Patent Grant
12083006
The present patent application is related to controlling bleeding during surgical procedures, and is more specifically related to systems, devices, and methods used for delivering sealants to target tissue for controlling bleeding of the target tissue.
Medical textiles are used during surgical procedures to control bleeding, minimize blood loss, reduce post-surgical complications, and shorten the duration of surgery. Commonly used medical textiles include adhesion barriers, sponges, meshes, and hemostatic wound dressings that are applied to the surface of tissue. Hemostatic wound dressings include absorbable hemostats such as those sold by Ethicon, Inc. of Somerville, NJ under the registered trademarks Surgicel®, Surgicel Nu-Knit®, and Surgicel® Fibrillar.
Traditionally, medical textiles have been delivered to surgical sites using grasping instruments such as clamps and forceps. It is also well-known to use applicator instruments for delivering medical textiles. For example, U.S. Pat. No. 3,857,395 discloses an inserter device having a pair of outwardly bendable arms that bilaterally spread an adhesion barrier within a vaginal cavity.
Commonly assigned U.S. Pat. No. 5,395,383 discloses an applicator instrument used for applying a sheet of surgical material (i.e., an adhesion barrier) through an endoscopic tube. The applicator instrument includes an expandable operating tip that is insertable into an endoscopic tube to enable a surgeon to apply the surgical material to tissue inside a body. In one embodiment, the applicator instrument comprises a set of telescoping tubes including an outer delivery tube, an intermediate deployment tube, and an inner irrigation tube. The expandable operating tip is mounted at the distal end of the irrigation tube and is connected to the distal end of the deployment tube. The spreader tip is exposed at the distal end of the delivery tube by advancing the deployment tube and the irrigation tube relative to the delivery tube. The spreader tip is expanded by movement of the deployment tube relative to the irrigation tube to spread the sheet of surgical material over the tissue. A nozzle is provided at the distal end of the irrigation tube for applying a fluid, e.g., a saline solution, to the surgical material.
Commonly assigned U.S. Pat. No. 5,397,332 discloses an applicator for applying a sheet of surgical material, e.g., a surgical mesh, to internal body tissue. The applicator includes a delivery tube, a deployment tube slidably received within the delivery tube, and a shaft or irrigation tube slidably received within the deployment tube. An expandable spreader tip is connected between the distal ends of the shaft and the deployment tube. The spreader tip is collapsed and inserted in the delivery tube with the surgical mesh. The applicator is inserted through a trocar tube into a body cavity and the spreader tip is exposed by retracting the delivery tube relative to the deployment tube and shaft. The applicator has a first actuator for urging the spreader tip and surgical mesh into engagement with the tissue as the deployment tube is retracted, and a second actuator for advancing the deployment tube relative to the shaft to expand the spreader tip to apply the surgical mesh to the tissue. The spreader tip includes a plurality of flexible strips each having opposite ends pivotally connected to the distal ends of the shaft and the deployment tube. The applicator includes a return spring to bias the deployment tube proximally relative to the shaft to normally maintain the spreader tip in a collapsed configuration.
U.S. Pat. No. 6,589,269 to Zhu et al. discloses a patch and glue delivery system for closing tissue openings during surgery. In one embodiment, a patch applicator has an elongate body with an inner lumen and an outer lumen arranged concentrically. A patch is also provided. In operation, a source of vacuum draws a vacuum through the inner lumen. The inner lumen is applied to a patch to releasably hold the patch. The patch is advanced within the patient until it is placed on top of and over a wound in tissue. Flowable adhesive is injected through the outer lumen onto the patch and tissue surrounding the patch. The patch applicator holds the patch in place, allowing the adhesive to at least partially set for attaching the adhesive patch to close an opening in tissue. The applicator is then removed from the patch, thereby leaving the adhesive patch attached to tissue for closing an opening in the tissue.
U.S. Pat. No. 8,372,092 to Gabel et al., assigned to Ethicon, Inc., the disclosure of which is hereby incorporated by reference herein, teaches an instrument for controlling bleeding including an outer shaft, an intermediate shaft telescopically received within a central lumen of the outer shaft, and an inner shaft telescopically received within a central lumen of the intermediate shaft, the inner shaft having a proximal end and a distal end that extends distally from the intermediate shaft. The instrument includes a hemostat disposed at the distal end of the inner shaft, and a fluid-resistant element connected to the distal end of the outer shaft and surrounding the hemostat. The fluid-resistant element has a breakable, fluid-resistant seal at a distal end thereof that protects the hemostat from fluids until the hemostat is delivered and deployed onto tissue. In one embodiment, the instrument includes an inflatable balloon to deploy and tamponade the hemostat.
U.S. Patent Application Publication No. 20120078293 to Hassidov et al. discloses applicators for patches and adhesives. The applicators are designed for applying one or two components of a single-component or a dual-component adhesive glue or sealant to a tissue surface, thus allowing optimal on-site curing of the adhesive. During a first stage of an adhesive application procedure, a first component of the adhesive, e.g., a viscous pre-gel, is applied to the tissue surface. During a second stage of the procedure, the applicators are used to apply a patch (e.g., a solid patch) or other solid support to the tissue surface. The patch comprises a second component of the adhesive, e.g., a curing agent, such that the patch and curing agent together serve as a curing/hardening patch. The curing agent, upon contact with the pre-gel, causes the pre-gel to become more solid and to adhere to the tissue surface. The patch also provides mechanical support to the tissue surface. The applicator is typically used to hold the patch against the tissue surface for about one minute. The patch is typically left on the tissue surface, and eventually biodegrades.
U.S. Pat. No. 9,592,108 to Lavigne et al. is directed to a method of applying a surgical patch during minimally invasive surgery. The method includes laparoscopically transferring a polymeric bag containing a surgical patch into a body cavity followed by removing the surgical patch from the polymeric bag within the body cavity, and applying the surgical patch to a site in the body cavity in need of hemostasis. The hemostatic patch may include a substrate having a first hydrogel precursor applied to a first portion of the substrate, and a second hydrogel precursor applied to a second portion of the substrate.
In spite of the above advances, surgeons have continued to experience difficulties when attempting to deploy sealants (e.g., a matrix with pre-applied sealant) to certain anatomical regions of a human body, such as the posterior aspect of the thoracic aorta. When attempting to apply sealants in hard to reach locations, surgeons have found it challenging to maneuver the sealant components into place, to avoid saturating medical textiles with blood, and to complete placement before the sealant sets.
Thus, there remains a need for systems, devices and methods that protect medical textiles (e.g. a matrix; a hemostatic substrate) prior to placement of the medical textile onto target tissue.
There also remains a need for systems, devices and methods that maintain the sealant that is applied to a matrix in an unmixed state until immediately prior to placing the matrix or medical textile onto target tissue.
In addition, there is a need for systems, device and methods for delivering a matrix (e.g., a medical textile; a hemostatic substrate) to target tissue that is located in hard to reach areas of a patient's anatomy.
Moreover, there is a need for systems, devices and methods that enable a matrix to be secured over target tissue without the possibility of the matrix sticking to non-target tissue as the matrix is delivered to the target tissue.
Furthermore, there is a need for systems, devices and methods that accomplish the above while using an economy of materials.
In one embodiment, a sealant delivery device enables surgeons to control bleeding at hard to reach places of a patient's anatomy.
In one embodiment, the sealant delivery device disclosed herein enables surgeons to reliably advance a matrix (e.g., a hemostatic substrate; a medical textile) to target tissue while minimizing the likelihood of the matrix sticking to surrounding tissue as the matrix is advanced to the target tissue.
In one embodiment, a sealant delivery device preferably includes a housing, a matrix container connected with a distal end of the housing that is moveable between closed and opened positions, and a matrix (e.g., a hemostat) disposed within the matrix container.
In one embodiment, the matrix may include medical textiles, biocompatible matrices, and/or biocompatible substrates. The matrix may be used during surgical procedures for controlling and/or stopping bleeding of target tissue.
In one embodiment, the matrix may comprise any biocompatible materials capable of being coated with a sealant.
In one embodiment, the matrix may be a thin substrate, a flexible substrate and/or a flat substrate.
In one embodiment, the matrix may be absorbable or non-absorbable.
In one embodiment, the matrix may include one or more of the following: natural polymers, such as polysaccharides, such as CMC, cellulose, oxidized cellulose, oxidized regenerated cellulose, chitosan, similar materials, and combinations thereof; biological derived materials, such as proteins, gelatin, collagen, fibrin, fibrinogen, thrombin, and combinations thereof; synthetic polymers, such as polyesters, such as polylactide-co-glycolide, PTFE, TELFA, silicone, polyethylene, and non-adherent dressings known in the art; combinations of natural and synthetic polymers; woven, non-woven, knit, felt, films, textiles, and combinations thereof; porous; non-porous materials, and combinations thereof; single-layer or multi-layer substrates; substrates coated by active or reactive components or hemostatic agents; and combinations of and of the above.
In preferred embodiments, the matrix may comprise one or more of the hemostats sold by Ethicon, Inc. of Raritan, N.J. under the trademarks SURGICEL®, SURGICEL SNoW™, SURGICEL ORIGINAL®, SURGICEL NU-KNIT®, and SURGICEL FIBRILLAR®.
In one embodiment, the sealant delivery device preferably includes a sealant dispensing system in fluid communication with the matrix container. The sealant dispensing system is preferably configured for dispensing a sealant (e.g., a flowable sealant) onto the matrix that is disposed within the matrix container.
Sealants are used in a wide range of different clinical applications. Sealants can be used as both a primary and/or secondary method of joining or sealing tissue. A common class of tissue adhesives is fibrin-based and contains a concentrate of fibrinogen and thrombin. Fibrin adhesives are typically two-component adhesives that when mixed together react to simulate the last stages of the coagulation cascade. The resulting clot adheres to tissue and bridges a gap between the tissues until healing can occur. Glues based on albumin or gelatin cross-linked with an aldehyde are also known. Representative of this class of glues are gelatin-resorcinol cross-linked with formaldehyde or glutaraldehyde. Gelatin-based glues have been extensively studied and shown to generally be effective. Cyanoacrylates, polyurethanes, polymethylmethacrylates, hydrogel-forming formulations, among other synthetic polymers, have been also investigated as tissue glues. The tissue adhesives/sealants based on PEG, PEO and PoX chemistries are typically delivered as liquids that react and crosslink to form hydrogels. Various other technologies have been developed for the formulation of tissue adhesives. Some of them are of synthetic origin, such as the glues based on cyanoacrylates (2-butyl cyanoacrylate, 2-octyl cyanoacrylate), or on synthetic polymers (polyurethanes, polymethylmethacrylates) and others contain biological materials such as collagen or fibrin which, in addition, have hemostatic properties and also act by controlling bleeding. As a result of their hemostatic and adhesive properties, sealants, and particularly fibrin sealants—have been extensively used in most surgical specialties for over two decades to reduce blood loss and post-operative bleeding because of the ability to adhere to human tissue as it polymerizes.
In one embodiment, tissue sealant compositions (also referred to herein as the sealant) preferably comprise an electrophilic-containing component, such as a multi-arm polyalkylene oxide, preferably from polyethylene glycol, having at least 2 electrophilic groups and a nucleophilic containing component, such as albumin, gelatin, collagen, or a multi-arm polyalkylene oxide, preferably from polyethylene glycol, having at least 2 nucleophilic groups; and optionally a buffer. In a preferred embodiment, the sealant composition comprises a multi-arm PEG-SG (PEG-Succinimidyl Glutarate ester) and PEG-NH2 (PEG-amine) or albumin.
In one embodiment, the sealant delivery device preferably includes an actuator coupled with the sealant dispensing system and the matrix container. In one embodiment, the actuator is engageable for moving the matrix container from the closed position to the opened position for exposing the matrix while the sealant dispensing system simultaneously expresses the sealant onto the matrix.
In one embodiment, the matrix container is configured to open before the sealant is expressed onto the matrix.
In one embodiment, the sealant is expressed onto the matrix before the matrix container is opened.
In one embodiment, the sealant delivery device may include a first actuator for opening the matrix container to expose the matrix, and second actuator for expressing the sealant onto the matrix. The first and second actuators may operate independently of one another.
In one embodiment, the matrix container desirably includes a tray having a proximal end connected with the distal end of the housing and a distal end that defines a distal-most end of the sealant delivery device. The tray may be malleable and may be transformed into various shapes (e.g., a curved shape). The tray may incorporate one or more wires for holding the transformed shape of the tray.
In one embodiment, the matrix container desirably includes a protective cover that overlies the tray and that is coupled with the actuator. In one embodiment, the protective cover is moveable between an extended position that defines the closed position of the matrix container and a retracted position that defines the opened position of the matrix container.
In one embodiment, the protective cover is configured to move simultaneously with the actuator as the actuator is pulled toward the proximal end of the housing.
In one embodiment, the tray may include a trough that is configured to receive the matrix that is disposed within the matrix container.
In one embodiment, the protective cover preferably includes a sealant dispensing channel that extends along the length of the protective cover and that is in fluid communication with the sealant dispensing system. In one embodiment, the protective cover desirably includes a sealant dispensing opening located at a distal end of the sealant dispensing channel that is configured for expressing the sealant onto the matrix as the protective cover moves from the closed position to the opened position.
In one embodiment, the actuator may include a handle secured to a proximal end of the housing, and a trigger coupled the housing and projecting from an underside of the housing. In one embodiment, the trigger is squeezable toward the handle and the proximal end of the housing for activating the sealant dispensing system while simultaneously retracting the protective cover toward the proximal end of the housing for moving the protective cover into the open position.
In one embodiment, the sealant dispensing system may include a dual barrel syringe disposed within the housing including a first syringe barrel containing a first part of the sealant and a second syringe barrel containing a second part of the sealant.
In one embodiment, the first and second parts of the sealant are mixed together to provide the sealant that is expressed onto the matrix for controlling bleeding of tissue. The first and second parts of the sealant may chemically react with one another to form the sealant that may be used for controlling bleeding. The sealant is preferably biocompatible and may be absorbed over time into a patient's body.
In one embodiment, a first syringe plunger is disposed within the first syringe barrel and has a proximal end connected with the proximal end of the housing.
In one embodiment, a second syringe plunger is disposed within the second syringe barrel and has a proximal end connected with the proximal end of the housing.
In one embodiment, the trigger is preferably coupled with the dual barrel syringe for pulling the dual barrel syringe toward the proximal end of the housing when the trigger is squeezed toward the handle and the proximal end of the housing.
In one embodiment, when the trigger is squeezed toward the proximal end of the housing, the first syringe plunger forces the first part of the sealant from the distal end of the first syringe barrel and the second syringe plunger forces the second part of the sealant from the distal end of the second syringe barrel.
In one embodiment, the sealant delivery device preferably includes a sealant mixer disposed between the first and second syringe barrels and the fluid dispensing channel of the protective cover for mixing the first and second parts of the sealant together and delivering the mixed sealant into the sealant dispensing channel of the protective cover.
In one embodiment, the sealant mixer may include a sealant mixing tube having a proximal and a distal end, a static mixer disposed within the sealant mixing tube, and a syringe barrel connector coupled with the proximal end of the sealant mixing tube for forming a fluid connection between distal ends of the respective first and second syringe barrels and the sealant mixing tube.
In one embodiment, the dual barrel syringe, the sealant mixer and the protective cover are configured to move together toward the proximal end of the housing as the trigger is squeezed toward the proximal end of the housing.
In one embodiment, a sealant delivery device preferably includes a housing having a proximal end and a distal end, a matrix container connected with the distal end of the housing, and a matrix (e.g., a hemostatic substrate; a medical textile) disposed within the matrix container
In one embodiment, the matrix container preferably includes a protective cover that is movable between an extended position (e.g., a closed position) and a retracted position (e.g., an opened position). In one embodiment, the protective cover has a sealant dispensing channel extending along the length thereof.
In one embodiment, the sealant delivery device preferably includes a sealant dispensing system in fluid communication with the sealant dispensing channel of the protective cover.
In one embodiment, the sealant delivery device may include an actuator coupled with the sealant dispensing system and the protective cover of the matrix container. In one embodiment, the actuator is engageable for moving the protective cover into the retracted position for opening the matrix container and activating the sealant dispensing system for expressing the sealant through the sealant dispensing channel of the protective cover and onto the matrix disposed within the matrix container.
In one embodiment, the actuator is engageable for moving the protective cover into the retracted position for opening the matrix container to expose the matrix while the sealant dispensing system simultaneously expresses the sealant through the sealant dispensing channel of the protective cover and onto the matrix disposed within the matrix container.
In one embodiment, the protective cover may include the sealant dispensing channel extending along the length of the protective cover, the sealant dispensing channel being in fluid communication with the sealant dispensing system, and a sealant dispensing opening located at a distal end of the sealant dispensing channel that is configured for expressing the sealant onto the matrix as the protective cover moves into the retracted position for opening the matrix container.
In one embodiment, the actuator may include a handle secured to the proximal end of the housing, and a trigger coupled with the housing and being slidable between the proximal and distal ends of the housing.
In one embodiment, the trigger is squeezable toward the handle and the proximal end of the housing for activating the sealant dispensing system while simultaneously moving the protective cover into the retracted position for opening the matrix container.
In one embodiment, the sealant dispensing system of the sealant delivery device may include a dual barrel syringe disposed within the housing including a first syringe barrel containing a first part of the sealant and a second syringe barrel containing a second part of the sealant.
In one embodiment, the sealant dispensing system desirably includes a first syringe plunger disposed within the first syringe barrel and having a proximal end connected with the proximal end of the housing, and a second syringe plunger disposed within the second syringe barrel and having a proximal end connected with the proximal end of the housing.
In one embodiment, the trigger is coupled with the dual barrel syringe for pulling the dual barrel syringe toward the proximal end of the housing when the trigger is squeezed toward the handle and the proximal end of the housing.
In one embodiment, when the trigger is squeezed toward the proximal end of the housing, the first syringe plunger forces the first part of the sealant from the distal end of the first syringe barrel and the second syringe plunger forces the second part of the sealant from the distal end of the second syringe barrel.
In one embodiment, the dual barrel syringe and the protective cover preferably move together toward the proximal end of the housing as the trigger is squeezed toward the proximal end of the housing.
In one embodiment, the sealant delivery device preferably includes a sealant mixer disposed between the first and second syringe barrels and the fluid dispensing channel of the protective cover for mixing the first and second parts of the sealant together and delivering the mixed sealant into the sealant dispensing channel of the protective cover.
In one embodiment, the sealant mixer may include a sealant mixing tube having a proximal and a distal end, a static mixer disposed within the sealant mixing tube, and a syringe barrel connector coupled with the proximal end of the sealant mixing tube for providing fluid communication between distal ends of the respective first and second syringe barrels and the sealant mixing tube.
In one embodiment, a method of controlling bleeding desirably includes obtaining a sealant delivery device including a housing, a matrix container connected with a distal end of the housing, a matrix disposed within the matrix container, a sealant delivery system in fluid communication with the matrix container, and an actuator for opening the matrix container to expose the matrix and express the sealant onto the matrix.
In one embodiment, the method preferably includes opening the matrix container while simultaneously expressing the sealant from the sealant delivery system onto the matrix.
In one embodiment, the method of controlling bleeding may include pulling the actuator toward a proximal end of the housing for opening the matrix container to expose the matrix while expressing the sealant onto the matrix.
In one embodiment, the method of controlling bleeding may include using a component of the matrix container (e.g., a malleable tip; the tray) to press the matrix and the sealant expressed onto the matrix against target tissue for controlling bleeding of the target tissue.
In one embodiment, a sealant delivery device preferably includes a dual barrel syringe that contains a two-part sealant that is directed through a sealant mixer and a sealant delivery channel of a protective cover. In one embodiment, the sealant delivery channel preferably widens and/or opens on an underside of the protective cover, at or adjacent the distal end of the protective cover.
In one embodiment, the sealant delivery device preferably includes a matrix container that holds a matrix (e.g., a medical textile; a hemostatic substrate). In one embodiment, the matrix container preferably includes a tray and the protective cover that overlies the tray and the matrix disposed within the tray. The tray may be flexible (e.g., malleable) and may include one or more embedded malleable wires that enable the tray to be shaped into a desired semi-rigid, curved configuration.
In one embodiment, the sealant delivery device preferably includes a push rod that interconnects the proximal end of the tray to a syringe plunger.
In one embodiment, the tray, the matrix, and the protective cover may be bent into a desired shape and maneuvered into position inside a patient. In one embodiment, as the dual barrel syringe is actuated (e.g., the plunger is held stationary while the syringe body is translated proximally), the protective cover translates proximally to progressively expose and/or uncover the matrix, while the sealant is mixed and expressed over the surface of the matrix. The sealant delivery device may be used to press the matrix and the expressed sealant against target tissue for controlling bleeding of the target tissue.
In one embodiment, the tray is preferably covered by the protective cover (e.g.; a slidable protective cover) that prevents the matrix from contacting outside moisture prior to deployment of the matrix onto the target tissue. Protecting and isolating the matrix prior to placement on target tissue provides many benefits including minimizing fluid runoff during access/positioning; minimizing fluid contact with unintended anatomy; and mixing the reactive components of the sealant only after the matrix is already in position at the target tissue, thus reducing any concerns around insufficient working time.
In one embodiment, the sealant delivery device preferably stores a flat matrix (e.g., a medical textile; a biocompatible patch; a biocompatible matrix) in a tray that is covered by the slidable, protective cover. In one embodiment, during deployment of the matrix onto target tissue (e.g., a wound), the protective cover may be retracted for exposing the matrix while the device expresses (e.g., simultaneously expresses) a sealant fluid that comprises a mixture of reactive components from the dual barrel syringe onto the exposed matrix. The matrix, infused with the sealant, may be pressed against the target tissue with the sealant fluid facing the target tissue.
In one embodiment, the distal end of the tray may have a “duckbill tip” for ease of insertion into a patient. The tray may be used as a tamponade to hold the matrix against the tissue while the sealant (e.g., a tissue adhesive) cures.
In one embodiment, a sealant delivery device preferably has a trigger design that enables the matrix (e.g., a medical textile; a hemostatic substrate) to remain stationary relative to target tissue as the protective cover is retracted and sealant is delivered to the matrix. In one embodiment, the sealant delivery device includes a housing that is connected directly to the tray (e.g., a malleable tray). The dual barrel syringe is connected directly to the trigger. The trigger may be squeezed toward the proximal end of the housing to pull the dual barrel syringe toward the proximal end of the housing, which forces the two parts of the sealant of the two syringe barrels to flow into the sealant dispensing channel of the protective cover.
In one embodiment, during an initial stage of delivering a sealant to target tissue, the matrix is protected by the protective cover and the two parts of a sealant are not yet mixed together.
In one embodiment, the tray (e.g., a malleable tip) may be pre-bent to a desired shape (e.g., a shape for accessing the posterior side of anastomosis; a curved shape).
In one embodiment, depressing one or more plungers forces the two parts of the sealant to flow through a static mixer and through a sealant dispensing channel formed in the protective cover. Upon reaching a sealant dispensing opening at the distal end of the protective cover, the mixed sealant spreads over the matrix disposed within the tray as the protective cover slides relative to the tray for exposing the matrix.
In one embodiment, engaging an actuator (e.g., a trigger; a thumb tab) retracts a dual barrel syringe to force the two parts of a sealant to flow through a static mixer and a sealant dispensing channel formed in the protective cover. The mixed sealant spreads over the matrix as the protective cover moves (e.g., slides) relative to the tray for exposing the matrix (e.g., a medical textile; a hemostatic substrate).
In one embodiment, the sealant flows distally through the protective cover as the protective cover moves relative to the tray to expose the matrix.
In one embodiment, a sealant delivery device may include a push rod that interconnects a plunger and the tray.
In one embodiment, the push rod extends along the length of the device and between the two barrels of a dual barrel syringe
In one embodiment, a sealant delivery device is preferably configured for delivering a two part sealant onto a matrix (e.g., a hemostat) for controlling bleeding of target tissue during open surgery. The sealant delivery device enables surgeons to effectively deliver a matrix/liquid sealant combination to target tissue of a patient. The device includes a protective cover that protects the matrix from contacting a wet field until the matrix is effectively positioned at the target tissue. Once the matrix is positioned where intended (e.g., at the target tissue), a single motion (e.g., pulling a trigger; engaging an actuator) will expose the matrix to the target tissue while delivering the mixed sealant onto the matrix. The matrix/liquid sealant combination may then be pressed against the target tissue for controlling bleeding of the target tissue.
In one embodiment, the protective cover has a sealant delivery channel that is in fluid communication with the two part sealant disposed within the dual barrel syringe. In one embodiment, the trigger design enables the dual barrel syringe to be pulled back toward the proximal end of the device, instead of pushed forward toward the distal end of the delivery device, which allows the tray that holds the matrix to remain stationary, providing an effective way to guarantee accurate matrix/sealant placement onto the target tissue for controlling bleeding.
In one embodiment, the sealant delivery device preferably includes a mixing element (e.g., a static mixer) that ensures effective mixing of the two part sealant. After the matrix has been infused with the sealant, the matrix/sealant combination may be pressed onto the bleeding source by the tray (e.g., a malleable tip) until the bleeding is controlled and/or stopped. Once bleeding is resolved, the sealant delivery device may be extracted from the patient, while leaving the matrix/sealant combination behind for controlling bleeding of the target tissue.
In one embodiment, squeezing the trigger results in the simultaneous retraction of the cover and the syringes of the dual barrel syringe, which simultaneously uncovering the matrix and expressing the mixed sealant over the exposed matrix.
In one embodiment, the sealant spreads distally as the cover is retracted to expose the matrix.
In one embodiment, a sealant delivery device may include a sealant mixer that is configured for mixing the reactive components to form a flowable, curable sealant (e.g., a tissue adhesive) that is applied to the matrix.
In one embodiment, the tray is covered by the protective cover for preventing contact of the matrix with outside moisture prior to deployment and tamponade of the matrix.
In one embodiment, the protective cover is configured to move relative to the tray (e.g., be retracted) for exposing the matrix that is disposed within the tray.
In one embodiment, the sealant dispensing channel of the protective cover is configured for directing a flowable sealant onto the matrix during retraction of the protective cover.
In one embodiment, actuating the dual barrel syringe for expressing the reactive components of the sealant simultaneously retracts the protective cover for exposing the matrix.
In one embodiment, partial retraction of the protective cover expresses a portion of the sealant onto the matrix.
In one embodiment, full retraction of the protective cover preferably expresses all of the sealant fluid that is disposed in the dual barrel syringe.
In one embodiment, a push or pull rod may be connected with the dual barrel syringe actuating mechanism.
In one embodiment, the syringe actuating mechanism is configured to retract the protective lid from the tray while simultaneously expressing the sealant (e.g., adhesive fluid) onto the matrix.
In one embodiment, retraction of the protective cover relative to the tray may be performed by pulling the protective cover toward the dual barrel syringe or pushing the tray away from the dual barrel syringe.
In one embodiment, the dual barrel syringe is mounted within a housing of a hand-operated handle/pistol grip assembly, whereby squeezing a trigger simultaneously activates expression of the reactive components from the dual barrel syringe and retracts the protective cover (e.g., a lid) for exposing the matrix.
In one embodiment, the dual barrel syringe may be mounted within a robot-operated mount having actuators that are configured to simultaneously activate expression of the reactive components from the dual barrel syringe and retract the protective cover to expose the matrix.
In one embodiment, a sealant delivery device may be configured so that expressing and mixing the reactive components of the sealant is initiated prior to initiating the retraction of the protective cover, whereby the delay in the retraction of the protective cover provides additional time for filling of the sealant dispensing channel of the protective cover with the curable sealant fluid.
In one embodiment, a sealant delivery device may include a hand-operated handle/pistol grip assembly with a three-way valve for connecting to an external compartment or external syringe for pre-mixing/reconstituting reactive components in the dual barrel syringe prior to co-expressing and mixing the reactive components.
In one embodiment, a sealant delivery device may include a three-way luer, which allows additional syringes to be connected to the device for reconstituting the content of the dual barrel syringe.
In one embodiment, the tray may include a backing component, which is adjustable to accommodate unwanted sliding of the cover while the sealant flows to the tip of the tray.
These and other preferred embodiments of the present patent application will be described in more detail below.
Referring to
In preferred embodiments, the matrix may comprise one or more of the hemostats sold by Ethicon, Inc. of Raritan, N.J. under the trademarks SURGICEL®, SURGICEL SNoW™, SURGICEL ORIGINAL®, SURGICEL NU-KNIT®, and SURGICEL FIBRILLAR®.
In one embodiment, the sealant delivery device 100 preferably has a proximal end 102 that is normally positioned closer to an operator (e.g., a surgeon) and a distal end 104 that is normally positioned further away from the operator. In one embodiment, the sealant delivery device 100 preferably includes a double plunger 106 including a first plunger 108, and a second plunger 110 that are joined together at the respective proximal ends thereof by a depressible thumb tab 112. The sealant delivery device 100 preferably includes a first piston 114 hat is secured to a distal end of the first plunger 108 and a second piston 116 that is secured to a distal end of the second plunger 110.
In one embodiment, the sealant delivery device 100 preferably includes a dual barrel syringe 118 having a first syringe barrel 120 and a second syringe barrel 122. In one embodiment, a first part of a flowable, curable sealant may be disposed within the first syringe barrel 120 and a second part of the flowable, curable sealant may be disposed within the second syringe barrel 122. In one embodiment, the two parts of the flowable sealant may be mixed together for forming a sealant that is expressed onto a matrix (e.g., a hemostatic matrix; a hemostatic patch), as will be described in more detail herein. The matrix, infused with the sealant, may be placed onto the target tissue for controlling bleeding.
In one embodiment, the curable, flowable sealant may comprise an electrophilic-containing component, such as a multi-arm polyalkylene oxide, preferably from polyethylene glycol, having at least 2 electrophilic groups and a nucleophilic containing component, such as albumin, gelatin, collagen, or a multi-arm polyalkylene oxide, preferably from polyethylene glycol, having at least 2 nucleophilic groups; and optionally a buffer. In a preferred embodiment, the sealant may comprise a multi-arm PEG-SG (PEG-Succinimidyl Glutarate ester) and PEG-NH2 (PEG-amine) or albumin.
In one embodiment, the dual barrel syringe 118 preferably has gripping structure 125 located at a proximal end thereof. In one embodiment, the gripping structure 125 may be gripped by a surgeon's fingers as the thumb tab 112 of the double plunger 106 is engaged by the surgeon's thumb. In one embodiment, the gripping structure 125 is utilized for pulling the dual barrel syringe 118 in the proximal direction DIR2 as the thumb tab 112 is depressed in the opposite, distal direction DIR1, whereupon the first and second plungers 108, 110 force the first and second parts of the flowable sealant from the distal ends of the respective first and second syringe barrels 120, 122 for being mixed together within a syringe barrel connector 132.
In one embodiment, the sealant delivery device 100 preferably includes a matrix container (e.g., a protective structure) that protects the matrix from surrounding tissue and/or moisture as the matrix is advanced into a patient and until the matrix is delivered to the target tissue, whereupon the matrix container may be manipulated and/or moved (e.g., retracted; extended; opened) for exposing the matrix to the surrounding environment and/or target tissue for being applied to the target tissue. In one embodiment, the matrix container may include a tray 124 that is located at the distal end 104 of the sealant delivery device. In one embodiment, the tray 124 may be coupled with the thumb tab 112 of the double plunger 106 via a push rod 126, whereby depressing the thumb tab 112 in the distal direction DIR1 also moves the tray 124 in the distal direction DIR1.
In one embodiment, the matrix container of the sealant delivery device 100 preferably includes a protective cover 128 that overlies a top side of the tray 124. In one embodiment, the protective cover 128 preferably includes a sealant dispensing channel 130 that extends along the length of the protective cover 128 and the syringe barrel connector 132 that is utilized for forming a fluid connection with dispensing openings located at the distal ends of the respective first and second syringe barrels 120, 122.
Although not shown in
In one embodiment, the tray 124 has a trough 136 (e.g., a pocket; a depression) and the matrix 134 is disposed within the trough 136 of the tray 124.
In one embodiment, the push rod 126 preferably has a proximal end 138 that is connected with the thumb tab 112 of the double plunger 106 and a distal end 140 that is inserted into a push rod connector 142 located at a proximal end of the tray 124. In one embodiment, as the thumb tab is depressed in the distal direction DIR1, the push rod moves distally for extending the tray 124 relative to the protective cover 128. As the tray 124 is extended relative to the protective cover 128, the matrix disposed within the trough 136 of the tray 124 is exposed.
Referring to
In one embodiment, the tray 124 preferably includes the push rod connector 142 located at the proximal end 144 of the tray 124, which is adapted to receive the distal end 140 of the push rod 126 (
Referring to
Referring to
In one embodiment, a static mixer (not shown) may be disposed within the lumen of the syringe barrel connector 132. The static mixer is preferably configured for mixing the first and second parts of the flowable, curable sealant together as the flowable sealant moves distally through the syringe barrel connector 132. The static mixer may be similar to that shown in
In one embodiment, the protective cover 128 preferably includes first and second lateral guide slots 154A, 154B that preferably extend along the length of the protective cover 128 between the proximal end 148 and the distal end 150 thereof. The first and second lateral guide slots 154A, 154B preferably mesh with respective lateral guide flanges 156A, 158B provided on the tray 124 for guiding sliding movement of the tray 124 relative to the protective cover 128.
Referring to
Referring to
In
Referring to
Referring to
In one embodiment, the thumb tab 112 of the dual barrel syringe 118 is depressed in the distal direction DIR1 for sliding the first and second plungers 108, 110 distally relative to the respective first and second syringe barrels 120, 122. As the first and second plungers 108, 110 move distally, the first and second plungers 108, 110 force the first and second parts of the sealant composition from the distal ends of the respective first and second syringe barrels and into the syringe barrel connector 132. The first and second parts of the sealant are preferably mixed together within the syringe barrel connector 132 and the sealant mixture is then forced into the sealant dispensing channel 130 of the protective cover 128 for being dispensed from the distal end of the sealant dispensing channel and onto the matrix 134. In one embodiment, as the thumb tab 112 is advanced in the distal direction DIR1, the thumb tab engages the proximal end 138 of the push rod 126 for moving the push rod 126 in the distal direction DIR1.
Referring to
In one embodiment, as the push rod 126 is extended in the distal direction DIR1, the distal end 140 (
In one embodiment, as the thumb tab 112 is pushed in the distal direction DIR1, the thumb tab forces the push rod 126 to also move in the distal direction, which, in turn, slides the tray 124 distally relative to the protective cover 128 for exposing the matrix 134 (
In one embodiment, as the push rod 126 forces the tray 124 to slide distally relative to the protective cover 128, the first and second parts of the sealant disposed within the first and second syringe barrels 120, 122 are forced into the syringe barrel connector 132 by the first and second plungers 108, 110 of the double plunger 106.
Referring to
In one embodiment, the sealant delivery device 200 preferably includes a matrix container including a tray 224 that is adapted to contain a matrix and a protective cover 228 that may be retracted toward the proximal end 202 of the sealant delivery device 200 for exposing the matrix disposed within the tray 224. In one embodiment, the protective cover 228 is preferably coupled with the trigger 225 so that the protective cover moves simultaneously with the trigger 225 as the trigger is squeezed proximally toward the handle 212. In one embodiment, the tray 224 remains stationary as the protective cover moves proximally relative to the tray for moving the matrix container into an opened position for exposing the matrix to the surrounding environment and/or target tissue.
Referring to
In one embodiment the sealant delivery device 200 preferably includes a dual barrel syringe 218 having a first syringe barrel 220 and a second syringe barrel 222. In one embodiment, the first syringe barrel 220 is preferably adapted to receive a first part of a flowable, curable sealant and the second syringe barrel 222 is preferably adapted to receive a second part of the flowable, curable sealant. The first and second parts of the sealant are preferably mixed together to form the flowable sealant that applied onto the matrix 234.
In one embodiment, the proximal end of the dual barrel syringe 218 preferably includes a syringe barrel grip 235 that is preferably adapted to engage a connecting notch 245 provided on the trigger 225 for coupling the trigger 225 with the dual barrel syringe 218. The dual barrel syringe 218 and the trigger 225 move together as the trigger is squeezed.
In one embodiment, the sealant delivery device 200 preferably includes a mixing tip 255 that is connected with dispensing openings located at the distal ends of the respective first and second syringe barrels 220, 222. In one embodiment, the mixing tip 255 may include a static mixer that preferably enhances mixing of the first and second parts of the sealant as the first and second parts of the sealant flow through the length of the mixing tip 255.
In one embodiment, the sealant delivery device 200 preferably includes a tray 224 that is connected with the distal end of the housing 205. In one embodiment, the tray 224 preferably includes a trough 236 that is adapted to receive (e.g., seat) the matrix 234. The sealant delivery device 200 preferably includes the protective cover 228 that is adapted to overlie the tray 224 and the matrix 234 for protecting the matrix 234 as the distal end 204 of the sealant delivery device 200 is moved into position prior to deployment of the matrix 234 onto target tissue.
In one embodiment the protective cover 228 preferably includes a mixing tip connector 232 that is adapted to receive a distal end of the mixing tip 255 so that the flowable sealant, preferably after being mixed, may be directed into a sealant dispensing channel 230 of the protective cover 228.
Referring to
The structural elements shown in
Referring to
Referring to
In one embodiment, the sealant delivery device 100 preferably includes the dual barrel syringe 218 disposed within the housing 205. The dual barrel syringe 218 preferably includes the first syringe barrel 220 and the second syringe barrel 222. In one embodiment, the first plunger 208 and the first piston 214 are preferably disposed within the first syringe barrel 220. In one embodiment, the second plunger 210 and the second piston 216 are preferably disposed within the second syringe barrel 222. In one embodiment, dispensing openings located at the distal ends of the respective first and second syringe barrels 220, 222 are preferably in fluid communication with a proximal end of the mixing tip 235. The distal end of the sealant delivery tube 257 (
Referring to
Referring to
Referring to
Referring to
Referring to
In one embodiment, the sealant delivery device 300 preferably includes a tray 324 that is adapted to contain a matrix and a protective cover 328 that may be retracted toward the proximal end 302 of the sealant delivery device 300 for exposing the matrix disposed within the tray 324. In one embodiment, the protective cover 328 is preferably coupled with the actuator 325 so that the protective cover moves simultaneously with the actuator 325 as the actuator is squeezed and/or pulled proximally toward the palm stop 312.
Referring to
Referring to
In one embodiment, the proximal end of the dual barrel syringe 318 preferably includes a syringe barrel grip 335 that is preferably adapted to engage a connecting notch 345 provided on a proximal side of the actuator 325 for coupling the actuator 325 with the dual barrel syringe 318.
In one embodiment, the sealant delivery device 200 preferably includes a mixing tip 355 that is in fluid communication with dispensing openings located at the distal ends of the respective first and second syringe barrels 320, 322. In one embodiment, the mixing tip 355 may include a static mixer 359 that preferably enhances mixing of the first and second parts of the sealant as the first and second parts of the sealant flow through the length of the mixing tip 355.
In one embodiment, the sealant delivery device 300 preferably includes a tray 324 that is connected with the distal end of the housing 305. In one embodiment, the tray 324 preferably includes a trough 336 that is adapted to receive (e.g., seat) the matrix 334 (
In one embodiment the protective cover 328 preferably includes a mixing tip connector 332 that is adapted to receive a distal end of the mixing tip 355 so that the flowable sealant may be directed into a sealant dispensing channel 330 of the protective cover 328.
Referring to
Referring to
Referring to
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Referring to
In one embodiment, with the actuator 325 in an extended position relative to the palm stop 312 of the housing 305 (
Referring to
In one embodiment, once the protective cover 328 has been moved proximally into a fully retracted position relative to the tray 324, the matrix 334 is exposed so that it may be applied over target tissue for stopping and/or controlling bleeding. As the protective cover 328 slides in the proximal direction DIR2, the flowable sealant moves through the sealant dispensing channel 330 in the distal direction DIR1 for being dispensed onto the matrix 334.
Referring to
Referring to
With the protective cover 528 in the extended position shown in
While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof, which is only limited by the scope of the claims that follow. For example, the present invention contemplates that any of the features shown in any of the embodiments described herein, or incorporated by reference herein, may be incorporated with any of the features shown in any of the other embodiments described herein, or incorporated by reference herein, and still fail within the scope of the present invention.
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| 20230190439 A1 | Jun 2023 | US |
