Abstract: The present invention provides a coronary artery bypass surgery treatment tool or the like including a flexible tube, a suction cup in which an opening portion is formed to communicate with the flexible tube and which is provided at a distal end of the flexible tube, a joint portion which has a suction path, a male connector which is provided in one of a proximal end of the flexible tube and a distal end of the suction path of the joint portion, and a female connector which is provided in the other thereof and is detachably connected to the male connector.

Abstract: A reduced-pressure system for treating a tissue site on a patient includes a distribution manifold that adheres to a tissue site to allow retention without external support. The distribution manifold includes a porous member and a tissue-fixation element. The tissue-fixation element maintains the porous member substantially adjacent to the tissue site while a sealing member is applied. In one instance, the tissue-fixation element is a soluble adhesive that partially covers either the tissue-facing side of the porous member or a tissue-facing side of a fluid-permeable substrate layer that is on the tissue-facing side of the porous member. Other systems, distributions manifolds, and methods are presented.

Abstract: The present invention provides a coronary artery bypass surgery treatment tool or the like including a flexible tube, a suction cup in which an opening portion is formed to communicate with the flexible tube and which is provided at a distal end of the flexible tube, a joint portion which has a suction path, a male connector which is provided in one of a proximal end of the flexible tube and a distal end of the suction path of the joint portion, and a female connector which is provided in the other thereof and is detachably connected to the male connector.

Abstract: Devices, systems, and methods for accessing the internal and external tissues of the heart are disclosed. At least some of the embodiments disclosed herein provide access to the external surface of the heart through the pericardial space for localized delivery of substances to the heart tissue. In addition, various disclosed embodiments provide access to the internal surface of the heart for aspiration and delivery of substances to a targeted region without disturbing or interfering with nearby structures or surfaces.

Abstract: An appliance which removably stores a portion of a catheter and an adapter, where the indwelling portion of catheter is still inside the body tissue of a patient. The appliance has an aperture that permits connection of a vacuum source such as hospital suction. When the appliance containing the catheter is held against the portion of the body including the indwelling site of the catheter, the vacuum source is applied, having a tendency to hold the appliance in place against the body. An orthopedic cast can be fabricated around the appliance, after which time the vacuum can be deactivated and the appliance can be removed, revealing a channel formed in the orthopedic cast. Through the channel, the distal portion of the catheter and the adapter can be accessed, facilitating continued post-operative anesthesia, easy visual inspection for signs of infection or dislodgment of the catheter and permitting easy removal when needed.

Abstract: Devices, systems, and methods for facilitating access to the pancreaticobiliary system are disclosed. In particular, the present disclosure relates to devices used to apply suction to the papilla, e.g., duodenal tissue surrounding the papilla, to facilitate cannulation to reach the bile duct and/or pancreatic duct. Devices may include a suction cup or an endoscope cap configured to apply suction to a tissue surface.

Abstract: A system for engaging heart tissue includes an engagement catheter defining a first lumen therethrough and having a suction port at or near a distal end and a vacuum port at or near a proximal end, a delivery catheter defining a delivery catheter lumen therethrough and configured for slidable insertion into the first lumen of the engagement catheter, and an implantable device capable of insertion into the delivery catheter lumen such that at least part of the implantable device extends from a delivery catheter distal end upon implantation into a patient, where the suction port is operable to removably attach to a targeted tissue on an interior wall of a heart of the patient after the engagement catheter has been advanced through a blood vessel and into the heart, thereby forming a reversible seal with the targeted tissue when a vacuum source is operatively coupled to the vacuum port.

Abstract: An attachable needle storage device is provided with a main body and a rotatable sleeve and a plurality of new needles stored within the sleeve, a leaf spring to direct each needle into a circumferential position of the pen body when rotated, and a ramp to move the needle into an axial position of the pen body when retracted or pulled rearward by the user. The attachable needle storage device is configured to attach to a pen device in a manner substantially the same as a conventional needle hub. In doing so, the rotation of the sleeve can be used to rotate a new needle onto a shuttle, and the retraction of the device can be used to cause a ramp to engage the needle and needle hub, moving the needle toward the axial position of the pen body and the septum. Once under the septum, the user continues pulling the device rearward, such that the needle is then moved rearward, pierces the septum of the medicament cartridge and exposes the distal end of the needle for injection.

Abstract: An engagement catheter for use with a vacuum source for engaging a tissue. An embodiment of the engagement catheter includes a first lumen extending between a proximal end and a distal end, a skirt operatively connected to the distal end, the skirt having a distal end with a circumference larger than the outer circumference of the engagement catheter, a suction port located at or near the distal end of the engagement catheter, the suction port configured to allow the distal end of the skirt to removably engage a surface of a bodily tissue, and a vacuum port located at the proximal end of the engagement catheter and capable of operative connection to a vacuum source, wherein when a vacuum source is operatively attached to the vacuum port, the skirt is capable of forming a reversible seal with the surface of the bodily tissue.

Abstract: An anchoring system provides secure attachment between a portion of a medical article and a body of a patient. The anchoring system comprises a securement device and a first fitting attached to the medical article, the first fitting having a first configuration. Embodiments of the anchoring system also comprise a second fitting attached to the medical article. The second fitting has a second configuration that differs from the first. The securement device includes a mounting surface for attaching the securement device to the patient's body and a receiving area. The receiving area is oriented so as to face away from the patient's body, and includes retainer mechanisms that are capable of engaging one or both of the first and second fittings, which have different configurations.

Abstract: A system for engaging heart tissue includes an engagement catheter defining a first lumen therethrough and having a suction port at or near a distal end and a vacuum port at or near a proximal end, a delivery catheter defining a delivery catheter lumen therethrough and configured for slidable insertion into the first lumen of the engagement catheter, and an implantable device capable of insertion into the delivery catheter lumen such that at least part of the implantable device extends from a delivery catheter distal end upon implantation into a patient, where the suction port is operable to removably attach to a targeted tissue on an interior wall of a heart of the patient after the engagement catheter has been advanced through a blood vessel and into the heart, thereby forming a reversible seal with the targeted tissue when a vacuum source is operatively coupled to the vacuum port.

Abstract: A system comprising: a nasogastric tube comprising: (a) a main lumen having one or more proximal connectors for connecting to a source of substances or pressure; (b) at least four vacuum lumens peripherally surrounding said main lumen; and (c) at least four suction ports for sealingly drawing an inner wall of an esophagus thereagainst, each of said at least four suction ports associated with a different one of said at least four vacuum lumens, wherein said at least four suction ports are distributed between at least two different locations along a longitudinal axis of said nasogastric tube.

Abstract: A medicinal delivery device adapted to being applied to a surface of an internal organ and exhibiting a three dimensional shaped body having an upper surface and at least one underside layer within which is entrained a medicinal application layer. Upon adhering the underside of the body to an exterior of the organ, medication is administered in a controlled and time release delivery fashion. A deformable upper portion of the body is provided in combination with at least one underside and suction inducing location. The medicinal and suction inducing locations further can include concentrically arranged layers. An aperture is located within an enclosed inner defined volume associated with the suction inducing location.

Abstract: A method of securing a medical article to the body of a patient is disclosed in which an anchoring device comprising an anchor and a retainer is used. The retainer is attached to an upper surface of the anchor and comprises a base, a cover and a post. The base is disposed on the upper surface of the anchor and the cover is connected to the base so as to move between an open and a closed position. When the cover is in the closed position, it lies above at least part of the base. The post is attached movably to either the base or the cover and is arranged so as to lie at least partially between the cover and the base when the cover is in the closed position. When securing a medical article, the cover is placed in the open position and the medical article placed onto the retainer. The cover may then be closed over the medical article and the anchoring device attached to the patient.

Abstract: An apparatus method for establishing a Transjugular Intrahepatic Portosystemic Shunt between the portal vein from a hepatic vein. The apparatus comprises an elongated hollow outer guide; an outer handle having an inner lumen and a first luer lock, the outer handle attached at a proximal end of the outer guide, the outer guide in flow communication with the inner lumen and the first luer lock; an elongated hollow inner needle; and a hub having a second luer lock, the hub attached at a proximal end of the inner needle, the inner needle in flow communication with the second luer lock. The inner needle is slidingly received into the outer guide through the inner lumen. The inner needle rotates within the outer guide by manipulation of the hub; and a distal tip of the inner needle is deployed out of and beyond a distal tip of the outer guide.

Abstract: A device and method for accessing a pericardial space of the heart includes a shaft having a cavity at a distal end, a suction lumen terminating in a distal port within the cavity and a hollow needle having a distal tip extending into the cavity. The cavity may be a recess in the shaft into which the distal tip of the needle fixedly protrudes. In other embodiments, the cavity is formed by an inflatable member positioned at the distal end of the shaft and the needle is slidable relative to the shaft. Suction is applied at the cavity to draw a pericardial bleb. The needle pierces the pericardial bleb for accessing the pericardial space and also facilitates delivery of payloads into the pericardial space.

Abstract: An apparatus including: a vacuum container configured to provide and substantially maintain a built-in vacuum pressure; a contact member configured to contact and substantially enclose a surface area; a vacuum device configured to couple the built-in vacuum pressure to the surface area thereby applying a suction force over the surface area; and a conduit coupled to the vacuum container; wherein the vacuum container is also configured to retain a substance collected from adjacent the surface area, wherein the conduit is configured to direct the substance to the vacuum container, and to maintain substantially the same level of vacuum pressure as the vacuum container, wherein the vacuum container comprises a collapsible container, and wherein the collapsible container comprises a spring member configured to maintain a tension in a wall of the vacuum container.

Abstract: A nasogastric tube (10) including a main lumen (12) having one or more proximal connectors (14) for connecting to a source of substances or pressure, and one or more vacuum lumens (16) peripherally surrounding the main lumen (12), each vacuum lumen (16) including a vacuum sealing portion (24), which includes one or more suction ports (26) for sealingly drawing an inner wall of an esophagus thereagainst.

Abstract: Multichannel systems for engaging a bodily tissue and methods of using the same. In at least one embodiment of an exemplary multichannel system for engaging a tissue of the present disclosure, the system comprises an engagement catheter comprising a proximal end, a distal end, and defining a first lumen and second lumen extending between the proximal end and the distal end, an inducer sheath having a proximal portion and a distal portion, and defining a lumen extending therethrough, the inducer sheath configured for insertion into the second lumen of the engagement catheter, and a dilator defining a first channel and a second channel extending therethrough and a tapered tip at the distal end of the dilator, the dilator sized and shaped for inserted into the lumen of the inducer sheath.

Abstract: A needle insertion assistance device is provided to easily hold a needle device, which comprises a syringe and a needle having a needle wing and being attached to the syringe, in order to more reliably control the advancement of the needle during insertion of the needle into a targeted part of a human body for many medical purposes. One embodiment of the needle insertion assistance device may comprise a supporting plate, a base connected hingedly to a rear surface of the supporting plate, and a syringe holder securely affixed to a top surface of the base to slidably hold the syringe on the base and prevent the syringe from moving from side to side. This embodiment of the needle insertion assistance device may further include a needle blocker, a handle, and an angle adjusting assembly.

Abstract: The catheter device comprises a drive shaft connected to a motor, and a rotor mounted on the drive shaft at the distal end section. The rotor has a frame structure which is formed by a screw-like boundary frame and rotor struts extending radially inwards from the boundary frame. The rotor struts are fastened to the drive shaft by their ends opposite the boundary frame. Between the boundary frame and the drive shaft extends an elastic covering. The frame structure is made of an elastic material such that, after forced compression, the rotor unfolds automatically.

Abstract: A wound treatment device comprises a wound surface contacting plug (10) and a cover (24) for covering the wound surface (22) and the plug (10), wherein said plug (10) consists of a flat textile isolating material comprising at least one first surface layer (12), one second surface layer (14) and one intermediate space (18) arranged between said surface layers (12, 14). At least the first surface layer (12) is provided with a biocompatible surface and a structure which enables a liquid to pass and prevents a wound tissue from growing in said structure. The intermediate space (18) is provided with isolating threads (16) elastically holding the first surface layer (12) and the second surface layer at a certain distance from each other.

Abstract: A device for reducing agent penetration at an insertion site is provided that has a porous inner sleeve fluidly connected to a conduit. A vacuum or hydrodynamic source is fluidly connected to the conduit. The device is stabilized by fibroblast in-growth and inhibits bacterial colonization. A device is also provided that has a conduit having a bore and an outer conduit surface. The outer conduit surface is optionally nanotextured to promote fibroblast adhesion and limit bacterial residency. A sleeve is provided in fluid communication with the bore of the conduit, and is formed from materials characterized by a pore matrix through which vacuum or hydrodynamic draw is achieved in a process to promote stabilization and reducing bacterial colonization by draw fluid from an area around the surrounding the site of the device. The sleeve optionally has a distal nanotextured surface.

Abstract: A system for engaging heart tissue includes an engagement catheter defining a first lumen therethrough and having a suction port at or near a distal end and a vacuum port at or near a proximal end, a delivery catheter defining a delivery catheter lumen therethrough and configured for slidable insertion into the first lumen of the engagement catheter, and an implantable device capable of insertion into the delivery catheter lumen such that at least part of the implantable device extends from a delivery catheter distal end upon implantation into a patient, where the suction port is operable to removably attach to a targeted tissue on an interior wall of a heart of the patient after the engagement catheter has been advanced through a blood vessel and into the heart, thereby forming a reversible seal with the targeted tissue when a vacuum source is operatively coupled to the vacuum port.

Abstract: A method of securing a medical article to the body of a patient is disclosed in which an anchoring device comprising an anchor and a retainer is used. The retainer is attached to an upper surface of the anchor and comprises a base, a cover and a post. The base is disposed on the upper surface of the anchor and the cover is connected to the base so as to move between an open and a closed position. When the cover is in the closed position, it lies above at least part of the base. The post is attached movably to either the base or the cover and is arranged so as to lie at least partially between the cover and the base when the cover is in the closed position. When securing a medical article, the cover is placed in the open position and the medical article placed onto the retainer. The cover may then be closed over the medical article and the anchoring device attached to the patient.

Abstract: An apparatus method for establishing a Transjugular Intrahepatic Portosystemic Shunt (“TIPS”) between the portal vein from a hepatic vein. The apparatus comprises a multi-needle TIPS device designed to facilitate safer and more rapid catheterization of the portal vein. The method utilizes the multi-needle TIPS device to access the portal vein from the hepatic vein approach. The multi-needle TIPS device and method provides numerous benefits over previous TIPS devices and procedures and results in shorter and safer procedures. Use of multiple needles increases the probability of finding the portal vein more quickly.

Abstract: Devices and methods are provided for inserting a sterile catheter, and for maintaining a sterilely sealed catheter and catheter insertion site over time. In one embodiment, a four-part integrated system is provided that includes (1) a novel vascular catheter with integrated uniform diameter mounting, capping, and needle safety procurement features, (2) a novel vascular catheter dressing designed to specifically mate with and seal to this vascular catheter to achieve a sterile seal both at the catheter-skin insertion site and the catheter-dressing exit site, (3) a hub protection and sterilizing apparatus that serves to stabilize, protect, and sterilize the working end of the catheter hub as it protrudes from the sterile dressing, and that also helps to improve the ergonomics of the catheter-dressing complex in order to avoid snagging on clothing etc., and (4) a whole dressing accessory secondary cover and securement device.

Abstract: Systems and methods for localization of a puncture site on an atrial wall relative to a mammalian tissue of interest. In at least one embodiment, such a system includes a bodily access system, having an engagement catheter with an open distal end, a first lumen therethrough, and configured to reversibly attach to a first tissue using suction, a puncture device, configured to fit at least partially within the first lumen, and a scanner configured to identify at least a portion of the bodily access system when positioned within the luminal organ and further configured to identify a distance between a second tissue and a portion of the bodily access system. When such a system is used in connection with a therapeutic procedure, the distance between the second tissue and the portion of the bodily access system is used to facilitate a puncture of the first tissue at a desired location.

Abstract: An engagement catheter for use with a vacuum source for engaging a tissue. An embodiment of the engagement catheter includes a first lumen extending between a proximal end and a distal end, a skirt operatively connected to the distal end, the skirt having a distal end with a circumference larger than the outer circumference of the engagement catheter, a suction port located at or near the distal end of the engagement catheter, the suction port configured to allow the distal end of the skirt to removably engage a surface of a bodily tissue, and a vacuum port located at the proximal end of the engagement catheter and capable of operative connection to a vacuum source, wherein when a vacuum source is operatively attached to the vacuum port, the skirt is capable of forming a reversible seal with the surface of the bodily tissue.

Abstract: A venipuncture base plate assembly includes an adapter and a patient interface platform. The adapter has a substantially flat retention clip and a platform coupled to the retention clip with two or more posts mounted on it. The patient interface platform includes a base pad having a bottom surface coated with an adhesive substance and a base unit coupled to the base pad. The base unit includes a base plate and a retainer mounted on the base plate that supports the adapter at two or more variable angles relative to the base plate.

Abstract: A modular, reduced-pressure, wound-closure system for generating a closing force on a surface wound on a patient includes a sealed contracting member, a plurality of attachment base members, and a plurality of connecting members. The combination of the plurality of attachment base members and plurality of connecting members forms a circumferential wall around the surface wound. The sealed contracting member is operable to be disposed within an interior space defined by the circumferential wall and coupled to at least of portion of the circumferential wall. When reduced pressure is provided to the sealed contracting member, the sealed contracting member contracts and the circumferential wall delivers a closing force. Other systems and methods are presented.

Abstract: An anchoring system provides secure attachment between a portion of a medical article and a body of a patient. The anchoring system comprises a securement device and a first fitting attached to the medical article, the first fitting having a first configuration. Embodiments of the anchoring system also comprise a second fitting attached to the medical article. The second fitting has a second configuration that differs from the first. The securement device includes a mounting surface for attaching the securement device to the patient's body and a receiving area. The receiving area is oriented so as to face away from the patient's body, and includes retainer mechanisms that are capable of engaging one or both of the first and second fittings, which have different configurations.

Abstract: Devices, systems, and methods for accessing tissue, including the internal and external tissues of the heart, are disclosed. At least some of the embodiments disclosed herein provide access to the external surface of the heart through the pericardial space for localized delivery of leads to the heart tissue. At least some of the embodiments disclosed herein provide access to the pericardial space for removal of accumulated fluid. In addition, various disclosed embodiments provide devices, systems, and methods for engaging a tissue, for removing fluid from a space within a body, and for the delivery of substances to a targeted site for therapeutic purposes.

Abstract: A method of securing a medical article to the body of a patient is disclosed in which an anchoring device comprising an anchor and a retainer is used. The retainer is attached to an upper surface of the anchor and comprises a base, a cover and a post. The base is disposed on the upper surface of the anchor and the cover is connected to the base so as to move between an open and a closed position. When the cover is in the closed position, it lies above at least part of the base. The post is attached movably to either the base or the cover and is arranged so as to lie at least partially between the cover and the base when the cover is in the closed position. When securing a medical article, the cover is placed in the open position and the medical article placed onto the retainer. The cover may then be closed over the medical article and the anchoring device attached to the patient.

Abstract: A drug delivery system utilizes a hand piece adapted to receive a probe. The hand piece may be made of a first segment and a second segment connected to one another by a swivel joint to accommodate a user's position and preference for switches provided thereon. Alternatively, the switches may be mounted on rotatable bases. A base unit connected to the hand piece delivers a substance to the hand piece via a drug line. The base unit may further include a nerve stimulator for transmitting current to the probe. A drug switch on the hand piece selectively activates a drug delivery and suction to facilitate aspiration. A current switch on the hand piece selectively delivers electric current to the probe. In practice, the hand piece of the invention may be used by a single operator operating an ultrasound wand with a first hand and operating the hand piece with a second hand, thereby reducing personnel typically required to perform certain tasks.

Abstract: Device for securing a line such as a medical tube, a catheter, diagnostic wires etc., the device including a line retaining part and a base part, the line retaining part having at least one groove for accommodating a line, the groove being designed with flexible retaining means, the base part including fixing means, where the line retaining part and the base part are provided with complementary locking means.

Abstract: An anchoring system provides secure attachment between a portion of a medical article and a body of a patient. The anchoring system comprises a securement device and a first fitting attached to the medical article, the first fitting having a first configuration. Embodiments of the anchoring system also comprise a second fitting attached to the medical article. The second fitting has a second configuration that differs from the first. The securement device includes a mounting surface for attaching the securement device to the patient's body and a receiving area. The receiving area is oriented so as to face away from the patient's body, and includes retainer mechanisms that are capable of engaging one or both of the first and second fittings, which have different configurations.

Abstract: Devices, systems, and methods for accessing the internal and external tissues of the heart are disclosed. At least some of the embodiments disclosed herein provide access to the external surface of the heart through the pericardial space for localized delivery of substances to the heart tissue. In addition, various disclosed embodiments provide access to the internal surface of the heart for aspiration and delivery of substances to a targeted region without disturbing or interfering with nearby structures or surfaces.

Abstract: Apparatus and methods for injecting biological agents into tissue. Devices are provided having elongate shafts and distal injection heads for driving needles into tissue and injecting medical agents into the tissue through the needles. A longitudinal force directed along the shaft can be translated to a needle driving force. Some devices provide controllably variable needle penetration depth. Devices include mechanical needle drivers utilizing four link pantographs, rack and pinions, and drive yokes for driving a first needle bearing body toward a second tissue contacting body. Other devices include inflatable members for driving and retracting needles. Still other devices include magnets for biasing the needles in extended and/or retracted positions. The invention includes minimally invasive methods for epicardially injecting cardiocyte precursor cells into infarct myocardial tissue.

Abstract: Device (1) for the implantation of an apparatus (40) on or in a mammalian internal organ, comprising: —a tube (10) for passing the apparatus through, one end (11) of which is intended to be applied to a site chosen for the implantation of the apparatus, and the other end of which is intended to emerge outside the body of the mammal, —fixing means (20) suitable for fixing the device on the organ and for applying the end of the tube to the chosen site, said means being controlled from outside the body, —rigidifying means (30) suitable for rigidifying the device, said means being controlled from outside the body, so as to fix the position of the tube relative to the fixing means and to the organ, once the device has been fixed on the organ and the end of the tube has been applied to the chosen site by the fixing means.

Abstract: A tissue perforation device and method. The device preferably includes a housing having a housing pass-through, a penetrator securely and sealably positioned so that the penetrator device passes through the housing pass-through, and a vacuum system comprising a vacuum source securely and sealably attached through the housing for advancing a patient's tissue onto the penetrator device.

Abstract: Apparatus and surgical methods establish temporary suction attachment to a target site on the surface of a bodily organ for enhancing accurate placement of a surgical instrument maintained in alignment with the suction attachment. A suction port on the distal end of a supporting cannula provides suction attachment to facilitate accurate positioning of a needle for injection penetration of tissue at the target site on the moving surface of a beating heart. Force applied via the suction attachment to the surface of the heart promotes perpendicular orientation of the surface of the myocardium for enhanced accuracy of placement of a surgical instrument thereon. A hollow needle and a supporting channel therefor, each include a slot along an outer wall between ends thereof, are selectably rotatable to align the slots for releasing a cardiac lead from within the needle through the aligned slots.

Abstract: A tissue perforation device and method. The device preferably includes a housing having a housing pass-through, a penetrator device securely and sealably positioned so that the penetrator device passes through the housing pass-through, and a vacuum system comprising a vacuum source securely and sealably attached through the housing for advancing a patient's tissue onto the penetrator device.

Abstract: An integrated securement and closure apparatus uses mechanical fasteners disposed in access lumens located radially outwardly from a centrally disposed opening for an endoscope. The mechanical fasteners are used to secure the distal end of an overtube against and isolate a target area of tissue inside a patient. An incision is made in the isolated target and the mechanical fasteners are used to approximate the tissue of the incision following and surgical intervention.

Abstract: Injection devices are provided, which reduce potential outflow of therapeutic agents from an injection site. Devices are provided having at least a first lumen containing one or more therapeutic agents and a second lumen containing a second material for injection into tissue. Other devices are provided having an inner lumen with an injection needle to inject a therapeutic agent and an outer lumen that provides a vacuum seal between the injection needle and the needle track. Further provided are methods of delivering a therapeutic agent to tissue.

Abstract: A transdermal transport device includes a reservoir for holding a formulation of an active principle, and one or more needles. Each needle has a bore through which the formulation is transported between the reservoir and a biological body, and has an end portion that is substantially aligned in a plane parallel to a surface of the biological body when the device is placed on the surface. The device also includes a vacuum generator which creates a suction to draw a portion of the surface beyond the plane of the end portions to enable the end portions to penetrate the portion of the surface as the needles are translated along an axis that is substantially parallel to the plane.

Abstract: A supportless atrioventricular valve intended for attaching to a circumferential valve ring and papillary muscles of a patient comprising a singular flexible membrane of tissue or synthetic biomaterial, wherein a minimally invasive delivery system is provided through a percutaneous intercostal penetration and a penetration at the cardiac wall into a left atrium of the heart.

Abstract: The invention is directed to a device and method for minimally invasive access to the pericardial space of a human or animal patient. The disclosed pericardial access device includes a penetrating body axially mobile within the lumen of a guide tube. The distal end of the guide tube includes a shoulder to buttress pericardial tissue drawn into the guide tube by a suction force applied to the guide tube lumen. The penetrating body is subsequently distally advanced within the guide tube to access the pericardium.

Abstract: An integral data logging system for a jet injector includes at least one electrical switch that changes state (e.g. from OFF to ON) during an injection procedure. The switch(es) are connected to an electrical circuit having a microprocessor, a clock and an electronic memory. When a switch changes state, this information along with the applicable date and time is recorded in the electronic memory. A communications link is provided to upload the stored data to a remote computer for subsequent manipulation and analysis to determine compliance with a prescribed dosing regimen. In one implementation, the injection duration is logged by using a trigger release switch and an end-of-stroke switch. The end-of-stroke switch is configured to change state after the drive bar of the injector transits through the injector tube. The injection duration is indicative of dose amount and can be used to distinguish between valid and invalid injections.

Abstract: A device and method for delivering an agent to the uterine cervix make use of a seal member that defines a chamber upon engagement with the cervix. An agent delivery port in fluid communication with the chamber is provided for delivery of the agent to the uterine cervix. A vacuum port in fluid communication with the chamber allows application and retention of vacuum pressure to the chamber. At least a portion of the seal member can be made deformable in response to contact with the outer surface of the uterine cervix and application of vacuum pressure. Upon deformation, the seal member substantially seals the chamber against leakage of the agent. The seal member may include a skirt-like member that promotes adhesion of the seal member to the cervix, and enhances the effectiveness of the seal. The device facilitates vacuum application, cervical fixation, and a resulting barrier against uterine fluid leakage, providing an atraumatic, temporary cervical plug that remains effective while the vacuum is applied.