Abstract: Devices, systems, and methods for performing ablation therapy on body tissue are disclosed. An example ablation device for treating body tissue includes an ionically conductive balloon and a radio-frequency electrode that delivers RF energy into a distal section of the balloon. The balloon is configured to transmit the RF energy in a direction distally towards a leading end of the ablation device. Multiple ablation electrodes on the device can be used for providing lesions of different size or shape.

Abstract: A method for performing a surgical procedure within lungs of a patient. The method comprising the steps of providing a plurality of surgical instruments and providing a housing. Attaching a flexible, elongated shaft with distal and proximal ends to the housing. Engaging at least one working end to the distal end of the housing, the working end including a plurality of tubes disposed therein that define a corresponding plurality of working channels for housing a corresponding plurality of surgical instruments. Controlling an actuator to engage at least one of the corresponding plurality of surgical instruments, wherein rotation of the working end with respect to a longitudinal axis of the elongated shaft engages at least one of the plurality of surgical instrument with the actuator to deploy the at least one surgical instrument to the lung as needed during a surgical procedure.

Abstract: A method for performing a surgical procedure within lungs of a patient. The method comprising the steps of providing a plurality of surgical instruments and providing a housing. Attaching a flexible, elongated shaft with distal and proximal ends to the housing. Engaging at least one working end to the distal end of the housing, the working end including a plurality of tubes disposed therein that define a corresponding plurality of working channels for housing a corresponding plurality of surgical instruments. Controlling an actuator to engage at least one of the corresponding plurality of surgical instruments, wherein rotation of the working end with respect to a longitudinal axis of the elongated shaft engages at least one of the plurality of surgical instrument with the actuator to deploy the at least one surgical instrument to the lung as needed during a surgical procedure.

Abstract: Devices, systems, and methods for performing ablation therapy on body tissue are disclosed. An example ablation device for treating body tissue includes an ionically conductive balloon and a radio-frequency electrode that delivers RF energy into a distal section of the balloon. The balloon can have a composite structure with a non-conductive section and a conductive section. A method for fabricating a semi-permeable ablation balloon using ionizing radiation and an etching process is also disclosed.

Abstract: A catheter and catheter system for eccentric remodeling and/or removal of atherosclerotic material of a blood vessel of a patient include an elongate flexible catheter body with a radially expandable structure. A plurality of electrodes or other electrosurgical energy delivery surfaces can radially engage atherosclerotic material when the structure expands. An atherosclerotic material detector near the distal end of the catheter body may measure circumferential atherosclerotic material distribution, and a power source selectively energizes the electrodes to eccentrically remodel the measured atherosclerotic material.

Abstract: An electrosurgical wand. At least some of the illustrative embodiments are electrosurgical wands configured as a surgical forceps including opposed legs that defines respective distal end portions, the legs of the forceps operable to be actuated between an open position and a closed position, an active and return electrode disposed on one of the respective distal end portions, a discharge aperture on one of the distal end portions coupled to a first fluid conduit, and an aspiration aperture through the return electrode on the other of the distal end portions fluidly coupled to a second fluid conduit. In embodiments, the position of the forceps' legs, and the electrical energy applied to the electrodes, is adjusted to provide dissection or coagulation to the tissue. A stop or latch on the forceps' legs may maintain the active and return electrode a fixed distance from one another.

Abstract: An end effector assembly is presented including a pair of first and second jaw members configured to move from a first position in spaced relation relative to one another to a second position for grasping tissue therebetween. The end effector assembly further includes an actuation mechanism configured to actuate the first and second jaw members relative to an elongated shaft attached to a flexible catheter having a longitudinal axis defined therethrough. Additionally, a spring mechanism is disposed between a supporting member and a distal most end of the elongated shaft, the spring mechanism configured to apply constant sealing pressure between the first and second jaw members irrespective of angular displacement of the elongated shaft.

Abstract: A number of orthopedic surgical instruments are also disclosed. A method, apparatus, and system for fabricating such instruments are also disclosed.

Abstract: A titanium body (2) of a femoral nail incorporates an opening (3) leading into a hollow region (4) which defines a cavity in which electronics may be incorporated. A potting compound overlays the electronics, within the region (4). A 100 to 150 ?m thick cover (18) made from polyetheretherketone is arranged to overlay the opening (3) and close the hollow region (4). The cover (18) is made from flat polyetheretherketone film of suitable thickness which is heat shrunk onto a former and then machined to define the desired shape.

Abstract: A patient specific instrument for use in a ball and socket joint arthroplasty procedure, method of manufacture and method of use are described. The instrument comprises an attachment mechanism for attaching the instrument to the socket of the patient, which has at least first and second parts which can engage the rim of the socket of the patient. Each part is shaped, or can transform to a shape, to match the shape of a respective portion of the rim of the socket. A body bears at least one guide formation for guiding a component to be used in the arthroplasty procedure. The instrument includes a locking mechanism by which the body and attachment mechanism can be assembled in a unique configuration into the patient specific instrument. The patient specific instrument is attachable to the socket of the patient only at a single pre-planned position.

Abstract: A surgical positioning apparatus (400) comprises a surgical positioning device (412) and a levelling device (422). The surgical positioning device (412) comprises a securing assembly (416), a locating arrangement (418) securable to the securing assembly in a selected position of the locating arrangement, and an indicating arrangement (420) securable to the securing assembly in a selected position of the indicating arrangement. The locating arrangement (418) comprises a locating member (432) to locate the positioning device in a desired orientation relative to a first article. The indicating arrangement (420) comprises an indicating member (488) to indicate the position of a second article relative to the first article. The levelling device (422) can be mounted on the surgical positioning device (412) to facilitate orientation of the surgical positioning device relative to the vertical.

Abstract: A surgical apparatus includes an orientation sensor that detects an actual orientation of a surgical tool. The apparatus also includes a tactile orientation feedback device that selectively provides a tactile orientation feedback signal. Moreover, the apparatus includes a controller that causes the tactile orientation feedback device to provide the tactile orientation feedback signal when the actual orientation of the surgical tool detected by the orientation sensor is substantially equal to a predetermined target orientation of the surgical tool.

Abstract: A hydraulic cement composition comprises a mixture of (a) a cement powder composition which is soluble or partly soluble in water, (b) a non-aqueous water-miscible liquid, and (c) an aqueous hydration liquid. Methods of producing a hardened cement, hardened cements, kits, and articles of manufacture employ such compositions.

Abstract: A non-aqueous hydraulic cement composition comprises a non-aqueous mixture of (a) ?-tricalcium phosphate powder, (b) monocalcium phosphate powder, and (c) non-aqueous water-miscible liquid, wherein (i) at least about 90% of the monocalcium phosphate powder has a grain size in a range of about 200-600 ?m and the powder (weight) to liquid (volume) ratio is about 2.5-5.5, (ii) at least about 90% of the monocalcium phosphate powder has a grain size in a range of about 1-400 ?m and the powder (weight) to liquid (volume) ratio is about 2-5, or (iii) at least about 90% of the monocalcium phosphate powder has a grain size in a range of about 1-600 ?m and the powder (weight) to liquid (volume) ratio is about 2.5-5.5. Methods, hardened cements, articles of manufacture and kits employ such compositions.

Abstract: Internal bone fixation devices and methods for using the devices for repairing a weakened or fractured bone are disclosed herein. In an aspect, a device for repairing a fractured bone includes a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, the delivery catheter having an inner void for passing at least one reinforcing material, and an inner lumen for accepting a light pipe, wherein a distal end of the inner lumen terminates in an optical lens; a conformable member releasably engaging the distal end of the delivery catheter, the conformable member moving from a deflated state to an inflated state when the at least one reinforcing material is delivered to the conformable member; and an adapter releasably engaging the proximal end of the delivery catheter for receiving the light pipe and the at least one reinforcing material.

Abstract: A non-aqueous hydraulic cement composition comprises a non-aqueous mixture of (a) ?-tricalcium phosphate powder, (b) monocalcium phosphate comprising monocalcium phosphate anhydrous (MCPA), monocalcium phosphate monohydrate (MCPM), or a combination thereof, and (c) non-aqueous water-miscible liquid, wherein a 0.1 g/ml saturated aqueous solution of the monocalcium phosphate has a pH less than 3.0. Methods of producing a hardened cement, hardened cements, kits, and articles of manufacture employ such compositions.

Abstract: A general uterine manipulator 10 incorporates an elongated hollow tube 12 defining an internal passage 14. Tube 12 has opposite first and second ends 16 and 18, formed with internal threads T1 and T2; and a smooth continuous outer surface 20 of constant outer diameter. A first fitting comprising a tail screw 22 is screwed into thread T1 and a second fitting cervical screw 24 is screwed in thread T2. An inner manipulator rod 26 extends through the first fitting 22, tube 12, and second fitting 24. A range of alternate first and second fitting is provided. A forceps holder 70 is attachable to the tube 12 between ends 16 and 18. The manipulator 10 may also support a cervical funnel 90 and a plug 92.

Abstract: A medical retrieval device may include an elongated member having first and second end portions and a middle portion. The elongated member may be configured such that the first and second end portions are proximal one another and extend substantially parallel to one another along a longitudinal axis. The middle portion may have an unconstrained basket configuration. A first sheath may be configured to receive at least a portion of the first end portion, and a second sheath may be configured to receive at least a portion of the second end portion. At least one of the first and second sheaths may be movable relative to the middle portion so as to constrain the middle portion in an elongated configuration.

Abstract: A medical device includes a sheath defining a lumen, a first elongate member, and a second elongate member. The first and second elongate members are movably disposed within the lumen. The medical device further includes a basket comprising a plurality of legs and a mesh portion. A proximal end of each leg of the plurality of legs is connected to the first elongate member, and a proximal end of the mesh portion is connected to the second elongate member.

Abstract: The present technology is directed generally to tapered, curved stylets for inserting spinal cord modulation leads, and associated systems and methods. In some embodiments, the stylet includes a handle and a shaft the shaft having a proximal portion adjacent to the handle, a distal portion adjacent to the proximal portion, and a rounded tip. The proximal portion can be elongated along a longitudinal axis and can have a generally constant diameter. The distal portion can have a tapered section with a diameter that decreases in a distal direction, and a pre-set curve with respect to the longitudinal axis. The rounded tip can have a diameter greater than or equal to the smallest diameter of the distal portion.

Abstract: A biopsy tool for MR imaging for operation by a robot arm is formed of relatively brittle ceramic materials which have a magnetic susceptibility which is substantially equal to that of human tissue. The tool has designed slip couplings and bend joints to prevent overloading of forces on the sampling jaws. Cleaning ports are integrated into the design so that sterility can be obtained by flushing the device interior with a cleaning fluid. A novel spring-loaded capstan operated by a crank movable longitudinally of the tool ensures proper cable tension. A unique jaw shape enables a cutting pressure to be applied simultaneously around the desired tissue and does not depend on sharp edges to obtain the sample. Springs in the main casing provide cable tensioning to keep the jaws in a default closed position for movement of the biopsy device along a trajectory to the sample to be acquired.

Abstract: A surgical instrument for performing treatment to a treatment target portion includes a cylindrical elongated member; a treatment part, and a connection part. The connection part includes a first turning axis part provided to the elongated member, a second turning axis part provided to the treatment part, a first rolling guide part that is provided to the elongated member and includes a circular-arc-shaped part coaxial with the first turning axis part, a second rolling guide part that is provided to the treatment part and includes a rolling guide part including a circular-arc-shaped part coaxial with the second turning axis part, the rolling guide part rollingly contacting the first rolling guide part, and an engaging part that brings the treatment part and the elongated member into an engaging state. The connection part is detachable between the first turning axis part and the second turning axis part.

Abstract: A medical trajectory guide includes a base a configured for alignment with a coordinate axis, a first guide member rotatably attached to the base, a guide sleeve guided by the first guide member, and a motor coupled to the first guide member and configured to rotate the first guide member in relation to the first axis. The first guide member is rotatable about a first axis.

Abstract: A method for moving an instrument aim of a laparoscopy robot into a predeterminable position relative to a trocar placed in a patient is proposed. A spatial marker that can be localized from outside of the patient is applied to the trocar. The spatial position of the trocar is detected based on the spatial marker. The intended position of the instrument arm is established from the spatial position and the relative position. The actual position of the instrument arm is detected. The instrument arm is moved into the intended position based on the actual position, the intended position and an error minimization method.

Abstract: An abrasive tip is used to exfoliate skin and tissue through abrasive materials integrated in the tip. The tip also delivers fluid to the skin and vacuums the fluid and abraded tissue during treatment. Treated skin will look younger and healthier in appearance. In an implementation, the tip is replaceable and disposable.

Abstract: A tissue displacing and fastening device is provided for manipulating and fastening tissue together. The device includes a tissue displacing elements, which displaces tissue. A fold is formed from the displaced tissue and the tissue is fastened together to secure the fold.

Abstract: A tissue displacing and fastening device is provided for manipulating and fastening tissue together. The device includes a tissue displacing elements, which displaces tissue. A fold is formed from the displaced tissue and the tissue is fastened together to secure the fold.

Abstract: The invention provides a surgical fastening or suturing device. The device of the invention has a slender shaft and an actuating mechanism configured to eject a surgical fastener from the distal end of the shaft or configured to perform suturing at the distal end of the shaft. The device also has an attachment arrangement for attaching a piece of surgical mesh material onto an external lateral surface of the shaft and around the distal end of the shaft.

Abstract: A surgical device of suturing vascular vessels is described, as well as methods for suturing tissue employing the surgical device. In one form the device includes a distal member that contains a suture and needle engaging fitting. A needle is advanced through tissue adjacent the puncture wound and into the needle engaging fitting to draw lengths of suture material which can then be used to close the puncture wound. In another form the device includes a needle advanceable through tissue and into a needle capture element within a distal end of the surgical device to draw lengths of suture material which can then be used to close various puncture wounds. In still another form the device includes at least one needle advanceable to draw lengths of suture material to close various puncture wounds. A foot is pivotal between a non-deployed and a deployed position.

Abstract: The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.

Abstract: The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.

Abstract: A device and method for delivering a graft or synthetic mesh for anatomical repair to the repair site, with the graft or synthetic mesh in position for attachment to repair the defect. A plurality of spaced apart, flexible fingers is connected to the graft or synthetic mesh. The flexible fingers are initially in a position that is generally parallel to a direction of travel of the actuator. The actuator moves the plurality of flexible fingers from the initial to form a radial array, which opens or extends the graft or synthetic mesh. The graft or synthetic mesh may then be attached. A novel trocar is disclosed that is useful with the device. A measuring device including a measuring scale that is useful for determining the required size of the graft is also disclosed.

Abstract: A tissue displacing and fastening device is provided for manipulating and fastening tissue together. The device includes a tissue displacing elements, which displaces tissue. A fold is formed from the displaced tissue and the tissue is fastened together to secure the fold.

Abstract: This disclosure is directed to systems and methods for providing a guiding device having a dilatable, drilling tip. The tip is formed by wound helical members such that resistance to rotation in an unwinding direction dilates the tip. The helical members are configured so that the dilatable tip increases in stiffness when the helical members are tensioned by a resistance to rotation in the winding direction. In some embodiments, application of relative force between coaxial inner and outer tubular members is used to control the dilation, stiffness and drilling of the guiding member.

Abstract: An intravascular catheter device is provided for use during a surgical procedure. The catheter device includes a catheter tube having an expandable portion with a plurality of struts each defining an outer surface. The expandable portion is operable between a closed position, wherein the expandable portion has a first diameter, and an opened position, wherein the expandable portion has a second diameter that is larger than the first diameter. An incising element is provided on the outer surface of at least one of the struts. The incising element has a blade that extends outwardly in a radial direction from the outer surface of the strut for creating an incision in atherosclerotic material located within a blood vessel when the expandable portion is in the opened position.

Abstract: A method of increasing blood flow through an obstructed blood vessel includes providing an expandable member substantially made of a mesh having a plurality of interstices. The expandable member is inserted into the blood vessel, positioned within the blood vessel with the proximal member end upstream of the distal member end and the member body located radially adjacent at least a portion of an obstruction, and expanded to bring at least a portion of the member body into contact with the obstruction. An outward radial force is exerted on the obstruction to dislodge at least one fragment from the obstruction and to enhance blood flow through the blood vessel past the obstruction. The at least one fragment is passed through at least one interstice of the member body in the radial direction, and is selectively retained within the expandable member.

Abstract: A method of increasing blood flow through an obstructed blood vessel includes providing an expandable member substantially made of a mesh having a plurality of interstices. The expandable member is inserted into the blood vessel, positioned within the blood vessel with the proximal member end upstream of the distal member end and the member body located radially adjacent at least a portion of an obstruction, and expanded to bring at least a portion of the member body into contact with the obstruction. An outward radial force is exerted on the obstruction to dislodge at least one fragment from the obstruction and to enhance blood flow through the blood vessel past the obstruction. The at least one fragment is passed through at least one interstice of the member body in the radial direction, and is selectively retained within the expandable member.

Abstract: An electronic odor sensor is used in conjunction with a surgical tool, for example when wounds are cleansed to remove dead tissue and exudates, known clinically as debridement. The surgical tool will atomize substrate tissues and thereby mechanically generate vapors that can be sensed. Abrasion will likewise atomize substrate tissues liberating odors. Air near the surgical tool is collected and fed into the electronic odor sensor. The odor is analyzed by the sensor and a signal fed back based on the analysis.

Abstract: Disclosed are methods and systems for treatment planning for deep brain or superficial neuromodulation using ultrasound and other treatment modalities impacting one or multiple points in a neural circuit to produce acute effects or Long-Term Potentiation (LTP) or Long-Term Depression (LTD) to treat indications such as neurologic and psychiatric conditions. Ultrasound transducers or other energy sources are positioned and the anticipated effects on up-regulation and/or down-regulation of their direction of energy emission, intensity, frequency, firing/timing pattern, and phase/intensity relationships mapped onto the recommended treatment-planning targets. The maps of treatment-planning targets onto which the mapping occurs can be atlas (e.g., Tailarach Atlas) based or image (e.g., fMRI or PET) based. Atlas and imaged-based maps may be representative and applied directly or scaled for the patient or may be specific to the patient.

Abstract: The present invention relates to a device and method for cutting an annular piece out of the soft tissue of a selected mammal. The device can be utilized in surgical situations such as capsularhexis. The device comprises one or more blades which when rotated, cut an annular path.

Abstract: A blood lancet device comprising a housing having one end formed as an opening; a sliding sleeve having one end extending from the opening to the outside of the housing; a blood lancet including a needle body and a needle tip arranged at one end of the needle body, the sliding sleeve being bushed at the outside of the housing, said blood lancet adapted to move relative to the sliding sleeve so as to expose the needle tip at the opening; and a biasing member having one end securely fixed with another end of needle body.

Abstract: Provided is a safety lancet including a reload double prevention structure for preventing a sliding block having a lancet needle from being reloaded to obtain blood, thereby fundamentally preventing reuse of the safety lancet. In addition, the safety lancet guides the sliding block to be straightly discharged without shaking, thereby minimizing pain when the lancet needle is inserted into a skin. The safety lancet includes an outer case forming a space part therein, an inner case sliding along the space part of the outer case, and having a through hole in a front end thereof, and a sliding block coupled to the inner case to straightly move along an inner portion of the inner case, and elastically supported within the outer case by a coil spring, wherein the sliding block comprises a lancet needle having an end protruding from a front end thereof, and a pair of loading hooks on both sides of a rear end thereof to engage with engagement protrusions of the inner case.

Abstract: The lancet device includes a housing and a lancet having a puncturing element. The lancet is disposed within the housing and is adapted for axial movement between an initial or pre-actuated position wherein the puncturing element is retained within the housing, and a puncturing position wherein the puncturing element extends through a forward opening in the housing. The lancet device includes a drive spring disposed within the housing for biasing the lancet toward the puncturing position, and a retraction or return spring for returning the lancet to a position within the housing where the puncturing element is disposed within the housing. The retraction spring thereafter maintains engagement with the lancet to assist in preventing the puncturing element from again projecting outward from the forward opening in the housing.

Abstract: An obturator assembly for use in dissection of tissue includes an obturator housing, an obturator member mounted to the obturator housing and an obturator sleeve coaxially mounted about the obturator member and adapted for reciprocal longitudinal movement between a retracted position and an extended position. The obturator member includes an obturator rod and a penetrating end. The obturator sleeve has a nose adjacent the penetrating end. The penetrating end defines outer edges leading toward a distal end surface. The outer edges are at least partially exposed from the nose when in the extended position of the obturator sleeve.

Abstract: The invention relates to a puncturing system for generating a puncture wound for obtaining a sample of a body fluid, comprising a press-on part to be pressed onto a body part in which a puncture wound is to be generated, a triggering means with which a user can trigger a puncturing motion of a puncturing element after the press-on part is pressed on, and a testing facility for determining a test parameter on which a sample-obtaining probability depends. A securing facility is also provided that, in a locked state, locks the triggering means and, in a triggering state, releases the triggering means such that a puncturing motion can be triggered by actuation thereof. The securing facility is transitioned from the locked state to the triggering state by the testing facility when the test parameter determined by the testing facility meets defined minimum requirements.

Abstract: Devices and methods for treating vascular defects, such as, for example, balloon-type aneurysms, are described herein. In one embodiment, an apparatus includes an insertion portion and an expandable implant. The expandable implant is configured to be deployed in an aneurysm and is coupled to the insertion portion. The expandable implant has a first portion and a second portion coupled to the first portion. The expandable implant is movable between a first configuration in which the first portion and the second portion are substantially linearly aligned and a second configuration in which the second portion at least partially overlaps the first portion.

Abstract: Systems, devices, and methods comprising an instrument for expanding a paranasal sinus. The instrument may comprise an expandable disposable medical device is adapted to extend away from a distal portion of a shaft of an insertion device.

Abstract: A vaso-occlusive device includes a coil made from coil wire, wherein the coil wire includes a core containing a core material having a first electrical potential covered by a coating containing a coating material having a second electrical potential, wherein the second electrical potential is less than the first electrical potential. A method of manufacturing a vaso-occlusive device includes cladding a core with a magnesium containing coating to form a wire, wrapping the wire around a mandrel to form a coil, and heat-setting the coiled wire. A method of occluding a body cavity with a vaso-occlusive device includes delivering the vaso-occlusive device to a body cavity and inducing a reduction reaction in the body cavity and adjacent the vaso-occlusive device, wherein the reduction reaction reduces infections and promotes cell proliferation in the body cavity.

Abstract: Embolic implants, delivery systems and methods of manufacture and delivery are disclosed. The devices can be used for aneurysm treatment and/or parent vessel occlusion. Implant designs offer low profile compressibility for delivery to neurovasculature, while maintaining other necessary features such as density for occlusion purposes and desirable radial strength characteristics.

Abstract: Apparatus for sealing a puncture through tissue to a blood vessel includes a cartridge including a proximal end, a distal end sized for insertion into a puncture, and a lumen extending therebetween. A bioabsorbable plug is disposed within the lumen adjacent the distal end, and an anchoring element is disposed within the lumen proximal to the plug. A pusher member is disposed within the lumen for deploying the plug and anchoring element out the distal end of the cartridge. The plug may be formed from lyophilized hydrogel and the anchoring element may be formed from air-dried hydrogel, the anchoring element hydrating slower than the plug when exposed to an aqueous environment. During use, the plug and anchoring element are delivered into the puncture, the plug is cinched against the vessel wall. Protrusions on the anchoring element engage tissue surrounding the puncture to prevent proximal movement of the plug.