HEMOSTASIS DEVICES WITH FOLDED BALLOON ASSEMBLIES
The present application discloses various embodiments of hemostasis devices with folded balloon assemblies.
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This application claims priority to U.S. Provisional Patent Application No. 62/812,436, filed Mar. 1, 2019, which is incorporated by reference herein in its entirety.
FIELD OF THE DISCLOSUREThe present disclosure relates to hemostasis devices (e.g., bands) that are adapted to act as compression devices to promote hemostasis at a surgical access site, and more particularly to hemostasis bands having folded balloon assemblies.
BACKGROUNDAfter a surgical procedure involving arterial or venous access, it may be desirable or necessary to apply pressure to the vascular access site to promote hemostasis. Some existing hemostasis devices use one or more inflatable balloons to apply pressure to the access site. In some instances, these balloons have experienced failures. Some existing hemostasis devices may also be time-consuming and expensive to construct. Accordingly, there is a need for hemostasis devices that address these and other drawbacks of the prior art.
SUMMARY OF THE DISCLOSUREIn one respect, the present disclosure comprises a balloon assembly for a hemostasis device, the balloon assembly comprising: a first chamber; a second chamber; and at least one channel that is in fluid flow communication between the first chamber and the second chamber, wherein a single perimeter of attachment between a first layer of material and a second layer of material defines at least a portion of a perimeter of the first chamber, at least a portion of a perimeter of the second chamber, and at least a portion of a perimeter of the at least one channel.
In another respect, the present disclosure comprises a balloon assembly for a hemostasis device, the balloon assembly comprising: a connector having a first air inlet, a first air outlet, and a second air outlet, the first air inlet being connected separately in fluid flow communication with each of the first air outlet and the second air outlet; a first balloon having an inlet and an interior; a first connection tubing connected in fluid flow communication between the first air outlet and the interior of the first balloon via the inlet thereof; a second balloon having an inlet and an interior; and a second connection tubing connected in fluid flow communication between the second air outlet and the interior of the second balloon via the inlet thereof; wherein the first balloon and the second balloon are not connected in direct fluid flow communication.
In yet another respect, the present disclosure comprises a balloon assembly for a hemostasis device, the balloon assembly comprising: a first chamber; a second chamber; and at least one channel that is in fluid flow communication between the first chamber and the second chamber; wherein the first chamber, the second chamber, and the at least one channel are formed between a first layer of material and a second layer of material; wherein at least a portion of the first chamber overlays at least a portion of the second chamber; and wherein the at least one channel is folded.
FURTHER ASPECTS OF THE INVENTIVE CONCEPT(S)Further aspects of the inventive concept(s) include:
Aspect 1: A balloon assembly for a hemostasis device, the balloon assembly comprising: a first chamber; a second chamber; and at least one channel that is in fluid flow communication between the first chamber and the second chamber, wherein a single perimeter of attachment between a first layer of material and a second layer of material defines at least a portion of a perimeter of the first chamber, at least a portion of a perimeter of the second chamber, and at least a portion of a perimeter of the at least one channel.
Aspect 2: The balloon assembly of Aspect 1, wherein the single perimeter of attachment defines the entireties of the perimeters of the first chamber and the second chamber.
Aspect 3: The balloon assembly of either of Aspect 1 or Aspect 2, wherein the single perimeter of attachment defines the entirety of the perimeter of the at least one channel.
Aspect 4: The balloon assembly of any of Aspects 1-3, the balloon assembly further comprising an exterior edge, wherein the at least one channel is folded around the exterior edge and wherein at least a portion of the first chamber overlays at least a portion of the second chamber.
Aspect 5: The balloon assembly of Aspect 4, wherein a first portion of the at least one channel overlays a second portion of the at least one channel.
Aspect 6: The balloon assembly of any of Aspects 1-5, further comprising at least one piece of secondary material located within the at least one channel.
Aspect 7: The balloon assembly of Aspect 6, wherein the at least one piece of secondary material is formed of a gas-permeable material.
Aspect 8: The balloon assembly of Aspect 6, wherein the at least one piece of secondary material is formed of a gas-impermeable material.
Aspect 9: The balloon assembly of Aspect 6, wherein the at least one piece of secondary material has a circular cross-sectional shape.
Aspect 10: The balloon assembly of any of Aspects 1-9, further comprising a third layer of material that is at least partially located between and attached to the first layer of material and the second layer of material.
Aspect 11: The balloon assembly of any of Aspects 1-10, the single perimeter of attachment comprising an outer perimeter, the balloon assembly further comprising an inner perimeter of attachment between the first layer and the second layer, the inner perimeter being located interior to the outer perimeter.
Aspect 12: The balloon assembly of Aspect 11, wherein the outer perimeter and the inner perimeter form a first air channel and a second air channel between the first chamber and the second chamber.
Aspect 13: The balloon assembly of Aspect 12, further comprising a cutout region interior to the inner perimeter from which portions of the first layer of material and second layer of material are absent.
Aspect 14: The balloon assembly of any of Aspects 1-13, further comprising an inlet located along the perimeter through which a fluid can be introduced into an interior of the balloon assembly.
Aspect 15: The balloon assembly of Aspect 14, wherein the inlet is in the form of a hollow cylindrical tubing.
Aspect 16: The balloon assembly of Aspect 14, wherein the inlet is in the form of a chimney port or hose barb.
Aspect 17: The balloon assembly of any of Aspects 1-16, further comprising at least one attachment portion that is formed along a first exterior edge of the balloon assembly.
Aspect 18: The balloon assembly of Aspect 17, wherein the at least one channel is folded around the first exterior edge, and wherein at least a portion of the first chamber overlays at least a portion of the second chamber.
Aspect 19: The balloon assembly of Aspect 17, wherein the at least one channel is folded around an exterior edge of the balloon assembly that is adjacent to the first exterior edge of the balloon assembly, and wherein at least a portion of the first chamber overlays at least a portion of the second chamber.
Aspect 20: The balloon assembly of Aspect 17, wherein the at least one channel is folded around an exterior edge of the balloon assembly that opposes the first exterior edge of the balloon assembly, and wherein at least a portion of the first chamber overlays at least a portion of the second chamber.
Aspect 21: A balloon assembly for a hemostasis device, the balloon assembly comprising: a connector having a first air inlet, a first air outlet, and a second air outlet, the first air inlet being connected separately in fluid flow communication with each of the first air outlet and the second air outlet; a first balloon having an inlet and an interior; a first connection tubing connected in fluid flow communication between the first air outlet and the interior of the first balloon via the inlet thereof; a second balloon having an inlet and an interior; and a second connection tubing connected in fluid flow communication between the second air outlet and the interior of the second balloon via the inlet thereof; wherein the first balloon and the second balloon are not connected in direct fluid flow communication.
Aspect 22: The balloon assembly of Aspect 21, wherein the first balloon and second balloon are physically connected together along a respective edge thereof.
Aspect 23: A balloon assembly for a hemostasis device, the balloon assembly comprising: a first chamber; a second chamber; and at least one channel that is in fluid flow communication between the first chamber and the second chamber; wherein the first chamber, the second chamber, and the at least one channel are formed between a first layer of material and a second layer of material; wherein at least a portion of the first chamber overlays at least a portion of the second chamber; and wherein the at least one channel is folded.
Aspect 24: The balloon assembly of Aspect 23, wherein the at least one channel is wrapped around an exterior edge of the balloon assembly.
Aspect 25: The balloon assembly of Aspect 24, wherein the at least one channel is folded such that a first portion of the at least one channel overlays a second portion of the at least one channel.
The present disclosure will hereinafter be described in conjunction with the appended drawing figures, wherein like numerals denote like elements.
The ensuing detailed description provides exemplary embodiment(s) only, and is not intended to limit the scope, applicability, or configuration thereof. Rather, the ensuing detailed description of the exemplary embodiment(s) will provide those skilled in the art with an enabling description for implementing these embodiment(s). It should be understood that various changes may be made in the function and arrangement of elements of the embodiment(s) without departing from the spirit and scope of the invention, as set forth in the appended claims.
Directional terms (e.g., upper, lower, left, right, etc.) may be used herein. These directional terms are merely intended to assist in disclosing the embodiment(s) and claiming the invention and are not intended to limit the claimed invention in any way. In addition, reference numerals that are introduced in the specification in association with a drawing figure may be repeated in one or more subsequent figure(s) without additional description in the specification, in order to provide context for other features.
Peripheral vascular interventions are commonly used to attempt to clear occlusions from, or surgically introduce stents into, vascular pathways. For example, antegrade crossing via the radial artery in a patient's wrist is common, and various retrograde approaches upwardly from below a patient's knee are also established procedures. After such a procedure, the vascular (i.e., either arterial or venous) access site is typically closed through application of pressure to encourage hemostasis.
Hemostasis devices that are wrapped around a patient's limb at a site on the limb where bleeding is to be stopped, and which include one or more inflatable balloons or bladders that target pressure at a vascular access site, are known in the art. Multiple embodiments of one such hemostasis device and methods of using such devices are described in U.S. Pat. No. 7,498,477, the entirety of which is incorporated by reference as if set forth herein. Additional embodiments of such hemostasis devices and methods of using same are described in U.S. patent application Ser. No. 16/288,303, filed Feb. 28, 2019, the entirety of which is incorporated by reference as if set forth herein. It should be understood that the devices and methods taught herein could be used or adapted for use with any of the hemostasis devices taught in the references noted above in this paragraph.
As discussed in the '477 Patent noted above, such hemostasis devices generally include a rigid member (e.g., a curved plate that slips into a band) and at least one inflatable balloon that, when inflated, expands in a direction away from the rigid member and presses into a targeted location on a patient's limb or other body part, thereby promoting hemostasis. Many of these devices have a dual-balloon design including a connection port that connects the chambers of the two balloons in fluid-flow connection, such that inflating one balloon will cause the fluid (e.g., air) to flow through the connection port and fill the other balloon. These connection ports are typically made via radio frequency (“RF”) welding or bonding between faces of the adjacent balloons. In some instances these connection ports can fail, thus causing the balloon assembly of the hemostasis device to fail to properly inflate. The connection port design also requires multiple manufacturing steps and costly and time-consuming manual placement of components during the construction process. Accordingly, there is a need for improved balloon assembly structures and methods of constructing same.
The present disclosure describes various embodiments of improved balloon assembly structures, each of which omit the connection port between the balloons. Several of these embodiments are formed of two or more layers of material (e.g., vinyl or PVC) connected together via a single welded perimeter and then folded to form a balloon assembly that includes both the large balloon and small balloon at the same time with an open air channel between the two sections. Said another way, the two or more balloon chambers and the air channel that connects between the balloon chambers collectively form a contiguous air chamber, with each component of the contiguous air chamber having been at least partially formed by a single welding step. In an alternative embodiment according to the present disclosure, a plurality of balloons are formed and a multi-output connector splits the inflation tubing into the appropriate number of output connection tubes, each of which is separately routed into one of the plurality of balloons. In either approach, significantly fewer manufacturing steps are needed, placement of the components of the balloon assembly is simpler and more automatable, and the relatively-weak connection port is eliminated.
Referring now to
Via a single welding step of forming the two perimeters 126,128, the folded balloon assembly 116 of the present embodiment creates a dual-balloon structure comprising the small balloon 120, the large balloon 122, and the integrated air channels 134a,134b connecting the balloons 120,122, thereby achieving elimination of the weak welded connection port of the prior art devices while reducing the number of steps involved in the construction process. The small balloon 120, the large balloon 122, and the integrated air channels 134a,134b collectively comprise a contiguous air chamber 160, each component of which is formed at least in part by the single welding step. More particularly, the small balloon 120 has a perimeter 121, the large balloon 122 has a perimeter 123, and each of the air channels 134a,134b has a respective perimeter 135a,135b, and at least a portion of each of the perimeters 121,123,135a,135b—specifically, respective outer edge portions of each perimeter 121,123,135a,135b—is formed by the outer perimeter 126.
In the embodiment shown in
Turning back to the embodiment of
In the present embodiment, the balloon assembly 116 includes an indicator 124 located on the large balloon 122 that is used to help the clinician properly align the hemostasis device 110 on the patient's body part (i.e., adjacent to or atop the vascular access site) before, during, or after inflation of the balloon assembly 116. Omitting a welded connection port from the balloon assembly 116 provides the additional benefit of enhancing the visibility of the indicator 124 and the underlying vascular access site, thereby increasing the likelihood that the clinician will perform the hemostasis procedure accurately. In alternative embodiments, the indicator 124 could be located elsewhere on the balloon assembly 116, located elsewhere on the hemostasis device 110 (e.g., on the band or rigid insert plate), or omitted entirely.
In some embodiments according to the present disclosure, when the balloon assembly is attached to the band of the hemostasis device in its intended configuration, there is some possibility that the folded channel could become tightly creased such that airflow is all or partially kinked off between the balloons. In the various embodiments described herein, one or more pieces of secondary material can optionally be included within each channel to help hold the channel open. These “breather strips” may be one or more additional pieces of material included within the channel, which may be comprised of either air-permeable or air-impermeable materials. Alternatively, or in addition, the channel(s) can be partially held open along their edge(s) by creating height along the one or more perimeter(s) of the balloon assembly construction using: one or more additional layer(s) of material; a glue line; and/or an extruded bead or weld line resulting from a RF welding process, along the one or more perimeter(s).
Rather than using connection tubing to feed air through an inlet that is located along a side edge of the balloon assembly, balloon assemblies according to the present disclosure could also utilize a “chimney”-style port that is routed perpendicularly to the surfaces of the balloon(s).
While the embodiments discussed above are designed as two-balloon structures, additional folds or split air lines could be used to form a balloon assembly having any number of balloons or separate air chambers in accordance with the inventive concepts taught herein. Further, in accordance with any of the embodiments, structures, concepts, or methods taught herein, the channel(s) or air passages between the balloons could be of any number, could be of any non-linear shape (e.g., angled, zig-zagged, curved), and/or could split, combine, or both. In alternative embodiments, any connection tubing could be replaced by a “chimney port” or hose barb.
Another drawback with the structure of existing balloon assemblies is expansion defects or failures caused by the top and bottom layers of balloons adhering to another and failing to properly separate and permit the balloon to inflate after long periods of having been adjacent to another (i.e., after long periods of the balloon being uninflated). Referring now to
In some embodiments according to the present disclosure, this expansion failure is addressed by including spacer(s), strip(s), and/or additional layer(s) of material between the top and bottom layers of the balloon, or otherwise forming space(s) between the layers of material. Materials can be added within formed air channel(s) to prevent these air paths from sealing off when the balloon assembly is folded. These “breather strips” are formed from air-permeable materials, including but not limited to felt, thread, paper, and porous plastic. In alternative embodiments, non-permeable materials can be placed such that they prop open air channel(s), thus allowing air to pass through the channel(s) adjacent to the material. Suitable non-permeable materials include but are not limited to tubing, stickers (adhesive backed paper), flexible sheets of either similar or dissimilar material to the material of the flexible sheet of the balloon, and/or cured glue. Holding channel(s) open at their edges via non-permeable materials, as shown in the example of
While the principles of the claimed invention have been described above in connection with specific embodiment(s), it is to be clearly understood that this description is made only by way of example and not as a limitation of the scope of the invention, as set forth in the appended claims.
Claims
1. A balloon assembly for a hemostasis device, the balloon assembly comprising:
- a first chamber;
- a second chamber; and
- at least one channel that is in fluid flow communication between the first chamber and the second chamber, wherein a single perimeter of attachment between a first layer of material and a second layer of material defines at least a portion of a perimeter of the first chamber, at least a portion of a perimeter of the second chamber, and at least a portion of a perimeter of the at least one channel.
2. The balloon assembly of claim 1, wherein the single perimeter of attachment defines the entireties of the perimeters of the first chamber and the second chamber.
3. The balloon assembly of claim 2, wherein the single perimeter of attachment defines the entirety of the perimeter of the at least one channel.
4. The balloon assembly of claim 1, the balloon assembly further comprising an exterior edge, wherein the at least one channel is folded around the exterior edge and wherein at least a portion of the first chamber overlays at least a portion of the second chamber.
5. The balloon assembly of claim 4, wherein a first portion of the at least one channel overlays a second portion of the at least one channel.
6. The balloon assembly of claim 1, further comprising at least one piece of secondary material located within the at least one channel.
7. The balloon assembly of claim 6, wherein the at least one piece of secondary material is formed of a gas-permeable material.
8. The balloon assembly of claim 6, wherein the at least one piece of secondary material is formed of a gas-impermeable material.
9. The balloon assembly of claim 6, wherein the at least one piece of secondary material has a circular cross-sectional shape.
10. The balloon assembly of claim 1, further comprising a third layer of material that is at least partially located between and attached to the first layer of material and the second layer of material.
11. The balloon assembly of claim 1, the single perimeter of attachment comprising an outer perimeter, the balloon assembly further comprising an inner perimeter of attachment between the first layer and the second layer, the inner perimeter being located interior to the outer perimeter.
12. The balloon assembly of claim 11, wherein the outer perimeter and the inner perimeter form a first air channel and a second air channel between the first chamber and the second chamber.
13. The balloon assembly of claim 12, further comprising a cutout region interior to the inner perimeter from which portions of the first layer of material and second layer of material are absent.
14. The balloon assembly of claim 1, further comprising an inlet located along the perimeter through which a fluid can be introduced into an interior of the balloon assembly.
15. The balloon assembly of claim 14, wherein the inlet is in the form of a hollow cylindrical tubing.
16. (canceled)
17. (canceled)
18. (canceled)
19. (canceled)
20. (canceled)
21. A balloon assembly for a hemostasis device, the balloon assembly comprising:
- a connector having a first air inlet, a first air outlet, and a second air outlet, the first air inlet being connected separately in fluid flow communication with each of the first air outlet and the second air outlet;
- a first balloon having an inlet and an interior;
- a first connection tubing connected in fluid flow communication between the first air outlet and the interior of the first balloon via the inlet thereof;
- a second balloon having an inlet and an interior; and
- a second connection tubing connected in fluid flow communication between the second air outlet and the interior of the second balloon via the inlet thereof; wherein the first balloon and the second balloon are not connected in direct fluid flow communication.
22. The balloon assembly of claim 0, wherein the first balloon and second balloon are physically connected together along a respective edge thereof.
23. A balloon assembly for a hemostasis device, the balloon assembly comprising:
- a first chamber;
- a second chamber; and
- at least one channel that is in fluid flow communication between the first chamber and the second chamber;
- wherein the first chamber, the second chamber, and the at least one channel are formed between a first layer of material and a second layer of material;
- wherein at least a portion of the first chamber overlays at least a portion of the second chamber; and
- wherein the at least one channel is folded.
24. The balloon assembly of claim 0, wherein the at least one channel is wrapped around an exterior edge of the balloon assembly.
25. The balloon assembly of claim 0, wherein the at least one channel is folded such that a first portion of the at least one channel overlays a second portion of the at least one channel.
Type: Application
Filed: Feb 28, 2020
Publication Date: Mar 31, 2022
Applicant: TERUMO KABUSHIKI KAISHA (Shibuya-ku, Tokyo)
Inventors: Victoria Moore O'BRIEN (Sewell, NJ), Brian HOFFMAN (Princeton, NJ), Kenichi HAZAMA (Bear, DE), Nicholas VARAMO (Hockessin, DE)
Application Number: 17/427,398