FIELD OF THE INVENTION [0002] This application relates to medical tools and methods, in particular to medical instruments and methods for delivering a viscous material to a site within a patient.

BACKGROUND OF THE INVENTION [0003] One example of delivering a viscous material to a medical site is in a vertebroplasty procedure. Typically, the clinician seeks to treat a compression fracture of a vertebral body by injecting bone cement, a highly viscous material into a fracture site. In order to assure that the injected cement does not travel far from its intended placement location, fluoroscopy is often used by the clinician to monitor the location of the injected cement. However, delivering the cement by simple syringe would require the clinician to place his hand in the fluoroscopy field causing the clinician to be exposed to significant radiation produced by the fluoroscope during delivery of the cement to the surgical site. Thus, in order to reduce such exposure, the clinician often performs this procedure when the fluoro is turned off, and only monitors the cement location intermittently when safely outside the range of the fluoroscopy field.

[0004] Known techniques for keeping the clinician outside the fluoro field typically involve the use of a long extension tube, whereby one end of the tube extends from an injection pump and the other end is coupled to a hollow bone needle. The extension tube is used as a conduit for delivering the bone cement from the pump to the bone needle for injection into the vertebral body. The additional length of the extension tube allows a clinician to perform the vertebroplasty at a distance outside the fluoro field.

[0005] A disadvantage of such injection devices is that the cement is a highly viscous material requiring a high force to move the cement through the tube, resulting in a high- pressure build up within the device. The pressure build-up increases the effort need to inject the cement and decreases the natural feedback to the clinician. For example, the lack of natural feedback can cause the clinician to inadvertently leak bone cement into the surrounding tissue or the spinal cord itself, resulting in a number of serious health risks.

Furthermore, the additional length of tube makes such injection devices susceptible to premature curing or hardening, resulting in the tube becoming clogged.

SUMMARY OF THE INVENTION In accordance with the present invention, there is provided a device for delivering a viscous material into a site in a patient, comprising: an actuator including an actuator vessel; a delivery tube, having a first end, a second end and an inner bore, wherein the first end is coupled to the actuator ; and a container having a connection port for connecting to the second end of the tube and an exit port.

In accordance with the present invention, there is provided a device for delivering a viscous material comprising: a delivery tube having a first end portion, a second end portion, and an inner bore therebetween, the first end portion adapted to contain an incompressible fluid and the second end portion adapted to contain a viscous material In accordance with the present invention, there is provided a method of delivering a viscous material under fluoroscopy to a site in a patient comprising the steps of : a) providing a delivery tube containing an incompressible fluid and a viscous material, wherein the viscous material is located within the fluoroscopy field; and b) pressurizing the incompressible fluid outside the fluoroscopy field to exert pressure on the viscous material.

In accordance with the present invention, there is provided a method of delivering a viscous material to a site in a patient comprising the steps of : a) providing a device having an actuator, a delivery tube filled with an incompressible fluid and a container; b) filling the container with a viscous material; and c) activating the actuator to pressurize the fluid to exert a force on the viscous material.

In accordance with the present invention, there is provided a device for delivering a viscous material into a site in a patient, comprising: a) a delivery tube, having a first end, a second end and an inner bore, b) an incompressible fluid contained within the inner bore of the delivery tube, c) a container having a connection port for connecting to the second end of the delivery tube, an inner bore, an exit port, d) a viscous material contained within the inner bore of the container, and e) a separator sized to move within the inner bore of the container for separating a viscous material from the incompressible fluid.

In accordance with the present invention, there is provided a device for delivering a viscous material into a site in a patient, comprising: a) a delivery tube, having a first end, a second end and an inner bore, b) a first fluid contained within the inner bore of the delivery tube, and c) a container having a connection port for connecting to the second end of the delivery tube, an inner bore, an exit port, and d) a second fluid contained within the inner bore of the container.

In accordance with the present invention, there is provided a device for delivering a viscous material into a site in a patient, comprising: a) a container having a connection port for connecting to the second end of the delivery tube, an inner bore, an exit port adapted for connection to the patient, b) a separator housed within the inner bore, thereby defining a distal bore and an proximal bore, c) a first fluid contained within the proximal bore of the container.

[0006] Disclosed herein are tools and methods for delivering a viscous material to a site within a patient. The methods and devices of the present invention are particularly advantageous in that they can safely remove the clinician from the fluoro field while providing the clinician with visual and mechanical feedback while injecting the material into the patient. Such features minimize safety concerns to the patient and the clinician.

[0007] In one embodiment, the invention is a device for delivering a viscous material into a site in a patient, including an actuator with an actuator vessel; a delivery tube, having a first end, a second end and an inner bore, wherein the first end is coupled to the actuator; and a container having a connection port for connecting to the second end of the tube and an exit port.

[0008] In another exemplary embodiment, the present invention is a device for delivering a viscous material comprising a delivery tube having a first end portion, a second end portion, and an inner bore therebetween, the first end portion adapted to contain an incompressible fluid and the second end portion adapted to contain a viscous material.

[0009] Another embodiment of the present invention is a device for delivering a viscous material into a site in a patient, having a delivery tube, with a first end, a second end and an inner bore, an incompressible fluid contained within the inner bore of the delivery tube, a container with a connection port for connecting to the second end of the delivery tube, an inner bore, an exit port, a viscous material contained within the inner bore of the container, and a separator sized to move within the inner bore of the container for separating a viscous material from the incompressible fluid.

[0010] Another embodiment of the present invention is a device for delivering a viscous material into a site in a patient, having a delivery tube, with a first end, a second end and an inner bore, a first fluid contained within the inner bore of the delivery tube, and a container with a connection port for connecting to the second end of the delivery tube, an inner bore, an exit port, and a second fluid contained within the inner bore of the container.

[0011] In yet another embodiment of the present invention the device for delivering a viscous material into a site in a patient, has a container having a connection port for connecting to the second end of the delivery tube, an inner bore, an exit port adapted for connection to the patient, a separator housed within the inner bore, thereby defining a distal bore and an proximal bore, a first fluid contained within the proximal bore of the container.

[0012] In other aspects of the present invention, a method of delivering a viscous material under fluoroscopy to a site in a patient comprises the steps of providing a delivery tube containing an incompressible fluid and a viscous material, wherein the viscous material is located within the fluoroscopy field; and pressurizing the incompressible fluid outside the fluoroscopy field to exert pressure on the viscous material.

BRIEF DESCRIPTION OF THE DRAWINGS [0013] These and other features and advantages of the methods and instruments disclosed herein will be more fully understood by reference to the following detailed description in conjunction with the attached drawings in which like reference numerals refer to like elements through the different views. The drawings illustrate principles of the methods and instruments disclosed herein and, although not to scale, show relative dimensions.

[0014] FIG. 1 is a schematic of a device for delivering a viscous material according to one embodiment of the present invention; [0015] FIG. 2 is a schematic of another embodiment of a device for delivering a viscous material connected to a cannula; [0016] FIG. 3 is a schematic of the device shown in FIG. 2 connected to a cannula at an angle; and [0017] FIG. 4 is a schematic of another embodiment of the present invention including a pressure relief valve.

DETAILED DESCRIPTION OF THE INVENTION [0018] Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

[0019] The present invention is directed to devices and methods for remotely delivering a viscous material to a targeted site in a patient. In general, the device is a delivery tube containing two materials, the viscous material to be injected into the patient and an incompressible fluid to act on the viscous material. The end of the tube containing the viscous material is placed at the delivery site while the other end of the delivery tube extends outside the fluoro field. The clinician can then safely activate the movement of the material into the patient from outside the fluoro field. The amount of pressure needed to deliver the material is also reduced because the material does not have to travel the entire distance through the tube from outside the fluoro field, resulting in a decrease in friction between the tube and the viscous material. Additionally, the present invention enables the viscosity of the viscous material to be higher because of the noncompliance of the tube and the positioning of the material with respect to the targeted delivery site.

[0020] FIG. 1 illustrates an exemplary embodiment of a delivery device. As shown the delivery device 10 includes a delivery tube 15 having a first end portion 13 and a second end portion 17 and an inner bore 19 defined therebetween. The tube 15 is adapted to contain an incompressible fluid 23 at the first end portion 13 and a viscous material 21 at the second end portion 17. The delivery device may be connected to a cannula seated at the delivery site in the patient.

[0021] The delivery tube can further include a separator 11 within the bore of the tube for separating the viscous material from the incompressible fluid. The separator 11 is slidably movable within the bore 19 of the tube.

[0022] The delivery tube 15 is preferably flexible so as to allow the tube to be of a length sufficiently long enough to place the clinician outside the fluoroscopy field and to minimize the amount of torque at the second end portion produced by any off-axis movement in relation to the cannula. Additionally, the tube is noncompliant to minimize the amount of viscous material that is delivered after actuation of the material is stopped. A preferred material for the construction of the delivery tube is PEEK, however, nylon, polypropylenes, and polytetraflouroethylenes (PTFE) or other fluorinated polycarbons could also be used.

Any materials, which are durable, sterilizable, biofriendly, chemically compatible with viscous materials such as bone cement and substantially noncompliant under the expected operating pressures of up to 1200 psi, but could, also withstand pressures up to 5000psi.

[0023] The tubing may be reinforced with a non-stretch coil or a braid such that together as a unit, the tube and reinforcing coil or braid exhibit less than a 10% change in volume under operating pressures of about 1200 psi, compared to their initial volume under atmospheric pressure. The reinforcing coil or braid can be formed from stainless steel, nitinol, titanium, nylon or polymers such as aramid fibers, KEVLAR fibers, etc. ) or other biocompatible materials having the same nonstretch characteristics described above.

[0024] In some embodiments, the inner bore 19 of the delivery tube 15 has a diameter di that is in the range of 1 to 10 mm, and preferably in the range of 2.5 to 5 mm. The smaller the diameter, the more flexible the tube will be when delivering the viscous material. The length of the delivery tube IT is at least 20 cm and more preferably between 20 and 60 cm. In this range the clinician may be placed safely outside the fluoroscopy field.

[0025] The delivery tube contains an incompressible fluid 23 or hydraulic fluid such as water, water and oil emulsion, water-glycol mixture, straight synthetic fluid (e. g. , silicone or phosphate esters, ester blends, and chlorinated hydrocarbon-based fluids) or petroleum oil.

Preferably, the incompressible fluid contained within the delivery tube is saline. The incompressible property of the fluid allows for a force generated at the first or proximal end of the delivery tube to be transferred to the viscous material. The incompressible fluid can be pre-filled and sealed within the delivery tube prior to use by the clinician or the clinician can fill the tube at the time of use.

[0026] In some embodiments, the device of the present invention is used to deliver a viscous material such as bone cement into a fractured vertebral body. The bone cement may be any material typically used to augment vertebral bodies, including acrylic based bone cements (such as PMMA-based bone cements), pastes comprising bone particles (either mineralized or demineralized or both); and ceramic based bone cements (such as hydroxyapatite and TCP based pastes). The present invention enables an increase in the acceptable viscosity of the cement to be delivered because of the substantial noncompliance within the delivery tube and the location of the cement close to the actual delivery site. The viscous material is contained within the device such that it is in the fluoroscopy field at all times during the procedure.

[0027] In some embodiments, as shown in FIG. 1 the delivery tube preferably includes a separator 11 located within the inner bore of the delivery tube between the incompressible fluid and the viscous material. The separator is movable and slidable within the inner bore.

A force generated on the incompressible fluid will transfer through the fluid to the separator and then to the viscous material to deliver the material to the desired location. A person skilled in the art will understand that the separator is not needed to transfer the force to the viscous material. In one embodiment the separator is a piston.

[0028] In an alternate embodiment of the present invention shown in FIG. 2, the delivery device 100 comprises an actuator 40 including an actuator vessel, a delivery tube 15, and a container 60. The tube is preferably filled with an incompressible fluid 23. The first end portion of the tube has a sealing connector 25 to connect to the actuator 40 and the second end portion of the tube has another sealing connector 26 to connect to the container 60. The container can be connected to a cannula 30 for positioning at the delivery site within the patient. The container is adapted to hold the viscous material to be delivered. The device can be packaged sterile and can be disposable.

[0029] In the illustrated embodiment shown in FIG. 2, the actuator 40 is linear and includes a knob 45, a threaded rod 42 mounted to an actuator vessel 46 containing the fluid to be pressurized. The distal end of the threaded rod 42 is attached to a plunger 44. The plunger 44 is slidably received within the vessel 46. The vessel is sized to hold a volume of fluid at least as much as the amount of viscous material to be delivered. Preferably, the vessel is sized to hold between 2 and 25 cc of fluid. As the threaded rod is advanced through the vessel, the plunger comes into contact and exerts force on the fluid pushing the fluid out of the vessel, through the delivery tube and into contact with the viscous material in the container. Preferably, the vessel is made from a material that is noncompliant such as PEEK or a polycarbonate.

[0030] In some embodiments, the actuator vessel 46 includes a visualization window (not shown) so that the user can observe the movement of the fluid as the actuator is engaged and the viscous material is delivered to the patient. Using a noncompliant system and an incompressible fluid results in the flow of the fluid to be the same as the flow of the viscous material so that 1 cc of fluid moved from the vessel correlates with 1 cc of viscous material moving out of the container. Other embodiments for viewing the amount of material delivered can include graduation lines on the outside of the vessel indicating the volume of material exiting the container. When the plunger tip reaches one of the graduation lines the clinician can determine the amount of material delivered. For actuators that use rotation to advance the plunger, a rotational scale could be used such that one turn of the actuator would correlate to a set amount of material exiting the container. A digital or analog counter could also be used to translate the movement of the plunger into the actual amount of viscous material delivered.

[0031] A person skilled in the art will appreciate that other actuators can be used in the device. Examples of linear actuators include a rack and pinion, ratchet and pawl, an electric motor with a worm gear, an angled clutch plate on a rod, or a walking beam. An example of a nonlinear actuator that could also be used is a hydraulic pump.

[0032] The delivery tube 15 has the same tube characteristics and design features as described in the embodiment shown in FIG. 1.

[0033] In some embodiments the delivery tube 15 has a sealing connector 26 at the second end for connecting to a container 60. Preferably this connector is a Luer-lock type of fitting.

Likewise in some embodiments, the delivery tube 15 has another sealing connector 25 at the first end for connecting to an actuator vessel 46. Preferably this connector is also a Luer-lock type of fitting.

[0034] The container 60 holds the viscous material to be delivered to the patient. The container may be filled with the viscous material by any number of conventional filling procedures. The container has a connection port 62 for coupling with the delivery tube 15 and an exit port 64 for the viscous material to exit through and for coupling with the cannula 30. Preferably, the container holds between 2 and 20 cc of viscous material. The container is also made from any noncompliant material but the material also has to be biocompatible with the viscous material. Accordingly the container can be made from the following materials: nylon, polyphenylene sulfide (PPS), ultrahigh molecular weight polyethylene, cyclic Olefin copolymer (COC) liquid crystalline polymer (LCP) acetal copolymers (POM), and polybutylene terephthalate (PBT). In some embodiments multiple containers can be filled with the viscous material and interchanged by the clinician as one is emptied. A separator 66 may be located in the container to separate the viscous material from the fluid so that the force is transferred through the separator to the viscous material pushing it out of the exit port to the desired delivery site within the patient. In one exemplary embodiment the separator is a piston.

[0035] In one embodiment, the container 60 is translucent allowing the clinician to visualize the viscous material at all times during delivery of the material. In an alternate embodiment, the container is color tinted and the separator inside the container is colored so that as the separator travels through the container pushing the viscous material out, there is a resultant color displayed that the clinician can visualize from outside the fluoro field. Alternately, a linear transducer could be used to display the path the separator travels as it advances through the container.

[0036] The container can connect to a cannula through the exit port 64. The connection between the container and the cannula is preferably made at an angle between 80 and 135 degrees, to move the container and delivery tube out of the way of the clinician and minimize interference with the imaging device. As shown in FIG. 3 the container connects to the cannula at approximately a 90-degree angle.

[0037] In another embodiment of the present invention, the delivery tube is connected to a stopcock to allow two containers at two implant sites within the same patient to be connected to the device allowing delivery of the viscous material to two sites without having to stop the procedure to disconnect and connect another container of material.

[0038] Excess pressure build up in the system has the potential to cause the device to fail resulting in possible harm to the patient or the clinician. Accordingly, in some embodiments of the invention, a safety mechanism for preventing excess pressure buildup can also be added to the device. One example of a safety mechanism is an in line pressure relief valve with a cracking pressure such that when an unsafe operating pressure is reached the valve will open and divert the pressurized fluid into a catch reservoir. The valve could use a spring force or membrane that ruptures to establish the cracking pressure. Another option shown in FIG. 4 would be to include a pressure relief valve 50 that the user can use at his discretion to divert pressure for example at the end of the procedure to ensure that extra viscous material is not inadvertently delivered. It is to be understood that the pressure relief valve could be placed anywhere along the fluid path.

[0039] There may also be a pressure monitoring means connected to the device so that the user can see when the pressure is becoming excessive. An example of a pressure monitoring means can be a gauge in the delivery tube that displays the instantaneous pressure or a binary indicator that visually indicates when the pressure is ok and when it has exceeded the limit.

[0040] Another example of a safety mechanism would be a torque-limiting device that would prevent the user from generating excessive force on the fluid. A clutch type mechanism could be used with a screw type actuator to slip when a certain torque was reached. A break away handle could be used if the device was driven similar to a caulking gun.

[0041] In one embodiment the device is pre-assembled such that the incompressible fluid is pre-filled and sealed within the delivery tube and the actuator vessel. In another embodiment, the delivery tube and actuator vessel are empty and the user would fill with the incompressible fluid. In all embodiments the viscous material would be placed in the container at the time of use.

[0042] An exemplary embodiment of a method for delivering a viscous material to a site within a patient is providing a device having an actuator, a delivery tube filled with an incompressible fluid, and a container; filling the container with a viscous material, and activating the actuator of the device to pressurize the fluid in the delivery tube to push the viscous material out of the container.

[0043] Another embodiment of a method for delivering a viscous material under fluoroscopy to a site in a patient includes the steps of providing a delivery tube containing an incompressible fluid and a viscous material, wherein the viscous material is located within the fluoroscopy field; and pressurizing the incompressible fluid outside the fluoroscopy field to exert pressure on the viscous material.

[0044] As previously stated, a person skilled in the art will appreciate that the method can be performed in any sequence using any of the steps. Moreover, the devices of the present invention can be used to perform a variety of other surgical procedures not illustrated or described herein.

[0045] One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

[0046] What is claimed is: