Abstract: Catheters configured to minimize, prevent, disrupt, and/or treat thrombus accumulation and subsequent occlusion are disclosed. Such catheters include at least one sidewall cut extending to the catheter distal end that forms catheter sidewall portions that move relative to each other when subjected to a force greater than a threshold force.

Abstract: A device for puncturing body and introducing catheter includes a puncture needle, a guide wire, a peelable catheter sheath, and a puncture protector. The peelable catheter sheath includes an outer sheath and an inner sheath inserted into the outer sheath and having an expansible performance. The inner sheath has a hollow internal cavity, and the guide wire can pass through the hollow internal cavity. The puncture protector includes an inner core, a nut and a spring. The inner core has an inner core head, an inner core tail, and an inner core lumen. The nut has a nut lumen. The inner core is surrounded by the spring, one end of which abuts against the nut, and the other end of which is fastened to the inner core. The inner core tail lies within the nut lumen. The guide wire matches with the inner core lumen.

Abstract: A method of introducing a catheter 38 into an umbilical artery 14. The artery 14 is dilated with an introducer 22. A cannula 30 is introduced into the end of the artery 14, and a catheter is introduced through the cannula 30, with the distal end of the catheter 38 not engaging with the cut end of the artery 14.

Abstract: An introducer sheath includes a tubular body portion having a proximal region and a distal region, and defines an internal lumen configured and dimensioned to slidably receive a catheter. A penetrating portion at a distal end of the tubular body has a first tapered configuration to enlarge an opening in a body tissue during distal advancement of the introducer sheath through the body tissue and a second expanded configuration to enable the passage of a distal end portion of a catheter through the penetrating portion.

Abstract: A delivery device includes an outer sidewall and an inner sidewall extending therein. An outer surface of the inner sidewall defines a plurality of longitudinally extending grooves, each of which interlock with a corresponding inward protruding member of a plurality of longitudinally extending inward protruding members defined by an inner surface of the outer sidewall. A longitudinally extending lumen of the device, which may accommodate delivery of an implantable medical device, is defined, at least in part, by the inner surface of the inner sidewall. A slitting zone of the device, for example, provided by one of the sidewalls extending less than 360 degrees about a longitudinal axis of the device, enables removal of the delivery device from around the delivered device.

Abstract: A catheter system for positioning of an instrument within a body. The catheter system includes a hub defining a lumen therethrough for passage of the instrument and an elongate tubular member defining a lumen therethrough. The lumen of the tubular member is in communication with the lumen of the hub. The system also includes a slitter member that is coupled to the hub. The slitter member is disposed to slit the tubular member. The slitter further includes a moveable member that is moveably coupled to the hub and that is coupled to the tubular member, the moveable member is operable to advance the elongate tubular member toward the slitter member as the moveable member is moved relative to the hub. The slitter member thereby slits the elongate tubular member.

Abstract: An introducer apparatus with a plurality of cutting edges along the outer surface of the distal end of an introducer with a blunt distal end is disclosed. The introducer may be adapted to extend from and be withdrawn into the sheath. The cutting edges may resect tissue located around the insertion site.

Abstract: A vascular introducer assembly is disclosed that includes a dilator, a sheath having an axial lumen for accommodating the dilator, a locking collar for securing the dilator and the sheath to one another and an adjustable hemostatic seal for preventing fluid egress from the axial lumen and restricting insertion of instruments through the axial lumen before and after the dilator is separated from the vascular introducer.

Abstract: A sheath can include a sheath body and a sheath hub. The sheath body can have a generally flexible tubular structure, a proximal end, and a distal end. The sheath body can further define a longitudinal axis. The sheath hub can attach to the proximal end of the sheath body and define a longitudinal axis generally aligned with the axis of the sheath body. The sheath body and sheath hub can also form a central cavity along their respective axes. The sheath hub can include two plates: a flexible plate and a rigid plate. The rigid plate can have a relief generally centered on the sheath body's axis. Advantageously, the flexible plate and rigid plate can overlap to substantially seal the central cavity.

Abstract: A tunneler for producing a subcutaneous tunnel in connection with the placement of a catheter within a body of a patient is disclosed. In one embodiment, the tunneler comprises an elongate tunneler member and a sheath. The tunneler member includes a handle on its proximal end and a tapered distal end. The sheath defines an elongate lumen inside which the tunneler member is initially received. The tunneler member is configured to define a tunnel through subcutaneous tissue while disposed in the sheath, then is removable from the sheath lumen thereafter. The sheath is configured to remain within the tunnel so that a catheter can be inserted through the sheath within the tunnel. The sheath is splittable in one embodiment so as to enable its removal from the tunnel while leaving the catheter in place.

Abstract: An access device places a medical article within a body space of a patient. The device has a needle that includes an elongated body and a needle hub. The device further includes a dilator disposed on and slideable along the elongated body of the needle and a medical article. The medical article is disposed on and slideable along the dilator. A track extends in a proximal direction from the dilator. The needle hub slides along at least a portion of the track between a first position and a second position. The device further includes a locking mechanism operably disposed between the track and the needle hub so as to inhibit further axial movement of the needle in the proximal direction when the needle hub is in the second position.

Abstract: A tearaway introducer sheath assembly (100,200) having an integrated valve (300). The valve is seated within a valve housing (222) defined by the hub portion (200) of the sheath (200). The valve (300) includes a pair of distally extending opposed side walls or flaps (324) extending to converge at a distal tip (328) having a virtual opening (334) therethrough. The valve further includes a pair of tensioners (340) along outer surfaces of the opposed side walls (324) that extend radially outwardly to engage and bear against the interior valve housing surface (230) to press the opposed side walls (324) together at the distal tip (328) for sealing, both when a dilator extends through the valve and sheath and afterward upon removal of the dilator.

Abstract: A tool for slitting an elongate sheath from about an elongate member that is disposed within a longitudinally extending lumen of the sheath includes a longitudinally extending tail portion projecting rearward of a slitting edge and a nose portion of the tool; a lower surface of the nose portion is disposed beneath the slitting edge for engaging a portion of the elongate member. The tail portion of the tool, approximately aligned with the sheath lumen when the lower surface engages the elongate member and a leading edge of the nose portion is within the sheath lumen, is sized to fit within the sheath lumen after the sheath is slit by the slitting edge. A passageway between the nose portion and the tail portion allows a proximal segment of the elongate member to bend away from the tail portion when the elongate member is engaged by the nose portion.

Abstract: A balloon dilation catheter comprising a tubular member having a proximal end and a distal end. An inflatable balloon is disposed at the distal end of the tubular member. A first lumen is disposed in the tubular member and in is communication with an interior of the inflatable balloon. A second lumen is disposed in the tubular member for receiving a guidewire substantially along a portion of its length. The second lumen has a first opening in the proximal region of the tubular member and a second opening at the distal region of the tubular member. A first slit is disposed longitudinally in the tubular member and extends along at least a portion of the tubular member, the first slit comprising a first pair of longitudinal edges in a side by side relationship.

Abstract: A slitter for slitting a guide catheter is assembled from a handle, a blade assembly coupled to the handle, and a holding mechanism coupled to the handle. The blade assembly includes a shroud for receiving an elongated body of a medical device and a slitting blade having an exposed cutting edge to slit the guide catheter.

Abstract: A catheter enables measuring and approximating its distal end position within the body to facilitate catheter insertion and improve accuracy and control. By wrapping a long infusion catheter with an outer coating, the catheter can be guided into a vein or vessel by pulling on the outer coating and forcing its separation in a Y-shaped separation housing anchored close to the insertion point. Since there is no need for a guidewire or stylet and the outer coating acts as a sterile peel package, the catheter can be placed while infusing and maintain its own closed sterile environment during insertion.

Abstract: A medical device is provided including a catheter shaft having a lumen extending therethrough with a splittable wall portion along a side of the lumen, and a tube that extends through at least a portion of the lumen and is configured to provide a patent path of fluid communication.

Abstract: Systems for gaining access into a body of a patient around an implanted body of an elongate medical device include a sheath having a deformable wall that allows insertion of the device body into a lumen surrounded by the sheath wall. The sheath wall may include first and second edges that extend from a proximal end to a distal end of the lumen, or just extend along a distal portion of the lumen. A tool, which includes a groove sized to grasp about a circumference of the device body, may facilitate insertion of the device body into the lumen of those sheath embodiments that include the first and second edges, by spreading at least one of the first and second edges of the wall apart from the other of the first and second edges while the device body is grasped within the tool.

Abstract: A system and/or apparatus for delivering a medical device into a body includes an elongate tubular member and a valve fitted within a proximal end thereof. The valve preferably includes a tubular body and a flap, wherein the tubular body is engaged within the proximal end of the tubular member and has an open end approximately aligned with a proximal termination of the proximal end of the tubular member. The flap of the valve preferably extends over a hole formed in an end wall of the tubular body opposite a side of the end wall that faces a passage of the tubular body, which passage extends between the open end and the end wall. The hole communicates with the passage and with the lumen of the tubular member, and the flap is movable away from the hole when the device is introduced through the passage and the hole.

Abstract: An improved splittable medical device introducer designed to introduce a medical device such as a lead or catheter, into a patient's vasculature without loss of blood or the introduction of air is described. The introducer assembly is designed to easily separate in a smooth tactile manner without disrupting placement of the medical device during removal of the introducer. The introducer is composed of a fluoropolymeric material which combined with an internal stress confining structure propagates a stress initiated by the operator that tears the entire introducer assembly in two without creating a jagged separated edge.

Abstract: Apparatus and methods are provided for use in filtering emboli from a vessel and/or performing thrombectomy and embolectomy, wherein a vascular device disposed on a guidewire includes a support hoop disposed from a suspension strut. Alternately, a support hoop having an articulation region may be directly connected to a region proximate the distal end of the guidewire. A blood permeable sac is affixed to the support hoop to form a mouth of the blood permeable sac. The support hoop is disposed obliquely relative to the longitudinal axis of the guidewire and is capable of being properly used in a wide range of vessel diameters. The vascular device collapses during removal to prevent material from escaping from the sac. A delivery sheath and introducer sheath for use with the vascular device of the present invention are also provided.

Abstract: A tool for cutting or slitting the tubular sheath of a guide-catheter in the presence of a lead placed in this sheath. The tool (10) has a flattened, substantially planar blade holder body (12) with a cutting area (14) and a prehension area (16). The cutting area has a blade (18) and a tubular guide (22) receiving the lead for isolating it from the guide-catheter. The prehension area (16) has on a first side (30) an area for receiving the thumb and a lead holding pathway (68) spreading in the continuation of the tubular guide following an overall orientation forming an angle with this guide. The thumb reception area has a concave footprint (34) crossed through and through by the lead holding pathway (68), which spreads in the prehension area following an “S” shaped curve having a first curved area (74) and a second counter-curved area (76). The minimal distance between the blade (18) and the contour of the first footprint (34) is to the most equal to 15-20 mm.

Abstract: A tool for slitting an elongate sheath from about an elongate member that is disposed within a longitudinally extending lumen of the sheath includes a longitudinally extending tail portion projecting rearward of a slitting edge and a nose portion of the tool; a lower surface of the nose portion is disposed beneath the slitting edge for engaging a portion of the elongate member. The tail portion of the tool, approximately aligned with the sheath lumen when the lower surface engages the elongate member and a leading edge of the nose portion is within the sheath lumen, is sized to fit within the sheath lumen after the sheath is slit by the slitting edge. A passageway between the nose portion and the tail portion allows a proximal segment of the elongate member to bend away from the tail portion when the elongate member is engaged by the nose portion.

Abstract: A method and apparatus for uncoupling a wire guide from and elongate medical device comprising a catheter shaft having a wire guide lumen extending there through, wherein the material surrounding the wire guide lumen is selected or adapted to facilitate splittability for removal of the wire guide. The catheter shaft includes a wire guide port having a stress riser, the stress riser being configured to reduce the force necessary to rupture or split the portion of the shaft wall adjacent to the wire guide port. In a preferred embodiment, the catheter shaft is coextruded and comprises a plurality of materials. The portion of the shaft adjacent the wire guide lumen is formed from a material is selected or adapted to facilitate splittability as compared to the remaining shaft materials.

Abstract: A percutaneous peel-away vascular introducer that includes an elongated tubular sheath having opposed proximal and distal ends, and a pair of diametrically opposed peel lines that extend along the length of the sheath from the proximal end thereof to the distal end thereof, wherein the diametrically opposed peel lines have an axially extending pitch. The introducer further includes a pair of spreadable handles associated with the proximal end of the sheath for splitting the sheath along the peel lines.

Abstract: A balloon dilation catheter comprising: a tubular member having a proximal end and a distal end and an inflatable balloon disposed at the distal end of the tubular member. The tubular member comprises a first lumen disposed in communication with an interior of the inflatable balloon and a second lumen for receiving a guidewire substantially along the entire length of the tubular member. The second lumen has a first opening at the proximal end of the tubular member and a second opening at the distal end of the tubular member. A first slit is disposed longitudinally from the first opening along substantially the entire length of the tubular member to permit separation of the guidewire with respect to the second lumen. The subject balloon dilation catheter provides improved rapid exchange advantages of either the catheter or the guidewire used in a catheterization technique.

Abstract: The present disclosure relates to catheterization systems and components thereof. In one embodiment of the present disclosure, a catheterization system is disclosed that includes a catheter including a body with proximal and distal ends and defining first and second lumens extending therethrough, and a stylet. The stylet includes first and second stylet portions each having proximal and distal end regions, wherein the distal end regions of the first and second stylet portions together define a tapered penetrating portion. The first and second stylet portions are configured and dimensioned to be slidably positioned within the first and second lumens of the catheter, respectively. The first and second stylet portions extend from the proximal end of the catheter and beyond the distal end of the catheter, and are independently movable in relation to each other to facilitate selective removal of the first stylet portion and/or the second stylet portion from the catheter.

Abstract: The present invention relates to a multi-size catheter for use in biliary endoscopic procedures. The multi-size catheter comprises an outer diameter defined by a plurality of superimposed peelable layers. The peelable layers allow the multi-size catheter to function as a single operator exchange catheter without the need, and additional expense, of an endoscope sheath. Before positioning the multi-size catheter within the working channel of an endoscope, the peelable layers may be selectively removed in order to obtain an outer diameter for the catheter that is less than, but approximate to, the inner diameter of the working channel of the endoscope. The resulting fit eliminates the potential for a guidewire to slip out of the guidewire channel and become pinched between the catheter and the endoscope working channel. With an incorrect fit, a pinched guidewire would restrict the desired movements of both the guidewire and the catheter.

Abstract: A peelable vascular introducer including an elongated tubular sheath having opposed proximal and distal ends and at least three circumferentially spaced peel lines extending from the proximal end to the distal end. The peelable vascular introducer also includes spreadable handles associated with the proximal end of the sheath configured to split the sheath along the peel lines.

Abstract: A peelable sheath is used to provide an atraumatic cover for an elongate medical device positionable through an incision. The peelable sheath includes a flexible tube, a pair of tabs on a proximal portion of the flexible tube, and a collar on a proximal portion of the flexible tube. The tabs extend laterally through at least one sidewall opening in the collar. The flexible tube is slidably disposed in a lumen of the collar. In use, the sheath is positioned covering at least a distal portion of the elongate medical device, and the elongate medical device is inserted into an incision or other opening in a patient. The sheath is withdrawn from the elongated medical device by pulling the tabs outwardly relative to the longitudinal axis of the flexible tube, causing at least a proximal portion of the flexible tube to split longitudinally into at least two longitudinal sections. The longitudinal sections move proximally through the at least one sidewall opening as the tabs are pulled.

Abstract: A tearaway sheath assembly (100) having a splittable sheath tube (102) a splittable hub (110), a split valve (150,250) and a split cap (180). The valve (150,250) has a slit (158,258) at least partially across the transverse distal section (154) such that transverse distal section may be displaced laterally during insertion through the slit (158,258), of a dilator (200) or a catheter. The valve (150,250) is formed in two separate halves (152A,152B;252) that are fused or adhered to each other to form a sealed weak bond (154) that is easily broken during splitting of the sheath; each valve half is mechanically affixed in a proximal valve-receiving recess (130) of the hub such as by anchor posts (136) extending through apertures (166A,166B) in ears (164A,164B) of each valve half. A two-part cap (180) is affixed to the hub proximal end (120) and traps the valve between itself and the hub.

Abstract: A detachable introducer and method of using such introducer is disclosed for inserting an embolic coil deployment system into the tortuous vasculature of the human brain for placing an embolic coil within an aneurysm. The introducer includes a sheath having a lumen, a side opening and a longitudinal slit. A deployment catheter with a conical expander member is slideably disposed through the side opening of the sheath and through the lumen of the sheath. The conical expander member detaches the introducer from the deployment catheter through the longitudinal slit of the sheath.

Abstract: An adjustable length catheter device, a kit and a method of providing the adjustable length catheter device to a patient are provided. The catheter device includes an elongate shaft having a proximal portion, a distal portion, a first lumen and a second lumen extending at least partially therethrough. The catheter device further includes a manifold operably connected to the shaft. The manifold is configured to longitudinally move along the shaft towards the distal portion for separating the proximal portion of the shaft into a first proximal shaft portion including the first lumen and a second proximal shaft portion including the second lumen.

Abstract: An improved splittable medical device introducer designed to introduce a medical device such as a lead or catheter, into a patient's vasculature without loss of blood or the introduction of air is described. The introducer assembly is designed to easily separate in a smooth tactile manner without disrupting placement of the medical device during removal of the introducer. The introducer is composed of a fluoropolymeric material which combined with an internal stress confining structure propagates a stress initiated by the operator that tears the entire introducer assembly in two without creating a jagged separated edge.

Abstract: A system and/or apparatus for delivering a medical device into a body includes an elongate tubular member and a valve fitted within a proximal end thereof. The valve preferably includes a tubular body and a flap, wherein the tubular body is engaged within the proximal end of the tubular member and has an open end approximately aligned with a proximal termination of the proximal end of the tubular member. The flap of the valve preferably extends over a hole formed in an end wall of the tubular body opposite a side of the end wall that faces a passage of the tubular body, which passage extends between the open end and the end wall. The hole communicates with the passage and with the lumen of the tubular member, and the flap is movable away from the hole when the device is introduced through the passage and the hole.

Abstract: A securing device for preventing the splitting of a splittable sheath in the body of a treated subject, for facilitating the insertion of a splittable introducer and the splitting of said splittable sheath during removal of said introducer from the body of the subject, and optionally for interfacing said splittable introducer with other devices, comprising a “U”-like shaped portion having a distal arm and one or two proximal arms connected by a base, wherein said distal arm comprises an aperture accessible via a vertical slit passing from its upper side and terminating in said aperture, and wherein the gap defined between said distal arm and proximal arms is suitable for fitting a splittable introducer therebetween such that its splittable sheath is retained in the aperture provided in the distal arm.

Abstract: The present invention is a tool coupled to a hemostasis valve and adapted to slit/split a tubular body of a catheter or sheath to facilitate the removal of the tubular body from about a medical device extending through the hemostasis valve and tubular body. The tool comprises a conical barrel portion supporting one or more radially outward extending blades. The tool also comprises a stabilizing component for preventing displacement between the tool and medical device when the tubular body is being removed from about the medical device.

Abstract: The present invention relates to a sensor for percutaneous insertion and intravascular residence without an indwelling cannula. In preferred embodiments, a glucose sensor is inserted into a blood vessel using a removable cannula. After the cannula is removed, the glucose sensor remains within the blood vessel by itself and forms a seal with the patient's tissue.

Abstract: A tearaway introducer sheath assembly (100,200) having an integrated valve (300). The valve is seated within a valve housing (222) defined by the hub portion (200) of the sheath (200). The valve (300) includes a pair of distally extending opposed side walls or flaps (324) extending to converge at a distal tip (328) having a virtual opening (334) therethrough. The valve further includes a pair of tensioners (340) along outer surfaces of the opposed side walls (324) that extend radially outwardly to engage and bear against the interior valve housing surface (230) to press the opposed side walls (324) together at the distal tip (328) for sealing, both when a dilator extends through the valve and sheath and afterward upon removal of the dilator.

Abstract: A device and method of placement of a chronic micro-catheter is shown that allows effective guiding of micro-catheters through a host catheter that is later removable while leaving the micro-catheter implanted in place within the patient. The novel configuration allows the micro-catheter to be completely radially enclosed during insertion, and still allows the host catheter to be removed, leaving the micro-catheter behind. Additionally, the configuration allows several micro-catheters to be placed at any number of depths and orientations while still using a minimally invasive host catheter.

Abstract: A device and method of making a peel-away introducer sheath adapted for use in transcutaneous insertions of medical instrumentation according to an embodiment of the present invention includes, forming at least two anchor apertures in an end portion of a peel-away sheath tube, molding a fitting around the end portion by passing molten resin into a fitting mold and through the at least two anchor apertures, and cooling the resin within the mold and the at least two anchor apertures to thereby fasten the fitting to the sheath tube.

Abstract: A percutaneous peel-away vascular introducer that includes an elongated tubular sheath having opposed proximal and distal ends, and a pair of diametrically opposed peel lines that extend along the length of the sheath from the proximal end thereof to the distal end thereof, wherein the diametrically opposed peel lines have an axially extending pitch. The introducer further includes a pair of spreadable handles associated with the proximal end of the sheath for splitting the sheath along the peel lines.

Abstract: A device and method for slitting a first elongated flexible catheter/sheath used with an elongated flexible component. The device includes a handle, an elongated groove and a cutter member. The cutter member has a sharp distally located cutting edge and a top surface from which a finger projects distally. The cutting edge is located under the finger and is arranged to be located within the annular space between the component and the first catheter/sheath when the first catheter/sheath is within the groove. The cutting edge serves to slice the first catheter/sheath longitudinally when the first catheter/sheath is pulled in a proximal direction. The finger protects the component from injury.

Abstract: A splittable/peelable tubular body (2) of a catheter or sheath wherein the tubular body (2) has a splittable/peelable atraumatic tip (14) is disclosed. The atraumatic tip (4) is generally softer than the tubular body (2). The tubular body (2) and atraumatic tip (4) each comprise a peel mechanism longitudinally extending along their respective lengths. The peel mechanisms are formed by longitudinally extending regions of interfacial bonding (11) between first and second longitudinally extending strips (8, 10) of polymer material. Each strip (8, 10) forms at least a portion of an outer circumferential surface of the tubular body (2) and atraumatic tip (4). A region of stress concentration extends along the region of interfacial bonding. The stress concentration facilitates the splitting of the tubular body (2) and atraumatic tip (4) along their respective peel mechanisms.

Abstract: A medical device is provided including a catheter shaft having a lumen extending therethrough with a splittable wall portion along a side of the lumen, and a tube that extends through at least a portion of the lumen and is configured to provide a patent path of fluid communication.

Abstract: A body (2) for a catheter or sheath is disclosed. The body (2) includes strips (8, 10) formed longitudinally from the proximal (6) portion of the body (2) to the distal (4) portion of the body (2). The strips are formed of different materials. The strips can have different radiopacities, or can be splittable/peelable. The splittable/peelable body comprises a peel mechanism longitudinally extending along its respective length. The peel mechanism can be formed by longitudinally extending regions of interfacial bonding between first and second longitudinally extending strips of polymer material. A region of stress concentration extends along the region of interfacial bonding. The stress concentration facilitates the splitting of the body (2) along its peel mechanism. The polymer material of the first strip (8) can have a greater amount of radiopaque filler than the polymer material of the second strip (10). Each strip forms at least a portion of an outer circumferential surface of the body (2).

Abstract: A method and apparatus for uncoupling a wire guide from and elongate medical device comprising a catheter shaft having a wire guide lumen extending there through, wherein the material surrounding the wire guide lumen is selected or adapted to facilitate splittability for removal of the wire guide. The catheter shaft includes a wire guide port having a stress riser, the stress riser being configured to reduce the force necessary to rupture or split the portion of the shaft wall adjacent to the wire guide port. In a preferred embodiment, the catheter shaft is coextruded and comprises a plurality of materials. The portion of the shaft adjacent the wire guide lumen is formed from a material is selected or adapted to facilitate splittability as compared to the remaining shaft materials.

Abstract: A connection system for connecting a hemostasis valve to a splittable sheath is disclosed. The connection system includes an adapter fitting having a shaft defining a lumen. The shaft has a proximal end and a distal end. On an external surface of the proximal end of the shaft, threading is provided for engagement with the hemostasis valve. A cannula portion defines the distal end of the shaft for interfacing with a splittable sheath. A wedge is disposed on an external surface of the cannula portion for interfacing with a weakened portion of the splittable sheath. A sliding connector is disposed about the shaft for engagement with the splittable sheath. Upon a first level of engagement between the sliding connector and the splittable sheath, a fluid-tight seal is created. Upon a second level of engagement between the sliding connector and the splittable sheath, the wedge initiates separation of the splittable sheath.

Abstract: A minimal incision maximal access system allows for maximum desirable exposure along with maximum access to the operative field utilizing a minimum incision as small as the METRx and Endius systems. Instead of multiple insertions of dilating tubes the design is is a streamlined single entry device to avoid repetitive skin surface entry. The system offers the capability to expand to optimum exposure size for the surgery utilizing hinged bi-hemispherical or oval working tubes applied over an introducer obturator which is controllably dilated to slowly separate muscle tissue. Deeper end working and visualization areas with maximum proximal access and work dimensions are provided to makes the operative procedure safer in application and shorten the surgeons's learning curve because it most closely approximates the ability to use open microdiskectomy techniques.

Abstract: A tool for protecting a cardiac stimulating lead from damage upon passing through a hemostasis valve of a vascular introducer in the course of an implantation procedure comprises a splittable, peal-away sheath that is rendered sufficiently rigid by a tool dilator or placement of the lead body within the sheath so that the combination can be forced through a self-closing aperture formed through the hemostatic valve member. The use of the tubular sheath in breaching the self-closing aperture shields the lead electrodes and any covering that may be present from becoming distorted as well as from contamination by silicon oil commonly found in vascular introducers having a hemostasis valve.