Patent Application
20180200494
The present technology relates generally to devices and methods for the delivery and placement of medical materials, including biodegradable devices for the delivery of therapeutic substances, within mammalian bodies.
Wounds to the human anatomy may result from interventional, minimally-invasive and/or intraoperative surgical procedures, acts, diseases, and/or underlying conditions. For example, iatrogenic wounds generally are formed during surgery for treating sinusitis, and due to the complicated topology of the sinuses, may take extended periods to heal. In addition, certain portions of the human anatomy are prone to the development of post-operative lesions, which often require treatment via subsequent surgical intervention.
Sinusitis is inflammation of the paranasal sinuses generally due to infection, allergies, or autoimmune issues. Chronic sinusitis affects persons of all age groups and is one of the more prevalent chronic diseases in the United States, affecting 37 million Americans. Chronic sinusitis is generally understood to be sinusitis that persists for 12 weeks or longer. Surgery, although minimally invasive, is generally reserved for acute/intermittent rhinosinusitis and chronic/persistent rhinosinusitis unresponsive to conservative medical treatment or where there are complications associated with those conditions. Functional endoscopic sinus surgery (FESS) of the diseased sinus mucosa is performed to enable ventilation through the natural ostia and restore mucociliary clearance using a minimally invasive endoscopic technique. Although FESS has proven to be an effective procedure in treating chronic sinusitis, the outcome of the surgery can become significantly complicated by operative pathologies, including delayed wound healing, stenosis of the sinus passageways (in 20-30% of cases), adhesions, and the formation of polyps. Various mechanical means such as nasal stents and packings have been developed to aid in postoperative wound care; however, experience has shown that these methods do not provide an effective way of addressing the complications.
Pharmaceutical treatment of iatrogenic wounds with therapeutic agents such as steroids has been shown to reduce postoperative complications. However, there does not exist in the prior art an effective manner for delivering appropriate dosages of therapeutic agents over a desired timeframe within the sinus cavities.
Balloon sinus dilation is a relatively new technique for treating chronic sinusitis by opening blocked passages with balloon inflation. While more limited in application than FESS, this modality may become the treatment of choice for limited or moderate sinus disease. Accordingly, it would be desirable to provide an effective device for delivering a therapeutic agent to sinus tissue over a period of time following balloon sinus dilation.
U.S. Pat. Nos. 8,529,941, 8,563,510, 9,072,681, 9,192,698, and 9,271,925 to Hakimimehr et al., assigned to the assignee of the present invention, the entire contents of each of which are hereby incorporated by reference, describe, inter alia, methods and devices having a free-standing film of solid fibrinogen, and optionally solid thrombin, configured in the form of a thin sheet in various configurations, including multi-layer configurations. These and other devices disclosed therein may be configured to release a therapeutic agent over time, among other features.
It would be desirable to provide systems and methods for the safe and effective delivery into a mammalian body of devices, including those described in the foregoing Hakimimehr patents, that permit the release of different therapeutic agents over the same temporal profiles and/or different therapeutic agents over different temporal profiles.
In view of the foregoing, the present invention is directed to methods and systems for delivering a biocompatible film to tissue of a patient. For example, one or more films may be delivered within one or more bodily cavities using the delivery systems such as nasal and/or sinus cavities of the patient. The delivery system may include a sheath having a distal end, a proximal end, and a lumen extending therebetween. In one embodiment, the distal end of the sheath is sized and shaped for insertion through a nostril of the patient and for advancement to at least one of the nasal cavities and/or the sinus cavity. The system also includes a handle disposed adjacent to the proximal end of the sheath, wherein the handle has an actuator.
In addition, the system includes a shaft coupled to the actuator and disposed within the lumen of the sheath. The shaft includes a groove extending between a proximal end and a distal end of the shaft, and the sheath includes a folded portion sized and shaped to align with the groove of the shaft. The folded portion of the sheath may include a slit that provides strain relief as the shaft is disposed within the lumen of the sheath. The longitudinal axis of the distal end of the shaft may be offset by a predetermined angle to a longitudinal axis of a proximal end of the shaft. Additionally, the shaft may include a channel disposed along an upper portion of the shaft, the channel sized and shaped to receive an actuator post.
The system includes a curved end effector coupled to a distal end of the shaft. The curved end effector has a convex outer surface such that the biocompatible film is disposed thereon during delivery. The curved end effector transitions from a delivery state, wherein the curved end effector is disposed within the lumen of the sheath, to a deployed state, wherein the curved end effector is exposed past the distal end of the sheath to deliver the biocompatible film to tissue at the bodily cavity, e.g., nasal cavity and/or the sinus cavity, responsive to actuation at the actuator. For example, the sheath may slide proximally while the shaft and curved end effector remain in place to expose the film past the distal end of the sheath for deployment at tissue. As another example, the shaft and curved end effector may move distally while the sheath remains in place to expose the film past the distal end of the sheath for deployment at tissue. Further still, the sheath and the curved end effector may slide relative to one another to expose the film past the distal end of the sheath. In some aspects, the curved end effector provides a uniform gap between an inner surface of the sheath and the biocompatible film when the sheath is disposed over the convex outer surface of the curved end effector. The convex outer surface of the curved end effector may have a radius of curvature decreasing axially in a direction from the flared distal surface toward the proximal end. Alternatively, the convex outer surface of the curved end effector has a constant radius of curvature along a longitudinal axis of the curved end effector.
The curved end effector also includes a flared distal surface. The flared distal end may include an atraumatic tip for to minimizing trauma or damage to the tissue during delivery. In addition, the curved end effector includes left and right rails extending from the flared distal surface longitudinally along at least a portion of opposite lateral ends of the curved end effector. The left and right rails facilitate consistent and reliable axial sliding of the shaft within the sheath, and keep fluid out of a vicinity of the biocompatible film to avoid premature wetting thereof. The convex outer surface of the curved end effector may include at least one indented portion extending longitudinally along the convex outer surface. The at least one indented portion has a radius of curvature less than a radius of curvature of the curved end effector, such that a surface of the indented portion is separated a predetermined distance from the biocompatible film when the biocompatible film is disposed on the convex outer surface of the curved end effector.
In accordance with one aspect of the present invention, a method for delivering a biocompatible film to a bodily cavity, e.g., nasal cavity and/or a sinus cavity, of a patient is provided. The method includes inserting a distal end of a sheath through a nostril of the patient, the sheath having a shaft disposed within a lumen of the sheath, the shaft having a curved end effector coupled to a distal end of the shaft and having a convex outer surface for having the biocompatible film disposed thereon during delivery; advancing the distal end of the sheath to the bodily cavity, e.g., nasal and/or sinus cavities; actuating an actuator disposed adjacent a proximal end of the sheath to transition the curved end effector from a delivery state, wherein the curved end effector is disposed within the lumen of the sheath, to a deployed state, wherein the curved end effector is exposed past the distal end of the sheath; and delivering the biocompatible film to tissue at the cavity. The method may be repeated to deliver additional films in the same cavity or in other bodily cavities.
Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present disclosure and are not intended to limit the scope of the present technology.
The present technology provides devices, systems, and methods for the delivery of devices such as films to target locations in mammalian bodies that may be configured to release a therapeutic agent over time, among other features. Specific details of several embodiments of delivery devices, systems and associated methods in accordance with the present technology are described below with reference to
In one proposed application, a delivery device is advanced using a delivery system of the present technology to a target location in the sinuses and is used to deploy a film containing a therapeutic substance to bodily tissue within the sinus to treat iatrogenic wounds resulting from surgical procedures for treating, for example, sinusitis. The delivery system may be used to apply a film to areas such as, but not limited to, a paranasal sinus, ethmoid sinus, ethmoidectomy channel, and frontal sinus outflow tract. A device or film may also be delivered using a delivery system of the present technology to the osteomeatal complex, along the maxillary ostium or any sinus insertion device capable of accessing the maxillary ostium. Such a device or film, including one in a multi-layer configuration, provides many advantages for treating wounds, such as iatrogenic wounds resulting from surgical procedures for treating sinusitis.
In such sinus and other applications, one advantage in using such films is that a therapeutic agent, such as a steroidal anti-inflammatory agent, may be delivered locally with minimal systemic exposure to significantly improve the outcome of surgery. Another advantage is that the device or film may be configured to naturally biodegrade so there is no need for subsequent removal. A further advantage is that the device or film improves the healing of the mucosal lining so as to reduce healing time, and thus, reduce the likelihood of the formation of adhesions. Yet another advantage is that the device may be configured to seal the mucosal wall, which may prevent adhesions of the opposing surfaces in the sinuses. Another advantage is that the device or film may be configured to adhere to the sinus wall of the nasal passageway in a thin layer such that it does not obstruct the flow of air and liquid, thereby improving a patient's quality of life after surgery. Yet a further advantage is that because in such a configuration the device or film adheres to the sinus wall, rather than being retained in position by mechanical force from, for example, a stent, further damage to the mucosal layer is prevented, which in turn leads to improved patient quality of life.
In another application, a device or film is advanced using a delivery system of the present technology to a target location in the bronchus and applied to bodily tissue at an anastomosis site within the bronchus to treat post-operative lesions following a surgical procedure, such as lung transplantation. Bronchial stenosis following lung transplantation is one such problem, often arising from scar stenosis at the bronchial anastomotic site with or without previous anastomotic dehiscence. The device or film may be delivered to the anastomosis site using a delivery system of the present technology and applied to bodily tissue using the adhesive properties of the device. The device or film may release therapeutic agent(s) such as cyclosporine or another antiproliferative agents that promote healing while the device biodegrades. The device or film may be applied to bodily tissue surgically or during an anastomosis procedure.
In a further application, a device or film is advanced to a target location using a delivery system of the present technology in the larynx, trachea, carina, or bronchi and applied to bodily tissue at a stenosed area within the larynx, trachea, carina, or bronchi to treat post-operative lesions resulting from surgical procedures for treating, for example, airway stenosis, such as post-intubation tracheal stenosis. The device or film may be delivered to the affected area using a suitable delivery system, e.g., as described herein alone or in conjunction with balloon dilation opening the restricted passageway. After application, the device or film may release therapeutic agent(s) such as antiproliferative agents and/or anti-inflammatory agents to the affected site to improve the outcome of the balloon dilation.
In yet another application, a device or film is advanced using a delivery system of the present technology to a target location in a neck in a lobe of the lung and applied to bodily tissue at the wall of the lobe to treat wounds from, for example, asthma. The device or film may release therapeutic agent(s) such as steroidal anti-inflammatory agents to the lungs. The device or film is believed to minimize the systemic exposure to steroids and to improve patient compliance with treatment.
In another application, a device or film is advanced using a delivery system of the present technology to a target location in the trachea or bronchi and applied to bodily tissue at an ulcer at the trachea or bronchi to treat lesions resulting from tumors, for example, squamous cell carcinomas. The device or film may be used to aid in the treatment of bronchial tumor resection or weakened bronchia due to external beam radiation therapy. The device or film may release therapeutic agent(s) such as chemotherapeutics (e.g., antiproliferative agents or antibody based therapies), anti-inflammatory agents, and/or antibiotics to the bodily tissue. The device or film may be delivered after open surgery or during an endoscopic procedure such as a bronchoscopy.
In yet another application, a device or film is advanced using a delivery system of the present technology to a target location in the body and applied to bodily tissue at an internal adhesion or (potential) dermal scar to treat lesions resulting from, for example, invasive surgical procedures. The device or film may be used in preventing or reducing the size of internal adhesions or dermal scarring. An adhesion is a band of scar tissue that binds together two internal body surfaces. Adhesions can cause subsequent health issues such as pain (back and abdominal), infertility, and digestive issues resulting in increased costs and potential secondary surgical interventions. The device or film may act as a barrier between two body surfaces during the healing process; it then biodegrades and provides a space between the two surfaces. The device or film also may release therapeutic agent(s) such as anti-inflammatory agents, antiproliferative agents, antibiotics, and/or mitomycin C to promote healing of an adhesion or scar.
In another application, a device or film is advanced using a delivery system of the present technology to a target location in or on the body and applied to bodily tissue to promote healing. The device or film may release therapeutic agent(s) such as antibiotic agents, antimicrobial agents, antifungal agents, growth factors, and/or analgesic agents to promote wound healing. For example, a device or film for treating diabetic ulcers may release an antibiotic agent. Advantageously, since the device or film is biodegradable, it does not need to be removed before a new dressing is put in place and therefore prevents interruption of wound healing due to change of dressing.
In a further application, a device or film is advanced by a delivery system of the present technology to a target location in or on the body and applied to bodily tissue at a site of pain to treat pain and/or inflammation. For example, the device or film may be used to treat radicular pain and sciatica of the lower back or articular pain of the joint. The device or film may be advanced to a target location at a joint or a space inside the body using a trocar delivery device. In one embodiment, the device or film is inserted minimally invasively via epidural trocar into the foraminal or interlaminar space of the lumbar spine. The device or film may be configured to release therapeutic agent(s) such as anti-inflammatory agents, analgesic agents, anti-infective agents, and/or anti-proliferative agents. The device or film may contain multiple film-layers for the programmed release of different therapeutic agents with different temporal profiles. For example, acute analgesics such as the—caine derivatives may be delivered immediately and over a duration of up to the first 8-12 hours, while an anti-inflammatory agent may be delivered for a much longer period. In another application, the device or film may be applied by a delivery system of the present technology after an open or minimally invasive surgery (laparoscopic surgery) to deliver therapeutic agents to improve the outcome of the surgery. For example, a device or film with a steroidal anti-inflammatory agent may be applied after a laparoscopic spinal surgery to reduce inflammation and pain after surgery. In addition, therapeutic agent(s) for promoting wound healing may alleviate the side effects of epidural steroid injections such as dural puncture and prevent cerebral spinal fluid leakage.
In yet another application, a device or film may be advanced by a delivery system of the present technology to a target location in the eye and applied to bodily tissue within or on the eye. In one embodiment, the device or film may be applied to the posterior segment of the eye via the vitreous or suprachoroidal space using a cannula, e.g., a 20 to 25 gauge cannula. The device or film also may be applied after vitreoretinal surgery to release a therapeutic agent(s) such as an anti-inflammatory agent over a period of time. The device or film may biodegrade slowly over time thus obviating the need for subsequent surgical extraction and may deliver a sustained profile of therapeutic agent. The adhesive properties of the device or film allow it to be applied in contact with and adhering to the macular surface within the eye so as to avoid visual problems associated with an untethered device in the vitreous.
In another application, a device or film is advanced using a delivery system of the present technology to a target location that is a tumor anywhere in or on the body and applied to bodily tissue at the tumor as a primary mode of treatment or in conjunction with surgery or a minimally invasive surgery as a maintenance therapy to prevent tumor re-growth. The device may release therapeutic agent(s) such as chemotherapeutics including anti-proliferative agents to the site of the tumor. Examples for this application include delivering the device or film having an anti-cancer therapeutic agent to a tumor of the bladder; delivering a device or film having an anti-cancer therapeutic agent to a tumor of the airway, and delivering the device or film having an anti-cancer agent to a resected tumor of the pancreas.
In yet another application, a device or film is advanced using a delivery system of the present technology to a target location in the heart or in a blood vessel and applied to bodily tissue at a wall of the heart or vessel to treat wounds from, for example, cardiac disease or surgical procedures for treating cardiac disease.
Additionally, the device or film may promote endothelialization by delivery of growth factors. In still other instances, one or more devices or films may be used to attach endothelial cells to the inside of the lumen to promote healing. In yet another proposed application, a device or film may be delivered using a delivery system of the present technology within a patient's bronchus or trachea to deliver chemotherapy or an anti-cancer drug through the patient's vasculature or tissue.
As described in U.S. Pat. Nos. 8,529,941, 8,563,510, 9,072,681, 9,192,698, 9,271,925, and 9,446,103, embodiments of the device or film for delivery to a target location may have a variety of configurations, geometries, and dimensions, depending on the specific use for which it is designed. For instance, the device may be a free-standing film of solid fibrinogen, and optionally solid thrombin, configured in the form of a thin sheet in various configurations, including single- and multi-layer configurations. For purposes of the present description, the term “film” may be used to describe not only single- and multi-layer film-based devices but also refers to any construction or configuration of the device that is intended to be delivered to a target location by a delivery system, embodiments of which are described below.
Additionally, several other embodiments of the technology can have different states, components, or procedures than those described herein. Moreover, it will be appreciated that specific elements, substructures, advantages, uses, and/or other features of the embodiments described with reference to
With regard to the terms “distal” and “proximal” within this description, unless otherwise specified, the terms can reference a relative position or location of the portions of the therapeutic devices described herein as well as the various delivery device embodiments. In addition, such terms may be used with reference to an operator and/or a location in a mammalian lumen, such as, e.g., those for accessing the sinus cavities.
I. Selected Film Delivery Systems and Associated Methods
Referring to
System 100 includes handle 110 having proximal portion 112 and distal portion 114. Handle 110 is of a two-piece construction with handle first half 116 and handle second half 118. Other constructions, including unitary and other multiple piece configurations, are possible. For brevity, the following description of the features of handle 110 are provided in terms of handle first half 116 (
As will be described in greater detail below in connection with, e.g.,
Turning now to
Shaft 150 as shown in
As seen in
Embodiments of shaft distal portion 156, including in particular distal tip or curved end effector 158, are discussed below in greater detail with reference to
For example, the curvature, or shape of flared end 160 may vary along the length of distal tip 158 and may take on any number of configurations, such as a circular radius of curvature (e.g., as seen in
The shape of curved end effector 158 generally may be constant or it may vary along the length of distal tip 158. For instance, in the embodiment of
Shaft 150 may be made of any suitable material that is amendable to sterilization, that has the appropriate properties, and that ranks favorably in other categories such as cost, biocompatibility, manufacturability and other performance factors. In addition, shaft distal portion 156, including distal tip or curved end effector 158, may include one or more optional coatings on its outer surface 172 to facilitate reliable release of film 200 during deployment. Coatings such as sodium stearate, oleo- and/or hydrophobic coatings, etc. may be used.
In the embodiment of
Sheath 180 may be of a unitary construction and may be extruded as a tube of uniform diameter or otherwise manufactured as known by those of skill in the art. During assembly of delivery system 100, sheath 180 is placed over shaft outer surface 172 such that folded portion 188 aligns with the matching groove 174 of shaft 150. Slit 190 may be cut into sheath 180 after or as it is placed into position on shaft 150. Slit 190 as disposed over shaft 150 such that the sheath folded portion 188 aligns with the folds of shaft groove 174 serves a strain relief function and eases assembly as the sheath 180 is disposed over shaft outer surface 172. Slit 190 also serves to help sheath 180, and, in particular, sheath distal portion 184, accommodate the larger shaft flared end 160 during delivery system 100 assembly. As assembled, delivery system 100 is configured in some embodiments such that sheath 180 covers both film 200 and the much of the length of shaft 150, including up to shaft flared end distal surface 160a on the distal portion 156 and at least up to and including a portion of shaft channel 166 near shaft proximal portion 152.
The properties of sheath 180, which may in various embodiments have a thickness of between about 0.50 mm and about 0.05 mm, between about 0.25 mm and about 0.10 mm, or about 0.15 mm, can be optimized to protect film 200 while affording the use of a small diameter shaft 150 (flaring to a larger diameter, as the compliant film may accommodate, at shaft distal portion 156). Having a small diameter shaft is useful in many procedures; including those in which access is limited in size and those in which an endoscope is used in the same lumen for visualization (such as is commonly done in sinus procedures).
Various aspects of shaft distal portion 156 (shown in, e.g.,
Alternative sheath embodiments of the present technology are discussed below and include a sheath that is pinched at its distal end and otherwise sealed, completely or partially (e.g., perforated) via an adhesive, ultrasonic or thermal welding or the like, during delivery system assembly. During delivery system 100 use, as such a sheath is retracted axially in a proximal direction and shaft flared end distal surface 160a eventually meets the distal end of sheath, the shaft forces such a sheath to open at the seal/perforation, which may be designed to fail upon the application of such force. Such a design has the advantage of largely encapsulating the film 200 from the surrounding environment, providing additional protection against it coming into contact with fluids or humidity, thus improving film reliability during deployment and use. Another alternative embodiment for a sheath according to the present technology includes an encapsulated string that may be used to tear open a distal end of the sheath when it is proximally retracted. Yet another alternative embodiment for a sheath according to the present technology includes a biocompatible frangible wrapper design in which the sheath disintegrates or otherwise breaks apart at the intended temporal and physical location during the delivery of a film to the target tissue.
As assembled, delivery system 100 is configured to deliver one or more films 200 to a target location in a mammalian body for any number of therapeutic applications. In the sinus, such films 200 may be tailored to provide pharmaceutical treatment of iatrogenic wounds with therapeutic agents such as steroids. Other film configurations may be tailored to contain other compounds having specific formulae and dosage densities, as described in U.S. Pat. Nos. 8,529,941, 8,563,510, 9,072,681, 9,192,698, 9,271,925, and 9,446,103, to otherwise treat tissue in the sinuses and improve a patient's health and delivered via delivery system 100 in a safe and effective manner. For delivery system 100, film 200 and flared end 160 may generally be sized and shaped to match one another, as shown schematically in
As previously described,
Handle first half 116 and second half 118 enclose shaft proximal portion 152 and sheath proximal portion 182 that is disposed concentrically thereover. The handle halves are bonded and/or otherwise mechanically joined to one another by methods known by those in the art. Handle 110 is configured such that a handle central lumen 129 tapers from a first diameter in its proximal portion 112 to a second, smaller diameter in its distal portion 114 to enclose the shaft 150 and sheath 180. This serves to minimize lateral movement of shaft and sheath during storage. One or more optional seals (not shown) may be included in handle to facilitate a solid construction and to prevent fluid ingress into handle central lumen 129.
As shown in, e.g.,
For sinus indications, the film deployment techniques using embodiments of delivery system 100 described herein typically are performed in conjunction with endoscopic visualization. Physicians skilled in endoscopic procedures expect a high degree of correlation between the operational performance of system 100 and what the operator sees via the endoscope. The construction of shaft 150 and handle 110 along with the other components of system 100 in embodiments of the present technology helps to ensure such correlation during use while at the same time providing enough overall system compliance such that delivery system 100 does not feel overly stiff to the operator or difficult to manage. The proper choice of materials for handle 110 and shaft 150 can also contribute to a delivery system 100 of the present technology that is optimized for its intended use.
Although shaft distal peg 170, handle distal peg receiving shaft aperture 120, shaft proximal peg 168 and handle proximal peg receiving shaft aperture 122 are described and shown as having particular cross-sectional shapes, other cross sectional shapes are within the scope of the present technology, including but not limited to various other shapes (e.g., pentagonal, octagonal, circular, elliptical, etc. as well as those shapes and dimensions varying throughout the width of the handle 110 halves and, accordingly, the length of the shaft 150 distal and proximal pegs.
In operation, after a user has unlocked actuator tab 137 from handle catch 127 by exerting downward force on actuator 130 via thumb pad 136, the user will move actuator 130 axially in a proximal direction towards the proximal portion of handle 110, bringing sheath 180 with it along shaft outer surface 172. This axial movement is depicted in
Various materials known in the art may be used for the various components of system 100. Considerations such as biocompatibility, cost, amenability to sterilization, shipping, storage and performance may be taken into account when choosing a specific material. Such materials include chromium, cobalt, platinum and alloys thereof, stainless steel, with or without coatings such as PTFE, may be used. Plastics such as injection molded or extruded PET may be used, as may polycarbonates, PTFE, and combinations thereof. Gamma radiation-stable plastics include thermosets, polystyrene, LCP, polyurethanes, polyethylenes (PE, PET), polycarbonates, silicones, PVC, polyamides, ABS, acrylics such as PMMA, while plastics that may be sterilized via autoclave techniques include fluoropolymers such as PFTE, PFA, FEP, ePTFE, polypropylenes and their copolymers, polycarbonates, silicones, polyacetals, polymethylpentenes, polysulfones, synthetic elastomers and natural elastomers such as rubber.
Exemplary Method of Use.
As previously described,
After the patient is prepared using standard protocols for interventional sinus procedures, delivery system 100 is positioned via the handle such that the shaft 150 is inserted under endoscopic visualization or like means within and through a bodily access lumen, such as the nasal passages. Once the shaft distal portion 156 has been advanced to the target tissue region 300 as shown generally by arrow A in
As the actuator or slider 130 is axially retracted in a proximal direction to its final position, the locking mechanism of the handle locking pawl or ramp 128 and actuator locking tooth 144 engages actuator so that actuator 130 may not be moved in a distal direction. Actuator proximal boss 142 engages handle stop 126 to prevent further axial motion of actuator 130 and sheath 180 in a proximal direction as previously described. The physician is then free to manipulate delivery system 100 under visualization to release film 200 to the target tissue. This typically may be accomplished as the physician manipulates the shaft distal portion 156 physically to place film 200 into direct contact with target tissue surface 302 as illustrated generally by arrow D in
Additional films 200 may be delivered by additional delivery systems 100. For procedures in the ethmoid sinus, for example, between one and two or more additional films optionally may be deployed at a single target tissue location or at other target tissue locations in the ethmoid or other sinuses.
Although described as configured for the delivery of a single film, delivery systems of the present disclosure may be configured with multiple films 200 such that a single delivery system 100 may deliver two, three, four or more films in a single procedure.
II. Alternative Film Delivery Systems and Associated Methods
Modified Forceps Film Delivery System
As shown in
In a method of use of the embodiment of applicator 1100 shown, once the physician or other operator accesses the target tissue region 300 of interest, he or she will effect proximal motion of upper arm 1110 as described above, pivoting it so to free film 200 such that is deployed onto the target tissue surface 302. The physician or other operator may use upper arm 1110 as a secondary repositioning and/or release feature, moving upper arm 1110 in a distal direction to re-clamp film 200 if desired to reposition film 200. After film deployment, the physician or other operator may withdraw applicator 1100 and optionally deploy additional films with additional applicators as desired.
Sponge Tip Applicator Film Delivery System
A perspective view of a distal portion of another alternative delivery system embodiment of the present technology is shown in
In a method of use of applicator 1200, once the physician or other operator accesses the target tissue region 300 of interest, a biocompatible fluid (e.g., water, saline, solutions containing one or more therapeutic substances, additives to control the film-sponge adhesion and release properties and timing, etc.) is introduced via optional pressure thorough passageway 1220. This may be accomplished any number of ways, including via a syringe connected by a luer or other fitting to a catheter that is connected to or part of shaft 1210, or via an Endoflator® or other device to control to pressure of fluid being delivered, etc. As the fluid enters the vicinity of the shaft distal end 1212, it flows through apertures 1230 and/or an optional open end of shaft 1210 to wet sponge 1240. As sponge 1240 becomes saturated with the fluid, particularly in the vicinity of film 200, the adherence between sponge 1240 and film 200 decreases to the point that when desired, the physician or other operator may deploy film 200 at the tissue target surface 302 via application of pressure and movement of shaft 1210 in the manners as described herein for other embodiments of the disclosure. After film deployment, the physician or other operator may withdraw applicator 1200 and optionally deploy additional films with additional applicators as desired.
As may also be accomplished with respect to the modified forceps delivery system 1100 and all the delivery system embodiments depicted herein, the sponge tip applicator system 1200 may be used for any number of film configurations, including those in which an therapeutic substance is largely on the side of film 200 adhering to sponge (given that once deployed, this side of film 200 will be exposed to, e.g., blood flow or the lumen of the passageway or bodily cavity in which it is deployed) and a different substance such as fibrinogen or combination of substances is largely on the opposite side of film 200 (given that once deployed, this opposite side of film 200 will be in direct contact with and intended to adhere to/incorporate with tissue in the region of target tissue surface 302.
Wireform Release Applicator Film Delivery System
Shaft 1310, which may be made from any biocompatible material such as molded plastic or, e.g., a metallic material such as stainless steel, may be a part of a tool 1340 shown in
Probe 1320, which is shown in
Wireform 1330 is a retractable guide that serves several functions, including holding the film 200 in place against probe film surface 1324, retracting to reveal film 200 at the desired target tissue region 300 for release and placement on tissue surface 302, and can be used to separate film 200 from probe 1320 if necessary (when, e.g., film 200 will not freely release from probe film surface 1324). Wireform 1330 may be made of any suitable medical grade material, such as stainless steel, plastic, or a shape memory material such as NiTi. Wireform 1330 may take on any number of shapes configured for optimal retention of and deployment of film.
In one configuration as shown in
In a method of use of this embodiment shown in
For the wireform release applicator embodiment 1300 described herein, as with the other applicator embodiments disclosed, film 200 may be configured such that a therapeutic substance is disposed on the side of the film facing probe film surface 1324, while one or more other substances (such as fibrinogen) may be disposed on the opposite side of the film.
Rotating Tine Film Delivery System
Outer shaft 1410 may be of a plastic or metallic (e.g., stainless steel) construction. In the embodiment of
Tines 1412 generally are of uniform length and diameter and orientation relative to shaft 1410. Stationary tines 1412 are spaced from one another and have lengths that optimally support a film 200, as shown in
Disposed within lumen 1416 of outer shaft 1410 is a rigid inner shaft 1420, shown as extending through outer shaft 1410 in
A method of using applicator 1400 includes a physician or other operator deploying applicator 1400 to a target body tissue site 300 of interest, under optional visualization. Film 200 is loaded onto applicator 1400 as shown in
In one embodiment as shown in
Applicator 1400 is amenable to deployment of multiple films 200 in a single procedure due to the relative ease with which film 200 may be loaded thereon.
For the rotating tine applicator embodiment 1400 described herein, as with the other applicator embodiments disclosed, film 200 may be configured such that a therapeutic substance is disposed on the side of the film facing rotating tine 1422, while one or more other substances (such as fibrinogen) may be disposed on the opposite side of the film.
Suction Tip Applicator Film Delivery System
Hollow shaft 1510 may be a shaft of rigid construction, made, e.g., of plastic, metallic or other material. Shaft 1510 proximal end 1512 can have a fitting or adapter that allows for its connection to a surgical suction system, such as via a clamping mechanism. Shaft proximal end 1512 may in other embodiments be connected to a different, dedicated source of suction designed for use with applicator 1500, such as, e.g., a self-contained portable or semi-portable vacuum system that may be handheld or even battery operated, that is part of applicator 1500 such as in a kit. In any configuration contemplated for the embodiment of application 1500, an optional handle 1518 (
Tip 1520 may be of a flat, circular or other shape amenable to the indication for which it would be used in the body region of interest 300. It may take on the shape of, e.g., a canoe paddle end or it may be a more streamlined design with an outer diameter similar or identical to that of shaft 1510 to which it is attached or is a part. Various examples of tip 1520 are shown in
An optional shoulder 1530 may be incorporated into applicator 1500 for providing an additional mechanism by which the physician or other operator can deploy film 200. For example, shoulder 1530 may be a stationary feature that serves mainly to protect the back edge of film 200, as shown in
In use, a physician or other operator configures applicator 1500 with the desired type of tip 1520 amenable to the procedure for which it is to be used. Alternatively, the physician or other operator may select a system 1500 that includes a pre-attached or even integral tip 1520, complete with an optional dedicated source of suction as described above. The physician or other operator connects shaft 1510 to a source of suction, if so configured, that may be present in the surgical suite, or activates a dedicated source of suction in the alternative configuration described above. The activation of suction through the components of applicator 1500 provides a vacuum force (indicated in
If movement or repositioning of the film is desired, suction may be reintroduced to pull film 200 back on to tip 1520, giving the physician or other operator a convenient means by which the film may be optimally placed.
For the suction tip applicator embodiment 1500 described herein, as with the other applicator embodiments disclosed, film 200 may be configured such that a therapeutic substance is disposed on the side of the film facing tip 1520, while one or more other substances (such as fibrinogen) may be disposed on the opposite side of the film.
Passive Applicator Film Delivery System
Film 200 may be shaped and sized to fit the dimensions of tip 1610 and may be assembled and integrated into tip 1610 at the manufacturing site or alternatively by the customer or end user, including the physician or other operator. Edges 1614 of tip 1610 are folded over so to form a compartment or channel 1616 into and out of which film 200 slides during assembly and deployment, respectively. Film 200 is supported on its underside 206 by tip main portion 1618. It is useful to size and assemble the folded-over portions of tip edges 1614 in a way to securely hold allow secure holding of film 200 in place until it is to be deployed, but to allow for a smooth and reliable film deployment procedure at the desired time, as film 200 slides out of tip 1610 in the manner described in the method example below. In addition, choosing a low-friction material to serve as tip 1610 will aid in a smooth film deployment method.
An alternative configuration includes a tip 1610 having a shaft or handle 1630, as shown in
A method of use for applicator 1600 may be accomplished as follows: tip 1610, having film 200 preassembled therewithin, is placed at proximal grab point 1612 by a physician or other operator by forceps or other suitable surgical instrument, with film 200 optionally being wetted prior to placement in the target tissue region 300. Under optional visualization, the physician or other operator places the tip 1610 with included film 200 near the target tissue surface 302 such that film top surface 208 faces tissue surface 302. The physician or other operator, once satisfied with the position of the tip 1610 and film 200, moves tip 1610 so that film top surface 208 is pressed into contact with the target tissue surface 302. Wetting of the tissue to film 200 allows the physician to then withdraw applicator tip 1610, allowing the adhesion force between newly-introduced film top surface 208 and tissue 302 to overcome forces holding film 200 within tip 1610 so that film 200 slides out of a distal end 1620 of tip 1610. The physician or other operator may then use tip 1610 to push any non-adhering portions of film 200 into contact with tissue 302 before withdrawing tip 1610 to complete the procedure. A configuration of applicator 1600 having tip 1610 with an optional (integral) handle 1630 may be used in the same basic manner as described above.
Applicator 1600 is particularly suited to a disposable kit configuration, in which applicator tip 1610 (either configuration with or without handle 1630) may be preassembled with film 200 incorporated therein and provided in a sterile package for single-time use. If additional films 200 are needed, additional applicator tips 1610 with a preloaded film 200 may be used as necessary.
For the passive applicator embodiment 1600 described herein, and in particular for the embodiment of tip 1610, as with the other applicator embodiments disclosed, film 200 may be configured such that a therapeutic substance is disposed on the underside of the film underside 206, while one or more other substances (such as fibrinogen) may be disposed on the opposite, or top side 208, of film 200.
Retracting Hooks Film Delivery System
Tool upper portion 1712 and lower portion 1714 may be connected at various locations, such as at handle juncture 1724 and/or at tool distal portion 1726.
In the vicinity of tool distal portion 1726, at least one pivot may be included. In the embodiment of
During a method of use, a physician or other operator navigates applicator 1700, under optional visualization, with film 200 loaded thereon, to the body tissue site of interest 300. When it is desired to release film 200 from applicator 1700 to the tissue target surface 302, the physician or other operator squeezes handle first portion 1720 relative to handle second portion 1722 (or, in an alternative configuration, when handle first portion 1720 and handle second portion 1722 are moved apart relative to one another). Relative motion between upper and lower portions 1712, 1714 causes pivots 1730 and 1740 to move within tool lower portion 1714 via rotation of dowel pins 1750. This motion releases film 200 as it is leveraged against tool lower portion bottom surface 1715 by motion of pivots 1730, 1740. The physician or other operator may use applicator 1700, such as tool bottom portion bottom surface 1715 (which now has a flat profile given that hooks 1732 and 1742 have retracted), to press film 200 into position.
An optional support flange 1740 may be included in the location shown as a dotted line in
Applicator 1700 is well-suited to being either a durable or disposable applicator. Applicator 1700 is amenable for the deployment of multiple films given the ease with which a film may be loaded thereon.
For the retracting hooks applicator embodiment 1700 described herein, as with the other applicator embodiments disclosed, film 200 may be configured such that a therapeutic substance is disposed on the side of the film facing tool lower portion bottom surface 1715, while one or more other substances (such as fibrinogen) may be disposed on the opposite side of the film.
Cartridge Tip Film Delivery System
As shown in the partial perspective view of
Tool 1810 may have an outer diameter of between about 3.0 mm and about 5.0 mm, between about 3.5 mm and 4.5 mm, about 4.0 mm, or any other diameter that is amenable to (a) carrying multiple films that are interlaid or alternatively stacked with one or more sheaths 1830 on tool distal portion 1812 and (b) tool access to and use at the location in the body where target tissue 302 resides. As tool distal portion 1812 accepts multiple layers of film and sheath thereon, it will have a larger diameter than that of tool in tool proximal portion 1814 where the film layers are not present. This results in the presence of a transition or flared section 1816 of decreasing diameter is present in the region proximal to the most proximal portion of films 200, transitioning down to a relatively constant diameter for the remainder of tool 1810.
Each sheath 1830 is disposed over tool shaft and extends from tool distal portion 1812 in a proximal direction for a length sufficient to allow retraction by a physician or other operator via any suitable technique, such as, e.g., by gripping with forceps or by use of a retraction mechanism associated with a handle. The sheath is designed such that its material properties afford close conformance to tool shaft 1830, tool distal portion 1812 in the vicinity of films 200, and in transition section 1816. Example materials from which sheath 1830 may be made includes a thin, clear extrusion of a medical grade thermoplastic material such as polyethylene terephthalate (PET).
Each sheath may have one or more rails 1852, as best seen in
Tool 1810 may likewise may be made from an appropriate plastic or metallic material, such as stainless steel, injection molded plastic, and the like.
In a method of use, and as shown in
The physician or other operator will next move the tool distal portion 1812 to the desired location in the body tissue of interest 300, perhaps in a location adjacent where film 200a has been placed (or on the same site if for some reason the initial deployment was unsuccessful or film 200a was damaged during deployment). The same step is repeated with adjacent sheath 1830b, which was exposed after film 200a deployment. As sheath 1830b is proximally retracted, second film 200b is exposed to the body tissue 300 of interest and may be deployed onto a target tissue site 302 as desired (
After the desired number of films has been deployed, the physician or other operator may withdraw tool 1810, thus completing the procedure or method of use.
Tool may be made of any suitable plastic or metallic material, such as, e.g., injection molded plastic that could be made clear so to aid in visualization of the films and sheaths.
For the cartridge tip applicator embodiment 1800 described herein, as with the other applicator embodiments disclosed, each film 200 may be configured such that a therapeutic substance is disposed on the side of the film facing the sheath 1830 immediately adjacent to and above it (e.g., the particular layer of sheath 1830 that is retracted to reveal that layer of film), while one or more other substances (such as fibrinogen) may be disposed on the opposite side of that layer of film.
Lead Screw Film Delivery System
Applicator 1900 may include lead screw 1910 over which is concentrically disposed outer tube 1930. Applicator 1900 is designed to advance one or more films 200 along a surface of lead screw 1910 as it rotates within outer tube 1930. The one or more films 200 may exit outer tube 1930 as described below to be deployed to the target tissue site 302.
Lead screw or shaft 1910 may be a plastic, metallic or composite component having an outer surface 1912, distal end 1914 with atraumatic distal tip 1916, a proximal end 1918 at which is disposed rotation handle 1920, and thread 1922 along its length on or integral with outer surface 1912. Distal tip 1916 may include an optional flange feature 1917 that can act as a stop or limiter to prevent distal movement of a film once the film reaches the distal window 1934 for deployment. The dimensions of the various features of lead screw 1910 and its accompanying thread 1922 (e.g., thread pitch, thread angle, helix angle, pitch diameter, major and minor diameters, pitch feature variations along length of screw 1910, etc.) may be appropriate for the purpose of readily and safely without damage moving one or more films 200 distally to deploy them at a body tissue site of interest. As such, shaft outer surface 1912 and/or the surfaces of part or all of thread 1922 (e.g., at the crest thread or over entire surface 1912) may be coated with an appropriate biocompatible material (e.g., PTFE or similar low-friction coating) to facilitate smooth motion of film 200 along lead screw 1910 and to prevent the film's underside of film 200 from being damaged or stuck.
Outer tube 1930 may be a tube of plastic or metallic construction having distal end 1932 with a distal opening or window 1934, proximal end 1936 with a proximal opening or window 1938, and central lumen 1940 having a diameter sized to securely accommodate lead screw 1910 therein along with one or more films while allowing for the movement of the one or more films in a distal direction along lead screw or shaft surface 1912 by rotation of handle 1920 without damage or disfigurement to the film and/or any of its contents (e.g., therapeutic substances, fibrinogen, etc.). Both distal and proximal openings or windows 1934 and 1938 are of a large enough radius angle so to allow for the optimal placement or insertion of film 200 (in the case of proximal opening 1938) and optimal exiting of film 200 (in the case of distal window 1934), and may not have the same radius angles. Windows 1924 and 1928 are generally of a length commensurate with or slightly larger than that of film 200.
During a method of use, a physician, other user or person will load one or more films onto the outer surface of lead screw 1910 by placing it in the outer tube proximal opening or window 1928 and rotating handle 1920 in the direction to advance film onto threads 1922 and in a distal direction towards shaft distal end 1914. Applicator 1900 may also be preloaded with one or more films by the manufacturer and packaged as a kit.
Next, under optional visualization, he or she guides applicator 1900 to the body tissue site of interest 300. When lead screw distal end 1914 is placed the desired location near the target tissue 302, physician or operator turns lead screw 1910 to deploy a first film by rotating handle 1920 in the appropriate direction. Rotation of lead screw 1910 may be accomplished any number of other ways, via, e.g., a motorized mechanism and/or component or components other than handle 1920. As first film 200a exits distal window 1934 via shaft 1910 rotation, the physician or operator will place film against the tissue target site 302 and may use the distal end 1914 of applicator 1900 to help first film 200a adhere to site 302 and/or to reposition film as may be desired.
If additional films are present in applicator 1900, the physician or operator will then move the applicator 1900 to the appropriate tissue location (or keep it at the same location if first film 200a did not deploy properly or was damaged, etc.) and rotate screw 1910 in the same manner to deploy and place second film 200b (not shown) at the desired location. This method may be repeated as necessary to deploy the desired number of additional films at a site 302. If a physician or other user desires to deploy a larger number of films at site 302 than are initially present or that have been loaded into proximal opening 1928, applicator 1900 may be withdrawn from the body to load one or more additional films, or another applicator 1900 with additional films may be used.
For the lead screw applicator embodiment 1900 described herein, as with the other applicator embodiments disclosed, film 200 may be configured such that a therapeutic substance is disposed on the side of the film that will be immediately adjacent the tissue at target site 302, while one or more other substances (such as fibrinogen) may be disposed on the opposite side of the film.
Belt-Guided Film Delivery System
Applicator 2000 may include inner tube 2010 having distal end 2012 and proximal end 2014, outer tube 2030 having distal end 2032 and proximal end 2034, belt or string 2050 onto which is adhered one or more films 200, disposed between inner tube 2010 and outer tube 2030, and handle 2060 with an integrated or attached rotating member 2070 for advancing belt 2050.
Inner tube 2010 may be of a plastic or metallic construction and includes central lumen 2016 and an optional groove or guide (not shown) disposed on inner tube outer surface 2018 along its length along or within which a belt or string 2050 may be disposed.
Belt or string 2050 may be of any biocompatible material that is has an adhesive disposed on its outer side 2052 to facilitate adherence of film 200 thereon. Belt 2050 may be in the shape of a string, e.g., generally circular in cross section, or it may be in the shape of a ribbon, e.g., generally rectangular in cross section with the wider dimension located on outer side 2052 and generally conforming to the width of film 200. Belt 2050 may be disposed in a loop in applicator 2000 such that (a) its inner side 2054 is proximal to inner tube outer surface 2018, optionally within or along an inner tube groove or guide (not shown), and (b) it is disposed within inner tube central lumen 2016. At inner tube distal end 2012, belt 2050 takes on a distal turn 2056 as it loops from inner tube outer surface 2018 into inner tube central lumen 2016. Applicator 2000 may have one or more films pre-loaded therein or one or more films may be loaded into applicator by a physician or other person prior to or during a film deployment procedure.
Outer tube 2030 may be of a plastic or metallic construction, but may be visually opaque or transparent to facilitate viewing of belt 2050 and inner tube 2010 through outer tube central lumen 2036. Outer tube may be disposed concentrically around the inner tube 2010 such that belt 2050 is looped within outer tube 2030 and partially within inner tube 2010 as described above and shown in
Both inner tube 2010 and outer tube 2030 are open on their respective distal ends 2012, 2032, such that belt 2050 is exposed as shown in
Handle 2060 may be of any configuration suitable for use by a physician or other operator, and may take on the embodiment shown in
In a method of use, applicator 2000 may come pre-loaded with one or more films 200 on belt 2050 or a physician, other user, or other person may load one or more films 200 onto belt 2050 as needed prior to the film deployment procedure. The physician or other user, under optional visualization, will guide applicator 2000 to the desired body tissue location 300 for the deployment of one or more films 200. As the distal end of inner tube 2012 and outer tube 2032 are in the vicinity of the tissue target surface 302, the physician or other user rotates rotating member 2070 to advance belt 2050 such that first film 200a that is adhered thereto moves out of applicator 2000 in the vicinity of belt distal turn 2056. As first film 200a encounters distal turn 2056, the belt's radius of curvature aids to detach first film 200a from belt outer side 2052, allowing it to be deployed on tissue target site 302. Any component of applicator 2000 may be used after first film 200a's deployment to aid in the film's positioning or repositioning on tissue target site 302. If desired, the physician or other operator further rotates rotating member 2070 to advance a second film 200b out of applicator 2000 and deploy second film 200b as described above. This process may be repeated as necessary to deploy additional films 200.
For the belt-guided applicator embodiment 2000 described herein, as with the other applicator embodiments disclosed, film 200 may be configured such that a therapeutic substance is disposed on the side of the film facing belt 1450, while one or more other substances (such as fibrinogen) may be disposed on the opposite side of the film.
Push Tube Film Delivery System
Applicator 2100 may include pusher 2110 and outer tube 2130. Pusher 2110 is configured to be disposed within outer tube 2130 to effect the ejection of one or more films 200 out of outer tube 2130 as described below.
Pusher 2110 may be made of any suitable plastic or metallic material (e.g., molded plastic or stainless steel) and may include an open area 2012 at pusher distal end 2114 and plunger element 2116 on pusher proximal end 2118. Closed region 2120 may be located proximal to open area 2012 into which one or more films may be loaded; closed region 2120 serves to protect one or more films prior to their deployment to the body tissue site of interest 300.
Outer tube 2130 may be made from any suitable plastic or metallic material (such as, e.g., a plastic extrusion or stainless steel). In
In a method of use, applicator 2100 may come pre-loaded with one or more films 200 or a physician, other user, or other person may load one or more films 200 into applicator 2100, as needed, prior to the film deployment procedure. The physician or other user, under optional visualization, will guide applicator 2100 to the desired body tissue location 300 for the deployment of one or more films 200. As outer tube distal end 2134 is moved into the vicinity of the tissue target surface 302, the physician or other user advances plunger element 2116 in a distal direction to advance pusher 2110 through outer tube central lumen 2132, pushing one or more films 200 along rails 2138. As pusher 2110 continues to advance, first film 200a moves out of applicator 2100; specifically, out of outer tube central lumen 2132, at outer tube distal end 2314. First film 200a may be made of a material having sufficient elasticity to unfold into a generally flat shape upon deployment from applicator 2100, or it may still take on the generally curved shape that it had while inside applicator 2100. At this point, the physician or other operator may use the applicator 2100 to manipulate first film 200a onto target tissue surface 302a and to ensure first film 200a conforms thereto. Any component of applicator 2100 may be used after first film 200a deployment to aid in the film's positioning or repositioning on tissue target site 302. If desired, the physician or other operator further advances plunger element 2116 in a distal direction to advance second film 200b out of applicator 2100; specifically, out of outer tube central lumen 2132, and deploy second film 200b as described above. This process may be repeated as necessary to deploy any or all remaining additional films 200.
For the push tube applicator embodiment 2100 described herein, as with the other applicator embodiments disclosed, film 200 may be configured such that a therapeutic substance is disposed on one side of the film while one or more other substances (such as fibrinogen) may be disposed on the opposite side of the film.
Although the technology has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the exampled technology. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the technology and should not be construed to limit the scope thereof.
This application claims the benefit of priority of U.S. Provisional Application Ser. No. 62/447,829, filed Jan. 18, 2017, the entire contents of which is incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62447829 | Jan 2017 | US |
