WO2016107157A1 - Dispositif d'hémostase par compression d'artère fémorale - Google Patents

Dispositif d'hémostase par compression d'artère fémorale Download PDF

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Publication number
WO2016107157A1
WO2016107157A1 PCT/CN2015/085253 CN2015085253W WO2016107157A1 WO 2016107157 A1 WO2016107157 A1 WO 2016107157A1 CN 2015085253 W CN2015085253 W CN 2015085253W WO 2016107157 A1 WO2016107157 A1 WO 2016107157A1
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WO
WIPO (PCT)
Prior art keywords
pad
femoral artery
compression
leg
hemostasis device
Prior art date
Application number
PCT/CN2015/085253
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English (en)
Chinese (zh)
Inventor
邱怀明
付涛
张磊
吴刚
孙耀华
Original Assignee
武汉奥绿新生物科技有限公司
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Publication of WO2016107157A1 publication Critical patent/WO2016107157A1/fr

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    • 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
    • A61B17/12009—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/00051—Accessories for dressings
    • A61F13/00063—Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/01—Non-adhesive bandages or dressings
    • A61F13/01008—Non-adhesive bandages or dressings characterised by the material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M35/00—Devices for applying media, e.g. remedies, on the human body
    • A61M35/003—Portable hand-held applicators having means for dispensing or spreading integral media
    • A61M35/006—Portable hand-held applicators having means for dispensing or spreading integral media using sponges, foams, absorbent pads or swabs as spreading means
    • 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
    • A61B2017/12004—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding
    • 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
    • A61B17/12009—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
    • A61B2017/12018—Elastic band ligators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F2013/15008—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterized by the use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0413—Blood

Definitions

  • the invention relates to a medical hemostat, in particular to a disposable compression hemostat for a femoral artery, belonging to the technical field of medical instruments.
  • Interventional surgery is a routine treatment for medical departments such as cardiology and neurology.
  • the advantage of interventional surgery is that the doctor can enter the patient's body without using general anesthesia or without surgery.
  • interventional diagnosis and treatment especially neurosurgical interventional surgery, is achieved through the patient's femoral artery access.
  • the interventional procedure of the femoral artery has the advantages of high success rate and low difficulty in operation.
  • due to the thick blood vessels of the femoral artery and high blood pressure it is challenging to completely stop bleeding after the operation of the artery.
  • the interventional procedure is completed.
  • the doctor or medical professional applies pressure at the arterial catheter puncture point to achieve hemostasis and closure of the arterial puncture point.
  • the hemostasis and arterial puncture point closure require a constant pressure, usually the initial pressure. Higher, after a period of time, it is necessary to gradually reduce the pressure, so that the blood vessels downstream tissue get rich blood supply.
  • the hemostasis of the femoral artery puncture is mainly controlled by the medical staff by manual pressing or applying a bandage to stop bleeding, but it is very labor-intensive and time-consuming, and the materials used by domestic doctors are different when performing pressure dressing, such as the use of universal bandages.
  • the problem is that, first, the quality of the self-made pressurized material is different, it is difficult to ensure the hemostasis: Second, the excessive pressure will also oppress the adjacent femoral vein, causing venous return disorder and even thrombosis, material The application of non-uniform and non-specialized equipment can not guarantee the effect and quality of dressing and hemostasis. Third, the bandage or tape needs to be manually pressed by the medical staff for 10 to 30 minutes before being pressurized, which is time-consuming and labor-intensive.
  • the existing mechanical pressure equipment is generally inflated or pushed and pressurized by the airbag or the knob, which can reduce the physical strength of the medical staff and improve the hemostasis efficiency, but there are three significant problems in the equipment, one is that the hemostasis effect is poor, and the hemostasis success rate There is no manual pressure high, and there is more oozing; the second is that it can only press the skin puncture point, can not hold the vascular puncture mouth, remove the pressure device, the intradermal hematoma is more; the third is the unstable pressure, easy to follow The rotation of the patient's leg causes displacement, causing the compression pressure to shift the puncture point.
  • the object of the present invention is to solve the deficiencies of the prior art, and to provide a hemostatic device which has high hemostatic efficiency, can be stably fixed at a puncture point of a human leg, and can reduce the compression force of the leg.
  • the technical solution adopted for achieving the object of the present invention is a femoral artery compression hemostasis device comprising at least a hemostasis unit and a fixing unit, the hemostasis unit comprising a pressure knob, a sleeve sleeved on the pressure knob and screwed with the pressure knob a housing, and a pressing pad movably connected to a bottom surface of the pressing knob, the fixing unit is coupled to the casing, the fixing unit includes a supporting stabilizer bar, a tail fin fixed on the support stabilizer bar, a leg support plate under the support stabilizer bar, and The fixing strap, the supporting stabilizing rod and the leg supporting plate are connected by a fixing strap, the supporting stabilizing rod is perpendicular to the pressing knob, one end is connected with the tail fin, and the other end is screwed with the sleeve; the pressing pad comprises a base pad, a blood vessel compression pad and hemostasis The dressing, the vascular compression pad and the hemostatic dressing are fixed on the bottom surface of
  • a buckle is arranged between the pressing pad and the pressing knob, the buckle is cylindrical, the upper end is located in the pressing knob and can be rotated along the central axis of the pressing knob, and the bottom surface of the buckle is fixedly connected with the upper surface of the base pad, the card The buckle is located above the contact surface of the vascular compression pad and the hemostatic dressing.
  • the empennage is butterfly-shaped, and the two wings of the empennage are curved downward in an arc shape, and the curvature is matched with the circumferential curve of the leg where the femoral artery is located, and the middle portion of the empennage is horizontally fixed on the lower surface of the end of the supporting stabilizer rod through the pin shaft. .
  • the support stabilizing rod is slightly bent downward in the axial direction, and the arc shape is coincident with the axis arc of the leg portion of the femoral artery, and the upper surface of the support stabilizing rod and the lower surface of the leg support plate are respectively disposed. There are grooves for fixing the fixing tape.
  • the shape of the leg support plate coincides with the shape of the back of the leg where the femoral artery is located.
  • a groove for fixing the fixing tape is provided on the upper surface of the support stabilizer bar and the lower surface of the leg support plate.
  • the upper end of the casing is provided with a pull-out hand position for finger gripping.
  • a transparent plate is disposed on a portion of the casing opposite to the connecting portion of the supporting stabilizer bar, and the transparent plate is engraved with a scale.
  • the middle portion of the pressing knob is provided with a zero line.
  • the base pad and the vascular compression pad are both silicone pads, and the base pad and the vascular compression pad are integrally connected to form a silicone step.
  • the hemostatic dressing is a lyophilized sponge containing a hemostatic drug.
  • the pressure adjustment knob can be used to provide continuous and adjustable pressure for the puncture point, thereby achieving compression and hemostasis.
  • the compression pad and the pressure knob are connected by the snap action, so that the compression pad is pressed and fixed. After that, the pressure knob can be rotated, so that the medical staff can remove the puncture tube.
  • the upper end of the sleeve is provided with a pull-out hand position for finger gripping, which is convenient for the medical staff to press the puncture mouth when the tube is pulled out;
  • a transparent plate with a scale is arranged at a portion of the sleeve opposite to the connecting portion of the support stabilizer bar.
  • the middle part of the pressure knob is provided with a zero line, which can determine the degree of rotation of the pressure knob through the scale, control the pressure force, and improve the hemostasis efficiency;
  • the hemostatic dressing is a freeze-dried sponge containing hemostatic drugs, which has a good water absorption effect.
  • the hemostatic dressing directly contacts the puncture mouth, thereby blocking and stopping the puncture and puncture channel, reducing the probability of puncture point bleeding, thereby solving the problem that the puncture point is easy to ooze blood;
  • the compression pad is an asymmetric structure, one side of the blood dressing, one side of the vascular compression pad, the buckle is located above the contact surface of the vascular compression pad and the hemostatic dressing, the compression force exerted by the vascular compression pad can directly compress the vascular puncture, and add
  • the pressing force of the pressure knob can be mainly concentrated on the vascular compression pad, because the height of the vascular compression pad is not less than the height of the hemostatic dressing, so that the pressure is further concentrated on the vascular compression pad, and the vascular puncture port is closed;
  • the support stabilizer bar, the tail wing and the leg support plate are all in conformity with the structure of the leg, so that the fixing unit is stably fixed on the leg and is not easy to be displaced relative to the leg; the stabilizer bar is supported to make the pressing pressure of the fixing band more It is concentrated on the front pressure knob; the tail has a butterfly shape and has a large contact area with the leg, which can significantly disperse the compression force, thereby reducing the compression of the vein by the hemostatic device, does not affect the blood return, and the tail is stable at the same time.
  • the role of the pole is provided.
  • FIG. 1 is a schematic structural view of a hemostatic device provided by the present invention.
  • Figure 2 is a schematic view showing the structure of a blood unit.
  • 1-pressure knob 11-zero line
  • 2-cup shell 21-pull tube hand position
  • 3-compression pad 31-silicone step
  • 311-vascular compression pad 312-base pad
  • 32-hemostatic Dressing 4-leg support plate, 5-tail, 6-support stabilizer, 7-strap, 8-transparent, 81-scale, 9-pin, 10-pin.
  • the femoral artery compression hemostasis device has the structure as shown in FIG. 1 and FIG. 2, and comprises a hemostasis unit and a fixing unit.
  • the hemostasis unit comprises a pressure knob 1 which is sleeved on the pressure knob and screwed with the pressure knob.
  • the fixing unit includes a support stabilizer bar 6, and is fixed on the support stabilizer bar
  • the upper tail 5, the leg support plate 4 and the fixing belt 7 under the support stabilizer bar, the support stabilizer bar 6 and the leg support plate 4 are connected by the fixing belt 7, and the support stabilizer bar is slightly bent downward in the axial direction to form an arc
  • the shape of the arc conforms to the axis arc of the leg where the femoral artery is located.
  • the support stabilizing rod 6 is perpendicular to the pressurizing knob 1, one end is connected to the tail fin 5, and the other end is screwed to the sleeve 2, and the tail is butterfly-shaped.
  • the two wings of the empennage are curved downwardly in an arc shape, and the curvature of the curve coincides with the circumferential curve of the leg where the femoral artery is located.
  • the middle portion of the empennage is horizontally fixed on the lower surface of the end of the support stabilizing rod by the pin 9, the support plate of the leg Shape and femoral artery
  • the shape of the back side of the leg is matched, and the lower surface of the leg support plate and the upper surface of the support stabilizer bar are provided with a groove for fixing the fixing belt; the portion of the sleeve opposite to the connecting portion of the supporting stabilizer bar
  • the transparent plate 8 is provided, and the transparent plate is engraved with a scale 81.
  • the middle portion of the pressing knob 1 is provided with a zero line 11 for determining the degree of rotation of the pressing knob with the scale 81;
  • the pressing pad 3 is asymmetric Structure, including The base pad 312, the vascular compression pad 311 and the hemostatic dressing 32, the vascular compression pad 311 and the hemostatic dressing 32 are fixed to the bottom surface of the base pad 312, the vascular compression pad abuts against the hemostatic dressing, and the area of the hemostatic dressing is compressed by the large blood vessel.
  • the area of the pad, the height of the vascular compression pad is not less than the height of the hemostatic dressing, the base pad and the vascular compression pad are both silicone pads, the base pad and the vascular compression pad are integrally fixed to form a silicone step 31, and the hemostatic dressing 32 is a hemostatic drug.
  • the freeze-dried sponge is prepared by the associated patent CN201210545888.8; a buckle 10 for fixing the compression pad is arranged between the compression pad 3 and the pressure knob 1, and the buckle 10 is clamped in the pressure knob and can be added along The central axis of the pressure knob 1 is rotated, and the upper surface of the base pad 312 is fixed to the bottom surface of the buckle 10, and the buckle is located above the contact surface of the blood vessel compression pad 311 and the hemostatic dressing 32.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Reproductive Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Surgical Instruments (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne un dispositif d'hémostase par compression d'artère fémorale qui comprend au moins une unité d'hémostase et une unité de fixation. L'unité d'hémostase comprend un bouton de pression (1), une enveloppe de manchon (2) raccordée par filetage avec le bouton de pression (1) et un bloc de compression (3) raccordé à la surface inférieure du bouton de pression (1). L'unité de fixation comprend une tige de stabilisation de support (6), une ailette arrière (5) fixée sur la tige de stabilisation de support (6), une plaque de support des jambes (4) positionnée au-dessous de la tige de stabilisation de support (6) et une sangle de fixation (7), et la tige de stabilisation de support (6) est raccordée à la plaque de support de jambes (4) par la sangle de fixation (7). La tige de stabilisation de support (6) est perpendiculaire au bouton de pression (1), une extrémité de la tige de stabilisation de support (6) est raccordée à l'ailette arrière (5), et l'autre extrémité de la tige de stabilisation de support (6) est raccordée par filetage avec l'enveloppe de manchon (2). Le bloc de compression (3) comprend un bloc de base (312), un bloc de compression de vaisseau sanguin (311) et un pansement hémostatique (32), le bloc de compression de vaisseau sanguin (311) et le pansement hémostatique (32) sont fixés de façon bilatérale à la base du bloc de base (312), le bloc de compression de vaisseau sanguin (311) est en butée contre le pansement hémostatique (32), l'aire du pansement hémostatique (32) est supérieure à celle du bloc de compression de vaisseau sanguin (311), et la hauteur du bloc de compression de vaisseau sanguin (311) n'est pas inférieure à celle du pansement hémostatique (32). Le dispositif d'hémostase présente une efficacité hémostatique élevée, peut être fixé de façon stable au niveau d'un point de ponction d'une jambe humaine, et peut réduire la pression appliquée sur la jambe.
PCT/CN2015/085253 2014-12-31 2015-07-28 Dispositif d'hémostase par compression d'artère fémorale WO2016107157A1 (fr)

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CN201410853155.X 2014-12-31
CN201410853155.XA CN104490443B (zh) 2014-12-31 2014-12-31 一种股动脉压迫止血装置

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CN107411798A (zh) * 2017-06-28 2017-12-01 四川大学华西第二医院 一种制动型压迫止血带
CN108158628A (zh) * 2018-01-25 2018-06-15 福建医科大学附属第医院 一种感应加压式股动脉压迫器
CN109567910A (zh) * 2019-01-28 2019-04-05 中国人民解放军陆军军医大学第附属医院 一种多功能血管介入穿刺装置及其使用方法
CN109730739A (zh) * 2019-03-22 2019-05-10 首都医科大学附属北京朝阳医院 一种便携式人体力学股动脉压迫止血装置及使用方法
CN109770986A (zh) * 2019-03-09 2019-05-21 吉林大学 手动指尖采血用指侧推压器
CN110327091A (zh) * 2019-04-28 2019-10-15 中国人民解放军联勤保障部队第九二〇医院 一种带有过压保护的止血压迫装置
CN111050671A (zh) * 2017-09-01 2020-04-21 泰尔茂株式会社 线压迫垫
CN111466991A (zh) * 2020-05-14 2020-07-31 沈阳新智源医疗用品有限公司 一种自锁式股动脉压迫止血器
CN113229881A (zh) * 2021-06-22 2021-08-10 中国人民解放军空军军医大学 一种肝动脉止血器
CN113730112A (zh) * 2021-09-28 2021-12-03 韩铭 一种医疗护理用止血包扎装置
CN115778465A (zh) * 2022-12-08 2023-03-14 南通市肿瘤医院 一种医疗止血用股动脉加压装置

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CN104490443B (zh) * 2014-12-31 2017-07-18 武汉奥绿新生物科技有限公司 一种股动脉压迫止血装置
CN105496495B (zh) * 2016-02-25 2018-03-30 郑州大学第一附属医院 一种股动脉止血器
CN106618906B (zh) * 2017-02-20 2022-12-27 金华市中心医院 用于血管介入术后的下肢制动固定器
CN110786906A (zh) * 2018-08-03 2020-02-14 连新龙 一种龙头式加压止血器

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