Double Balloon Catheter

Abstract

A double balloon multi-lumen catheter is disclosed. The catheter comprises an elongated catheter body including multiple lumens. The catheter also includes multiple occlusion balloons connected to one or more of the lumens and one or more inlet ports associated with the multiple lumens. The catheter also includes an attachable catheter hub including multiple inlet ports. The catheter hub is positioned to receive a proximal end of the elongated catheter body and fluidly connect one or more of the multiple lumens to an associated one or more of the multiple inlet ports. The entire length of the catheter body is configured to pass through a working channel of a gastrointestinal endoscope. The catheter hub is configured to attach to the proximal end of the elongated catheter body and allows removal of the endoscope from the catheter body without disturbing the balloon position.

Description

[Technical field]

[0001] (CROSS REFERENCE TO PRIOR APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 63 / 247,131, filed September 22, 2021, which is incorporated by reference in its entirety.

[0002] FIELD OF THEINVENTION The present disclosure relates to the field of medical devices used in surgical procedures. In particular, the present disclosure relates to a catheter having an occlusion balloon. [Background technology]

[0003] Gastric outlet obstruction (GOO) is a medical condition in which blockages occur around the pylorus (i.e., the outlet of the stomach) and duodenum (i.e., the entrance to the small intestine). This condition results in the expulsion (i.e., vomiting) of accumulated stomach contents that cannot enter the small intestine due to the obstruction. Such obstructions can be caused by a variety of conditions, including peptic ulcer disease and gastric cancer.

[0004] Prior art methods for treating GOO include delivering a duodenal stent over a guidewire through the working channel of an endoscope. Common drawbacks associated with such methods include a high incidence of tissue ingrowth and overgrowth, which often requires multiple follow-up procedures to address.

[0005] To address the problems associated with duodenal stents, other prior art methods of treating GOO have been developed. One promising method is known as endoscopic ultrasound guided gastroenterostomy (EUS-GE), during which a portion of the small intestine is distended by rapidly injecting a large volume of water into it, and the distension of the small intestine is used to deliver a lumen apposing metal stent (LAMS) to fluidly connect the stomach and small intestine. Problems associated with this solution include suboptimal distension of the small intestine leading to stent misplacement and gastrointestinal perforation, fluid reflux leading to aspiration pneumonia, and cardiovascular complications. Furthermore, it can be difficult to identify the location of the small intestine during such procedures, increasing the risk of mispuncture and inadvertently forming a connection between the stomach and colon instead of the stomach and small intestine.

[0006] To alleviate the problems associated with the EUS-GE technique, the endoscopic ultrasound-guided balloon occlusion gastrojejunostomy bypass procedure has been developed. This procedure uses a modified nasogastric tube with a media injection port between two balloons, which is delivered over a guidewire to the small intestine. The occlusion balloon is then filled with fluid, and liquid is injected into the space between the occlusion balloons to expand a portion of the small intestine, ultimately aiding in the insertion and deployment of the LAMS. This procedure has not been widely adopted because it can be very difficult to deliver the tube over the guidewire to the small intestine. Some operators resort to the use of an overtube (e.g., a splint tube) to help deliver the double balloon tube to the desired location, which further complicates the procedure.

[0007] Thus, there is a clear need for a device that can facilitate the deployment of various catheters within the human body during surgical procedures.

[0008] The features which distinguish the present invention over the background art will become apparent upon review of the disclosure, drawings, and description of the invention provided below. Summary of the Invention

[0009] The following summary is intended to introduce the reader to various aspects of the applicants' teachings but does not define any of the invention.

[0010] The various embodiments described herein generally relate to a double balloon catheter having an attachable catheter hub. In some embodiments, the catheter hub is both attachable and detachable.

[0011] In one aspect of the disclosure, a double balloon catheter is provided that includes an elongated catheter body including multiple lumens. The double balloon catheter further includes first and second inflatable occlusion balloons disposed proximate a distal end of the elongated catheter body. The first and second inflatable occlusion balloons are configured to receive a fluid through at least one of the multiple lumens. The double balloon catheter further includes an injection port disposed proximate a distal end of the elongated catheter body. The injection port is in fluid communication with another of the multiple lumens and is located between the first and second inflatable occlusion balloons. The double balloon catheter also includes a catheter hub having multiple inlet ports. The catheter hub is disposed to be attachable to a proximal end of the elongated catheter body. The catheter hub is also disposed to fluidly connect two or more of the multiple lumens to an associated one or more of the multiple inlet ports. The entire length of the elongated catheter body is configured to pass through a working channel of a gastrointestinal endoscope.

[0012] According to some embodiments, the catheter hub is further arranged to be detachable from the proximal end of the elongate catheter body.

[0013] According to some embodiments, the cross-section of the portion of the elongate catheter body connected to the catheter hub is substantially the same diameter as the remainder of the elongate catheter body.

[0014] According to some embodiments, both the first and second occlusion balloons are fluidly connected to one of two or more of the multiple lumens.

[0015] According to some embodiments, the first and second occlusion balloons are each connected to separate one of two or more of the multiple lumens.

[0016] According to some embodiments, the double balloon catheter further comprises a second injection port located between the first and second occlusion balloons and the proximal end of the elongate catheter body.

[0017] According to some embodiments, the double balloon catheter further comprises a second injection port located between the first and second occlusion balloons and the distal end of the elongate catheter body.

[0018] According to some embodiments, the double balloon catheter further comprises a lumen suitable for advancing a guidewire therethrough.

[0019] According to some embodiments, the catheter hub is further positioned to receive a portion of the proximal end of the elongate catheter body.

[0020] According to some embodiments, each of the multiple lumens includes a luminal sidewall, and fluid communication between the multiple lumens and the catheter hub is provided by openings in the luminal sidewalls of two or more of the multiple lumens.

[0021] According to some embodiments, the openings are disposed at different longitudinal positions along the length of the proximal end of the elongate catheter body.

[0022] According to some embodiments, the catheter hub is further positioned to receive a portion of the proximal end of the elongate catheter body along the insertion axis.

[0023] According to some embodiments, the catheter hub further comprises a plurality of chambers disposed longitudinally along the insertion axis, each chamber fluidly connected to an inlet port, and the plurality of lumens including one or more lumens associated with each chamber, wherein each of the one or more lumens is positioned such that its lumen opening is located inside its associated chamber when the proximal end of the elongate catheter body is fully received within the catheter hub along the insertion axis.

[0024] According to some embodiments, the multiple chambers are separated by a seal configured to fluidly seal the chambers from one another when the elongate catheter body is received therethrough.

[0025] According to some embodiments, the seal is made of a resilient material such as latex, silicone including gel-filled and / or intact gel silicone structures, or a soft acrylic polymer.

[0026] According to some embodiments, the chamber comprises a cage structure extending longitudinally along the insertion axis from a top end to a bottom end. The top and bottom ends are separated by at least one structure that allows an elongate catheter body to be received therethrough and that allows fluid to flow through a volume formed by the cage structure. According to some embodiments, the chamber and the seal are made of a monolithic piece of molding material.

[0027] According to some embodiments, the first inflatable occlusion balloon and the second inflatable occlusion balloon have a length between 32 mm and 50 mm and a height between 32 mm and 50 mm.

[0028] According to some embodiments, at least one of the multiple lumens is configured to deliver a gas therethrough.

[0029] According to some embodiments, the double balloon catheter further comprises a locking mechanism configured to lock the proximal end of the elongate catheter body in place when fully inserted into the catheter hub.

[0030] According to some embodiments, the fixation mechanism comprises an annular flange or rib formed around a portion of the proximal end of the elongate catheter body and configured to be inserted into a corresponding recess in the catheter hub.

[0031] According to some embodiments, the double balloon catheter further comprises a disposable sheath configured to facilitate insertion of the proximal end of the elongate catheter body through the seal. [Brief description of the drawings]

[0032] The drawings included herein are for the purpose of illustrating various embodiments of the disclosed apparatus and methods and are not intended to limit the scope of the teachings in any way. [Figure 1A] 1 shows a stomach and a portion of the small intestine with a gastric outlet obstruction (GOO). [Figure 1B] 1 shows a portion of the stomach and small intestine with a duodenal stent delivered to the duodenum according to the prior art. [Diagram 2] 1 illustrates a portion of the stomach and small intestine during a balloon occluded gastrojejunostomy bypass procedure using a device according to an embodiment of the present disclosure. [Diagram 3] 1 illustrates a catheter according to an embodiment of the present disclosure. [Figure 4] 1 illustrates a functional diagram of a catheter according to an embodiment of the present disclosure. [Diagram 5] 1 illustrates the internal configuration of a catheter port and catheter hub according to an embodiment of the present disclosure. [Figure 6A] 1 illustrates the internal configuration of a catheter hub of a catheter according to an embodiment of the present disclosure. [Figure 6B] 1 shows an exploded view of the internal configuration of a catheter hub of a catheter according to an embodiment of the present disclosure. [Figure 7A] 1A-1D show various side views of a catheter port and catheter hub according to an embodiment of the present disclosure. [Figure 7B] 1A-1D show various side views of a catheter port and catheter hub according to an embodiment of the present disclosure. [Figure 7C] 1A-1D show various side views of a catheter port and catheter hub according to an embodiment of the present disclosure. [Figure 8] FIG. 1 shows a side view of a catheter hub and catheter body introducer according to an embodiment of the present disclosure. [Figure 9A] 1A-1D show different cross-sectional views of a catheter body according to different embodiments of the present disclosure. [Figure 9B] 1A-1D show different cross-sectional views of a catheter body according to different embodiments of the present disclosure. [Figure 10A] 1 illustrates a fixation mechanism that may form part of a catheter according to an embodiment of the present disclosure. [Figure 10B] 1 illustrates a fixation mechanism that may form part of a catheter according to an embodiment of the present disclosure. [Figure 11] 1 illustrates a flow chart of the steps involved in an endoscopic ultrasound-guided balloon occluded gastrojejunostomy bypass procedure using a catheter according to an embodiment of the present disclosure. [Figure 12] 1 illustrates a catheter hub according to another embodiment of the present disclosure. [Figure 13] 13 shows the internal configuration of a catheter hub of the catheter according to the embodiment of FIG. 12. [Figure 14] FIG. 15 shows an exploded view of the internal configuration of a catheter hub of a catheter according to the embodiment of FIGS. 13 and 14. [Figure 15] 1 shows a catheter hub according to yet another embodiment of the present disclosure.

[0033] Further details of the devices disclosed herein and their advantages will become apparent from the detailed description contained below. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] Various devices and methods are described below to provide examples of embodiments of each claimed invention. The embodiments described below do not limit the claimed inventions, and any claimed invention may encompass devices or methods other than those described below. The claimed inventions are not limited to devices or methods having all of the features of any one device or method described below, nor are they limited to features common to more than one or all of the devices or methods described below. The devices or methods described below may not be embodiments of the claimed invention. Any inventions disclosed in the devices or methods described below that are not claimed herein may be the subject of another means of protection, such as a continuing patent application, and the applicant, inventor, or owner does not intend to abandon, relinquish, or dedicate to the public any such inventions by their disclosure in this document.

[0035] As used herein, the term "small intestine" or "small bowel" is defined as the organ of the digestive tract that includes the duodenum, jejunum, and ileum.

[0036] As used herein, the term "fluid" is defined as a liquid or gas, or generally any material that cannot withstand shear forces at rest and that changes shape continuously when subjected to such stress.

[0037] As used herein, the term "infusion" is defined as the continuous introduction of a fluid into a space.

[0038] As used herein, the term "inflation" is defined as the continuous introduction of a fluid into the space defined by the interior of an inflatable body.

[0039] Figure 1A shows a stomach 10 and a portion of the small intestine 11 having a gastric outlet obstruction (GOO) 12. As can be seen in Figure 1A, a gastric outlet obstruction is a blockage of the portion of the small intestine that leads to the stomach, which may prevent food from passing through it. This portion of the small intestine, also known as the duodenum, proximal gut, or anterior gut, is a 25-38 cm long hollow tube that connects the stomach to the second portion of the small intestine (also known as the jejunum).

[0040] If left untreated, GOO can progress to the point where it adversely affects or completely blocks food digestion. GOO is caused by pressure on the duodenum (as indicated by the arrow in Figure 1A). This pressure can be caused by a number of conditions, including but not limited to peptic ulcer swelling, pancreatic swelling, peptic ulcer scar tissue, or cancerous growths.

[0041] FIG. 1B shows a portion of the stomach 10 and small intestine 11 with a duodenal stent 13 delivered to the duodenum 12 according to the prior art, which involves delivering a duodenal stent over a guidewire and through a working channel of an endoscope. Common drawbacks associated with such methods include a high incidence of tissue ingrowth and overgrowth, which often requires multiple follow-up interventions to address. Other complications associated with this technique include duodenal perforation, migration of the stent further into the small intestine, bleeding, ulceration, food impaction, and further blockage.

[0042] To address the shortcomings associated with duodenal stent placement, a technique known as endoscopic ultrasound-guided gastroenterostomy (EUS-GE) was developed. This prior art technique involves using an endoscope to distend the small intestine by rapidly injecting a large amount of water into the small intestine through the endoscope, and using the resulting pressure to deliver a luminal apposing metallic stent (LAMS) to the stomach.

[0043] LAMS stents typically comprise a short lumen with flanged ends. LAMS are used for many reasons including, but not limited to, draining intraperitoneal fluid collections, decompressing blocked ductal systems, or creating fistula tracts between organs. In addressing GOO, the LAMS 24 is used to create a fistula tract between the stomach 10 and the small intestine 11, allowing the stomach contents to effectively bypass any obstruction in the duodenum.

[0044] To place the LAMS 24, the cauterized tip of the LAMS delivery catheter must be used to puncture the walls of the stomach 10 and small intestine 11 and deploy the stent 13 in the appropriate location through the small intestine 11 and stomach 10. The dual flange configuration of the LAMS 24 helps to keep the perforated wall of the stomach 10 in close proximity to the perforated wall of the small intestine 11, thereby minimizing the possibility of leakage.

[0045] As described elsewhere herein, problems associated with direct injection of fluids using an endoscope include suboptimal distension of the small intestine 11 leading to stent misplacement and gastrointestinal perforation, fluid reflux leading to aspiration pneumonia, and cardiovascular complications. Additionally, locating the small intestine 11 during such procedures can be difficult, increasing the risk of accidental puncture and inadvertently forming a connection between the stomach 10 and the colon (not shown) instead of the stomach 10 and small intestine 11.

[0046] To alleviate these problems, nasogastric tubes have been developed that use an inflatable balloon to occlude the area around the point of puncturing the wall of the small intestine 11 in order to optimize distension of the small intestine and reduce the amount of fluid required to distend the small intestine 11 and bring its wall closer to the wall of the stomach 10. This procedure, known as endoscopic ultrasound-guided balloon-occluded gastrojejunostomy bypass, uses a double balloon tube that includes a first inflatable balloon, a second inflatable balloon, and a media injection port between them.

[0047] Current endoscopic ultrasound-guided balloon-occluded gastrojejunostomy bypass procedures using a modified nasogastric tube with an occlusion balloon typically involve the following steps:

[0048] Using the working channel of the endoscope, a guidewire is first delivered through the stomach 10, past the GOO 12, and into the small intestine 11. The endoscope is then removed, leaving the guidewire in place. A modified nasogastric tube is then advanced over the guidewire into the small intestine 11. Once in place within the small intestine 11, both balloons are filled with fluid (usually saline), thereby occluding the small intestine 11 around the site where the LAMS is to be delivered. The space in the small intestine 11 between the balloons is then filled with fluid to locally expand the small intestine 11. By locally expanding the small intestine 11, the walls of the small intestine 11 are brought into approximation to the walls of the stomach 10, thereby facilitating puncture of these walls and deployment of the LAMS 24.

[0049] One significant problem with this method is that, given the GOO and circuitous path between the stomach 10 and the small intestine 11, and the tendency of the modified nasogastric tube to bend and fold inside the stomach, it can be very difficult to deliver the modified nasogastric tube over a guidewire to the small intestine 11. For this reason, some operators resort to the use of an overtube (e.g., a splint tube) to help deliver the double balloon tube to the desired location, which further complicates the procedure.

[0050] FIG. 2 illustrates a portion of the stomach 10 and small intestine 11 during a balloon-occluded gastrojejunostomy bypass procedure using a catheter 20 according to an embodiment of the present disclosure. The catheter 20, shown fully deployed in FIG. 2, includes an elongated catheter body 22 with multiple lumens connected to a first balloon 21a, a second balloon 21b, and an injection port 23. In some embodiments, one lumen can be used to pass a guidewire therethrough. FIG. 2 also illustrates a deployed LAMS 24 and an echo endoscope 25 used to deploy the LAMS 24. A technique for balloon-occluded gastrojejunostomy bypass using a catheter 20 according to an embodiment of the present disclosure is described in detail elsewhere herein with reference to FIG. 11.

[0051] The catheters disclosed herein include an elongated catheter body including multiple lumens. The catheter also includes one or more inlet ports associated with the multiple lumens. The catheters disclosed herein also include a catheter hub including multiple inlet ports. The catheter hub is positioned to receive the proximal end of the elongated catheter body and fluidly connect one or more of the multiple lumens to an associated one or more of the multiple inlet ports. The catheter hub 30 is configured to be removable and reattachable at the proximal end of the elongated catheter body, the entire length of the catheter body being configured to pass through a working channel of an endoscope.

[0052] 3 shows another view of a catheter 20 according to an embodiment of the present disclosure. The catheter 20 includes a catheter hub 30 having multiple ports 31, 32, and 33, and an elongated catheter body 22 with multiple lumens connected to a first balloon 21a, a second balloon 21b, and an infusion port 23. In some embodiments, a catheter 20 according to the present disclosure can include three or more occlusion balloons.

[0053] The catheter body 22 includes multiple lumens suitable for various purposes. The catheter body 22 may be of any length and diameter suitable to allow the entire length of the catheter body 22 to pass through the working channel of a known gastrointestinal endoscope. In some embodiments, the catheter body 22 is preferably 3.3 mm (i.e., 10 French gauge) or less in diameter so that the catheter body 22 can pass through the working channel of some gastrointestinal endoscopes available on the market. In some embodiments, the catheter body 22 is 200-230 cm long so that the catheter body 22 can pass through the working channel of some gastrointestinal endoscopes available on the market. As will be appreciated, the devices disclosed herein may be of any diameter suitable for insertion through the working channel of an endoscope, particularly with endoscopes having relatively small (e.g., 2.4 mm-4.4 mm) working channel diameters.

[0054] The catheter body 22 may be made of any suitable material, including but not limited to polymers such as silicone rubber, nylon, polyurethane, polyethylene, polyethylene terephthalate (PET), latex, and thermoplastic elastomers. Preferably, the catheter body 22 is made of Pebax®, a thermoplastic elastomer. Pebax® has suitable stiffness and is capable of heat sealing to balloon materials. However, other suitable materials or combinations thereof may be used, as will be appreciated by those skilled in the art. In some embodiments, the catheter body may be made of two pieces. For example, in some embodiments, the catheter body may be made of a Pebax® core that includes multiple lumens and a braided Pebax® exterior to reinforce the catheter body and provide sufficient stiffness (i.e., pushability) and flexibility (i.e., navigability) for advancement within the anatomy.

[0055] The catheter hub 30, described in more detail elsewhere herein, is configured to be attached from a proximal portion of the catheter body 22. As will be appreciated by those skilled in the art, by providing a catheter hub 30 as disclosed herein that can be attached during a procedure, it is possible to provide a catheter body 22 that can be delivered into the human or animal body without a hub via the working channel of a GI endoscope. This not only allows the use of a GI endoscope to deliver a catheter to the gastric outlet, but also allows the endoscope to be replaced (i.e., removed from the body) while the catheter body 22 remains in the body, and then the catheter hub 30 can be attached to the catheter body 22 and the catheter used in the procedure. Gastrointestinal endoscopes are particularly advantageous for catheter delivery due to their excellent maneuverability, visualization, and optimal stiffness.

[0056] The catheter hub 30 is also configured to provide fluid communication from multiple lumens in the catheter body 22 to multiple corresponding ports 31, 32, and 33 that form part of the catheter hub 30. As described in more detail elsewhere herein, the catheter body 22 can connect any number of ports to any number of lumens depending on the configuration of the multi-lumen catheter. In some embodiments, the catheter hub 30 can be injection molded and made of any suitable injectable polymeric material, including but not limited to acrylonitrile butadiene styrene (ABS), polycarbonate, polypropylene, polyvinyl chloride (PVC), polyether block amide (PEBA), or mixtures thereof. In some embodiments, the catheter hub 30 can be injection molded in several pieces that are then assembled.

[0057] In some embodiments, the first balloon 21a and the second balloon 21b can have a length of 32 mm to 50 mm and a height of 32 mm to 50 mm and can be made of any suitable material, including but not limited to thermoplastic polyurethane or latex alternative materials. As will be appreciated, the first balloon 21a and the second balloon 21b can be of any dimension required to occlude the small intestine and can be made of any suitable material for the procedure as described and referenced herein. The interior of each balloon is in fluid communication with the lumen of the catheter body 22.

[0058] In some embodiments, both occlusion balloons 21a, 21b are positioned in fluid communication with one lumen in the catheter body 22. In other embodiments, each occlusion balloon 21a, 21b is positioned in fluid communication with a separate and distinct lumen in the catheter body 22. The embodiment in which each balloon can be inflated independently is particularly advantageous when the catheter is unable to reach an optimal location for isolating and inflating the small intestine at both ends to create an enterostomy. In such a situation, the distal balloon 21b can be inflated alone, with fluid injection occurring distal or proximal to the balloon. This allows some expansion of the small intestine, making it easier to localize the enterostomy site, even if the catheter could not be placed in an ideal location.

[0059] At least one of the lumens forming part of the catheter body 22 provides fluid communication from one port 32 in the catheter hub 30 to at least one infusion port 23 located at a point between the first occlusion balloon 21 a and the second occlusion balloon 21 b. In some embodiments, the catheter 20 as described herein can also be provided with infusion ports proximal and / or distal to the occlusion balloons 21 a, 21 b.

[0060] FIG. 4 shows a functional diagram of a device according to an embodiment of the present disclosure. As shown in FIG. 4, the catheter body 22 comprises a first catheter lumen 22a. In some embodiments, the first catheter lumen 22a is configured to provide fluid communication from a chamber 35 to the first occlusion balloon 21a and the second occlusion balloon 21b. The chamber 35 is itself in fluid communication with a port 31. In some embodiments, the second catheter lumen 22b is configured to provide fluid communication from a chamber 34 to an injection port 23 to operatively fill or partially fill the space S between the first occlusion balloon 21a and the second occlusion balloon 21b. The chamber 34 is itself in fluid communication with a port 32. In some embodiments, the third catheter lumen 22c is configured to allow a guidewire (not shown) to be inserted into the port 33 and threaded to a point extending beyond the catheter body 22, as shown in FIG. 4.

[0061] A removable catheter hub 30 according to an embodiment of the present disclosure will now be described in detail with reference to Figures 5, 6A, 6B, 7A, 7B, and 7C. In particular, Figure 5 illustrates the internal configuration of ports 31, 32, 33 and catheter hub 30 of catheter 20 according to an embodiment of the present disclosure. Figures 6A and 6B illustrate the internal configuration of catheter hub 30 of catheter 20 according to an embodiment of the present disclosure. Figures 7A-7C illustrate various side views of ports 31, 32, 33 and catheter hub 30 of catheter 20 according to an embodiment of the present disclosure.

[0062] 5 shows the catheter hub 30 without the proximal end of the catheter body 22 attached. The catheter hub 30 includes a chamber 34 defined by the interior sidewall of the catheter hub 30 and seals 36 and 37. Similarly, a chamber 35 is defined by the interior sidewall of the catheter hub and seals 37, 38. The seals 36, 37, and 38 may be made of a resilient material such as latex, silicone (including gel-filled and / or intact gel silicone structures), soft acrylic polymers, or any other material or structure suitable for sealing the chambers 34, 35 and allowing the proximal end of the catheter body to be inserted therethrough. In some embodiments, the seals 36, 37, 38 are made of silicone 40A due to its biocompatibility and relatively high tear and tensile strength and flexibility. In other embodiments, other suitable materials may be used.

[0063] In some embodiments, the seals 36, 37, 38 are cylindrically shaped seals disposed along the insertion axis A of the catheter hub 30. Each seal 36, 37, 38 includes a central opening O positioned to receive a portion of the proximal end of the catheter body 22 when inserted along the insertion axis A of the catheter hub 30, as shown in FIG. 6B. In some embodiments, each central opening O of each seal 36, 37, 38 is generally frustoconical in shape, having a wide end and a narrow end, thereby allowing the catheter body to be easily received by the wide end, and when pushed through the seal 36, 37, 38, the narrow end provides an inward force against the outer wall of the catheter body 22, thereby providing a seal. Each central opening O of the seals 36, 37, 38 is positioned to provide a substantially liquid-tight seal against the outer periphery of the catheter body 22 when inserted therethrough. Thus, in some embodiments, it may be necessary to apply pressure to the catheter body 22 along the insertion axis A of the catheter hub 30 to force the catheter body 22 through the central opening O of each seal 36, 37, 38. In some embodiments, the seals 36, 37, 38 are static valves. In some embodiments, the seals 36, 37, 38 are silicone static valves.

[0064] In some embodiments, other types of seals may be used, including, but not limited to, duckbill seals, umbrella seals, flapper seals, membranes, diaphragms, and cross slits.

[0065] Chamber 34 is fluidly connected to port 32 via lumen 39. Similarly, chamber 35 is fluidly connected to port 31 via lumen 41. Lumen 22c of catheter body 22 is configured to connect to lumen 40 when fully inserted into catheter hub 30. Lumen 22c is connectable to lumen 40 to allow a guidewire to be inserted into port 33, through lumen 40, and into lumen 22c of catheter body 22. Those skilled in the art will appreciate that the particular arrangement of chambers and lumens 39, 40, 41 need not be as shown in FIG. 5. Other embodiments may include one or more different configurations for fluidly connecting chambers 34, 35 to ports 31, 32.

[0066] As shown in Figures 6B and 7C, each shows the catheter body 22 fully inserted into the catheter hub 30 along the insertion axis A. As will be appreciated, the catheter hub 30 can be attached to the catheter body 22 by fully inserting the proximal end of the catheter body 22 into the catheter hub 30. Similarly, the catheter hub 30 can be removed from the catheter body 22 by removing the proximal end of the catheter body 22 from the catheter hub 30. As can be seen in Figures 6B and 7C, the lumens 22a and 22b include lumen openings 44 and 43, respectively. The lumen openings allow for fluid communication between the interior and exterior of the lumens. The openings 43 are located along the proximal end of the catheter body 22 such that when the catheter body 22 is fully inserted into the catheter hub 30 along the insertion axis A, the openings 43 are located within the chamber 35, thereby allowing for fluid communication between the interior of the chamber 35 and the interior of the lumen 22a. Similarly, opening 44 is located along the proximal end of catheter body 22 such that when catheter body 22 is fully inserted into catheter hub 30, opening 44 is located within chamber 34, thereby allowing fluid communication between chamber 34 and the interior of lumen 22c.

[0067] FIG. 8 shows a side view of a hub and catheter body introducer according to an embodiment of the present disclosure. In some embodiments of the present disclosure, and for some specific applications, it may be desirable for the catheter body 22 to be very thin and / or flexible. In such cases, it may be difficult to fully insert the catheter body 22 into the catheter hub 30 due to the mechanical resistance provided by the seals 36, 37, 38. In such embodiments, the introducer 80 may be used with a catheter as disclosed herein. In some embodiments, the introducer may include a hollow, rigid shaft or sheath portion 80c that is operable for insertion into the catheter hub 30 along an insertion axis A. The shaft portion 80c is open at either end and is sufficiently rigid to allow easy insertion through the seals 36, 37, 38.

[0068] Upon insertion, the elongated catheter body 22 may be received by the wide cylindrical receiver 80a and then guided into the shaft portion 80c by the flared portion 80b, as shown in Figure 8. Once the elongated catheter body 22 is fully inserted into the catheter hub 30, the introducer 80 may be removed from the catheter hub 30 and guided down the length of the catheter body 22 before being removed therefrom at the distal end of the catheter body 22. Removal of the introducer 80 allows the catheter body 22 within the catheter hub 30 to be sealed.

[0069] 9A and 9B show different cross-sectional views of a catheter body according to different embodiments of the present disclosure. As shown in FIG. 9A, in some embodiments, the elongated catheter body 22 can include multiple lumens 22a, 22b, 22c that are circular in cross-section. As shown in FIG. 9B, in some embodiments, the elongated catheter body 22 can include a central lumen 22c of a particular diameter and multiple crescent-shaped lumens 22a and 22b defined by inner and outer diameters. As described in more detail elsewhere herein, the elongated catheter body 22 described herein can include any number of lumens. As will be appreciated by one of ordinary skill in the art, the catheter body 22 according to the present disclosure may include any number of lumens having any suitable configuration in cross-section.

[0070] Lumens forming part of the same catheter body may have different cross-sectional sizes. For example, in embodiments in which the catheter body includes two inflation lumens to allow independent inflation of each balloon 21a, 21b (such as described herein with reference to the embodiment shown in Figures 12-15), the lumens may have different cross-sectional sizes. For example, in a preferred embodiment, the lumen used to inflate the balloons 21a, 21b has a smaller cross-sectional size than the other lumens of the catheter body to optimally use the space available inside the catheter body.

[0071] 7B, 7C, 8, 10A, and 10B show a securing mechanism that can form part of the catheter 20 according to an embodiment of the present disclosure. In some embodiments, it may be desirable to provide a securing mechanism 100, 101 between the elongated catheter body 22 and the catheter hub 30 to prevent the elongated catheter body 22 from slipping through the seals 36, 37, 38 during use. In some embodiments, the securing mechanism may also align the lumen openings 43, 44 on the elongated catheter body 22 with the chambers 34, 35 of the catheter hub 30. In some embodiments, the snap fit of the securing mechanisms 100, 101 can provide audio and tactile feedback to the user, allowing the user to determine when the catheter body 22 is fully inserted into the catheter hub 30.

[0072] In some embodiments, the securing mechanism 100, 101 may be provided by an annular flange or rib 100 forming part of or located on the elongated catheter body 22 and an associated annular groove 101 forming part of the catheter hub 30. In other embodiments, the securing mechanism 100, 101 may be provided by an O-ring forming part of or located on the elongated catheter body 22 and an associated annular groove 101 forming part of the catheter hub 30. As shown in Figures 7C and 10B, when the elongated catheter body 22 is fully inserted into the catheter hub 30, the annular flange or rib 100 snaps into the annular groove 101, thereby providing increased mechanical resistance in both directions along the insertion axis. In other embodiments, the securing mechanism may be any suitable rigid protrusion that mates with a corresponding recess in the catheter hub 30.

[0073] 11 shows a flow diagram of method steps involved in an ultrasound endoscopically guided balloon occlusion gastrojejunostomy bypass procedure 1100 using a catheter 20, according to an embodiment of the present disclosure. In step 1101, a user navigates a GI endoscope through the esophagus and stomach 10 to the gastric outlet. In step 1102, a user advances a guidewire through the working channel of the GI endoscope, past the GOO 12, and through the target enterostomy site. Next, in step 1103, a user attaches a catheter body 22 to the trailing end of the guidewire. In step 1104, a user advances the catheter body 22 over the guidewire until the first and second occlusion balloons 21a, 21b are positioned on either side of the location of the enterostomy stent placement site.

[0074] Next, in step 1105, the user removes the endoscope 25 by exchange (on the catheter body 22), leaving the catheter body 22 in the patient. This step is possible only because the catheter body 22 is attachable to the catheter hub 30, and is thin enough that the entire catheter body 22 can be routed through the working channel of the endoscope 25 before being attached to the catheter hub 30. Thus, this step is not possible to accomplish with prior art catheters.

[0075] In step 1106, the user routes the proximal end of the guidewire through the opening in the catheter hub 30. In step 1107, the user then attaches the catheter body 22 to the catheter hub 30. As described elsewhere herein, attaching the catheter body 22 to the catheter hub 30 may include fully inserting a portion of the proximal end of the catheter body 22 into the catheter hub 30. In step 1108, the user may then inflate the occlusion balloons 21 a, 21 b through the port 31. In step 1109, the user may then inject into the intestinal space between the occlusion balloons 21 a, 21 b to inflate the small intestine.

[0076] In step 1110, the user advances the echo endoscope to the stomach to identify the distended and obstructed portion of the small intestine. In step 1111, the user performs the gastroentero / gastrojejunostomy procedure and deploys the LAMS 24. Finally, in step 1112, the user deflates the occlusion balloons 21 a, 21 b and removes the catheter body 22 and guidewire from the patient's body.

[0077] 12 shows a diagram of a catheter hub 130 of a catheter according to an alternative embodiment of the present disclosure. The catheter hub 130 includes a number of ports 131, 132, 133, 134 in fluid communication with lumens 163, 162, 161, 160, respectively.

[0078] It will be understood by those skilled in the art that the catheter hub 130 may be connected to and cooperate with a catheter body similar to those described with respect to the previous embodiments, as described in more detail elsewhere herein. In particular, the catheter hub 130 is configured to be attached from a proximal portion of the catheter body and configured to provide fluid communication from multiple lumens within the catheter body to a corresponding number of ports 131, 132, 133 and 134 that form a portion of the catheter hub 130.

[0079] As can be seen in Figure 12, the catheter hub 130 may include four ports 131, 132, 133, 134, each of which is in fluid communication with a corresponding catheter body lumen opening. Thus, according to the embodiment of Figure 12, two ports may be used to inflate the balloons, thereby allowing independent inflation of each balloon.

[0080] As with the previous embodiment, by providing a catheter hub 130 as disclosed herein that can be attached during a procedure, it is possible to provide a catheter body that can be delivered into the human or animal body without a hub via the working channel of a GI endoscope.

[0081] In some embodiments, the catheter hub 130 may be injection molded and made of any suitable injectable polymeric material, including but not limited to acrylonitrile butadiene styrene (ABS), polycarbonate, polypropylene, polyvinyl chloride (PVC), polyether block amide (PEBA), or mixtures thereof. In some embodiments, the catheter hub 130 may be injection molded in several pieces and then assembled.

[0082] 13 shows a cross-sectional view of the internal configuration of a catheter hub 130 of a catheter according to an alternative embodiment of the present disclosure. FIG. 14 shows an exploded perspective view of the internal configuration of the catheter hub 130 of the catheter of FIG.

[0083] 13 and 14 show the catheter hub 130 without the proximal end of the catheter body attached. Those skilled in the art will appreciate that the technical principles of how to attach the catheter hub 30 to the catheter body 22 apply mutatis mutandis to how to attach the catheter hub 130 to a similar catheter body.

[0084] The catheter hub 130 includes a chamber 140, which is generally cylindrical and includes a cage structure having two or more radially extending fins separating the ends of the cylinder and surrounding a central cavity. In other embodiments, the fins can be replaced by posts, or shapes and / or structures that provide space between the ends of the generally cylindrical cage structure. Each end of the cage structure has a hole for receiving the proximal end of the catheter body. The cage structure can be made of any suitable material, such as a rigid or semi-rigid polymer and / or metal. In a preferred embodiment, the cage structure is axially rigid to withstand compressive loads and does not deform to compress the seals 150, 151, 152, 153 within the catheter hub 130. The cage structure can be 3D printed using BioMed Clear Resin™. However, in other embodiments, the cage structure can be made of any rigid plastic material, including but not limited to injection molding with acrylonitrile butadiene styrene (ABS), polycarbonate (PC), and the like.

[0085] Chambers 140, 141, 142, 143 comprise a cage structure that extends longitudinally along the insertion axis from a top end to a bottom end separated by a structure that allows an elongated catheter body to be received therethrough and that allows fluid to flow through a volume defined by the cage structure.

[0086] As will be appreciated by those skilled in the art, other cage structures are possible that define chambers having a substantially rigid structure of constant height along insertion axis A and allow fluid to flow around the interior of each chamber and into a corresponding lumen, thereby fluidly connecting the center of the chamber to a corresponding lumen in catheter hub 130. Similarly, chambers 141, 142 and 143, which are in fluid communication with lumens 162, 163 and 160, respectively, are constructed in the same manner using a cage structure.

[0087] Between the chambers 140, 141, 142, 143 are seals 150, 151, 152, 153, which may be made of a resilient material such as latex, silicone (including gel-filled and / or intact gel silicone structures), soft acrylic polymer, or any other material or structure suitable for sealing the chambers 140, 141, 142, 143 and allowing the proximal end of the catheter body to be inserted therethrough. In some embodiments, the seals 150, 151, 152, 153 are made of silicone due to its biocompatibility and relatively high tear and tensile strength and flexibility. In other embodiments, other suitable materials may be used.

[0088] In some embodiments, the seals 150, 151, 152, 153 are cylindrically shaped seals disposed along the insertion axis A of the catheter hub 130, as shown in Figures 13 and 14. Each seal 150, 151, 152, 153 includes a central opening positioned to receive a portion of the proximal end of the catheter body when inserted along the insertion axis A of the catheter hub 130, as shown in Figures 13 and 14.

[0089] In some embodiments, each central opening of each seal 150, 151, 152, 153 is tapered toward the center of the seal and has two wide upper and lower ends and a narrower center portion, thereby allowing the catheter body to be easily received by the wide ends and, when pushed through the seal 150, 151, 152, 153 having a narrow center, provides a force to push the outer wall of the catheter body inward, thereby providing a seal. Each central opening of the seals 150, 151, 152, 153 is positioned to provide a substantially liquid-tight seal around the outer periphery of the catheter body when inserted therethrough. Thus, in some embodiments, it may be necessary to apply pressure to the catheter body along the insertion axis A of the catheter hub 130 to push the catheter body through the central opening of each seal 150, 151, 152, 153.

[0090] In some embodiments, the catheter hub 130 includes a push plug 154 for securing the chambers 140, 141, 142, 143 and the seals 150, 151, 152, 153 inside the catheter hub 130. In some embodiments, when fully inserted, the push plug 154 also provides a constant pressure along the insertion axis A toward the center of the catheter hub 130. The push plug 154 may be made from a suitable material, such as a rigid or semi-rigid polymer and / or metal. In a preferred embodiment, the push plug 154 is axially stiff to withstand compressive loads and does not deform to contribute to the compression of the seals 150, 151, 152, 153 inside the catheter hub 130.

[0091] In other words, the push plug applies a compressive load to a series of cage structures and seals, compressing and pushing the seals outward to seal the central cavity. Thus, the cage structures and push plugs must withstand the compressive load and not deform, i.e., to deform the seals instead. The push plug 154 can be 3D printed using BioMed Clear Resin™. However, in other embodiments, the push plug 154 can be made of any hard plastic material, including, but not limited to, injection molded with acrylonitrile butadiene styrene (ABS), polycarbonate (PC), and the like.

[0092] As will be appreciated by those skilled in the art, due to the rigidity provided by the cage structure of the chambers 140, 141, 142, 143, any mechanical pressure caused by the insertion of the catheter body and / or push plug 154 along the insertion axis A will be transmitted to the resilient seals 150, 151, 152, 153, causing them to deform outward (away from the insertion axis A) and inward (toward the insertion axis A). Such deformation will further increase the pressure on the inner sidewall of the catheter hub 130 and the outer sidewall of the catheter body, thereby increasing the effectiveness of the seal.

[0093] In some embodiments, other types of seals may be used, including, but not limited to, duckbill seals, umbrella seals, flapper seals, membranes, diaphragms, and cross slits.

[0094] The catheter hub 130 can be attached to a catheter body (not shown) by fully inserting the proximal end of the catheter body into the catheter hub 130. Similarly, the catheter hub 130 can be removed from the catheter body by removing the proximal end of the catheter body from the catheter hub 130. It will be understood by those skilled in the art that when the catheter body is fully inserted into the catheter hub 130, the chamber 140 provides fluid communication between the lumen 161 and the corresponding lumen of the catheter body (not shown), the chamber 141 provides fluid communication between the lumen 162 and the corresponding lumen of the catheter body (not shown), the chamber 142 provides fluid communication between the lumen 163 and the corresponding lumen of the catheter body (not shown), and the chamber 143 provides fluid communication between the lumen 160 and the corresponding lumen of the catheter body (not shown).

[0095] Thus, by providing an elongated catheter body 22 having a number of longitudinally disposed openings, and providing a catheter hub 130 that is positioned to receive the elongated catheter body 22 along an insertion axis and includes a corresponding number of longitudinally disposed chambers along the insertion axis, it is possible to provide a removable hub and a catheter having a very thin catheter body along its entire length. As will be appreciated by those skilled in the art, such a thin catheter body is suitable for advancement through a working channel of an endoscope, as described in more detail elsewhere herein.

[0096] 15 shows a diagram of a catheter hub 230 of a catheter according to another alternative embodiment of the present disclosure. Catheter hub 230 includes multiple ports (not shown) in fluid communication with lumens 263, 262, 261, 260, respectively.

[0097] It will be understood by those skilled in the art that the catheter hub 230 may be connected to and cooperate with the catheter bodies of the previously described embodiments, as described in more detail elsewhere herein. In particular, the catheter hub 230 is configured to be attached from a proximal portion of the catheter body and configured to provide fluid communication from multiple lumens within the catheter body to corresponding lumens that form a portion of the catheter hub 130.

[0098] As with the previous embodiment, by providing a catheter hub 230 as disclosed herein that can be attached during a procedure, a catheter body can be provided that is deliverable into the human or animal body without a hub via the working channel of a GI endoscope.

[0099] In some embodiments, the catheter hub 230 may be injection molded and made of any suitable injectable polymeric material, including but not limited to acrylonitrile butadiene styrene (ABS), polycarbonate, polypropylene, polyvinyl chloride (PVC), polyether block amide (PEBA), or mixtures thereof. In some embodiments, the catheter hub 230 may be injection molded in several pieces and then assembled.

[0100] 15 shows an exploded perspective view of the internal configuration of catheter hub 230 without the proximal end of the catheter body attached. Those skilled in the art will appreciate that the technical principles of how catheter hub 30 is attached to catheter body 22 apply mutatis mutandis to how catheter hub 230 is attached to a similar catheter body.

[0101] The catheter hub 130 comprises a monolithic insert 200 formed from a molded material. The insert 200 comprises chambers 241, 242, 243 defined by inner walls of a central cavity extending longitudinally of the insert 200.

[0102] Between the chambers 241, 242, 243 are pinch points 251, 252, 253, which may be narrower portions within the central cavity.

[0103] The insert may be made of a resilient material such as latex, silicone (including gel-filled and / or intact gel silicone structures), soft acrylic polymer, or any other material or structure suitable for sealing the chambers 241, 242, 243 and allowing the proximal end of the catheter body to be inserted therethrough. In some embodiments, the insert 200 is made of silicone due to its biocompatibility and relatively high tear and tensile strength and flexibility. In other embodiments, other suitable materials may be used.

[0104] In some embodiments, the pinch points 251, 252, 253 function as cylindrically shaped seals disposed along the insertion axis A of the catheter hub 230, as shown in Figure 15. Each pinch point 251, 252, 253 includes a central opening positioned to receive a portion of the proximal end of the catheter body when inserted along the insertion axis A of the catheter hub 230, as shown in Figure 15.

[0105] Each pinch point 251, 252, 253 is positioned to form a substantially fluid-tight seal around the circumference of the catheter body when inserted therethrough.

[0106] The catheter hub 230 can be attached to a catheter body (not shown) by fully inserting the proximal end of the catheter body into the catheter hub 230. Similarly, the catheter hub 230 can be removed from the catheter body by removing the proximal end of the catheter body from the catheter hub 230. It will be understood by those skilled in the art that when the catheter body is fully inserted into the catheter hub 230, the chamber 241 provides fluid communication between the lumen 262 and the corresponding lumen in the catheter body (not shown), the chamber 242 provides fluid communication between the lumen 263 and the corresponding lumen in the catheter body (not shown), and the chamber 243 provides fluid communication between the lumen 260 and the corresponding lumen in the catheter body (not shown).

[0107] As will be appreciated by those of skill in the art upon understanding the above embodiments, by providing an elongated catheter body 22 having a number of longitudinally disposed openings, and providing a catheter hub 30, 130, 230 that includes a corresponding number of longitudinally disposed chambers along the insertion axis and that are positioned to receive the elongated catheter body, it is possible to provide a removable hub and a catheter having a catheter body that is very thin along its entire length, and as will be appreciated by those of skill in the art, such a thin catheter body is suitable for advancement through a working channel of an endoscope, as described in more detail elsewhere herein.

[0108] Another important advantage of the double balloon catheter described herein is that the catheter hub 30 comprises a plurality of chambers arranged longitudinally along the insertion axis, each chamber communicating with an opening of a lumen of the catheter body 22. Because the proximal end of the catheter body 22 is directly inserted into the catheter hub 30 along the insertion axis, each fluid connection between a lumen of the catheter body 22 and a chamber of the catheter hub 30 can be provided by a simple opening in the side wall of the lumen. Thus, there is no need to provide a connector between the catheter body 22 and the catheter hub 30, which is typically larger in diameter than the catheter body 22. Requiring such a connector would limit the size of the catheter body 22 (and therefore the number of lumens) to the number of lumens that are connectable to the catheter hub 30 using a connector. Instead, with a catheter as disclosed herein, the only limitation on the number of lumens is the overall diameter of the catheter body 22, which in some embodiments must fit through the working channel of a GI endoscope.

[0109] Furthermore, if a liquid such as water or saline is used for balloon inflation, the inflation lumen must be large enough to facilitate infusion of the liquid throughout the working length of the catheter. If instead a gas (e.g., air) is used for balloon inflation, the inflation lumen can be significantly smaller in size because gas has a lower resistance than liquid. Thus, by using a gaseous inflation fluid in accordance with the catheter as described herein, a relatively large number of lumens can be provided within the catheter body 22. Another advantage of reducing the size of the inflation lumen is that it allows for a larger infusion lumen while maintaining a diameter of the catheter body 22 that can fit through the working channel of a gastrointestinal endoscope. A larger infusion lumen allows for easier and faster infusion of saline solution for inflation.

[0110] Various embodiments are described herein by way of example only. Various modifications and variations can be made to these exemplary embodiments without departing from the scope of the appended claims. For example, a catheter according to the present disclosure may include any number of lumens. Those skilled in the art will also appreciate that the features of Figures 8, 9A, 9B, 10A, 10B can be readily combined with the embodiments described with reference to Figures 12, 13, 14, and 15.

[0111] Additionally, catheters according to the present disclosure may include any number of lumens for inflating any number of occlusion balloons with any fluid suitable therefor, and further, catheters according to the present disclosure may include any number of lumens for infusing the spaces between any number of occlusion balloons with any fluid suitable therefor.

Claims

1. A double balloon catheter, an elongated catheter body including multiple lumens; first and second inflatable occlusion balloons located proximate a distal end of the elongate catheter body, the first and second inflatable occlusion balloons configured to receive fluid through at least one of the plurality of lumens; an injection port located proximate the distal end of the elongate catheter body, the injection port in fluid communication with another lumen of the plurality of lumens and located between the first and second inflatable occlusion balloons; a catheter hub comprising a plurality of inlet ports, the catheter hub being attachable to a proximal end of the elongate catheter body and arranged to fluidly connect two or more of the plurality of lumens to an associated one or more of the plurality of inlet ports; A double balloon catheter, wherein the entire length of the elongated catheter body is configured to pass through a working channel of a gastrointestinal endoscope.

2. The double balloon catheter of claim 1 , further configured to be detachable from the proximal end of the elongate catheter body.

3. 3. The double balloon catheter of claim 1, wherein the cross section of the portion of the elongate catheter body that is connected to the catheter hub is substantially the same diameter as the remainder of the elongate catheter body.

4. 3. The double-balloon catheter of claim 1, wherein the first and second occlusion balloons are both fluidly connected to one of the two or more of the plurality of lumens.

5. 3. The double-balloon catheter according to claim 1, wherein the first and second occlusion balloons are each connected to separate one of the two or more of the plurality of lumens.

6. 3. The double balloon catheter of claim 1, further comprising a second injection port located between the first and second occlusion balloons and the proximal end of the elongate catheter body.

7. 3. The double balloon catheter of claim 1, further comprising a second injection port located between the first and second occlusion balloons and the distal end of the elongate catheter body.

8. 3. The double balloon catheter of claim 1, further comprising a lumen suitable for advancing a guidewire therethrough.

9. The double balloon catheter of claim 1 or 2, wherein the catheter hub is further arranged to receive a portion of the proximal end of the elongate catheter body.

10. 10. The double balloon catheter of claim 9, wherein the plurality of lumens each include a luminal sidewall, and fluid communication between the plurality of lumens and the catheter hub is provided by openings in the luminal sidewalls of the two or more of the plurality of lumens.

11. 11. The double balloon catheter of claim 10, wherein the openings are disposed at different longitudinal positions along the length of the proximal end of the elongate catheter body.

12. The double balloon catheter of claim 10, wherein the catheter hub is further positioned to receive a portion of the proximal end of the elongate catheter body along an insertion axis.

13. the catheter hub a plurality of chambers longitudinally disposed along the insertion axis, each chamber fluidly connected to an inlet port, the plurality of lumens including one or more lumens associated with each chamber; 13. The double-balloon catheter of claim 12, wherein each of the one or more lumens is positioned such that its lumen opening is positioned inside its associated chamber when the proximal end of the elongate catheter body is fully received within the catheter hub along the insertion axis.

14. 14. The double balloon catheter of claim 13, wherein the plurality of chambers are separated by a seal configured to fluid-tightly seal the chambers from one another when the elongate catheter body is received therethrough.

15. 15. The double balloon catheter of claim 14, wherein the seal is made of a resilient material such as latex, silicone, including gel-filled and / or intact gel silicone structures, or a soft acrylic polymer.

16. 14. The double balloon catheter of claim 13, wherein each chamber comprises a cage structure extending longitudinally along the insertion axis from an upper end to a lower end, the upper and lower ends being separated by at least one structure that allows the elongate catheter body to be received therethrough and that allows fluid to flow through a volume defined by the cage structure.

17. 14. The double balloon catheter of claim 13, wherein the chamber and seal are made from a monolithic piece of molded material.

18. 3. The double balloon catheter of claim 1, wherein the first inflatable occlusion balloon and the second inflatable occlusion balloon have a length of 32 mm to 50 mm and a height of 32 mm to 50 mm.

19. 3. The double-balloon catheter of claim 1, wherein at least one of the plurality of lumens is configured to carry a gas therethrough.

20. 3. The double balloon catheter of claim 1, further comprising a locking mechanism configured to lock the proximal end of the elongate catheter body in place when fully inserted into the catheter hub.

21. 21. The double balloon catheter of claim 20, wherein the fixation mechanism comprises an annular flange or rib formed around a portion of the proximal end of the elongate catheter body and configured to be inserted into a corresponding recess in the catheter hub.

22. 3. The double balloon catheter of claim 1, further comprising a disposable sheath configured to facilitate insertion of the proximal end of the elongate catheter body through the seal.

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