EP3962571A1

EP3962571A1 - Inflation device

Info

Publication number: EP3962571A1
Application number: EP20727492.9A
Authority: EP
Inventors: Nitin Sharma; Peeyush Tomar
Original assignee: Boston Scientific Ltd Barbados
Current assignee: Boston Scientific Ltd Barbados
Priority date: 2019-05-03
Filing date: 2020-04-30
Publication date: 2022-03-09
Also published as: CN113766942A; WO2020227034A1; JP2022531378A

Abstract

An inflation device (10) for inflating an intravascular balloon. The inflation device may include a barrel (12) and a plunger (24) movably disposed within the barrel. The plunger may include a helical thread (40). A housing (20) may be coupled to the plunger. A nut (38) may be disposed within the housing. The nut may include a threaded region along a side thereof. A thrust member (34) may be disposed within the housing and positioned opposite the nut. The thrust member may include an acurate surface (36) designed to be positioned along the plunger.

Description

INFLATION DEVICE

Cross-Reference To Related Applications

[0001] This application claims the benefit of priority under 35 U.S.C. §119 to U.S. Provisional Application Serial No. 62/843,022 filed May 3, 2019, the entirety of which is incorporated herein by reference.

Technical Field

[0002] The present disclosure pertains to medical devices, and methods for manufacturing medical devices. More particularly, the present disclosure pertains to inflation devices for use with intravascular balloons.

Background

[0003] A wide variety of intracorporeal medical devices have been developed for medical use, for example, intravascular use. Some of these devices include guidewires, balloon catheters, and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices.

Brief Summary

[0004] This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An example medical device includes an inflation device for inflating/deflating an intravascular balloon. The inflation device comprises: a barrel; a plunger movably disposed within the barrel; wherein the plunger includes a helical thread; a housing coupled to the plunger; a nut disposed within the housing, the nut having a threaded region along a side thereof; wherein the nut is designed to shift between a first configuration where the threaded region is threadably engaged with the helical thread and a second configuration where the threaded region is disengaged from the helical thread; an actuator for shifting the nut between the first configuration and the second configuration; and a thrust member disposed within the housing and positioned opposite the nut, the thrust member including an arcuate surface designed to be positioned along the plunger. [0005] Alternatively or additionally to any of the embodiments above, a depressible member is coupled to the actuator and wherein actuation of the depressible member shifts the nut between the first configuration and the second configuration.

[0006] Alternatively or additionally to any of the embodiments above, the actuator includes a camming member.

[0007] Alternatively or additionally to any of the embodiments above, the side of the nut includes a camming surface designed to interact with the camming member.

[0008] Alternatively or additionally to any of the embodiments above, the actuator is designed to shift within the housing between a first position and a second position.

[0009] Alternatively or additionally to any of the embodiments above, further comprising one or more springs coupled to the actuator, the one or more springs being designed to bias the actuator toward the first position.

[0010] Alternatively or additionally to any of the embodiments above, the nut is in the first configuration when the actuator is at the first position.

[0011] Alternatively or additionally to any of the embodiments above, the nut is in the second configuration when the actuator is at the second position.

[0012] Alternatively or additionally to any of the embodiments above, the camming member is engaged with the camming surface when the actuator is in the second position.

[0013] Alternatively or additionally to any of the embodiments above, the plunger includes a root and wherein the helical thread projects radially outward from the root.

[0014] Alternatively or additionally to any of the embodiments above, the arcuate surface is radially spaced from the root when the nut is in the first configuration and when the nut is in the second configuration.

[0015] Alternatively or additionally to any of the embodiments above, the arcuate surface is disposed adjacent to the helical thread when the nut is in the first configuration and when the nut is in the second configuration.

[0016] An inflation device is disclosed. The inflation device comprises: a syringe barrel having a distal end region designed to engage a balloon catheter and a proximal end region; a plunger movably disposed within the syringe barrel; wherein the plunger includes a helical thread; a housing coupled to the proximal end region of the plunger; a nut disposed within the housing, the nut having a threaded region along a side thereof; wherein the nut is designed to shift between a first configuration where the threaded region is threadably engaged with the helical thread and a second configuration where the threaded region is disengaged from the helical thread; an actuator for shifting the nut between the first configuration and the second configuration; and a thrust member disposed within the housing and positioned opposite the nut, the thrust member including an arcuate surface designed to be positioned adjacent to the helical thread.

[0017] Alternatively or additionally to any of the embodiments above, the actuator includes a camming member and wherein the side of the nut includes a camming surface designed to interact with the camming member.

[0018] Alternatively or additionally to any of the embodiments above, the actuator is designed to shift within the housing between a first position and a second position, wherein the nut is in the first configuration when the actuator is at the first position, and wherein the nut is in the second configuration when the actuator is at the second position.

[0019] Alternatively or additionally to any of the embodiments above, the camming member is engaged with the camming surface when the actuator is in the second position.

[0020] Alternatively or additionally to any of the embodiments above, the plunger includes a root, wherein the helical thread projects radially outward from the root, and wherein the arcuate surface is radially spaced from the root when the nut is in the first configuration and when the nut is in the second configuration.

[0021] Alternatively or additionally to any of the embodiments above, the plunger includes a root, wherein the helical thread projects radially outward from the root, and wherein the arcuate surface is disposed adjacent to the helical thread when the nut is in the first configuration and when the nut is in the second configuration.

[0022] A method for using an inflation device with a balloon catheter is disclosed. The method comprises: attaching an inflation device to a balloon catheter, the inflation device comprising: a barrel, a plunger movably disposed within the barrel, wherein the plunger includes a helical thread, a housing coupled to the plunger, a nut disposed within the housing, the nut having a threaded region along a side thereof, wherein the nut is designed to shift between a first configuration where the threaded region is threadably engaged with the helical thread and a second configuration where the threaded region is disengaged from the helical thread, an actuator for shifting the nut between the first configuration and the second configuration, and a thrust member disposed within the housing and positioned opposite the nut, the thrust member including an arcuate surface designed to be positioned adjacent to the helical thread; distally advancing the plunger within the barrel while the nut is in the first configuration; and actuating the actuator to shift the nut from the first configuration to the second configuration.

[0023] Alternatively or additionally to any of the embodiments above, actuating the actuator to shift the nut from the first configuration to the second configuration includes pressing a depressible member coupled to the actuator.

[0024] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments.

Brief Description of the Drawings

[0025] The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which:

[0026] FIG. 1 is a perspective view of an example inflation device.

[0027] FIG. 2 is an exploded view of an example inflation device.

[0028] FIG. 3 is a partial cross-sectional view of a portion of an example inflation device.

[0029] FIG. 4 is a partial cross-sectional view of a portion of an example inflation device.

[0030] FIG. 5 is a perspective view of a portion of an example inflation device.

[0031] FIG. 6 is a perspective view of a portion of an example inflation device.

[0032] FIG. 7 is a perspective view of a portion of an example inflation device. [0033] FIG. 8 is a partially exploded view of a portion of an example inflation device.

[0034] 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

[0035] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

[0036] All numeric values are herein assumed to be modified by the term“about”, whether or not explicitly indicated. The term“about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the terms“about” may include numbers that are rounded to the nearest significant figure.

[0037] The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0038] As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term“or” is generally employed in its sense including“and/or” unless the content clearly dictates otherwise.

[0039] 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 recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used connection with other embodiments whether or not explicitly described unless clearly stated to the contrary. [0040] The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0041] A number of medical interventions are utilized to diagnose and/or treat intervascular conditions. Some of these interventions include percutaneous transluminal coronary angioplasty (PTCA), stent delivery/deployment (e.g., including deployment that includes the expansion of a balloon to expand the stent), and the like. Interventions like these that utilize a balloon may include the use of an inflation device to inflate/deflate the balloon. Generally, such inflation devices may include syringe or syringe-like device where a plunger can be advanced to move inflation media into the balloon (e.g., to inflate the balloon) and retracted to withdraw inflation media from the balloon (e.g., to deflate the balloon).

[0042] FIG. 1 is a perspective view of an example inflation device 10. The inflation device 10 may include a barrel 12 (e.g., a syringe barrel). In some instances, a pressure gauge or meter 14 may be coupled to the barrel 12. A tubular member 16 may be coupled to the barrel 12 and extend therefrom. A connector 18 may disposed at a distal end 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 PTCA device, a stent delivery catheter, a catheter, and/or the like). This allows the inflation device 10 to be used to transfer inflation media into a balloon and/or withdraw inflation media from the balloon.

[0043] A housing 20 may be coupled to the barrel 12. In some instances, the barrel 12 may extend into the housing 20 and/or be secured (e.g., rigidly secured) within the housing 20. A depressible member 22 may be coupled to the housing 20. The depressible member 22 may be part of a locking/release mechanism that can be utilized to help maintain pressure within the balloon and, as desired, allow a clinician to rapidly deflate the balloon as described in more detail herein. A plunger 24 may be coupled to the barrel 12. The plunger 24 can be advanced to move inflation media that may be disposed within the barrel 12 into the balloon (e.g., to inflate the balloon) and can be retracted to withdraw inflation media from the balloon (e.g., to deflate the balloon). [0044] It can be appreciated that as inflation media is transferred to a balloon, pressure/forces within an inflation device increase. Such pressure/forces can be exerted onto the plunger. In some instances, these forces could result in“self-release” (e.g., where pressure is unintentionally released when the locking/release mechanism is unable to withstand higher pressures, which may result in balloon deflation), plunger deformation, increased forces required to active/deactivate a locking mechanism, etc. The inflation device 10 is designed to withstand higher pressures and appropriately handle increased forces associated with higher pressures. This may provide the inflation device 10 with a number of desirable features. For example, the inflation device 10 (a) may be less likely to“self-release”, (b) may reduce the amount of force required by a user to activate the locking/release mechanism, (c) may reduce deformation of the plunger 24, (d) may be capable of withstanding higher pressures/forces, and/or provide additional desirable features.

[0045] FIG. 2 is an exploded view of the inflation device 10. Here a number of components of the inflation device 10 can be seen. For example, the housing 20 may include a first portion 26 and a second portion 28. This need not be the case, however, as the housing 20 may be formed from a single piece or more than two pieces/portions. An actuator 30 may be coupled to the depressible member 22 and 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 thrust element or thrust member 34 and a nut 38 may be disposed within the housing 20. The plunger 24 may be movably/slidably disposed relative to (e.g., within) the barrel 12. The plunger 24 may include a threaded region 40 and a handle 42.

[0046] The depressible member 22, actuator 30, springs 32, thrust member 34, and nut 38 (and/or other components of the inflation device 10) may make up part of the locking/release mechanism. In general, threads on the nut 38 can engage the threaded region 40 of the plunger 24. When engaged, the plunger 24 can be moved (e.g., rotated and/or or distally advanced) to advance inflation media. When doing so, pressure may build up within the balloon and/or inflation device 10. The threaded engagement between the nut 38 and the threaded region 40 of the plunger 24 is designed to resist proximal movement of the plunger 24 (e.g., unless the plunger 24 is rotated in the opposite direction). In some instances, it may be desirable to rapidly deflate the balloon. The locking/release mechanism is designed to allow a clinician to rapidly deflate the balloon by pressing the depressible member 22. Doing so, actuates the actuator 30 and shifts the threads on the nut 38 out of engagement with the threaded region 40 of the plunger 24, thereby allowing the plunger 24 to be retracted (e.g., rapidly retracted, as desired) and the balloon to be deflated. When the depressible member 22 is released, the springs 32 may shift the actuator 30 so that the threads on the nut 38 can engage (e.g.,“re-engage” or otherwise“lock”) the threaded region 40 of the plunger 24. Some additional details regarding the use of the locking/release mechanism are disclosed herein.

[0047] The nut 38 may be designed to shift between a first configuration and a second configuration as depicted in FIGS. 3-4. Shifting between the first and second configurations may be understood as shifting between a“locked” configuration where 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 where the threads on the nut 38 are spaced from or otherwise disengaged with the threaded region 40 of the plunger 24. Shifting between configurations may include the interactions of a number of structural features on the nut 38 with the actuator 30, plunger 24, etc. For example, when in the first configuration as depicted in FIG. 3, a camming member or flange 46 of the actuator 30 is disposed adjacent to a side portion 65 of the nut 38 and the camming member 46 is spaced away from or otherwise not mated with a camming surface 48 of the nut 38. In addition, a lower surface 78 of the actuator 30 may be generally positioned adjacent to but not necessary engaged with an inside surface 75 of the nut 38. Thus, when in the first configuration, the camming member 46 engages the top portion 66 of the nut 38, which allow the nut 38 to take smaller shape or more compressed shape. When so arranged/positioned, a threaded region 54 along a side of the nut is engaged with the threaded region 40 of the plunger 24.

[0048] The thrust member 34 may be disposed adjacent to the nut 38. The thrust member 34 may include an arcuate surface 36 designed to engage the plunger 24. In general, the arcuate surface 36 is designed to fit closely adjacent to the plunger 24. As such, when forces are applied to the plunger 24 that could be sufficient to deflect/deform the plunger 24, the arcuate surface 36 may provide structural support that can help to resist deflection/deformation. Because of this, the plunger 24 is less likely to disengage from the nut 38 (e.g., the threaded region 54 of the nut is less likely to disengage from the threaded region 40 of the plunger 24). In some instances, the plunger 24 may include a root 24a and a thread 24b projected from the root 24a. Because the thread 24b projects from the root 24a, it can be appreciated that the arcuate surface 36 may be radially spaced from the root 24a while the arcuate surface 36 is disposed adjacent (e.g., directly adjacent, in close proximity to, etc.) to the thread 24b. In some instances, this may include the arcuate surface 36 being radially spaced from the thread 24b.

[0049] When the depressible member 22 is pressed, the actuator 30 may shift (e.g., from an initial or first position as shown in FIG. 3 to a second position as shown in FIG. 4 due to being urged by the depressible member 22) so that the camming member 46 generally follows, moves toward, and/or mates with the camming surface 48 as shown in FIG. 4. In addition, the surface 78 of the actuator 30 may move toward and engage the inside surface 75 of the nut 38 (e.g., it is noted that FIG. 4 shows the surfaces 76, 78 moved toward the inside surface 75; in practice, the surface 78 may be engage with the inside surface 75). When this happens, the nut 38 pivots/enlarges/expands so that the threaded region 54 moves away from and out of engagement from the threaded region 40 of the plunger 24. This allow the plunger 24 to be rapidly pulled out, as desired, so that that balloon can be deflated. When the depressible member 22 is released, the springs 32, which may bias the actuator 30 to the first position, shift the actuator 30 back to the first position (e.g., as shown in FIG. 3).

[0050] The inflation device 10, for example utilizing nut 38, may be able to withstand higher pressures. For example, the inflation device 10 may be able to 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-releasing” and/or without deflection/deformation of the plunger 24. In addition, the forces required to press the depressible member 22 may be less than 85 N, or less than 65 N, or less than 50 N, or about 30-60 N, or about 45-55 N.

[0051] Other views of components of the inflation device 10 are shown in FIGS. 5- 7. For example, FIG. 5 is a perspective view of the thrust member 34. Here the arcuate surface 36 can be seen. In some instances, the arcuate surface 36 may include one or more curved ledge sections 36a, 36b. The thrust member 34 may also include a channel 68. FIGS. 6-7 are perspective views of the nut 38. The nut 38 may be a molded piece (e.g., formed from a suitable metal, polymer, composite, and/or the like). The nut 38 may include one or more top portions 66a, 66b. The nut 38 may also include a pin 70 designed to fit within the channel 68 of the thrust member 34. The threaded region 54 can also be seen in FIGS> 6-7. FIG. 8 illustrates the nut 38 coupled to the thrust member 34.

[0052] 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 that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The invention's scope is, of course, defined in the language in which the appended claims are expressed.

Claims

What is claimed is:

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

a barrel;

a plunger movably disposed within the barrel;

wherein the plunger includes a helical thread;

a housing coupled to the plunger;

a nut disposed within the housing, the nut having a threaded region along a side thereof;

wherein the nut is designed to shift between a first configuration where the threaded region is threadably engaged with the helical thread and a second configuration where the threaded region is disengaged from the helical thread;

an actuator for shifting the nut between the first configuration and the second configuration; and

a thrust member disposed within the housing and positioned opposite the nut, the thrust member including an arcuate surface designed to be positioned along the plunger.

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

3. The inflation device of any one of claims 1-2, wherein the actuator includes a camming member.

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

5. The inflation device of claim 4, wherein the actuator is designed to shift within the housing between a first position and a second position.

6. The inflation device of claim 5, further comprising one or more springs coupled to the actuator, the one or more springs being designed to bias the actuator toward the first position.

7. The inflation device of any one of claims 5-6, wherein the nut is in the first configuration when the actuator is at the first position.

8. The inflation device of any one of claims 5-7, wherein the nut is in the second configuration when the actuator is at the second position.

9. The inflation device of any one of claims 5-8, wherein the camming member is engaged with the camming surface when the actuator is in the second position.

10. The inflation device of any one of claims 1-9, wherein the plunger includes a root and wherein the helical thread projects radially outward from the root.

11. The inflation device of claim 10, wherein the arcuate surface is radially spaced from the root when the nut is in the first configuration and when the nut is in the second configuration.

12. The inflation device of claim 11, wherein the arcuate surface is disposed adjacent to the helical thread when the nut is in the first configuration and when the nut is in the second configuration.

13. An inflation device, comprising:

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

a plunger movably disposed within the syringe barrel;

wherein the plunger includes a helical thread;

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

a nut disposed within the housing, the nut having a threaded region along a side thereof; wherein the nut is designed to shift between a first configuration where the threaded region is threadably engaged with the helical thread and a second configuration where the threaded region is disengaged from the helical thread;

a thrust member disposed within the housing and positioned opposite the nut, the thrust member including an arcuate surface designed to be positioned adjacent to the helical thread.

14. The inflation device of claim 13, wherein the actuator includes a camming member and wherein the side of the nut includes a camming surface designed to interact with the camming member.

15. The inflation device of claim 14, wherein the actuator is designed to shift within the housing between a first position and a second position, wherein the nut is in the first configuration when the actuator is at the first position, and wherein the nut is in the second configuration when the actuator is at the second position.