阅读说明：本技术 充胀装置 (Inflation device ) 是由 尼廷·夏尔马 普拉蒂克·古普塔 弗兰克·瑞安 皮尤什·托马尔 于 2020-04-30 设计创作，主要内容包括：一种用于使血管内球囊充胀的充胀装置(10)。该充胀装置可包括筒体(12)和可移动地布置在筒体中的柱塞(24)。柱塞可包括螺旋状螺纹(40)。外壳(20)可联接到柱塞。螺母(36)可布置在外壳内部。该螺母可包括沿其第一侧的第一螺纹区(54)和沿其第二侧的第二螺纹区(56)。(An inflation device (10) for inflating an intravascular balloon. The inflation device may include a barrel (12) and a plunger (24) movably disposed in the barrel. The plunger may include a helical thread (40). A housing (20) may be coupled to the plunger. A nut (36) may be disposed inside the housing. The nut may include a first threaded region (54) along a first side thereof and a second threaded region (56) along a second side thereof.)

1. An inflation device for inflating an intravascular balloon, the inflation device comprising:

a barrel;

a plunger movably disposed inside the barrel, wherein the plunger comprises a helical thread;

a housing coupled to the barrel;

a nut disposed inside the housing, the nut having a first threaded region along a first side thereof and a second threaded region along a second side thereof, wherein the nut is designed to transition between a first configuration in which the first and second threaded regions are in threaded engagement with the helical thread and a second configuration in which the first and second threaded regions are separated from the helical thread; and

an actuator for transitioning the nut between the first configuration and the second configuration.

2. The inflation device of claim 1, wherein a depressible member is coupled to the actuator, and wherein actuation of the depressible member transitions the nut between the first configuration and the second configuration.

3. The inflation device of any one of claims 1-2, wherein the actuator comprises a first cam member.

4. The inflation device of claim 3, wherein the first side of the nut includes a first cam surface designed to interact with the first cam member.

5. The inflation device of claim 4, wherein the actuator comprises a second cam member.

6. The inflation device of claim 5, wherein the second side of the nut includes a second cam surface designed to interact with the second cam member.

7. The inflation device of claim 6, wherein the actuator is designed to transition between a first position and a second position inside the housing.

8. The inflation device of claim 7, further comprising one or more springs coupled to the actuator, the one or more springs designed to bias the actuator toward the first position.

9. The inflation device of any one of claims 7-8, wherein the nut is in the first configuration when the actuator is in the first position.

10. The inflation device of any one of claims 7-9, wherein the nut is in the second configuration when the actuator is in the second position.

11. The inflation device of any one of claims 7-10, wherein the first cam member engages the first cam surface when the actuator is in the second position.

12. The inflation device of claim 11, wherein the second cam member engages the second cam surface when the actuator is in the second position.

13. An inflation device comprising:

a barrel having a distal end region designed to engage a balloon catheter and a proximal end region;

a plunger movably disposed inside the barrel, wherein the plunger includes a helical thread;

a housing coupled to a proximal end region of the barrel;

a nut disposed inside the housing, the nut having a first threaded region along a first side thereof and a second threaded region along a second side thereof,

wherein the nut is designed to transition between a first configuration in which the first and second threaded zones are in threaded engagement with the helical thread and a second configuration in which the first and second threaded zones are separated from the helical thread; and

an actuator for transitioning the nut between the first configuration and the second configuration.

14. The inflation device of claim 13, wherein the actuator comprises a first cam member, wherein the first side of the nut comprises a first cam surface designed to interact with the first cam member, wherein the actuator comprises a second cam member, and wherein the second side of the nut comprises a second cam surface designed to interact with the second cam member.

15. The inflation device of claim 14, wherein the actuator is designed to transition between a first position and a second position inside the housing, wherein the nut is in the first configuration when the actuator is in the first position, wherein the nut is in the second configuration when the actuator is in the second position, wherein the first cam member is engaged with the first cam surface when the actuator is in the second position, and wherein the second cam member is engaged with the second cam surface when the actuator is in the second position.

Technical Field

The present application relates to medical devices and methods for manufacturing medical devices. More particularly, the present application relates to an inflation device for an intravascular balloon.

Background

A wide variety of in vivo medical devices have been developed for medical use, such as intravascular use. Some of these devices include guidewires, balloon catheters, and the like. These devices are manufactured by any of a number of different manufacturing methods and may be used according to any of a number of methods. With respect to known medical devices and methods, each has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods for making and using medical devices.

Disclosure of Invention

The present disclosure provides designs, materials, methods of manufacture, and alternatives for use of medical devices. Exemplary medical devices include inflation devices for inflating an intravascular balloon. The inflation device includes: a barrel; a plunger movably disposed inside the barrel; wherein the plunger comprises a helical thread; a housing coupled to the barrel; a nut disposed inside the housing, the nut having a first threaded region along a first side thereof and a second threaded region along a second side thereof; wherein the nut is designed to transition between a first configuration in which the first and second threaded regions are threadably engaged with the helical thread and a second configuration in which the first and second threaded regions are disengaged from the helical thread; and an actuator for transitioning the nut between the first configuration and the second configuration.

Alternatively or additionally to any of the embodiments above, the depressible member is coupled to the actuator and wherein actuation of the depressible member transitions the nut between the first configuration and the second configuration.

Alternatively or additionally to any of the embodiments above, the actuator comprises a first cam member.

Alternatively or additionally to any of the embodiments above, the first side of the nut includes a first cam surface designed to interact with the first cam member.

Alternatively or additionally to any of the embodiments above, the actuator comprises a second cam member.

Alternatively or additionally to any of the embodiments above, the second side of the nut includes a second cam surface designed to interact with a second camming member.

Alternatively or additionally to any of the embodiments above, the actuator is designed to transition between the first position and the second position within the housing.

Alternatively or additionally to any of the embodiments above, further comprising one or more springs coupled to the actuator, the one or more springs designed to bias the actuator toward the first position.

Alternatively or additionally to any of the embodiments above, the nut is in the first configuration when the actuator is in the first position.

Alternatively or additionally to any of the embodiments above, the nut is in the second configuration when the actuation is in the second position.

Alternatively or additionally to any of the embodiments above, the first cam member engages the first cam surface when the actuator is in the second position.

Alternatively or additionally to any of the embodiments above, the second cam member engages the second cam surface when the actuator is in the second position.

An inflation device is disclosed. The inflation device includes: a barrel having a distal end region configured to engage a proximal end region of a balloon catheter; a plunger movably disposed inside the barrel; wherein the plunger comprises a helical thread; a housing coupled to the proximal end region of the barrel; a nut disposed inside the housing, the nut having a first threaded region along a first side thereof and a second threaded region along a second side thereof; wherein the nut is designed to transition between a first configuration in which the first and second threaded regions are threadably engaged with the helical thread and a second configuration in which the first and second threaded regions are disengaged from the helical thread; and an actuator for transitioning the nut between the first configuration and the second configuration.

Alternatively or additionally to any of the embodiments above, the actuator comprises a first cam member, and wherein the first side of the nut comprises a first cam surface designed to interact with the first cam member.

Alternatively or additionally to any of the embodiments above, the actuator comprises a second camming member, and wherein the second side of the nut comprises a second camming surface designed to interact with the second camming member.

Alternatively or additionally to any of the embodiments above, the actuator is designed to transition between a first position and a second position within the housing, wherein the nut is in the first configuration when the actuator is in the first position, and wherein the nut is in the second configuration when the actuator is in the second position.

Alternatively or additionally to any of the embodiments above, the first cam member engages the first cam surface when the actuator is in the second position, and wherein the second cam member engages the second cam surface when the actuator is in the second position.

A method of using an inflation device with a balloon catheter is disclosed. The method comprises the following steps: the method includes attaching an inflation device to the balloon catheter, advancing a plunger inside the barrel while the nut is in a first configuration, and activating an actuator to transition the nut from the first configuration to a second configuration. The inflation device includes: a barrel; a plunger movably disposed within the barrel, wherein the plunger includes a helical thread; a housing coupled to the barrel; a nut disposed inside the housing, the nut having a first threaded region along a first side thereof and a second threaded region along a second side thereof, wherein the nut is designed to transition between a first configuration (in which the first and second threaded regions are threadably engaged with the helical thread) and a second configuration (in which the first and second threaded regions are disengaged from the helical thread); an actuator for transitioning the nut between the first configuration and the second configuration.

Alternatively or additionally to any of the embodiments above, the method further comprises retracting the plunger proximally inside the barrel.

Alternatively or additionally to any of the embodiments above, activating the actuator to transition the nut from the first configuration to the second configuration includes depressing a button coupled to the actuator.

Alternatively or additionally to any of the embodiments above, wherein the actuator comprises a first cam member and wherein the first side of the nut comprises a first cam surface designed to interact with the first cam member; the actuator comprises a second cam member, and wherein the second side of the nut comprises a second cam surface designed to interact with the second cam member; the actuator is designed to be switched between a first position and a second position inside the housing; the first cam member engages the first cam surface when the actuator is in the second position, and wherein the second cam member engages the second cam surface when the actuator is in the second position; and wherein activating the actuator to transition the nut from the first configuration to the second configuration includes moving the actuator from the first position to the second position.

The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The figures and the detailed description that follow more particularly exemplify these embodiments.

Drawings

The present disclosure will become more fully understood from the detailed description given herein below when taken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view of an exemplary inflation device.

Fig. 2 is an exploded view of an exemplary inflation device.

FIG. 3 is a partial cross-sectional view of a portion of an exemplary inflation device.

FIG. 4 is a partial cross-sectional view of a portion of an exemplary inflation device.

FIG. 5 is a perspective view of a portion of an exemplary inflation device.

FIG. 6 is a perspective view of a portion of an exemplary inflation device.

FIG. 7 is a partial exploded view of a portion of an exemplary inflation device.

FIG. 8 is a front view of a portion of an exemplary inflation device.

While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.

Detailed Description

For the terms defined below, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

All numerical values herein are assumed to be modified by the word "about", whether or not explicitly indicated. The term "about" generally refers to a series of numbers that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many cases, the word "about" may include numbers that are rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the word "or" is generally employed in its sense including "and/or" unless the context clearly dictates otherwise.

It is noted that references in the specification to "an embodiment," "some embodiments," "other embodiments," etc., indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitation does not necessarily imply that all embodiments include the particular features, structures, and/or characteristics. Further, when a particular feature, structure, and/or characteristic is described in connection with an embodiment, it is understood that such feature, structure, and/or characteristic may also be used in connection with other embodiments, whether or not explicitly described, unless explicitly stated to the contrary.

The following detailed description should be read with reference to the drawings, in which like elements are numbered alike in the various figures. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

Several medical interventions are used to diagnose and/or treat intervascular conditions. Some of these interventions include Percutaneous Transluminal Coronary Angioplasty (PTCA), stent delivery/placement (e.g., including placement, which includes expansion of a balloon to expand the stent), and the like. Interventions employing balloons like these may include the use of inflation devices to inflate/deflate the balloon. Typically, such an inflation device may include a syringe or syringe-like device, wherein a plunger may be advanced to move inflation medium into the balloon (e.g., to inflate the balloon) and retracted to move inflation medium out of the balloon (e.g., to deflate the balloon).

Fig. 1 is a perspective view of an exemplary inflation device 10. The inflation device 10 may include a barrel 12 (e.g., a syringe barrel). In some cases, a pressure gauge or gauge 14 may be coupled to the barrel 12. The tubular member 16 may be coupled to and extend from the barrel 12. The connector 18 may be disposed at a distal region of the tubular member 16. In general, the connector 18 may be designed to connect the inflation device 10 to another device (e.g., a Percutaneous Transluminal Coronary Angioplasty (PTCA) device, a stent delivery catheter, a catheter, etc.). This allows the inflation device 10 to be used to deliver inflation media into and/or remove inflation media from the balloon.

The housing 20 may be coupled to the barrel 12. Depressible member 22 may be coupled to housing 20. Depressible member 22 may be part of a lock/release mechanism that may be used to help maintain pressure inside the balloon and allow the clinician to quickly deflate the balloon as desired, as described in more detail herein. The plunger 24 may be coupled to the barrel 12. Plunger 24 may be advanced to move inflation medium disposable inside barrel 12 into the balloon (e.g., to inflate the balloon) and plunger 24 may be retracted to remove inflation medium from the balloon (e.g., to deflate the balloon).

It will be appreciated that when the inflation medium is delivered to the balloon, the pressure/force inside the inflation device increases. Such pressure/force may be applied to the plunger. In some cases, these forces may result in "self-release" (e.g., where pressure is accidentally released when the lock/release mechanism cannot withstand higher pressures, which may result in balloon deflation), plunger deformation, increased force required to activate/deactivate the locking mechanism, etc. The inflation device 10 is designed to withstand higher pressures and properly handle the increased forces associated with higher pressures. This may provide several desirable features to the inflation device 10. For example, the inflation device 10(a) may be less likely to "self-release"; (b) the amount of force required by the user to activate the lock/release mechanism may be reduced; (c) deformation of the plunger 24 can be reduced; (d) may be able to withstand higher pressures/forces and/or provide additional desirable characteristics.

Fig. 2 is an exploded view of the inflation device 10. Several components of the inflation device 10 can be seen here. For example, the housing 20 may include a first portion 26 and a second portion 28. However, this need not be the case, as the housing 20 may be constructed of a single component or more than two components/portions. The actuator 30 may be coupled to the depressible member 22 and is generally disposed at least partially within the housing 20. One or more biasing members or springs 32 may be coupled to the actuator 30. A base 34 may be disposed within the housing 20. The pin member 36 may be coupled to the base 34 and may be used to secure the nut 38 to the base 34. The plunger 24 may be movably/slidably disposed (e.g., internally) relative to the barrel 12. Plunger 24 may include a threaded region 40 and a handle 42. In some cases, a sealing member or O-ring 44 may be disposed adjacent to the plunger 24.

The depressible member 22, the actuator 30, the spring 32, and the nut 38 (and/or other components of the inflation device 10) may form part of a lock/release mechanism. Generally, the threads on the nut 38 may engage the threaded region 40 of the plunger 24. When engaged, the plunger 24 may be moved (e.g., rotated and/or advanced distally) to advance the inflation media. When so performed, the pressure may gradually increase within the balloon and/or inflation device 10. The threaded engagement between nut 38 and threaded region 40 of plunger 24 is designed to prevent proximal movement of plunger 24 (e.g., unless plunger 24 is rotated in the opposite direction). In some cases, it is desirable to deflate the balloon quickly. The lock/release mechanism is designed to allow the clinician to quickly deflate the balloon by depressing depressible member 22. To do so, actuator 30 is activated to switch the threads on nut 38 out of engagement with threaded region 40 of plunger 24, thereby allowing plunger 24 to be retracted (e.g., rapidly retracted as needed) and the balloon to be deflated. When depressible member 22 is released, spring 32 can shift actuator 30 such that threads on nut 38 can engage (e.g., "re-engage" or "lock") with threaded region 40 of plunger 24. Some additional details regarding the use of the lock/release mechanism are discussed herein.

The nut 38 may be designed to transition between a first configuration and a second configuration, as shown in fig. 3-4. Transitioning between the first configuration and the second configuration may be understood as transitioning between a "locked" configuration (in which the threads on the nut 38 are threadably engaged with the threaded region 40 of the plunger 24) and a "released" or "quick-release" configuration (in which the threads on the nut 38 are spaced apart or separated from the threaded region 40 of the plunger 24). Transitioning between configurations may include interaction of several structural features on the nut 38 with the actuator 30, plunger 24, etc. For example, when in the first configuration as shown in fig. 3, the first cam member or flange 46 of the actuator 30 is disposed adjacent a side 65 of the nut 38 and/or engages the side 65 of the nut 38, and the first cam member 46 is spaced from or does not mate with the first cam surface 48 of the nut 38. Likewise, the second cam member 50 of the actuator is disposed adjacent a side of the nut 38 and/or engages a side 67 of the nut 38, and the second cam member 50 is spaced from or does not mate with the second cam surface 52 of the nut 38. Thus, when in the first configuration, the cam members 46, 50 engage the sides 65, 67 of the nut 38, which allows the nut 38 to assume a smaller or more compressed shape. When so positioned, both the first threaded region 54 along the first side of the nut and the second threaded region 56 along the second side of the nut 38 engage the threaded region 40 of the plunger 24. In some cases, the threaded zones 54, 56 are on opposite sides of the nut 38. However, other arrangements are also conceivable. Threading at two locations/sides may be desirable for several reasons. For example, engaging the threaded region 40 of the plunger 24 on more than one side may help reduce the likelihood that the plunger 24 may deform (e.g., due to pressure) from engagement with the threaded regions 54, 56 of the nut 38. Additionally, when the nut 38 is in the first configuration, the surfaces 76, 78 of the actuator 30 are disposed adjacent the inner surfaces 73, 75 of the nut 38. In some cases, this includes surfaces 76, 78 of actuator 30 being spaced from inner surfaces 73, 75 of nut 38.

When the depressible member 22 is depressed, the actuator 30 may transition (e.g., from an initial or first position as shown in fig. 3 to a second position as shown in fig. 4 as driven by the depressible member 22) such that the first cam member 46 substantially follows and/or engages the first cam surface 48 and the second cam member 50 substantially follows and/or engages the first cam surface 52 as shown in fig. 4. Additionally, surfaces 76, 78 of actuator 30 may move toward inner surfaces 73, 75 of nut 38 and engage inner surfaces 73, 75 of nut 38 (e.g., note that FIG. 4 shows surfaces 76, 78 moving toward inner surfaces 73, 75; indeed, surfaces 76, 78 may engage inner surfaces 73, 75). When this occurs, the nut 38 expands such that the first and second threaded regions 54, 58 move in a direction away from the threaded region 40 of the plunger 24 and out of engagement with the threaded region 40 of the plunger 24. This allows the plunger 24 to be pulled out quickly as needed so that the balloon can be deflated. When depressible member 22 is released, spring 32 (which can bias actuator 30 to the first position) transitions actuator 30 back to the first position (e.g., as shown in fig. 3).

The inflation device 10 (e.g., using the nut 38) is capable of withstanding relatively high pressures. For example, the inflation device 10 can withstand pressures of 10-80 atmospheres or more, or 20-60 atmospheres or more, or 20-50 atmospheres or more, or 30-40 atmospheres or more, or greater than 25 atmospheres, or greater than 45 atmospheres without "self-release". Additionally, the force required to depress the depressible member 22 may be less than 85N, or less than 65N, or less than 50N, or about 30-60N, or about 45-55N.

Figures 5-7 show additional views of the components of the inflation device 10. For example, fig. 5 is a perspective view of the base 34. Here, it can be seen that base 34 may include one or more curved mounts 58a, 58 b. The base 34 may also include a channel 60. Fig. 6 is a perspective view of the nut 38. The nut 38 may be a molded piece (e.g., constructed of a suitable metal, polymer, composite, etc.). Here, it can be seen that nut 38 may include an annular region 62, with annular region 62 having an opening 64 formed therein. The nut 38 may also include one or more top portions 66a, 66b, 68a, 68 b. The top 66a, 66b, 68a, 68b may be understood to be the top of two walls of the nut 38 that are connected at one end (e.g., adjacent the annular region 62) and have a top opening 72 (e.g., where the "arms" are spaced apart from each other). The nut 38 may include one or more sides 65a, 65b, 67a, 67b (e.g., the sides 65, 67 shown in fig. 3-4 may be provided/arranged as pairs of sides 65a, 65b, 67a, 67 b). The nut 38 may also include one or more inner surfaces 73a, 73b, 75a, 75b (e.g., the surfaces 73, 75 depicted in fig. 3-4 may be provided/arranged as pairs of inner surfaces 73a, 73b, 75a, 75 b). The nut 38 may also include one or more undulating zones 70a, 70 b. Fig. 7 shows the nut 38 coupled to the base 34.

Fig. 8 illustrates another exemplary nut 138, which nut 138 may be similar in shape and function to nut 38. Nut 138 may include top portions 166, 168 separated by a top opening 172. The nut 138 may also include a first threaded region 154 and a second threaded region 158. Nut 138 may function similar to nut 38, i.e., nut 138 may be transitioned between a first configuration (e.g., where threaded regions 154, 158 are engaged with threaded region 40 of plunger 24) and a second configuration (e.g., where threaded regions 154, 158 are disengaged from threaded region 40 of plunger 24).

It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the disclosure. This may include, to the extent appropriate, applying the use of any feature of one exemplary embodiment to the other embodiments. The scope of the invention is, of course, defined in the language in which the appended claims are expressed.