Abstract: Deflection mechanisms are disclosed that are positionable to deflecting portions of a flexible body, such as a catheter, in more than one direction in a single plane, as well as in more than one plane. The invention allows a distal portion of a catheter to be deflected more than 360 degrees to provide a loop.

Abstract: A device and method for cryosurgical ablation. A tip has a thermally transmissive region along a length thereof in which the thermally transmissive region is operable at a temperature sufficient to cryosurgically ablate tissue in contact therewith. A plurality of cryosurgical fluid injection lumens each have a first end positioned within the tip at a different point along the length of the thermally transmissive region. Each of the first ends is arranged to cool overlapping respective portions along the length of the thermally transmissive region when cryogenic fluid is ejected from the plurality of cryogenic fluid injection lumens.

Abstract: An elongated catheter device with a distal balloon assembly is adapted for endovascular insertion. Coolant injected through the device may, in different embodiments, directly cool tissue contacting the balloon, or may cool a separate internal chamber. In the first case, the coolant also inflates the balloon, and spent coolant is returned to the handle via a return passage extending through the body of the catheter. Plural balloons may be provided, wherein a secondary outer balloon surrounds a primary inner balloon, the primary balloon being filled with coolant and acting as the cooling chamber, the secondary balloon being coupled to a vacuum return lumen to serve as a robust leak containment device and thermal insulator around the cooling chamber. Various configurations, such as surface modification of the balloon interface, or placement of particles, coatings, or expandable meshes or coils in the balloon interface, may be employed to achieve this function.

Abstract: A medical implement that employs a mechanically supported expandable element. In one embodiment, the mechanically supported expandable element is a balloon. In another embodiment, the mechanically supported expandable membrane is a balloon disposed within a cryogenic catheter usable to treat tissue. A variety of illustrative mechanical support schemes are possible.

Abstract: A surgical device includes a device body defining a sealed fluid path having a first end and a second end, a refrigerant supply in communication with the first end of the sealed fluid path, and a vacuum source in communication with the second end of the sealed fluid path. Leak detection apparatus can be provided in communication with the sealed fluid path.

Abstract: A cryocatheter includes a catheter body defining a coolant flow path, a catheter tip exposed to the coolant flow path, and a heating element associated with the catheter tip. The heating element can be disposed entirely or partially within the catheter tip. Alternatively, the heating element can be exterior to the catheter tip. The heating element can include an electrically resistive element.

Abstract: A method of promoting blood vessel growth includes the steps of providing a cryocatheter having a thermally transmission region; placing the cryocatheter proximate an area of tissue to be treated; cooling the thermally transmissive region of the cryocatheter proximate the area of tissue to a temperature sufficient to injure the area of tissue; allowing the area of tissue to warm; and removing the cryocatheter from the area of tissue. Prior, during or after the cooling step, the area of tissue can be mechanically traumatized, and drugs can be injected into the tissue.

Abstract: A cryogenic catheter includes an outer flexible member having at least one cryogenic fluid path through the flexible member. The at least one fluid path is defined by a plurality of flexible members disposed within the outer flexible member.

Abstract: A cryogenic catheter system includes a first handle portion having a proximal end, a distal end, a first fluid flow path, and a second fluid flow path; a second handle portion having a proximal end, a distal end, a first fluid flow path, and a second fluid flow path; and a catheter having a proximal end, a distal end, a first fluid flow path, and a second fluid flow path. The first handle portion is matable with the second handle portion to place the respective first and second fluid flow paths of each handle portion in fluid communication. Additionally, the catheter system includes a multiple lumen co-axial connector for connecting the catheter flow pathways with a fluid source and control console.

Abstract: A cryocatheter for treatment of tissue has a tip adapted to provide a signal indicative of the quality and/or orientation of the tip contact with surrounding tissue. In one embodiment, a signal conductor extends through the catheter to the tip and connects to a thermally and electrically conductive shell or cap that applies an RF current to the region of tissue contacted by the tip. The tissue impedance path between the signal lead and a surface electrode mounted on the patient's skin is monitored to develop a quantitative measure of tissue contact at the distal tip, which is preferably displayed on the screen of a catheter monitoring console. In yet a further embodiment, the catheter is provided with a split tip having temperature monitoring sensors, such as thermistors, mounted on opposed halves of the tip so as to sense temperature on two sides of the catheter axis.

Abstract: A cryogenic catheter system provides safe and effective treatment of tissue. The system includes a catheter that is coupled to a console via fluid and electrical umbilicals. The console controls the overall operation of the system based to provide and maintain a predetermined temperature at the catheter tip. The console also controls and monitors operating parameters for providing warning indications to the user and terminating operation of the system in the event of a failure that may compromise patient safety.

Abstract: A cryocatheter system includes a first handle portion having a proximal end, a distal end, a first fluid flow path, and a second fluid flow path; a second handle portion having a proximal end, a distal end, a first fluid flow path, and a second fluid flow path; and a catheter having a proximal end, a distal end, a first fluid flow path, and a second fluid flow path. The distal end of the first handle portion is matable with the proximal end of the second handle portion to place the respective first and second fluid flow paths of each handle portion in fluid communication; and the distal end of the second handle portion is matable with the proximal end of the catheter to place the respective first and second fluid flow paths of the second handle portion and the catheter in fluid communication.

Abstract: A cryogenic catheter includes an outer flexible member having at least one cryogenic fluid path through the flexible member. The at least one fluid path is defined by a plurality of flexible members disposed within the outer flexible member.

Abstract: A coolant system for a cryoablation or treatment probe such as a mapping or ablation catheter, or a treatment wand, includes a compressor and condenser having a low pressure inlet side and a high pressure outlet side, wherein the outlet side passes through a heat exchanger and is cooled by the inlet side and conditioned for injection to a catheter inlet. A vacuum return system connectable to the catheter outlet draws thermally expended coolant from the catheter and returns it to the low pressure inlet side. A motorized pressure regulator between the heat exchanger and the catheter inlet determines the pressure of coolant passing into the catheter and thus regulates the cooling rate for a selected mapping or ablation regimen. The low pressure compressor inlet supply preferentially conditions the pressurized coolant to ambient temperature or lower before injection into the catheter, allowing the coolant to travel through the body at ambient before expansion in the tip.

Abstract: A spray catheter includes a flexible member having a spray tip and a fluid path through the flexible member to the spray tip. The catheter can be deformable and may include a mechanism for varying the spray geometry of the spray tip.

Abstract: A cryogenic catheter includes an outer flexible member having a cryogenic fluid path defined by an injection tube disposed in the outer flexible member. The injection tube is slidably disposed within the outer flexible member. A guide member may be provided to support the injection tube within the outer flexible member. A wire is attached to the injection tube at one end and further attached to a spool to provide for take-up of the wire.

Abstract: A cryocatheter for treatment of tissue includes a coolant line communicating with a cryochamber having a coolant receiving interior and a thermally conductive wall for contacting and conductively treating tissue. A return line returns spent coolant, and an insert or partition in the cryochamber conditions flow or channels fluid from the coolant line to the return line to enhance the rate or uniformity of cooling. The partition may extend axially to define an elongated sub-chamber which is preferentially cooled, or it may isolate one side to define an uncooled side of the cryochamber. The partition may extend axially to define a sub-chamber extending along a segmented length around a partial circumference of the catheter tip, or may channel the coolant from a central region outwardly against the peripheral wall of the cryochamber. The return line may be a vacuum return line.

Abstract: A catheter for ablating tissue, for example to treat a cardiac arrhythmia, includes a handle, a shapeable shaft and a distal ablation segment. The shaft retains a first position until manipulated to a further position with the application of moderate manual pressure. The shaft incorporates plastically deformable elements and is shapeable to conform to an insertion path or the particular anatomy of a patient for accessing a site to be ablated. Once shaped, the shaft retains its shape as the catheter is inserted or manipulated to the predetermined tissue treatment location and the distal segment is urged into contact with the tissue site. A deflection mechanism may be provided to facilitate navigation to, or to deflect the ablation segment into conformal contact with, the tissue target. In a further or alternative embodiment, a second or auxiliary shaft member extends distally from the ablation segment, allowing the segment to be threaded by or pulled past occluding tissue to a remote target tissue site.

Abstract: A method for inhibiting restenosis includes applying cryogenic energy to a treatment site for a predetermined amount of time. In one embodiment, the treatment site, e.g., a region of an artery dilated by means of a balloon catheter, is cooled to a temperature of about minus fifty degrees Celsius for about two minutes. The application of cryogenic energy inhibits restenosis of the dilated region of the vessel.

Abstract: A cryogenic catheter having an elongate outer member and a plurality of inner members disposed within the elongate outer member is provided. The inner members define at least one cryogenic path through the outer member. At least one of the inner members has at least one controllable opening formed thereon to selectively release cryogenic fluid. The inner members also include an overtube and an injection tube slideably disposed to one another.