Device and method for achieving hemostasis in blood vessels

Abstract

A system for effecting hemostasis in a blood vessel includes a balloon insertable within a tissue track, the balloon being positioned outside the blood vessel over an opening formed in the blood vessel. A hemostatic layer is removably positioned on at least a portion of an outer surface of the balloon. A balloon tube is fluidly connected to the balloon and configured to selectively inflate or deflate the balloon. The balloon is inflatable over the opening such that the hemostatic layer is positioned on the outer surface of the blood vessel to close the opening. The hemostatic layer is separable from the balloon and remains positioned on the outer surface of the blood vessel when the balloon is removed from the tissue track and continues to close the opening after removal of the balloon.

Description

Technical Field

[0001] Cross - Reference to Related Applications This disclosure claims the benefit and priority of U.S. Provisional Application No. 63 / 156,861, filed on Mar. 4, 2021, the entire disclosure of which is incorporated herein by reference.

[0002] This disclosure generally relates to devices and methods for hemostasis of blood vessels using an inflatable balloon without leaving any structure within the blood vessel after achieving hemostasis.

Background Art

[0003] Vascular trauma such as arterial or venous trauma can cause rapid blood loss and is potentially fatal if the hemostasis of the blood vessel, that is, the closure and repair of the opening of the bleeding blood vessel, is not performed promptly to quickly stop the blood flow. By performing hemostasis, the cardiovascular system can resume its normal function of supplying blood to various parts of the body at normal blood pressure. Conventionally, hemostasis has been achieved by manually compressing the patient's body part on the patient's skin, but closing the opening is not very effective and may take a relatively long time even if hemostasis is achieved. Furthermore, manual compression requires the patient to lie down for hours, delaying the walking time, that is, the time when the patient can get up and walk around, and is generally uncomfortable for the patient. Vascular closure devices (VCDs) have been used to achieve hemostasis quickly. Such devices generally have an intravascular component (i.e., located within the blood vessel) and an extravascular component (i.e., located outside the blood vessel). Although rapid hemostasis can be achieved using the intravascular and extravascular components, generally the intravascular component remains within the blood vessel even after hemostasis is achieved. Such intravascular components are at risk of peeling off the blood vessel wall and causing embolism events.

Summary of the Invention

[0004]

[0002] Embodiments described herein relate generally to devices and methods for achieving extravascular hemostasis, and more particularly to the use of an inflatable balloon that provides extravascular compression against a vascular opening to achieve hemostasis. A hemostatic layer can be detachably disposed on the balloon such that the balloon positions the hemostatic layer at the vascular opening to close the opening and remains on the exterior surface of the vessel when the balloon is removed. A secondary balloon or anchor can be used to provide intravascular support when the balloon and hemostatic layer are positioned on the exterior surface of the vessel, but is removed from the vessel once hemostasis is achieved.

[0005] In some embodiments, a device for performing hemostasis on a blood vessel includes: a first balloon insertable into a tissue track, the first balloon being positioned outside the blood vessel over an opening formed in the blood vessel; a hemostatic layer removably positioned on at least a portion of an outer surface of the first balloon; and a first balloon tube fluidly connected to the first balloon and configured to selectively inflate or deflate the first balloon; wherein the first balloon is inflatable over the opening such that the hemostatic layer is positioned on the outer surface of the blood vessel to close the opening, and the first balloon applies pressure to the opening to achieve hemostasis, and the hemostatic layer is separable from the first balloon and remains positioned on the outer surface of the blood vessel when the first balloon is removed from the tissue track and continues to close the opening after the first balloon is removed.

[0006] In some embodiments, the device further comprises a carrier tube defining at least one lumen in which the first balloon, the hemostatic layer, and the balloon tube are disposed.

[0007] In some embodiments, the device further includes a sheath defining a central channel in which the first balloon, the hemostatic layer, the first balloon tube, and the carrier tube are disposed, at least a portion of the sheath being removably insertable into the tissue track and the blood vessel.

[0008] In some embodiments, at least one of the distal ends of the sheath or the carrier tube is perforated such that the distal end can be torn by the perforation when the first balloon expands within the distal end.

[0009] In some embodiments, the hemostatic layer is formed of an absorbent material.

[0010] In some embodiments, the device further includes a first guide wire extending through or adjacent to the first balloon, and the distal end of the first guide wire is configured to be removably disposed within the blood vessel through the opening before the first balloon is positioned over the opening.

[0011] In some embodiments, the device includes a second balloon configured to be removably disposed within the blood vessel through the opening such that when inflating each of the first balloon and the second balloon, the hemostatic layer is easily fixed to the outer surface of the blood vessel by interposing the blood vessel wall and the hemostatic layer between the first balloon and the second balloon.

[0012] In some embodiments, the second balloon is axially offset from the first balloon.

[0013] In some embodiments, the device further includes a second balloon tube fluidly connected to the second balloon, and the second balloon tube is configured to selectively inflate or deflate the second balloon.

[0014] In some embodiments, the device further includes a carrier tube defining a first lumen in which the first balloon tube and the first balloon are disposed, and a second lumen axially offset from the first lumen, and the second balloon tube and the second balloon are disposed through the second lumen.

[0015] In some embodiments, the device further includes a second guide wire extending through or adjacent to the second balloon, and the tip of the second guide wire is configured to be removably disposed within the blood vessel before the second balloon is disposed within the blood vessel.

[0016] In some embodiments, the second balloon is axially aligned with the first balloon.

[0017] In some embodiments, the device further includes a second balloon tube fluidly coupled to the second balloon and configured to selectively inflate or deflate the second balloon, and the second balloon tube is disposed through the first balloon tube.

[0018] In some embodiments, the second balloon is axially aligned with the first balloon.

[0019] In some embodiments, the device further includes a second balloon tube fluidly coupled to the second balloon and configured to selectively inflate or deflate the second balloon, and the second balloon tube is disposed through the first balloon tube.

[0020] In some embodiments, the device further includes a carrier tube that defines a lumen in which each of the first balloon tube, the first balloon, the second balloon tube, and the second balloon is disposed.

[0021] In some embodiments, the device further includes an anchor wire having an anchor wire tip configured to be positioned within the blood vessel through the opening, the anchor wire tip being movable between a contracted configuration when the anchor wire tip is positioned outside the blood vessel and an expanded configuration when the anchor wire tip is positioned within the blood vessel, and in the expanded configuration, the anchor wire tip forms an anchor such that when the first balloon is inflated, the wall of the blood vessel and the hemostatic layer are interposed between the first balloon and the anchor, thereby facilitating securing the hemostatic layer to the outer surface of the blood vessel.

[0022] In some embodiments, the anchor wire is formed from a shape memory alloy, and when no force is applied to the anchor wire tip, the anchor wire is in a relaxed state in the expanded configuration.

[0023] In some embodiments, the anchor wire is axially offset from the first balloon.

[0024] In some embodiments, the anchor wire is axially aligned with the first balloon such that the anchor wire is disposed through the first balloon.

[0025] In some embodiments, a method for performing hemostasis on a blood vessel includes inserting a first balloon through a tissue track toward an opening formed in the blood vessel using a first balloon tube fluidly connected to the first balloon so that the first balloon is positioned near the opening formed in the blood vessel; inflating the first balloon so that a tip of the first balloon presses against the outer surface of the wall of the blood vessel to close the opening; maintaining the first balloon in an inflated position for a period of time; deflating the first balloon after a period of time; and withdrawing the first balloon tube, thereby withdrawing the first balloon from the blood vessel.

[0026] In some embodiments, a hemostatic layer is disposed on at least a portion of the outer surface of the first balloon, and when the first balloon is inflated, the hemostatic layer is interposed between the outer surface of the blood vessel wall and the inflated first balloon so that the hemostatic layer closes the opening, and when the first balloon is deflated after a certain period of time, the hemostatic layer is separated from the outer surface of the first balloon so that the hemostatic layer remains disposed on the outer surface of the blood vessel and continues to close the opening even when the first balloon is removed from the tissue track.

[0027] In some embodiments, the method further includes the steps of: inserting a first guidewire through the tissue track until a tip of the first guidewire is positioned through the opening and into the blood vessel before inserting the first balloon through the tissue track, the first balloon being inserted over or adjacent to the first guidewire toward the blood vessel; and removing the first guidewire from the tissue track before removing the first balloon from the tissue track.

[0028] In some embodiments, the method further includes inserting a second balloon into the blood vessel through the opening using a second balloon tube before inflating the first balloon; inflating the second balloon within the blood vessel before inflating the first balloon such that the wall of the blood vessel is interposed between the first and second balloons when the first balloon is inflated; deflating the second balloon while the first balloon is still inflated; and withdrawing the second balloon from the blood vessel.

[0029] In some embodiments, the second balloon is axially offset from the first balloon.

[0030] In some embodiments, the method further includes inserting a sheath over the first guidewire through the tissue track so that a portion of the sheath is inserted into the blood vessel through an opening formed in the blood vessel before inserting the first balloon and the second balloon, the sheath defining a central channel through which a first balloon tube including the first balloon and a second balloon tube including the second balloon are inserted toward the blood vessel; withdrawing the sheath until a sheath tip of the sheath is positioned outside the blood vessel near the opening; and after inflating the second balloon, withdrawing the sheath a second distance without withdrawing the first balloon so that the first balloon is positioned outside the central channel near the opening.

[0031] In some embodiments, the method further includes, prior to inserting the first balloon and the second balloon, inserting a carrier tube through a central channel defined by the sheath toward the blood vessel so that a distal end of the carrier tube is adjacent to the opening formed in the blood vessel, the carrier tube defining a first lumen through which the first balloon tube and the first balloon are inserted and a second lumen axially offset from the first lumen, the second balloon tube and the second balloon being inserted through the second lumen, and the carrier tube together with the sheath being withdrawn from the blood vessel.

[0032] In some embodiments, the first balloon is positioned within a first lumen defined by the carrier tube and the second balloon is positioned within a second lumen defined by the carrier tube, and the step of inserting the first balloon and the second balloon includes inserting the carrier tube through a central channel defined by the sheath toward the blood vessel so that the tip of the carrier tube is adjacent to the opening formed in the blood vessel.

[0033] In some embodiments, the method further includes inserting a second guidewire into the blood vessel through the opening before inserting the second balloon into the blood vessel, the second guidewire extending through or adjacent to the second balloon.

[0034] In some embodiments, the second balloon is axially aligned with the first balloon.

[0035] In some embodiments, the second balloon tube is disposed through the first balloon tube.

[0036] In some embodiments, the method further includes inserting a sheath over the first guidewire through the tissue track so that a portion of the sheath is inserted into the blood vessel through an opening formed in the blood vessel before inserting the first and second balloons, the sheath defining a central channel through which a first balloon tube including the first balloon and a second balloon tube including a second balloon (tube) are inserted toward the blood vessel; retracting the sheath until a sheath tip of the sheath is positioned outside the blood vessel near the opening; and after inflating the second balloon, retracting the sheath a second distance without retracting the first balloon so that the first balloon is positioned outside the central channel near the opening.

[0037] In some embodiments, the method further includes, prior to inserting the first balloon and the second balloon, inserting a carrier tube through a central channel defined by the sheath toward the blood vessel so that a distal end of the carrier tube is adjacent to the opening formed in the blood vessel, the carrier tube defining lumens into which the first balloon tube containing the first balloon and the second balloon tube containing the second balloon are respectively inserted.

[0038] In some embodiments, each of the first balloon and the second balloon is positioned within a lumen defined by a carrier tube, and the step of inserting the first balloon and the second balloon includes inserting the carrier tube toward the blood vessel through a central channel defined by the sheath so that the tip of the carrier tube is adjacent to the opening formed in the blood vessel.

[0039] In some embodiments, the method further includes inserting an anchor wire tip of an anchor wire through the opening into the blood vessel before inflating the first balloon, the anchor wire tip being in a contracted configuration before insertion through the opening and the anchor wire tip being in an expanded configuration that forms an anchor after insertion into the blood vessel such that the wall of the blood vessel is interposed between the first balloon and the anchor when the first balloon is inflated; and withdrawing the anchor wire from the blood vessel by moving the anchor wire tip to the contracted configuration while the first balloon is still inflated.

[0040] In some embodiments, a hemostatic layer is disposed on at least a portion of the outer surface of the first balloon, and when the first balloon is inflated, the hemostatic layer and the wall of the blood vessel are interposed between the inflated first balloon and the anchor so that the hemostatic layer closes the opening, and when the first balloon is deflated after a period of time, the hemostatic layer is separated from the outer surface of the first balloon so that the hemostatic layer remains disposed on the outer surface of the blood vessel and continues to close the opening even when the first balloon is removed from the tissue track.

[0041] In some embodiments, the anchor wire is formed of a shape memory alloy, and when no force is applied to the anchor wire tip, the anchor wire is in a relaxed state in the expanded configuration.

[0042] In some embodiments, the anchor wire is axially offset from the first balloon.

[0043] In some embodiments, the anchor wire is axially aligned with the first balloon such that the anchor wire is disposed through the first balloon.

[0044] It should be understood that all combinations of the foregoing concepts and additional concepts discussed in more detail below (subject to such concepts not being mutually inconsistent) are contemplated as part of the subject matter of the invention disclosed herein. In particular, all combinations of the subject matter recited in the claims set forth at the end of this disclosure are contemplated as part of the subject matter of the invention disclosed herein.

Brief Description of the Drawings

[0045] The foregoing features and other features of the present disclosure will become more fully apparent from the following description and the appended claims in conjunction with the accompanying drawings. It is to be understood that these drawings illustrate only some embodiments of the present disclosure and are not to be considered as limiting its scope, and the present disclosure will be described more specifically and in detail with reference to the accompanying drawings.

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[0046] Reference is made to the accompanying drawings throughout the following detailed description. In the drawings, like symbols typically identify like components unless context dictates otherwise. The illustrative embodiments set forth in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that the aspects of the present disclosure, as generally described and illustrated in the figures herein, can be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are expressly contemplated and form a part of this disclosure.

[0047] The embodiments described herein generally relate to devices and methods for performing hemostasis of extravascular blood vessels, and more particularly to the use of an inflatable balloon to apply extravascular compression to an opening in a blood vessel to achieve hemostasis. The hemostatic layer can be separably disposed on the balloon such that the hemostatic layer is positioned at the opening of the blood vessel by the balloon, closes the opening, and remains on the outer surface of the blood vessel even after the balloon is removed. A secondary balloon or anchor can be used to provide intravascular support when positioning the balloon and the hemostatic layer on the outer surface of the blood vessel, but is removed from the intravascular space once hemostasis is achieved.

[0048] Embodiments of the devices and methods described herein can provide one or more advantages, including, for example: (1) enabling closure of a blood vessel by applying extravascular compression to an opening formed in the blood vessel, thereby achieving hemostasis more rapidly compared to manual compression and compression devices; (2) achieving hemostasis and blood vessel closure without leaving intravascular components within the blood vessel; (3) enabling the hemostatic layer to be positioned on the outer surface of the blood vessel to maintain blood vessel closure even after removal of the extravascular balloon used to apply the compression; and (4) reducing the risk of embolization events, thereby reducing the likelihood of post-treatment complications or death.

[0049] As used herein, the term "proximal end" refers to the end closer to the user of the VCD, and the term "distal end" refers to the end that is distal from the user of the VCD and closer to the subject on whom the blood vessel closure procedure is being performed using the VCD.

[0050] Referring to FIGS. 1 and 2, a VCD 100 for achieving hemostasis of an extravascular blood vessel according to one embodiment is shown. The VCD 100 includes a balloon 102, a balloon tube 104, and may optionally include a sheath 110 and a carrier tube 120.

[0051] 1 illustrates a blood vessel V located within human or animal tissue T. The blood vessel V may include an artery (e.g., a femoral artery, a tibial artery, a leg artery, etc.) or a vein having an opening O. The opening O may have been created, for example, by a surgical procedure. If the opening O is not quickly closed to achieve hemostasis, blood may leak from the opening O, resulting in blood loss and even death.

[0052] A tissue track TT may be formed in tissue T (e.g., by a surgical procedure) to provide access to an underlying blood vessel V and an opening O formed in the blood vessel. For example, prior to performing a surgical procedure, a physician may access the underlying blood vessel V by inserting a needle and sheath through tissue T to form a tissue track TT. A balloon 102 is inserted through the tissue track TT toward blood vessel V via a balloon tube 104 until a portion of the balloon 102 is proximate to the opening O on the outside of the blood vessel V. The balloon tube 104 is fluidly coupled to the balloon 102 and configured to selectively inflate or deflate the balloon 102. The balloon 102 is inflated over the opening O using a gas (e.g., air, oxygen, or any other suitable gas inserted into the balloon 102 via the balloon tube 104) or a liquid (e.g., water, a radiopaque inflation fluid, blood, plasma, saline, contrast fluid, etc.) so that a portion of the balloon 102 contacts the outer surface of the wall of the blood vessel V and applies pressure to close the opening O. In this manner, the balloon 102 closes the blood vessel. The balloon 102 may be maintained in the inflated position for a period of time sufficient to achieve hemostasis and blood vessel closure (e.g., 1 minute, 2 minutes, 5 minutes, 10 minutes, 20 minutes inclusive, or any other suitable period of time as desired).

[0053] The balloon 102 can be formed from any suitable material, such as nylon, polyethylene terephthalate, polyurethane, silicone, polymer, PEBAX, or combinations thereof. The balloon 102 can be coupled to the balloon tube 104 by welding, fusing, crimping (e.g., via a swage band), mechanical coupling (e.g., connecting or folding), or an adhesive. The position of the balloon 102 within the blood vessel V can be established before or after inserting the balloon 102 through the tissue track TT, e.g., via the sheath 110, via the user's manipulation, or via a blood flashback (i.e., backflow) into the balloon tube 104, the carrier tube 120, the sheath 110, or a separate locator. In some embodiments, a guide wire (not shown) can extend through the center of the balloon 102 or adjacent to the balloon 102. In some embodiments, the guide wire can include a retractable structure (e.g., a retractable plate) that is used to establish the position of the balloon 102 within the track TT, i.e., to identify whether the balloon 102 is positioned near the outer surface of the wall of the blood vessel V outside the opening O. In other configurations, the sheath 110 can be used to establish the position. In some embodiments, the balloon 102 may resemble a percutaneous transluminal angioplasty balloon (e.g., fixed around a central guide wire). In other embodiments, the balloon 102 can be disposed and delivered on, adjacent to, on top of, or at the tip of a wire.

[0054] In various embodiments, the outer surface of the balloon 102 may be coated with a non - adhesive coating to prevent the balloon 102 from sticking to the outer surface of the blood vessel V around the opening O. Any non - adhesive coating may use (for example, a hydrophobic coating, a lipophilic coating, a nanoparticle coating, a hydrophilic coating, a PTFE coating, a fluoropolymer coating, etc.). The non - adhesive coating can facilitate the removal of the balloon 102 from the outer surface of the blood vessel V when the balloon 102 is contracted to achieve hemostasis and removed from the tissue track TT. Thereby, it is possible to prevent a blood clot formed in the opening O and closing the opening O from being removed by the balloon 102, and thereby prevent the opening O from reopening during the removal of the balloon 102.

[0055] In some embodiments, the balloon 102 may have a cross - sectional width or diameter in an inflated configuration that does not overly expand the tissue track TT but is still sufficient to close the opening O, and may be large enough to prevent the inflated balloon 102 from being inserted into the blood vessel V through the opening O. In some embodiments, the balloon 102 may have a diameter that is 1X to 2X (times) the diameter of the sheath 110 at the inflated position of the balloon 102. In various embodiments, the sheath 110 may have a diameter in the range of 2 mm to 10 mm (including the boundaries), and the balloon 102 may have a diameter in the range of 2 mm to 20 mm (including the boundaries) at the inflated position.

[0056] The balloon tube 104 may be formed from any suitable material, such as metal, plastic, or polymer (e.g., high-density polyethylene (HDPE), Pebax, nylon, polycarbonate, polyurethane, acrylonitrile butadiene styrene, etc.). The tube 104 may have an inner diameter ranging from 0.2 mm to 1 mm, inclusive, and an outer diameter ranging from 0.3 mm to 2 mm, inclusive. In some embodiments, the balloon tube 104 may be coated with a lubricant or non-stick coating, such as MDX, silicone, etc. In some embodiments, the wall thickness of the balloon tube 104 may be in the range of 0.1 mm to 2.5 mm, inclusive (e.g., in embodiments in which the balloon tube includes a single lumen). In some embodiments, the balloon tube 104, or any other balloon tube described herein, may define multiple lumens through which a fluid can pass (e.g., an air channel for inflating the balloon 102) and another lumen for passing a guidewire (not shown). Ports may be defined in the sidewall or axial end of the balloon tube 104 through which fluid may be communicated into the balloon 102 to inflate it.

[0057] The sheath 110 can be formed from metal, plastic, polymer, or any other suitable biocompatible material, or combinations thereof, and is insertable into the tissue track TT. The carrier tube 120 can be insertable through a central channel 111 defined by the sheath 110 and can define a lumen 121 through which the balloon tube 104, and thus the balloon 102, can be inserted toward the opening O of the blood vessel V. In some embodiments, the sheath 110 is not used, and the carrier tube 120 is placed directly through the tissue track TT. In some embodiments, the sheath 110 can include a product (e.g., a procedure sheath) already present in the tissue track TT, and the carrier tube 120 is inserted through the product toward the blood vessel V. In various embodiments, a fixation mechanism, such as a clip, clamp, or collar, can be coupled to the sheath 110 and configured to secure the sheath 110 in place once the sheath 110 is positioned at a desired location (e.g., by coupling the fixation mechanism to the tissue T).

[0058] Figure 2 shows an exemplary method 200 for achieving hemostasis of a blood vessel using the VCD 100. Method 200 includes, in step 1, inserting the sheath 110 through a tissue track formed in the tissue such that a portion of the sheath 110 (e.g., the sheath tip) is inserted into the blood vessel V through the opening O of the blood vessel V. In step 2, a carrier tube 120 having a balloon 102 and a balloon tube 104 disposed within the lumen 121 of the carrier tube 120 is inserted into a central channel 111 defined by the sheath 110 until the carrier tube tip of the carrier tube 120 is disposed near the sheath tip. In some embodiments, the carrier tube 120 is not used and the balloon 102 may be inserted directly into the central channel 111 of the sheath 110 via the balloon tube 104. In other embodiments, the sheath 110 is not used and the carrier tube 120 may be inserted directly through the tissue track. In still other embodiments, neither the carrier tube 120 nor the sheath 110 is used and the balloon 102 may be inserted through the tissue track toward the opening O via a balloon tube 104 fluidly coupled to the balloon 102.

[0059] In step 3, the sheath 110, together with the carrier tube 120, is withdrawn from the tissue track together with the carrier tube 120 and the balloon 102 until the sheath tip is disposed near the opening O outside the blood vessel V. The user can determine that the sheath tip is disposed at a desired position outside the blood vessel V, for example, by withdrawing the sheath 110 a predetermined distance from the tissue track, feeling a pressure difference, and receiving tactile feedback from the sheath 110 (e.g., via manual sensing or via a tactile feedback sensor disposed at the sheath tip, which can indicate to the user that the sheath 110 is disposed at a desired position outside the blood vessel V), or via a blood flashback from the sheath 110. In this way, the sheath 110 can help to position the balloon 102 at a desired position outside the blood vessel V proximate to the opening O.

[0060] In step 4, without withdrawing the balloon 102, the sheath 110 together with the carrier tube 120 is withdrawn from the tissue track TT, e.g., a sufficient distance so that the sheath 110 and / or carrier tube 120 no longer cover the distal end of the balloon tube 104 and thus the balloon 102, or is withdrawn outside the tissue track TT so that the balloon 102 is positioned outside the central channel 111 and lumen 121 adjacent to the opening O. In step 5, the balloon 102 is inflated (e.g., via a fluid such as saline, contrast agent, or air pumped into the balloon via the balloon tube 104) over the opening outside the vessel V so that the distal end of the balloon 102 presses against the outer surface of the wall of the vessel V, closing the opening O. Inflation can be performed manually or via a computer-controlled pump. The balloon 102 is maintained in the inflated position for a period of time (e.g., a period of time sufficient to allow a clot to form that closes the opening O and promotes hemostasis). In step 6, the balloon 102 is deflated, for example, by withdrawing fluid from the balloon 102 through the balloon tube 104. The balloon 102 is then removed from the tissue track TT, for example, by withdrawing the balloon tube 104, thereby moving the deflated balloon 102 away from the vessel V and into the carrier tube 120.

[0061] In some embodiments, the balloon 102 may be formed from an absorbable material. In such embodiments, the balloon 102 may be separated from the balloon tube 104 after achieving hemostasis in either the inflated or deflated position and remain on the exterior surface of the vessel V to continue to close the opening O when the balloon tube 104 is removed. Over time, the balloon 102 is reabsorbed into the tissue T.

[0062] In some embodiments, a VCD may include a hemostatic layer. Referring now to Figures 3-4, a VCD 300 according to one embodiment is shown. VCD 300 is substantially similar to VCD 100 and includes a balloon 102, a balloon tube 104, both of which may include a sheath 110 and a carrier tube 120. However, unlike VCD 100, a hemostatic layer 106 is removably disposed on at least a portion of the outer surface of balloon 102.

[0063] The hemostatic layer 106 is configured so that when the balloon 102 is inflated over the opening O, the hemostatic layer 106 is disposed on the outer surface of the wall of the blood vessel V, and pressure applied to the opening O by the balloon 102 closes the opening O and promotes clot formation against the hemostatic layer 106. The hemostatic layer 106 is separable from the balloon 102 such that the hemostatic layer 106 remains disposed on the outer surface of the blood vessel V when the balloon 102 is removed from the tissue track TT. In this manner, the hemostatic layer 106 continues to close the opening O even after the balloon 102 is removed from the tissue track TT.

[0064] The hemostatic layer 106 is formed from a biocompatible material. In some embodiments, the hemostatic layer 106 may be formed from an absorbable material. Suitable materials may include, but are not limited to, polyglycolide (PGA), poly(lactic-co-glycolic acid) (PLGA), polylactic acid (PLLA), polycaprolactone, collagen, absorbable fabrics, hydrogels, other suitable materials, or combinations thereof. In some embodiments, the hemostatic layer 106 may be formed into a rigid disk or pellet, or into a flexible, woven layer. In some embodiments, the hemostatic layer 106 may conform to the outer surface of the balloon 102 prior to deployment. In other embodiments, the hemostatic layer 106 may be separate from the balloon 102. In some embodiments, the hemostatic layer 106 may include a hemostatic powder (e.g., chitin, kaolin, silica, polyethylene glycol, cyanoacrylate, gelatin, cellulose, etc.), a hydrogel, collagen, an absorbable adhesive, or other agent that promotes vascular closure. As previously mentioned, to facilitate separation of the hemostatic layer 106 from the outer surface of the balloon 102, the outer surface of the balloon 102 may be coated with a non-stick coating.

[0065] Figure 4A shows an exemplary method 400 for achieving hemostasis of a blood vessel using the VCD 300. Method 200 includes, in step 1, inserting the sheath 110 through a tissue track formed in the tissue such that a portion of the sheath 110 (e.g., the sheath tip) is inserted into the blood vessel V through the opening O of the blood vessel V. In step 2, the carrier tube 120 having the balloon 102 and the balloon tube 104 on which the hemostatic layer 106 is disposed, each disposed within the lumen 121 of the carrier tube 120, is inserted into the central channel 111 defined by the sheath 110 until the carrier tube tip of the carrier tube 120 is positioned near the sheath tip. In some embodiments, the carrier tube 120 is not used and the balloon 102 can be inserted directly through the central channel 111 of the sheath 110 via the balloon tube 104. In other embodiments, the sheath 110 is not used and the carrier tube 120 can be inserted directly through the tissue track. In still other embodiments, neither the carrier tube 120 nor the sheath 110 is used and the balloon 102 can be inserted through the tissue track via the balloon tube 104 toward the opening O.

[0066] In step 3, the sheath 110, together with the carrier tube 120, is withdrawn from the tissue track together with the carrier tube 120 and the balloon 102 until the sheath tip is disposed outside the blood vessel V near the opening O. In step 4, without withdrawing the balloon 102, the sheath 110 is withdrawn outside the tissue track together with the carrier tube 120 such that the balloon 102 is disposed outside the central channel 111 and the lumen 121 in proximity to the opening O. In step 5, the balloon 102 is inflated (e.g., via a fluid such as saline or air sent into the balloon via the balloon tube 104) over the opening outside the blood vessel V such that the hemostatic layer 106 presses against the outer surface of the wall of the blood vessel V to close the opening O. The balloon 102 is maintained in the inflated position for a period of time (e.g., a period sufficient to attach the hemostatic layer 106 over the opening O on the outer surface of the blood vessel V).

[0067] In step 6, balloon 102 is contracted, for example, by withdrawing fluid from balloon 102 via balloon tube 104. In step 7, balloon 102 is removed from the tissue track, for example, by withdrawing balloon tube 104, whereby the contracted balloon 102 moves away from blood vessel V and enters carrier tube 120, and hemostatic layer 106 separates from the outer surface of balloon 102 and remains attached to the outer surface of the wall of blood vessel V. In some embodiments, the user can apply a light pressure to the skin of the subject in which the blood vessel occlusion is being performed to remove the hemostatic layer from balloon 102. In this way, hemostatic layer 106 continues to close opening O even after balloon 102 is removed. In embodiments where hemostatic layer 106 is formed from an absorbent material, hemostatic layer 106 is absorbed by tissue T after the natural absorption time of the absorbent material.

[0068] FIG. 4B is a side view of a sheath of a first configuration having a plurality of perforations at its distal end according to one embodiment. And FIG. 4B shows a sheath in a second configuration in which the distal sheath is torn along the perforations due to the inflation of the balloon within the distal end of the sheath.

[0069] In some embodiments, the sheath distal end of sheath 110 may be perforated or flexible such that the sheath distal end is torn or bent when balloon 102 expands. For example, FIG. 4A shows a side front view of a sheath 110b having a plurality of perforations 114b defined at its distal end 112b. When the first balloon 102 expands within the distal end, the distal end is torn as balloon 102 expands. Alternatively or additionally, the perforations may be made in carrier tube 120, and the distal end of the carrier tube may be perforated or made flexible so as to tear or bend when balloon 102 expands. In various embodiments, the sheath can have a width (e.g., diameter) in the range from 0.2 mm to 10 mm (including the boundaries).

[0070] FIG. 5A shows an exemplary method 500a for achieving hemostasis of a blood vessel using the VCD300a according to one embodiment. The VCD300a is substantially similar to the VCD300, but differs in that it includes a guide wire 108a that can facilitate positioning of the balloon 102 over the opening O. The guide wire 108a can prevent the user from losing sight of the blood vessel V. That is, when the sheath 110b is withdrawn from the blood vessel V or when the sheath 110b is not used, the guide wire 108a maintains access to the blood vessel V and enables guiding the balloon tube 104 towards the blood vessel V when the sheath 110b is removed from the tissue track TT or when the sheath 110b is not used. In some embodiments, the guide wire 108 can extend through the balloon 102, for example, through a lumen defined through the balloon tube 104. In other embodiments, the guide wire 108 can extend adjacent to the balloon 102. For example, the carrier tube 120 can define another lumen adjacent to the lumen 121 in which the balloon tube 104 and the balloon 102 are disposed, and the guide wire 108 can be disposed through that other lumen. The guide wire 108 can be formed from any suitable material, such as stainless steel, titanium, or a shape memory alloy (e.g., copper-aluminum-nickel, nickel-titanium, etc.). The distal end of the guide wire 108 is removably disposed through the opening O in the blood vessel V before positioning the balloon 102 over the opening O and can facilitate positioning of the balloon 102 over the opening O. The guide wire 108a can remain within the blood vessel V as medically necessary. In various embodiments, the guide wire 108 can have a cross-sectional width in the range of 0.2 mm to 0.5 mm (including the boundaries).

[0071] As shown in FIG. 5A, method 500a includes, in step 1, inserting sheath 110 through a tissue track formed in tissue T such that a portion of sheath 110 (e.g., the sheath tip) is inserted into blood vessel V through opening O of blood vessel V, with guidewire 108 extending through lumen 121 and the tip of guidewire 108 being positioned through opening O within blood vessel V. Guidewire 108a may already be positioned at a predetermined location within tissue track TT, with the tip of the guidewire within blood vessel V through opening O, and sheath 110 is positioned within tissue track TT over guidewire 108, with guidewire 108 guiding the position of sheath 110 relative to tissue track TT. In some embodiments, sheath 110 may include a locator (positioner) or dilator (not shown), e.g., a tapered structure within sheath 110 that facilitates guiding of sheath 110 over guidewire 108.

[0072] In step 2, carrier tube 120 having balloon 102 with hemostatic layer 106 and balloon tube 104 is inserted into central channel 111 defined by sheath 110 until the carrier tube tip of carrier tube 120 is positioned near the sheath tip. Balloon tube 104 may be inserted over guidewire 108 (e.g., by sliding guidewire 108 into a guidewire lumen defined within balloon tube 104) or adjacent to guidewire 108 (e.g., carrier tube 120 may define a lumen separate from the guidewire adjacent to lumen 121). Thus, guidewire 108 can guide the displacement of the various components of VCD 300a towards opening O.

[0073] In step 3, the sheath 110 is withdrawn from the tissue track together with the carrier tube 120 and the balloon 102 until the distal end of the sheath is positioned near the opening O outside the blood vessel V. In step 4, the sheath 110 is withdrawn from the tissue track together with the carrier tube 120 without withdrawing the balloon 102 or the guide wire 108, whereby the balloon 102 is positioned close to the opening O and outside the central channel 111 and the lumen 121. In step 5, the balloon 102 is inflated above the opening outside the blood vessel V (e.g., via a fluid such as physiological saline or air sent to the balloon via the balloon tube 104) such that the hemostatic layer 106 presses against the outer surface of the wall of the blood vessel V to close the opening O. The balloon 102 is maintained in the inflated position for a certain period (e.g., a period sufficient to attach the hemostatic layer 106 to the outer surface of the blood vessel V above the opening O).

[0074] In step 6, the balloon 102 is deflated, for example, by withdrawing fluid from the balloon 102 via the balloon tube 104. In step 7, the balloon 102 is removed from the tissue track while the guide wire 108 maintains its position. For example, the balloon tube 104, and thus the deflated balloon 102, is withdrawn into the carrier tube 120 from the blood vessel V along or facilitated by the guide wire 108 such that the hemostatic layer 106 is separated from the outer surface of the balloon 102 and remains attached to the outer surface of the wall of the blood vessel V. In step 8, the guide wire 108 is removed while leaving the hemostatic layer 106 disposed on the outer surface of the blood vessel V.

[0075] FIG. 5B shows another method 500b for hemostasis of a blood vessel using a sheath 110, a balloon tube 504 including a balloon 102, and a hemostatic layer 106, according to one embodiment. The balloon tube 504 functions as a locator and includes a flashback opening 506 formed at its distal end. The flashback opening 506 allows flashback of blood into the balloon tube 504, thereby enabling the user to determine the position of the distal end of the balloon tube 504.

[0076] Method 500b includes, in step 1, inserting sheath 110 through a tissue track formed in tissue such that a portion of sheath 110 (e.g., the distal end of the sheath) is inserted into blood vessel V through the opening of blood vessel V. In step 2, balloon tube 504 is inserted through sheath 110 (e.g., through a dedicated channel defined through sheath 110) until the distal end of balloon tube 504 exits the distal end of the sheath and is positioned within blood vessel V. Insertion of balloon tube 504 may create one, two, or more flashback channels leaving a gap in sheath 110. In some embodiments, sheath 110 is not used and balloon tube 504 is inserted into blood vessel V over a guide wire (e.g., guide wire 108).

[0077] In step 3, sheath 110 is withdrawn from the tissue track together with balloon tube 504 until the distal end of the sheath is positioned near opening O outside blood vessel V rather than at the distal end of balloon tube 504, whereby flashback opening 506 remains within blood vessel V. Flashback (i.e., blood flow) can be observed through balloon tube 504 because blood flows back through flashback opening 506, but not through the lumen defined within sheath 110. Blood flashback through flashback opening 506 can help provide the user with feedback that balloon 102 is at a desired distance from the outer surface of blood vessel V.

[0078] In step 4, sheath 110 is withdrawn from the tissue track without withdrawing balloon tube 504, whereby balloon 102 is positioned near opening O outside the sheath and balloon 102 is inflated to place hemostatic layer 106 at the opening. In step 5, balloon 102 deflates and balloon tube 502 is withdrawn outside blood vessel V and outside the tissue track together with sheath 110 and balloon 102, leaving hemostatic layer 106 disposed on the outer surface of blood vessel V.

[0079] In some embodiments, a separate hemostatic layer wire can be used to position the hemostatic layer on the outer surface of a blood vessel. For example, FIG. 5C shows a method 500c for performing hemostasis of a blood vessel using a sheath 110, a balloon 102, and a hemostatic layer 106, a guide wire 108, and a hemostatic layer wire 514 according to one embodiment.

[0080] Method 500c includes, in step 1, inserting the sheath 110 through a tissue track formed in the tissue such that a portion of the sheath 110 (e.g., the sheath tip) is inserted into the blood vessel V through an opening of the blood vessel V. In step 2, the guide wire 108 is inserted through the sheath 110 together with the balloon 102, for example, through a balloon tube (not shown) on which the hemostatic layer 106 is disposed. Simultaneously or thereafter, the hemostatic layer wire 514 is disposed through the sheath 110 such that the tip of the hemostatic layer wire 514 is disposed within the blood vessel V through the hemostatic layer 106 or, if not, in contact with the hemostatic layer 106. In step 3, the sheath 110 is withdrawn together with the guide wire 108, the balloon 103, and the hemostatic layer 106 until the balloon 102 is disposed near the outer surface of the blood vessel V, the sheath 110 is withdrawn to expose the balloon 102, and the balloon 102 is inflated such that the hemostatic layer 106 is disposed on the outer surface of the blood vessel V, which is facilitated by the hemostatic layer wire 154. In step 4, the hemostatic layer wire 514 is withdrawn from the blood vessel V, leaving the hemostatic layer 106 disposed in the blood vessel V (e.g., the hemostatic layer 106 detaches from the hemostatic layer wire 514 when the hemostatic layer wire 514 is withdrawn). In step 5, the balloon 102 is deflated and the balloon 102 is withdrawn from the tissue track together with the guide wire 108.

[0081] In some embodiments, the balloon 102 is a first balloon 102, the balloon tube 104 is a first balloon tube 104, and the VCD may include a second balloon that facilitates positioning of the first balloon 102 over the vessel V and also provides rear support for compressing the first balloon 102, thereby providing rear support for the hemostatic layer 106 over the opening formed in the vessel. For example, FIG. 6A is a side cross-sectional view of a VCD 600 including a carrier tube 620, a first balloon tube 104 including the first balloon 102 and the hemostatic layer 106, and a second balloon tube 624 including a second balloon 622, each disposed through the carrier tube 620, according to one embodiment. The second balloon 622 is configured to be removably disposed through an opening in the vessel V such that the walls of the vessel V and the hemostatic layer 106 are interposed between the first balloon 102 and the second balloon 622 when each of the first balloon 102 and the second balloon 622 are inflated. This facilitates securing the hemostatic layer 106 to the exterior surface of the blood vessel V.

[0082] The second balloon 622 may have a similar width (e.g., diameter) to the first balloon 102, or may be larger or smaller than the first balloon 102 when each of the first balloon 102 and the second balloon 622 are inflated. The second balloon tube 624 is fluidly coupled to the second balloon 622 and configured to selectively inflate or deflate the second balloon 622. The second balloon tube 624 may be made of the same material as the first balloon tube 104. In some embodiments, the second balloon tube 624 may be stiffer (e.g., have a greater wall thickness or be made of a stiffer material) than the first balloon tube 104.

[0083] As shown in FIG. 6A, the second balloon 622 and the second balloon tube 624 are axially offset (i.e., non-concentric) from the first balloon 102 and the first balloon tube 104 and are disposed within different lumens of the carrier tube 620. For example, FIG. 6B is a front view of the carrier tube 620 of FIG. 6A. The carrier tube 620 defines a first lumen 621 into which the first balloon tube 104 and the first balloon 102 are inserted and a second lumen 623 axially offset from the first lumen 621 into which the second balloon tube 624 and the second balloon 622 are inserted. The second lumen 623 may have a larger cross-section than the first lumen 621, for example, to accommodate, in addition to the second balloon 622, a second guidewire 626 disposed therethrough and / or a second balloon 622 larger than the first balloon 102. In other embodiments, the second balloon 622 may be larger than the first balloon 102, and the second lumen 623 may be smaller than the first lumen 621. In some embodiments, the first balloon tube 104 and the second balloon tube 624 may have an inner diameter in the range of 0.2 mm to 1.0 mm (inclusive) and an outer diameter in the range of 0.3 mm to 2.0 mm (inclusive), and the first balloon 102 and the second balloon 622 have a post-inflation diameter in the range of 2 mm to 20 mm (inclusive). In some embodiments, the VCD 600 may also include a second guidewire 626 extending through or adjacent to the second balloon 622, for example to facilitate positioning of the second balloon 622 within the blood vessel (FIG. 7).

[0084] The first balloon 102 and the second balloon 622 are each independently movable through the respective lumens 621 and 623 of the carrier tube 620. For example, FIG. 7 shows an exemplary method 700 for achieving hemostasis of a blood vessel using a VCD 600. Method 700 includes, in step 1, inserting the sheath 110 (e.g., the sheath tip) and the tip of the second guide wire 626 through a tissue track formed in the tissue T and into the blood vessel V through the opening O of the blood vessel V. In some embodiments, the second guide wire 626 can be removed after the sheath 110 is positioned through the tissue track TT. In other embodiments, it may not be necessary to use the second guide wire 626 or the first balloon guide wire.

[0085] In step 2, the carrier tube 620 having the first balloon 102 and the first balloon tube 104 on which the hemostatic layer 106 is disposed (each disposed within the lumen 621 of the carrier tube 120) is inserted into the central channel 111 defined by the sheath 110 until the carrier tube tip of the carrier tube 620 is located near the sheath tip. Also, upon insertion of the carrier tube 620, the second balloon tube 624 is disposed near the sheath tip within the second lumen 623 of the carrier tube 620 together with the second balloon 622. The second balloon tube 624 can be easily advanced through the second lumen 623 by the second guide wire 626 until the second balloon 622 is disposed within the blood vessel V. In other embodiments, the carrier tube 620 is inserted into the central channel 111 before the first balloon 102 and the second balloon 622 are inserted into their respective lumens 621 and 623.

[0086] In step 3, the second balloon 622 is inflated. In step 4, the sheath 110 is withdrawn from the tissue track together with the carrier tube 620, the first balloon 102, and the second balloon 622 until the second balloon 622 contacts the inner surface of the wall of the blood vessel V. Thereby, the user can be warned that the distal end of the sheath is disposed near the opening O outside the blood vessel V. The user may continue to apply tension to the second balloon 622 toward the blood vessel V to ensure that the second balloon 622 remains in contact with the inner surface of the wall of the blood vessel V until at least the first balloon 102 is inflated.

[0087] In step 5, the sheath 110 is withdrawn from the blood vessel V together with the carrier tube 620 without withdrawing the first balloon 102 so that the first balloon 102 is disposed outside the central channel 111 and the lumen 121 in proximity to the opening O. In some embodiments, the sheath 110 and / or the carrier tube 620 may be withdrawn from the tissue track TT. In step 6, the first balloon 102 is inflated (e.g., via a fluid such as saline or air sent to the balloon via the balloon tube 104) above the opening outside the blood vessel V such that the hemostatic layer 106 presses against the outer surface of the wall of the blood vessel V to close the opening O. Also, by inflating the first balloon 102, the hemostatic layer 106 and the wall of the blood vessel V are interposed between the first balloon 102 and the second balloon 622. The first balloon 102 is maintained in the inflated position for a certain period (e.g., a period sufficient for the hemostatic layer 106 to adhere to the outer surface of the blood vessel V over the opening O).

[0088] In step 7, the second balloon 622 contracts and is withdrawn from the blood vessel V, while the first balloon 102 remains inflated and applies pressure to the hemostatic layer 106. In step 8, the first balloon 102 is contracted, for example, by withdrawing fluid from the balloon 102 through the balloon tube 104. In step 9, the balloon 102 is removed from the tissue track, for example, by withdrawing the balloon tube 104, whereby the contracted balloon 102 leaves the blood vessel V and enters the carrier tube 120, whereby the hemostatic layer 106 separates from the outer surface of the balloon 102 and remains attached to the outer surface of the wall of the blood vessel V.

[0089] In some embodiments, the VCD600 may also include a first guide wire 108 to facilitate positioning of the first balloon 102 on the blood vessel V. For example, FIG. 8 shows an exemplary method 800 for achieving hemostasis of a blood vessel using the VCD600. Method 800 includes, in step 1, inserting the sheath 110 (e.g., the tip of the sheath) and the tip of the second guide wire 626 into the blood vessel V through the opening O of the blood vessel V by inserting the sheath 110 together with the second guide wire 626 through a tissue track formed in the tissue.

[0090] In step 2, a carrier tube 620 having the first balloon 102 and the first balloon tube 104 on which the hemostatic layer 106 is disposed (each disposed within the lumen 621 of the carrier tube 120) is inserted into the central channel 111 defined by the sheath 110 until the carrier tube tip of the carrier tube 120 is located near the sheath tip and the tip of the first guide wire 1 extends into the blood vessel V. Also, by inserting the carrier tube 620, the second balloon tube 624 is disposed near the tip of the sheath within the second lumen 623 of the carrier tube 620 together with the second balloon 622. The second balloon tube 624 can be easily advanced through the second lumen 623 by the second guide wire 626 until the second balloon 622 is disposed within the blood vessel V.

[0091] Steps 3-8 are substantially the same as steps 3-8 of method 700, with the only difference being that the positioning of the first balloon 102 on the blood vessel V is facilitated by the first guide wire 108. In step 9, the first balloon 102 is removed from the tissue track without removing the first guide wire. In other embodiments, the first guide wire 108 is removed before the first balloon 102 is removed from the tissue track TT. In step 10, the first guide wire 108 is removed from the tissue track, leaving the hemostatic layer 106 disposed on the outer surface of the blood vessel V.

[0092] In some embodiments, the first balloon and the second balloon may be axially aligned with each other and configured to move independently of each other. For example, FIG. 9 shows an exemplary method 900 for achieving hemostasis of a blood vessel using a VCD 900a. The VCD 900a includes a sheath 110, a first balloon tube 930, a first balloon 102 fluidly coupled to the first balloon tube 930 and having a hemostatic layer 106 disposed on at least a portion of its outer surface, a first guide wire 108, a second balloon 622 coupled to a second balloon tube 624, and a carrier tube 620.

[0093] Unlike the VCD 600, the second balloon 622 is axially aligned with the first balloon 102. For example, the first balloon tube 930 can define a lumen in which the second balloon tube 624 is disposed such that the first balloon tube 930 and the second balloon tube 624 are coaxial with each other. The first balloon tube 930 and the second balloon tube 624 can be movable relative to each other, for example, in a telescopic configuration. The first balloon 102 can be disposed around the outer periphery of the first balloon tube 930, can have, for example, a donut shape, and the first balloon tube 930 can define a port in its sidewall through which fluid is transmitted into the first balloon 102 to inflate the first balloon 102.

[0094] In some embodiments, the carrier tube 920 defines a single lumen 921 in which the first balloon tube 930 is slidably disposed, and the second balloon tube 624 is disposed through the first balloon tube 930. The first guide wire 108 can be disposed through the lumen of the second balloon tube 624 such that the first guide wire 108 is coaxial with each of the first balloon tube 930 and the second balloon tube 624. In other embodiments, the first guide wire 108 may be axially offset from the first and second balloon tubes 930 and 624 (e.g., through the same lumen adjacent to the first and second balloon tubes 930 and 624, or through a separate lumen defined within the carrier tube 920 parallel to the lumen 921 of the carrier tube 920).

[0095] Method 900 includes, in step 1, inserting the sheath 110 together with the first guide wire 108 through a tissue track formed in the tissue such that a portion of the sheath 110 (e.g., the sheath tip) and the tip of the first guide wire 108 are inserted into the blood vessel V through the opening O of the blood vessel V.

[0096] In step 2, a carrier tube 920 having a first balloon tube 930 and a first balloon 102 on which a hemostatic layer 106 is disposed (each being disposed within the lumen 921 of the carrier tube 920) is inserted into a central channel 111 defined by a sheath 110 until the carrier tube tip of the carrier tube 920 is located near the sheath tip. Also, upon insertion of the carrier tube 620, a second balloon tube 624 together with a second balloon 622 is disposed near the sheath tip within a lumen 623 defined by the first balloon tube 930. The second balloon tube 624 can be easily advanced through the second lumen 623 by a first guide wire 108 until the second balloon 622 is disposed within the blood vessel V. In other embodiments, the carrier tube 920 is inserted into the central channel 111 before the first balloon 102 and the second balloon 622 are inserted into the lumen 921.

[0097] In step 3, the second balloon 622 is inflated. In step 4, the sheath 110 is withdrawn from the tissue track together with the carrier tube 920, the first balloon 102, and the second balloon 622 until the second balloon 622 contacts the inner surface of the wall of the blood vessel V. In step 5, the sheath 110 is withdrawn out of the tissue track together with the carrier tube 620 without withdrawing the first balloon 102, thereby disposing the first balloon 102 outside the central channel 111 and the lumen 921 in proximity to the opening O.

[0098] In step 6, the first balloon 102 is inflated over the opening O outside the blood vessel V (e.g., via a fluid such as physiological saline or air sent to the first balloon 102 through the first balloon tube 930) such that the hemostatic layer 106 presses against the outer surface of the wall of the blood vessel V to close the opening O. Also, when the first balloon 102 is inflated, the hemostatic layer 106 and the wall of the blood vessel V will be interposed between the first balloon 102 and the second balloon 622, whereby the hemostatic layer 106 tampers between the first balloon 102 and the second balloon 622. The first balloon 102 is maintained in the inflated position for a certain period (e.g., a period sufficient to attach the hemostatic layer 106 to the outer surface of the blood vessel V over the opening O).

[0099] In step 7, the second balloon 622 is deflated and withdrawn from the blood vessel V, and in some embodiments, the carrier tube 620 is also withdrawn through the first balloon tube 930 via the second balloon tube 624. In some embodiments, in step 7, the first guide wire 108 may also be withdrawn from the tissue track. In step 8, the first balloon 102 is deflated, for example, by withdrawing fluid from the first balloon 102 via the first balloon tube 930. In step 9, the first balloon 102 may be removed from the tissue track TT, for example, by withdrawing the balloon tube 930, thereby placing the deflated balloon 102 into the carrier tube 120 away from the blood vessel V, or by simultaneously withdrawing the carrier tube 120 and the balloon tube 930 from the tissue track TT, whereby the hemostatic layer 106 is separated from the outer surface of the balloon 102 and remains attached to the outer surface of the wall of the blood vessel V.

[0100] In some embodiments, the first balloon and the second balloon may be axially aligned with each other and positioned at a fixed distance from each other. For example, FIG. 10 illustrates an exemplary method 1000 for achieving hemostasis in a blood vessel using a VCD 1000a. The VCD 1000a includes a sheath 1010 defining a central channel 1011, a balloon tube 1030, a first balloon 102 fluidly coupled to the balloon tube 1030 and having a hemostatic layer 106 disposed on at least a portion of its outer surface, a first guidewire 108, and a second balloon 622 also coupled to the balloon tube 1030.

[0101] The second balloon 622 is disposed on the balloon tube 1030 closer to a distal end of the balloon tube 1030 than the first balloon 102, such that when the distal end of the tube 1030 is inserted through an opening O defined in the blood vessel V, the second balloon 622 enters the blood vessel V before the first balloon 102. The balloon tube 1030 may be structured to independently inflate or deflate the first and second balloons 102 and 622, for example, to define separate lumens for selectively and independently communicating inflation fluid to each of the first and second balloons 102 and 622. Thus, the first and second balloons 102 and 622 are axially aligned and axially spaced apart by a predetermined distance. The separation distance may be selected such that the hemostatic layer 106 is tamp or compressed between the first balloon 102 and the second balloon 622 when each of the first balloon 102 and the second balloon 622 is inflated. Although not shown, in some embodiments, the VCD 1000a may include a carrier tube (eg, carrier tube 920).

[0102] The method 1000 includes, in step 1, inserting a sheath 1110 together with a first guidewire 108 through a tissue track formed in tissue T such that a portion of the sheath 1010 (e.g., a sheath tip) and a tip of the first guidewire 108 are inserted into blood vessel V through an opening O of the blood vessel V.

[0103] In step 2, the balloon tube 1030, including the first balloon 102 with the hemostatic layer 106 disposed thereon and the second balloon 622, is inserted through the central channel 1011 of the sheath 1010 until the second balloon 622 extends beyond the distal end of the sheath into the blood vessel V. Displacement of the balloon tube 1030 may be facilitated or guided by the first guidewire 108.

[0104] In step 3, the second balloon 622 is inflated. In step 4, the sheath 1010, together with the balloon tube 1030, is withdrawn from the tissue track until the second balloon 622 contacts the inner surface of the wall of the vessel V. In step 5, the sheath 1010 is withdrawn out of the tissue track without withdrawing the balloon tube 1030, thereby causing the first balloon 102 to be positioned near the outer opening O of the central channel 1011.

[0105] In step 6, the first balloon 102 is inflated (e.g., via a fluid such as saline or air delivered to the first balloon 102 via the first balloon tube 930) over the opening O outside the blood vessel V such that the hemostatic layer 106 presses against the outer surface of the wall of the blood vessel V to close the opening O. Further, the hemostatic layer 106 is interposed between the first balloon 102 and the second balloon 622. The first and second balloons 102 are maintained in the inflated position for a period of time (e.g., a period of time sufficient to attach the hemostatic layer 106 to the outer surface of the blood vessel V over the opening O). As shown in FIG. 10, in step 6, the first guidewire 108 may be withdrawn from the tissue track. In other embodiments, the first guidewire 108 may be withdrawn from the tissue track simultaneously with the balloon tube 1030 or after the balloon tube 1030 is withdrawn from the tissue track.

[0106] In step 7, each of the first and second balloons 102 and 622 are deflated (e.g., simultaneously, or with the first balloon 102 being deflated before or after the second balloon 622 is deflated). In step 8, the balloon tube 1030 is withdrawn from the tissue track, leaving behind the hemostatic layer 206 disposed on the exterior surface of the vessel V.

[0107] In some embodiments, the VCD may include a tamper tube to facilitate positioning the hemostatic layer 106 on the outer surface of the blood vessel. For example, FIG. 11 illustrates a method 1100 for performing hemostasis on a blood vessel using a VCD 1100a. The VCD 1100a is similar to the VCD 1000a, in that the VCD 1100a includes a sheath 1010, a balloon tube 1030, a first balloon 102, a hemostatic layer 106, a second balloon 622 axially aligned with the first balloon 102, and a first guidewire 108. However, unlike the VCD 1000a, the VCD 1100a also includes a tamper tube 1040 configured to compress or tamp the hemostatic layer 106 on the outer surface of the blood vessel V to maintain the hemostatic layer 106 on the outer surface of the blood vessel V after the balloon tube 1030 is withdrawn from the tissue track.

[0108] The method 1100 includes, in step 1, inserting a sheath 1110 together with a first guidewire 108 through a tissue track formed in tissue T such that a portion of the sheath 1010 (e.g., a sheath tip) and a tip of the first guidewire 108 are inserted into blood vessel V through an opening O of the blood vessel V.

[0109] In step 2, the balloon tube 1030, which includes the first balloon 102 with the hemostatic layer 106 disposed thereon and the second balloon 622, is inserted through the central channel 1011 of the sheath 1010 until the second balloon 622 extends into the blood vessel V beyond the sheath tip. Further, the tamp tube 1040 is also inserted through the central channel 1011 such that the first balloon 102 extends beyond the tip of the tamp tube 1040 and the second balloon 622 expands. The tamp tube 1040 applies a tamp to facilitate hemostasis by the hemostatic layer 106 and / or removal of the hemostatic layer 106 from the outer surface of the first balloon 102 when pulling the first balloon 102 out of the tissue track TT, i.e., functions to press the first balloon 102 and / or the hemostatic layer 106 against the wall of the blood vessel V. The displacement of the balloon tube 1030 can be facilitated or induced by the first guide wire 108.

[0110] In step 3, the sheath 1010 is withdrawn from the tissue track together with the balloon tube 1030 and the tamp tube 1040 until the second balloon 622 contacts the inner surface of the wall of the blood vessel V. In step 4, the sheath 1010 is withdrawn from the tissue track without withdrawing the balloon tube 1030 or the tamp tube 1040.

[0111] In step 5, the tamp tube 1040 is axially displaced within the tissue track toward the blood vessel V over the first balloon 102 which is still in the deflated position. Thereby, the tip of the tamp tube 1040 contacts the hemostatic layer 106, the hemostatic layer 106 unfolds (is deployed), the layer is disposed over the opening O, and closes the opening O. In step 6, the tamp tube 1040 is displaced away from the blood vessel V and the first balloon 102 expands such that the hemostatic layer 106 and the wall of the blood vessel V are interposed between the first balloon 102 and the second balloon 622. The first and second balloons 102 and 622 can be maintained in their inflated positions for a period sufficient to achieve hemostasis as described above.

[0112] In step 7, the second balloon 622 is deflated. As shown in FIG. 11, in step 7, the first guide wire 108 may be withdrawn from the tissue track. In other embodiments, the first guide wire 108 may be withdrawn from the tissue track simultaneously with the balloon tube 1030, or after the balloon tube 1030 has been withdrawn from the tissue track.

[0113] In step 8, the first balloon 102 is deflated, and the tamp tube 1040 moves back towards the blood vessel V until the tip of the tamp tube 1040 contacts the hemostatic layer 106. In step 9, the balloon tube 1030 is withdrawn from the tissue track without moving the tamp tube 1040, thereby leaving the tip of the tamp tube 1040 in contact with the hemostatic layer 106 and separating the hemostatic layer 106 from the first balloon 102. This prevents the hemostatic layer 106 from being removed from the outer surface of the blood vessel V when the balloon tube 1030 is withdrawn from the tissue track. In step 10, the tamp tube 1040 is removed from the tissue track.

[0114] In some embodiments, the VCD may include an anchor to provide posterior support for compressing or wedging the hemostatic layer 106 against the outer surface of the blood vessel V. FIG. 12 shows a method 1200 for hemostasis of a blood vessel using a VCD 1200a that includes a sheath 110, a carrier tube 620, a first balloon tube 104, a first balloon 102, a hemostatic layer 106, and an anchor wire 1250, according to one embodiment.

[0115] The anchor wire 1250 includes an anchor wire tip 1251 configured to be disposed within the blood vessel V through the opening O. The anchor wire tip 1251 is selectively movable between a contracted configuration when the anchor wire tip 1251 is disposed outside the blood vessel V and an expanded configuration when the anchor wire tip 1251 is disposed within the blood vessel. In the expanded configuration, the anchor wire tip 1251 forms the anchor 1252 such that when the first balloon 102 is inflated, the wall of the blood vessel V and the hemostatic layer 106 are interposed between the first balloon 102 and the anchor 1252, facilitating fixation of the hemostatic layer 106 to the outer surface of the blood vessel V. The anchor wire 1250 is axially offset from the first balloon 102. In some embodiments, the first balloon 102 and the first balloon tube 104 are disposed through the first lumen 621 of the carrier tube 620, and the anchor wire 1250 is disposed through the second lumen 623 of the carrier tube 620 or any other carrier tube. The anchor wire 1250 and the first balloon tube 104 are independently movable through the respective lumens 621 and 623 of the carrier tube 620. In other embodiments, the carrier tube 620 can define a single lumen, and the first balloon tube 104 and the anchor wire 1250 can be disposed through the same lumen while being axially offset from each other.

[0116] In some embodiments, the anchor wire 1250 may be formed from a shape memory alloy (e.g., copper-aluminum-nickel, nickel-titanium, etc.). The anchor wire tip 1251 may be preformed into a desired shape (e.g., a figure-of-eight shape) to form the anchor 1252. The anchor wire 1250 may be configured to contract and straighten while the anchor wire tip 1251 passes through the carrier tube 620 through its respective lumen (e.g., lumen 623) and expand to form the anchor 1252 emerging from the carrier tube 620. In other embodiments, the anchor 1252 may include a flexible cage, a flexible disk, or any other flexible structure for coupling to the anchor wire tip 1251. In such embodiments, the anchor 1252 may be configured to bend into a contracted or folded position when positioned within the lumen 623 of the carrier tube 620 and expand upon exiting the carrier tube 620. When the anchor 1252 is replaced within the carrier tube 620, the anchor 1252 returns to the contracted or folded position. In some embodiments, the anchor wire 1250 is formed of a shape memory alloy. In such embodiments, the anchor wire 1250 is in a relaxed state in the expanded configuration when no force is applied to the anchor wire tip by the walls of a lumen (e.g., lumen 623).

[0117] The method 1200 includes, in step 1, inserting the sheath 110 with the anchor wire 1250 through a tissue track formed in the tissue T such that a portion of the sheath 110 (e.g., the sheath tip) and the anchor wire tip 1251 of the anchor wire 1250 are inserted through the opening O and into the blood vessel V. The anchor wire tip 1251 may be inserted a predetermined distance such that a portion of the anchor wire tip 1251 that forms the anchor 1252 remains within the sheath 110.

[0118] In step 2, a carrier tube 620 having a first balloon 102 and a first balloon tube 104 on which a hemostatic layer 106 is disposed (each being disposed within the lumen 621 of the carrier tube 620) is inserted into a central channel 111 defined by a sheath 110 until the carrier tube tip of the carrier tube 120 is located near the sheath tip. The carrier tube 620 can be inserted into the sheath 110 such that an anchor wire 1250 is disposed within each lumen (e.g., lumen 623) defined by the carrier tube 620. Thus, the anchor wire 1250 can also serve to guide or facilitate movement of the carrier tube 620 toward the blood vessel V. The carrier tube 620 is inserted such that the anchor wire 1250 is axially offset from the first balloon 102 and is axially offset from the anchor wire 1250.

[0119] In step 3, the anchor wire tip 1251 is further inserted into the blood vessel V or is manipulated such that the anchor wire tip 1251 forms an anchor 1252. In step 4, the sheath 110 is withdrawn from the tissue track together with the carrier tube 620, the first balloon 102, and the anchor wire 1250 until the anchor 1252 contacts the inner surface of the wall of the blood vessel V. Thereby, the user can be warned that the tip of the sheath is disposed near the opening O outside the blood vessel V.

[0120] In step 5, the sheath 110 is withdrawn outside the tissue track together with the carrier tube 620 without withdrawing the first balloon 102 so that the first balloon 102 is disposed outside the central channel 111 and the lumen 121 close to the opening O. In step 6, the first balloon 102 is inflated over the opening O outside the blood vessel V such that the hemostatic layer 106 presses against the outer surface of the wall of the blood vessel V to close the opening O. By inflating the first balloon 102, the hemostatic layer 106 and the wall of the blood vessel V are interposed between the first balloon 102 and the anchor 1252. The first balloon 102 is maintained in the inflated position for a certain period (for example, a period sufficient for the hemostatic layer 106 to adhere to the outer surface of the blood vessel V over the opening O).

[0121] In step 7, while the first balloon 102 is still inflated and applying pressure to the hemostatic layer 106, the anchor wire 1250 is withdrawn from the blood vessel V, and in some embodiments, the carrier tube 620 is also withdrawn. For example, the anchor wire 1250 may be manipulated to deploy the anchor wire tip 1251, or the anchor wire 1250 may be drawn into the carrier tube 620, whereby the anchor wire tip 1251 is deployed and straightened, enabling the anchor wire 1250 to be withdrawn from the blood vessel V.

[0122] In step 8, the first balloon 102 is deflated by withdrawing fluid from the balloon 102, for example, via the balloon tube 104. In step 9, the balloon 102 is removed from the tissue track, for example, by withdrawing the balloon tube 104, whereby the deflated balloon 102 is separated from the blood vessel V (for example, into or together with the carrier tube 120), and thereby the hemostatic layer 106 is separated from the outer surface of the balloon 102 and remains attached to the outer surface of the wall of the blood vessel V.

[0123] FIG. 13 shows another method 1300 for hemostasis of a blood vessel using a VCD 1300a that includes a sheath 110, a carrier tube 620, a first balloon tube 104, a first balloon 102, a first guide wire 108, a hemostatic layer 106, and an anchor wire 1250. Method 1300 is substantially the same as method 1200, except that in step 2, the point at which the tip of the first guide wire 108 is inserted into the blood vessel V is different before the first balloon tube is inserted through the tissue track toward the opening O of the blood vessel V. Further, in step 9, the first guide wire 108 is finally withdrawn from the tissue track.

[0124] In some embodiments, the anchor wire 1250 can be axially aligned with the first balloon 102 such that the anchor wire 1250 is disposed through the first balloon 102. For example, FIG. 14 shows an exemplary method 1400 for achieving hemostasis of a blood vessel using a VCD 1400a. The VCD 1400a includes a sheath 110, a first balloon tube 930, a first balloon 102 fluidly coupled to the first balloon tube 1430 and having a hemostatic layer 106 disposed on at least a portion of its outer surface, a first guide wire 108, an anchor wire 1250, and a carrier tube 620. Method 1400 is substantially the same as method 900, except that in step 2, instead of inserting the second balloon tube 624 through the first balloon tube 1430, the first balloon tube 1430 is inserted onto an anchor wire 1450 such that the anchor wire is coaxial or axially aligned with the first balloon tube 1430 (e.g., disposed through a lumen defined through the first balloon tube 1430).

[0125] Figures 15A and 15B are side views of an anchor 1552 of a first configuration and a second configuration, respectively, coupled to an anchor wire 1550 for use in a VCD, such as any VCD described herein. The anchor 1252 can include a flat plate or disk pivotally attached to a pivot mount 1554 at the tip of the anchor wire 1550. The pivot mount 1554 can be disposed at the central portion of the anchor 1552. In the first configuration, the anchor 1252 is oriented parallel to the anchor wire 1550. This facilitates entry of the anchor 1552 into the opening of the blood vessel, as described above. In the second configuration, the anchor 1552 pivots about its pivot mount 1554 such that the anchor 1552 is oriented substantially parallel to the longitudinal axis of the blood vessel (e.g., at an angle in the range of about 0 ± 5 degrees). In the second configuration, the anchor 1552 provides a rear support for tamping the hemostatic layer 106, as described above. In some embodiments, the anchor 1552 can move between the first configuration and the second configuration via a biasing member or an external manipulation. In some embodiments, the VCD can include any suitable means for moving the anchor 1552 between the first configuration and the second configuration, holding the anchor 1552 in a predetermined position, and / or removing the anchor 1552 from the blood vessel.

[0126] FIG. 16A1 is a side view of an anchor 1652a in a first configuration attached to an anchor wire 1650a used in any of the VCDs described herein, according to one embodiment, and FIG. 16A2 shows the anchor 1652a in a second configuration. The anchor 1652a may be formed from a flexible material or a shape memory alloy. In the first configuration, the anchor 1652a bends away, i.e., defines a curvature such that when the anchor wire 1650a is inserted into a vessel, the periphery of the anchor 1652a is located distal (i.e., proximal to the user) from the vessel relative to the location of the anchor 1652a coupled to the anchor wire 1650a. This facilitates insertion of the anchor 1652a into the vessel. In the second configuration, the anchor 1652a is located within the vessel and bends in a direction opposite to the first configuration to provide rearward support for tamping the hemostatic layer in cooperation with the extravascular balloon, and to facilitate removal of the anchor 1652a from the vessel.

[0127] The anchor 1652a may be maintained in a first configuration by a lumen of a carrier tube in which the anchor 1652a and anchor wire 1650a are disposed. When the anchor 1652a emerges from the carrier tube into the vessel, the anchor 1652a moves to (e.g., is biased to move to) the second configuration. The anchor 1652a may then be withdrawn from the vessel via the carrier tube as the anchor wire 1650a is withdrawn from the vessel.

[0128] Figures 16B1 to 16B2 show an anchor wire 1650b configured to form an anchor 1652b according to one embodiment. The anchor wire 1650b can be formed from a shape memory alloy. The tip of the anchor wire 1650b includes a tip first portion 1650b1 and a tip second portion 1650b2. The tip first portion 1650b1 and the tip second portion 1650b2 may be in a contracted linear configuration while being disposed in a first configuration within the carrier tube 1620b. When the anchor wire 1650b is linearly displaced within the carrier tube 1620b and the tip of the anchor wire 1650b appears from the tip of the carrier tube 1620b, as shown in Figure 16B2, the tip first portion 1652b and the tip second portion 1652b bend in opposite directions to form the anchor 1652b in a second configuration.

[0129] Figures 17A to 21B show top views and side views of various extravascular balloons for use with a VCD according to various embodiments. For example, Figure 17A shows a top view of a donut-shaped extravascular balloon 1702, and Figure 17B shows a side view of the balloon 1702. The donut-shaped extravascular balloon can be configured to be disposed around a balloon tube such that the balloon tube is disposed through the extravascular balloon 1702.

[0130] Figure 18A shows a top view of a disk-shaped extravascular balloon 1802, and Figure 18B shows a side view of the balloon 1802. The extravascular balloon 1802 can be disposed at the tip or sidewall of the balloon tube.

[0131] FIG. 19A shows a top view of an extravascular balloon 1902 according to an embodiment, and FIG. 19B shows a side view of the balloon 1902. The balloon 1902 is generally disk-shaped and further includes a slot 1904 defined through the balloon 1902. The slot 1904 is configured to accommodate a guide wire or, in other embodiments, an anchor wire passing through the slot 1904. In other embodiments, a balloon tube may be disposed through the slot 1904, and the side walls of the balloon forming the slot 1904 may be coupled to the outer surface of the balloon tube.

[0132] FIG. 20A is a top view of a teardrop-shaped extravascular balloon 2002, and FIG. 20B is a side view of the balloon 2002. The teardrop-shaped extravascular balloon 2002 can facilitate applying a compressive force to an opening of a blood vessel to obtain occlusion of the blood vessel.

[0133] FIG. 21A is a top view of an extravascular balloon 2102 according to another embodiment, and FIG. 21B is a side view of the balloon 2102. The balloon 2102 has a generally cylindrical profile.

[0134] 22A shows a side perspective view of a balloon tube 2204 fluidly coupled to a balloon 2202 with the balloon 2202 in a deflated configuration, according to one embodiment, and FIG. 22B shows a perspective view of the balloon 2202 in an inflated configuration. The balloon 2202 is disposed around the balloon tube 2204 such that the balloon tube 2204 is disposed through the balloon 2202. The hemostatic layer 2206 is disposed on the outer surface of a portion of the balloon 2202 located near the distal end 2207 of the balloon tube 2204 such that the balloon tube 2204 is also disposed through the hemostatic layer 2206. In other embodiments, the balloon 2202 may be disposed at the distal end of the balloon tube 2204 such that the balloon tube 2204 is not disposed through the balloon 2202 or the hemostatic layer 2206. A port 2205 is defined in a sidewall of the balloon tube 2204 and is in fluid communication with the interior volume of the balloon 2202. The balloon tube 2204 is configured to deliver fluid through the port 2205 into the balloon 2202 to inflate the balloon 2202 .

[0135] Figure 23A shows a side view of a portion of a balloon tube 2304 fluidly connected to an extravascular balloon 2302 with the balloon 2302 in a deflated configuration, according to one embodiment, and Figure 23B shows the balloon 2302 in an inflated configuration. The balloon 2302 has a donut-shaped cross-section and is disposed about the exterior surface of the balloon tube 2304.

[0136] FIG. 24A is a top front perspective view of a balloon tube 2404 configured for use with either an extravascular balloon or an intravascular balloon as described herein, FIG. 24B is a bottom front perspective view of the balloon tube 2404, and FIG. 24C is a rear top perspective view of the balloon tube 2404. The balloon tube 2404 defines a port 2405 in a sidewall proximate to the distal end 2407 of the balloon tube 2404, through which fluid can be selectively sent into or taken out of a balloon coupled to the balloon tube 2404 to inflate or deflate the balloon. The slot 2409 can be defined in a sidewall of the balloon tube 2404 near the proximal end 2411 of the balloon tube 2404 opposite the distal end 2407. The actuating member is coupled to the slot 2409 to axially displace the balloon tube 2404, for example, to move the balloon tube 2404 toward the outer surface of a blood vessel to dispose an extravascular balloon near the outer surface of the blood vessel, insert the distal end 2407 into the blood vessel through an opening formed in the wall of the blood vessel, and / or withdraw the balloon tube 2404 from the blood vessel or tissue track.

[0137] FIG. 25A is a top front perspective view of a carrier tube 2520 according to one embodiment, and FIG. 25B is a front view of the carrier tube 2520. As shown in FIGS. 25A-25B, the carrier tube 2520 is a generally cylindrical member that defines a first lumen 2521 and a second lumen 2523 that is adjacent to and axially extends through the first lumen 2521. In some embodiments, a first balloon tube that includes an extravascular balloon is linearly displaceable through the first lumen 2521, and a second balloon tube or an anchor wire that includes a second balloon is linearly displaceable through the second lumen 2523. In other embodiments, a carrier tube having a single lumen may be used, and a first balloon tube that includes a first balloon and a second balloon tube that includes a second lumen (e.g., axially aligned or axially offset from each other) are disposed through the single lumen.

[0138] The hub 2522 is coupled to the proximal end of the carrier tube 2520. The hub 2522 may include multiple arms 2525 extending axially from the hub 2522 toward the distal end of the carrier tube 2520. The multiple arms 2525 may be disposed about the carrier tube 2520 radially spaced apart from the outer surface of the carrier tube 2520. In some embodiments, the multiple arms 2525 may function as snap-fit arms to which a sheath (e.g., sheath 110) may be coupled. In some embodiments, coupling the sheath to the hub 2522 may allow the carrier tube 2520 to move synchronously with the sheath without any relative movement between the sheath and the hub 2522.

[0139] The connecting assembly 2524 is coupled to the hub 2522 and couples the hub 2522, thereby configuring the carrier tube 2520 to be coupled to a handle used to operate a VCD including the carrier tube 2520. The connecting assembly 2524 can include a first connecting arm 2524a and a second connecting arm 2524a, with each connecting arm extending axially from the hub 2522 in a direction away from the carrier tube 2520. The first connecting arm 2524a is radially spaced from the second connecting arm 2524b. A first shelf 2526a and a second shelf 2526b extend radially from the distal ends of the first connecting arm 2524a and the second connecting arm 2524b, and can be used to snap-fit the connecting arms to a handle (e.g., the handle assembly 2860 shown in FIGS. 28-29). A plurality of detents 2528 can project from the respective outer surfaces of the first and second connecting arms 2524a and 2524b and can be configured to mate with corresponding recesses defined within the handle to secure the first and second connecting arms 2524a and 2524b to the handle. The first shelf 2526a and the second shelf 2526b can also be engaged by a user to release the connecting arms 2524a / b, such that the connecting arms 2524a / b can move between a first position where only a portion of the detent 2528 engages a portion of the recess, or a position where all of the detent 2528 engages the corresponding recess. In this way, the length of the carrier tube 2520 extending from the handle can be adjusted.

[0140] FIG. 26 is a schematic block diagram of a handle assembly 2660 that can be used with a VCD according to one embodiment. The handle assembly 2660 includes a handle body 2661 within which various components of the handle assembly 2660 can be disposed. In some embodiments, the hub 2622 (e.g., the hub 2522) can be coupled to the distal end 2667 of the handle body 2661, e.g., to a housing portion (not shown) of a handle assembly coupled (e.g., slidably coupled) to the handle body 2661.

[0141] As previously discussed, the hub 2622 may include snap-fit arms or protrusions (e.g., arms 2525) configured to couple to a sheath (e.g., sheath 110) and a coupling assembly (e.g., coupling assembly 2524) extending from a distal end of the hub 2622 towards the handle body 2661 and configured to couple to a distal end 2667 (e.g., coupling portion) of the handle body 2661. In other embodiments, the hub 2622 may include threads, a friction fit mechanism, or any other suitable coupling mechanism for coupling the hub 2662 to the handle body 2661.

[0142] The hub 2622 may be used to retract the sheath after insertion into the tissue track, for example to expose a first balloon (e.g., an extravascular balloon) and / or a second balloon (e.g., an intravascular balloon). For example, in a first position, the hub 2622, and thus the sheath, is moved axially (e.g., by sliding the coupling portion) by a user from the handle body 2661 into the tissue track toward the vessel. In a second position, the user can retract the hub 2622 toward the handle body 2661 to move the sheath away from the vessel. In some embodiments, a user interface (e.g., notches, protrusions, handles, etc.) may be provided on the handle assembly 2660 (e.g., the coupling portion) to allow a user to slide the hub 2622, thereby moving the sheath closer to or away from the vessel.

[0143] The handle assembly 2660 can also include a first actuator 2664 disposed near the proximal end portion 2665 of the handle body 2661. The first actuator 2664 is coupled to a first balloon tube (e.g., an extravascular balloon tube) and is configured to axially displace the first balloon tube, and thereby move the first balloon closer to or away from a blood vessel through the sheath (e.g., through a carrier tube disposed within the sheath), when engaged, for example, by a user or a robotic actuator. Further, the handle assembly 2660 can also include a second actuator 2666 disposed adjacent to the proximal end portion 2665 of the handle body 2661 (e.g., parallel to the first actuator 2664). The second actuator 2666 is coupled to a second balloon tube (e.g., an intravascular balloon tube) and is configured to axially displace the second balloon tube, and thereby move the second balloon closer to or away from a blood vessel through the sheath (e.g., through a carrier tube disposed within the sheath), when engaged, for example, by a user or a robotic actuator.

[0144] The first and second actuators 2664 and 2666 can be configured to lock the first and second actuators 2664 and 2666 in a proximal position and a distal position such that a user can operate the handle assembly while preventing the first and second balloon tubes from moving relative to the handle body 2661. In some embodiments, the first balloon is in a fixed position relative to the second balloon, such that the first balloon does not move relative to the second balloon. In such embodiments, the second actuator 2666 can be excluded.

[0145] In some embodiments, the handle assembly 2660 may include a first balloon injector 2668 and a second balloon injector 2670 configured to selectively operate to inflate the first and second balloons, respectively. An injector actuator (e.g., a button, slider, or any other suitable actuator) may be provided on the handle body to be engaged by the user to operate injectors 2668 and 2670.

[0146] In some embodiments, the handle assembly 2660 may also include a fluid reservoir 2672 provided within the handle body 2661, in which an inflation fluid (e.g., saline) may be stored. In such embodiments, the handle assembly 2660 may include a fluid port 2674 through which fluid is inserted into the fluid reservoir 2672. In some embodiments, the fluid port 2674 may include an attachment for a fluid delivery device (e.g., a syringe) to fill the reservoir 2672 with saline. The first and second balloon injectors 2668 and 2670 may be coupled to the reservoir 2672, engaged by the user, configured to draw fluid from the reservoir 2672 and deliver a predetermined amount of fluid to the first and second balloons, or configured to draw fluid from the first and second balloons, respectively. The handle assembly 2660 may have a shape configured such that the user can handle and operate the VCD by holding the handle body 2661.

[0147] In some embodiments, the handle assembly 2660 also interfaces with an interlock or other locking mechanism that can prevent the user from completing later steps while performing vascular closure unless earlier steps of the vascular closure process are completed. For example, a first interlock can be used to prevent the sheath slider from retracting from the tissue track unless tension is applied to the handle assembly. This can prevent the extravascular first balloon from being deployed intravascularly if the extravascular second balloon is not in close proximity to the vessel wall when the outer balloon is exposed with the contracted fabric on the vessel by retracting the sheath and / or carrier tube. In some embodiments, a second interlock can prevent the user from engaging the first balloon injector 2668 unless tension is applied to the handle body 2661. This can prevent the inflation of the extravascular first balloon unless the intravascular balloon is pulled against the vessel to prevent the first balloon from being accidentally deployed and inflated intravascularly. In some embodiments, the third interlock can prevent the coupling portions of the handle assembly, and thus the sheath and carrier tube, from advancing unless tension is maintained on the handle assembly 2660. This can prevent the user from forcing the extravascular first balloon against the exterior surface of the vessel, as the first balloon would actually be located within the vessel and could accidentally deploy within the vessel.

[0148] 27 is a schematic block diagram of a handle assembly 2760 that may be used with a VCD, according to another embodiment. The handle assembly 2760 is substantially similar to the handle assembly 2660, except that the handle assembly 2760 does not include a reservoir and fluid ports. In such an embodiment, inflation fluid may be communicated to the handle assembly from an external reservoir via a fluid communication tube or conduit.

[0149] Figures 28A - 29B are various views of a handle assembly 2860 according to another embodiment. The handle assembly 2860 includes a handle body 2861 and a connecting portion 2863 that can be slidably disposed within the handle body 2861. As shown in Figure 28A, a first actuator 2864 and a second actuator 2866 are disposed near the proximal end 2865 of the handle body 2861. The first and second actuators 2866 and the second actuator 2866 may include a slider or any other suitable actuator coupled to the first balloon tube 2804 and the second tube 2824, and the slider or any other suitable actuator is configured to move the tubes 2804 and 2824 (Figure 29A), or an anchor wire (Figure 29B) disposed within the second tube 2824, toward or away from the blood vessel, respectively. The first balloon tube 2804 and the second tube 2824 may be the second balloon tube as shown in Figure 29A, or may be a tube for supporting an anchor wire as shown in Figure 29B.

[0150] The connecting portion 2863 defines a slot 2871 in its end wall that is proximate to the distal end 2867 of the handle body 2861. The slot 2871 is configured to receive a portion of the hub 2522. The connecting portion 2863 also defines a set of notches 2869 in opposing side walls that are orthogonal to the end wall defining the slot 2871. The set of notches 2869 are configured such that corresponding ledges 2526a / b snap fit into the notches to removably couple the first and second coupling arms 2524a / b, and thus the hub 2522, the carrier tube 2520, and the sheath (e.g., sheath 110) to the connecting portion 2863. Further, a recess 2873 may be defined in a portion of the side wall of the handle body 2861 proximate to the slot 2871. The recess 2873 may be configured to receive a detent 2528 for securing the coupling arm 2524a within the connecting portion 2863 to prevent movement of the coupling assembly 2524, and thus movement of the hub 2522 relative to the connecting portion 2863.

[0151] In some embodiments, the first port 2868 may be defined in the first sidewall, and the second port 2870 may be defined in the sidewall opposite the connection portion. Fluid communication lines 2891 and 2892 may be introduced through the first port 2868 and the second port to feed fluid to or draw fluid from the first balloon and the second balloon, respectively, via the first balloon tube 2804 and the second balloon tube 2824.

[0152] In some embodiments, the connection portion 2863 may be slidable within the handle body 2861. In other embodiments, the connection portion 2863 may be integrally formed with the handle body 2861, and a separate cover including the actuators 2864 and 2866 may be disposed over the handle body 2861.

[0153] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, the term "member" is intended to mean a single member or a combination of members, and the term "material" is intended to mean one or more materials, or combinations thereof.

[0154] It should be noted that the term "exemplary" as used herein to describe various embodiments is intended to indicate that such embodiments are possible examples, representations, and / or illustrations of possible embodiments (and such terms are not intended to mean that such embodiments are necessarily exceptional or superior examples).

[0155] As used herein, the terms "coupled," "connected," and the like refer to the joining of two members directly or indirectly to one another. Such joining may be fixed (e.g., permanent) or movable (e.g., removable or releasable). Such joining may be achieved by the two members, or by the two members and any additional intermediate members being integrally formed with one another as a single unit, or by the two members or the two members and any additional intermediate members being attached to one another.

[0156] The term "fluidly connected" means that fluid can flow between two components that are connected to each other.

[0157] It is important to note that the construction and arrangement of the various exemplary embodiments are merely illustrative. While only a few embodiments have been described in detail in this disclosure, those skilled in the art who review this disclosure will readily appreciate that numerous modifications (e.g., changing parameter values of the size, dimensions, structure, shape, and proportions of the various elements, mounting arrangements, use of materials, color, orientation, etc.) are possible without substantially departing from the novel teachings and advantages of the subject matter described herein. Furthermore, it should be understood that features of one embodiment disclosed herein can be combined with features of other embodiments disclosed herein, as would be understood by one skilled in the art. Other substitutions, modifications, changes, and omissions can also be made in the design, operating conditions, and arrangement of the various exemplary embodiments without departing from the scope of the present embodiments.

[0158] Although this specification contains many details of particular embodiments, these should not be construed as limitations on the scope of any embodiment or of the content described in the claims, but rather as descriptions of features particular to a particular embodiment of a particular embodiment. The particular features described in this specification in the context of individual embodiments can also be implemented in combination in a single embodiment. Conversely, the various functions described in the context of a single embodiment can also be implemented in multiple embodiments individually or in any suitable sub-combination. Furthermore, although features may be described above as acting in a particular combination and may initially be claimed as such, in some cases one or more features from the claimed combination may be deleted from the combination, and the claimed combination may be directed to a sub-combination or variation of a sub-combination.

Claims

1. An apparatus for hemostasis of a blood vessel, the apparatus comprising: a first balloon insertable into a tissue track and disposed above an opening formed in the blood vessel outside the blood vessel; a hemostatic layer removably disposed on at least a part of the outer surface of the first balloon; a first balloon tube fluidly connected to the first balloon and configured to selectively expand or contract the first balloon; a second balloon configured to be removably disposed into the blood vessel through the opening; a second balloon tube fluidly connected to the second balloon and configured to selectively expand or contract the second balloon; a carrier tube defining at least one lumen in which the first balloon, the hemostatic layer, the first balloon tube, the second balloon, and the second balloon tube are disposed; a sheath defining a central channel in which the first balloon, the hemostatic layer, the first balloon tube, and the carrier tube are disposed, wherein at least a part of the sheath is configured to be removably insertable into the tissue track and the blood vessel; the first balloon is expandable above the opening, the second balloon is expandable within the blood vessel, and by interposing the wall of the blood vessel and the hemostatic layer between the first balloon and the second balloon, it becomes easy to fix the hemostatic layer to the outer surface of the blood vessel, the hemostatic layer is disposed on the outer surface of the blood vessel to close the opening, the first balloon applies pressure to the opening to achieve hemostasis, the hemostatic layer remains disposed on the outer surface of the blood vessel when the first balloon is removed from the tissue track, and is separable from the first balloon so as to continue closing the opening even after the removal of the first balloon; apparatus.

2. The apparatus according to claim 1, wherein at least one of the tip portions of the sheath or the carrier tube includes a plurality of perforations, and the tip portion is torn by the plurality of perforations when the first balloon expands within the tip portion.

3. The apparatus according to claim 1, wherein the hemostatic layer is formed of an absorbent material.

4. The apparatus according to claim 1, further comprising a first guide wire extending through or adjacent to the first balloon, wherein a distal end portion of the first guide wire is configured to be removably disposed through the opening in the blood vessel before the first balloon is disposed over the opening.

5. The apparatus according to claim 1, wherein the second balloon is axially offset from the first balloon.

6. In the at least one lumen of the carrier tube, a first lumen in which the first balloon tube and the first balloon are disposed, and a second lumen axially offset from the first lumen, are included, The apparatus according to claim 5, wherein the second balloon tube and the second balloon are disposed through the second lumen.

7. The apparatus according to claim 1, further comprising a second guide wire extending through or adjacent to the second balloon, wherein a distal end portion of the second guide wire is configured to be removably disposed within the blood vessel before the second balloon is disposed within the blood vessel.

8. The apparatus according to claim 1, wherein the second balloon is axially aligned with the first balloon.

9. An apparatus for hemostasis of a blood vessel, the apparatus comprising: a first balloon insertable into a tissue track and disposed over an opening formed in the blood vessel outside the blood vessel; a hemostatic layer removably disposed on at least a portion of an outer surface of the first balloon; a first balloon tube fluidly connected to the first balloon and configured to selectively inflate or deflate the first balloon; and an anchor wire having an anchor wire tip configured to be disposed within the blood vessel through the opening, wherein the anchor wire tip is movable between a contracted configuration when the anchor wire tip is disposed outside the blood vessel and an expanded configuration when the anchor wire tip is disposed within the blood vessel. The first balloon is inflatable above the opening, the distal end of the anchor wire is expandable within the blood vessel, the distal end of the anchor wire forms an anchor, and the blood vessel wall and the hemostatic layer are interposed between the first balloon and the anchor. The hemostatic layer is disposed on the outer surface of the blood vessel to close the opening. The first balloon applies pressure to the opening to achieve hemostasis. The hemostatic layer remains disposed on the outer surface of the blood vessel when the first balloon is removed from the tissue track and continues to close the opening even after removal of the first balloon, and is separable from the first balloon. Device.

10. The device according to claim 9, wherein the anchor wire is formed of a shape memory alloy, and the anchor wire is in a relaxed state in the expanded configuration when no force is applied to the distal end of the anchor wire.

11. The device according to claim 9, wherein the anchor wire is axially offset from the first balloon.

12. The device according to claim 9, wherein the anchor wire is axially aligned with the first balloon such that the anchor wire is disposed through the first balloon.

13. A device for hemostasis of a blood vessel, the device comprising: A first balloon insertable into a tissue track, the first balloon being disposed above an opening formed in the blood vessel outside the blood vessel; A hemostatic layer removably disposed on at least a portion of the outer surface of the first balloon; A first balloon tube fluidly connected to the first balloon and configured to selectively expand or contract the first balloon; A second balloon configured to be removably disposed within the blood vessel through the opening, the second balloon being axially offset from the first balloon; A second balloon tube fluidly connected to the second balloon and configured to selectively expand or contract the second balloon; A carrier tube defining at least one lumen in which the first balloon, the hemostatic layer, the first balloon tube, the second balloon, and the second balloon tube are disposed; The at least one lumen includes: A first lumen in which the first balloon tube and the first balloon are disposed; A second lumen axially offset from the first lumen, wherein the second balloon tube and the second balloon are disposed through the second lumen, the first balloon is inflatable above the opening, the second balloon is inflatable within the blood vessel, and by interposing the wall of the blood vessel and the hemostatic layer between the first balloon and the second balloon, it becomes easy to fix the hemostatic layer to the outer surface of the blood vessel, the hemostatic layer is disposed on the outer surface of the blood vessel to close the opening, the first balloon applies pressure to the opening to achieve hemostasis, the hemostatic layer remains disposed on the outer surface of the blood vessel when the first balloon is removed from the tissue track, and is separable from the first balloon so as to continue closing the opening even after removal of the first balloon. Device. **Claim 14** A device for hemostasis of a blood vessel, the device comprising: a first balloon insertable into a tissue track and disposed above an opening formed in the blood vessel outside the blood vessel; a hemostatic layer removably disposed on at least a part of the outer surface of the first balloon; a first balloon tube fluidly connected to the first balloon and configured to selectively inflate or deflate the first balloon; a second balloon configured to be removably disposed within the blood vessel through the opening; a second balloon tube fluidly connected to the second balloon and configured to selectively inflate or deflate the second balloon; a carrier tube defining at least one lumen in which the first balloon, the hemostatic layer, the first balloon tube, the second balloon, and the second balloon tube are disposed; the first balloon tube defines at least one lumen, the second balloon tube is disposed within the at least one lumen through the at least one lumen, and the first balloon fluidly connected to the first balloon tube and the second balloon fluidly connected to the second balloon tube are axially coaxially aligned. The first balloon is inflatable above the opening, the second balloon is inflatable within the blood vessel, and by interposing the wall of the blood vessel and the hemostatic layer between the first balloon and the second balloon, it becomes easy to fix the hemostatic layer to the outer surface of the blood vessel. The hemostatic layer is disposed on the outer surface of the blood vessel to close the opening. The first balloon applies pressure to the opening to achieve hemostasis. The hemostatic layer remains disposed on the outer surface of the blood vessel when the first balloon is removed from the tissue track and is separable from the first balloon so as to continue closing the opening even after the first balloon is removed. Device.

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