Abstract: Total occlusions are crossed by passing a guidewire or other penetrating wire from a point proximal to the occlusion into a subintimal space between the intimal layer and adventitial layer of the blood vessel wall. The wire is advanced to a point distal to the occlusion and thereafter deflected back into the blood vessel lumen, typically using a deflecting catheter which is advanced over the guidewire after it has been positioned within the subintimal space. After the guidewire is returned to the blood vessel lumen, the deflecting catheter may be withdrawn and the guidewire is available for introduction of other interventional and diagnostic catheters.

Abstract: A medical apparatus for dispensing a biologically active compound. The medical apparatus includes a sleeve, wherein (1) the sleeve has a working channel defined therein through which medical instruments may be advanced, (2) the sleeve includes a fluid delivery channel which is distinct from the working channel, (3) the fluid delivery channel has an exit, and (4) the sleeve includes a housing having an interior cavity defined therein. The medical apparatus also includes an insufflation valve in fluid communication with the working channel. The insufflation valve is positionable between an open position and a closed position such that (i) when the insufflation valve is located in the open position an insufflation gas can be advanced into the working channel and (ii) when the insufflation valve is located in the closed position the insufflation gas is prevented from being advanced into the working channel.

Abstract: A method is provided for delivering a drug to a selected tissue region within a patient's body with a catheter having a deployable puncturing element, a drug delivery element and an orientation element on a distal portion thereof. The distal portion of the catheter is percutaneously introduced into a blood vessel, and directed endovascularly to a vessel location adjacent to the selected tissue region. The puncturing element is oriented towards the selected tissue region, and deployed to access the selected tissue region. A drug is delivered with the drug delivery element to the selected tissue region.

Abstract: Methods, systems, and kits for subcutaneously implanting articles, such as drug inserts and reservoirs. The methods rely on percutaneously forming a tissue tract and radially dilating the tract to a diameter which permits introduction of the article. By fully expanding the lumenal diameter of the tissue tract prior to introduction of the article, damage to the article resulting from passage through a partially expanded tissue tract can be avoided. In the exemplary embodiment, a radially expandable sleeve is first percutaneously introduced to the subcutaneous target site. An assembly of a cannula and dilator is then passed through the sleeve, effecting radial expansion. The dilator is removed and the article is then introduced through a lumen of the cannula.

Abstract: A retractable needle cannula module for connecting to a conventional syringe has a biased spring needle cannula. The spring needle cannula is biased and locked to prevent the spring needle cannula from pulling the needle into the hub chamber. After medicament has been injected into a body, the spring needle cannula is released and trapped inside the hub chamber.

Abstract: An apparatus delivers an agent to a treatment region, the apparatus having an outer cannula or lumen that has an internal surface and an external surface, the external surface being substantially smooth to penetrate tissue whereas the distal end is tapered; an inner cannula, or lumen coaxial to the outer cannula, providing a common fluid path (that is the same fluid passes through both the inner cannula and outer cannula) at the distal end with the inner surface of the outer cannula; a source of fluid to be passed through the common fluid path, the source of fluid comprising at least a reservoir of nutrients and/or gases for maintaining cells contained in a lumen coaxial and internal to the inner cannula; a semipermeable membrane comprises the surface of the lumen, thus allowing controlled material transport across the lumen surface; a source of cells or other biologically active material mass flow connected to the proximal lumen so that the cells or other biologically active material can exit the distal port

Abstract: A system and method is provided for maintaining a proper intervertebral disc height during the replacement or augmentation of the spinal disc. In one embodiment, a cannulated distractor is used to distract the adjacent vertebrae and maintain a proper disc space height. The cannulated distractor is fluidly connected to a source of fluent material for injection into the disc space. The distraction includes a distraction tip resident within the disc space that includes a central lumen and a number of openings communicating with the lumen to dispense the fluent material within the disc space.

Abstract: Methods and apparatuses for inserting a catheter into a patient. In one exemplary embodiment, a guide-tube is disposed within the catheter lumen to guide the insertion of the catheter into a patient. The catheter having two ends and at least a catheter lumen and is surrounded by a catheter wall. The guide-tube is hollow, and having a guide-tube lumen which is surrounded by a guide-tube wall. The dimension of the guide-tube is less than that of the catheter lumen.

Abstract: A needle and obturator assembly for access to entrance lumens in an access device disposed subcutaneously in a body of a mammal, for transfer of fluid into and/or out of the mammal body, comprising a first needle and obturator unit for insertion through a skin portion of the mammal body and into a first of the lumens of the access device, a second needle and obturator unit for insertion through the skin portion of the mammal body and into a second of the lumens of the access device, and hub structure for supporting the first and second needle and obturator units in fixed, spaced-apart positions relative to each other after complete insertion of the first and second needle and obturator units in the respective lumens. The first and second obturators are withdrawable from their respective needles to open first and second passageways in the respective needles for the transfer of fluid into and/or out of the access device.

Abstract: A set of cannulae for tissue injections is disclosed. The cannulae are ideally suited for tissue injections in the human body. In particular, the cannulae are well-suited for muscle injections in the human face. Each cannula injecting device includes a hub attached to a tubular needle with a blunt tip or spatula-like tip. The tubular needle is curved and includes a side opening located near the tip.

Abstract: A kit includes a point-of-care testing cartridge and a blunt cannula assembly. The blunt cannula assembly includes a blunt cannula that has a filter therein for filtering cellular components from whole blood and enabling plasma to be delivered by the blunt cannula to the testing cartridge.

Abstract: The present invention comprises a vulnerable plaque treatment catheter arrangement for the treatment of a lipid pool at a site of vulnerable plaque within an artery. The catheter arrangement includes an elongated, hollow, flexible shaft having a proximal end and a distal end and an elongated, flexible, steerable, lipid-enterable needle arranged within the shaft. The needle has at least one lumen therethrough in communication with a treatment source, to permit the rendering of the lipid pool into an innocuous entity.

Abstract: A catheter and introducer needle assembly with needle shield is provided wherein the needle includes an enlarged diameter portion and a distally facing shoulder. The needle shield includes a means for engaging the distally facing shoulder to prevent unwanted distal movement of the needle once the needle has been withdrawn into the needle shield. The needle shield also includes a small diameter opening adjacent to its proximal portion to limit proximal movement of the needle out of the needle shield.

Abstract: A device and method for delivering and injecting fluid into heart tissue utilizing a laterally directed needle to increase injectate (fluid) retention in the heart tissue. The device may comprise a catheter having a shaft wherein the distal end of the shaft includes a primary penetrating member and a secondary penetrating member. The secondary penetrating member includes an injection lumen in fluid communication with a pressurized fluid source. The primary penetrating member penetrates the heart tissue at the injection site in a first direction, and the secondary penetrating member penetrates the heart tissue in a second direction different from the first direction such that fluid leakage from the injection site is reduced and the volume of treated tissue is increased.

Abstract: A medical device (10) includes at least a stylet (12) for establishing the location of tissue of interest, such as a nonpalpable lesion in breast tissue. The device may also include a needle assembly (14) and an aspiration syringe (16). The medical device (10) can most readily be understood as an improvement in Kopans-type or hookwire-type localizer stylet having a wire shaft (18) with a distal end (28), and a hook (36) depending in a proximal direction from the wire shaft (18). The improvements entail spacing the hook (36) proximally of the distal end (28) of the wire shaft (18), and providing the wire shaft with a twist between the hook (36) and the distal end (28) of the wire shaft (18). Wire shaft (18) has first and second wire segments (20 and 30), each including a respective distal twisted portion (24 or 34) adjacent its respective distal end (22 or 32).

Abstract: Methods, systems, and kits for subcutaneously implanting articles, such as drug inserts and reservoirs. The methods rely on percutaneously forming a tissue tract and radially dilating the tract to a diameter which permits introduction of the article. By fully expanding the lumenal diameter of the tissue tract prior to introduction of the article, damage to the article resulting from passage through a partially expanded tissue tract can be avoided. In the exemplary embodiment, a radially expandable sleeve is first percutaneously introduced to the subcutaneous target site. An assembly of a cannula and dilator is then passed through the sleeve, effecting radial expansion. The dilator is removed and the article is then introduced through a lumen of the cannula.

Abstract: A transvascular system (10) for delivering a drug to a tissue region from a blood vessel, such as a coronary vein, includes a catheter (12) having a distal portion (26) with puncturing (14), orientation (16), drug delivery (62), and imaging elements (18). The puncturing element (14) is deployable for penetrating the vessel wall to access the tissue region. The orientation element (16), e.g. a “cage” including a plurality of struts (38) (40) and/or a radiopaque marker, has a predetermined relationship with the puncturing element (14), the imaging element (18) detecting the location of the orientation element (16) with respect to the tissue region to orient the puncturing element. The catheter (12) is percutaneously introducing into the vessel, the puncturing element (14) is oriented towards the tissue region, the puncturing element (14) is deployed to access the tissue region, and the drug is delivered to the tissue region.

Abstract: A syringe has a protective sleeve with finger seats effective in both axial directions and the thumb rest of the plunger is also effective in both axial locations, so that, after injection, the fingers and thumb are spread apart to advance the protective sleeve over the needle.

Abstract: The present invention provides a catheter head including a cannula housing, a needle holder connectable to the cannula housing and a guide sleeve associated with the needle holder for positioning and guiding a connecting needle, and for being narrowly slide-guided over a portion of said cannula housing.

Abstract: There is disclosed a clear view cannula for use in surgical procedures having a tubular body, a cylindrical sleeve mounted about and slidably secured to the tubular body, and a plurality of shield members secured to the cylindrical sleeve. The cylindrical sleeve is slidably movable relative to the tubular body causing the shield members to expand and deploy such that the shield members retain torn and fragmented soft tissue within an anatomical cavity. Means are provided on the tubular body to co-act with means on the cylindrical sleeve to lock the expanded and deployed shield members and secure the tubular body within an anatomical body.

Abstract: A catheter for injecting medicants into the endocardium, myocardium or other portions of the cardiovascular system is presented where the catheter has apertures therein for ejection and retraction of a needle. The catheter is designed for the apertures in the catheter to press against the tissue to be injected in the heart while the heart is beating. A needle for inserting a prescribed dose of a medicant is ejected through the aperture and a plunger, pump, or diaphragm is moved to deliver a dose of the medicant to tissue adjacent the aperture. By use of the catheter gene therapy, wherein a small does of a gene are injected into the endocardium of the right or left ventricle, can be used to grow new blood vessels in the injected area of a damaged heart. The apertures in the catheter can be spaced at a prescribed distance for the dosage of medicant to form a precise pattern of injections in the area to be treated.

Abstract: The present invention is directed to an apparatus for use in internal surgical procedures and is particularly advantageous for use in laparoscopic surgical procedures. An example implementation is directed to a tool having a depth-adjustable cannula having an upper portion that rests on the body, and having an automatically-sealing channel that readily accepts the insertion and removal of surgical instruments without permitting gases to pass. In one particular embodiment, the tool includes a low-profile platform for stabilizing the tool on a body layer, a projection channel with a flexible sleeve for maintaining the channel closed, and an adjustable member for setting the penetration depth of the tool. The flexible sleeve is sufficiently elastic to close the inner channel in response to pressurization between the outside of the flexible sleeve and the inner surface of the hollow channel. The low-profile platform and the adjustable member permit use of the same tool for different body-wall thicknesses.

Abstract: In a method and apparatus for delivering a composition to a targeted area of tissue, exposure of a non-targeted tissue to the composition is minimized. The apparatus has at least one needle-like shaft which is inserted through a track in the non-targeted tissue to deliver the composition to the targeted tissue through an opening in the shaft. The track may be a naturally occurring lumen in a tissue, such as a vascular lumen, or may be a track created surgically by a diagnostic instrument, or by the needle-like shaft of the present apparatus. A valve-like mechanism closes the opening in the shaft to prevent premature delivery of the composition during insertion of the shaft, and to prevent loss of composition during withdrawal of the shaft. The valve-like mechanism also prevents excessive delivery of the composition to targeted tissue. An annular dam is mounted on an exterior portion of the shaft near the opening.

Abstract: A Body Access System for the collection of samples and the administration of fluids comprising means to prevent complete withdrawal of a needle stylet, means to dispose of needles and needle stylets provides for limited exposure to samples collected, needle sticks and stylet sticks.

Abstract: A sheath is provided for covering a device on the distal end of a catheter system during the delivery of the device to an intravascular site within a patient. The sheath can be added to any delivery system prior to use and is intended to protect a deliverable device, such as an intravascular stent, from being dislodged prematurely from the catheter system or moved with respect thereto.

Abstract: A transvascular system for delivering a drug to a tissue region from a blood vessel, such as a coronary vein, includes a catheter having a distal portion with puncturing, orientation, drug delivery, and imaging elements. The puncturing element is deployable for penetrating the vessel wall to access the tissue region. The orientation element, e.g. a “cage” including a plurality of struts and/or a radiopaque marker, has a predetermined relationship with the puncturing element, the imaging element detecting the location of the orientation element with respect to the tissue region to orient the puncturing element. The catheter is percutaneously introducing into the vessel, the puncturing element is oriented towards the tissue region, the puncturing element is deployed to access the tissue region, and the drug is delivered to the tissue region.

Abstract: Total occlusions are crossed by passing a guidewire or other penetrating wire from a point proximal to the occlusion into a subintimal space between the intimal layer and adventitial layer of the blood vessel wall. The wire is advanced to a point distal to the occlusion and thereafter deflected back into the blood vessel lumen, typically using a deflecting catheter which is advanced over the guidewire after it has been positioned within the subintimal space. After the guidewire is returned to the blood vessel lumen, the deflecting catheter may be withdrawn and the guidewire is available for introduction of other interventional and diagnostic catheters.

Abstract: This invention relates to a sealing cannula device which can be easily and properly inserted while effectively sealing an incision made during a surgical or non-surgical process. The sealing cannula device includes a cannula sleeve having an external flange and tissue engaging threads. The screw threads on the external surface of the cannula sleeve allows the device to be easily screwed through an incision made in a body cavity wall or blood vessel until the tissue abuts against the flange. The vessel or body cavity wall is compressed between the flange and a flat surface formed by the helical thread. An effective compression seal is formed between the device and cavity or vessel wall which protects the puncture site from environmental contaminants. An axial through hole in the device provides vascular or body cavity access during surgical or non-surgical procedures.

Abstract: Devices and methods for performing percutaneous spinal surgery under direct visualization and through a single cannula are shown. A device (10) is provided which includes an elongated cannula (20) having a first inner diameter (DI) and an outer diameter (DO) sized for percutaneous introduction into a patient. The cannula (20) defines a working channel (25) between its ends (21, 22) which has a second diameter (D2) equal to the diameter (DI) of the cannula sized for receiving a tool therethrough. An elongated viewing element (50) is engageable to the cannula (20) adjacent the working channel (25), preferably by a fixture (30). The fixture (30) includes a housing (31) attachable to the proximal end (22) of the cannula (20) that defines a working channel opening (35) which is in communication with the working channel (25). The housing (31) also defines an optics bore (60) adjacent the working channel opening (35).

Abstract: A soft cannula including a flexible exosheath having a flexible, shape retainable annular member attached at one end. In one preferred embodiment the soft cannula includes a retrieval suture attached to the annular member. One end of the soft cannula is positioned within the patient's body cavity so that medical instruments may be inserted into the other and giving access to the patient's body cavity. The present invention also includes at least two preferred methods for inserting the soft cannula.