

[0061]

[0038] Certain embodiments herein can be used in one or more tubular organs or hollow areas of the body of a human or other living being, including but not limited to any enteric structure, enteric space, mouth, oral cavity, nasal cavity, pharynx, esophagus, stomach, duodenum, jejunum, ileum, cecum, ascending colon, transverse colon, descending colon, sigmoid colon, rectum, anus, gallbladder, biliary duct, pancreatic duct, sphincter of Oddi, ampulla of Vater, peritoneum, peritoneal structure, peritoneal space, cardiorespiratory structure, cardiorespiratory space, larynx, trachea, bronchus, bronchiole, lung, pleural structure, pleural space, heart, ventricle, atrium, appendage, pericardial structure, pericardial space, mediastinal structure, mediastinal space, vascular structure, vascular space, aorta, superior vena cava, inferior vena cava, artery, vein, vessel, neurologic structure, neurologic space, cerebral spinal fluid (CSF) space, subarachnoid space, subdural space, epidural space, lateral ventricle, interventricular foramen, third ventricle, cerebral aqueduct, fourth ventricle, foramen of Luschka, foramen of Magendie, gynecologic structure, uterus, cervix, vagina, urologic structure, kidney, ureter, bladder, retroperitoneal structure, retroperitoneal space, pelvic structure, pelvic space, etc., or any combination thereof. In addition to tubular organs or hollow areas, certain embodiments of the invention may be used in other areas, including but not limited to any musculoskeletal or fascial structure, space, plane, or compartment, etc., or any combination thereof. Further, embodiments may be used in applications not related to a living being.

[0062]

[0039] FIG. 1 depicts a catheter 101 and balloon 102 comprising outer surface 103 and grooves 104. Balloon 102 has a long axis 111 parallel to catheter 101, short axis 112 perpendicular to long axis 111, and length 113 along long axis 111. Balloon 102 also has a

[0063] Page 8 of 23

[0064] 136989352.7 PCT / US24 / 59104 09 December 2024 (09.12.2024) perimeter 114 oriented around a cross section along short axis 112, which is seen in FIG. 2. FIG. 2 also shows the grooves 104 result in a grooved surface area 105 versus a non-grooved surface area 106. Balloon 102 is inflatable such that the grooved surface area 105 can expand up to a core diameter 107 and the non-grooved surface area 106 can expand, further, up to a greater, outer diameter 108.

[0065]

[0040] FIGS. 2 and 3 depict balloon 102 when it is fully inflated. In certain embodiments, like FIGS. 1-3, a balloon 102 can be annular around catheter 101. In further embodiments, again such as FIGS. 1-3, a balloon 102 can be generally spherical. FIGS. 1-3 also illustrate how, in some embodiments, grooves 104 can be generally linear, aligned with at least one axis (e.g., long axis 111), and / or extend partially (versus fully) along length 113.

[0066]

[0041] In other embodiments, a balloon could be generally cylindrical, and / or any other rounded, non-rounded, orthogonal, or non-orthogonal shape, which would be readily apparent to those of skill in the art. Further, grooves could be curved and / or non-linear — e.g., punctate, dotted, dashed, and / or any other regular, irregular, symmetric, or asymmetric pattern, which again will be readily apparent to those of skill in the art. For instance, in FIGS. 4 and 5, balloon 102 is generally cylindrical and grooves 104 extend fully along length 113. FIG. 4’s grooves 104 may be described as extended and longitudinal (extending fully along length 113). By way of further example, in FIG. 6, balloon 102 comprises one groove 104, which is oriented within short axis 112 along the full extent (versus a portion) of perimeter 114. Given the nature of perimeter 114, FIG. 6’s grooves 104 may be referred to as circumferential.

[0067]

[0042] Grooved balloon embodiments described herein address problems in the prior art by permitting peripheral flow, and / or avoiding having an occlusive effect, when the balloon is inflated. With a non-grooved surface area 106 inflated to an outer diameter 108, the balloon can be used for intended functionality, such as, e.g., dilating a stricture, administering

[0068] Page 9 of 23

[0069] 136989352.7 PCT / US24 / 59104 09 December 2024 (09.12.2024) an agent or otherwise treating a diseased vessel wall, capturing and retrieving or removing a stone with retraction, etc. Yet, with grooved surface area 105 inflated to a core diameter 107, balloon embodiments herein result in one or more areas along the balloon wall that are relatively recessed, given outer diameter 108 is at least partially greater than core diameter 107. When such portions do not seal with the wall of the vessel or tubular structure, etc., then the vessel or tubular structure retains intact fluid communication on either side of the balloon, such that fluid can continue to flow (e.g., around the balloon). Therefore, suction and vacuum effect, etc., and possible associated tissue trauma and possible infectious spread, etc., can be avoided.

[0070]

[0043] Turning to FIGS. 7A and 8A, embodiments of the invention are illustrated wherein at least one groove 104, and / or part or all of grooved surface area 105, possesses a compliance that is less than non-grooved surface area 106. Less compliant non-grooved surface area 106 can expand and dilate further (e.g., to a larger outer diameter 108) relative to a more compliant part of outer surface 103 (e.g., groove(s) 104 / grooved surface area 105), which would only expand and dilate to a more limited extent (e.g., a smaller core diameter 107).

[0071]

[0044] Achieving difference between core diameter 107 and outer diameter 108, and / or between grooved surface area 105 and non-grooved surface area 106, can manifest and / or be accomplished in various different ways, which can be readily appreciated by those of skill in the art. For example, in FIGS. 7A-B, grooves 104 are illustrated with plications 120. In FIGS. 7C-D, balloon 102 is shown wherein one or more grooves 104 are at least partially attached to catheter 101 via one or more attachments 121. Such attachment can be variable and can be via, for example, stitches. A groove 104 could be attached to catheter 101 by, e.g., magnetic attraction limiting the distance by which groove 104 could translate away from catheter 101, resulting in a core diameter 107. Other attachments 121 will be readily apparent to those of skill in the art.

[0072] Page 10 of 23

[0073] 136989352.7 PCT / US24 / 59104 09 December 2024 (09.12.2024)

[0074]

[0045] By way of further example, in FIGS. 8A-C, balloon 102 is shown with outer surface 103 comprising two or more wall thicknesses 122, where wall thickness 122a of outer surface 103 along at least a part of grooved surface area 105 is greater (i.e., thicker) than wall thickness 122b of outer surface 103 along at least a part of non-grooved surface area 106. Increased wall thickness can result in smaller core diameter 107 (versus outer diameter 108), and may, e.g., be at least in part due to difference in compliance within outer surface 103.

[0075]

[0046] Further embodiments may comprise a catheter 101 and balloon 102 with one or more side ports 130, an example of which is illustrated in FIG. 9. A side port 130 can be along catheter 101 itself, like side ports 130a. A catheter side port 130a may be positioned closer to the tip of catheter 101 (i.e., ‘distal’ to balloon 102), which is depicted in FIG. 9. However, a catheter side port 130a may also be placed along catheter 101 along the portion of catheter 101 where the balloon 102 is, or ‘proximal’ to balloon 102 (these two configurations not illustrated). In certain embodiments, a side port 130 can be along balloon 102’s outer surface 103, such as side port 130b. A balloon side port 130b can be along non-grooved surface area 106 (not illustrated), or positioned within grooved surface area 105 as in FIG. 9. Stated differently, a balloon side port 130b can be along at least one groove 104, at least partially. Side ports 130 may occupy some or all of either a catheter 101, balloon 102, groove 104, grooved surface area 105, or non-grooved surface area 106, and / or may overlap between any cross-combination or permutation thereof. Variations will be readily apparent to those of skill in the art.

[0076]

[0047] In FIG. 9, catheter 101 may also comprise one or more internal channels (not illustrated), and one or more side port(s) 130 can be, separately or in combination, in fluid communication with one or more internal channel(s). FIG. 9 also shows catheter 101 comprising one or more proximal ports 132, one or more of which can be, separately or in

[0077] Page 11 of 23

[0078] 136989352.7 PCT / US24 / 59104 09 December 2024 (09.12.2024) combination, in fluid communication with one or more internal channel(s) and / or side port(s) 130. While two proximal ports 132 (and three side ports 130) are illustrated, other variations and combinations fall within the scope and will be readily apparent to those of skill in the art. For example, a first proximal port 132 may communicate with a first internal channel that occupies the center of catheter 101 with a distal opening at the tip of catheter 101. Such a first internal channel may be, e.g., for the use of guidewires. A second proximal port 132 may communicate with a second internal channel that communicates with a lumen of balloon 102. Such a second internal channel may be, e.g., for the inflation (and / or deflation) of balloon 102. A third proximal port 132 may communicate with a third internal channel that communicates with one or more side ports 130. Such a third internal channel may be, e.g., for aspiration and / or drainage of the contents of a body cavity or tubular structure. Examples provided are for illustrative purposes only and not limiting, and other configurations will be readily apparent to persons having ordinary skill in the art.

[0079]

[0048] FIG. 10 illustrates another embodiment of a catheter and grooved balloon.

[0049] In certain embodiments discussed throughout the present disclosure, grooves 104 can be generally linear. In further embodiments, one or more grooves 104 can be generally aligned with at least one axis of balloon 102. In certain embodiments, a balloon 102 may comprise grooves 104 generally aligned with long axis 111 as well as grooves 104 generally aligned with short axis 112. Grooves 104 can be curved and / or non-linear. In some embodiments, at least one groove 104 can be spiral and / or helical, etc. For example, a grooved surface area 105 can generally spiral around perimeter 114 along length 113 (e.g., with a helical groove 104). A balloon 102’s grooved surface area 105 may comprise both linear as well as non-linear (e.g., helical) grooves 104. In certain embodiments, grooves 104 comprise at least one generally linear groove 104 generally aligned with long axis 111, at least one generally

[0080] Page 12 of 23

[0081] 136989352.7 PCT / US24 / 59104 09 December 2024 (09.12.2024) linear groove 104 generally aligned with short axis 112, and / or at least one helical groove 104, or any combination thereof.

[0082]

[0050] For instance, in FIG. 10, balloon 102 comprises long axis grooves 104a and helical groove 104b, as well as side ports 130b along a portion of grooved surface area 105 (specifically, along a portion of helical groove 104b) and side ports 130c along a portion of non-grooved surface area 106. In FIG. 10, catheter 101 also comprises side ports 130a distal to balloon 102.

[0083]

[0051] The embodiment illustrated in FIG. 10, and others within the scope and disclosed and described herein, can be particularly useful for indwelling drainage (e.g., urinary catheters, pleural or abscess drains, etc.). The configuration of side ports 130 and especially grooved surface area 105 can minimize residual fluid stasis and promote near complete drainage (e.g., of a bladder, or of an abscess or other cavity), which can result in beneficial treatment outcome (e.g., by decreasing, minimizing, and / or avoiding infectious risk).

[0084]

[0052] Similarly, the embodiment illustrated in FIG. 9, and others within the scope and discussed herein, can be particularly useful for a peripherally inserted central venous catheter (PICC line). Where balloons in the prior art have been utilized in an effort to prevent a catheter tip from resting against or adhering to a vessel wall and thus occluding its internal channel, the balloon itself can be occlusive of surrounding flow, especially when the balloon has a uniform wall, and this again obstructs the catheter from being able to be used (e.g., in drawing blood for testing, as well as in administering medications, including caustic or heavy agents that must be administered centrally such as certain medicine used in intensive settings or critical conditions). The configuration of grooved surface area 105 and especially its associated side port 130b can promote and / or preserve the ability to utilize the catheter and

[0085] Page 13 of 23

[0086] 136989352.7 PCT / US24 / 59104 09 December 2024 (09.12.2024) help prevent the need to replace it, whether being used to extract serum and / or infuse medication through the catheter (e.g., a PICC or other central line).

[0087]

[0053] FIG. 11 depicts a free standing balloon 102 in accord with an embodiment of this invention, without an associated catheter. Balloon 102 comprises outer surface 103, which comprises longitudinal grooves 104a along long axis 111 as well as circumferential groove 104b along short axis 112, which together form grooved surface area 105, the rest of outer surface 103 forming non-grooved surface area 106. Balloon 102 is inflatable to outer diameter 108 along non-grooved surface area 106, and only to the smaller core diameters 107a and 107b along grooved surface area 105, with core diameter 107a corresponding to longitudinal grooves 104a and core diameter 107b corresponding to circumferential groove 104b. Embodiments of balloons herein, including isolated balloons or catheter balloons, may comprise more than one core diameter, and may comprise more than one outer diameter.

[0088]

[0054] Other embodiments encompass isolated balloons having any or all of the features described herein regarding embodiments of catheter balloons, as will be readily apparent to those of ordinary skill in the art. Grooved surface area can be accomplished via one or more attachments to an internal support (not illustrated), differences in outer surface compliance and / or wall thickness, and / or plication, etc. Such isolated balloons can also be maneuvered and deployed in different ways, including with the advent of one or more catheters and / or wires, prior to becoming isolated / freestanding, which will also be readily apparent to those of ordinary skill in the art.

[0089]

[0055] Isolated balloons, including balloon 102 of FIG. 11, may function as a space filler. For example, such balloons could serve as a plug, or filter, and / or to occupy a space and / or occlude a lumen or other flow, as desired. Various other utilizations within the scope of this disclosure will be apparent to those of skill in the art.

[0090] Page 14 of 23

[0091] 136989352.7 PCT / US24 / 59104 09 December 2024 (09.12.2024)

[0092]

[0056] Catheters and balloons herein and components thereof may each comprise carbon fiber, medical grade plastic, latex, metal, nylon, polyester, polyurethane, silicone, etc., or any combination thereof.

[0093]

[0057] Catheters and balloons herein may vary in size and pressure features, as will be readily apparent to those of ordinary skill in the art. For example, a microcatheter caliber may comprise 3 French or smaller, other catheter calibers may comprise between 4 or 5 French to over 20 French, and lengths may include 25 cm, 60 cm, 150 cm, or otherwise. A balloon length may comprise 4 cm or less, or 10 cm or greater. A balloon’s caliber (e.g., the maximal outer diameter) may comprise 2 mm, 20 mm, or otherwise. A balloon’s lumen may be inflatable by up to 10 milliliters of sterile water, or otherwise. Certain balloons (and areas thereof) may vary in size depending on inflation pressure. For example, a balloon may be graded to burst at 20 atmospheres of pressure, with a nominal inflation pressure of 8 atmospheres. Other balloons may have smaller or greater nominal and burst pressures, as well as other ranges or differences therein between the nominal and burst pressures. A balloon’s core diameter may vary depending on the pressure within the balloon at a given time, or may be designed rigidly such that the permissible range of inflation pressures all reflect a uniform core diameter. Similarly, a balloon’s outer diameter may vary depending on pressure, or be more uniform within the range of therapeutic inflation pressures. Such variability in diameter (or lack thereof) may be desirable depending on the treatment tissue, and whether more pressure needs to be applied but without surpassing a certain size, or if a balloon should be more form fitting and expand flexibly to match a surrounding contour, etc. Various different pressure characteristics and dimensions, all within the scope, will be readily apparent to those of ordinary skill in the art.

[0094]

[0058] Also disclosed herein are methods of using balloons and catheters. Catheter balloons can be directed and navigated to a target area of treatment (e.g., inside a cavity or

[0095] Page 15 of 23

[0096] 136989352.7 PCT / US24 / 59104 09 December 2024 (09.12.2024) tubular structure), then selectively inflated such that the outer diameter therapeutically engages the treatment target. In certain embodiments, the core diameter does not engage a surface (e.g., does not reach the lumen of the vessel or other anatomy being treated), thereby maintaining fluid communication across the balloon at least via one groove (or the entire grooved surface area). In other embodiments, isolated balloons can be directed and navigated to a target area of treatment then selectively deployed such that at least a portion of the non-grooved surface area (e.g., by reaching the outer diameter) therapeutically engages the treatment target. With both catheter balloons and isolated balloons, deployment and / or inflation can be complete or partial, and can be for varied lengths of time. For instance, treatment can be on the order of seconds to minutes (e.g., angioplasty) or days to months (e.g., indwelling catheters). Various locations, durations, and degrees of inflation and / or deployment, and combinations thereof, will be readily apparent to those of ordinary skill in the art.

[0097]

[0059] The foregoing description is of certain embodiments. Other embodiments will be within the scope of the claims. Those having ordinary skill in the art will readily appreciate variations and / or improvements that may be included in alternate embodiments in light of this disclosure.

[0098]

[0060] In the foregoing description of embodiments according to the present invention, details are set forth for purpose of explanation. However, one of ordinary skill in the art will realize that the embodiments described herein may be practiced without the use of all of these specific details. The embodiments (and descriptions) disclosed herein are intended, therefore, to be only illustrative and not limiting. Numerous other variations, all within the scope, will readily occur to those of ordinary skill in the art. Similarly, where examples are used herein, no example is intended to be limiting, unless the context in which the example is used clearly indicates otherwise. Accordingly, “e.g.” or “for example” should be read as “for

[0099] Page 16 of 23

[0100] 136989352.7 PCT / US24 / 59104 09 December 2024 (09.12.2024) example, and without limitation,” unless the context clearly indicates that limitation to the given example(s) is intended.

[0101]

[0061] The meanings of terms used herein shall be apparent, from the description, the figures, and / or the context in which the terms are used, to those of ordinary skill in the art.

[0102]

[0062] While this specification contains many specific details, these should not be construed as limitations on the scope, but rather as descriptions of features that may be specific to particular embodiments. Those of ordinary skill in the art will readily appreciate that: (i) certain features that are described in the context of separate embodiments can also be implemented in combination; (ii) various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination; and (iii) although features may be described or claimed as acting in certain combinations, one or more features can in some cases be excised from the combination, and / or the feature(s) may be directed to any other subcombination or variation of a subcombination.

[0103]

[0063] It is not possible to illustrate examples of all possible embodiments. It will be understood by those of ordinary skill in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the present embodiments without departing from the scope. Any resulting claims shall not be limited to the embodiments shown in the figures and / or discussed in the detailed description.

[0104] Page 17 of 23

[0105] 136989352.7

Claims

PCT / US24 / 59104 09 December 2024 (09.12.2024)We claim:

1. A catheter comprising a balloon having an outer surface with one or more grooves forming a grooved surface area versus a non-grooved surface area, the grooved surface area inflatable to at least one core diameter and the non-grooved surface area inflatable to at least one outer diameter, at least one outer diameter being greater than at least one core diameter.

2. The catheter of claim 1, wherein the balloon is annular.

3. The catheter of claim 1, wherein the balloon is generally spherical.

4. The catheter of claim 1, wherein the balloon is generally cylindrical.

5. The catheter of claim 1, wherein at least one groove is generally linear.

6. The catheter of claim 5, the balloon comprising a long axis that is parallel to the catheter and a short axis that is perpendicular to the long axis, wherein the long axis corresponds to a length of the balloon and the short axis corresponds to a cross sectional perimeter of the balloon, further wherein at least one generally linear groove is generally aligned with at least one axis.

7. The catheter of claim 6, wherein at least one groove is generally aligned with the long axis.

8. The catheter of claim 7, wherein at least one long axis groove extends along the full length of the balloon.

9. The catheter of claim 6, wherein at least one groove is generally aligned with the short axis.

10. The catheter of claim 9, wherein at least one short axis groove extends along the full perimeter of the balloon.Page 18 of 23136989352.7PCT / US24 / 59104 09 December 2024 (09.12.2024)11. The catheter of claim 6, wherein at least one groove is generally aligned with the long axis and at least one groove is generally aligned with the short axis.

12. The catheter of claim 6, further comprising at least one groove that is generally helical.

13. The catheter of claim 1, wherein at least one groove is generally helical.

14. The catheter of claim 13, the balloon comprising a long axis that is parallel to the catheter and a short axis that is perpendicular to the long axis, wherein the long axis corresponds to a length of the balloon and the short axis corresponds to a cross sectional perimeter of the balloon, further wherein at least one groove spirals around the perimeter along the long axis of the balloon.

15. The catheter of claim 1, wherein the outer surface of the balloon is at least partially less compliant along at least one groove relative to the non-grooved surface area.

16. The catheter of claim 1, the outer surface comprising a plurality of wall thicknesses, wherein grooved surface area wall thickness is at least partially greater than non-grooved surface area wall thickness.

17. The catheter of claim 1, wherein the grooved surface area is at least partially attached to the catheter.

18. The catheter of claim 17, wherein the grooved surface area is at least partially attached to the catheter via one or more stitches.

19. The catheter of claim 1, wherein at least one groove comprises one or more plications.

20. The catheter of claim 1, further comprising at least one side port opening operable to fluidically communicate with at least one inner channel.

21. The catheter of claim 20, wherein at least one side port opening is positioned along the balloon outer surface.Page 19 of 23136989352.7PCT / US24 / 59104 09 December 2024 (09.12.2024)22. The catheter of claim 21, wherein at least one side port opening is positioned along at least one groove.

23. A balloon having an outer surface with one or more grooves forming a grooved surface area and a non-grooved surface area, the grooved surface area inflatable to at least one core diameter and the non-grooved surface area inflatable to at least one outer diameter, whereby at least one outer diameter is greater than at least one core diameter.

24. The balloon of claim 23, wherein the balloon is generally spherical.

25. The balloon of claim 23, wherein the balloon is generally cylindrical.

26. The balloon of claim 23, wherein at least one groove is generally linear.

27. The balloon of claim 26, the balloon comprising a long axis and a short axis that is perpendicular to the long axis, wherein the long axis corresponds to a length of the balloon and the short axis corresponds to a cross sectional perimeter of the balloon, further wherein at least one generally linear groove is generally aligned with at least one axis.

28. The balloon of claim 27, wherein at least one groove is generally aligned with the long axis.

29. The balloon of claim 28, wherein at least one long axis groove extends along the full length of the balloon.

30. The balloon of claim 27, wherein at least one groove is generally aligned with the short axis.

31. The balloon of claim 30, wherein at least one short axis groove extends along the full perimeter of the balloon.

32. The balloon of claim 27, wherein at least one groove is generally aligned with the long axis and at least one groove is generally aligned with the short axis.

33. The balloon of claim 32, further comprising at least one groove that is generally helical.Page 20 of 23136989352.7PCT / US24 / 59104 09 December 2024 (09.12.2024)34. The balloon of claim 27, further comprising at least one groove that is generally helical.

35. The balloon of claim 23, wherein at least one groove is generally helical.

36. The balloon of claim 23, the balloon comprising a long axis and a short axis that is perpendicular to the long axis, wherein the long axis corresponds to a length of the balloon and the short axis corresponds to a cross-sectional perimeter of the balloon, further wherein the at least one groove spirals around the perimeter along the long axis of the balloon.

37. The balloon of claim 23, wherein the balloon outer surface is at least partially less compliant along at least one groove relative to the non-grooved surface area.

38. The balloon of claim 23, the outer surface comprising a plurality of wall thicknesses, wherein grooved surface area wall thickness is at least partially greater than non-grooved surface area wall thickness.

39. The balloon of claim 23, wherein the grooved surface area is at least partially attached to an internal support.

40. The balloon of claim 39, wherein the grooved surface area is at least partially attached to the internal support via one or more stitches.

41. The balloon of claim 23, wherein at least one groove comprises one or more plications.

42. A method of using a balloon and catheter, comprising: directing a catheter comprising a balloon having an outer surface with one or more grooves forming a grooved surface area versus a non-grooved surface area, the grooved surface area inflatable to at least one core diameter and the non-grooved surface area inflatable to at least one outer diameter, at least one outer diameter being greater than at least one core diameter; navigating the catheter wherein the balloon is positioned at a target area of treatment within a tubular structure or cavity; andPage 21 of 23136989352.7PCT / US24 / 59104 09 December 2024 (09.12.2024) selectively inflating the balloon wherein the outer diameter therapeutically engages the target area of treatment and the core diameter does not, wherein fluid communication is maintained across the balloon over at least one part of the grooved surface area.

43. A method of using a balloon, comprising: directing a balloon having an outer surface with one or more grooves forming grooved versus non-grooved surface areas, the grooved surface area inflatable to at least one core diameter and the non-grooved surface area inflatable to at least one outer diameter, whereby at least one outer diameter is greater than at least one core diameter; navigating the balloon to a target area of treatment; and deploying the balloon wherein at least one part of the outer diameter therapeutically engages the target area of treatment.Page 22 of 23136989352.7

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