Inflation lumen kink protection and balloon contouring

Abstract

The present invention is entitled "Inflation Lumen Kink Protection and Balloon Contour". The present invention provides a balloon guide catheter having a sleeve-like inflation lumen secured with a wire wrap to improve inflation lumen kink protection and a welded balloon construction, the balloon guide catheter provides a robust and flexible catheter having an interior lumen that is particularly large relative to its exterior contour, and enables rapid and reliable inflation and deflation of the balloon in a highly deliverable and kink-resistant catheter. The present invention also provides a balloon guide catheter having multiple sleeve-like inflation lumens and a proximal Luer interface for utilizing the multiple inflation lumens.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This patent application claims the benefit of U.S. Provisional Application No. 62 / 845,683, filed May 9, 2019, U.S. Provisional Application No. 62 / 845,699, filed May 9, 2019, U.S. Provisional Application No. 62 / 845,711, filed May 9, 2019, and U.S. Provisional Application No. 62 / 845,747, filed May 9, 2019, each of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present invention relates generally to medical devices and, more particularly, to balloon devices for occluding blood vessels during vascular surgery. Background Art

[0004] A catheter may be a flexible tubular structure that is introduced into the vasculature of a patient. Catheters may be used for a variety of purposes and applications. For example, a catheter may be guided into a specific region of interest within the vasculature and then serve as a guide for guiding other peripheral, central venous, or arterial devices therethrough through the lumen of the guide. Such devices may include single or multi-lumen catheters, clot capture devices, balloon catheters, and the like.

[0005] Balloon guide catheters can be used in ischemic stroke surgery to serve as conduits for diagnostic and therapeutic devices, and also provide flow arrest and / or flow control and / or flow reversal to help safely remove clots from the patient. These balloon guide catheters must be flexible enough to be delivered to the target site (if used in the anterior vasculature, usually the patient's internal carotid artery) through a tortuous vascular system, and must be stable enough to remain stable in this position when other devices are advanced, manipulated and withdrawn by the catheter. It is desirable that the balloon guide catheter used in such applications has an internal lumen as large as possible so that the largest possible treatment catheter (such as an intermediate or suction catheter) can be advanced through it, and the distal opening size is maximized to safely remove the clot. It is also desirable that any guide or sheath used has an outer diameter as small as possible to minimize the patient's trauma and minimize the size of the access port that must be closed once the catheter is removed from the patient.

[0006] Therefore, there remains a need for new devices that address these conflicting requirements and provide a large lumen, low profile, and flexible balloon guide. Summary of the invention

[0007] The present invention facilitates installation of a catheter into the internal carotid artery for use as a conduit for a device, as well as securing the catheter, stopping blood flow, and producing improved suction efficacy when aspirating the main central lumen of the catheter. The present invention achieves such objectives by increasing the flexibility of the distal end of the catheter and by the shape and contour of the seamless balloon.

[0008] The surgery may involve placing a balloon guide catheter in the internal carotid artery to serve as a conduit for a device such as a guidewire, microcatheter, stent retriever, or intermediate catheter. The installation of the guide catheter can protect access to the blood vessel and shorten the operation time. The balloon can fix the balloon guide catheter near the treatment site, stop blood flow, and produce improved suction efficacy when the main central lumen of the balloon guide catheter is aspirated and / or when aspirated through the intermediate catheter and / or when manipulating a stent retriever or other thrombectomy device. Depending on the tortuosity of the vessel, the balloon guide catheter may be exposed to extreme angles presented by the vessel and the carotid ring and curved tubular geometry. The tortuosity can cause forces on the catheter and the expansion lumen. In some cases, extreme angles and / or forces can cause "kinks" in the expansion lumen.

[0009] A kinked inflation lumen can inhibit flow to and from the balloon of the balloon guide catheter, which can reduce the rate of inflation or deflation of the balloon. In some cases, a kinked inflation lumen can result in complete balloon failure or a complete inability to inflate or deflate the balloon. This can cause complications during treatment because the non-functional balloon guide catheter may need to be removed, the physician may need to perform surgery without stopping blood flow, or a mandrel may need to be inserted through the inflation lumen to deflate the balloon.

[0010] It was also observed during testing that when the thrombectomy device is retracted into the balloon catheter, soft clots can shear off the thrombectomy device and remain on the catheter tip (proximal to the tip and distal to the balloon). This can occur when there is dead space between the balloon and the distal end of the catheter. Upon balloon deflation, these fragments can travel distally and cause embolization of distal vessels, potentially resulting in additional procedure time or impact on patient health.

[0011] To address the deficiencies in the prior art, the disclosed invention incorporates an enhanced wire configuration into the catheter and changes the balloon profile and / or shape. The wire configuration can be woven above and below the expansion lumen to enhance the catheter and the elongated tubular member. The disclosed invention also includes a bonding layer, a weld, and a bonding member to facilitate the balloon shape and profile. The disclosed invention can increase the flexibility of the distal end of the catheter while minimizing the possibility of kinking through the wire configuration design and the balloon profile and / or shape.

[0012] Disclosed herein are various exemplary devices for inflation lumen kink protection and balloon contours that may address tracking of catheters through tortuous anatomy and maximize clot removal and other problems in the art.

[0013] The device may generally include an elongated tubular member and a balloon.

[0014] The elongated tubular member may have a proximal end, a distal end, an outer surface, a top, and a bottom. The elongated tubular member has an internal hollow lumen, an inner core, and an inflation lumen. The internal hollow lumen may extend between the proximal and distal ends of the elongated tubular member. The internal lumen may be sized to maximize clot capture and may be indicated for use as a conduit for a clot retrieval device. The internal lumen may have an inner diameter of approximately 0.088". The inner core may extend between the proximal and distal ends of the elongated tubular member having an inner core thickness. The inflation lumen may extend between a port at the proximal end of the elongated tubular member and the inside of a balloon at the distal end. The elongated tubular member may have a wire configured to secure the inflation lumen.

[0015] The expansion lumen can be used as a conduit for inflating and deflating the balloon. The expansion lumen can be connected to a port at the proximal end of the catheter, extend along most of the length of the elongated tubular member, and connect to the inside of the balloon. The expansion lumen can have any number of shapes, including but not limited to specific arc radius sizes. The expansion lumen can be a sleeve of polytetrafluoroethylene (PPTFE), polyethylene (PE), polyethylene terephthalate (PET), fluorinated ethylene propylene (FEP), etc. The expansion lumen can be a CSA of about or about 0.2 mm. 2 Crescent shape.

[0016] The elongated tubular member may include two inflation lumens. Each inflation lumen may be used as a conduit for inflating and deflating the balloon. The combination of inflation lumens may be used as a continuous path for flushing the balloon and the inflation lumens with fluid, such that the fluid may enter one of the two inflation lumens and exit the other inflation lumen during flushing. The combination of inflation lumens may provide additional flow paths to accelerate the inflation and deflation of the balloon. The combination of inflation lumens may provide redundancy of the flow paths; in the event that one of the inflation lumens becomes blocked, kinked, or otherwise compromised, the other of the inflation lumens may be used to inflate and deflate the balloon.

[0017] The elongated tubular member may include three inflation lumens. Each inflation lumen may be used as a conduit for inflating and deflating the balloon. The third lumen may provide the benefits of having two inflation lumens, as described in conjunction with an additional inflation lumen for additional redundancy.

[0018] The inflation lumen may have a cross-sectional area of ​​about 0.15 mm or a combination of multiple inflation lumens may have a cross-sectional area of ​​about 0.15 mm. 2To about 0.20mm 2 , about 0.20mm 2 To about 0.25mm 2 and / or about 0.25 mm 2 To about 0.30mm 2 The total expansion lumen cross-sectional area may be comprised of more than one expansion lumen.

[0019] The elongated tubular member may include a wire configured to secure an expansion lumen along at least a portion or a majority of the length of the elongated tubular member. The wire may provide kink protection for the expansion lumen. The wire configuration may enhance the torque of the catheter and the flexibility of the distal end of the catheter. The wire configuration may also contribute to the strength of the elongated tubular member while increasing the flexibility of the catheter and reducing the overall stiffness of the catheter.

[0020] The elongated tubular member may be reinforced with a braided wire matrix having a pattern such that all wires extending above the expansion lumen extend substantially parallel to each other and do not cross each other in the area of ​​the expansion lumen. The same is true for those wires extending below the expansion lumen. They intersect each other on either side of the expansion lumen, but not above or below it. This minimizes the chance of the wires constricting and damaging the expansion lumen, causing leakage.

[0021] The wire configuration may be a braided configuration separated above and below the inflation lumen. The wire configuration may be a double-wire double diamond. When the elongated tubular member includes two inflation lumens, the wire configuration may be a double-wire double diamond wrapped around the two inflation lumens.

[0022] Although the expansion lumen may increase the stiffness of the catheter compared to catheters that do not include the expansion lumen, the wire configuration may help reduce the bending stiffness of the catheter compared to known balloon guide catheters. Thus, the wire configuration may reduce stiffness and / or increase flexibility to potentially offset the increased stiffness due to the expansion lumen, thereby allowing the balloon guide catheter to have increased flexibility compared to known balloon guide catheters. The reduced stiffness and / or increased flexibility provided by the wire configuration may allow for easier orientation during insertion of the device.

[0023] The elongated tubular member may have a uniform stiffness throughout its entire length, a stiffness that varies along the length of the elongated tubular member. In order to achieve the desired stiffness, materials and / or additives having the desired stiffness properties may be used in the construction of the elongated tubular member. The materials and / or additives may vary along the length of the elongated tubular member to form portions with different stiffness, each portion having a different stiffness or hardness. Additional layers or additives may be provided to control individual stiffness. In some examples, the stiffness of the elongated tubular member may decrease from the proximal end to the distal end. Alternatively, the stiffness of the elongated tubular member may increase from the proximal end to the distal end. In some examples, a stiffness gradient may gradually transition along the length of the elongated tubular member. In some examples, the transition in stiffness may prevent local stiffness and potential kink points.

[0024] In addition, the strength, flexibility and / or stiffness of the elongated tubular member can be varied by using the number of wires, different wire materials or wire configurations, including but not limited to braided configurations, coiled configurations, double configurations and separate coil configurations. For example, the wires can enhance the polymer matrix and thus support the expansion lumen and prevent it from kinking. The wire configuration of the expansion lumen can be implemented for single lumen, double lumen and triple lumen. The braided wire configuration can be present below the expansion lumen, while the coil configuration can be present above and / or around the expansion lumen. In addition, the wire configuration can be composed of multiple wires and winding configurations to meet the needs of flexibility and structural support of the expansion lumen. The wire configuration can be a double wire configuration. The wire configuration may include a separate wire configuration, in which the wire is braided above and below the expansion lumen. In addition, the wire configuration may include a double wire having a diamond design over the length of the elongated tubular member and a double coil design over the axis of the expansion lumen. The individual wires themselves are made to have a circular, square or rectangular profile.

[0025] The elongated tubular member may include an outer sheath covering at least a portion of the wrapped wire, thereby providing a friction-reduced outer surface of the elongated tubular member. When the catheter is navigated through the vasculature, the outer sheath can effectively provide a smooth surface for contacting the interior of the blood vessel without damaging or abrading the blood vessel or generating excessive friction that would hinder the catheter from being delivered to the treatment site.

[0026] The elongated tubular member may include a strike layer covering at least a portion of the inflation lumen. The strike layer may be positioned between the inflation lumen and the overlapping braided wires to reduce the likelihood of rupture, puncture, and abrasion due to movement of the wires over the inflation lumen. The strike layer may include Urethane material, PU, ​​etc. The impact layer can provide a protective layer around the inflation lumen, thereby minimizing the risk of rupture, puncture and wear.

[0027] The expansion lumen and the impact layer may comprise compatible materials, so that if the expansion lumen is damaged, the impact layer can effectively seal the damaged portion, thereby preventing leakage from the expansion lumen. A strike layer constructed of a urethane material can effectively seal a damaged portion of an inflation lumen comprising PTFE (eg, impregnated PTFE).

[0028] The polymeric strike layer may comprise a material that is compatible with the material of the outer sheath. The outer sheath is laminated in place. During manufacture, the strike layer and outer sheath may be fused to one another during the manufacturing process.

[0029] The polymer strike layer may comprise a material that is compatible with the inner core. The inner core may be made of PTFE and the strike layer may be made of PU.

[0030] The balloon may be located at the distal end of the elongated tubular member. The balloon may enable fixation of the catheter, stop blood flow, and produce improved aspiration efficacy when aspirating the main central lumen of the catheter.

[0031] The balloon can be connected to the elongated tubular member by a weld, which in some embodiments is formed between the balloon and an intermediate material, hereinafter referred to as a joining layer. The balloon can be made of a variety of materials and can be coated, uncoated, tacky or non-tacky. In some known devices, the catheter balloon is made of silicone because this material has a very high recoverable elastic strain and can be used to make a very soft and compliant balloon. However, silicone is a material that is very difficult to join to other materials. It may require a bonding joint that increases the stiffness and profile of the distal end of the catheter. Recent developments in polymer formulations have resulted in new polymer elastomer alloys that have material properties similar to silicone but can be melted, extruded and welded to other materials. The catheter of the present invention preferably includes a A balloon made of a blend of a balloon material and a urethane material (such as Polyblend 1100 from AdvanSource Biomaterials) can be welded to other similar materials to achieve much greater flexibility and a thinner construction. The successful formation of such welds can be further aided by another material (a bonding layer) made from a blend of materials. Thus, the bonding layer is constructed to be compatible with both the balloon material and the material used to construct the outer layer of the elongated tubular member (the sheath material), thereby achieving much better reflow behavior and a much better weld than can be obtained by welding the balloon directly to the sheath material.

[0032] The balloon may be designed as a seamless balloon. The seamless balloon may be designed such that the balloon may reach or extend beyond the distal end of the elongated tubular member and minimize any dead space at the distal end of the catheter.

[0033] The profile and / or shape of the seamless balloon can be constrained in any manner, including but not limited to being constrained on one side of the elongated tubular member by one or more adhesives. The one or more adhesives can have any number of shapes and / or patterns. The adhesive can ensure that when the seamless balloon is expanded, it does not expand circumferentially. The adhesive can ensure that the seamless balloon has more than one section when expanded.

[0034] The bonded seamless balloon can facilitate the removal of medical devices through the internal hollow lumen, thereby maximizing clot capture while minimizing the capture of soft clots. In known balloon guide catheters, soft clots can be sheared off from the distal end of the catheter due to the "dead space" between the catheter and the vessel wall distal to the balloon. When the balloon of the known balloon guide catheter is deflated, in some cases, these soft clots can travel distally and cause embolism of the distal vessel, which may result in additional surgical time or impact on the patient's health. The bonded seamless balloon can be formed to have minimal or no "dead space", thereby reducing the possibility of the aforementioned complications. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The above and other aspects of the present invention will be further discussed with reference to the following description and in conjunction with the accompanying drawings, in which the same reference numerals indicate the same structural elements and features in the various figures. The accompanying drawings are not necessarily drawn to scale, but instead, emphasis is placed on illustrating the principles of the present invention. The accompanying drawings depict one or more specific implementations of the apparatus of the present invention by way of example only and not by way of limitation.

[0036] Figure 1 is a top front perspective view of a portion of an elongated tubular member of the present invention.

[0037] Figure 2A is a top front perspective view of an inflated seamless balloon of the present invention.

[0038] Figure 2B is a top front perspective view of a deflated seamless balloon of the present invention.

[0039] Figure 3 It is a top front perspective view of the expansion lumen kink protection wire configuration cutout of the present invention.

[0040] Figure 4A is a top front perspective view of the inflation lumen kink protection wire configuration of the present invention and the inflated seamless balloon.

[0041] Figure 4B is a top front perspective view of the inflation lumen kink protection wire configuration and deflated seamless balloon of the present invention.

[0042] Figure 5 is a side view of the expansion lumen kink protection wire configuration of the present invention.

[0043] Fig. 6A is a side view of the inflation lumen kink protection wire configuration and the inflated seamless balloon of the present invention.

[0044] Figure 6B It is a cross-sectional view of the balloon guide catheter, the expanded seamless balloon and the expanded lumen kink protection wire configuration of the present invention.

[0045] Figure 6C It is a cross-sectional view of the balloon guide catheter and the inflated seamless balloon of the present invention.

[0046] Fig. 7A It is a side view of the inflation lumen kink protection wire configuration and the deflated seamless balloon of the present invention.

[0047] Figure 7B It is a cross-sectional view of the balloon guide catheter, the deflated seamless balloon and the expansion lumen kink protection wire configuration of the present invention.

[0048] Figure 7C It is a cross-sectional view of the balloon guide catheter and the deflated seamless balloon of the present invention.

[0049] Figure 8 1 is a top view of the balloon guide catheter, the inflated seamless balloon, and the inflation lumen kink protection wire configuration of the present invention.

[0050] Fig. 9 is a top view of the balloon guide catheter, the deflated seamless balloon, and the inflation lumen kink protection wire configuration of the present invention.

[0051] Fig.10 It is a side view of the additional wire configuration of the expansion lumen kink protection of the present invention.

[0052] Fig.11 It is a side view of the expansion lumen kink protection separation coil wire configuration of the present invention.

[0053] Fig.12 It is a top front perspective view of the expansion lumen kink protection separation coil wire configuration cutout of the present invention.

[0054] Fig.13A is a top front perspective view of a bonded inflatable seamless balloon of the present invention.

[0055] Fig. 13B is a top front perspective view of a bonded, collapsed seamless balloon of the present invention.

[0056] Fig.14A is a side view of a bonded expandable seamless balloon of the present invention.

[0057] Fig. 14B is a side view of a bonded, collapsed seamless balloon of the present invention.

[0058] Fig.15A is a side view of the distal portion of an inflated balloon guide catheter of the present invention.

[0059] Fig. 15B is a side view of the proximal portion of a balloon guide catheter of the present invention inserted into the proximal luer.

[0060] Fig.16A is a cross-sectional view of an elongated tubular member of the present invention having a dual inflation lumen and a reinforcing wire.

[0061] Fig. 16B is a cross-sectional view of an elongated tubular member of the present invention having a dual inflation lumen and a reinforcing wire.

[0062] Fig. 16C is a cross-sectional view of an elongated tubular member of the present invention having three inflation lumens.

[0063] Fig.16D is a cross-sectional view of an elongated tubular member of the present invention having dual inflation lumens positioned on opposite sides of the circumference of the elongated tubular member.

[0064] Fig.17A is a perspective view of a dual-inflation lumen catheter and a proximal Luer interface of the present invention.

[0065] Fig. 17B is a cross-sectional view of an elongated tubular member of the present invention.

[0066] Fig.18A is a cross-sectional view of a proximal Luer interface of the present invention, which is configured to flush the balloon and inflate the lumen.

[0067] Fig.18B is a cross-sectional view of a proximal Luer interface of the present invention configured to simultaneously deflate a balloon through a double lumen. DETAILED DESCRIPTION

[0068] Figure 1A catheter 100 is shown. As shown, the catheter 100 may have an elongated tubular member 110. The elongated tubular member 110 may have a proximal end 112, a distal end 114, a top 122, a bottom 124, and an outer surface 126, two inner surfaces of an inner hollow lumen 130, an inflation lumen 200, and an inner core 140. The inner hollow lumen 130 may extend from the proximal end 112 of the elongated tubular member 110 to the distal end 114 of the elongated tubular member 110. The inflation lumen 200 may extend between the proximal end 112 of the elongated tubular member 110 and the distal end 114 of the elongated tubular member 110. The inflation lumen 200 may be smaller than the inner hollow lumen 130. The inflation lumen 200 may be located approximately at the top 122 of the elongated tubular member 110 or the bottom 124 of the elongated tubular member and outside the inner hollow lumen 130.

[0069] Figure 2A An outline of an inflated seamless balloon 210 of the catheter 100 is shown. The seamless balloon 210 may be secured to the elongated tubular member 110 by a bonding layer 240. The seamless balloon 210 may extend beyond the distal end 114 of the elongated tubular member 110. The seamless balloon 210 may be inflated as shown.

[0070] The bonding layer 240 may comprise a material to which both the balloon and shaft sheath materials may be welded. The sheath may comprise a polyurethane material at least a few centimeters beyond the distal portion of the catheter 100. The bonding layer 240 may comprise a 50 / 50 blend of the balloon material and the polyurethane sheath material. The balloon 210 may be welded to the sheath.

[0071] Figure 2B An outline of a collapsed seamless balloon 210 of the catheter 100 is shown. The seamless balloon 210 may be secured to the elongated tubular member 110 by a bonding layer 240. The seamless balloon 210 may extend beyond the distal end 114 of the elongated tubular member 110. The seamless balloon 210 may be collapsed as shown.

[0072] Figure 3A wire configuration 400 of a kink-protected wire 300 of an inflation lumen of a catheter 100 is shown, including a cross-section of an elongated tubular member 110. The wire configuration 400 may have a wire 300 that may be located within the elongated tubular member 110, extending above and below the inflation lumen 200. The wire configuration 400 enables a more flexible catheter 100 and torque transmission from the proximal end 112 to the distal end 114 of the catheter 100. This allows a user to apply torque to the proximal end 112 to more easily orient the distal end 114 in a desired direction to advance the catheter through the vasculature while still maintaining the integrity of the inflation lumen 200. It is noted that some catheters 100 may be advanced from the patient's inner thigh over the cardiac arch and up into the patient's cranial neurovascular vessels, so the distance and tortuosity may be significant.

[0073] The wiring acts similarly to the rebar in a concrete reinforcement that supports an arched structure of an aircraft hangar or underground silo. Utilizing the polymer matrix reinforcement wire network of the elongated tubular member 110 above and below the expansion lumen 200 helps reduce or prevent kinking.

[0074] During manufacturing, the braided wire 300 is separated when encountering the expansion lumen 200 on the braiding machine to extend above and below the expansion lumen 200. The wire strengthens the polymer matrix of the catheter 100, and thus supports a thin PTFE sleeve or a lumen with a standard sleeve such as PE or PET or FEP or no sleeve (i.e., a "raw extrusion lumen") and prevents kinking. In some examples, the braid occurs substantially along most of the elongated tubular member 110 to enhance the torque capacity and pushing capacity of the shaft. Other examples may change the coil geometry to reduce the bending stiffness of the catheter 100 compared to the braid. The PTFE lumen increases the bending stiffness, and the coil helps to reduce the stiffness. Stiffness can provide the device with an orientation preference during insertion of the device, and adding a coil instead of a braid will reduce this "whip-like" orientation around the bend in the blood vessel.

[0075] Exemplary wire protection for inflation lumen 200 may be performed for dual and triple lumens within a catheter (not shown). In other examples, wire configuration 400 is ideally suited for a single lumen having a particular arc radius size.

[0076] The cross section of the elongated tubular member 110 shows the positioning of the wire 300 above and below the expansion lumen 200 (i.e., the wire configuration 400). The wire configuration 400 helps to enhance the strength of the catheter 100 and reduce its stiffness. In addition, compared with the wire 300, the wire configuration 400 helps to reduce the bending stiffness of the catheter. The expansion lumen 200 can increase the stiffness of the catheter 100, and the wire configuration can reduce stiffness and / or increase flexibility. Stiffness and / or flexibility can provide the device with an orientation preference during insertion of the device, and the wire configuration 400 reduces the challenges of the prior art devices.

[0077] In addition to using various numbers of wires 300, different wire 300 materials, or wire configurations 400 (including but not limited to braided configurations, coil configurations, dual wire configurations 500, and split wire configurations 510), stiffness and flexibility can also be varied by using different materials for each portion of the shaft, so that each portion has a different stiffness or hardness. Braided wire configurations 400 may be present below the expansion lumen 200, while coil configurations may be present above and / or around the expansion lumen 200. In addition, the wire configuration 400 may be composed of any number of wires 300, including dual wire configurations 500. The wire configuration 400 may include a split wire configuration 510, in which the wire 300 is braided above and below the expansion lumen 200. Alternatively, the elongated tubular member 110 may be made of the same material, and additional layers or additives may be provided to control individual stiffness. These examples may be combined to provide the desired flexibility and / or stiffness. It should be noted that the elongated tubular member may have a uniform stiffness throughout its length, or it may vary. For example, the stiffness of the elongated tubular member 110 may decrease from the proximal end 112 to the distal end 114. For another example, the stiffness of the elongated tubular member 110 may increase from the proximal end 112 to the distal end 114. In some examples, any transition in stiffness may prevent localized stiffness.

[0078] Figure 4A The outline of the expanded seamless balloon 210 of the catheter 100 and the wire configuration 400 of the wire 300 are shown. The seamless balloon 210 can be fixed to the elongated tubular member 110 by the bonding layer 240. The seamless balloon 210 can extend beyond the distal end 114 of the elongated tubular member 110. The seamless balloon 210 can be expanded as shown. The reinforcement of the wire configuration 400 by the wire 300 does not hinder the expansion of the seamless balloon 210. In this example, the seamless balloon 210 can be expanded concentrically with the internal hollow lumen 130, or wherein the outer edge of the expanded balloon is approximately equidistant from the center of the internal hollow lumen 130. There may be some eccentricity based on the location of the expanded lumen 200.

[0079] Figure 4BThe outline of the collapsed seamless balloon 210 of the catheter 100 and the wire configuration 400 of the wire 300 are shown. The seamless balloon 210 can be fixed to the elongated tubular member 110 by the bonding layer 240. The seamless balloon 210 can extend beyond the distal end 114 of the elongated tubular member 110. The seamless balloon 210 can be collapsed as shown. The reinforcement of the wire configuration 400 by the wire 300 does not hinder the collapse of the seamless balloon 210. In some examples, when collapsed, the seamless balloon 210 can have the same outer profile as the elongated tubular member 110, thereby giving the catheter 100 a uniform diameter / profile for insertion and removal.

[0080] Figure 5 A side view of a braided and coiled wire configuration 400 of a catheter 100 is shown. The wire 300 can extend above and below the expansion lumen 200. The braided wire configuration 400 achieves a stiffer catheter 100 while minimizing cost and weight, among many other factors. The braided design facilitates the transfer of torque from the proximal end 112 to the distal end 114 of the catheter 100. This allows the user to apply torque to the proximal end 112 to more easily orient the distal end 114 in a desired direction, thereby advancing the catheter through the vascular system while still maintaining the integrity of the expansion lumen 200.

[0081] Fig. 6A The profile of the expanded seamless balloon 210 of the catheter 100 and the braided and coiled wire configuration 400 are shown. The seamless balloon 210 can be fixed to the elongated tubular member 110 by the bonding layer 240. The seamless balloon 210 can extend beyond the distal end 114 of the elongated tubular member 110. The seamless balloon 210 can be expanded as shown. The reinforcement of the braided wire configuration 400 by the wire 300 does not hinder the expansion of the seamless balloon 210.

[0082] Figure 6B Shows Fig. 6A A cross-sectional view across section BB depicts the outline of the expanded seamless balloon 210 and the wire configuration 400 of the catheter 100. The cross-sectional view shows the position of the wire 300 above and below the expansion lumen 200 within the elongated tubular member 110. The cross-sectional view also shows the relative positions of the seamless balloon 210, the expansion lumen 200, and the wire 300, and how the wire configuration 400 does not hinder the expansion of the seamless balloon 210.

[0083] Figure 6C Shows Fig. 6A A cross-sectional view across section CC depicts the profile of the expanded seamless balloon 210 and wire configuration 400 of the catheter 100. The cross-sectional view shows the relative positions of the seamless balloon 210, the bonding layer 240, the inner core 140, and the inner hollow lumen 130 and how the bonding layer 240 does not hinder the expansion of the seamless balloon 210.

[0084] The balloon 210, when inflated, can have an aspect ratio and height that can effectively occlude a blood vessel while minimizing fluid shear. The height of the balloon can be about 0.004" to about 0.008". In some applications, the height of the balloon can be about 0.0055" to about 0.0065". Fig. 6A As shown, when viewed from the side, the balloon 210, when inflated, may have a generally trapezoidal profile, tapering to a smaller width on the proximal end of the balloon 210, and expanding to a larger width on the distal end of the balloon. The tapering may define an angle θ, which is the angle between the angled surface of the balloon and a line parallel to the elongated tubular member 110. The balloon 210, when inflated, may define an angle θ of less than 70° when used on an elongated tubular member 110 having an internal hollow lumen 130 with a diameter of approximately 0.088". The balloon 210, when inflated, may define an angle θ of approximately 60° to approximately 65° when used on an elongated tubular member 110 having an internal hollow lumen 130 with a diameter of approximately 0.088".

[0085] Fig. 7A The outline of the collapsed seamless balloon 210 and the braided and coiled wire configuration 400 of the catheter 100 are shown. The seamless balloon 210 can be fixed to the elongated tubular member 110 by the bonding layer 240. The seamless balloon 210 can extend beyond the distal end 114 of the elongated tubular member 110. The seamless balloon 210 can be collapsed as shown. The reinforcement of the braided and coiled wire configuration 400 by the wire 300 does not hinder the collapse of the seamless balloon 210.

[0086] Figure 7B Shows Fig. 7A A cross-sectional view across section BB depicts the outline of the deflated seamless balloon 210 and the wire configuration 400 of the catheter 100. The cross-sectional view shows the position of the wire 300 above and below the inflation lumen 200 within the elongated tubular member 110. The cross-sectional view also shows the relative positions of the seamless balloon 210, the inflation lumen 200, and the wire 300, and how the wire configuration 400 does not hinder the deflation of the seamless balloon 210.

[0087] Figure 7C Shows Fig. 7A A cross-sectional view across section CC depicts the outline of the collapsed seamless balloon 210 and wire configuration 400 of the catheter 100. The cross-sectional view shows the relative positions of the seamless balloon 210, the bonding layer 240, the inner core 140, and the inner hollow lumen 130 and how the bonding layer 240 does not hinder the collapse of the seamless balloon 210.

[0088] Figure 8A top view of the seamless balloon 210 and wire configuration 400 depicting the expansion of the catheter is shown. This view shows the relative positions of the seamless balloon 210, the expansion lumen 200, and the wire 300, and how the wire configuration 400 does not hinder the expansion of the seamless balloon 210. This view also shows the coil configuration above the expansion lumen 200.

[0089] Fig. 9 A top view of the outline of the seamless balloon 210 and the wire configuration 400 depicting the deflation of the catheter is shown. This view shows the relative positions of the seamless balloon 210, the inflation lumen 200, and the wire 300 and how the wire configuration 400 does not hinder the deflation of the seamless balloon 210. This view also shows the coil configuration above the inflation lumen 200.

[0090] Fig.10 and Fig.11 A side view of a possible wire configuration 400 is shown. Specifically, Fig.10 A dual wire configuration 500 is shown, and Fig.11 A separate wire configuration 510 is shown.

[0091] Fig.12 A split wire configuration 510 of the kink-protected wire 300 of the inflation lumen of the catheter 100 is shown, including a cross-section of the elongated tubular member 110. The wire configuration 400 may have the wire 300, which may be located within the elongated tubular member 110, braided above and below the inflation lumen 200. The split wire configuration 510 enables a more flexible catheter 100 and torque transmission from the proximal end 112 to the distal end 114 of the catheter 100. This allows the user to apply torque to the proximal end 112 to more easily orient the distal end 114 in a desired direction to advance the catheter through the vasculature while still maintaining the integrity of the inflation lumen 200. It is noted that some catheters 100 may be advanced from the patient's inner thigh over the cardiac arch and up into the patient's cranial neurovascular vessels, so the distance and tortuosity may be significant.

[0092] Fig.13A The outline of the expanded bonded seamless balloon 210 of the catheter 100 and the wire configuration 400 of the wire 300 are shown. The seamless balloon 210 can be fixed to the elongated tubular member 110 by the bonding layer 240 and / or the bonding member 600 so that when expanded, it does not expand circumferentially. The seamless balloon 210 can extend beyond the distal end 114 of the elongated tubular member 110. The seamless balloon 210 can be expanded as shown. The reinforcement of the wire 300 to the wire configuration 400 does not hinder the expansion of the seamless balloon 210.

[0093] In one example, the seamless balloon 210 can be constrained on one side of the elongated tubular member 110 by a bonding member 600. The bonding member 600 can have any number of shapes and / or patterns. The bonding member 600 connecting the seamless balloon 210 to the elongated tubular member 110 ensures that the seamless balloon 210 does not expand circumferentially when expanded. The bonded seamless balloon 210 is conducive to removing the medical device through the internal hollow lumen 130, thereby maximizing clot capture while minimizing the capture of soft clots. Soft clots can be sheared off from the catheter 100 and retained on the distal end 114 of the catheter 100. When the seamless balloon 210 is deflated, these soft clots can travel distally and cause embolism of distal blood vessels, which may cause additional surgical time or impact on patient health.

[0094] Fig. 13B The outline of the collapsed bonded seamless balloon 210 of the catheter 100 and the wire configuration 400 of the wire 300 are shown. The seamless balloon 210 can be fixed to the elongated tubular member 110 by the bonding layer 240 and / or the bonding member 600. The seamless balloon 210 can extend beyond the distal end 114 of the elongated tubular member 110. The seamless balloon 210 can be collapsed as shown. The reinforcement of the wire 300 to the wire configuration 400 does not hinder the collapse of the seamless balloon 210.

[0095] Fig.14A The outline and wire configuration 400 of the expanded bonded seamless balloon 210 of the catheter 100 are shown. The seamless balloon 210 can be fixed to the elongated tubular member 110 by the bonding layer 240 and / or the bonding member 600 so that when expanded, it does not expand circumferentially. The seamless balloon 210 can extend beyond the distal end 114 of the elongated tubular member 110. The seamless balloon 210 can be expanded as shown. The reinforcement of the braided wire configuration 400 by the wire 300 does not hinder the expansion of the seamless balloon 210.

[0096] Fig. 14B The outline and wire configuration 400 of the collapsed bonded seamless balloon 210 of the catheter 100 are shown. The seamless balloon 210 can be fixed to the elongated tubular member 110 by the bonding layer 240 and / or the bonding member 600. The seamless balloon 210 can extend beyond the distal end 114 of the elongated tubular member 110. The seamless balloon 210 can be collapsed as shown. The reinforcement of the braided and coiled wire configuration 400 by the wire 300 does not hinder the collapse of the seamless balloon 210.

[0097] The degree of eccentricity or expansion asymmetry can be varied by positioning the bonding member 600. The seamless balloon 210 can be bonded across a minor or major arc of the elongated tubular member 110. Additionally, eccentricity can be applied by varying the inner core thickness 144 between the top and bottom so that the inner hollow lumen 130 is offset from the center of the central axis of the catheter 100.

[0098] In most examples, saline or other neutral fluid is used to inflate the seamless balloon 210 within the patient's blood vessel. The fluid is pumped into the proximal end 112 of the inflation lumen 200 and fills the seamless balloon 210. The fluid volume and / or pressure is kept constant to keep the balloon 210 engaged with the vessel lumen, thereby preventing flow through the balloon 210. To deflate, the fluid is withdrawn through the same inflation lumen 200.

[0099] Fig.15A The distal portion of the balloon guide catheter 100 of the present invention with an expansion balloon 210 is shown. The catheter 100 may include a tubular sheath 250 extending over the wire 300. The tubular sheath 250 may extend over the distal portion of the balloon guide catheter 100, beyond the distal end 204 of the expansion lumen 200. The balloon 210 may be welded proximally and distally to an intermediate (or bonding layer) sheath material formed of a blend of balloon material and soft urethane (such as Pellethane 80A). The sheath 250 may include openings to enable a flow path between the expansion lumen 200 and the interior of the balloon 210.

[0100] The distal end 114 of the catheter 100 may be formed from this intermediate (or junction layer) material, or from the balloon material itself, or from another soft material that is compatible with the intermediate (or junction layer) material.

[0101] The distal tip material may extend slightly beyond the PTFE liner (core 140 of the inner hollow lumen 130) to form a very soft tip that can be opened to accept a soft clot with minimal risk of shearing. A radiopaque marker band 260 may be positioned just proximal to the distal end 114 of the catheter 100, and the catheter reinforcement braid may terminate below the marker band 260 to minimize the risk of exposed braided wires 300. The inflation lumen 200 may terminate below the balloon 210, and a shaved port or cutout 212 may be added to allow the lumen of the inflation lumen 200 to communicate with the interior of the balloon 210 to allow for inflation / deflation.

[0102] The stiffness of the catheter 100 can gradually increase from the distal side to the proximal side. The stiffness gradient can be primarily formed by the modulus of different sections of the polymer sheath material. The polymer sheath material can be laminated to the catheter 100 above the braid and the expansion lumen 200. The lamination process ideally melts the sheath material sufficiently to allow the sheath material to flow under the expansion lumen and bond to the impact layer of the expansion lumen and the impact layer of the PTFE liner of the main catheter lumen.

[0103] Fig. 15BThe proximal portion of the balloon guide catheter 100 of the present invention is shown inserted into the proximal Luer 700. The outer sheath 250, the wire 300, and the shaved opening or cutout 152 in the inflation lumen 200 can provide a flow path through the inflation lumen 200 to the angled port 702 of the proximal Luer 700, and thus facilitate control of balloon inflation / deflation through the port 702.

[0104] Fig.16A -D shows various alternative inflation lumen configurations using multiple inflation lumens 200a, 200b, 200c, 200d. The interior hollow lumen 130a, 130b, 130c, 130d of each elongated tubular member 110a, 110b, 110c, 110d is identified in each respective figure to orient the reader.

[0105] A catheter with multiple expansion lumens can help in the preparation of the catheter and facilitate the accelerated expansion and contraction of the balloon. During preparation, one or more expansion lumens can receive the injection of a 50 / 50 contrast agent mixture to expand the balloon, and one or more different expansion lumens can be used as a vent or exhaust port for any air in the system and the contrast agent mixture. Therefore, in a catheter with a double expansion lumen, the contrast agent mixture will enter the first expansion lumen in the expansion lumen, advance distally along the elongated tubular member, enter the balloon, enter the second expansion lumen in the expansion lumen at its distal end, advance proximally along the elongated tubular member, and leave the catheter from the second expansion lumen. The expansion lumen for ventilation (e.g., the second expansion lumen in the double lumen catheter in the aforementioned example) may also be referred to as a ventilation lumen. The expansion lumen and ventilation lumen can be used to purge air from the expansion lumen, ventilation lumen, and balloon during preparation. During surgery, all lumens can be used in parallel to expand or contract simultaneously. Thus, multiple inflation lumens can facilitate faster inflation and deflation of the balloon compared to a single lumen catheter. Multiple inflation lumens can also provide redundancy; in the event that one inflation lumen becomes kinked, blocked, or otherwise compromised, in some applications, the remaining one or more operable inflation lumens can provide flow to and from the balloon sufficient to inflate and / or deflate the balloon.

[0106] Fig.16A A cross-sectional view of an elongated tubular member 110a is shown, comprising a dual inflation lumen 200a having a wire pattern, wherein a reinforcing wire 300a extends above and below both inflation lumens 200a together.

[0107] Fig. 16B 1 shows a cross-sectional view of an elongated tubular member 110b including dual expansion lumens 200b having a wire pattern, wherein reinforcing wires 300b extend individually above and below each expansion lumen 200b. Fig. 16BIn the illustrated configuration, the wires 300b may separate the inflation lumens 200b so as to prevent the inflation lumens 200b from shifting to overlap when the elongated tubular member 110b is bent.

[0108] Fig. 16C A cross-sectional view of an elongated tubular member 110c having three inflation lumens 200c is shown. Although not shown, other variations having more than three inflation lumens are also contemplated.

[0109] Fig.16D A cross-sectional view of an elongated tubular member 110d is shown having dual inflation lumens 200d positioned on opposite sides of the circumference of the elongated tubular member 110d, the dual inflation lumens being offset by approximately 180 degrees.

[0110] Fig.17A A dual inflation lumen catheter 100 is shown connected to a proximal Luer hub 700 that is configured to flush, inflate, and deflate the balloon. Fig. 17B A cross-sectional view of an elongated tubular member 110 is shown, which may be used as Fig.17A The elongated tubular member 110 is shown. Those skilled in the art will recognize and appreciate that dual-inflation lumen catheters having alternative configurations may be used as Fig.17A The catheter 100 shown. For example, Fig.16A , Fig. 16B and Fig.16D The catheter shown having elongated tubular members 110a, 110b, 110d is suitable.

[0111] See also Fig.17A and Fig. 17B , the catheter 100 may include an inflation port 252 positioned below the balloon, the inflation port being an opening in the elongated tubular member 110d that provides a flow path from one or both of the inflation lumens 200 into the balloon 210. The catheter 100 may include two inflation ports 252, one for each inflation lumen 200 in the dual inflation lumen catheter 100.

[0112] The proximal Luer interface 700 may include two inflation lumen ports 702, 704 that may be used to provide fluid to flush and inflate the inflation lumen and balloon and to provide suction to deflate the balloon. The proximal Luer interface 700 may include a valve 710 that may be moved to isolate the inflation lumens from each other within the proximal Luer interface 700 or to provide a flow path between two inflation lumens within the proximal Luer interface 700.

[0113] Fig.18A and Fig.18BA cross-sectional view of a proximal luer 700 is shown that can receive an elongated tubular member 110, 110a, 110b, 110d having dual inflation lumens 200, 200a, 200b, 200d. Fig.18A The proximal luer interface 700 is shown with the valve 710 in an isolated position such that the two inflation lumens are isolated from each other within the proximal luer interface 700 . Fig.18B The proximal luer interface 700 is shown with the valve 710 in a communicating position such that the two inflation lumens are in communication with each other within the proximal luer interface 700 .

[0114] See also Fig.18A , when the valve 710 is in the isolation position, the proximal Luer interface 700 can be used to flush the inflation lumen and balloon. A fluid, such as a 50 / 50 contrast agent mixture, can be injected into the first port 702, through which it flows into the cutout 152b in the elongated tubular member 110, thereby providing fluid flow into one of the inflation lumens. The fluid can flow through the system as shown by the arrows. The injected fluid can flow distally through the elongated tubular member 110, through the inflation port 252 below the balloon 210, into the balloon 210, back into the inflation port 252 below the balloon, proximally through the elongated tubular member 110, out of the second cutout 152a in the elongated tubular member 110, into the proximal Luer interface 700, through the opening in the valve 710, and out of the second port 704 in the proximal Luer interface. The proximal luer 700 may also include a proximal opening 712 through which a device may be delivered into the proximal end 112 of the elongated tubular member 110 and through the interior hollow lumen 130 of the elongated tubular member 110 .

[0115] The luer 700 may also include a filter that allows air flow but is impermeable to fluid in communication with the second port 704 so that fluid flowing into the first port 702 may fill the inflation lumen and balloon with fluid and purge the inflation lumen and balloon with air.

[0116] See also Fig.18B When valve 710 is in the communicating position, proximal Luer port 700 can be used to simultaneously inflate or deflate a balloon through two inflation lumens of a double lumen catheter. Fig.18BFluid flow during contraction as shown by arrows is shown. For expansion, fluid flows in the opposite direction as shown by arrows. In the connected position, the second port 704 in the proximal Luer interface 700 can be blocked, and the passage connecting the two expansion lumens can be unblocked. In order to contract, a vacuum can be applied to the first port 702 of the proximal Luer interface 700. The vacuum can be translated through the proximal Luer interface 700 as shown by the arrows, and fluid is extracted from the double lumen via each incision 152a, 152b in the elongated tubular member 110. The vacuum can be translated to the balloon through the two expansion lumens, thereby extracting fluid from the balloon simultaneously via the two expansion lumens. For expansion, a pressurized fluid source can be provided at the first port 702 of the proximal Luer interface 700, and the fluid flows in the opposite direction to that described.

[0117] The descriptions contained herein are examples of embodiments of the present invention and are not intended to limit the scope of the present invention in any way. As described herein, the present invention contemplates many variations and modifications of the device. These modifications will be apparent to those of ordinary skill in the art and are intended to be within the scope of the following claims.

Claims

1. A catheter (100), comprising: An elongated tubular member (110), the elongated tubular member comprising: a proximal end (112); a distal end (114); top(122); bottom (124); and an outer surface (126); Two inner surfaces, the two inner surfaces comprising: an internal hollow lumen (130) extending between the proximal end (112) and the distal end (114); an inflation lumen (200) extending between the proximal end (112) and the distal end (114); wherein the expansion lumen (200) is smaller than the inner hollow lumen (130); wherein the inflation lumen (200) is located outside the inner hollow lumen (130) near at least one of the top (122) or bottom (124) portions of the elongated tubular member (110); an inner core (140), the inner core having an inner core thickness (142); a balloon (210) connected to the inflation lumen (200); wherein the balloon (210) extends from the distal end (114) and is secured to the elongated tubular member (110); A wire configuration (400) includes wires (300) and separates the wires (300) above the inflation lumen (200).

2. The catheter (100) of claim 1, wherein the balloon (210) extends beyond the distal end (114) of the elongated tubular member (110).

3. The catheter (100) of claim 1, wherein the balloon (210) is secured to the elongated tubular member (110) by a bonding layer (240).

4. The catheter (100) of claim 1, wherein the balloon (210) is secured to the elongated tubular member (110) by an adhesive (600), wherein the balloon (210) is eccentrically inflated.

5. The catheter (100) of claim 1, wherein the wire configuration (400) comprises a braided pattern.

6. The catheter (100) according to claim 1, wherein the wire configuration is a separation wire configuration (510), the separation wire configuration including the wire (300), the separation wire configuration separating the wire (300) both below and above the inflation lumen (200).

7. The catheter (100) of claim 6, wherein the wire configuration (400) comprises a braided pattern.

8. A catheter (100), comprising: Tubular inner core; a first expansion sleeve including a first lumen therethrough and extending along a majority of the length of the tubular core; a wrapping wire mesh securing the first expansion sleeve to an outer surface of the tubular inner core; wherein the wrapped wire mesh secures the second expansion sleeve to the outer surface of the tubular inner core; A balloon is attached to the distal portion of the tubular core and is in fluid communication with the first lumen of the first inflation sleeve.

9. The catheter (100) of claim 8, wherein the first expansion sleeve comprises a crescent-shaped cross-section.

10. The catheter (100) of claim 8, further comprising a polymer layer disposed between the first expansion sleeve and the wrapped wire mesh.

11. The catheter (100) of claim 10, further comprising a polymer sheath sleeve surrounding the tubular inner core.

12. The catheter (100) of claim 11, wherein the polymer jacket sleeve is welded to the polymer layer disposed between the expansion sleeve and the wrapped wire mesh, and wherein the polymer jacket sleeve effectively seals a damaged opening in the first expansion sleeve.

13. The catheter (100) of claim 8, wherein the wrapped wire mesh comprises wires that co-extend together above and below the first expansion sleeve and the second expansion sleeve.

14. The catheter (100) of claim 8, wherein the wrapped wire mesh comprises wires extending individually above and below the first expansion sleeve and the second expansion sleeve, thereby separating the first expansion sleeve from the second expansion sleeve.

15. The catheter (100) of claim 8, wherein the balloon is inflated to have a trapezoidal profile characterized by a larger diameter distal end and a smaller diameter proximal end.

16. The catheter (100) of claim 15, wherein the balloon is inflated to define an angle measurable between a line parallel to the non-parallel sides of the trapezoidal profile and a line parallel to the distal portion of the tubular core, and wherein the angle is measured to be less than 70 degrees.

17. The catheter of claim 8, wherein the wrapped wire mesh comprises: a first plurality of line segments extending across an outer surface of the first expansion sleeve; and a second plurality of line segments extending below an inner surface of the first expansion sleeve, wherein each of the line segments in the first plurality of line segments is substantially parallel to each other, wherein each of the line segments in the second plurality of line segments is substantially parallel to each other, and Wherein some of the first plurality of line segments intersect with some of the second plurality of line segments.

18. A Luer interface (700), comprising: an inlet sized to receive a proximal portion of a catheter according to claim 8; a vent port (704) configured to communicate with the second opening (152a); a pump port (702) configured to communicate with the first opening (152b); and A proximal opening (712) configured to allow insertion of a device into the interior hollow lumen (130) of the catheter (100).

19. The Luer interface (700) of claim 18, further comprising: A valve is configured to move from an isolation position to a communication position, wherein when the valve is in the isolation position, the Luer interface (700) is configured to isolate flow to and from the second opening (152a) from flow to and from the first opening (152b), and wherein when the valve is in the communication position, the Luer interface (700) is configured to provide a fluid path between the second opening (152a) and the first opening (152b).

20. A method for operating a catheter according to claim 8, the catheter comprising a first inflation lumen, a second inflation lumen and a balloon, the method comprising the steps of: Fluid is flowed into and out of the catheter by flowing the fluid into the first inflation lumen, through the balloon, and out of the second inflation lumen.

21. The method according to claim 20, further comprising the steps of: The balloon is inflated by providing the fluid into the first inflation lumen and the second inflation lumen simultaneously.

22. The method according to claim 20, further comprising the steps of: The balloon is deflated by simultaneously providing suction at the first inflation lumen and the second inflation lumen.

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