Systems, devices, and methods for tumor cysts incorporating bioabsorbable foam with vacuum technology

Abstract

A device for draining a cyst includes a catheter system configured to deploy an absorbent material, including but not limited to a foam, into a cyst. The absorbent material advantageously absorbs fluid contained within the cyst, e.g., fluid that can remain after aspiration, thereby reducing the likelihood of cyst recurrence. In various embodiments, the absorbent material can be bioabsorbable, radiolucent, echogenic, drug-eluting, or a combination thereof. In some embodiments, the device can also include or be coupled to a vacuum source that applies negative pressure to the cyst during foam delivery, thereby reducing the overall size and / or profile of the cyst.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims the benefit of priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application No. 62 / 970,387, filed February 5, 2020, and U.S. Provisional Patent Application No. 62 / 984,395, filed March 3, 2020, the entire contents of which are incorporated herein by reference for all purposes. TECHNICAL FIELD

[0003] The present invention relates generally to medical devices, and in particular to medical devices such as for cyst management. BACKGROUND

[0004] Pancreatic cancer is the third leading cause of cancer death in the United States. Approximately 20% to 30% of pancreatic cancers arise from mucinous pancreatic cysts, which are found in 2% of the U.S. population and become more prevalent with age.

[0005] Because cyst rupture can accelerate disease spread, cysts are often monitored using non-invasive imaging techniques, such as computed tomography (CT) and magnetic resonance imaging (MRI) to classify and monitor cyst progression. Imaging can be repeated periodically, such as every six months. While imaging is less invasive, it provides inaccurate diagnoses, which can increase patient anxiety and delay diagnosis.

[0006] Endoscopic ultrasound (EUS) is a procedure used to diagnose and evaluate pancreatic cysts. In the procedure, an endoscopic ultrasound is advanced through a patient’s mouth into the stomach and duodenum, from which the pancreas can be imaged. A needle can be used to aspirate fluid from a cyst for biopsy purposes. While these techniques are effective for diagnostic purposes, a high recurrence rate of cysts, particularly in previously aspirated cyst locations, is common and can increase the frequency and number of biopsy procedures. Less invasive devices and methods for cyst classification, diagnosis, and treatment with improved accuracy are desirable. SUMMARY

[0007] According to one aspect, a device, such as, but not limited to, a device for draining a cyst, includes a catheter having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end; and a sheath disposed about the distal end of the catheter, wherein a distal tip of the sheath extends beyond the distal end of the catheter to form a chamber distal of the distal end of the catheter. The device includes an absorbent material disposed within the chamber of the sheath; a handle coupled to the sheath and including a release or deployment mechanism (referred to herein for convenience and not by way of limitation as a "release" mechanism) configured and positioned to release the absorbent material from the chamber; and a vacuum passageway disposed for applying a proximal suction force through the catheter lumen.

[0008] In various embodiments, the handle can include a vacuum source, or the handle can be coupled to a vacuum source. The handle can include a housing having a bore extending from a proximal opening of the housing to a distal inlet of the housing, wherein the proximal end of the catheter is fluidly coupled to the distal inlet of the housing. In one embodiment, the vacuum source includes a plunger rod translatably disposed within the bore, the plunger rod including a plunger translatable within the bore, wherein advancing the plunger rod and the plunger proximally through the bore increases a pressure within the housing and lumen of the catheter to generate the proximal suction force. In some embodiments, the release mechanism includes one of a knob, a switch, a thumbwheel, a button, a dial, or a combination thereof. In various embodiments, the absorbent material includes a foam. The foam can be bioabsorbable, formed of a radiolucent or echogenic material, a drug-eluting foam, or a combination thereof. In one embodiment, the catheter of the device can be shaped and configured to translate through a working channel of an endoscope. In one embodiment, the catheter can be shaped and configured to translate through a needle lumen of a needle catheter.

[0009] According to another aspect, a catheter system includes a catheter having a proximal end, a distal end, and a catheter lumen extending from the proximal end to the distal end; and a sheath disposed about the distal end of the catheter, the sheath having a distal tip extending distally beyond the distal end of the catheter to form a chamber distal of the distal end of the catheter. The catheter system includes an absorbent material having a compressed configuration sized to fit within the chamber of the sheath and an expanded configuration larger than the compressed configuration, the absorbent material including a radiolucent material, an echogenic material, a drug-eluting material, a bioabsorbable material, or a combination thereof. The catheter system includes a handle coupled to the sheath and including a release mechanism configured and positioned to release the absorbent material from the chamber; and a vacuum passageway disposed for applying a proximal suction force through the catheter lumen.

[0010] In various embodiments, the release mechanism configured and positioned to release the absorbent material can include one of a knob, a switch, a thumbwheel, a button, a dial, or a combination thereof. The catheter system can further include a housing having a bore extending from a proximal opening of the housing to a distal inlet of the housing, wherein the distal inlet is fluidly coupled to the proximal end of the catheter. The vacuum source can include a plunger rod translatably disposed within the bore, the plunger rod including a plunger translatable within the bore, wherein advancing the plunger rod and the plunger proximally through the bore decreases a pressure within the housing and the catheter lumen to generate the proximal suction force. The catheter can be shaped and configured to be translated through a working channel of an endoscope, a lumen of a needle catheter, or both.

[0011] According to another aspect, a method includes advancing a catheter through a body lumen into a cyst, the catheter having a proximal end, a distal end, and a catheter lumen extending therethrough, the catheter including an elongate body disposed within a sheath, the sheath extending distally from the distal end of the catheter to form a chamber having an absorbent material stored therein. The method includes releasing the absorbent material from the chamber of the sheath into the cyst, applying a proximal suction force through the catheter lumen to reduce the cyst and compress the absorbent material within the cyst, and removing the catheter from the cyst and the body lumen.

[0012] In various embodiments, the catheter includes a proximal handle including a housing having a bore extending from a proximal opening of the housing to a distal inlet of the housing, wherein the distal inlet of the housing is fluidly coupled to the proximal end of the catheter; a plunger rod translatably disposed within the bore, the plunger rod including a plunger translatable within the bore. The method includes applying a proximal suction force including withdrawing the plunger rod and the plunger proximally through the bore to generate the proximal suction force through the distal inlet and the catheter. In some embodiments, the method includes advancing the catheter through a working channel of an endoscope to the cyst. In some embodiments, the method includes advancing the catheter through a needle lumen of a needle catheter to the cyst. In some embodiments, the method includes draining the cyst using the needle catheter prior to inserting and advancing the catheter through the needle catheter, and wherein applying the proximal suction force through the catheter lumen uses a needle suction aspiration force. BRIEF DESCRIPTION OF DRAWINGS

[0013] The foregoing and other features of the invention will become more apparent from the accompanying drawings, the following description, and the appended claims. It should be understood that these drawings depict only a few embodiments of the invention and are not intended to limit its scope; rather, the invention will be described with additional specificity and detail using the drawings. Reference is made to the drawings, which form a part of the following detailed description. In the drawings, similar symbols generally identify similar components unless the context otherwise indicates. The illustrative embodiments described in the detailed description, drawings, and claims are not intended to be limiting. Other embodiments and variations may be utilized without departing from the spirit and scope of the subject matter described herein. It will be readily understood that aspects of the invention, as generally described herein and shown in the drawings, can be arranged, substituted, combined, and designed in a variety of different configurations, all of which are clearly contemplated and form part of this description.

[0014] Figure 1 A and Figure 1 B illustrates an embodiment of a conduit system for deploying expandable materials;

[0015] Figure 2 yes Figure 1 Cross-sectional view of A's conduit system;

[0016] Figure 3 An embodiment of an ultrasonic endoscope including a working channel is shown. Figure 1 A's conduit system can be deployed via a working channel, as disclosed herein;

[0017] Figure 4A and Figure 4B It is shown in catheter systems, such as those with endoscopes, such as Figure 2 The related endoscope Figure 1 A cross-sectional view of an embodiment of the method of using the catheter system described in A;

[0018] Figure 5A and Figure 5B It is shown in catheter systems, such as those with endoscopes, such as Figure 2 The related endoscope Figure 1 A cross-sectional view of an embodiment of the method of using the catheter system described in A;

[0019] Figures 6A to 6D The pancreas with a cyst treatment site is shown and used to describe the use. Figure 1 Various views of an embodiment of a catheter system for deploying expandable materials to treat pancreatic cysts. Detailed Implementation

[0020] A device such as for managing a cyst includes a catheter system configured to deploy an absorbent material (including but not limited to foam) into a cyst such as. The absorbent material advantageously absorbs fluid (e.g., contained within the cyst), for example, fluid that can remain after aspiration, thereby reducing the likelihood of cyst recurrence. In various embodiments, the absorbent material can be bioabsorbable, radiolucent, echogenic, drug-eluting, or combinations thereof.

[0021] In one embodiment, the device can also include or be coupled to a vacuum source that applies negative pressure to the cyst during and / or after foam delivery to drain the cyst, thereby reducing the overall size and / or profile of the cyst. Reducing the overall profile of the cyst can reduce the likelihood of cyst recurrence. Additionally, reducing the overall profile of the cyst can increase contact between the foam and the cyst sidewall. In embodiments where the foam is coated or otherwise contains a drug for local treatment of the cyst, applying such vacuum pressure can improve the efficacy of the treatment.

[0022] Various embodiments of such cyst management devices and methods will now be described. Reference throughout this specification to "one embodiment," "an embodiment," or "a number of embodiments" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the application. The appearances of the phrases "in one embodiment," "in an embodiment," or "in some embodiments" in various places in the specification are not necessarily all referring to the same embodiment, nor are they necessarily all

[0023] As used herein, the term "distal" refers to the end of a medical device that is farthest from a medical professional when the medical device is introduced into a patient, while the term "proximal" refers to the end of a medical device that is closest to a medical professional when the medical device is introduced into a patient. With respect to an opening, a central axis refers to a line that bisects the center point of the opening, which extends longitudinally along the length of the opening when the opening includes, for example, a tubular frame, strut, or bore.

[0024] Figure 1A illustrates an example of a catheter system 100 including a handle 120 coupled to a catheter 140. In one embodiment, the catheter 140 includes an elongated body 142 having a proximal end 141 releasably coupled to (e.g., threaded via knob 121 to) the handle 120 and a distal end 143. In one embodiment, the catheter can include a composite of a thermoplastic elastomer (TPE) layer. Alternatively, nylon, polyurethane, polyester, silicone, or other similar materials can be used to provide a thin wall that can be extruded and layered over a braided wire or coil to obtain stretch and hoop strength, however the disclosed system is not limited to any particular material composition.

[0025] According to one embodiment, the catheter system is shaped and configured to manage a pancreatic cyst, however the present invention is not limited to use in the pancreas, and it should be appreciated that the principles disclosed herein can be extended to cyst management throughout the body by those skilled in the art.

[0026] For embodiments in which the catheter is shaped and configured to perform pancreatic cyst management, however, the length of the catheter 140 can be selected to enable the catheter to be navigated transluminally through the gastrointestinal tract to the pancreas. For example, the length of the catheter can be in a range of at least about 1300 millimeters (mm) to about 1600 mm, such as between about 1300 mm and 1500 mm, or between about 1400 mm and 1600 mm, etc.

[0027] In one embodiment, the catheter 140 can include a sheath 145 disposed over the elongated body of the catheter 140. Like the elongated body, the sheath can be composed of a thermoplastic elastomer, nylon, polyurethane, polyester, silicone, or other similar materials. In one embodiment, the sheath 145 can have a distal end 147 that extends beyond the distal end 143 of the elongated body 142, thereby forming a chamber inside the distal end 147 of the sheath in which an absorbent material (such as a foam) can be disposed for delivery to the cyst treatment site. In some embodiments, the distal end 147 can include one or more echogenic features 148 to facilitate visualization of the distal end 147 during ultrasound.

[0028] The outer diameter of the elongated body 142 and / or sheath 143 is selected to enable the catheter to be freely advanced within the working channel of an endoscope. For example, in various embodiments, the outer diameter of the elongated body 142 and / or sheath 145 can be at least about 1.5 mm and at most about 3.5 mm to fit within and be extendable within the working channel of an endoscope (e.g., having a 3.8 mm diameter working channel), however the present invention is not so limited.

[0029] In some embodiments, the sheath 145 and the elongated body 142 can be translatably disposed relative to one another to enable the release of the foam from the distal end 147 of the sheath 145. For example, in some embodiments, the sheath can be configured and disposed to be pulled proximally from the distal end 143 of the elongated body 142 of the catheter 140, or the elongated body 142 can be disposed to move proximally within the sheath 145.

[0030] In other embodiments, the sheath 145 and the elongated body 142 can be fixedly disposed relative to one another, and the elongated body can include a suitable release mechanism (e.g., push rod, etc.) configured and positioned to release and / or expel and / or deploy (for convenience, and not intended to be limiting, hereinafter referred to as "release") the sheath foam from the distal end 147 of the sheath. Various embodiments of release mechanisms configured and positioned to release the material, such as absorbable material, from the distal end 147 of the sheath 145 at a desired site are known to those of ordinary skill in the art and are considered to be within the scope of the present application. For example, any of the following release mechanisms can be used: a pneumatic assisted mechanism for releasing the foam / powder / gel; a mechanical mechanism (e.g., a screw mechanism, a plunger (push) mechanism, etc.) for releasing the foam / powder / gel; a release mechanism that releases the foam (by changing the state of the foam / powder / gel).

[0031] In one example, the lumen 144 Figure 2 extends from the proximal end 141 of the elongated body 142 of the catheter 140 through the distal end 147 of the sheath. The lumen 144 provides a fluid flow path between the distal end 147 and a vacuum source associated with the handle 120, thereby enabling proximal fluid aspiration through the catheter 140 during a cyst management procedure as disclosed below.

[0032] The handle 120 includes a housing 126 having a bore 250 Figure 2 In one embodiment, the vacuum cartridge 125 is adjustably disposed within a proximal portion of the handle housing bore, and the distal inlet port 123 is disposed at the distal end of the bore of the housing 126. In one embodiment, the housing 126 can include a tab lock 127 that can be used to control the adjustment height, and the attendant available vacuum force provided by the vacuum cartridge 125. The distal inlet port 123 fluidly couples the internal lumen 144 of the catheter 140 to the bore 250 of the housing 126.

[0033] In one embodiment, the plunger rod 124 is translatably disposed within the vacuum cylinder 125, wherein the plunger rod 124 includes a distal plunger 224 whose proximal end seals the orifice to prevent air from entering from outside the housing 126. As a result, the proximal translation of the plunger rod 124 within the vacuum cylinder 125 creates a negative pressure within the orifice of the housing 126, thereby providing a proximal vacuum / suction force through the distal inlet 123 of the housing, which draws fluid (e.g., gas and / or liquid) through the cavity 144 of the conduit 140.

[0034] In some embodiments, the handle 120 may further include a release mechanism configured and positioned to control the delivery of absorbent material to the cyst. For example, a turntable 129 is shown disposed around the vacuum cylinder 125 of the handle 120. In one embodiment, rotation of the turntable may control a release mechanism within the handle / catheter configured and positioned to release absorbent material from the distal end 147 of the catheter sheath 145. It should be understood that any of a variety of release mechanisms may be used to manage the release of absorbent material, and other release mechanisms, such as switches, knobs, buttons, thumbwheels, etc., are considered to be within the scope of the invention.

[0035] Figure 1 B illustrates one embodiment of absorbent material 160 that can be disposed in a cavity located at the distal end 147 of the sheath 145 and used in the manner disclosed herein.

[0036] In one embodiment, the absorbent material 160 may comprise a foam, gel, powder, or similar material having the ability to absorb and retain biological fluids, including but not limited to blood, mucus, and other bodily fluids, from the cyst. The foam may be an open-pore foam designed to facilitate drainage. According to one aspect, it should be understood that deploying a foam into the cyst to absorb excess fluid may reduce cyst recurrence at that location. Examples of foams suitable for this purpose include those with hemostatic properties, such as those formed from porcine gelatin (e.g., GelForm manufactured by Pharmacia Corporation of Kalamazoo, Michigan). TM The sponge or Surgifoam manufactured by Ethicon, Somerville, New Jersey. TM (sponges), and those made of bovine collagen (e.g., Ultrafoam made by Integra, Plainfield, New Jersey). TM Helistat, manufactured by Ethicon / J&J in Somerville, New Jersey; those composed of oxidized regenerated cellulose (ORC), such as Surgicel Oxycel manufactured by Ethicon / J&J; or combinations thereof. Although Figure 1The absorbent material 160 of B is shown as having a generally cylindrical shape, but the present application is not limited to foams having any particular shape and / or size. It should be appreciated that the amount of foam delivered to a cyst depends on the size of the cyst cavity, and that the amount of foam provided within the distal end 147 of the sheath 145 can store enough foam to treat multiple cysts. In various embodiments, the foam can be stored in a compressed form in a volume that is less than the delivery form, which can be an expanded form, when the foam is outside of the sheath 145. In various embodiments, the foam can exhibit substantially the same volume, shape, and / or form within the sheath 145 and when delivered outside of the sheath 145. By way of example, enough foam can be stored to treat more than one cyst, or a cyst that requires more foam than is provided. The foam can be provided in one or more cartridges and deployed according to cyst size and / or number of cysts. It should be appreciated that the foam need not be stored in the catheter. Alternatively (or additionally), the foam can be loaded through the handle 120, such as by a syringe, or through the distal end 143 of the catheter 140.

[0037] In some embodiments, the foam can include additional properties in addition to absorbent properties. For example, in one embodiment, the foam can be a soft, elastic hemostatic bio-foam that is able to conform to the cyst cavity and transform over time into a porous gel or other substance that can be absorbed by the body. In some embodiments, the foam can be coated or otherwise contain a therapeutic agent that accelerates cyst healing and / or provides a local treatment, including a cancer treatment, such as any therapeutic agent with properties that delay fluid generation or delay the transformation of the cyst into malignant tissue, or any drug with healing properties (already or to be developed). In some embodiments, the foam can be marked or formed from a substance that increases the visibility of the treated cyst cavity during subsequent foam placement and during subsequent imaging, for example, including radiolucent or echogenic markers, etc.

[0038] Figure 2 is a cross-sectional view of the catheter system 100 showing the distal portion of the catheter 140 and the handle 120. In Figure 2 In the distal end 147 of the catheter 140, the foam 160 is visible within a chamber 230 that extends between the distal end 143 of the elongated body 142 of the catheter 140 and the distal end 147 of the sheath 145. A push rod 240 is positioned with its distal end 241 adjacent to the chamber 230 and extending axially within the lumen 220 of the elongated body 142 from the adjacent chamber 230 through a distal inlet 123 of the handle housing 126 and into the housing 126 to a proximal end 242 of the push rod 240 positioned adjacent to the release mechanism (e.g., dial) 129. Advancing the push rod 240 distally by actuating the release mechanism 129 expels the foam 160 through the distal end 147 of the sheath 145.

[0039] An example of a vacuum source in the form of a plunger rod and plunger is shown in Figure 2 A vacuum cylinder 125 is shown disposed within a bore 250 of a housing 126, and a plunger rod 124 is shown disposed axially within the vacuum cylinder 125. A plunger 224 disposed on a distal end of the plunger rod 124 can be formed of rubber or other material that enables the plunger rod 124 to move axially within the vacuum cylinder 125 without allowing external airflow into the bore 250. In various embodiments, a lumen (e.g., lumen 144 of Figure 2 may be in fluid communication with a vacuum source (e.g., located at a proximal end of the system 100).

[0040] According to one aspect, the catheter system 100 can be used as part of an endoscopic ultrasound (EUS) procedure for pancreatic cyst management. Figure 3 One embodiment of an ultrasound endoscope 300 is shown, including a handle 310 and a steerable catheter 320 having an ultrasound transducer 330 disposed at a distal end thereof. Various working channels can be disposed within the catheter 320, and instruments can enter the working channels using one or more of the ports 340 disposed within the handle. A dial 315 of the handle 310 can be used to navigate a distal end 325 of the catheter 320 to a treatment site, e.g., to a cyst. Figure 3 A suction needle 350 is shown that has been disposed through a working channel of the endoscope 300 and deployed to aspirate fluid from a cyst.

[0041] Figure 4A and Figure 4B is a cross-sectional view of a distal end of the endoscope 300 during a procedure, e.g., during cyst management. In Figure 4A a suction needle system 360, including a distal suction needle 350, has been advanced distally through a working channel 322 of the catheter 320 of the endoscope. The needle 350 330 extends distally adjacent the ultrasound transducer, enabling visualization of the aspiration procedure.

[0042] After aspiration, the suction needle system 360 can be withdrawn from the working channel 322, while the endoscope remains in place, and as shown in Figure 4B the catheter 140 of the catheter system 100 can be advanced through the working channel 322 of the steerable catheter 320 to the aspirated cyst. Visualization of the distal end 147 of the catheter 140 is facilitated using echogenic markers 148 that can be visualized using the ultrasound transducer 330.

[0043] Figure 5A and 5B is a cross-sectional view of a distal end of the endoscope 300, e.g., during another embodiment such as a cyst management procedure. As Figure 4A shown, inFigure 5A In this process, the aspiration needle system 360, including the distal aspiration needle 350, has advanced downward through the working channel 322 of the catheter 320 of the endoscope 300. The needle 350 extends distally adjacent to the ultrasound transducer 330, thereby enabling visualization of the aspiration procedure. Figure 5A In the middle, the needle cavity 365 that defines the suction path is visible.

[0044] exist Figure 5B In this process, after aspiration, the aspiration needle system 360 remains in the appropriate position in the working channel 322, and the catheter 140 of the catheter system 100 can be advanced through the needle lumen 365 of the needle system 360 to reach the aspirated cyst. Therefore, the catheter system can be advanced toward the cyst using multiple available paths within the endoscopic ultrasound, and visualization can be achieved.

[0045] Figures 6A to 6D An example of a process for cyst management using the catheter system 100 described above is shown.

[0046] exist Figure 6A During the procedure, the endoscope 300 can be advanced, for example, along the gastrointestinal tract to a target location of the cyst 610 adjacent to the pancreas 600. An ultrasound transducer 330 can be used to facilitate visualization of the surroundings and targeting of the cyst. A suction needle 350 can be advanced from the working channel of the endoscope 300 into the cyst 610 to drain cyst fluid.

[0047] like Figure 6B As shown, after draining the cyst fluid, in one embodiment, the needle is withdrawn, and the distal end 147 of the catheter 140 can be advanced toward the cyst 610 through the endoscope 300.

[0048] like Figure 6C As shown, after the distal end 147 of the catheter 140 is advanced into the cyst 610, foam 160 can be released into the cyst 610. In one embodiment, before, during, and / or after the release of foam 160 into the cyst 610, a proximal vacuum force pulls the cyst wall and / or foam toward the distal end 147 of the catheter 140, thereby reducing the size of the cyst.

[0049] exist Figure 6D After foam is applied, the endoscope can be removed from the gastrointestinal tract and / or positioned for treatment of different cysts. Cyst 610 is retained in a reduced form with added foam 160, which continues to absorb cyst fluid over time, thereby reducing cyst recurrence.

[0050] It should be noted that although catheter systems and methods of use have been described as part of transcavitary procedures, other access methods, including laparoscopic, percutaneous and / or endoscopic retrograde cholangiopancreatography, can similarly benefit from the concepts disclosed herein.

[0051] Thus, catheter systems and methods of using the same have been shown and described. Various modifications to the implementations described in this disclosure will be readily apparent to those skilled in the art, and the generic principles defined herein can be applied to other implementations without departing from the spirit and scope of this disclosure. Accordingly, the disclosure is not intended to be limited to the implementations shown herein but is to be accorded the widest scope consistent with the claims, the principles and the novel features disclosed herein. The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any implementation described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other implementations.

[0052] Certain features described in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment can also be implemented separately or in any suitable subcombination. Moreover, although features can be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination and the claimed combination can be directed to a subcombination or variation of a subcombination.

[0053] Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring such an order, or that all illustrated operations be performed, to achieve desirable results. Additionally, other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results.

[0054] Those skilled in the art will appreciate that the term "includes," "including," and "have" are generally intended to be open and permitting language (e.g., the term "including" will be interpreted as "including but not limited to," the term "have" will be interpreted as "have at least," the term "including" will be interpreted as "including but not limited to," etc.). Those skilled in the art will further appreciate that if a specific number in a claim recitation is intended, such an intent will be expressly recited, and in the absence of such recitation, no such intent is present. For example, to aid in understanding, the following dependent claims can contain the use of introductory phrases such as "at least one" and "one or more" to introduce a claim recitation. However, the use of these phrases is not to be construed as implying that the claim recitation introduced by the indefinite article "a" or "an" will limit any specific claim to contain only one such recitation of the claim recitation, even when the same claim includes the introductory phrase "one or more" or "at least one" and the indefinite article such as "a" or "an" (e.g., "a" and / or "an" should generally be interpreted to mean "at least one" or "one or more"); the same applies to the use of the definite article. Additionally, even if a specific number in a claim recitation is expressly recited, those skilled in the art will recognize that such a recitation is generally intended to mean at least the recited number (e.g., a simple recitation of "two recitations" generally means at least two recitations, or two or more recitations, in the absence of other modifiers). Furthermore, in those instances where convention dictates the use of a phrase such as "at least one of A, B, and C, etc." it will be understood that such a structure generally is intended to mean at least one of A, B, or C (e.g., a system having at least one of A, B, and C will include but not be limited to a system having A alone, a system having B alone, a system having C alone, a system having both A and B, a system having both A and C, a system having both B and C, and / or a system having A, B, and C, etc.). Moreover, in those instances where convention dictates the use of a phrase such as "at least one of A, B, and C, etc." it will be understood that such a structure generally is intended to mean at least one of A, B, or C (e.g., a system having at least one of A, B, and C will include but not be limited to a system having A alone, a system having B alone, a system having C alone, a system having both A and B, a system having both A and C, a system having both B and C, and / or a system having A, B, and C, etc.). Those skilled in the art will further appreciate that virtually any transitive word and / or phrase that presents two or more alternative terms in a transitive sense and / or phrase, whether in the specification, claims, or drawings, should be understood to consider the possibility of including one of the terms, either of the terms, or both terms. For example, the phrase "A or B" will be understood to include the possibility of "A," or "B," or "A and B."

Claims

1. A medical device comprising: A catheter having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end; A sheath, the sheath being disposed around the distal end of the catheter and having a distal tip extending distally beyond the distal end of the catheter to form a chamber within the sheath distal to the distal end of the catheter, wherein the catheter extends through the sheath. Absorbent material, wherein the absorbent material is disposed within the cavity of the sheath; A handle, which is coupled to the sheath and includes a release mechanism configured and positioned to release the absorbent material from the chamber; A vacuum passage, configured to apply proximal suction through the lumen of the catheter, and A push rod is coupled to the release mechanism and extends through the cavity, wherein the push rod forces the absorbent material out of the cavity.

2. The medical device according to claim 1, wherein the handle includes a suction source.

3. The medical device according to claim 2, wherein: The handle includes a housing having a hole extending from a proximal opening of the housing to a distal inlet of the housing, the proximal end of the conduit being fluidly connected to the distal inlet of the housing; The suction power source includes a plunger rod that can be translatably disposed within the hole, and the plunger rod includes a plunger that can be translatably disposed within the hole; as well as Advancing the plunger rod and the plunger proximally through the orifice reduces the pressure within the cavities of the housing and the conduit to generate the proximal suction force.

4. The medical device of claim 1, wherein the release mechanism comprises a switch.

5. The medical device of claim 1, wherein the release mechanism comprises a knob or a button.

6. The medical device of claim 1, wherein the release mechanism comprises a thumb wheel or a turntable.

7. The medical device of claim 1, wherein the absorbent material comprises foam.

8. The medical device of claim 7, wherein the foam is bioabsorbable.

9. The medical device of claim 7, wherein the foam comprises a radiation-permeable or echo-permeable material.

10. The medical device of claim 7, wherein the foam is a drug-eluting foam.

11. The medical device of claim 1, wherein the catheter of the device is shaped and configured to translate through the working channel of an endoscope.

12. The medical device of claim 1, wherein the catheter is shaped and configured to translate through the needle lumen of the needle catheter.

13. A catheter system comprising: A catheter having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end; A sheath, the sheath being disposed around the distal end of the catheter, the sheath having a distal tip extending distally beyond the distal end of the catheter to form a chamber distal to the distal end of the catheter, wherein the catheter extends through the sheath. The absorbent material has a compressed form sized to fit within the cavity of the sheath and an expanded form larger than the compressed form, the absorbent material comprising a radiation-permeable material, an echo-producing material, a drug-eluting material, a bioabsorbable material, or a combination thereof; A handle, which is coupled to the sheath and includes a release mechanism that is shaped and configured to release the absorbent material from the chamber; A vacuum passage configured to apply a proximal suction force through the catheter lumen; as well as A push rod is connected to the release mechanism and extends through the cavity, wherein all of the absorbent material is located on the distal side of the push rod, and the push rod forces the absorbent material out of the cavity.

14. The catheter system of claim 13, further comprising: A housing having a hole extending from a proximal opening of the housing to a distal inlet of the housing; wherein: The distal inlet of the housing is fluidly connected to the proximal end of the conduit; A suction source, comprising a plunger rod translatably disposed within a bore in the housing, the plunger rod including a plunger translatably displaceable within the bore in the housing; and Advancing the plunger rod and the plunger proximally through the orifice of the housing reduces the pressure within the housing and the lumen of the catheter, thereby generating the proximal suction force.

15. The catheter system according to any one of claims 13 to 14, wherein the catheter is configured to translate through the working channel of an endoscope, the lumen of a needle catheter, or both.

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