Patent Publication Number: US-2022211938-A1

Title: Fluid delivery device, transcutaneous access tool and fluid drive mechanism for use therewith

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 16/552,492 filed Aug. 27, 2019, which is a continuation of U.S. patent application Ser. No. 15/226,510 (now U.S. Pat. No. 10,420,883) filed Aug. 2, 2016, which is a continuation of U.S. patent application Ser. No. 13/854,456 (now U.S. Pat. No. 9,402,950) filed Apr. 1, 2013, which is a continuation of PCT Application Serial No. PCT/US13/34674 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 
     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 
     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. 
     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. 
     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 
     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. 
     In certain embodiments, the drive mechanism may comprise a clutch mechanism. As explained herein, by using a clutch mechanism, the number of fluid path prime pulses to prime the pump may be reduced and a full and proper priming of the fluid path before placement on the body may be better assured. The clutch mechanism may also be made suitable for other drug applications without significant redesign, and be more easily inspected than conventional drive mechanisms for infusion devices. 
     In certain embodiments, the fluid delivery device may comprise a fluid reservoir; a transcutaneous access tool fluidly coupled to the fluid reservoir; and a drive mechanism for driving fluid from the reservoir. The drive mechanism may comprise a plunger received in the reservoir; a leadscrew extending from the plunger; a nut threadably engaged with the leadscrew; a drive wheel; and a clutch mechanism coupled to the drive wheel, wherein the clutch mechanism is configured to allow the nut to pass through the clutch mechanism when disengaged and is configured to grip the nut when engaged such that the drive wheel rotates the nut to advance the leadscrew and the plunger into the reservoir. 
     In certain embodiments, the fluid delivery device may comprise a fluid reservoir; a transcutaneous access tool fluidly coupled to the fluid reservoir; and a drive mechanism for driving fluid from the reservoir The drive mechanism may comprise a plunger received in the reservoir; an elongated assembly comprising a first elongated member and a second elongated member; the first elongated member extending from the plunger; the second elongated member coupled to the first elongated member; a drive wheel; and a clutch mechanism coupled to the drive wheel, wherein the clutch mechanism is configured to allow the second elongated member to pass through when disengaged and is configured to grip the second elongated member when engaged such that the drive wheel rotates the second elongated member to advance the first elongated member and the plunger into the reservoir. 
     In certain embodiments, a method of operating a foregoing fluid delivery device may comprise providing the fluid delivery device; holding the clutch mechanism in a disengaged position; filling the fluid reservoir with fluid; passing the second elongated member through the clutch mechanism such that the plunger is retracted within the reservoir; releasing the clutch mechanism from the disengaged position; and engaging the clutch mechanism with the second elongated member. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       These and other features and advantages will be better understood by reading the following detailed description, taken together with the drawings wherein: 
         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; 
         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 ; 
         FIG. 3  is a top perspective view of the fluid delivery device shown in  FIG. 1  with the insertion mechanism in an intermediate position; 
         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 ; 
         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; 
         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 ; 
         FIG. 7  is a top perspective view of a fluid driving mechanism of the fluid delivery device shown in  FIG. 1  with a clutch mechanism in a disengaged position prior to filling; 
         FIG. 8  is a side cross-sectional view of the fluid driving mechanism shown in  FIG. 7 ; 
         FIG. 9  is a top perspective view of the fluid driving mechanism shown in  FIG. 7  with the clutch mechanism in a disengaged position after filling; 
         FIG. 10  is a top perspective view of the fluid driving mechanism shown in  FIG. 7  with the clutch mechanism being released to the engaged position; and 
         FIGS. 11 and 12  are top perspective views of the fluid driving mechanism shown in  FIG. 7  with the clutch mechanism in the engaged position. 
     
    
    
     DETAILED DESCRIPTION 
     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. 
     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. 
     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. 
     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 . 
     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. 
     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 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 ). 
     Referring to  FIGS. 7-12 , one embodiment of the fluid drive mechanism  150  uses a clutch mechanism  160  to facilitate filling of the reservoir  130  and engagement of the fluid drive mechanism  150  for driving fluid out of the reservoir  130 . The fluid drive mechanism  150  includes a first threaded member in the form of an elongated shaft such as a threaded drive rod or leadscrew  152 , with external threads extending from a plunger  136  received in the reservoir  130  and sealed with an o-ring  137  against the inside surface of the reservoir  130 . The leadscrew  152  and plunger  136  may be an inseparable, insert-molded assembly. A second threaded member in the form of an elongated shaft such as a tube nut  154  with internal threads threadably engages the leadscrew  152  and may be driven by a drive wheel  156  via a clutch mechanism  160 . 
     When the reservoir  130  is empty ( FIGS. 7 and 8 ), the plunger  136  is positioned at one end of the reservoir  130  such that the plunger  136  is extended and the clutch mechanism  160  is disengaged. In certain embodiments, the reservoir  130  may be filled with fluid, particularly insulin, by opening an inlet port to the reservoir  130  and pumping in the insulin under sufficient hydraulic pressure to retract the plunger  136  within the reservoir  130 . Thereafter, the inlet port may be closed. When the reservoir  130  is filled and the plunger  136  moves to the opposite (retracted) end of the reservoir  130  ( FIG. 9 ), the clutch mechanism  160  remains disengaged to allow the tube nut  154  to pass into an elongated cylindrical bore (along the drive axis) of a hub of the drive wheel  156 . The clutch mechanism  160  may then be engaged ( FIGS. 10-12 ) such that rotation of the drive wheel  156  causes the clutch mechanism  160  to rotate the tube nut  154 , which causes the leadscrew  152  to advance the plunger into the reservoir  130  to deliver the fluid from the reservoir  130 . In alternative embodiments, the reservoir  130  may be filled when the plunger  136  is already retracted. 
     In the illustrated embodiment, the clutch mechanism  160  includes a clutch spring  162  (e.g., a helical torsion spring) located in a counterbore at one end of the drive wheel  156 , adjacent the reservoir  130 . The inside diameter of the clutch spring  162  is larger than the outside diameter of the tube nut  154  when the clutch spring  162  is loaded, thereby disengaging the clutch spring  162  from the tube nut  154  and allowing the tube nut  154  to pass through the center aperture of the spring  162  and into the elongated bore of the drive wheel  156 . Alternatively, the inside diameter of the clutch spring  162  is smaller than the outside diameter of the tube nut  154  when the clutch spring  162  is unloaded, thereby engaging or gripping the tube nut  154  and allowing the drive wheel  156  to rotate the tube nut  154 . In the illustrated embodiment, prior to filing the reservoir  130 , the clutch spring  162  is held in the loaded, disengaged position by a spring latch  164  engaged with the drive wheel  156  ( FIGS. 7-9 ). After the reservoir  130  has been filled, the clutch spring  162  may thus be engaged by rotating the drive wheel  156  until the spring latch  164  releases the clutch spring  162  ( FIG. 10 ) allowing the clutch spring  162  to unload and grip the tube nut  154  ( FIGS. 11 and 12 ), at which time fluid may be dispensed from the reservoir  130  with continued rotation of the drive wheel  156 . 
     As shown, the spring latch  164  may be biased by the clutch spring  162  such that as the drive wheel  156  rotates the spring latch  164  moves rotationally against a surface of a reservoir cap  132  until clutch spring  162  deflects the spring latch  164  into a window  133  in the reservoir cap  132 . When the spring latch  164  moves into the window  133 , the end of the clutch spring  162  held by the spring latch  164  is released, thus engaging the clutch mechanism  160 . When the clutch spring  162  is engaged, the drive wheel  156  contacts an end  163  of the clutch spring  162  to create a thrust on the clutch spring  162  that causes the clutch spring  162  to rotate the tube nut  154 . The fluid drive mechanism  150  may also use other clutch mechanisms capable of allowing the tube nut  154  or other type of nut or threaded member to pass through the clutch mechanism and then being activated to engage the nut or threaded member. 
     In the illustrated embodiment, the drive wheel  156  includes ratchets  157  that are engaged by an actuator  158  to incrementally drive the wheel  156  and advance the plunger  136  into the reservoir  130 . Examples of this actuation mechanism are described in greater detail in U.S. Patent Application Publication No. 2005/0238507, which is fully incorporated herein by reference. 
     By using a clutch mechanism, the engagement between the leadscrew and the nut occurs at assembly, and thus no rotation is needed for the nut to engage the leadscrew by operation of the device. This reduces the number of fluid path prime pulses to prime the pump and assures a full and proper priming of the fluid path before placement on the body. The clutch mechanism also enables the changing of thread pitch for other drug applications without a need to redesign the tilt nut used in fluid driving mechanisms in other existing pumps. The components of the clutch mechanism are also more easily inspected than the tilt nut assembly. 
     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.