Medical delivery system and method of use thereof

Abstract

A medical device (100), e.g., a delivery catheter, can include a handle portion (105), a shaft portion extending distally from the handle portion (105), a deployment mechanism (200), and an actuation member (115) positioned on the handle portion (105). The shaft portion (100) can include a working channel (135) and a distal tip portion (130) having a load chamber (175) configured to receive a load (180), such as a bioabsorbable foam. The distal tip portion (130) can be operably connected to the working channel (135). The deployment mechanism (200) can be positioned in the working channel (135) and can be operable to deploy the load (180) out of the distal tip portion (130). The actuation member (115) can be actuated to operate the deployment mechanism (200).

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 027,657, filed May 20, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present invention generally relates to medical delivery systems, devices, and related methods. Examples of the invention relate to systems, devices, and related methods for delivering bioabsorbable materials for absorbing fluids present in wounds or cysts, such as in the gastrointestinal tract, bile ducts, pancreas, and others. Background Technology

[0004] Endoscopic and open surgical procedures of the gastrointestinal tract (GI) include, for example, colectomy, bariatric surgery, esophagectomy, gastric bypass, and sleeve gastrectomy. These procedures can result in perforation, postoperative leakage, or other wounds in the duct. Perforation, wounds, or cysts may also occur independently as a result of the procedure. There are limited treatment options for managing such wounds, which have significant morbidity and mortality rates. Options include surgical reoperation and endoscopic placement of stents or clips. Surgery is relatively invasive and has high morbidity and mortality rates. Endoscopic stent placement is a less invasive option. However, the placed stent may migrate from the intended location and / or isolate infection at the treatment site, thereby inhibiting drainage. Summary of the Invention

[0005] Various aspects of the present invention relate, among others, to systems, apparatus, and methods for using a delivery catheter to deliver bioabsorbable materials for treating targeted treatment sites such as wounds or cysts by absorbing fluid. Each of the aspects disclosed herein may include one or more features described in conjunction with any of the other disclosed aspects.

[0006] According to one example, a medical device may include a handle portion, a shaft portion extending distally from the handle portion, a deployment mechanism, and an actuation member positioned on the handle portion. The shaft portion may include a working channel and a distal tip portion having a load chamber configured to receive a load, such as a bioabsorbable foam. The distal tip portion may be operatively connected to the working channel. The deployment mechanism may be positioned within the working channel and operable to deploy a load from the distal tip portion. The actuation member may be actuated to operate the deployment mechanism.

[0007] Any of the medical devices described herein may include one or more of the following features. A distal tip portion defines a slit extending through a wall of the distal tip portion, wherein the slit is configured to allow the distal tip portion to bend for receiving and deploying a load. The shaft portion further includes: a pair of fluid channels configured to selectively allow fluid and negative pressure to pass through them. The shaft portion further includes a guide channel configured to allow a guidewire to pass through it. The shaft portion further includes a slit extending through a sidewall of the shaft portion to the guide channel and extending along at least a portion of the length of the shaft portion, and configured to allow at least a portion of the length of the guidewire to pass through it. The distal tip portion further includes a pair of distal fluid openings operatively connected to the pair of fluid channels. The distal tip portion further includes a distal guidewire opening operatively connected to the guide channels. The handle portion includes a fluid connector in fluid communication with the pair of fluid channels and is configured to connect to at least one of a negative pressure source or a delivery fluid source. The load includes a plurality of capsules. The inner surface of the load chamber defines a plurality of cavities for receiving each of the respective plurality of capsules. The distal tip portion defines a slit between the working channel and the outer surface of the distal tip portion, and wherein actuation of the actuating member causes the slit to expand. The distal tip portion is a separate member from the shaft portion. The distal tip portion is coupled to the distal end of the shaft portion. The distal tip portion is preloaded before being coupled to the distal end of the shaft. The medical device also includes a coupling member. The coupling member includes: a first end configured to be directly coupled to the distal end of the shaft portion; a second end opposite the first end configured to be directly coupled to the proximal end of the distal tip portion for coupling the distal tip portion to the tubular portion; and at least one alignment element configured to align the shaft portion and the distal tip portion. The shaft portion also includes a cauterization chamber. The handle portion includes a cauterization connector configured to operatively couple the cauterization chamber to a cauterization device. The distal tip portion also includes a cauterization element positioned on the outer surface of the distal tip portion. The deployment mechanism includes: a pull wire; and a plunger positioned at the distal tip of the pull wire. The actuating member includes a roller knob operably engaging the proximal end of a drawwire. The deployment mechanism includes a pressure channel configured to provide positive pressure from a pressure source to the load for deployment. The deployment mechanism includes a gripper mechanism operably connected to the actuating member and includes two arms operable to selectively hold and release the load. The handle portion includes a connecting member configured to removably attach the medical device to the endoscope. The distal tip portion also includes at least one echo mark positioned on the outer surface of the distal tip portion.

[0008] According to another example, a medical device may include a delivery catheter and a cassette. The delivery catheter may include a handle portion, a shaft portion extending distally from the handle portion, a deployment mechanism, and an actuating member positioned on the handle portion. The shaft portion may include a working channel and a distal tip portion having a load chamber configured to receive a load and operably connected to the working channel. The deployment mechanism may be positioned in the working channel and operable to deploy a load from the distal tip portion. The actuating member may be actuated to operate the deployment mechanism. The cassette may include an opening into the interior of the cassette, the opening being configured to receive the distal tip portion of the delivery catheter; and a bioabsorbable foam load positioned therein and arranged such that a housing is configured to load the distal tip portion with a load in response to the distal tip portion being advanced into the housing via the opening.

[0009] Any of the medical devices described herein may include one or more of the following features. The cassette comprises two half-shells joined together. At least one of the two half-shells is at least partially transparent, allowing the load to be seen through it. At least one of the two half-shells includes a load channel extending from an opening and configured to receive a distal apical portion. The load is positioned within the load channel. The load comprises a plurality of individual capsules. The plurality of individual capsules have a spherical or oval shape.

[0010] According to another example, a delivery catheter may include a handle portion at a proximal end of the delivery catheter, a shaft portion extending distally from the handle portion, a deployment mechanism, and an actuation member positioned on the handle portion. The shaft portion may include a distal tip portion comprising a load chamber configured to receive a bioresorbable foam load; and a working channel operatively connected to the load chamber. The deployment mechanism may be positioned in the working channel and operable to deploy the load from the distal tip portion. The actuation member may be actuated to operate the deployment mechanism. The distal tip portion may also include a slit extending through a sidewall of the working channel, the slit being sized and configured to allow the distal tip portion to fold in response to operating the deployment mechanism to receive and deploy the load. The load may be a plurality of capsules. The shape of the inner surface of the load chamber may be configured to define a corresponding cavity for each of the capsules, and the shape of the corresponding cavity may be configured to provide tactile feedback to the actuation member for actuating each of the individual capsules.

[0011] According to another example, a delivery device can be used to deliver a load to a target treatment site within the body. A method of using the delivery device to deliver a load may include introducing a shaft portion of the delivery device into a proximal end of an endoscope, wherein the distal end is located at the target treatment site. The shaft portion of the delivery device can be advanced such that a distal tip portion of the delivery device is pushed out of the endoscope and into the target treatment site. An actuating member positioned on a proximal handle portion of the delivery device can be actuated. The actuating member can be configured to operate a deployment mechanism positioned in a working channel of the delivery device. The working channel of the delivery device can be operatively connected to the distal tip portion. The distal tip portion may include a load chamber having a load. The deployment mechanism can be operated to deploy the load from the load chamber such that actuation of the actuating member deploys the load into the target treatment site.

[0012] It is understood that the foregoing general description and the following detailed description are merely exemplary and illustrative of the claimed invention, and not restrictive. Attached Figure Description

[0013] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the invention and, together with the description, serve to explain the principles of the invention.

[0014] Figure 1 This is a perspective view of an exemplary delivery conduit used for conveying materials.

[0015] Figure 2 yes Figure 1 A three-dimensional view of the distal tip portion of the delivery conduit.

[0016] Figure 3 yes Figure 1 End view of the distal tip portion of the delivery catheter.

[0017] Figure 4 yes Figure 1 A side cross-sectional view of the distal tip portion of the delivery conduit.

[0018] Figure 5 This is a perspective view of an exemplary cassette including a capsule for loading into a delivery catheter.

[0019] Figure 6 The capsule is loaded into the system during use. Figure 1 The distal portion of the delivery catheter Figure 5 A three-dimensional view of the outer shell.

[0020] Figures 7A to 7H Depicting in use Figure 1 Delivery conduit.

[0021] Figure 8This is a side cross-sectional view of the distal tip portion of another exemplary embodiment of the delivery conduit.

[0022] Figure 9 This is a side cross-sectional view of the distal tip portion of another exemplary embodiment of the delivery conduit.

[0023] Figure 10 This is a side cross-sectional view of the distal tip portion of another exemplary embodiment of the delivery conduit.

[0024] Figure 11 This is a perspective view of the distal end of the tubular portion of another exemplary embodiment of the delivery conduit.

[0025] Figure 12 This is a perspective view of another exemplary embodiment of the distal tip portion of a delivery catheter.

[0026] Figure 13 This is a perspective view of an exemplary embodiment of the connecting member.

[0027] Figure 14 yes Figure 11 The far end Figure 12 The distal apex portion and Figure 13 A three-dimensional view of the connecting components.

[0028] Figure 15 This is a perspective view of another exemplary embodiment of the delivery conduit.

[0029] Figure 16 yes Figure 15 An end view of the tubular portion of the delivery conduit.

[0030] Figure 17 yes Figure 15 A three-dimensional view of the distal tip portion of the delivery conduit.

[0031] Figure 18 This is an end view of the tubular portion of another exemplary embodiment of the delivery conduit.

[0032] Figures 19A to 19C This is an illustration depicting the distal tip portion of another exemplary embodiment of a delivery conduit used for deploying materials in use.

[0033] Figure 20 This is a perspective view of another exemplary embodiment of the distal tip portion of a delivery catheter.

[0034] Figure 21 yes Figure 20 A three-dimensional view of the cross-section of the distal apex portion.

[0035] Figure 22This is a perspective view of the distal end of the tubular portion of another exemplary embodiment of the delivery conduit.

[0036] Figure 23 It is connected to Figure 22 The distal end of the tubular portion Figure 20 A three-dimensional view of the far-top portion.

[0037] Figure 24 yes Figure 20 The distal apex portion and Figure 22 A three-dimensional view of the component at the distal end of the tubular section.

[0038] Figure 25 yes Figure 24 A side cross-sectional view of the component.

[0039] Figure 26 This is a perspective view of another exemplary embodiment of the delivery conduit. Detailed Implementation

[0040] Treatments for wounds or cysts in the GI tract, bile duct, pancreas, and other locations in the body have been proposed. However, conventional treatments can be invasive, complex, or uncomfortable for patients and may require frequent follow-up or monitoring. Therefore, there is a need for a medically less invasive treatment protocol. There is also a need for a treatment protocol that requires less or less frequent postoperative monitoring. Furthermore, there is a need for a treatment protocol suitable for use in various locations within the body and suitable for safe and controlled use.

[0041] Examples of the present invention include systems, apparatus, and methods for treating wounds or cysts in the body with materials, such as bioabsorbable foam. In examples, in procedures for treating wounds or cysts in the body, for example, in the GI tract, bile duct, pancreas, and / or other locations typically accessible via endoscopic devices (e.g., endoscopes, laparoscopes, bronchoscopes, colonoscopes, ureteroscopes, duodenoscopes, endoscopic ultrasound), the endoscopic device can be advanced into the body and reach the site of the wound or cyst. A delivery device (including, for example, a catheter) can be advanced through a working channel of the endoscopic device such that a distal tip portion of the delivery device protrudes distally from the endoscopic device. An actuating member of the delivery device can be actuated to operate a deployment mechanism to deploy a load of material, such as bioabsorbable foam, from the distal tip portion and deploy it to the site of the wound or cyst.

[0042] Reference will now be made in detail to various aspects of the invention, examples of which are shown in the accompanying drawings. Wherever possible, the same or similar reference numerals will be used throughout the drawings to refer to the same or similar parts. The term "far side" refers to a direction away from the operator, and the term "proximal side" refers to a direction towards the operator. The terms "channel," "cavity," etc., generally encompass a passageway for the transfer of material and / or operation of the connecting elements through the components. As used herein, the terms "comprising," "including," or any other variation thereof are intended to cover non-exclusive contents such that a process, method, article, or apparatus that comprises a list of elements does not necessarily include only those elements, but may include other elements not expressly listed or not inherent to such process, method, article, or apparatus. The term "exemplary" is used in the sense of "example" rather than "exemplary." As used herein, the terms "about," "substantially," and "approximately" indicate a range of values ​​within + / - 10% of the stated value.

[0043] Examples of the present invention may relate to apparatus and methods for performing various medical procedures and / or treating the large intestine (colon), small intestine, cecum, portions of the esophagus, any other portion of the gastrointestinal tract, and / or any other suitable patient anatomy (collectively referred to herein as “target treatment sites”). The various examples described herein include single-use or disposable medical devices. Unless otherwise expressly stated, the examples described herein may include single-use / disposable medical devices or reusable medical devices.

[0044] Figure 1 An exemplary delivery device 100 according to an example of the present invention is shown. The delivery device 100 may include a proximal handle portion 105 and a shaft 110 extending distally from the handle portion 105. The handle portion 105 may have an ergonomic shape configured to be gripped by an operator's hand. The handle portion 105 may include an actuation member 115, a guide wire inlet 120, and a fluid connector 125, each of which will be described in further detail below. The handle portion 105 may be formed of any suitable material (e.g., plastic).

[0045] The distal tip of the distal portion 130 of shaft 110 may taper distally. The taper of the distal portion 130 of delivery device 100 may facilitate non-invasive entry of delivery device 100 into the body cavity and / or treatment site of the subject. Shaft 110 may define multiple channels (e.g., working channel 135, guidewire channel 140, and two fluid channels 145) operatively and / or fluidly connected to one or more of actuation member 115, guidewire inlet 120, and / or fluid connector 125. Channels may extend through the length of shaft 110 to the distal portion 130, as discussed in further detail below. The distal tip 130 may be more rigid than the more proximal portion of shaft 110.

[0046] Shaft 110 can be made of any acceptable flexible material, such as polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM), polyether block copolymers, polyurethane, polypropylene (PP), polyvinyl chloride (PVC), polyether copolymers, ether-based or ester-based copolymers (e.g., butene phthalate / poly(alkylene ether) and / or other polyester elastomers), polyamides, elastomeric polyamides, block polyamides / ethers, polyether block amides (PEBA), ethylene-vinyl acetate copolymers (EVA), silicone resins, polyethylene (PE), polyesters, polybutylene terephthalate... Polyethylene terephthalate (PBT), polyethylene terephthalate (PET), propylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene ether (PPO), poly(p-phenylene terephthalamide), polysulfone, nylon, nylon-12, perfluoro(propyl vinyl ether) (PFA), polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), polycarbonate, ionomers, biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, polymer / metal composites, etc. The material of shaft 110 can minimize kinks while allowing flexibility.

[0047] Axis 110 may include coatings, such as, for example, lubricating, hydrophilic, protective, or other types of coatings. Lubricating coatings can improve maneuverability and the ability to pass through lesions. Hydrophilic coatings can improve the accessibility of axis 110 within the working channel of the endoscope and / or through strict anatomical curvatures, as discussed in further detail below. Some examples of suitable coating materials may include silicone resins, hydrophilic polymers such as high-density polyethylene (HDPE), PTFE, polyarylate oxides, polyvinylpyrrolidone, polyvinyl alcohol, hydroxyalkyl cellulose, algae, sugars, caprolactone, etc., and mixtures and combinations thereof. Some coating polymers may be mixed together or with formulated amounts of water-insoluble compounds (including some polymers) to produce a coating with suitable lubricity, adhesion, and solubility.

[0048] Figure 2 and Figure 3 They respectively show the origins of Figure 1Perspective and end views of the distal portion 130 of shaft 110. Shaft 110 may define a working channel 135, a guidewire channel 140, and a pair of fluid channels 145. For example, shaft 110 may include compressed tubing defining four cavities—the working channel 135, the guidewire channel 140, and the two fluid channels 145. The working channel 135, the guidewire channel 140, and the pair of fluid channels 145 may each extend from the proximal end of shaft 110, along the length of shaft 110, to the distal portion 130.

[0049] The working channel 135, the guidewire channel 140, and the pair of fluid channels 145 may terminate in a distal opening on the distal side 150 of the distal tip portion 130. The distal openings of the working channel 135 and the guidewire channel 140 may be aligned along the diameter of the distal side 150 of the shaft 110. The pair of fluid channels 145 may be arranged symmetrically about a diameter along which the distal openings of the working channel 135 and the guidewire channel 140 are arranged. In other examples, any suitable arrangement of various channels may be used. Although two fluid channels 145 are shown, it should be understood that any suitable number of fluid channels 145 (e.g., one fluid channel 145 or more fluid channels 145) may be utilized.

[0050] The distal portion 130 may define a first slit 155. The first slit 155 may extend along the longitudinal axis of the shaft 110. The first slit 155 may extend only along a portion of the distal portion 130 (e.g., the most distal portion). The first slit 155 may extend through the outer wall of the distal portion 130 between the outer surface 165 of the distal portion 130 and the working channel 135. The size of the first slit 155 may be set and / or configured to allow the shaft 110 to bend in order to receive and / or deploy loads, as discussed in further detail below.

[0051] The distal portion 130 can also define a second slit 156 (see...) Figure 4 The second slit 156 may extend through the wall of the distal portion 130 between the working channel 135 and the guide wire channel 140. The second slit 156 may extend from the distal side 150 to the proximal side along the longitudinal axis of the distal portion 130. The second slit 156 may extend along a length less than the entire length of the distal portion 130. The second slit 156 may have the same length along the longitudinal axis as the first slit 155. The second slit 156 may be configured, together with the first slit 155, to allow the shaft 110 to bend while receiving or deploying a load, as discussed below. The first slit 155 and the second slit 156 may be located along the same diameter of the distal portion 130, such that the first slit 155 is aligned with the second slit 166.

[0052] The distal portion 130 may also include one or more echo markers 160 to facilitate visualization of the distal portion 130. Echo markers 160 may include any suitable echo markers, such as, for example, pits, grooves, etc., and / or may include any acceptable material, such as, for example, powdered tantalum, tungsten, barium carbonate, bismuth oxide, barium sulfate, or other barium or bismuth-containing compounds. Echo markers 160 may include echo material inserted into and / or impregnated into the outer wall of the housing 150 or on the outer surface 165 of the distal portion 130. Echo markers 160 may additionally or alternatively include structures formed in the outer wall of the distal portion 130. Figure 2 As shown, the distal tip portion 130 may include three echo markers 160. Any suitable number of echo markers may be included. As discussed in further detail below, the echo markers 160 may be used to position and / or direct the distal tip portion 130 of the delivery device 100 during surgery to deploy materials, such as bioabsorbable foam, to the treatment site.

[0053] refer to Figures 1 to 3 The guidewire channel 140 may communicate with the guidewire inlet 120. The guidewire inlet 120 and guidewire channel 140 may be configured to receive and deliver the guidewire 170 to advance the delivery device 100 along the working channel of the mirror apparatus. For example, the proximal end of the guidewire 170 may be inserted into the distal end of the working channel 135, and the delivery device 100 may guide the guidewire 170 toward the target site. Due to the advancement of the delivery device 100, the proximal end of the guidewire 170 may protrude outward from the guidewire inlet 120. Any suitable guidewire 170 may be used with the delivery device 100.

[0054] The pair of fluid channels 145 can be in fluid communication with the fluid connector 125. For example, one or more channels (not shown) can extend from the connector 125, through the handle portion 105, and to the proximal end of the pair of fluid channels 145. The fluid connector 125 can be configured to interface with at least one of a negative pressure (e.g., aspiration) source or a fluid (e.g., air, water, or a medical active agent) source. The fluid connector 125 may include, for example, a Luer connector for connecting the handle portion 105 to the aspiration or fluid source. The aspiration source may include, for example, a syringe or a compressor. Fluid can be transferred between the distal portion 130 and the fluid connector 125 via the fluid channels 145.

[0055] As discussed in further detail below, in some examples, a negative pressure source may be coupled to the fluid connector 125 and operable to remove fluid (e.g., bodily fluids or fluid delivered from a scope) from the treatment site via a distal opening of the fluid channel 145. While other examples may include any number of fluid channels 145 or none at all, two fluid channels 145 have been found (e.g., Figure 2 and Figure 3 The size of the fluid connector 125 (as shown) can be set and configured to deliver the desired amount of fluid proximally while maintaining the desired amount of negative pressure. Alternatively, a fluid source (e.g., air, water, dye, or contrast agent) can be coupled to the fluid connector 125 to provide fluid outward from the distal opening of the fluid channel 145. In a single procedure, the fluid channel 145 can be used for different functions. For example, a suction source or a fluid source can be coupled to the fluid connector 125 at different times. Alternatively, the handle portion 105 may include additional fluid connectors 125 that can communicate with different fluid channels 145, allowing both suction and other fluids (e.g., air / water) to be provided via the respective fluid channel 145.

[0056] The distal portion of the working channel 135 may form a load chamber 175, which is configured to receive a load 180. The load 180 may include a bioabsorbable foam, which may be deployed at the treatment site by the delivery device 100. Alternatively or additionally, the load 180 may include alternative materials, such as therapeutic materials (e.g., pharmaceutical materials). The delivery device 100 is not limited to use with any one type of load 180 and may be used with a variety of materials, as described below. Slits 155 and 156 may extend the length of the load chamber 175 to allow for bending, as described below.

[0057] Figure 4 A cross-sectional view of the distal apex portion 130 is depicted. (See image.) Figure 4 As shown, the load 180 may include a plurality of individual capsules 185. The load chamber 175 may have an inner surface 190, the shape of which is configured to define a corresponding cavity 195 for each of the plurality of individual capsules 185. The inner surface 190 may define a plurality of circumferential ribs 196 extending into the load chamber 195. The inner surface including the ribs 196 may define cavities 195 having a shape substantially corresponding to the shape of the individual capsules 185. The ribs 196 may be longitudinally spaced apart from each other, such that a capsule 185 can be fitted between two adjacent ribs 196. The shape of each cavity 195 may be configured to hold and / or retain an individual capsule 185 therein prior to deployment, as discussed in further detail below. The plurality of cavities 195 may correspond to the maximum number of capsules 185 to be loaded into the delivery device 100 and delivered to the treatment site. Some of the cavities 195 may not be used during the procedure and may remain empty. For example, one or more cavities 195 at the proximal end of chamber 175 can remain empty. Figure 4 As shown, the load chamber 175 may include four cavities 195 for receiving up to four capsules 185. Alternatively, the load chamber may include any number of cavities for receiving any number of capsules.

[0058] Deployment mechanism 200 can be positioned in the working channel 135 of shaft 110. Deployment mechanism 200 can be operatively connected to actuation member 115. Deployment mechanism can extend distally from actuation member 115, through the working channel 135 and toward chamber 175. Deployment mechanism 200 can be operated via actuation member 115 to deploy load 180 (including bladder 185) from a distal opening of working channel 135.

[0059] The deployment mechanism 200 may include a draw cable 205 and a plunger 210 positioned at the distal end of the draw cable 205. The plunger 210 and the draw cable 205 may be separate components connected to each other, or they may be a single, one-piece material. The draw cable 205 may be coupled to an actuating member 115. Any acceptable type of operable engagement between the actuating member 115 and the draw cable 205 may be used, such as, for example, a rack and pinion, gear, spool, or other suitable mechanism. The actuating member 115 may include a rotatable wheel 215. The axis of the rotatable wheel 215 may be perpendicular to the longitudinal axis of the conveying device 100. Rotation of the rotatable wheel 215 may cause the draw cable 205, and thus the plunger 210, to move proximally or distally. For example, rotation of the rotatable wheel 215 in the distal direction may cause the draw cable 205, and consequently the plunger 210, to advance (movement distally). Rotation of the rotatable wheel 215 proximally can cause the line 205 and subsequently the plunger 210 to retract (movement proximally). The rotatable wheel 215 allows for precise actuation to deploy only the required amount of load 180. The rotatable wheel 215 is merely exemplary. The actuating member 115 may additionally or alternatively include any suitable mechanism (e.g., a knob, lever, rotatable wheel, slider, or switch) that can be used to move the plunger 210 proximally and / or distally.

[0060] As the drawstring 205 and plunger 210 move distally, plunger 210 can apply a distal force on load 180 along the longitudinal axis of the delivery device 100 toward the distal opening of the working channel 135. As described below, plunger 210 can be advanced distally to push one or more of the bladders of load 180 out of the distal opening of the working channel 135.

[0061] The plunger 210 can be configured, either alone or in combination with the shape of the capsule 185, to provide tactile feedback to the user. For example, the maximum diameter of the capsule 185 can be larger than the diameter of the chamber 175 at the rib 196. Therefore, when the plunger 210 pushes the capsule 185 against the rib 196, a certain amount of force may be required on the rotatable wheel 115 to flex the shaft 110 via the first slit 155 and the second slit 156. When the shaft 110 flexes, the first slit 155 and the second slit 156 can widen or expand. When the shaft 110 flexes, the diameter of the chamber 175 can increase, allowing the capsule 185 to pass through the rib 196. After the shaft 110 flexes, a smaller force may be required on the rotatable wheel 115 to continue advancing the plunger 210. The difference in force required on the rotatable wheel 215 before and after the shaft 110 flexes can provide tactile feedback to the user. Alternatively, the capsule 185 may be compressible, such that when sufficient force is applied to the capsule 185, the capsule 185 can be compressed to pass through the rib 196, thereby providing similar tactile feedback.

[0062] like Figure 4 As shown, plunger 210 may have a tapered shape with a larger diameter at its proximal end than at its distal end. A portion of plunger 210 (e.g., the proximal end of plunger 210) may have a larger diameter than the diameter of the chamber 175 at each rib 196. To allow plunger 210 to pass through one of the ribs 196, shaft 110 may bend via a first slit 155 and / or a second slit 156, thereby providing tactile feedback to the user, as explained above.

[0063] Alternatively or concurrently, plunger 210 may be formed of a flexible and / or compressible material with elasticity. When plunger 210 encounters a rib 196 forming one of the proximal or distal ends of the cavity 195, the rib 196 may exert a radially inward force on plunger 210 sufficient to compress plunger 210, thereby allowing plunger 210 to pass through rib 196. Plunger 210 may be configured to allow only unidirectional distal movement of plunger 210 through rib 196. For example, a tapered shape of plunger 210 may allow distal movement of plunger 210 through rib 196 but not proximal movement of plunger 210. Alternatively, the middle portion of plunger 210 may have the widest diameter, and plunger 210 may be tapered inwardly in both the proximal and distal directions to allow bidirectional movement of plunger 210 through rib 196. Alternatively, the plunger 210 as a whole may have a diameter smaller than the diameter of the chamber 175 at the rib 196. Alternatively, the plunger may have any suitable shape, such as, for example, a spherical shape, a circular shape, a tubular shape, or a straight shape.

[0064] As discussed above, the load 180 may include multiple individual capsules 185. Each capsule 185 may be bioabsorbable and may include a bioabsorbable foam configured to assist the body in absorbing fluid that may be present at the treatment site. For example, the bioabsorbable foam may be configured to absorb fluid at the treatment site until the bioabsorbable foam has been absorbed by the body. Each capsule 185 may be a gelatin-based bioabsorbable cassette filled with bioabsorbable foam. The bioabsorbable foam within the capsule 185 may be in the form of a foaming agent, powder, granules, etc. The load 180 may also include or be coated with materials such as, for example, bioactive or chemotherapeutic agents, dyes, or contrast agents. The material may be mixed or impregnated into the material of the capsule 185 (e.g., the bioabsorbable foam). The material may serve, for example, to reduce mucocele and / or inhibit the formation of cancerous tissue. Alternatively, the load 180 (formed from, for example, capsules 185) may include any other suitable substance that needs to be delivered to the subject's body.

[0065] The load chamber 175 without load 180 (e.g., before first use or after initial deployment of load 180) can be in the retracted position of the deployment mechanism 200 (e.g., Figure 4 Loading or reloading occurs in the position depicted in the diagram. In other words, when the pull wire 205 and plunger 210 do not occupy the load chamber 175, the load 180 can be loaded from the distal end of the conveyor 100 into the load chamber 175. Alternatively or additionally, the load chamber can be preloaded with the load 180 before the first use of the conveyor 100.

[0066] Figure 5A perspective view of an exemplary embodiment of a cassette 300 is depicted, which can be used to store a load 180 and load the load chamber 175 of a loading conveyor 100. The cassette 300 may be particularly useful in situations where the load 180 is small and / or fragile relative to a human hand, making it difficult to manually load the load 180 into the load chamber 175. The cassette 300 may be formed of two half-shells 305a and 305b joined together to form the body of the cassette 300, defining a hollow interior 310 and an opening 315 providing access to the hollow interior 310. The interior 310 may define a load channel 320 extending from the opening 315 and terminating at a closed end within the cassette 300. The cassette 300 can load a load 180 (e.g., multiple individual capsules 185) positioned within the internal channel 320, such that the cassette 300 is configured to load the distal tip portion 130 in response to advancing the distal tip portion 130 through the opening 315 into the load channel 320, as discussed in further detail below. The cassette 300 can be a single-use device for loading the load 180 or a reusable device that can be refilled.

[0067] At least one of the half-shells 305a and 305b may be at least partially transparent, allowing the load 180 to be visible through it. At least one of the half-shells 305a and 305b may include markings indicating the number of individual capsules included in the load 180 disposed in the cassette 300, such as, for example, coloring, symbols, text, structures, the shape of the cassette 300, etc.

[0068] Figure 6 The distal tip portion 130 of the delivery device 100 is depicted, which is advanced into the load channel 320 via an opening 315 to load a load 180 into the load chamber 175 of the distal tip portion 130. As the distal tip portion 130 is advanced, a first bladder 185 can be introduced into the load chamber 175 via the distal opening of the working channel 135. As the distal tip portion 130 continues to advance within the load channel 320, the first bladder 185 is brought to abutment with the distal rib 196, which defines the most distal portion of a corresponding cavity 195.

[0069] For example, further pushing the distal tip portion 130 with an increased amount of force can cause the shaft 110 to bend via the first slit 155 and the second slit 156, thereby expanding the contracted shape of the cavity 195 and allowing the capsule 185 to pass through the distal rib 196 defining the distal cavity 195 and enter the cavity 195. Alternatively or additionally, the capsule 185 can be compressed to allow the capsule 185 to pass through the distal rib 196 defining the distal cavity 195 and enter the cavity 195.

[0070] Increasing the force required to pass the cyst 195 through the rib, and then releasing the force along with guiding the cyst into the cavity, can result in tactile feedback instructing the loading of the cyst 185 into the load chamber 175. This procedure can be repeated to load additional cysts into the load chamber 175, wherein any previously loaded cyst 185 moves to the corresponding next nearest-neighbor cavity 195 for each new cyst 185 to be loaded, until the load chamber 175 is full. While in the illustrated example, the cassette 300 and load chamber 175 are configured to hold four individual cysts 185, it should be understood that in other embodiments, the housing and load chamber can be configured to hold any number of cysts.

[0071] Figures 7A to 7H An exemplary surgical procedure is depicted using a delivery device 100 to deliver a load 180 to a treatment site 400. In this embodiment, the treatment site 400 includes a fluid-filled cyst 405 (e.g., an esophageal cyst). Figure 7A In this process, the distal end 410 of the endoscopic device 415 (e.g., an endoscope) can be advanced intracavitarily to the treatment site 400. A guidewire 170 can be introduced into the working channel of the endoscopic device 415 and advanced to the treatment site 400. The proximal and / or proximal portion of the guidewire 170 (in...) Figures 7A to 7H (not shown) can be introduced into the conveying device 110 (see, for example, Figure 1 The guidewire 170 is inserted into the guidewire inlet 120 and guidewire channel 140, and the shaft 110 of the delivery catheter can be introduced into the proximal end of the working channel of the endoscope device 415. The guidewire 170 can facilitate the advancement of the shaft 110 along the working channel of the endoscope device 415 toward the treatment site 400. For example, the guidewire 170 can inhibit the formation of kinks in the shaft 110 and / or guide the advancement of the shaft 110 through strictly anatomically curved portions of the body.

[0072] exist Figure 7B In this process, the distal tip portion 130 of the delivery device 100 can be pushed out from the working channel of the endoscope device 415 and advanced into the treatment site 400. In some embodiments, a medical imaging procedure can be used to observe the position of the distal tip portion 130 in the body. For example, in some embodiments, an ultrasound imaging procedure can be performed, whereby the echo marker 160 ( Figure 2 The endoscope 415 can be located within the treatment site 400 via an ultrasound imaging procedure to determine whether the distal apical portion 130 has been pushed out of the endoscope 415. Any suitable medical imaging procedure can be used.

[0073] In some embodiments, a negative pressure source (not shown) may be connected to the conveying device 100. Figure 1The fluid connector 125 is operated to generate suction within the pair of fluid channels 145 to remove at least a portion of the fluid from the treatment site. Removing at least a portion of the fluid from the treatment site can reduce healing time and / or the frequency or need for future intervention or monitoring of the treatment site 400.

[0074] In some embodiments, a source (not shown) for conveying the fluid may be connected to the conveying device 100. Figure 1 The fluid connector 125 is configured to deliver fluid to the treatment site 400. The delivered fluid may include, for example, a bioactive agent or chemotherapeutic agent, a dye or contrast agent, a fluid for rinsing the treatment site, etc. The bioactive agent or chemotherapeutic agent delivered to the treatment site 400 may promote healing, inhibit infection, etc. The dye or contrast agent may be positioned within the treatment site 400 and / or in the distal tip portion 130 of the delivery device 100 to facilitate medical imaging procedures.

[0075] It can actuate the actuating component 115 ( Figure 1 ) with operation and deployment organization 200 ( Figure 4 For example, the user can rotate the roller knob 215 forward (in the distal direction) and advance the cable 205, applying a distal force to the load 180. When a distal force is applied, the shaft 110 can pass through the first slit 155 and the second slit 156 ( Figures 2 to 3 The pleats 185 can be bent or compressed to allow the nearest pleat 185 to exit from the nearest cavity 195 through the distal opening of the working channel 135, and to advance any distal pleat 185 into the next nearest cavity 195. When deploying the nearest pleat 185 through the distal opening of the working channel 135, the applied force can be released, thereby generating tactile feedback to the user at the actuating member 115 via the pull wire 205. The above process can be repeated to deploy additional pleats 185.

[0076] In some embodiments, when the load 180 is depleted from the housing 100, the delivery device 100 can retract from the mirror device 415, which remains in place at the treatment site 400. The delivery device 100 can be reloaded, for example, by employing a new load 180 ( Figure 6 The dark box 300 is used for this purpose, and it can be reintroduced into the mirror device 415 and pushed back to the treatment site 400 to deploy a new load 180.

[0077] like Figure 7CAs shown, the endoscope device 415 and delivery device 100 can be retracted from the body when the required number of capsules 185 are deployed. This is advantageous for systems that deliver bioresorbable foam in one or more capsules, for example, to allow delivery of foam volumes required through the working channel of an endoscope and / or for customized wound treatment. In some embodiments, the delivery device 100 is configured as a single-use device. In other words, after the required number of capsules 180 are deployed and the delivery device 100 is retracted, the delivery catheter can be disposed of and / or destroyed.

[0078] Figure 7D The cyst 185 is depicted being absorbed and / or dissolved by a biological organism, releasing bioabsorbable foam 450. Figures 7E to 7H Progress has been made in the absorption of fluid from the treatment site by bioabsorbable foam, the bioabsorption of bioabsorbable foam into the body, and the reduction of cysts 405.

[0079] Additional aspects of the invention may be illustrated in the following additional embodiments. It should be understood that the invention is not limited to the specific embodiments described herein, and features derived from one or more embodiments may be incorporated into other embodiments.

[0080] In various embodiments, any acceptable type of payload can be used. For example, Figure 8 The distal tip portion 130' of the delivery device 100' is depicted. Unless specifically specified, the device 100' may have any of the properties of the delivery device 100. The loading chamber 175' of the distal tip portion 130' may comprise only a single cavity 195', and the load 180' may include a single bioabsorbable extruded tubing structure 185' having a bioabsorbable foam disposed therein. The tubing structure 185' may function similarly to a stent, such as a drug-eluting stent. The tubing structure 185' may facilitate the directional application of the material contained therein (e.g., bioabsorbable foam). The tubing structure 185' may contain more material than the capsule 185. While the delivery device 100' comprises only a single cavity 195' for a single tubing structure 185', other embodiments may also include any number of cavities and tubing structures. The tubing structure 185' can be used for delivery, as described above for the capsule 185. Alternatively, the piping structure 185' can be deployed via alternative delivery means or methods. For example, the piping structure 185' can be punctured before or after delivery of the contents stored therein.

[0081] In another example, Figure 9The distal tip portion 130” of the conveying device 100” is depicted. Unless otherwise specified, the conveying device 100” may have any of the properties of conveying device 100 or 100’. In this embodiment, the load 180” may include a plurality of individual spherical beads 185”, which may have a smaller longitudinal dimension than the bladder 185 or piping structure 185”. The cavity 195” may be correspondingly shorter longitudinally, with the protrusions 196” being closer together longitudinally. The device 100” can function as the device 100 described above.

[0082] Compared to other shapes of the load 180” (e.g., capsule 185 or piping structure 185”), the reduced longitudinal extent of the bead 185” may result in a reduction in the length of the distal tip portion 130”, which may be relatively rigid. This reduction in the length of the distal tip portion 130” can facilitate the advancement of the delivery device 100” through the tight anatomical bends and can reduce the extent to which the delivery device 100” needs to be pushed out of the working channel of the endoscope device to facilitate the deployment of the load 180”. In other embodiments, the load 180” may have any other acceptable shape, such as, for example, oval, disc-shaped, cubic, cylindrical, etc.

[0083] Figure 10 Another example delivery device 500 is depicted, which may have the properties of delivery devices 100, 100', and 100"". The distal end 130 of device 500 may be the same as the distal end 130 of delivery device 100. Alternatively, distal ends 130' and 130" may be utilized. Deployment mechanism 505 (which may have some features of deployment mechanism 200) may include a pressure channel 510. The handle portion of delivery device 500 may be the same as the handle portion 105 of delivery device 100 and may include a triggering mechanism. Any acceptable triggering mechanism may be used. In some embodiments, for example, a roller knob 215 may operate as a triggering mechanism. In some embodiments, the handle portion may include additional actuating elements (e.g., triggers, levers, knobs, sliders, or other structures) that operate as triggering mechanisms. In one example, the triggering mechanism may be configured to selectively engage pressure channel 500 with a positive pressure source. For example, the positive pressure source may be connected via features such as the fluid connector 125 of device 100. The presence of positive pressure in pressure channel 500 can generate a distal force on load 180 toward the distal end of distal portion 130. The positive pressure can be configured such that the distal force is sufficient to actuate load 180, for example, actuating each bladder 185 toward the distal end of distal portion 130 and deploying at least the distal bladder 185.

[0084] In some embodiments, the triggering mechanism may be configured to couple the pressure channel 500 to positive pressure during discrete time periods of each actuation of the triggering mechanism, or may be configured to transmit discrete portions of the pressure medium, etc. For example, in some embodiments, the triggering mechanism may be configured such that each actuation of the triggering mechanism results in the deployment of a single bladder 185 of the load 180.

[0085] Figure 11 This is a perspective view of the distal end of the shaft 610 of an exemplary conveying device 600, wherein the distal tip portion 630 is a separate element from the shaft 610. In other cases, the shaft 610 and the distal tip portion 630 may have the properties of either the shaft 110 or the distal tip portion 130. The shaft 610 may define four channels—a working channel 635, a guide wire channel 640, and two fluid channels 645—which may have the properties of either the working channel 135, the guide wire channel 140, or the fluid channel 145, respectively.

[0086] Shaft 610 may also include a first alignment indicator 612 indicating the orientation of channels 635, 640, 645 within shaft 610. For example, the alignment indicator may be an arrow or a triangle pointing to the distal end of shaft 610. Figure 10 As shown, indicator 612 can be aligned with working channel 635.

[0087] Figure 12 It is the distal apex portion 630 (which is with) Figure 11 A perspective view of an exemplary embodiment of the component separated from shaft 610. The distal tip portion 630 may define a channel cavity that can be configured to communicate with the channel of shaft 610. For example, the distal tip portion 630 may define a distal tip working channel 635', a distal tip guidewire channel 640', and two distal tip channels 645'. The channels of the distal tip portion 630 may have any of the qualities of the channels of the distal tip portion 130.

[0088] The distal tip portion 630 may include a second alignment indicator 614 indicating the orientation of the distal tip portion 630 and configured to facilitate connection of the proximal end of the distal tip portion 630 to the distal end of the shaft 610, such that the channel of the distal tip portion 630 is aligned with the channel of the shaft 610. For example, the second alignment indicator 614 may include an arrow or triangle pointing proximally. The second alignment indicator 614 may be aligned with the distal tip working channel 635'.

[0089] The distal tip portion 630 can be loaded (e.g., preloaded) with a load 180 positioned in a load chamber 675 (which has the properties of either load chamber 175). Therefore, the conveying device 600 can be loaded via coupling the distal tip portion 630 to the shaft 610. When the distal tip portion 630 has exhausted the load 180, the distal tip portion 630 can be detached from the shaft 610 and replaced with a new distal tip portion 630.

[0090] Any acceptable type of connection can be used between the proximal end of the distal tip portion 630 and the distal end of the shaft 610, such as, for example, a screw connection, a key and slot connection, a pin connection, an interference fit, etc. Any acceptable alignment indicator can be used for the first alignment indicator 612 and the second alignment indicator 614, such as, for example, a visual indication of the orientation of the corresponding portion, a structure that suppresses misalignment (e.g., protrusion), etc.

[0091] Figure 13 This is a perspective view of an exemplary embodiment of a connecting member 690 configured to facilitate a connection between a distal tip portion 630 and a distal end of a shaft 610. The connecting member 690 may include a first end 692 configured to directly engage with the distal end of the shaft 610; and a second end 694 configured to directly engage with the proximal end of the distal tip portion 630 to connect the distal tip portion 630 to the shaft 610. The first end 692 and the second end 620 may be sized to form an interference fit with the distal end of the tubular member 610 and the proximal end of the distal tip portion 630, respectively. In other embodiments, any acceptable connecting technique may be used. The connecting member 690 may include a sealing element (not shown), such as an O-ring, flange, etc., configured to seal the connection between the distal tip portion 630 and the shaft 610.

[0092] The connecting member 690 may define four channels corresponding to the channels of the shaft 610 and the distal tip portion 630. For example, the connecting member 690 may define a connecting member working channel 635”, a connecting member guide wire channel 640”, and two connecting member fluid channels 645”. The channels of the connecting member 690 may be configured to be fluidly connected to the corresponding channels of the shaft 610 and the distal tip portion 630.

[0093] The connecting member 610 may include a third alignment member 696 configured to align the connecting member 690 with the shaft 610. For example, the third alignment member 696 may include a proximal-facing arrow or triangle. The third alignment member 696 may be used in conjunction with a first alignment member 612 of the shaft 610 to align the channel of the alignment member 696 with the channel of the shaft 610. For example, when the shaft 610 is connected to the connecting member 690, the apexes of the triangles / arrows of the first alignment member 612 and the third alignment member 696 may be aligned with each other. The connecting member may also include a fourth alignment member 638, which may be used in conjunction with a second alignment member 614 to align the distal apex portion 630 with the connecting member 690, and thus with the shaft 110. For example, when the distal apex portion 630 is connected to the connecting member 690, the apexes of the triangular arrows of the second alignment member 614 and the fourth alignment member 698 may be aligned with each other. Alternatively, the third and fourth alignment members 696, 698 may be combined into a single alignment member. In some embodiments, the first and second alignment members respectively include longitudinally or radially extending ribs or grooves, and the third and fourth alignment members include corresponding grooves or ribs.

[0094] Figure 14 This is a perspective view of the assembly of shaft 610, connecting member 690, and distal end portion 630. The alignment members are aligned with each other to connect the corresponding channels of shaft 610 and distal end portion 630. In an alternative, connecting member 690 can be omitted, and shaft 610 can be directly connected to distal end portion 630.

[0095] Figure 15 A perspective view of the conveying device 700 is depicted. In addition to the specific description, the conveying device 700 may have any of the properties of any of the conveying devices described herein. The handle portion 705 may also include a cauterization connector 702 configured to connect with a cauterization device (not shown).

[0096] Figure 16 Depicting Figure 15 An end view of the distal portion 730 of the shaft 710 of the conveying device 700. Except as specified herein, the shaft 710 may have any of the features of the shaft 100 or other shafts described herein. Figure 16 As shown, shaft 710 may define a cauterization cavity 705. The cauterization cavity 705 may extend along the length of shaft 710 and be operatively connected to a cauterization connector 702, such that the cauterization connector 702 is configured to operatively connect the cauterization cavity 705 to a cauterization device. For example, the cauterization cavity 705 may be configured to allow the cauterization wire of the cauterization device to pass through and / or may operate as the cauterization wire of the cauterization device.

[0097] Figure 17 Depicting Figure 15 A perspective view of the distal tip portion 730 of the conveying device 700. The distal tip portion may have any of the properties of any of the distal tip portions described herein (including distal tip portion 130). Figure 17 As shown, the distal tip portion 730 also includes an ablation member 706, such as an ablation ring, positioned around the circumferential outer surface 765 of the distal tip portion 730. The ablation member 706 may have alternative forms and may be disposed on the distal side 750 of the distal tip member 730 and may have any suitable shape. In various embodiments, the ablation member 706 may be operable (e.g., via ablation device coupled to the ablation connector 700) to ablate at least a portion of the treatment site 400 and / or to enable the delivery device 700 to access internal parts of the body, such as organs, like the pancreas, by forming an opening through which the delivery device 700 can pass.

[0098] Figure 18 An end view of the shaft 810 of the delivery device 100 is depicted, which may have any of the properties of other delivery devices described herein, except as specifically illustrated. The shaft 810 may also define a third slit 802 extending through the wall of the distal tip portion 830, thereby connecting the outer surface 865 of the shaft 810 to the guide wire channel 840. The third slit 802 may extend along at least a portion of the length of the shaft 810 between the distal tip portion 830 and the guide wire inlet, such as guide wire inlet 120. The third slit 802 may have a length substantially similar to or the same as the first slit 155. The third slit 802 may extend along the length of the shaft 810. The size of the third slit 802 may be set and configured to allow the shaft 810 to bend (and to allow the third slit 802 to widen) so that the guide wire 170 passes through the third slit 802 and enters the guide wire channel 840.

[0099] The delivery device 800 can be removed from the guide wire via slit 802 without retracting the delivery device 100 over the entire range of the guide wire 170. A portion of the guide wire 170 can be inserted into the guide wire channel 140 and the guide wire inlet 120 via the third slit 802, such that the guide wire 170 protrudes outward from the guide wire inlet, without advancing the delivery device 100 along the guide wire 170, rather than inserting the end of the guide wire 170 into the guide wire channel 840 and advancing the delivery device 800 along the guide wire 170, such that the guide wire 170 is advanced outward from the guide wire inlet, as discussed above. The third slit 802 facilitates simple and rapid insertion, removal, and / or exchange of the delivery device 800.

[0100] Figure 19ASections C to C depict the operation of another exemplary embodiment of the conveying mechanism 902 of the conveying device 900. The conveying device 900 may have any of the features of other conveying devices disclosed herein. The conveying device 900 may include a handle portion 105 (not shown).

[0101] The conveying mechanism 902 may include a gripper mechanism 904 operably connected to the actuation member 115 via a draw wire 205. The gripper mechanism 904 may include a plurality of (e.g., a pair) arms 906. The arms 906 may have a distal end that is radially inwardly curved toward the central longitudinal axis of the shaft 910 of the conveying device 900.

[0102] In the retracted position of the pull cord 205, the gripper mechanism 904 can extend distally into the load chamber 975. In the closed position, as... Figure 19A As depicted, the distal end of arm 906 can be brought close enough that gripper mechanism 904 holds load 980 (which may have the properties of any of the loads described herein) in a proper position within load chamber 975 such that load 980 does not pass through the distal side of arm 906.

[0103] The arm 906 of the gripper mechanism 904 may, for example, be biased toward the open position via an internal elasticity, spring member, shape memory material, etc., such that when the pull cable 205 is pushed forward and the distal end of the gripper mechanism 904 is pushed out from the distal end of the shaft 910, the gripper mechanism 904 is in the open position (see...). Figure 19B Actuation. The arm 906 of the gripper mechanism 904 can be opened, causing the distal ends of the arms to separate from each other, thereby allowing the load 180 to be deployed (see...). Figure 19C The shape of the gripper mechanism 904 can be set and configured such that when the pull cable 210 is retracted, the gripper mechanism 904 abuts against the distal end of the shaft 910 and moves toward the closed position.

[0104] Figures 20 to 23 Another example of a medical device 1000 is depicted. Figure 20 A cassette 1002 is shown to be coupled to the shaft 1010 of the conveying device 1000. The cassette 1002 can be preloaded with a load 1080, which can have any of the characteristics of the loads disclosed herein. The cassette 1002 can be configured to be loaded onto the distal end of the shaft 1010, as discussed in further detail below. The cassette 1002 can be formed from a wall 1003 having a generally arcuate or semi-circular shape.

[0105] Figure 21 yes Figure 20 A three-dimensional view of a cross-sectional slice of the obscure box component 1002. (See image below.) Figure 21As shown, wall 1003 may define a first protruding structure 1004 configured to support alignment of load 1080 with the working channel 1035 of shaft 1010 and / or prevent load 1080 from sliding distally from conveyor 1000. Wall 1003 may also define two sliding structures 1015 (e.g., protrusions) configured to mate with portions (e.g., recesses) of shaft 1010, as described below. Each sliding structure 1015 may have a T-shape, such as... Figure 21 As shown. However, any suitable shape can be used. The load 1080 can be received by the inner surface of the wall 1003.

[0106] Figure 22 This is a perspective view of the distal end 1012 of shaft 1010. A portion of the defining guidewire cavity 1040 and fluid cavity 1045 of shaft 1010 may continue through the distal end 1012. A portion of the wall defining a working channel 1035 of shaft may terminate before the distal end 1012, such that the working channel 1035 terminates before the distal end 1012. Cavity 1022 may be formed by a portion of the wall continuing distally from the working channel 1035. After the cassette assembly 1002 is coupled to the distal end 1012, cavity 1022 may receive load 1080.

[0107] The wall of the distal end 1012 may have a shape complementary to that of the cassette member 1002, such that when assembled, the cassette member 1002 and the distal end 1012 can continue to form a tubular shape together with the rest of the shaft 1010. For example, the wall of the distal end 1012 may have an arcuate or semi-circular shape. The wall of the distal end 1012 may include a guide structure 1025 (e.g., a recess) configured to slidably receive a sliding structure 1015 of the cassette member 1002 to engage the cassette member 1002 to the distal end 1012 of the shaft 1010.

[0108] Figure 23 A perspective view depicts the sliding structure 1015 of the dark box 1000 introduced into the guide rail structure 1025 at the distal end 1012. Figure 24 and Figure 25 A perspective view and a side cross-sectional view of the assembly of the dark box component 1002 and the shaft 1010 are depicted, respectively. (See attached image.) Figure 24 and Figure 25 As shown, when the cassette 1002 is mounted on the shaft 1010, the load chamber 1075 is formed by the walls of the cassette 1002 and the shaft 1010. The load chamber 1075 can communicate with the working channel 1035.

[0109] Figure 26A perspective view of another exemplary delivery device 1100 is depicted. The delivery device 1100 may also include a connecting member 1102 configured to removably engage the delivery device 1100 to an endoscope (e.g., an endoscope). The connecting member 1102 may include a clamp, clip, etc., configured to removably attach the delivery device 1100 to the endoscope. The connecting member 1102 may include a strip configured to wrap around a handle of the endoscope. Any suitable type of connecting member 1102 can be used. When engaged with an endoscope, the delivery device 100 can be operated in a partially hands-free (e.g., one-handed) or fully hands-free manner. The connecting member 1102 may include a locking ring, strip, clamp, lock, arm, mating surface, or any other suitable component. The delivery device 1100 also depicts a syringe 1104 connected to a fluid connector 1125 (which may have any of the properties of a fluid connector 125). The syringe can be used, for example, to provide suction or negative pressure via a fluid cavity of the delivery device 100.

[0110] Any of the shafts disclosed herein may include at least one manipulator cavity. The manipulator cavity may receive a hinged wire or other structure that can be used to steer and / or deflect the distal end of the shaft. For example, in a procedure for delivering bioabsorbable foam to a treatment site, echo markers may be used to determine the orientation of the distal tip of the shaft (e.g., after the distal tip has been advanced from the endoscope, such as...). Figure 7B (As shown). In cases where the distal tip of the axis is not optimally oriented relative to the treatment site, at least one manipulation cavity (e.g., via an actuation line in the manipulation cavity) can be used to reorient the distal side of the axis, which can be further observed via echo marker 160.

[0111] Each of the aforementioned systems, devices, components, and methods can be used to treat perforations, wounds, or cysts by deploying a load (e.g., bioabsorbable foam) for absorbing fluids and / or delivering therapeutic substances to the perforation, wound, or cyst. By providing the medical device with an intuitive handle interface that allows for single-handed control of the load deployment, a user can use their other hand to control other devices and / or tools during surgery at the target site. In this case, the user can reduce overall surgical time, improve surgical efficiency, and / or avoid unnecessary harm to the subject's body caused by limited control over other tools / devices.

[0112] Although the principles of the invention have been described herein with reference to illustrative examples for specific applications, it should be understood that the invention is not limited thereto. Those skilled in the art and who access the teachings provided herein will recognize that additional modifications, applications, and substitutions of equivalents fall within the scope of the examples described herein. Therefore, the invention should not be considered limited to the foregoing description.

Claims

1. A medical device comprising: Handle part; A shaft portion extending distally from the handle portion, the shaft portion comprising: Work passage; The distal tip portion has a load chamber configured to receive a load, wherein the operating channel communicates with the load chamber; and A fluid passage configured to allow selective passage of fluid or negative pressure; Deployment mechanism, positioned within the working channel and operable to deploy the load from the distal top portion; and An actuating member is positioned on the handle portion and is actuable to operate the deployment mechanism.

2. The medical device of claim 1, wherein the distal tip portion defines a slit extending through the wall of the distal tip portion, wherein the slit is configured to allow the distal tip portion to bend in order to receive and deploy the load.

3. The medical device according to any one of the preceding claims, wherein: The shaft portion also includes: The guide channel is configured to allow the guidewire to pass through; and A slit extending through the sidewall of the shaft portion to the guide channel and along at least a portion of the length of the shaft portion, and configured to allow at least a portion of the length of the guidewire to pass through; The distal apical portion also includes: Operable to connect to the distal fluid opening of the fluid channel; and Operable to connect to the distal guidewire opening of the guide channel; and The handle portion includes a fluid connector in fluid communication with the fluid channel, and the fluid connector is configured to connect to at least one of a negative pressure source or a fluid delivery source.

4. The medical device of claim 1, wherein the load comprises a plurality of sacs, and wherein the inner surface of the load chamber defines a plurality of cavities for receiving each of the respective plurality of sacs.

5. The medical device of claim 1, wherein the distal tip portion defines a slit between the working channel and the outer surface of the distal tip portion, and wherein actuation of the actuating member causes the slit to expand.

6. The medical device of claim 1, wherein the distal tip portion is a separate member from the shaft portion, and wherein the distal tip portion is configured to be coupled to the distal end of the shaft portion.

7. The medical device of claim 6, wherein the distal tip portion is preloaded with the load prior to coupling with the distal end of the shaft portion.

8. The medical device according to claim 6, further comprising: The connecting member includes: A first end, configured to be directly connected to the distal end of the shaft portion; A second end, opposite the first end, is configured to be directly coupled to the proximal end of the distal tip portion, so as to connect the distal tip portion to the shaft portion; and At least one alignment element, the at least one alignment element being configured to align the shaft portion with the distal tip portion.

9. The medical device of claim 1, wherein the shaft portion further includes a cauterization chamber; The handle portion includes a cauterization connector configured to operatively connect the cauterization chamber to a cauterization device; and The distal tip portion also includes a cauterization element positioned on the outer surface of the distal tip portion.

10. The medical device according to claim 1, wherein: The deployment organization includes: Pull the string; and A plunger, the plunger being positioned at the distal end of the pull cable; and The actuating component includes a roller knob operably engaged with the proximal end of the pull wire.

11. The medical device according to claim 1, wherein: The deployment mechanism includes a pressure channel configured to provide positive pressure from a pressure source to the load in order to deploy the load.

12. The medical device of claim 1, wherein the deployment mechanism includes a gripper mechanism operably connected to the actuating member and includes two arms operable to selectively hold and release the load.

13. The medical device of claim 1, wherein the handle portion includes a connecting member configured to removably connect the medical device to the endoscope.

14. The medical device of claim 1, wherein the distal tip portion further comprises at least one echo mark positioned on the outer surface of the distal tip portion.

15. The medical device according to claim 1, further comprising: The dark box includes: An opening inside the cassette, the opening being configured to receive the distal tip portion of the shaft portion; and A bioabsorbable foam load is located inside the housing and arranged such that the cassette is configured to load the load onto the distal tip portion in response to the distal tip portion being pushed into the housing via the opening.

Images