Patent Description:
The present disclosure relates generally to medical systems and devices for delivering protective barriers to the gastrointestinal (GI) region, and more particularly, to methods and tools for delivering and deploying patches or other tissue barriers to the gastrointestinal system.

Conventional endoscopic procedures, such as endomucosal resection (EMR), endosubmucosal dissection (ESD), and anastomosis, as well as diseases, such as inflammatory bowel disease (IBD) and IBD subsidiary diseases, result in damage to GI tissues. These procedures and diseases cause very thin layers in the GI tract wall, leaving the GI tract wall vulnerable to GI perforation or other trauma.

Current procedures for repairing the GI tract require surgical procedures, including clipping or endoscopic suturing, to appose tissue and allow time for healing. These conventional techniques and associated technologies are not suitable for large defects, or for repair of friable or fibrotic tissue. Yet, failure to provide a protective barrier between the damaged GI tract lining and the GI cavity can cause perforation, infection, and/or sepsis. The present disclosure may solve one or more of these problems or other problems in the art. The scope of the disclosure, however, is defined by the attached claims and not the ability to solve a specific problem. <CIT> discloses a medical device that may include an elongate member having a proximal end and a distal end, and a lumen disposed through the elongate member. The medical device may also include an opening disposed at the distal end of the elongate member in communication with the lumen, and a pushing element disposed with the lumen. The medical device may also include at least one fiducial disposed within the lumen and distal to the pushing element, and a separating mechanism disposed at the distal end of the elongate member. The separating mechanism may be configured to apply a separating force to deploy the at least one fiducial. <CIT> discloses a system and method for implanting pellets containing local anesthetic agents into tissues of the heart for temporary treatment of angina pectoris. The mechanism of delivery can be transcatheter via chambers of the heart, endoscopic epicardial approach via minimally invasive transthoracic access, or intraoperative epicardial approach during open-chest surgery. <CIT> discloses a fluid dispenser having a plunger to expel flowable material through a band provided with patches which serve as detachable bandages or buttress material.

The present invention is defined in appended claim <NUM>. Specific embodiments are set forth in the dependent claims. According to an embodiment, a medical dispensing device comprises a catheter defining a lumen having a longitudinal axis and a distal opening, a plunger disposed in the lumen and movable along the longitudinal axis, and a plurality of elements disposed in the lumen proximal to the distal opening and distal to the plunger, the plurality of elements being stacked along the longitudinal axis for dispersement one element at a time through the distal opening via a force applied by the plunger.

The device may include a wire or a cable disposed in the lumen and connected to a proximal end of the plunger, and the wire or the cable may be configured to move the plunger axially along the longitudinal axis.

The plurality of elements include a plurality of stacked patches, and each of the plurality of stacked patches has an adhesive layer and a non-adhesive layer proximal to the adhesive layer.

The non-adhesive layer may be configured to remain attached to the adhesive layer after dispensing the respective patch from the device.

The non-adhesive layer may not extend across an entire proximal surface of the adhesive layer, exposing a portion of the proximal surface of the adhesive layer, and the exposed portion of the proximal surface may be attached to (<NUM>) a distal surface of the adhesive layer of an adjacent and proximal patch from the plurality of stacked patches, or (<NUM>) the plunger.

A proximal surface of the non-adhesive layer of a distalmost patch of the plurality of stacked patches may be configured to contact a distalmost surface of the catheter outside of the lumen.

The device may include a second wire or a second cable extending from a proximal end to a distal end of the catheter and may be attached to each of the non-adhesive layers, and may be configured to remove each separate non-adhesive layer from a corresponding adhesive layer.

The device may include a second lumen defined by the catheter, the second wire or the second cable may extend through the second lumen, and the second lumen may receive each of the non-adhesive layers separate from the corresponding adhesive layer.

Each of the adhesive layers may include one or more therapeutic agents.

The distal end of the catheter may include an annular ring at a distalmost portion of the catheter and extending from a sidewall of the catheter toward the distal opening, wherein a distance between an innermost surface of the annular ring and the longitudinal axis may be less than a distance between an innermost surface of the sidewall of the catheter and the longitudinal axis.

A distal surface of a distalmost element of the plurality of elements may be configured to contact a proximal surface of the annular ring, and the force applied by the plunger may push the distalmost element out the distal opening.

The device may include a wall disposed in the lumen, transverse to the longitudinal axis, and fixed to a sidewall of the lumen at a location proximal to the plurality of elements, and may include a biasing element attached at a first end to the wall, and at a second end to the plunger, such that a force provided by the biasing element may push the plunger against the plurality of elements and toward the distal opening.

In embodiments which do not form part of the present invention, the plurality of elements may include a plurality of deformable spheres, an outer surface of each of the deformable spheres including a first material and surrounding and containing therein a second material, different from the first material.

A protrusion may extend from a sidewall defining the lumen toward the longitudinal axis, and distal to a distalmost one of the plurality of deformable spheres.

The device may include one or more cutters distal to the protrusion and extending from the sidewall defining the lumen toward the longitudinal axis, wherein the one or more cutters may be configured to cut the outer surface of each of the plurality of deformable spheres and expose the second material as each of the plurality of deformable spheres is dispensed from the device.

According to another embodiment, a medical dispensing device includes a handle, a catheter extending distally from the handle, an applicator tip at a distal end of the catheter, the catheter and the applicator tip defining a lumen having a longitudinal axis and a distal opening, a plunger disposed in the lumen and movable along the longitudinal axis, and a plurality of elements disposed in the lumen proximal to the distal opening and distal to the plunger, the plurality of elements being stacked along the longitudinal axis for dispersement one element at a time through the distal opening.

In embodiments which do not form part of the present invention, the plurality of elements may include a plurality of deformable spheres, an outer surface of each of the deformable spheres including a first material and surrounding and containing therein a second, flowable material, different from the first material.

The plurality of elements include a plurality of stacked patches each of the plurality of stacked patches may have an adhesive layer and a non-adhesive layer proximal to the adhesive layer.

According to yet another embodiment, a method for applying a medical patch to tissue includes pushing a stack of patches toward a distal opening of a catheter, moving the catheter toward a target, such that a distalmost patch from the stack of patches contacts the target, and moving the catheter in a proximal direction, away from the target, thereby releasing the distalmost patch from the catheter.

The method may include, after releasing the distalmost patch from the catheter, pushing the remaining patches of the stack of patches toward the distal opening, moving the catheter toward a second target, such that a second distalmost patch contacts the second target, and moving the catheter in a proximal direction, away from the second target, thereby releasing the second distalmost patch from the catheter.

Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features, as claimed. As used herein, the terms "comprises," "comprising," "having," "including," or other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such a process, method, article, or apparatus. In this disclosure, relative terms, such as, for example, "about," "substantially," "generally," and "approximately" are used to indicate a possible variation of ±<NUM>% in a stated value or characteristic.

Referring to <FIG>, an endoscopic applicator <NUM> according to an embodiment is shown. Endoscopic applicator <NUM> includes a handle <NUM>, a catheter <NUM> connected to handle <NUM>, and an applicator tip <NUM> at a distal end of catheter <NUM>, opposite handle <NUM>.

<FIG> illustrates handle <NUM> according to an exemplary embodiment. Handle <NUM> includes a body <NUM> defining a hole 22a in body <NUM> at a proximal end thereof. Catheter <NUM> is attached at an opposite, distal end of body <NUM>. A slot <NUM> extends through body <NUM> in a direction parallel to a direction of extension of catheter <NUM>. A spool <NUM> is disposed in slot <NUM> and moves within and along slot <NUM> in a direction parallel to the direction of extension, as shown by arrow A. As further shown in <FIG>, spool <NUM> includes two annular protrusions 24a at a distal end and a proximal end thereof and extending from spool <NUM> in a direction perpendicular to the direction of extension of catheter <NUM>. Annular protrusions 24a define an annular grip 24b, which is grasped by a user as will be described in greater detail herein. It will be understood that handle <NUM> may be made of any material known in the art, including, but not limited to, a medical grade plastic or rubber, a ceramic, a metal, or a combination thereof.

As further shown in <FIG>, a wire <NUM> (or a cable) extends distally from the distal end of spool <NUM>. Wire <NUM> extends through a hole (not shown) in handle <NUM> and into a lumen <NUM> (<FIG>) of catheter <NUM>. As will be described in greater detail herein, actuation of wire <NUM> dispenses a regenerative patch. As will be understood, catheter <NUM> is a generally circular sheath extending from handle <NUM> to applicator tip <NUM>. While catheter <NUM> is described as including lumen <NUM> (<FIG>), catheter <NUM> may include multiple lumens to incorporate other tools and/or elements (e.g., lighting, imaging, etc.) at applicator tip <NUM>. Additionally, or alternatively, catheter <NUM> may be placed in another, larger catheter or endoscope (not shown), if use of tools, suction, light-emitting elements, or the like associated with the larger catheter are so desired. It will be understood that wire <NUM> may include any material known in the art, including, but not limited to, medical grade plastic, metal, or other resin suitable to be used to push and/or pull a plunger <NUM> (<FIG>), as described herein, during application of a regenerative patch or agent. It will be understood that while examples discuss a regenerative agent applied to a patch, the patch may include an adhesive without a regenerative agent. Further, it will be understood that catheter <NUM> may be formed of any medical grade plastic, rubber, resin, or the like that is suitable for use in medical applications.

Referring to <FIG>, applicator tip <NUM> according to an embodiment will be described. Applicator tip <NUM> is disposed at the distal end of catheter <NUM>. Applicator tip <NUM> includes an outer wall <NUM> having a generally circular cross-section. As shown in <FIG>, applicator tip <NUM> is the distalmost portion of catheter <NUM>, as applicator tip <NUM> may be integrally formed with catheter <NUM>. Applicator tip <NUM> further includes an annular ring <NUM> provided at a distalmost portion of applicator tip <NUM>. Annular ring <NUM> extends annularly from an outermost part of outer wall <NUM> toward a central longitudinal axis Z (e.g., central axis Z) of lumen <NUM>, has a uniform thickness, and forms a radially-inward directed flange at the distalmost end of endoscopic applicator <NUM>. The flange assists in retaining patches within applicator tip <NUM>. A distance from central axis Z to an innermost portion 44a of annular ring <NUM> is less than a distance from central axis Z to an innermost portion 42a of outer wall <NUM>. Alternatively, or additionally, applicator tip <NUM>, including outer wall <NUM>, may be a separate element from catheter <NUM>, such as an add on device attached via screw threads, adhesive, snap fit, or the like. Applicator tip <NUM> may be any material known in the art, including, but not limited to, a medical grade plastic, resin, or rubber. Alternatively, any other mechanism for retaining patches <NUM>, e.g., tabs, may be provided at the distalmost portion of applicator tip <NUM>.

As shown in <FIG>, a stack of patches <NUM>, for example patches having a regenerative agent, are disposed in applicator tip <NUM> for application to a target <NUM>, as explained herein. Plunger <NUM>, connected to a distalmost portion of wire <NUM>, is disposed in applicator tip <NUM> at a position proximal to the stack of patches <NUM>. Plunger <NUM> may be any material known in the art, including, but not limited to a medical grade metal alloy, a plastic, a resin, or a rubber, suitable for being used to place pressure against the stack of patches <NUM>.

With continued reference to <FIG>, the stack of patches <NUM> may include a first patch 51a having a first layer 52a including an adhesive substance and a second layer 54a including a non-adhesive backing, so that adjacent patches <NUM> do not adhere to one another. As described herein, first layer 52a may include a regenerative agent, an adhesive regenerative agent, or any other therapeutic or diagnostic agent and/or attachment mechanism for attaching first patch 51a to target <NUM>.

First layer 52a is provided at a distalmost position of lumen <NUM> and is adjacent to and in contact with annular ring <NUM> of applicator tip <NUM>. First layer 52a is applied to target <NUM>, e.g., tissue, or another suitable target site, as will be described herein. A second patch 51b having a first layer 52b including an adhesive agent (and/or a regenerative agent) and a second layer 54b including a non-adhesive backing is disposed proximal to and adjacent second layer 54a of first patch 51a. A third patch 51c having a first layer 52c and a second layer 54c is disposed proximal to and adjacent second layer 54b of second patch 51b, and so on and so forth for n number of patches (an n patch <NUM>n is illustrated in <FIG> and has a first layer <NUM>n and a second layer <NUM>n). It will be understood that target <NUM> may be any tissue known in the art, including but not limited to endomucosal tissue, gastrointestinal tissue, bone tissue, cartilage, etc..

An operation of endoscopic applicator <NUM> illustrated in <FIG> will now be described.

Endoscopic applicator <NUM> is introduced to the body through an opening, such as through the mouth or nose, or through an opening formed by an incision, e.g., during a surgical procedure. Applicator tip <NUM> is inserted into the body through the opening and advanced to the desired deployment site, e.g., the GI tract. According to an embodiment, applicator tip <NUM> and catheter <NUM> are advanced along a guidewire (not shown). It will be understood that applicator tip <NUM> and catheter <NUM> may be advanced along a pre-positioned sheath, catheter, endoscope, bronchoscope, colonoscope, or the like, e.g., a catheter with multiple lumens to provide light emission, suction, tools, or the like, or may be positioned in any other manner or using any other device known in the art.

After positioning applicator tip <NUM> at the desired location, e.g., at target <NUM>, deployment and placement of the stack of patches <NUM>, one-by-one in a serial fashion, is performed. Referring to <FIG>, handle <NUM> is maneuvered to push the distalmost portion of applicator tip <NUM>, including annular ring <NUM>, in a direction indicated by arrows B, such that annular ring <NUM> abuts target <NUM>. At a same time, or subsequently, spool <NUM> (grasped by an index finger and a middle finger of the user's hand, while a thumb is in hole 22a, for example) is advanced longitudinally along handle <NUM> in a direction indicated by arrow C toward a distal end 20a of handle <NUM>, thereby pushing wire <NUM> and plunger <NUM> in the direction indicated by arrow C in <FIG>. Plunger <NUM> pushes against the proximalmost patch <NUM>n (n is a number of patches in the stack of patches <NUM>, and may be a maximum number of patches in the stack of patches <NUM> that can be disposed in applicator tip <NUM>), thereby forcing the stack of patches <NUM> against target <NUM>, and causing first layer 52a of first patch 51a to contact and adhere to target <NUM>. Subsequently, while continuing to push spool <NUM> toward distal end 20a of handle <NUM>, or maintaining a position of spool <NUM> relative to handle <NUM>, endoscopic applicator <NUM>, including applicator tip <NUM>, is pulled in a proximal direction, as indicated by arrow D in <FIG>. As shown in <FIG>, first patch 51a adheres to target <NUM> via first layer 52a, and second layer 54a remains attached to a side of first layer 52a opposite target <NUM>. After application of first patch 51a, applicator tip <NUM> is moved to another application location, e.g., a position adjacent first patch 51a, and the application of second patch 52a is performed. In this manner, one or more patches from the stack of patches <NUM> is applied to target <NUM>.

Referring to <FIG>, an endoscope applicator <NUM> according to another embodiment is disclosed. Like reference numerals will be used to describe like elements.

Endoscope applicator <NUM> includes a handle <NUM>, a catheter <NUM> attached to handle <NUM>, and an applicator tip <NUM> attached to catheter <NUM> at a distal end opposite handle <NUM>. Spool <NUM> is shown in <FIG>; however, since a spool is unnecessary in the operation of endoscope applicator <NUM> according to the embodiment in <FIG> as described herein, handle <NUM> may be formed without spool <NUM>. With continued reference to <FIG>, catheter <NUM> is a generally circular sheath extending from handle <NUM> to applicator tip <NUM> and defining a lumen <NUM>, similar to catheter <NUM> described above.

Referring to <FIG>, applicator tip <NUM> according to an embodiment will be described. Applicator tip <NUM> is disposed at a distal end of catheter <NUM>. Applicator tip <NUM> includes an outer wall <NUM> and an annular ring <NUM>, similar to applicator tip <NUM>. As shown in <FIG>, a stack of patches <NUM> are disposed in applicator tip <NUM> for application to a target <NUM>, as explained herein. A plunger <NUM> is connected to a fixed plate <NUM> via a spring <NUM>, all of which are disposed in applicator tip <NUM> at a position proximal to the stack of patches <NUM>. Fixed plate <NUM> may have an area equal to or smaller than a cross-section area of lumen <NUM> and may be fixed to a sidewall of lumen <NUM> via an adhesive, sonic welding, or the like. Plunger <NUM>, spring <NUM>, and fixed plate <NUM> may be any material known in the art, including but not limited to a medical grade metal alloy, a plastic, a resin, or a rubber, suitable for being used to place pressure against the stack of regenerative <NUM> and push the stack of patches <NUM> toward a distal opening of applicator tip <NUM>.

With continued reference to <FIG>, the stack of patches <NUM> may include a first patch 151a having a first layer 152a including an adhesive substance and a second layer 154a, including a non-adhesive surface 154a1, so that adjacent patches <NUM> do not adhere to one another, and an adhesive surface 154a2, which may include the same material as first layer 152a. As described herein, first layer 152a may include a regenerative agent, an adhesive regenerative agent, or any other agent and/or attachment mechanism for attaching first patch 151a to target <NUM>.

Prior to a first application, first patch 151a is partially exposed from applicator tip <NUM>, outside of the distal opening of the applicator tip <NUM> such that non-adhesive surface 154a1 is adjacent to and/or contacts an outer surface of annular ring <NUM>, thereby exposing first layer 152a outside applicator tip <NUM>, as will be described in greater detail herein. Adhesive surface 154a2 is attached to a first layer 152b of a second patch 151b, as shown in <FIG>. Second patch 151b also includes a second layer 154b having a non-adhesive layer 154b1 and an adhesive surface 154b2. A patch <NUM>n, which is a proximalmost patch, has an adhesive surface <NUM>n<NUM>, which attaches to plunger <NUM> (n is a number of patches in the stack of patches <NUM>, and may be a maximum number of patches in the stack of patches <NUM> that can be disposed in applicator tip <NUM>). First layer 152a is applied to target <NUM>, e.g., a tissue or another suitable target site, as will be described herein. It will be understood that target <NUM> may be any tissue known in the art, including but not limited to endomucosal tissue, gastrointestinal tissue, bone tissue, cartilage, etc..

An operation of endoscopic applicator <NUM> illustrated in <FIG> will now be described. Endoscopic applicator <NUM> is introduced to the body in a same manner an endoscopic applicator <NUM> in <FIG>, as described above. After positioning applicator tip <NUM> at the desired location, e.g., at target <NUM>, placement of one or more of the stack of patches <NUM> is performed. Handle <NUM> is maneuvered to push the distalmost portion of applicator tip <NUM> in <FIG>, including annular ring <NUM>, in a direction indicated by arrow B and against target <NUM>. Pushing applicator tip <NUM> against target <NUM> causes a surface of first layer 152a, opposite a surface of second layer 154a contacting annular ring <NUM>, to contact and adhere to tissue <NUM>. Subsequently, as shown in <FIG>, applicator tip <NUM> is pulled in a direction indicated by arrow D, via handle <NUM>, which causes the remainder of patch 151a to exit applicator tip <NUM>. If necessary to completely deploy all of patch 151a against target <NUM>, handle <NUM> and applicator tip <NUM> are again moved in the direction indicated by arrow B in <FIG>, such that annular ring <NUM> presses against a surface 154b1 of second layer 154b of second patch 151b, as shown in <FIG>, causing first patch 151a to adhere to target <NUM>. Applicator tip <NUM> is again moved in a direction indicated by arrow D in <FIG>, which pulls first layer 152b of second patch 151b from surface 154a2 of first patch 151a. Spring <NUM> forces plunger <NUM> against patch <NUM>n, thereby forcing the stack of regenerative patches <NUM> toward the distal end of applicator tip <NUM>, allowing second patch 151b to be applied to the same target <NUM> or a different target. As shown in <FIG>, second patch 151b is set to be applied to another location on target <NUM>. As further shown in <FIG>, second layer 154a remains attached to first layer 152a, but the embodiment is not limited to this configuration, since second layer 154a may be released from first layer 152a during and/or subsequent to application of first patch 151a to target <NUM>.

According to another embodiment, an applicator tip <NUM> is illustrated in <FIG>, and has similar features as applicator tip <NUM>, described above. As shown in <FIG>, a stack of patches <NUM> is disposed in applicator tip <NUM> for application to a target <NUM>, as explained herein. The stack of patches <NUM>, including first patch 251a having a first layer 252a and a second layer 254a, are applied to target <NUM> using a plunger <NUM> attached to a wire <NUM> in a manner as described above with reference to <FIG>. Applicator tip <NUM> according to an embodiment is used with, e.g., handle <NUM> shown in <FIG>.

An operation of an endoscopic applicator, such as endoscopic applicator <NUM> in <FIG>, having an applicator tip <NUM> will now be described. Applicator tip <NUM> is inserted into the body through the opening and advanced to the desired deployment site, e.g., the GI tract, as in the previous embodiments. After positioning applicator tip <NUM> at the desired location, deployment and placement of the stack of patches <NUM> is performed, in any manner described above.

As shown in <FIG>, first patch 251a adheres to target <NUM> via first layer 252a. As shown in <FIG>, after first patch 251a is attached to target <NUM>, second layer 254a disengages or disconnects from, or otherwise falls off of, a back side (e.g., a side opposite target <NUM>) and is passed from the body via normal excretion, is retrieved by another tool, and/or is biodegradable. After application of first patch 251a, applicator tip <NUM> is moved to another application location, e.g., a position adjacent first patch 251a, and the application of second patch 251b is performed. In this manner, one or more patches from the stack of patches <NUM> is applied to the same target <NUM>, or a different target. While handle <NUM>, including spool <NUM>, is described in the operation of applicator tip <NUM>, the application device (e.g., spring <NUM>, fixed plate <NUM>, and plunger <NUM>) illustrated in <FIG> may alternatively be used with applicator tip <NUM> to advance patches <NUM> along applicator tip <NUM> during application.

According to another embodiment, an applicator tip <NUM> is illustrated in <FIG>. Like reference numerals will be used to describe like elements.

Applicator tip <NUM> is disposed at a distal end of a catheter (such as catheter <NUM> shown in <FIG>). Applicator tip <NUM> includes an outer wall <NUM> and an annular ring <NUM>, like those in prior embodiments.

The stack of patches <NUM> includes a plurality of patches as described herein. Each of the plurality of patches has a first layer, e.g., 352a, and a second layer, e.g., 354a. As shown in <FIG>, each second layer, e.g., 354a, is attached to a pulley system <NUM>, as will be described herein.

As shown in <FIG>, a stack of patches <NUM> are disposed in applicator tip <NUM> for application to a target <NUM>. One or more of patches <NUM> are applied to target <NUM> using a plunger <NUM> attached to a wire <NUM> disposed in a first lumen 336a in a manner as described above with reference to <FIG>. First lumen 336a and a second lumen 336b may include a pulley system, as shown in <FIG>. The pulley system may include a wire or cable <NUM> that may extend around a pulley <NUM> at a distalmost end of applicator tip <NUM> and into a second lumen 336b, adjacent first lumen 336a, and which extends to a proximal end of a catheter, e.g., catheter <NUM> described herein. Cable <NUM> may attach to each of the second layers (e.g., second layer 354a) at connection points <NUM>. Alternatively, applicator tip <NUM> may be formed without second lumen 336b, and cable <NUM> may extend on an outer side of applicator tip <NUM>. As a further alternative, pulley <NUM> may be located within one or more lumens of the catheter so no parts of the pulley system are outside of the catheter. Cable <NUM> extends to a handle, e.g., handle <NUM>, to allow a user to manipulate cable <NUM>, as will be described herein. Applicator tip <NUM> according to an embodiment is used with handle <NUM> shown in <FIG>.

An operation of an endoscopic applicator, such as endoscopic applicator <NUM> in <FIG>, having an applicator tip <NUM> will now be described. Applicator tip <NUM> is inserted into the body through the opening and advanced to the desired deployment site, e.g., the GI tract, in any of the manners described above. After positioning applicator tip <NUM> at the desired location, deployment and placement of the stack of patches <NUM> is performed, in any manner described above. As shown in <FIG>, first layer 352a was previously adhered to target <NUM>. Subsequently, while continuing to push spool <NUM> toward distal end 20a of handle <NUM>, an endoscopic applicator (including handle <NUM>, catheter <NUM>, and applicator tip <NUM>) is pulled in a proximal direction, as indicated by arrow D in <FIG>. As shown in <FIG>, first layer 352a adheres to target <NUM>. After first layer 352a is attached to target <NUM>, second layer 354a, which is attached to cable <NUM>, is detached from first layer 352a and pulled proximally inside second lumen 336b. Cable <NUM> may be operated in any manner known in the art, for example by a user or by a motor (not shown). Alternatively, or additionally, cable <NUM> may pull second layer 354a on an external side of applicator tip <NUM>.

After application of first layer 352a, applicator tip <NUM> is moved to another application location, e.g., a position adjacent first layer 352a, and the application of a first layer of second patch 351b is performed. In this manner, one or more patches from the stack of patches <NUM> is applied to target <NUM>. While handle <NUM>, including spool <NUM>, is described in the operation of applicator tip <NUM>, the application device (e.g., spring <NUM>, fixed plate <NUM>, and plunger <NUM>) illustrated in <FIG> may alternatively be used with applicator tip <NUM> to advance patches <NUM> along applicator tip <NUM> during.

According to another embodiment not forming part of the present invention, applicator tips <NUM> and <NUM> will be described with reference to <FIG>.

As shown in <FIG>, an applicator tip <NUM> is disposed at a distal end of a catheter (such as catheter <NUM> shown in <FIG>). Applicator tip <NUM> includes an outer wall <NUM> having a generally circular cross-section. Applicator tip <NUM> is the distalmost portion of the catheter. Applicator tip <NUM> further includes a protrusion <NUM> extending into a lumen <NUM> of applicator tip <NUM>. Protrusion <NUM> may be an annular protrusion, or one or more protrusions, that extends over less than a full circumference of lumen <NUM>. A distance from central axis Z to an innermost portion of protrusion <NUM> is less than a distance from central axis Z to an innermost surface of outer wall <NUM>. Protrusion <NUM> secures a plurality of spheres or balls <NUM> in applicator tip <NUM> until a force applied to the plurality of spheres <NUM>, e.g., provided by a plunger <NUM>, forces the distalmost ball past protrusion <NUM>.

A stack of spheres <NUM> includes a plurality of spheres 452a, 452b, etc. as described herein. Each of the plurality of spheres, e.g., 452a, 452b, has a reagent, e.g., 454a (see <FIG>), provided within for application to a target <NUM>. One or more of the stack of spheres <NUM> are applied to target <NUM> using a plunger <NUM> in a manner as described above with reference to <FIG>. Applicator tip <NUM> according to an embodiment is used with handle <NUM> shown in <FIG>.

With reference to <FIG>, an applicator tip <NUM>, similar to applicator tip <NUM>, will be described. Applicator tip <NUM> is disposed at a distal end of a catheter (such as catheter <NUM> shown in <FIG>). Applicator tip <NUM> includes an outer wall <NUM> and a protrusion <NUM>, like those in prior embodiments. Applicator tip further includes one or more blades <NUM> (or other cutting elements) distal of annular protrusion <NUM>. Blades <NUM> are used to cut through an outer shell, which may be a rigid or deformable shell containing a substance container therein, of each of the plurality of spheres <NUM> during application to target <NUM>, as described herein.

The plurality of spheres <NUM> include, e.g., spheres 552a, 552b, etc., and including a reagent, e.g., 554a, as described herein with reference to applicator tip <NUM>.

An operation of applicator tip <NUM> and <NUM> will now be described with reference to <FIG> and <FIG>. Applicator tips <NUM> or <NUM> are inserted into the body through the opening and advanced to the desired deployment site, e.g., the GI tract, in any of the manners described above. After positioning applicator tips <NUM> and <NUM> at the desired location, deployment and placement of the plurality of spheres <NUM> or <NUM> is performed in any manner described above.

With reference to <FIG>, a first ball 452a is forced from applicator tip <NUM> and against target <NUM>. The pressure between first sphere 452a and target <NUM> and/or applicator tip <NUM> causes first ball 452a to rupture, thereby releasing a first reagent 454a, which coats target <NUM>. First reagent 454a may be hydrophilic and or otherwise designed to be attracted to target <NUM>.

Dispensing the plurality of spheres <NUM> using applicator tip <NUM> may be performed, as shown in <FIG>. A first sphere 552a is forced past annular protrusion <NUM> and out a distal end of applicator tip <NUM>. As first ball 552a is dispensed, an outer layer of first ball 552a is cut by one or more blades <NUM>, thereby releasing a first reagent 554a, which coats target <NUM>. After application of first reagents 454a, 554a, applicator tips <NUM> or <NUM> are moved to another application location, e.g., a position adjacent the application area or another target area, and the application of another reagent using second spheres 452b, 552b is performed. In this manner, reagents from one or more spheres from the stack of spheres <NUM>, <NUM> are applied to targets <NUM>, <NUM>, respectively.

Applicator tip <NUM> is disposed at a distal end of a catheter (such as catheter <NUM> shown in <FIG>). Applicator tip <NUM> includes an outer wall <NUM> having a generally circular cross-section and an annular ring <NUM>, similar to applicator tip <NUM>.

The stack of patches <NUM> includes a plurality of patches 651a, 651b, etc. as described herein. Each of the plurality of patches has a first layer, e.g., 652a, and a spacer, e.g., 654a. As shown in <FIG>, each spacer, e.g., 654a, separates from each first layer e.g., 652a, after application to target <NUM>, as will be described herein.

As shown in <FIG>, a stack of patches <NUM> are disposed in applicator tip <NUM> for application to a target <NUM>, as explained herein. The stack of patches <NUM> are applied to target <NUM> in any manner described above. For example, applicator tip <NUM> according to an embodiment is used with handle <NUM> shown in <FIG>.

An application of the stack of patches <NUM> will be described with reference to <FIG>. Applicator tip <NUM> is inserted into the body through the opening and advanced to the desired deployment site, e.g., the GI tract, in any manner described herein. After positioning applicator tip <NUM> at the desired location, deployment and placement of the stack of patches <NUM> is performed, similar to the manner described with respect to the embodiments above. After patch 651a is attached to target <NUM>, first separator 654a is detached from first layer 652a. Separator 654a may be biodegradable. Alternatively, or additionally, separator 654a may be small enough to pass through the body and be excreted during normal bowel movements by a patient, or may be removed by a tool.

After application of first patch 651a, applicator tip <NUM> is moved to another application location, e.g., a position adjacent first patch 651a or another target site, and the application of second patch 651b is performed. In this manner, one or more patches from the stack of regenerative <NUM> is applied to target <NUM>.

It will be understood that, unless specifically set forth herein, any material known in the art may be used for the various elements. For example, features may include a medical grade plastic or rubber, a ceramic, a metal, or a combination thereof. Spacers and/or separation layers may be may include a material that is biodegradable and/or may include one or more of a medical grade plastic or rubber, a ceramic, a metal, or a combination thereof, such as polyvinyl acetate (PVA), polyhydroxyethylmethacrylate (PHEMA), polytetrafluoroethylene (PTFE), HDPE (high-density polyethylene), polydimethylsiloxane (PDMS), polyurethane (PU), and/or poly(methyl methacrylate) (PMMA). The attachment agent(s) may be one or more biocompatible materials and may be adhesive prior to introduction into a body lumen and/or may be activated by moisture. Further, the regenerative agent may include an adhesive agent as described above, and/or may be any agent now known or later developed for the treatment of the inner walls of a human body, such as the GI tract.

Claim 1:
A medical dispensing device (<NUM>; <NUM>) comprising:
a catheter (<NUM>; <NUM>) defining a lumen (<NUM>; <NUM>; 336a; <NUM>) having a longitudinal axis (Z) and a distal opening;
a plunger (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) disposed in the lumen (<NUM>; <NUM>; 336a; <NUM>) and movable along the longitudinal axis; and
a plurality of elements disposed in the lumen (<NUM>; <NUM>; 336a; <NUM>) proximal to the distal opening and distal to the plunger (<NUM>), the plurality of elements being stacked along the longitudinal axis (Z) and configured for dispensation of one element at a time through the distal opening via a force applied by the plunger (<NUM>);
wherein the plurality of elements include a plurality of stacked patches (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>), each of the plurality of stacked patches (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) having an adhesive layer and a non-adhesive layer (154b1) proximal to the adhesive layer.