WO2019217528A1 - Dispositif d'hémostase de patient - Google Patents

Dispositif d'hémostase de patient Download PDF

Info

Publication number
WO2019217528A1
WO2019217528A1 PCT/US2019/031279 US2019031279W WO2019217528A1 WO 2019217528 A1 WO2019217528 A1 WO 2019217528A1 US 2019031279 W US2019031279 W US 2019031279W WO 2019217528 A1 WO2019217528 A1 WO 2019217528A1
Authority
WO
WIPO (PCT)
Prior art keywords
patient
cuff
hand
hemostasis device
pressure application
Prior art date
Application number
PCT/US2019/031279
Other languages
English (en)
Inventor
John LUBISICH
Original Assignee
Tz Medical, Inc.
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 Tz Medical, Inc. filed Critical Tz Medical, Inc.
Publication of WO2019217528A1 publication Critical patent/WO2019217528A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/132—Tourniquets
    • A61B17/135—Tourniquets inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/132—Tourniquets
    • A61B17/1322—Tourniquets comprising a flexible encircling member
    • A61B17/1325—Tourniquets comprising a flexible encircling member with means for applying local pressure

Definitions

  • This disclosure relates to vascular delivery devices and techniques, which can be advantageous by allowing access to a patient's body without the requiring general anesthetic or more invasive
  • patient's peripheral arteries is performed by use of a sheath having a hemostatic valve.
  • the sheath is introduced into the patient via a peripheral artery and a device such as a catheter or other apparatus can then be received into a desired location within the patient's vascular system via the sheath.
  • US patent 6,355,026 entitled “Coronary catheters for use in a transradial catheterization” gives a example of how these techniques may be accomplished, via a patient's radial arteries.
  • the artery is punctured in the so called snuff box region of the patient's hand (the area between the upper wrist and lower dorsal portion of the thumb) and a catheter is inserted at this location.
  • the catheter is removed and pressure is applied to the insertion site to achieve hemostasis. This can be accomplished by use of compression applied directly to the artery upon removal of the catheter or other device.
  • pressure application to provide compression of the radial artery at the access site is required to obtain hemostasis of the site opening that was formed into the artery wall.
  • this pressure can potentially cause the artery to occlude or close, blocking blood flow beyond the occlusion point, which is detrimental to the patient. So, to lessen the likelihood of occlusion, during at least part of the time while pressure is applied, some flow of blood through the artery should be allowed to continue .
  • Adjustment over time of the pressure being applied to maintain hemostasis can be desirable to allow blood to flow through the artery of the access site and to get to tissue beyond the access site, by gradually reducing the pressure so that blood flow is increased as the clot at the access incision
  • a cuff fits comfortably over the patient's hand, with a thumb opening to provide placement guidance and to help hold the cuff in place.
  • the device can be secured to the patient's hand by use of tightening straps, such as hook and loop fastener straps.
  • the cuff sits above the wrist and encapsulate the thumb. It applies pressure to the lower portion of the hand in the location of the extensor pollicis longus or abductor pollicis longus end extensor.
  • At least one inflatable member is positioned between the inner face of the cuff and the catheter insertion point, and the member is inflated to sufficient degree to provide the desired amount of pressure against the puncture site to achieve
  • FIGs. 1-5 are perspective views taken from different angles of a compression device positioned on a patient's hand in accordance with the disclosure.
  • FIG. 6 is a stand-alone of an exemplary
  • the system comprises a partial cuff member, adapted to comfortably fit over a patient's hand, with securement strap (s) to secure it in place.
  • An inflatable member which may be in the form of a bubble, is positionable between the patient's hand and the cuff member. The inflation member can be adjusted to be positioned over a puncture site in the snuff box region of the patient's hand.
  • An inflation port may employ a standard luer lock or other connector to allow attachment of a syringe or other inflation source for inflation of the inflation member to provide pressure against the puncture site, for achieving non-occlusive hemostasis.
  • a valve may be present as part of the inflation port to prevent unintended release of pressure from the inflation member .
  • the hand receiving cuff assembly 20 includes a thumb opening 22 such that the patient's thumb extends through the opening.
  • the cuff assembly can be formed as an open ended loop member that wraps around the user's hand. Once wrapped around the wrist, the cuff will sit above the wrist and encapsulate the thumb.
  • the cuff assembly may be secured via
  • the compression straps may be hook and loop fastener types, or other suitable manner of securing can be employed.
  • the cuff assembly can be produced in different sizes, to accommodate different sized patient hands. Typically a size is chosen that is just slightly larger than the patient's hand.
  • the cuff and pressure application device may be suitably clear such that they are easily seen through, useful for example for observation of positioning of the pressure application device
  • the cuff can be provided with a color if desired.
  • the different sizes can be provided with slight color tints, each size being given a different color, to allow quick
  • the cuff is substantially rigid in a particular embodiment, but can be made at least partially flexible for conforming to the shape of the patient's hand.
  • a pressure application member 26 Positioned on the hand facing side of the inner surface of the cuff is a pressure application member 26, which in the preferred embodiment takes the form of an inflatable bubble member (FIG. 6) .
  • the pressure application member formed as an inflatable member 26 carries an inflation/deflation tube 28, suitably provided with an inflation port 30, which in a particular embodiment can be a standard luer lock connector.
  • an inflation/deflation tube 28 suitably provided with an inflation port 30, which in a particular embodiment can be a standard luer lock connector.
  • This allows attachment of a syringe, for example, for inflation of the inflation member to provide pressure against the puncture site, for achieving non-occlusive hemostasis.
  • a valve prevents unintended loss of pressure from the inflation member.
  • the inner face of the cuff member has a pressure application member receiving area 32, which allows the member 26 to be held in position to the cuff.
  • the pressure member can be designed to fit to be held in precise position relative to the cuff, or be movable within the receiving area 32 so as to allow re
  • the cuff is put onto the patient's hand and inflatable member is positioned between the patient's skin and the inner surface of the cuff, in the general area of the puncture, (illustrated in phantom in FIG. 1 to show placement between the inner surface of the cuff and the patient's skin) .
  • the inflatable member can be positionable within the receiving area 32 for more options on placement if desired, so that it can be positioned over the
  • the pressure application member is formed as an accordion action bubble that lays substantially flat when deflated, but expands in the directions of arrow 34 when inflated.
  • the hemostasis device When the cuff is positioned on the patient's hand and the pressure application member is inflated, the hemostasis device, by operation of the inflated bubble in combination with the cuff member, pressure is applied in the anatomical snuff box region of the hand, to the lower portion of the hand in the location of the extensor pollicis longus or abductor pollicis longus end extensor.
  • the inflation member will press against the rigid plastic of the cuff that encompasses it and will secure the inflation member in place.
  • the cuff is secured with the compression strap member 24, which can include hook and loop fasteners to allow adjustment and fixing the cuff to the patient's hand.
  • the device allows specific pressure application where needed by inflation of the inflatable member, which mimics manual pressure applied by a finger by medical personnel, as is done when no cuff is
  • the inflatable member in the illustrated configurations is suitably inflatable, for example to 10 psi, which is more than sufficient.
  • inflation medium is air, fluid or other gases may be employed to inflate the illustrated inflation medium
  • the inflatable member can be any inflatable member.
  • the inflatable member can be any inflatable member.
  • the inflatable member can be any inflatable member.
  • the inflatable member can be any inflatable member.
  • the skin contact surface of the inflatable member can be provided with a medication or other substance to assist with accomplishing hemostasis, which may be provided in a receptacle formed in the face of the inflatable member wherein the substance is dispensed to the patient by pressure provided by the pressure application device.
  • the substance may comprises a hemostatic substance, for example.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif d'hémostase utilisant un manchon de main et un élément de gonflage qui peut être positionné entre une région de tabatière anatomique du patient (entre la partie dorsale du pouce et le poignet supérieur) et le manchon de main pour permettre le positionnement de l'élément de gonflage sur un site de perforation. Le gonflage de l'élément de gonflage applique une pression au site de perforation, de telle sorte qu'une hémostase peut être obtenue sans nécessiter de personnel médical pour appliquer manuellement une pression sur le site de perforation.
PCT/US2019/031279 2018-05-08 2019-05-08 Dispositif d'hémostase de patient WO2019217528A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862668755P 2018-05-08 2018-05-08
US62/668,755 2018-05-08

Publications (1)

Publication Number Publication Date
WO2019217528A1 true WO2019217528A1 (fr) 2019-11-14

Family

ID=68467066

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2019/031279 WO2019217528A1 (fr) 2018-05-08 2019-05-08 Dispositif d'hémostase de patient

Country Status (1)

Country Link
WO (1) WO2019217528A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6986779B2 (en) * 2003-06-16 2006-01-17 Karen Begley, legal representative Pain relieving pressure maintenance apparatus and method
US20060190026A1 (en) * 2005-02-24 2006-08-24 Laurie Sanders Adjustable acupressure device
US20150018868A1 (en) * 2013-07-12 2015-01-15 Samir Pancholy Method of transradial catheterization, device for ulnar artery compression, and method of use
US20170273693A1 (en) * 2016-03-25 2017-09-28 Tz Medical, Inc. Radial compression band
WO2018181314A1 (fr) * 2017-03-29 2018-10-04 テルモ株式会社 Garrot et procédé hémostatique
CN108635011A (zh) * 2018-06-06 2018-10-12 安吉特（天津）科技有限公司 一种远端桡动脉压迫止血器

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6986779B2 (en) * 2003-06-16 2006-01-17 Karen Begley, legal representative Pain relieving pressure maintenance apparatus and method
US20060190026A1 (en) * 2005-02-24 2006-08-24 Laurie Sanders Adjustable acupressure device
US20150018868A1 (en) * 2013-07-12 2015-01-15 Samir Pancholy Method of transradial catheterization, device for ulnar artery compression, and method of use
US20170273693A1 (en) * 2016-03-25 2017-09-28 Tz Medical, Inc. Radial compression band
WO2018181314A1 (fr) * 2017-03-29 2018-10-04 テルモ株式会社 Garrot et procédé hémostatique
CN108635011A (zh) * 2018-06-06 2018-10-12 安吉特（天津）科技有限公司 一种远端桡动脉压迫止血器

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
SOYDAN, ELTON ET AL.: "Coronary angiography using the left distal radial approach - An alternative site to conventional radial coronary angiography", THE ANATOLIAN JOURNAL OF CARDIOLOGY, vol. 19, no. 4, 25 March 2018 (2018-03-25), pages 243 - 248, XP055650862 *

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