Fluid conduit insertion device

Abstract

Disclosed herein are techniques related to insertion of a fluid conduit (e.g., a tube connected to a fluid reservoir or a cannula sharing a pre-assembled fluid path with such a tube). In some embodiments, an insertion mechanism can include one or more springs (e.g., torsion springs or compression springs). The one or more springs can cause a trocar or trocar glide to pierce tissue and insert into a fluid conduit. The one or more springs can further cause the trocar or trocar glide to be removed from the tissue.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit and priority of U.S. Patent Application Serial No. 17 / 515,721, filed November 1, 2021, the entire contents of which are incorporated herein by reference.

[0003] This application claims the benefit and priority of U.S. Provisional Patent Serial No. 63 / 112,573, filed November 11, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0004] This disclosure relates in general to medical insertion devices, and more specifically to fluid catheter insertion devices. Background Technology

[0005] Insulin therapy can be used to control type 1 or type 2 diabetes. Insulin therapy may include the use of an insulin infusion system to deliver or dispense insulin. An insulin infusion system may include an infusion device that typically includes a small motor and drive components configured to deliver insulin from a reservoir into the body, for example, via a percutaneous needle or cannula placed in subcutaneous tissue. Insulin infusion systems may be beneficial for diabetes control in some individuals. Summary of the Invention

[0006] This disclosure relates generally to techniques for inserting medical devices into a patient's body. More specifically, this disclosure relates to techniques for inserting fluid conduits (e.g., tubing directly connected to a fluid reservoir or cannula indirectly connected to a fluid reservoir).

[0007] According to an aspect of this disclosure, the torsion insertion mechanism includes a torsion spring configured to rotate a crank based on a difference between a first spring state and a second spring state; and an insertion assembly coupled to the crank and configured to move from a first position to a second position in response to rotation of the crank. The insertion assembly includes a catheter holder and a trocar slide configured to puncture tissue. The trocar slide is slidably disposed along the catheter holder and configured to disengage from the catheter holder upon puncture of tissue.

[0008] In one aspect of this disclosure, the catheter holder may include a flexible tube having a distal portion configured for insertion into tissue in response to rotational movement of a crank.

[0009] In another aspect of this disclosure, the cannula slide can be configured to puncture tissue in response to the rotational movement of a crank.

[0010] In yet another aspect of this disclosure, the cannula slide may include a tab configured to move the catheter holder into a second position.

[0011] In another aspect of this disclosure, the torsion insertion mechanism may also include a housing configured to retain a distal portion of the torsion spring. The torsion spring may include a proximal portion configured to engage with a slot in the crank and the sleeve needle slide.

[0012] In one aspect of this disclosure, the torsion insertion mechanism may further include a triggering mechanism configured to selectively enable the crank to rotate.

[0013] In another aspect of this disclosure, the insertion assembly may also include a fluid flow path that passes through a flexible tube in the catheter holder. The fluid flow path may be configured for fluid communication between a distal portion of the flexible tube and a drug reservoir.

[0014] In yet another aspect of this disclosure, the cannula slide and the catheter holder can be configured to move together from a first position to a second position.

[0015] In another aspect of this disclosure, the cannula slide can be configured to return from a second position to a first position while the catheter holder remains in the second position.

[0016] According to an aspect of this disclosure, the infusion pump system includes a torsional insertion mechanism. The torsional insertion mechanism includes a torsion spring configured to rotate a crank based on a difference between a first spring state and a second spring state; and an insertion assembly coupled to the crank and configured to move from a first position to a second position in response to rotation of the crank. The insertion assembly includes a catheter holder and a trocar slide configured to puncture tissue. The trocar slide is slidably disposed along the catheter holder and configured to disengage from the catheter holder upon puncture of tissue.

[0017] In yet another aspect of this disclosure, the catheter holder may include a flexible tube having a distal portion configured for insertion into tissue in response to rotational movement of a crank.

[0018] In yet another aspect of this disclosure, the trocar slide can be configured to puncture tissue in response to the rotational movement of a crank.

[0019] In another aspect of this disclosure, the cannula slide may include a tab configured to move the catheter holder into a second position.

[0020] In one aspect of this disclosure, the torsion insertion mechanism may further include a housing configured to retain a distal portion of the torsion spring. The torsion spring may include a proximal portion configured to engage a slot in the crank and the sleeve needle slide.

[0021] In another aspect of this disclosure, the torsion insertion mechanism may also include a triggering mechanism configured to selectively enable the crank to rotate.

[0022] In one aspect of this disclosure, the cannula slide and the catheter holder can be configured to move together from a first position to a second position.

[0023] In yet another aspect of this disclosure, the cannula slide can be configured to return from a second position to a first position while the catheter holder remains in the second position.

[0024] According to another aspect of this disclosure, a method for operating a torsion insertion mechanism of an insulin infusion system includes: rotating a crank based on a difference between a first spring state and a second spring state of a torsion spring; moving a cannula slide and a catheter holder from a first position to a second position in response to the rotation of the crank; and returning the cannula slide to the first position while retaining the catheter holder in the second position in response to continued rotation of the crank.

[0025] In one aspect of this disclosure, the method may further include moving the cannula slide and catheter holder from a first position to a second position, including puncturing tissue at least with the cannula slide.

[0026] In yet another aspect of this disclosure, returning the cannula slide to the first position while retaining the catheter holder in the second position may include disengaging the crank from the catheter holder via a slot in the end opening of the catheter holder.

[0027] According to another aspect of this disclosure, the torsion insertion mechanism includes a torsion spring configured to rotate a crank based on a difference between a first spring state and a second spring state; and an insertion assembly coupled to the crank and configured to move from a first position to a second position in response to rotation of the crank. The insertion assembly includes a cannula holder and a trocar slide configured to puncture tissue. The trocar slide is slidably disposed along the cannula holder and configured to disengage from the cannula holder upon puncture of tissue.

[0028] In one aspect of this disclosure, the cannula holder may include a cannula configured for insertion into tissue in response to rotational movement of a crank.

[0029] In another aspect of this disclosure, the cannula slide includes a cannula slidably disposed within an insertion cannula. The cannula is configured to puncture tissue in response to rotational movement of a crank.

[0030] In one aspect of this disclosure, the cannula slide includes a tab configured to move the cannula holder into a second position.

[0031] In yet another aspect of this disclosure, the torsion insertion mechanism may further include a housing configured to retain a distal portion of the torsion spring. The torsion spring includes a proximal portion configured to engage with a slot in the crank and the sleeve needle slide.

[0032] In one aspect of this disclosure, the torsion insertion mechanism may further include a triggering mechanism configured to selectively enable the crank to rotate.

[0033] In another aspect of this disclosure, the triggering mechanism may be configured to engage a recess in the crank to prevent rotation of the crank, and disengage from the recess in the crank to allow the crank to rotate.

[0034] In yet another aspect of this disclosure, the insertion assembly may further include a fluid flow path that passes through the cannula in the cannula holder. The fluid flow path is configured for fluid communication between the cannula and the drug reservoir.

[0035] In one aspect of this disclosure, the cannula slide and the cannula holder can be configured to move together from a first position to a second position.

[0036] In another aspect of this disclosure, the cannula slide can be configured to return to a first position while the cannula holder remains in a second position.

[0037] According to another aspect of this disclosure, the infusion pump system includes a torsional insertion mechanism. The torsional insertion mechanism includes a torsion spring configured to rotate a crank based on a difference between a first spring state and a second spring state; and an insertion assembly coupled to the crank and configured to move from a first position to a second position in response to rotation of the crank. The insertion assembly includes a cannula holder and a cannula slide configured to puncture tissue. The cannula slide is slidably disposed along the cannula holder and configured to disengage from the cannula holder upon puncture of tissue.

[0038] In one aspect of this disclosure, the cannula holder may include a cannula configured for insertion into tissue in response to rotational movement of a crank.

[0039] In another aspect of this disclosure, the cannula slide may include a cannula slidably disposed within an insertion cannula. The cannula may be configured to puncture tissue in response to rotational movement of a crank.

[0040] In another aspect of this disclosure, the cannula slide may include a tab configured to move the cannula holder into a second position.

[0041] In another aspect of this disclosure, the torsion insertion mechanism may also include a housing configured to retain a distal portion of the torsion spring. The torsion spring may include a proximal portion configured to engage with a slot in the crank and the sleeve needle slide.

[0042] In one aspect of this disclosure, the torsion insertion mechanism may further include a triggering mechanism configured to selectively enable the crank to rotate.

[0043] In another aspect of this disclosure, the cannula slide and the cannula holder can be configured to move together from a first position to a second position. The cannula slide can be configured to return to the first position while the cannula holder remains in the second position.

[0044] According to another aspect of this disclosure, a method for operating a torsion insertion mechanism of an insulin infusion system includes: rotating a crank based on a difference between a first spring state and a second spring state of a torsion spring; moving a cannula slide and a cannula holder from a first position to a second position in response to the rotation of the crank; and returning the cannula slide to the first position while leaving the cannula holder in the second position in response to continued rotation of the crank.

[0045] In one aspect of this disclosure, moving the cannula slide and cannula holder from a first position to a second cannula position includes: puncturing tissue at least with the cannula slide.

[0046] In another aspect of this disclosure, returning the cannula slide to the first position while leaving the cannula holder in the second position may include disengaging the crank from the cannula holder via a slot in the end opening of the cannula holder.

[0047] According to another aspect of this disclosure, an insertion mechanism includes: a first compression spring configured to apply a linear force based on the difference between a compressed state and an uncompressed state; and an insertion assembly configured to move from a first position to a second position in response to the linear force applied by the first compression spring. The insertion assembly includes a catheter holder and a cannula configured to puncture tissue. The catheter holder includes a first opening and a second opening, through which an insertion cannula extends, and a tube connected to a fluid reservoir extends through the second opening. The cannula is slidably disposed within the insertion cannula.

[0048] In one aspect of this disclosure, the catheter holder and the cannula may be configured to move together from a first position to a second position.

[0049] In another aspect of this disclosure, the cannula may be configured to return to a first position while the catheter holder remains in a second position.

[0050] In yet another aspect of this disclosure, the insertion mechanism may also include a second compression spring configured to return the cannula needle to the first position.

[0051] In another aspect of this disclosure, the insertion mechanism may also include a second compression spring connected to the cannula needle.

[0052] In another aspect of this disclosure, the cannula may be a solid needle integral with a second compression spring configured to return the cannula to a first position.

[0053] In one aspect of this disclosure, the insertion mechanism may also include a second compression spring configured to move the trocar needle to the outside of the insertion tube.

[0054] In another aspect of this disclosure, the catheter holder may also include a third opening in which a cannula seal is disposed.

[0055] In one aspect of this disclosure, the cannula can be slidably disposed within the cannula seal.

[0056] In another aspect of this disclosure, when the cannula returns to the first position while the catheter holder remains in the second position, the distal end of the cannula can be moved to a position within the cannula seal.

[0057] According to another aspect of this disclosure, the infusion pump system includes an insertion mechanism. The insertion mechanism may include: a first compression spring configured to apply a linear force based on the difference between a compressed state and an uncompressed state; and an insertion assembly configured to move from a first position to a second position in response to the linear force applied by the first compression spring. The insertion assembly includes a catheter holder and a cannula configured to puncture tissue. The catheter holder includes a first opening and a second opening, through which an insertion tube extends, and a tube connected to a fluid reservoir extends through the second opening. The cannula is slidably disposed within the insertion tube.

[0058] In one aspect of this disclosure, the cannula is configured to return to a first position while the catheter holder remains in a second position.

[0059] In another aspect of this disclosure, the infusion pump system may also include a second compression spring configured to return the cannula to a first position.

[0060] In yet another aspect of this disclosure, the cannula is a solid needle integral with a second compression spring configured to return the cannula to a first position.

[0061] In one aspect of this disclosure, the infusion pump system may also include a second compression spring configured to move the cannula needle outside the insertion tube.

[0062] In another aspect of this disclosure, the catheter holder also includes a third opening in which the cannula needle seal is disposed.

[0063] In another aspect of this disclosure, when the cannula returns to the first position while the catheter holder remains in the second position, the distal end of the cannula moves to a position within the cannula seal.

[0064] According to another aspect of this disclosure, a method for operating an insertion mechanism of an insulin infusion system includes: moving a cannula and a catheter holder from a first position to a second position in response to a force applied by a first compression spring. The catheter holder includes a first opening and a second opening, through which an insertion cannula extends, and through which a tube connected to a fluid reservoir extends. The cannula obstructs the connection between the insertion cannula and the tube. The method further includes: returning the cannula to the first position while retaining the catheter holder in the second position in response to a force applied by a second compression spring, thereby allowing the connection between the insertion cannula and the tube.

[0065] In one aspect of this disclosure, moving the cannula from a first position to a second position allows the cannula to puncture tissue and insert a catheter into the tissue.

[0066] In another aspect of this disclosure, the catheter holder may further include a third opening in which a needle seal is disposed. Returning the needle to the first position may include moving the distal end of the needle into the position within the needle seal. Attached Figure Description

[0067] The above and other aspects and features of this disclosure will become more apparent when considered in conjunction with the accompanying drawings, in view of the following detailed description, wherein similar reference numerals identify similar or identical elements.

[0068] Figure 1 This is a diagram of an exemplary torsion insertion mechanism having a torsion spring in an unexcited state, according to aspects of this disclosure;

[0069] Figure 2 Based on the aspects of this disclosure Figure 1 A diagram of a torsion insertion mechanism having a torsion spring in an activated state;

[0070] Figure 3 Based on the aspects of this disclosure Figure 1 A perspective view of the housing of the torsion insertion mechanism;

[0071] Figure 4 Based on the aspects of this disclosure Figure 1A perspective view of the torsion spring of the torsion insertion mechanism;

[0072] Figure 5 Based on the aspects of this disclosure Figure 1 A perspective view of the crank of the torsion insertion mechanism;

[0073] Figure 6 Based on the aspects of this disclosure Figure 1 A perspective view of the cannula needle slider of the torsion insertion mechanism;

[0074] Figure 7A and Figure 7B Based on the aspects of this disclosure Figure 1 A perspective view of the catheter holder of the torsion insertion mechanism;

[0075] Figures 8A to 8C yes Figure 1 A progressive side view of the insertion component 130 of the torsion insertion mechanism, corresponding to the torsion spring transitioning from an unexcited state to an excited state.

[0076] Figure 9 This is an illustration of another exemplary torsion insertion mechanism with a torsion spring according to aspects of this disclosure;

[0077] Figure 10 Based on the aspects of this disclosure Figure 9 A perspective view of the cannula needle slider of the torsion insertion mechanism;

[0078] Figure 11 and Figure 12 Based on the aspects of this disclosure Figure 9 A perspective view of the catheter holder of the torsion insertion mechanism;

[0079] Figure 13 Based on the aspects of this disclosure Figure 11 A cross-sectional perspective view of the catheter support;

[0080] Figure 14 Based on the aspects of this disclosure Figure 9 A cross-sectional side view of the torsion insertion mechanism;

[0081] Figure 15 This is a side perspective view of the insertion mechanism for the tube connection according to aspects of this disclosure;

[0082] Figure 16 Based on the aspects of this disclosure Figure 15 A cross-sectional side view of the insertion mechanism for the tube connection; and

[0083] Figure 17 This is a perspective view of an exemplary infusion pump system according to aspects of this disclosure. Detailed Implementation

[0084] This disclosure relates throughout to techniques for inserting medical devices into a patient's body. More specifically, this disclosure relates to techniques for inserting fluid conduits (e.g., tubing directly connected to a fluid reservoir or cannula indirectly connected to a fluid reservoir).

[0085] As used herein, “exemplary” does not necessarily mean “preferred” and may simply indicate an example unless the context clearly indicates otherwise.

[0086] refer to Figure 1 An exemplary torsion insertion mechanism 100 is shown. The torsion insertion mechanism 100 can be an infusion pump system (e.g., Figure 17 The components of the 1700). The torsion insertion mechanism 100 typically includes a housing 110, a torsion spring 106, a crank 104, and an insertion assembly 130. As will be described in more detail below, the insertion assembly 130 includes a cannula needle slide 122 and a catheter holder 120 configured to carry a tube 125 (e.g., a flexible tube connected to a fluid reservoir). Figure 1 The torsion insertion mechanism 100 in the unactivated position is shown. Figure 2 The torsion insertion mechanism 100 in the activated position is shown.

[0087] refer to Figure 3 The housing 110 is configured to receive a component of the torsion insertion mechanism 100. The housing 110 typically includes a recess 110b configured to retain the distal portion 106b of the torsion spring 106. Figure 4 ); boss 110c, configured to receive and / or guide torsion spring 106; hole 110d; and guide defined by housing fingers 103a and 103b, configured to activate torsion spring 106. Figure 2 When inserting the component 130, the insertion component 130 is guided to enter vertically. Figure 1 ).

[0088] refer to Figure 4 The diagram shows a torsion spring 106 of the torsion insertion mechanism 100. The torsion spring 106 is configured to store potential energy and, when excited, convert that potential energy into kinetic energy that causes rotational motion of the crank 104. The torsion spring 106 can use any of a variety of triggering mechanisms (e.g., Figure 9The crank 104 is actuated by triggering mechanisms 902, which selectively enable the crank 104 to rotate. A torsion spring 106 is slidably disposed around a boss 110c of the housing 110. The torsion spring 106 is configured to rotate the crank 104 based on the difference between a first spring state (e.g., unexcited state) and a second spring state (e.g., excited state). For example, this difference could be the amount of potential energy stored by winding the torsion spring 106 (e.g., 360 degrees). The torsion spring 106 includes a proximal portion 106a and a distal portion 106b. The proximal portion 106a of the torsion spring 106 can be held in a through-hole 104 through a surface 104c of the crank 104. Figure 5 Torsion spring 106 can be installed in an infusion pump system (e.g., Figure 17 The torsion spring 106 is preloaded (e.g., placed under tension) before the 1700, so that it stores potential energy for later use.

[0089] refer to Figure 5 The crank 104 is shown. The rotational motion of the crank 104 is converted into linear motion of the insertion assembly 130. The crank 104 includes a boss 104d projecting from a surface 104c and a through hole 104a configured to retain a proximal portion 106a of a torsion spring 106. The boss 104d includes a central opening 104e (e.g., a through hole) that can be configured for use with a shaft (not shown).

[0090] When crank 104 rotates in response to the rotation of torsion spring 106, insertion assembly 130 is in the vertical direction (e.g., in...). Figure 2 (In the direction of arrow A, in the insertion direction toward the patient's skin) moves. This is based on the proximal portion 106a of the torsion spring 106 within the horizontal slot 122c of the cannula slide 122. Figure 6 And along the bracket slot 120b of the conduit bracket 120 ( Figure 7B This is achieved by moving the insertion component 130 downward from the first position ( Figure 1 The cannula slides 122 to a second position, corresponding to the puncture portion 122a of the cannula slide 122 and the distal portion 125b of the tube 125 protruding from the bottom of the housing 110. As the crank 104 continues to rotate, the cannula slide 122 (but not the catheter holder 120) moves upward back to the first position, thereby retracting the cannula slide 122 (but not the catheter holder 120) back into the housing 110. Thus, the distal portion 125b of the tube 125 can be retained in the patient for fluid delivery (e.g., fluid delivery of medications such as insulin).

[0091] refer to Figure 6 , Figure 7A and Figure 7B , showed Figure 1The insertion assembly 130 of the torsion insertion mechanism 100 is a component of the insertion component 130. The insertion component 130 is configured to use the piercing portion 122a of the trocar slide 122. Figure 6 ) and / or the inclined surface of the distal portion 125b of the tube 125 ( Figure 2 The distal portion 125b is inserted into the subcutaneous tissue by piercing the tissue. In various respects, the proximal portion 125a of the tube 125 is connected to a drug reservoir (e.g., Figure 17 (1704). This feature has the benefit of connecting a drug reservoir to a single fluid conduit in the subcutaneous tissue. The insertion assembly 130 typically includes a cannula slide 122 and a catheter holder 120. The catheter holder 120 is slidably disposed along the cannula slide 122. The insertion assembly 130 is configured to move between a first position and a second position in response to rotation of the crank 104. The first position of the insertion assembly 130 may be a proximal position, and the second position of the insertion assembly 130 may be a distal position. Components of the insertion assembly 130 may be configured to move upward and / or downward or translate axially relative to a longitudinal axis defined by the distal portion 125b of the tube 125. In operation, during the insertion of the distal portion 125b through the skin and into the subcutaneous tissue, the cannula slide 122 may move downward (e.g., in a direction toward the patient's skin) and may push downward or otherwise cause downward movement of the catheter holder 120. During operation, the cannula slide 122 (but not the catheter holder 120) can also move upward (e.g., away from the user's skin) to retract the cannula slide 122. For example, the cannula slide 122 can return to a first position ( Figure 2 ).

[0092] refer to Figure 6 The image shows a perspective view of the cannula slide 122 of the insertion assembly 130. The cannula slide 122 includes an arm 122b, a slot 122c passing through the arm 122b, one or more tabs 122d configured to move the catheter holder 120 from a first position to a second position, and a puncture portion 122a. The puncture portion 122a is configured to protrude from the bottom of the housing 110 to puncture the user's skin and facilitate placement of the distal end 125b of the tube 125 into the user's subcutaneous tissue. The slot 122c is configured to interact with a proximal portion of the torsion spring 106. The slot 122c is configured to convert rotational motion of the crank 104 into linear motion. In various aspects, the cannula slide 122 may have a U-shaped cross-section for receiving at least a portion of the tube 125 (e.g., the distal portion 125b).

[0093] refer to Figure 7A and Figure 7B , showed Figure 1The insertion assembly 130 includes a catheter holder 120. The catheter holder 120 is configured to move in response to movement of the cannula slide 122. The catheter holder 120 of the insertion assembly 130 typically includes a tube 125 configured for connection with a medication reservoir (e.g., Figure 17 The catheter reservoir (1704) is in fluid communication with the drug reservoir, which is configured to contain a fluid drug (e.g., insulin). A fluid flow path is possible from the drug reservoir through a tube 125 in the catheter holder 120. The catheter holder 120 may include a holder slot 120b configured to convert rotational motion of the crank 104 into linear motion. The holder slot 120b may include a curved portion with an open end configured to allow a proximal portion 106a of the torsion spring 106 to disengage from the catheter holder 120. Thus, rotational motion of the crank 104 can cause the catheter holder 120 to move from a first position to a second position where the catheter holder 120 can be held therein.

[0094] Figures 8A to 8C This is a progressive view of the insertion component 130 of the twisting insertion mechanism 100. The insertion component 130 is in its first position ( Figure 8A Move to the second position. Figure 8B Both the distal end 125b and the piercing end 122a extend through the bottom of the housing 110. Figure 8C The cannula slide 122 is shown retracted to the first position, while the catheter holder 120 remains in the second position.

[0095] Figure 9 It shows what can be used in infusion pump systems (e.g., Figure 17 Another exemplary torsion insertion mechanism 100' used in (1700). Torsion insertion mechanism 100' may include a trigger mechanism 902 configured to actuate torsion spring 106. Although torsion insertion mechanism 100' is similar to... Figure 1 The torsion insertion mechanism 100 shares many similarities, but there are some differences, which will be described below. The difference lies in the external fluid seal 904, which may be at least partially made of an elastomeric material (e.g., rubber) or some other suitable material, for preventing external fluid from entering the torsion insertion mechanism 100'. In all respects, Figure 9 The fluid flow path may include a tube 125' (e.g., a flexible tube configured to be in fluid communication with a drug reservoir), a cannula 123 ( Figure 10 The cannula 124 may include a channel configured for fluid delivery and for receiving a trocar 123. In various respects, the trocar 123 may be configured to slidably move within the channel of the cannula 124.

[0096] The twisting insertion mechanism 100' includes an insertion assembly 130', which includes a catheter holder 120' and a trocar slide 126. Figure 10 The catheter holder 120' is configured to move in response to movement of a cannula slide 126, which includes a tab 126a configured to move the catheter holder 120' from a first position to a second position. The catheter holder 120' includes a tube 125'. A fluid flow path is available from a drug reservoir (e.g., Figure 17 1704) passes through tube 125' in catheter holder 120'. Catheter holder 120' may include holder slot 120b ( Figure 12 The bracket slot 120b is configured to convert the rotational motion of the crank 104 into linear motion. The bracket slot 120b may include a curved portion with an open end configured to allow the proximal portion of the torsion spring 106 (not shown, but similar) to... Figure 4 The proximal portion 106a) disengages from the catheter holder 120'. The catheter holder 120' moves from the first position to the second position in response to the rotational movement of the crank 104.

[0097] The trigger mechanism 902 may be a latch or a side surface for engaging or disengaging the crank 104 (not shown, but similar). Figure 5 The grooves in surface 104b) of the torsion spring 106 are used to actuate some other suitable mechanism to prevent or allow the crank 104 to rotate. Actuating trigger mechanism 902 disengages the trigger mechanism 902 from the crank 104, and the crank 104 can rotate in response to the potential energy stored in the torsion spring 106 being converted into kinetic energy. The torsion spring 106 (which may be preloaded) can apply torque to the crank 104, causing the crank 104 to rotate based on the difference between a first spring state (e.g., unexcited state) and a second spring state (e.g., excited state).

[0098] In various aspects, the catheter holder 120' of the torsion insertion mechanism 100' may include a magnet 903. The magnet 903 may be used to sense the relative position and / or excitation state of the catheter holder 120'. For example, the magnet 903 may interact with a sensor (e.g., a Hall effect sensor) configured to output an electrical signal based on the detected proximity of the magnet 903.

[0099] The twisting insertion mechanism 100' may include a cannula needle slide 126. Figure 10The cannula slide may include a cannula 123 configured to support the cannula 124 (e.g., a flexible tube) and enable skin penetration. For example, the cannula 123 may be configured to slide within and extend beyond the distal end of the cannula 124, thereby providing rigidity and / or acting as a guide when the bevel of the cannula 123 pierces the skin. The twisting insertion mechanism 100' may include a catheter holder 120'. Figures 11 to 13 The catheter holder includes a magnet 903 and a cannula needle seal 1302. Figure 13 ) and cannula needle seal retainer 120c ( Figures 11 to 13 The needle seal 1302 may be at least partially made of an elastomeric material (e.g., rubber) or some other suitable material to provide a fluid-tight seal between the needle 123 and the cannula 124. The needle seal retainer 120c may be an opening in the housing of the catheter holder 120', and this opening may be configured to receive the needle seal 1302 and / or secure the needle seal 1302 to the catheter holder 120' (e.g., via friction fit).

[0100] Figure 14 It shows Figure 9 A side sectional view of the torsion insertion mechanism 100'. Among the other components, Figure 14 The catheter holder 120' is shown, and the cannula 123 within the cannula 124 is depicted. Figure 14 In the example, activating the torsion insertion mechanism 100' causes the catheter holder 120' to move downward, exposing both the cannula 123 and the cannula 124 from the external fluid seal 904 for insertion into the patient. However, the cannula 123 can move independently of the cannula 124, such that the distal end of the cannula 123 can be pulled upward and away from the distal end of the inserted cannula 124, but not so far as to be outside the cannula seal 1302 (e.g., such that the distal end of the cannula 123 moves into the cannula 124 but closer to the proximal end of the cannula 124). The external fluid seal 904 can engage (e.g., push for frictional engagement) the catheter holder 120' during insertion, thereby preventing external fluid from entering the torsion insertion mechanism 100'.

[0101] Figure 15 It shows that it can be used in infusion pump systems (e.g., Figure 17 The 1700 uses a first compression spring 108 and a second compression spring 107. Figure 16 An exemplary insertion mechanism 100. Figure 16A side cross-sectional view of the insertion mechanism 100” in an unactivated state (e.g., a first state) is shown. The insertion mechanism 100” includes an insertion assembly 130”, which includes a cannula 123' (or, for example, a capture insertion needle) and a catheter holder 120”. The cannula 123' is configured to puncture tissue and facilitate the insertion of a cannula 124 into the subcutaneous tissue for fluid delivery. The catheter holder 120” has a first opening, a second opening, and a third opening, through which the cannula 124 extends, a tube 125 (e.g., a flexible tube connected to a fluid reservoir) extends through the second opening, and a cannula seal 1302' is disposed in the third opening (e.g., via friction engagement). The advantage of this design is that it allows for the placement of fluid in the reservoir (e.g., Figure 17 A pre-assembled fluid passage is provided between the cannula 1704 and the insertion cannula 124 while maintaining a similar form factor to existing inserter designs (e.g., the inserter design described in U.S. Patent Application Serial No. 16 / 038,049, filed July 17, 2018, entitled “AMBULATORYINFUSION PUMPS AND ASSEMBLIES FOR USE WITH SAME”, the entire contents of which are incorporated herein by reference).

[0102] The insertion mechanism 100” also includes a housing 110”, which includes a first portion 110a and a second portion 110f. An insertion assembly 130” is slidably disposed between the first portion 110a and the second portion 110f, but movement of the insertion assembly 130” can be controlled by a triggering mechanism (e.g., a latch configured to engage and disengage a recess in the insertion assembly 130”). The insertion assembly 130” is configured to cooperate with the first portion 110a to retain the spring 108. In various respects, the insertion assembly 130” may be integral with the catheter holder 120” such that movement of the insertion assembly 130” is accompanied by a corresponding movement of the catheter holder 120”. Thus, when the spring 108 is actuated (e.g., allowing a transition from a compressed state to an uncompressed state via the triggering mechanism), the insertion assembly 130” moves linearly (e.g., downwardly) relative to the first portion 110a, such that the catheter holder 120” moves similarly in response to the force applied by the spring 108.

[0103] The catheter holder 120” may be at least partially composed of an elastomeric material (e.g., rubber) or some other suitable material to form a fluid-impermeable seal between a portion 1602 (e.g., the bottom portion) of the catheter holder 120” and an opening 110e in the housing 110”. When the spring 108 is actuated, it can apply a downward force on the insertion assembly 130”, thereby causing the catheter holder 120” to... Figure 16The first position depicted moves downward to a second position, where portion 1602 engages with opening 110e to prevent fluid ingress. In the second position, cannula 124 and cannula needle 123' extend through opening 110e in housing 110".

[0104] The movement of the catheter holder 120” to the second position allows the second compression spring 107 to actuate (e.g., transition from a compressed state to an uncompressed state), thereby allowing the cannula 123’ to return to the first position (e.g., by applying an upward force to the cannula 122’, which pulls the cannula 123’ out of the cannula 124 and out of the path of the fluid flow path). Figure 16 As depicted, the cannula needle 123' may be a solid needle coupled (e.g., integral) to the second compression spring 107. When the cannula needle 123' returns to the first position, the distal end of the cannula needle 123' is positioned within the cannula needle seal 1302' in a manner that avoids obstructing the fluid flow path while preventing fluid from flowing out through the third opening. In various respects, the tube 125" may be part of a fluid flow path that moves together with the tube holder 120".

[0105] Figure 17 An exemplary infusion pump system 1700 is illustrated according to aspects of this disclosure. The infusion pump system 1700 may be a wearable patch pump, which includes a fluid conduit insertion mechanism 100, 100', or 100" (…). Figure 1 , Figure 9 and Figure 15 ) and a drug reservoir 1704 in fluid communication with the fluid conduit insertion mechanism 100, 100' or 100”.

[0106] The phrases “in one embodiment,” “in an embodiment,” “in various embodiments,” “in some embodiments,” or “in other embodiments” may each refer to one or more of the same or different embodiments according to this disclosure. Phrases in the form “A or B” mean “(A), (B), or (A and B).” Phrases in the form “at least one of A, B, or C” mean “(A); (B); (C); (A and B); (A and C); (B and C); or (A, B, and C).” It should be understood that the foregoing description is merely illustrative of this disclosure. To the extent consistent, any or all aspects detailed herein may be used in conjunction with any or all other aspects detailed herein. Various alternatives and modifications can be devised by those skilled in the art without departing from this disclosure. Therefore, this disclosure is intended to encompass all such alternatives, modifications, and variations. The embodiments described with reference to the accompanying drawings are merely illustrative of certain examples of this disclosure. Other elements, steps, methods, and techniques that are not materially different from those described in the foregoing and / or appended claims are also intended to be included within the scope of this disclosure.

[0107] Some exemplary implementation schemes are provided below.

[0108] Example 1. A torsion insertion mechanism, comprising:

[0109] A torsion spring configured to rotate a crank based on the difference between a first spring state and a second spring state; and

[0110] An insertion assembly coupled to a crank and configured to move from a first position to a second position in response to rotation of the crank, the insertion assembly including a cannula holder and a cannula slide configured to puncture tissue, wherein the cannula slide is slidably disposed along the cannula holder and configured to disengage from the cannula holder upon puncture of tissue.

[0111] Example 2. The torsion insertion mechanism according to Example 1, wherein the cannula holder includes a cannula configured to be inserted into tissue in response to the rotational movement of a crank.

[0112] Example 3. The torsion insertion mechanism according to Example 1, wherein the trocar slide includes a trocar slidably disposed within the cannula, and wherein the trocar is configured to puncture tissue in response to the rotational movement of a crank.

[0113] Example 4. The torsion insertion mechanism according to Example 1, wherein the cannula needle slide includes a tab configured to move the cannula holder into a second position.

[0114] Example 5. The torsion insertion mechanism according to Example 1 further includes a housing configured to retain a distal portion of a torsion spring, wherein the torsion spring includes a proximal portion configured to engage with a slot of a crank and a sleeve needle slide.

[0115] Example 6. The torsion insertion mechanism according to Example 1 further includes a triggering mechanism configured to selectively enable the crank to rotate.

[0116] Example 7. The torsion insertion mechanism according to Example 6, wherein the triggering mechanism is configured to engage a recess in the crank to prevent rotation of the crank, and disengage from the recess in the crank to allow the crank to rotate.

[0117] Example 8. The torsion insertion mechanism according to Example 2, wherein the insertion assembly further includes:

[0118] A fluid flow path that passes through the cannula in the cannula holder, wherein the fluid flow path is configured for fluid communication between the cannula and the drug reservoir.

[0119] Example 9. The torsion insertion mechanism according to Example 1, wherein the cannula needle slide and the cannula holder can be configured to move together from a first position to a second position.

[0120] Example 10. The torsion insertion mechanism according to Example 1, wherein the cannula needle slide is configured to return to a first position while the cannula holder remains in a second position.

[0121] Example 11. An infusion pump system, comprising:

[0122] The torsion insertion mechanism includes:

[0123] A torsion spring configured to rotate a crank based on the difference between a first spring state and a second spring state; and

[0124] An insertion assembly coupled to a crank and configured to move from a first position to a second position in response to rotation of the crank, the insertion assembly including a cannula holder and a cannula slide configured to puncture tissue, wherein the cannula slide is slidably disposed along the cannula holder and configured to disengage from the cannula holder upon puncture of tissue.

[0125] Example 12. The infusion pump system according to Example 11, wherein the cannula holder includes a cannula configured to be inserted into tissue in response to the rotational movement of a crank.

[0126] Example 13. The infusion pump system according to Example 11, wherein the cannula slide includes a cannula slidably disposed within the cannula, and wherein the cannula is configured to puncture tissue in response to the rotational movement of a crank.

[0127] Example 14. The infusion pump system according to Example 11, wherein the cannula needle slide includes a tab configured to move the cannula holder into a second position.

[0128] Example 15. The infusion pump system according to Example 11, wherein the torsion insertion mechanism further includes a housing configured to retain a distal portion of the torsion spring, and wherein the torsion spring includes a proximal portion configured to engage with a slot of the crank and the cannula needle slide.

[0129] Example 16. The infusion pump system according to Example 11, wherein the torsion insertion mechanism further includes a triggering mechanism configured to selectively enable the crank to rotate.

[0130] Example 17. The infusion pump system according to Example 11, wherein the cannula needle slide and the cannula holder can be configured to move together from a first position to a second position, and wherein the cannula needle slide is configured to return to the first position while the cannula holder remains in the second position.

[0131] Example 18. A method for operating a torsion insertion mechanism of an insulin infusion system, the method comprising:

[0132] Rotate the crank based on the difference between the first and second spring states of the torsion spring;

[0133] In response to the rotation of the crank, the cannula slide and cannula holder are moved from a first position to a second position; and

[0134] In response to the continued rotation of the crank, the cannula slide is returned to the first position while the cannula holder is retained in the second position.

[0135] Example 19. The method according to Example 18, wherein moving the cannula slide and cannula holder from the first position to the second cannula position includes: puncturing the tissue at least with the cannula slide.

[0136] Example 20. The method according to Example 18, wherein returning the cannula slide to the first position while retaining the cannula holder in the second position comprises: disengaging the crank from the cannula holder via a slot in the end opening of the cannula holder.

[0137] Example 21. An insertion mechanism, comprising:

[0138] A first compression spring, configured to apply a linear force based on the difference between a compressed state and an uncompressed state; and

[0139] An insertion assembly configured to move from a first position to a second position in response to a linear force applied by a first compression spring, the insertion assembly including a catheter holder and a cannula configured to puncture tissue, the cannula holder including a first opening and a second opening, the cannula extending through the first opening, a tube connected to a fluid reservoir extending through the second opening, and the cannula slidably disposed within the cannula.

[0140] Example 22. The insertion mechanism according to Example 21, wherein the catheter holder and the cannula are configured to move together from a first position to a second position.

[0141] Example 23. The insertion mechanism according to Example 21, wherein the cannula is configured to return to a first position while the catheter holder remains in a second position.

[0142] Example 24. The insertion mechanism according to Example 21 further includes a second compression spring configured to return the cannula needle to the first position.

[0143] Example 25. The insertion mechanism according to Example 21 further includes a second compression spring connected to the cannula needle.

[0144] Example 26. The insertion mechanism according to Example 21, wherein the cannula needle is a solid needle integral with a second compression spring configured to return the cannula needle to a first position.

[0145] Example 27. The insertion mechanism according to Example 21 further includes a second compression spring configured to move the trocar needle to the outside of the insertion tube.

[0146] Example 28. The insertion mechanism according to Example 21, wherein the catheter holder further includes a third opening in which the cannula needle seal is disposed.

[0147] Example 29. The insertion mechanism according to Example 28, wherein the cannula needle is slidably disposed within the cannula needle seal.

[0148] Example 30. The insertion mechanism according to Example 28, wherein when the cannula returns to the first position while the catheter holder remains in the second position, the distal end of the cannula moves to a position within the cannula seal.

[0149] Example 31. An infusion pump system, comprising:

[0150] The insertion mechanism includes:

[0151] A first compression spring, configured to apply a linear force based on the difference between a compressed state and an uncompressed state; and

[0152] An insertion assembly configured to move from a first position to a second position in response to a linear force applied by a first compression spring, the insertion assembly including a catheter holder and a cannula configured to puncture tissue, the cannula holder including a first opening and a second opening, the cannula extending through the first opening, a tube connected to a fluid reservoir extending through the second opening, and the cannula slidably disposed within the cannula.

[0153] Example 32. The infusion pump system according to Example 31, wherein the cannula is configured to return to a first position while the catheter holder remains in a second position.

[0154] Example 33. The infusion pump system according to Example 31 further includes a second compression spring configured to return the cannula to the first position.

[0155] Example 34. The infusion pump system according to Example 31, wherein the cannula needle is a solid needle integral with a second compression spring configured to return the cannula needle to a first position.

[0156] Example 35. The infusion pump system according to Example 31 further includes a second compression spring configured to move the cannula needle outside the insertion tube.

[0157] Example 36. The infusion pump system according to Example 31, wherein the catheter bracket further includes a third opening in which the cannula needle seal is disposed.

[0158] Example 37. The infusion pump system according to Example 36, wherein when the cannula returns to the first position while the catheter holder remains in the second position, the distal end of the cannula moves to a position within the cannula seal.

[0159] Example 38. A method for operating an insertion mechanism of an insulin infusion system, the method comprising:

[0160] In response to a force applied by a first compression spring, the cannula and catheter holder are moved from a first position to a second position. The cannula holder includes a first opening and a second opening, with the cannula extending through the first opening and a tube connected to a fluid reservoir extending through the second opening. The cannula blocks the connection between the cannula and the tube.

[0161] In response to the force applied by the second compression spring, the cannula is returned to the first position while the catheter holder is retained in the second position, thereby allowing connection between the cannula and the tube.

[0162] Example 39. The method according to Example 38, wherein the cannula is moved from a first position to a second position such that the cannula punctures the tissue and the insertion cannula is inserted into the tissue.

[0163] Example 40. The method according to Example 39, wherein the catheter holder further includes a third opening, a needle seal is disposed in the third opening, and wherein returning the needle to the first position includes: moving the distal end of the needle to a position within the needle seal.

Claims

1. A torsion insertion mechanism, comprising: A torsion spring configured to rotate a crank based on a difference between a first spring state and a second spring state, the torsion spring having a proximal portion; and An insertion assembly includes a catheter holder and a cannula slide, the cannula slide being slidably arranged along the catheter holder and configured to puncture tissue, wherein the catheter holder includes a first slot, the cannula slide includes a second slot, and a proximal portion of a torsion spring engages with the first slot of the catheter holder and the second slot of the cannula slide, such that the insertion assembly is configured to move from a first position to a second position in response to rotation of the crank. The proximal portion of the torsion spring is configured to disengage from the catheter holder by disengaging from the first slot via the open end of the first slot after puncturing the tissue, thereby separating the cannula slide from the catheter holder.

2. The torsion insertion mechanism of claim 1, wherein the catheter holder comprises a flexible tube having a distal portion configured for insertion into tissue in response to rotational movement of the crank.

3. The torsion insertion mechanism of claim 1, wherein the cannula slide is configured to puncture tissue in response to the rotational movement of the crank.

4. The torsion insertion mechanism of claim 1, wherein the cannula slide includes a tab configured to move the catheter holder into the second position.

5. The torsion insertion mechanism of claim 1, further comprising a housing configured to retain a distal portion of the torsion spring, wherein the proximal portion of the torsion spring is configured to engage the crank.

6. The torsion insertion mechanism of claim 1 further includes a triggering mechanism configured to selectively enable the crank to rotate.

7. The torsion insertion mechanism according to claim 2, wherein the insertion assembly further comprises: A fluid flow path that passes through the flexible tube in the catheter holder, wherein the fluid flow path is configured for fluid communication between the distal portion of the flexible tube and the drug reservoir.

8. The torsion insertion mechanism of claim 1, wherein the cannula slide and the catheter holder are configured to move together from the first position to the second position.

9. The torsion insertion mechanism of claim 1, wherein the cannula slide is configured to return from the second position to the first position while the catheter holder remains in the second position.

10. An infusion pump system, comprising: The torsion insertion mechanism includes: A torsion spring, configured to rotate a crank based on a difference between a first spring state and a second spring state, the torsion spring having a proximal portion; and An insertion assembly includes a catheter holder and a cannula slide, the cannula slide being slidably arranged along the catheter holder and configured to puncture tissue, wherein the catheter holder includes a first slot, the cannula slide includes a second slot, and a proximal portion of a torsion spring engages with the first slot of the catheter holder and the second slot of the cannula slide, such that the insertion assembly is configured to move from a first position to a second position in response to rotation of the crank. The proximal portion of the torsion spring is configured to disengage from the catheter holder after puncturing tissue by disengaging from the first slot via the open end of the first slot, thereby separating the cannula slide from the catheter holder.

11. The infusion pump system of claim 10, wherein the catheter holder comprises a flexible tube having a distal portion configured for insertion into tissue in response to rotational movement of the crank.

12. The infusion pump system of claim 10, wherein the cannula needle slide is configured to puncture tissue in response to the rotational movement of the crank.

13. The infusion pump system of claim 10, wherein the cannula needle slide includes a tab configured to move the catheter holder into the second position.

14. The infusion pump system of claim 10, wherein the torsion insertion mechanism further comprises a housing configured to retain a distal portion of the torsion spring, and wherein the proximal portion of the torsion spring is configured to engage the crank.

15. The infusion pump system of claim 10, wherein the torsion insertion mechanism further comprises a triggering mechanism configured to selectively enable the crank to rotate.

16. The infusion pump system of claim 10, wherein the cannula needle slide and the catheter holder are configured to move together from the first position to the second position.

17. The infusion pump system of claim 10, wherein the cannula needle slide is configured to return from the second position to the first position while the catheter holder remains in the second position.

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