WO2020176245A1 - Hemostasis band with improved edge design - Google Patents

Hemostasis band with improved edge design Download PDF

Info

Publication number
WO2020176245A1
WO2020176245A1 PCT/US2020/017618 US2020017618W WO2020176245A1 WO 2020176245 A1 WO2020176245 A1 WO 2020176245A1 US 2020017618 W US2020017618 W US 2020017618W WO 2020176245 A1 WO2020176245 A1 WO 2020176245A1
Authority
WO
WIPO (PCT)
Prior art keywords
attachment strap
side edge
edge
hemostatic device
flexible connector
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2020/017618
Other languages
English (en)
French (fr)
Inventor
Victoria Moore O'brien
Brian Hoffman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Medical Corp
Original Assignee
Terumo Medical Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Terumo Medical Corp filed Critical Terumo Medical Corp
Priority to EP20762470.1A priority Critical patent/EP3930592B1/en
Priority to JP2021549774A priority patent/JP7307187B2/ja
Publication of WO2020176245A1 publication Critical patent/WO2020176245A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/132Tourniquets
    • A61B17/135Tourniquets inflatable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B2017/12004Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord for haemostasis, for prevention of bleeding

Definitions

  • the second attachment strap hingedly attached to the main body by a second flexible connector
  • the second attachment strap including a second fastener half that is attachable to the first fastener half such that the first attachment strap and second attachment strap are attachable together to hold the hemostatic device in place around the at least a portion of the limb
  • the second attachment strap further including an interior side and a perimeter, the perimeter of the second attachment strap being measured along a lateral edge of the second flexible connector and along a first side edge, an end edge, and a second side edge of the second attachment strap between a first point where the first side edge of the second attachment strap meets the second flexible connector and a second point where the second side edge of the second attachment strap meets the second flexible connector, the lateral edge of the second flexible connector being defined by a line drawn between the first point on the second attachment strap and the second point on the second attachment strap, the end edge of the second attachment strap including a first comer corresponding to where the end edge of the second attachment strap meets the first side edge thereof and a second corner corresponding to where the end
  • Aspect 4 The hemostatic device of either of Aspect 2 or Aspect 3, wherein each of the first side edge of the first attachment strap, the second side edge of the first attachment strap, the first side edge of the second attachment strap, and the second side edge of the second attachment strap includes at least one cutout.
  • Aspect 8 The hemostatic device of any of Aspects 1-7, wherein at least one of the first attachment strap and the second attachment strap is comprised of a primary piece of material and at least one secondary piece of material that is attached to the primary piece of material to form at least a portion of the first side edge or second side edge of the respective attachment strap, the at least one secondary piece of material being rolled or curled away from the interior side of the respective attachment strap.
  • Aspect 13 The hemostatic device of Aspect 12, wherein the at least one compression element comprises a plurality of inflatable elements that press into each other when inflated to assist in the application of pressure to the at least one artery or vein.
  • a hemostatic device comprising:
  • first attachment strap hingedly attached to the main body by a first flexible connector
  • the first attachment strap including a first fastener half and a perimeter, the perimeter being measured along a lateral edge of the first flexible connector and along a first side edge, an end edge, and a second side edge of the first attachment strap between a first point where the first side edge meets the first flexible connector and a second point where the second side edge meets the first flexible connector, the lateral edge of the first flexible connector being defined by a line drawn between the first point and the second point, the end edge including a first corner corresponding to where the end edge meets the first side edge and a second comer corresponding to where the end edge meets the second side edge;
  • first side edge of the first attachment strap, the second side edge of the first attachment strap, the first side edge of the second attachment strap, and the second side edge of the second attachment strap is non-linear.
  • Aspect 15 The hemostatic device of Aspect 14, wherein at least one of the first side edge of the first attachment strap, the second side edge of the first attachment strap, the first side edge of the second attachment strap, and the second side edge of the second attachment strap includes at least one cutout.
  • Aspect 16 The hemostatic device of Aspect 15, wherein at least one of the first side edge of the first attachment strap, the second side edge of the first attachment strap, the first side edge of the second attachment strap, and the second side edge of the second attachment strap includes a plurality of cutouts.
  • main body adapted to fit around at least a portion of a limb of a patient, the main body including at least one compression element adapted to apply pressure to at least one artery or vein located in the limb when the hemostatic device is attached around the at least a portion of the limb;
  • the second attachment strap hingedly attached to the main body by a second flexible connector
  • the second attachment strap including a second fastener half that is attachable to the first fastener half such that the first attachment strap and second attachment strap are attachable together to hold the hemostatic device in place around the at least a portion of the limb, the second attachment strap further including an interior side bounded by a perimeter, the perimeter of the second attachment strap being measured along a first side edge, an end edge, and a second side edge of the second attachment strap between a first point where the first side edge of the second attachment strap meets the second flexible connector and a second point where the second side edge of the second attachment strap meets the second flexible connector;
  • FIG. 2 is a sectional view of a hemostasis band according to the prior art, taken along a hypothetical section line similar to section line X-X of FIG. 1;
  • FIG. 8 is a side perspective view of a first end of a hemostasis band according to another embodiment of the present disclosure.
  • the hemostasis band 30 is shown in its undeployed or unwrapped state, lying flat on a planar surface.
  • the hemostasis band 30 comprises a main body 32, an attachment strap 62 attached to the main body 32 by a flexible connector 60, and an attachment strap 80 attached to an opposing side of the main body 32 by a flexible connector 78.
  • the main body 32 comprises an interior side 34 that is oriented towards (i.e., faces) the wrist 3 and an exterior side 36 that is oriented away from the wrist 3 when the hemostasis band 30 is attached thereto.
  • the hemostasis band 30 further comprises a curved plate 38 attached to the main body 32, the curved plate 38 adapted to wrap around at least a portion of the wrist 3 when the hemostasis band 30 is attached thereto, such that at least one compression element, as further discussed below, is located between the curved plate 38 and the at least one artery or vein where the access site is located.
  • the curved plate 38 is held in the hemostasis band 30 by being inserted between two layers of overlapping material (not separately labeled in FIG. 1) that comprise the main body 32 of the hemostasis band 30.
  • the curved plate 38 is comprised of a material that is more rigid than that of the hemostasis band 30 and is designed to maintain a substantially constant shape.
  • FIG. 1 also shows the compression element 41, which in this embodiment is provided with an inflatable dual -balloon configuration similar to the embodiments taught in U.S. Patent No. 7,498,477.
  • the dual pneumatic balloon design supports a process to titrate air and reduce compression (pressure) during recovery, which allows for the artery or vein to remain patent over time.
  • the compression element 41 is comprised of a main balloon 42, a secondary balloon 44, and a connector 40 which serves as a j oining portion between the main body 32, the main balloon 42, and the secondary balloon 44.
  • the compression element 41 could be formed with only one balloon and/or balloon(s) of different sizes than the balloons 42,44 of the present embodiment.
  • the balloons could be omitted entirely, and the hemostatic pressure could be achieved via a material pad or a mechanical device that applies pressure to the desired vascular access site.
  • the attachment strap 62 comprises an interior side 63 that is oriented towards ⁇ i.e., faces) the wrist 3 and an exterior side 64 that is oriented away from the wrist 3 when the hemostasis band 30 is attached thereto, and a fastener half 65 that is located on the exterior side 64 thereof.
  • the attachment strap 80 comprises an interior side 81 that is oriented towards (i.e., faces) the wrist 3 and an exterior side 82 that is oriented away from the wrist 3 when the hemostasis band 30 is attached thereto, and a fastener half 83 that is located on the interior side 81 thereof.
  • the attachment strap 80 further comprises a perimeter 84 that is measured along a lateral edge 79 of the flexible connector 78 and along a side edge 86, an end edge 94, and a side edge 90 of the attachment strap 80 between a first point (not labeled) where the side edge 86 meets the flexible connector 78 and a second point (not labeled) where the side edge 90 meets the flexible connector 78, the lateral edge 79 of the flexible connector 78 being defined by a line drawn between the first point and the second point, and the end edge 94 including a corner 85 corresponding to where the end edge 94 meets the side edge 86 and a corner 95 corresponding to where the end edge 94 meets the side edge 90.
  • FIGS. 8-11 show various views of another embodiment of a hemostasis band 610 according to the present disclosure, including attachment straps 614,632 that include edges that curl to the exterior of the band 610 (i.e., away from the patient) around at least a portion of a respective perimeter 622,640 thereof.
  • the hemostasis band 610 according to the present disclosure include a main body 611 and a compression element (not shown or labeled) that may be similar to the main body 32 and compression element 41 of the embodiment of FIG. 1, or similar to other known or not-yet-developed hemostatic devices.
  • the perimeter 640 is measured along a lateral edge 631 of the flexible connector 630 and along a side edge 642, an end edge 646, and a side edge 644 of the attachment strap 632 between a first point (not labeled) where the side edge 642 meets the flexible connector 630 and a second point (not labeled) where the side edge 644 meets the flexible connector 630, the lateral edge 631 of the flexible connector 630 being defined by a line drawn between the first point and the second point, and the end edge 646 including a comer 641 corresponding to where the end edge 646 meets the side edge 642 and a corner 643 corresponding to where the end edge 646 meets the side edge 644.
  • the patch of“loops” of the hook-and-loop fastener is preferably placed on the limb-facing side of the attachment strap in case this fastener half engages with the patient’s skin, and the patch of“hooks” is preferably placed oriented facing away from the patient’s skin when the attachment strap is in use, to minimize skin irritation caused by the fastener halves. In alternate embodiments, this arrangement could be reversed.
  • any of the comfort-improving features disclosed herein could be combined, mutatis mutandis , in alternate embodiments according to the present disclosure.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
PCT/US2020/017618 2019-02-28 2020-02-11 Hemostasis band with improved edge design Ceased WO2020176245A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP20762470.1A EP3930592B1 (en) 2019-02-28 2020-02-11 Hemostasis band with improved edge design
JP2021549774A JP7307187B2 (ja) 2019-02-28 2020-02-11 改良された縁部のデザインを備える止血バンド

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US16/288,303 US11596417B2 (en) 2019-02-28 2019-02-28 Hemostasis band with improved edge design
US16/288,303 2019-02-28

Publications (1)

Publication Number Publication Date
WO2020176245A1 true WO2020176245A1 (en) 2020-09-03

Family

ID=72236312

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2020/017618 Ceased WO2020176245A1 (en) 2019-02-28 2020-02-11 Hemostasis band with improved edge design

Country Status (4)

Country Link
US (1) US11596417B2 (https=)
EP (1) EP3930592B1 (https=)
JP (1) JP7307187B2 (https=)
WO (1) WO2020176245A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11272941B1 (en) * 2020-08-07 2022-03-15 William P Buchanan Secondary device holder and compression system, method of making and using the same
CN113499117B (zh) * 2021-06-28 2024-08-02 北京朝阳急诊抢救中心 正压分区透明可调控肢体创面止血装置
EP4487792A4 (en) * 2022-03-18 2025-07-16 Terumo Corp HEMOSTASIS TOOL

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See also references of EP3930592A4

Also Published As

Publication number Publication date
EP3930592A1 (en) 2022-01-05
EP3930592B1 (en) 2026-04-29
EP3930592A4 (en) 2022-11-23
US20200275936A1 (en) 2020-09-03
JP7307187B2 (ja) 2023-07-11
US11596417B2 (en) 2023-03-07
JP2022522150A (ja) 2022-04-14

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