Abstract:
Connectors are attached to a pump housing. The pump squeezes tubing of a particular outer diameter creating a peristaltic contraction of the tubing to push the fluid in the tubing in a particular direction. The connectors hold the tubing in slots having walls that are narrower than the outer diameter of the tubing. To aid in pushing the tubing into the slots, a door is attached to the connectors that pushes the tubing into the slots while closing thereby covering the slots, which helps assure that the tubing is properly attached to the connector. Alternatively, the connector may be permanently attached to the tubing, but may be detached from the pump housing, so that as long as the connectors are connected properly, the tubing is connected properly.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. patent application Ser. No. 13/359,455, entitled “Method and Device for Insertion of Tubing into Irrigation and Infusion Fluid Pumps,” by Sean Y. Sullivan, filed Jan. 26, 2012 (Docket # B6-1), which claims priority benefit of U.S. Provisional Patent Application No. 61/436,589, entitled “Improved Method and Device for Insertion of Tubing into Irrigation and Infusion Fluid Pumps,” filed Jan. 26, 2011, by Sean Y. Sullivan et al., and the contents of all the above listed applications are incorporated herein by reference, in their entirety. 
     
    
     FIELD 
       [0002]    This specification generally relates to embodiments for delivering fluids to patients. 
       BACKGROUND 
       [0003]    Medical diagnostic and therapeutic procedures often involve delivering fluids to patients. For example, procedures affecting subcutaneous or internal tissues often utilize catheters to access these tissues. There are many other medical procedures involving delivery of fluids to patients including delivery of medications, nutrients, anesthetic agents, and diagnostic agents. Examples of procedures utilizing catheters include delivery of medicines to tissue sites, measurement of tissue electrical and mechanical properties, imaging of tissues and ablation of tissues. These procedures may use catheters which require the delivery of fluids to these tissues or the circulation of fluids within the catheter. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0004]    In the following drawings like reference numbers are used to refer to like elements. Although the following figures depict various examples of the invention, the invention is not limited to the examples depicted in the figures. 
           [0005]      FIG. 1  shows an embodiment of a device for inserting tubing into irrigation and infusion fluid pumps. 
           [0006]      FIG. 2  shows an embodiment of the tubing being inserted into an irrigation and infusion fluid pump, using the device of  FIG. 1 . 
           [0007]      FIG. 3  shows an embodiment of a device for inserting tubing into irrigation and infusion fluid pumps having connectors, in which the connectors are not attached to the pump. 
           [0008]      FIG. 4  shows an embodiment of a device for inserting tubing into irrigation and infusion fluid pumps in which the connectors are attached to the pump. 
           [0009]      FIGS. 5A and 5B  show an embodiment of the guides and supports of the connectors of  FIGS. 3 and 4 . 
           [0010]      FIGS. 6A and 6B  show an embodiment of the manner in which the connectors of  FIGS. 4  and  FIGS. 5A and 5B  provide support for the tubing. 
           [0011]      FIGS. 7A and 7B  show an embodiment in which the tubing is permanently attached (e.g., glued) to the connector, but the connector is not permanently attached to the pump mechanism. 
           [0012]      FIGS. 8A-8D  show an embodiment having enlarged tubing slots in the area where the tubing passes by the sensors. 
           [0013]      FIGS. 9A and 9B  show an embodiment of mounting the sensors in the pump receptacle such that a small amount of vertical movement allows the sensors&#39; tubing slots to align with the tubing attached to the connector during the insertion or extraction of the tubing. 
       
    
    
     DETAILED DESCRIPTION 
       [0014]    Although various embodiments of the invention may have been motivated by various deficiencies with the prior art, which may be discussed or alluded to in one or more places in the specification, the embodiments of the invention do not necessarily address any of these deficiencies. In other words, different embodiments of the invention may address different deficiencies that may be discussed in the specification. Some embodiments may only partially address some deficiencies or just one deficiency that may be discussed in the specification, and some embodiments may not address any of these deficiencies. 
         [0015]    In embodiments, pumps are used to deliver fluid to these catheters for irrigation or infusion purposes. For example, ablation catheters may use fluid to provide cooling of the catheter tip or adjacent tissues. The fluid may be circulated in a loop enclosed within the catheter, often referred to as closed loop cooling, or delivered into the heart&#39;s chambers, often referred to as open irrigation, where the fluid is mixed with blood. The pump is required to deliver this fluid, typically sterile saline, in a controlled and safe manner. The saline is typically supplied from bags connected to tubing that is inserted into the pump mechanism. 
         [0016]    The pumping method is typically a peristaltic style that moves the fluid by successive compression and relaxation of the tubing, causing the fluid to be pushed through the tubing into the catheter. The pump device typically contains sensors to detect the presence of air bubbles in the fluid, which could pose a safety risk to the patient. Additional types of sensors may be used to detect other fluid properties including pressure, velocity, flow rate, composition, optical, and electrical characteristics. 
         [0017]    The user must insert the tubing into slots in these sensors and the peristaltic pump mechanism for the pump to function correctly. In order for the sensors to function properly, the tubing must fit snuggly into the sensor slots such that there is intimate contact between the walls of the sensors and the wall of the tubing. In order to secure the tubing in the sensors, the sensors are typically designed with slots that are 0.030″ to 0.050″smaller than the tubing outside diameter and may have an entrance slot that is even smaller to act as a retainer for the tubing. This tight fit of the tubing into the sensors requires users to elongate the tubing prior to insertion and then to push the tubing into the sensor slots, attempting to fully insert the tubing by this method. This process is subject to user technique and can often lead to partially inserted tubing and complaints by users regarding the difficulty of tubing insertion. 
         [0018]    This specification describes devices that improve the ease and reliability of tubing insertion into medical irrigation and infusion fluid pumps and particularly the insertion of tubing into sensor slots on the pumps. 
         [0019]    Embodiment 1 of the invention comprises of a hinged door on the pump mechanism with guides and supports that align with the sensor openings intended for tubing insertion ( FIGS. 1 and 2 ). With the door open, the user positions the tubing at the entrance to the sensor slots using guides on either side(s) of the sensor(s) to retain the tubing in the proper position. In an alternative embodiment, the tubing is retained by guides on the door. The user then closes the door. The guides and supports on the door engage the tubing along its length and apply uniform pressure across the length of the tubing that fits into the sensors. 
         [0020]    The door&#39;s design provides mechanical leverage allowing the user to have an Improved Method and Device for Insertion of Tubing into Irrigation and Infusion Fluid Pumps, which overcomes the resistance of the tight fit of the tubing into the sensor slots and to fully and uniformly insert the tubing into the sensor slots. When the door is fully closed, a latch mechanism retains the door in its closed position and the tubing in a fully inserted position in the sensors. Tubing may be removed by releasing the door&#39;s latch mechanism, opening the door, and then pulling the tubing out of the sensors. In an alternative embodiment, the tubing is retained by the door and is removed from the sensors when the door is opened. 
         [0021]    Embodiment 2 of the invention comprises the addition of connectors on the tubing which allow the user to insert the tubing into the pump sensor slots by pushing the connectors into mating receptacles on the pump that contain the sensors ( FIGS. 3 and 4 ). The connectors may be made of a variety of materials including plastic. The connectors have guides and supports that position the tubing in the connectors ( FIGS. 5A and 5B ). The support webs contact an arc of the tubing&#39;s outside diameter preferably, but not limited to between 120 degrees and 180 degrees to provide maximum support for the tubing without interfering with the sensor tubing slots during insertion ( FIGS. 6A and 6B ). 
         [0022]    The insertion of the connectors into the pump receptacle inserts the tubing fully into the sensors&#39; tubing slots. The connectors typically include a latch which mates with the receptacle and retains the connectors in the pump sensor receptacles ( FIGS. 5A and 5B ). The latch mechanism provides a clear visual and audible indication to the user that the tubing is fully and properly inserted into the pump sensor slots. In addition, the receptacles may contain electrical, optical, or other means for detecting that the tubing connectors are properly and fully inserted. This detection means has the advantage of providing a means for the pump to ensure that the tubing is properly inserted independent of the user. For example, this means will prevent the user from bypassing the use of the connectors, installing the tubing in a reverse direction, or using an incompatible tubing set which does not contain the proper mating connectors. When the tubing set contains more than one connector, the connectors shall each be of a shape and size that prevents each connector from mating with the other connector&#39;s receptacle. The connectors provide support around the tubing to prevent tubing deformation that would prevent the tubing from being inserted into the sensors ( FIGS. 6A and 6B ). 
         [0023]    This support web provides a mechanical advantage allowing the user to overcome the resistance of the tight fit of the tubing into the sensor slots and to fully and uniformly insert the tubing into the sensors&#39; tubing slots. The tubing is removed from the sensors by depressing the connectors&#39; latch mechanism, which releases the connector from the receptacle, and then pulling the connectors out of the pump sensor receptacles. A further advantage of this invention is that the tubing is glued or otherwise affixed onto the connectors only at the tubing&#39;s end points of the support web for each connector such that once the connectors are inserted into the pump receptacles, pulling on the tubing will not cause a stress on or subsequent movement of the tubing in the sensor slots which could adversely affect the measurement of the fluid properties by the sensors ( FIGS. 7A and 7B ). 
         [0024]    Equally advantageous is that the tubing is not glued or otherwise affixed onto or along the connector support webs. Since the tubing is not affixed to the support webs, small motions of the tubing connector along the insertion/retraction axis do not disturb the tubing&#39;s position in the sensor slot which could adversely affect the measurement of the Improved Method and Device for Insertion of Tubing into Irrigation and Infusion Fluid Pumps fluid properties by the sensors. An alternative embodiment is that the connectors can be affixed or loosened from the tubing in a non-permanent manner allowing the user to reposition the connectors along the length of the tubing. This allows the user to provide the optimum length of tubing for the inlet and outlet portions of the tubing set. A further advantage of this invention is that the mechanical retention force of the tubing in the sensors is provided by the connector to receptacle mating and not by the mechanical resistance of the sensor tubing slots against the tubing walls. Thus, the sensors&#39; tubing slots may be enlarged so that the mechanical interference between the sensor walls and the tubing walls is minimized while still meeting the measurement requirement of an air tight fit between the sensor walls and the tubing wall ( FIGS. 8A-8D ). 
         [0025]    This enlargement increases the slot size preferably, but not limited, an opening of 0.010″ to 0.030″ less than the tubing outside diameter. Additionally, portions of the sensor slot that do not affect the measurement function can be enlarged even further to a size greater than or equal to the tubing outside diameter. This reduces the overall force required by the user to insert the tubing into the sensors. Tubing insertion force may be further reduced by mounting the sensors in the pump receptacle such that a small amount of vertical movement allows the sensors&#39; tubing slots to align with the tubing attached to the connector during the insertion or extraction of the tubing ( FIGS. 9A and 9B ). 
         [0026]    Each embodiment disclosed herein may be used or otherwise combined with any of the other embodiments disclosed. Any element of any embodiment may be used in any embodiment. 
         [0027]    Although the invention has been described with reference to specific embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the true spirit and scope of the invention. In addition, modifications may be made without departing from the essential teachings of the invention.