Abstract:
An infusion device comprising a fluid reservoir for containing a therapeutic fluid; and a transcutaneous access tool fluidly coupled to the fluid reservoir for delivering the therapeutic fluid subcutaneously and for introducing a monitoring test strip subcutaneously, and methods of use thereof.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of PCT Application Serial No. PCT/US 13/34674 filed Mar. 29, 2013 and claims the benefit of the filing date of U.S. Provisional Application Ser. No. 61/618,028, filed Mar. 30, 2012, the teachings of which are incorporated herein by reference. 
     
    
     TECHNICAL FIELD 
       [0002]    The present invention relates to fluid delivery devices for delivering therapeutic liquids to a patient, and more particularly, to an infusion pump for delivering therapeutic liquids to a patient. 
       BACKGROUND INFORMATION 
       [0003]    Fluid delivery devices have numerous uses such as delivering a liquid medicine or other therapeutic fluid to a patient subcutaneously. In a patient with diabetes mellitus, for example, ambulatory infusion pumps have been used to deliver insulin to a patient. These ambulatory infusion pumps have the ability to offer sophisticated fluid delivery profiles including variable basal rates and bolus requirements. The ability to carefully control drug delivery can result in better efficacy of the drug and therapy and less toxicity to the patient. 
         [0004]    Some existing ambulatory infusion pumps include a reservoir to contain the liquid medicine and use electromechanical pumping or metering technology to deliver the liquid medicine via tubing to a needle and/or soft cannula that is inserted subcutaneously into the patient. These existing devices allow control and programming via electromechanical buttons or switches located on the housing of the device. The devices include visual feedback via text or graphic screens and may include alert or warning lights and audio or vibration signals and alarms. Such devices are typically worn in a harness or pocket or strapped to the body of the patient. 
         [0005]    Some infusion pumps have been designed to be relatively small, low cost, light-weight, and easy-to-use. One example of such a pump is the OMNIPOD® insulin infusion pump available from Insulet Corporation. Examples of infusion pumps are also described in greater detail, for example, in U.S. Pat. Nos. 7,128,727; 7,018,360; and 7,144,384 and U.S. Patent Application Publication Nos. 2007/0118405, 2006/0282290, 2005/0238507, and 2004/0010207, which are fully incorporated herein by reference. These pumps include insertion mechanisms for causing a transcutaneous access tool, such as a needle and/or soft cannula, to be inserted into a patient. Although such pumps are effective and provide significant advantages over other insulin infusion pumps, the design of the insertion mechanism may be improved, for example, to reduce the size of the pump, to improve the comfort to the user, and/or to incorporate continuous glucose monitoring (CGM). These pumps also include fluid driving mechanisms for driving fluid from a reservoir through the transcutaneous access tool. The fluid driving mechanisms may also be improved to facilitate assembly and use of the pump. 
       SUMMARY 
       [0006]    The present disclosure provides various fluid delivery devices to deliver a liquid medicine or other therapeutic fluid to a patient subcutaneously. In certain embodiments the fluid delivery device may comprise an ambulatory insulin infusion device to administer insulin to a patient. The fluid delivery device may include one or more batteries for providing a power source, a fluid reservoir for holding a fluid, a fluid drive mechanism for driving the fluid out of the reservoir, a fluid passage mechanism for receiving the fluid from the reservoir and passing the fluid to a destination via a transcutaneous access tool, and a transcutaneous access tool insertion mechanism for deploying the transcutaneous access tool. 
         [0007]    In certain embodiments, an infusion device may comprise a fluid reservoir for containing a therapeutic fluid; and a transcutaneous access tool fluidly coupled to the fluid reservoir, which may deliver the therapeutic fluid subcutaneously and introduce a monitoring test strip subcutaneously. 
         [0008]    In certain embodiments, a method to treat diabetes mellitus may be provided comprising providing an infusion device with integrated monitoring, with the device comprising a fluid reservoir for containing a therapeutic fluid; and a transcutaneous access tool fluidly coupled to the fluid reservoir, which may deliver the therapeutic fluid subcutaneously and introduce a monitoring test strip subcutaneously; delivering the therapeutic fluid subcutaneously with the transcutaneous access tool to a patient, and introducing the monitoring test strip subcutaneously with the transcutaneous access tool to the patient. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]    These and other features and advantages will be better understood by reading the following detailed description, taken together with the drawings wherein: 
           [0010]      FIG. 1  is a top perspective view of a fluid delivery device with a transcutaneous access tool insertion mechanism in a pre-deployment position, consistent with the present disclosure; 
           [0011]      FIG. 2  is a bottom perspective view of a needle and cannula retracted into the fluid delivery device in the pre-deployment position shown in  FIG. 1 ; 
           [0012]      FIG. 3  is a top perspective view of the fluid delivery device shown in  FIG. 1  with the insertion mechanism in an intermediate position; 
           [0013]      FIG. 4  is a bottom perspective view of the needle and cannula extending from the fluid delivery device in the intermediate position shown in  FIG. 3 ; 
           [0014]      FIG. 5  is a top perspective view of the fluid delivery device shown in  FIG. 1  with the insertion mechanism in a post-deployment position; 
           [0015]      FIG. 6  is a bottom perspective view of the cannula extending from the fluid delivery device in the post-deployment position shown in  FIG. 5 ; 
           [0016]      FIG. 7  is a side perspective view of another embodiment of the insertion mechanism, consistent with the present disclosure, in a pre-deployment position; 
           [0017]      FIG. 8  is a side perspective view of the insertion mechanism shown in  FIG. 7  in an intermediate position; 
           [0018]      FIG. 9  is a side perspective view of the insertion mechanism shown in  FIG. 7  in a post-deployment position; 
           [0019]      FIG. 10  is a top perspective view of the second sliding member of the insertion mechanism shown in  FIG. 7  locked in the pre-deployment and post-deployment positions; 
           [0020]      FIGS. 11-17  are views of a bi-lumen cannula used in the fluid delivery device shown in  FIGS. 1-6  to insert a monitor test strip transcutaneously; 
           [0021]      FIGS. 18-23  are views of another embodiment of a fluid delivery device including a cannula with a D-shaped lumen for inserting a monitor test strip transcutaneously; 
           [0022]      FIGS. 24-26  are views of the D-lumen cannula used in the fluid delivery device of  FIGS. 18-23 ; 
           [0023]      FIGS. 27 and 28  are views of a semi-circular trocar used with the D-lumen cannula in the fluid delivery device of  FIGS. 18-23 ; 
           [0024]      FIGS. 29-35  are views of another embodiment of a fluid delivery device including an oval trocar for inserting a monitor test strip transcutaneously; 
           [0025]      FIG. 36  is a side view of the oval trocar for use in the fluid delivery device shown in  FIGS. 29-35 ; 
           [0026]      FIG. 37  is a top perspective view of a second sliding member for use in the fluid delivery device shown in  FIGS. 29-35 . 
       
    
    
     DETAILED DESCRIPTION 
       [0027]    A fluid delivery device, consistent with embodiments of the present disclosure, may be used to deliver a therapeutic fluid (e.g. a liquid medicine) to a patient via a transcutaneous access tool, such as a needle/trocar and/or a cannula. A transcutaneous access tool insertion mechanism may be used to deploy the transcutaneous access tool, for example, by inserting and retracting a needle/trocar in a single, uninterrupted motion. The insertion mechanism may also provide an increasing insertion force as the needle/trocar moves in the insertion direction. The fluid delivery device may also include a clutch mechanism to facilitate filling a reservoir and engagement of a drive mechanism for driving fluid out of the reservoir. In certain embodiments, the fluid delivery device may comprise an ambulatory insulin infusion device. 
         [0028]    In other embodiments, a fluid delivery device may be used to deliver a therapeutic fluid to a patient with integrated monitoring, such as continuous glucose monitoring (CGM). In these embodiments, the fluid deliver device may include a transcutaneous access tool configured to introduce a monitoring test strip through the skin of the patient, for example, using one or more needles, cannulas and/or trocars. 
         [0029]    Referring to  FIGS. 1-6 , one embodiment of a fluid delivery device  100  is shown and described. In the exemplary embodiment, the fluid delivery device  100  is used to subcutaneously deliver a fluid, such as a liquid medicine (e.g. insulin), to a person or an animal. Those skilled in the art will recognize that the fluid delivery device  100  may be used to deliver other types of fluids. The fluid delivery device  100  may be used to deliver fluids in a controlled manner, for example, according to fluid delivery profiles accomplishing bolus requirements, continuous infusion and variable flow rate delivery. 
         [0030]    According to one embodiment, the fluid delivery device  100  may include one or more batteries  110  for providing a power source, a fluid reservoir  130  for holding a fluid, a fluid drive mechanism  150  for driving the fluid out of the reservoir  130 , a fluid passage mechanism  170  for receiving the fluid from the reservoir  130  and passing the fluid to a destination via a transcutaneous access tool  172 , and a transcutaneous access tool insertion mechanism  180  for deploying the transcutaneous access tool  172 . The fluid delivery device  100  may include a circuit board  101  with control circuitry for controlling the device and a chassis  102  that provides mechanical and/or electrical connections between components of the fluid deliver device  100 . The fluid delivery device  100  may also include a housing  104  to enclose the circuit board  101 , the chassis  102 , and the components  110 ,  130 ,  150 ,  170 ,  180 . 
         [0031]    The fluid delivery device  100  may also include integrated monitoring such as continuous glucose monitoring (CGM). A monitor test strip  120  coupled to a monitor (not shown) in the device  100  may be introduced by the transcutaneous access tool  172  subcutaneously. One example of the monitor test strip is a CGM test strip (such as the type available from Nova Biomedical) which may be understood as a glucose sensor configured to test for a concentration level of glucose in the blood of a patient. The fluid delivery device  100  may be configured to receive data from the monitoring test strip concerning a glucose level of the patient, and determining an output of insulin from the reservoir based on the glucose level. 
         [0032]    The transcutaneous access tool  172  includes an introducer trocar or needle  174  at least partially positioned within a lumen  175  of a cannula  176  (e.g., a soft flexible cannula), which is capable of passing the fluid into the patient. In particular, the introducer needle/trocar  174  may initially penetrate the skin such that both the introducer needle/trocar  174  and the cannula  176  are introduced (inserted) into the patient, and the introducer needle/trocar  174  may then be retracted within the cannula  176  such that the cannula  176  remains inserted. A fluid path, such as tubing  178 , fluidly couples the reservoir  130  to the lumen  175  of cannula  176  of the transcutaneous access tool  172 . The transcutaneous access tool  172  may also be used to introduce a monitoring test strip subcutaneously into the patient for monitoring purposes, as described in greater detail below. 
         [0033]    The transcutaneous access tool insertion mechanism  180  is coupled to the transcutaneous access tool  172  to deploy the transcutaneous access tool  172 , for example, by inserting the needle/trocar  174  and cannula  176  through the skin of a patient and retracting the needle/trocar  174 . In the illustrated embodiment, the insertion mechanism  180  includes a spring-biased linkage mechanism  182  and sliding members  184 ,  186  coupled to the needle/trocar  174  and cannula  176 , respectively, for moving the needle/trocar  174  and cannula  176  in the insertion direction and for moving the needle/trocar  174  in the retraction direction. In a single, uninterrupted motion, the spring-biased linkage mechanism  182  moves from a pre-deployment position ( FIG. 1 ) with both needle/trocar  174  and cannula  176  retracted ( FIG. 2 ) to an intermediate position ( FIG. 3 ) with both needle/trocar  174  and cannula  176  inserted ( FIG. 4 ) to a post-deployment position ( FIG. 5 ) with the needle/trocar  174  retracted and the cannula  176  inserted ( FIG. 6 ). 
         [0034]    One embodiment of the spring-biased linkage mechanism  182  includes a helical torsion spring  181  and first and second linkages  183   a,    183   b  coupled between the torsion spring  181  and the first sliding member  184 . Energy stored in the torsion spring  181  applies a force to the linkages  183   a,    183   b,  which applies a force to the first sliding member  184  to move the first sliding member  184  in both the insertion direction and in the retraction direction. In the pre-deployment position ( FIG. 1 ), the torsion spring  181  is loaded and the sliding members  184 ,  186  are locked and prevented from moving. When the sliding members  184 ,  186  are released, the energy stored in the torsion spring  181  causes the first linkage  183   a  to rotate (e.g., clockwise as shown), which applies a force to the first sliding member  184  through the second linkage  183   b  causing the first sliding member  184  with the needle/trocar  174  to move (with the second sliding member  186 ) in the insertion direction. In the intermediate position ( FIG. 3 ), the linkages  183   a,    183   b  are fully extended with the needle/trocar  174  and cannula  176  being inserted, the second sliding member  186  is locked, and the remaining energy stored in the torsion spring  181  causes the first linkage  183   a  to continue to rotate, which applies an opposite force to the first sliding member  184  through the second linkage  183   b  causing the first sliding member  184  with the needle/trocar  174  to move in the retraction direction to the post-deployment position ( FIG. 5 ). In the illustrated embodiment, the second sliding member  186  is locked against retraction by one or more latches  187 . Thus, in the foregoing manner, the continuous uninterrupted clockwise rotation of first linkage  183   a  via the energy of torsion spring  181  provides the transcutaneous access tool insertion mechanism  180  with the ability to insert and retract the needle/trocar  174  in a single, uninterrupted motion. 
         [0035]    The spring-biased linkage mechanism  182  allows a single spring and motion to achieve both the insertion and retraction and has a relatively small size. The spring-biased linkage mechanism  182  also reduces the static stresses caused by locking and holding back the sliding members  184 ,  186  and provides a smoother and more comfortable needle/trocar insertion because of the way the linkages  183   a,    183   b  vector the forces applied to the sliding members  184 ,  186 . The static forces on the sliding members  184 ,  186  are relatively small in the pre-deployment position when the linkages  183   a,    183   b  are fully retracted. When the deployment starts and the linkages  183   a,    183   b  start to become extended, the insertion forces increase because the force vectors increase in the insertion direction as the linkages extend  183   a,    183   b  until a maximum insertion force is reached at the fully extended, intermediate position. By gradually increasing the insertion forces, the needle/trocar insertion and retraction is smoother, quieter and less painful. 
         [0036]    Another embodiment of an insertion mechanism  280  is shown in greater detail in  FIGS. 7-10 . The sliding members  284 ,  286  are slidably received in a frame  290  and moved by a spring-biased linkage mechanism  282  including torsion spring  281  and linkages  283   a,    283   b.  In this embodiment, a cam finger  292  (e.g., extending from the frame  290 ) engages beneath one or both of the sliding members  284 ,  286  to lock the sliding members in the retracted or pre-deployment position ( FIG. 7 ). In this pre-deployment position, the cam finger  292  is held against the sliding members  284 ,  286  by a release bar  296 , which may be moved (rotated) to allow the cam finger  292  to move and release the sliding members  284 ,  286  ( FIG. 8 ). The cam finger  292  may be biased in a downward direction and/or the second sliding member  286  may include a cam surface  287  to help facilitate movement along the cam finger  292  over locking mechanism  293  upon actuation. 
         [0037]    The release bar  296  includes a lever  297  for pivoting the release bar  296  between an engaged position against the cam finger  292  ( FIG. 7 ) and a disengaged position releasing the cam finger  292  ( FIG. 8 ). The release bar  296  may be biased toward the disengaged position and held against the cam finger  292  in the engaged position until the lever  297  is released allowing the release bar  296  to move to the disengaged position. In the illustrated embodiment, the lever  297  engages a rotating surface  257  of a drive wheel  256  of the fluid drive mechanism  150  such that the lever  297  is held in the engaged position for part of the rotation and is released at a certain point during the rotation (e.g., when a flat portion of the rotating surface  257  allows the lever  297  to move). 
         [0038]    As shown in  FIGS. 9 and 10 , the cam finger  292  may also be used to lock the second sliding member  286  in the insertion position. A locking portion  288  of the second sliding member  286  engages a locking portion  293  of the cam finger  292  when the linkage mechanism  282  is fully extended in the intermediate position and prevents the second sliding member  286  from retracting such that the cannula remains inserted. As discussed above, the second sliding member  286  may also be locked by one or more latches (not shown) extending from a top of the frame  290 . 
         [0039]    According to one embodiment, as shown in  FIGS. 11-17 , the cannula  176  providing the transcutaneous access for delivery the fluid may also be used to introduce the monitor test strip  120 . In this embodiment, the cannula  176  includes a first lumen  175  for receiving the needle/trocar  174  and a second lumen  177  for receiving the test strip  120 . As shown, the first lumen  175  has a circular (cylindrical) profile and the second lumen  177  has a rectangular profile. The cannula  176  may also include one or more windows  179   a,    179   b  providing access to one or more sensors  122   a,    122   b  on the test strip  120 . As shown, the plurality of windows  179   a ,  179   b  of the cannula  176  may be arranged on a same side of the sidewall of cannula  176 , with the first window  179   a  arranged at a distance from the distal end tip of the cannula  176  which is less than the distance of the second window  179   b  from the distal end tip of the cannula  176 . 
         [0040]    To insert the test strip  120  into second lumen  177 , the test strip  120  passes into second lumen  177  at the head  178  of the cannula  176  and extends to the window(s)  179   a,    179   b.  Thus, at least one window  179   a,    179   b  exposes a sensor  122   a ,  122   b  of the monitoring test strip  120 . In the example embodiment, two windows  179   a,    179   b  are provided with the window  179   a  closest to the tip of the cannula  176  providing access to the main sensor area and the window  179   b  farthest from the tip providing a reference. Although a specific shape and configuration of a bi-lumen cannula is shown, other configurations of a cannula with first and second lumens may also be used to both deliver a therapeutic fluid and introduce a test strip subcutaneously. 
         [0041]    According to another embodiment, as shown in  FIGS. 18-28 , a fluid delivery device  300  may include a transcutaneous access tool  372  with a first cannula  376  for delivering fluid and a second cannula  377  for introducing a test strip  320 . 
         [0042]    The first cannula  376  receives a first needle/trocar  374  (shown as a circular needle) to facilitate insertion of the first cannula  376  and the second cannula  377  receives a second needle/trocar  375  (shown as a semi-circular trocar) to facilitate insertion of the second cannula  377 . The fluid deliver device  300  includes an insertion mechanism  380 , similar to the first described embodiment above, but with sliding members  384 ,  386  coupled to both the needle  374  and the trocar  375  and both cannulas  376 ,  377 . The insertion mechanism  380  inserts the second cannula  377  and the trocar  375  and then retracts the trocar  375  in the same manner as described above. The test strip  320  remains inserted after the trocar  375  is retracted. Thus, both the first needle/trocar  374  and the second needle/trocar  375  may be introduced into the patient simultaneously, particularly to reduce the pain of sequential insertions. 
         [0043]    Similar to the above described embodiment, first cannula  376  includes a circular (cylindrical) lumen  376   a.  As shown in greater detail in  FIGS. 24-26 , the second cannula  377  includes a semi-circular (D-shaped) lumen  377   a  to allow the monitor strip to sit relatively flat within the cannula  377 . The second cannula  377  also includes one or more windows  379   a,    379   b  providing access to one or more sensors  320   a,    320   b  on the test strip  320  (see  FIGS. 21 and 23 ). As shown, similar to the prior embodiment, the plurality of windows  379   a,    379   b,  of the cannula  377  may be arranged on a same side of the sidewall of the cannula  377 , with the first window  379   a  arranged at a distance from the distal end tip of the cannula  377  which is less than the distance of the second window  379   b  from the distal end tip of the cannula  377 . Thus, at least one window  379   a,    379   b  exposes a sensor  320   a,    320   b  of the monitoring test strip  320 . In the example embodiment, two windows  379   a,    379   b  are provided with the window  379   a  closest to the tip of the cannula  377  providing access to the main sensor area and the window  379   b  farthest from the tip providing a reference. As shown in greater detail in  FIGS. 27 and 28 , the trocar  375  has a shape corresponding to the D-shaped lumen  377   a  to allow the trocar  375  to be retracted leaving the test strip  320  inserted (see  FIG. 23 ). As shown, the trocar includes a planar side surface  373  which corresponds to a planar test strip  320  such that, when assembled, the planar test strip  320  may be located adjacent the planar side surface  373  of the trocar  375  in the second cannula  377 . 
         [0044]    According to another embodiment, as shown in  FIGS. 29-37 , a fluid delivery device  400  may include a transcutaneous access tool  472  with a cannula  476  for delivering fluid and a needle or trocar  475  (shown as a semi-circular trocar) for introducing a test strip  420 . The cannula  476  receives a needle/trocar  474  (shown as circular needle) to facilitate insertion of the cannula  476  and the trocar  475  is inserted with the test strip  420 . The fluid deliver device  400  includes an insertion mechanism  480 , similar to the first described embodiment above, but with sliding members  484 ,  486  coupled to both the needle  474  and the trocar  475 . The insertion mechanism  480  inserts the trocar  475  ( FIGS. 31 and 32 ) and then retracts the trocar  475  ( FIGS. 33 and 34 ) in the same manner as the needle/trocar described above. The test strip  420  remains inserted after the trocar  475  is retracted ( FIG. 35 ). In contrast to the prior embodiment, the needle/trocar  475  introduces the monitoring test strip  420  subcutaneously solely (i.e. without the monitoring test strip  420  being introduced with a cannula). 
         [0045]    The trocar  475  is shown in greater detail in  FIG. 36 . The second sliding member  486  is shown in greater detail in  FIG. 37 . In this embodiment, the second sliding member  486  is designed to capture the cannula  476  and to receive and allow the trocar  475  to pass through. 
         [0046]    Accordingly, various embodiments of the fluid delivery device may use the transcutaneous access tool both to deliver fluid and to introduce a test strip subcutaneously to provide integrated monitoring. 
         [0047]    While the principles of the invention have been described herein, it is to be understood by those skilled in the art that this description is made only by way of example and not as a limitation as to the scope of the invention. Other embodiments are contemplated within the scope of the present invention in addition to the exemplary embodiments shown and described herein. Modifications and substitutions by one of ordinary skill in the art are considered to be within the scope of the present invention, which is not to be limited except by the following claims.