Abstract: An example method is provided for maintaining stability to an injury defined by a separation of two bones (e.g., the tibia and fibula), the separation being an injured distance greater than a pre-injury distance between the two bones in a first human patient. The method may include delivering a first apparatus for approximation of the two bones in the first human patient comprising the injury, the first apparatus including a flexible segment disposed between a first anchor and a second anchor. The method may further include maintaining, by the first apparatus, a restored distance between the two bones in the first human patient after a repetitive dynamic loading, the restored distance approximately equal to the pre-injury distance.

Abstract: An apparatus for the approximation of two bones with a first anchor having a proximal end and a distal end configured for insertion into a first hole in a first bone. A second anchor has a proximal end and a distal end configured for insertion into a second hole in a second bone. A flexible link extends between the first and second anchors limiting a spacing from the first anchor to the second anchor when in a deployed configuration. The first hole comprises a first diameter, the second hole comprises a second diameter and the first diameter is smaller than the second diameter. The second diameter is uniform across the entire length of the second hole.

Abstract: An apparatus for the approximation of two bones with a first anchor having a proximal end and a distal end configured for insertion into a first hole in a first bone. A second anchor has a proximal end and a distal end configured for insertion into a second hole in a second bone. A flexible link extends between the first and second anchors limiting a spacing from the first anchor to the second anchor when in a deployed configuration. The first hole comprises a first diameter, the second hole comprises a second diameter and the first diameter is smaller than the second diameter. The second diameter is uniform across the entire length of the second hole.

Abstract: Apparatus and methods are provided for the approximation of two bones, the apparatus including a first anchor that is rotationally driven into a first bone by a second bone anchor, which receives driving torque from a driver tool. After the first anchor is secured in the first bone, the second anchor is disengaged from the first anchor but remains connected to the first anchor by a flexible link of a designed length. The second bone anchor is secured in the second bone and has provisions to be lengthened or shortened to adjust the overall length of the implant, thereby adjusting the approximation between the two bones.

Abstract: Apparatus and methods are provided for the approximation of two bones, the apparatus including a first anchor that is rotationally driven into a first bone by a second bone anchor, which receives driving torque from a driver tool. After the first anchor is secured in the first bone, the second anchor is disengaged from the first anchor but remains connected to the first anchor by a flexible link of a designed length. The second bone anchor is secured in the second bone and has provisions to be lengthened or shortened to adjust the overall length of the implant, thereby adjusting the approximation between the two bones.

Abstract: Apparatus and methods are provided for the approximation of two bones, the apparatus including a first anchor that is rotationally driven into a first bone by a second bone anchor, which receives driving torque from a driver tool. After the first anchor is secured in the first bone, the second anchor is disengaged from the first anchor but remains connected to the first anchor by a flexible link of a designed length. The second bone anchor is secured in the second bone and has provisions to be lengthened or shortened to adjust the overall length of the implant, thereby adjusting the approximation between the two bones.

Abstract: A system for facilitating creation of a patient treatment plan includes components configured to receive at least one feature associated with patient data and search a database of previously planned radiation treatments to identify one or more matching plans from the database based on the at least one feature. Parameters corresponding to the identified matching treatment plans may be used to facilitate creation of the patient treatment plan.

Abstract: Apparatus and methods are provided for the approximation of two bones, the apparatus including a first anchor that is rotationally driven into a first bone by a second bone anchor, which receives driving torque from a driver tool. After the first anchor is secured in the first bone, the second anchor is disengaged from the first anchor but remains connected to the first anchor by a flexible link of a designed length. The second bone anchor is secured in the second bone and has provisions to be lengthened or shortened to adjust the overall length of the implant, thereby adjusting the approximation between the two bones.

Abstract: A system for facilitating creation of a patient treatment plan includes components configured to receive at least one feature associated with patient data and search a database of previously planned radiation treatments to identify one or more matching plans from the database based on the at least one feature. Parameters corresponding to the identified matching treatment plans may be used to facilitate creation of the patient treatment plan.

Abstract: Valves for medical devices and methods for making them are provided. In one embodiment, a valve is injection molded as a single piece that includes a tubular body and a flap. The tubular body includes an open first end, a closed second end, and a passage extending between the first and second ends defining a central longitudinal axis. The second end includes an end wall including a hole therein communicating with the passage. The flap is formed in the end wall over the hole and is movable away from the second end when an elongate device is introduced through the passage and the hole. Apparatus are also provided for delivering a medical device into a patient's body that includes an elongate tubular member including proximal and distal ends, a lumen extending between the proximal and distal ends; and a valve attached to the proximal end.

Abstract: Apparatus and methods are provided for substantially continuously forming thin-walled sleeves that may be incorporated into tubular devices sized for introduction into a patient. In one embodiment, a pair of sheets including coated surfaces oriented towards one another are directed through a cutting apparatus to cut the sheets into multiple pairs of strips. The pairs of strips are bonded together to create a plurality of sleeves having lumens defined by the coated surfaces. In another embodiment, a sheet having a coated surface is fed through a cutting tool to separate the sheet into a plurality of strips, and the strips are formed into sleeves, e.g., by feeding the strips through a die or mandrel using a substantially continuous process. Optionally, the sleeves may be subsequently cut into individual tubular devices and/or further processed, e.g., by providing one or more layers around the sleeves to create catheters, sheaths, or other apparatus.

Abstract: Splittable tubular devices and methods for making them are provided. In one embodiment, a tubular device includes a proximal end, a distal end sized for introduction into a body lumen, and a lumen extending between the proximal and distal ends. The tubular device includes an outer tubular layer defining a circumference; and a reinforcing layer bonded to the outer tubular layer, the reinforcing layer including a circumferential interruption. To make a tubular device, an elongate tubular reinforcing structure may be folded into itself to define first and second longitudinal edges, and rolled until the longitudinal edges are disposed adjacent one another. The reinforcing structure may be attached to a tubular structure such that the longitudinal edges define a circumferential interruption extending along a length of the tubular structure.

Abstract: Apparatus, systems, and methods are provided for delivering stem cells or other agents to cardiac tissue surrounding a cardiac vessel or to tissue adjacent other body lumens. The apparatus includes an expandable member and a source of one or more agents communicating with a lumen extending between proximal and distal ends of the apparatus. The distal end of the apparatus is advanced through one or more body lumens until the distal end is disposed within or adjacent the target body lumen. The target body lumen is sealed, e.g., by expanding the expandable member, thereby isolating the target body lumen. One or more agents are delivered into the target body lumen with sufficient pressure to extravasate the one or more agents into tissue surrounding the target body lumen.

Abstract: An apparatus for imaging a body structure within a body cavity includes a catheter including proximal and distal ends, an imaging element on the distal end, and an extension extending distally from the distal end for contacting a surface of a body cavity into which the catheter is introduced. The extension has a length to maintain the optical imaging element away from the surface. Optionally, a transparent member, e.g., an expandable balloon, may be attached to the distal end of the tubular member and the extension to isolate the imaging element from contact with fluid within the body cavity. During use, the catheter is inserted into a chamber of a beating heart, and the extension and/or balloon is placed against the wall of the chamber. Sufficient force is applied to stabilize the imaging element relative to the wall while the heart is beating.

Abstract: Coated devices for introduction into bodies and methods for making and using them are provided, such as delivery sheaths, guidewire lumen cores, and elongate leads. In one embodiment, a tubular device includes a proximal end, a distal end sized for introduction into a body lumen, and a lumen extending between the proximal and distal ends. The tubular device includes a relatively thin inner polyurethane liner including a coating on an inner surface thereof, e.g., providing a lubricious and/or hydrophilic lumen, and an outer layer surrounding the liner. In another embodiment, a lead is provided that includes a proximal end, a distal end, and at least one electrode on the distal end. A polyurethane cover surrounds at least a portion of an outer surface of the lead that include a coating, e.g., including a lubricious and/or hydrophilic material. Optionally, the cover may be removable from around the lead body.

Abstract: A method for making a tubular device includes coating a first surface of a thin sheet, rolling the sheet such that side edges of the sheet are disposed adjacent one another with the coating disposed inwardly, creating a longitudinal seam along the side edges to create a sleeve, and attaching a tubular structure around the sleeve. In another embodiment, the method includes coating a first surface of a thin sheet, wrapping the sheet partially around a mandrel with the coating disposed inwardly, positioning a slotted tube around the sheet and mandrel, attaching the tube to the thin, and trimming any excess material of the sheet. In another embodiment, the method includes coating an outer surface of a thin sleeve, inverting the sleeve, and attaching a tubular structure around the inverted sleeve, thereby providing a tubular device including a lubricious, hydrophilic, and/or otherwise coated inner surface.

Abstract: Apparatus and methods are provided for accessing a body lumen within a patient's body. Generally, the apparatus includes a tubular member including proximal and distal ends, a steering element extending between the proximal and distal ends, and an actuator for directing the distal end between a relaxed configuration and a complex curved configuration. In the relaxed configuration, the distal end may assume a straight or curved shape. In the complex curved configuration, the distal end may assume a curvilinear shape. In one embodiment, the complex curved configuration may include a first curved portion defining an arc within a plane, and a second portion that extends out of the plane. An embodiment with a left hand rule configuration may be introduced into the right atrium of a heart from a superior approach, and the complex curved configuration may facilitate accessing the coronary sinus.

Abstract: An apparatus for imaging a body structure within a body cavity includes a catheter including proximal and distal ends, an imaging element on the distal end, and an extension extending distally from the distal end for contacting a surface of a body cavity into which the catheter is introduced. The extension has a length to maintain the optical imaging element away from the surface. Optionally, a transparent member, e.g., an expandable balloon, may be attached to the distal end of the tubular member and the extension to isolate the imaging element from contact with fluid within the body cavity. During use, the catheter is inserted into a chamber of a beating heart, and the extension and/or balloon is placed against the wall of the chamber. Sufficient force is applied to stabilize the imaging element relative to the wall while the heart is beating.

Abstract: Apparatus and methods are provided for providing access to a body lumen. The apparatus includes a tubular member including a proximal end, a distal end sized for insertion into a body lumen, and a lumen extending therebetween. A pushable stiffening member extends from the distal end of the tubular member. An expandable sheath extends along at least a portion of the stiffening member, the sheath being expandable from a contracted condition to facilitate insertion into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen communicating with the tubular member lumen. A distal portion of the sheath is steerable, e.g., using a pull wire disposed within a lumen of the sheath or within the stiffening member. In addition or alternatively, the stiffening member may be biased to a predetermined shape to facilitate introduction.

Abstract: Apparatus and methods for locating morphological features within a body cavity using a catheter including proximal and distal ends, a transparent balloon carried on the distal end, and an optical imaging assembly carried on the distal end for imaging through the balloon. The balloon includes a channel extending therethrough to a lumen extending through the catheter. A guidewire or other localization member is received in the lumen that is extendable through the channel. During use, the catheter is inserted into a right atrium of a heart, and the balloon is expanded and placed against the wall of the heart to locate the coronary sinus. Sufficient force is applied to clear blood between the surface and the wall and clear the field of view of the imaging assembly. The catheter is manipulated to locate the coronary sinus, whereupon the localization member is advanced into the coronary sinus.