RU2635081C1 - Device for hemostasis in puncture opening of femoral artery - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: device consists of a horizontal arm, the proximal end of which is connected to a proximal column with a clamping unit to squeeze the soft tissues above the puncture opening. The device contains a tensioning strap on the horizontal arm to secure the device on the hip. The distal end of the arm is connected to a distal column provided with a fixing member. The arm is connected to the distal column by a hinge with a clamping device with a possibility of column longitudinal movement along the arm. A fixing belt is attached to the base of the distal column as a fixing member around the hip. The tensioning belt on the horizontal arm is located with a possibility of its free movement along the arm. Belts are made of elastic material.

EFFECT: increased reliability and ease of device application.

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Description

The invention relates to medicine, namely to devices for hemostasis in the puncture opening of the femoral artery (surgical access site) after performing endovascular diagnostic and therapeutic interventions on the heart and blood vessels performed through the lumen of a valve-containing introducer of a medical device acting as a temporary port in the lumen arterial bed.

A device for mechanical pressing of a puncture hole is known, which is a vertical support rack along which a horizontal bar moves, a clamping unit having three degrees of freedom is located at the free end of the bar, allowing the device to be adapted to patients with different dimensions. The design is fixed on a flat wide base. The patient is laid on the base of the structure, a horizontal bar with a clamping unit to the puncture hole is moved along the rack, the wound is pressed and parts of the structure are fixed in this position (US patent No. 5304186 A, IPC А61В 17/12, priority dated June 23, 1992, publ. 19.04. 1994; or CompressAR Universal System, Advanced Vascular Dynamics, http://www.compressar.com/products/femoral-hemostasis/mechanical-compression.php, 2008, video: https://www.youtube.com/ watch? v = D9_qGour5o0).

The main disadvantage is the inability to move the patient in cases of transportation for medical reasons, in addition, the patient must be in a forced position - strictly motionless, which reduces the reliability and ease of use of the device, since the slightest movement in the lumbar spine and lower extremities will lead to the displacement of the pressure unit regarding a postoperative wound. In this case, the patient should be on a solid foundation to ensure the stability of the device.

A device is known for pressing a puncture hole by inflating an elastic balloon above it (FemoStop), including a belt for encircling a patient at the operational access level, the front part of the belt is represented by a synthetic strip acting as a rail along which an elastic hemisphere connected with a hand pump moves, with the possibility inflating the hemisphere to increase its volume and pressing the lower hemisphere pole to the puncture hole to provide hemostasis (application US No. 2012/0271179 A1, IPC A61B 5/022, A61B 5/0235, p priority from 06/19/2010, published on 10/26/2012; or Femostop Vascular Device - http://lzk.me/femostop/femostop-vascular-device-lzk-gallery.html), http://lzk.me/femostop- vascular-device.html).

The disadvantages of the known device are the lack of visual monitoring of the state of the wound (puncture opening) and difficult positioning, since the individual structure and parameters of the buttocks, areas of the hip joints, the size of these areas, the consistency of soft tissues are very different. Due to these factors, with the slightest inaccuracy in the positioning of the pressure element (hemisphere), postoperative complications may develop - bleeding, hematoma formation, etc. Over time (device exposure 6-8 hours), the probability of displacement increases.

The closest in technical essence to the claimed technical solution is a device for hemostasis, containing a horizontal lever, the distal end of which is rigidly connected to a vertical strut equipped with a support element for fixing the device on the patient’s hip, the proximal end is connected to a vertical strut containing a retractable lumen a clamping unit that performs a hemostatic function by squeezing the soft tissues of the inguinal region above the puncture opening of the femoral artery, a tightening (tension) belt on a horizontal lever with the possibility of fixing the device around the thigh and restricting its movement in the process of activating the clamping device. The fixing strap is fixedly attached to the horizontal arm, the presser assembly is secured to the withdrawable rack, connected with an electric motor mounted inside the horizontal arm (GoldFingerFemoralHemostasisCompressionDevice, developed by KeweiRisingMedicalhttp: //www.diytrade.com/china/pd/12776181/Goldfinger_Electronic_Femoral_Hemostasis_Compression_Device.html).

A disadvantage of the known device is that when the hemostasis procedure is carried out for a long time (6-8 hours) in the zones of contact between the racks and the belt, the patient’s body is deformed, the pressure of the pressure device to the hemostasis zone decreases, which leads to serious negative consequences. Due to the different anthropometric parameters of patients, the use of a prototype having an unchanged geometry reduces reliability and ease of use, and in some cases (in obese patients) it is impossible to use. The distal stand with the element for fixing the device is not sufficiently fixed on the patient’s body, since it is kept from displacement only by the force of friction against the body of the distal supporting element. During the hemostasis procedure, it is impossible to guarantee the patient's calm behavior, including involuntary movements, which leads to micro movements of the supporting surface, which, when combined, can cause its movement, which also leads to a decrease in the reliability of its use and the risk of complications.

The technical problem of this invention is to increase the reliability and ease of use of the device for hemostasis at the site of puncture of the artery by providing optimal clamping pressure and reliable fixation of the device on the patient’s body.

The technical problem is solved in that in the device for hemostasis in the puncture opening of the femoral artery, consisting of a horizontal lever, the proximal end of which is connected to the proximal stand with a clamping unit for squeezing soft tissue over the puncture hole, a tension belt on a horizontal lever to secure the device to the hip , the distal end of the lever is connected to the distal column provided with a locking element, according to the invention, the lever is connected to the distal column by a hinge with a clamp With the device with the possibility of longitudinal movement of the rack along the lever, a fixing belt is fixed as a fixing element around the thigh on the base of the distal rack, the tension belt on the horizontal lever is located with the possibility of its free movement along the lever, while the belts are made of elastic material.

The connection of the horizontal arm with the distal column is movable in the longitudinal direction and the rack is hinged with a clamping device that allows the column to move freely along the lever, find the optimal position of the column for each patient and fix it in the optimal position, which increases the convenience and reliability of use.

The use of a belt on a distal rack as a fixation element provides additional circular fixation of the rack on the thigh, excluding its displacement, which increases the reliability of fastening the device for hemostasis.

The free location of the tension belt on the horizontal lever allows it to be moved along the lever and gives the choice of optimal positioning for a particular patient, which increases the reliability and ease of use of the device.

The implementation of belts made of elastic material allows you to compensate for body deformation due to its own deformation during hemostasis, ensuring the preservation of optimal pressure on the hemostasis zone, which increases the reliability and ease of use of the device.

A device for hemostasis in the puncture opening of the femoral artery is shown in the drawing and contains:

1 - horizontal lever;

2 - proximal stance;

3 - clamping unit;

4 - a tension belt on the horizontal lever;

5 - distal rack;

6 - hinge;

7 - clamping device;

8 - a fixing belt on a distal rack.

A device for hemostasis in the puncture opening of the femoral artery consists of a horizontal arm 1, the proximal end of which is connected to the proximal stand 2. The proximal stand 2 is equipped with a clamping unit 3. The clamping unit 3 serves to compress soft tissues and to press the puncture hole of the artery wall. On the horizontal arm 1 there is a tension belt 4 for securing the device on the thigh and creating a pressing force. By moving the tension belt 4 along the lever 1, its location for a particular patient is determined. The tension belt 4 freely moves along the lever 1. The distal end of the lever 1 is connected to the distal column 5. A hinge 6 with a clamping device 7 is mounted on the column 5, which serve to ensure free longitudinal movement of the rack 5 along the lever 1. The hinge 6 with the clamping device 7 in the connection of the lever 1 with the rack 5 at the distal end allows the rack 5 to move freely along the lever 1 and find the optimal location of the rack 5 for each patient. As a fixation element around the thigh on the base of the distal rack 5, close captive fixing belt 8. Belt 8 fixes the rack 5 on the thigh, excluding its displacement. The locking belt 4 and the tension belt 8 are made of elastic material. The elasticity of belts 4 and 8 compensates for body deformations during the procedure, ensuring the preservation of optimal pressure on the hemostasis zone. The device operates as follows.

Before installing the device, determine the optimal location of the distal post 5 on the patient’s hip, measure the distance from the center of the post 5 to the center of the hemostasis and at this distance fix the distal post 5 on the horizontal arm 1 in the same plane with the proximal post 2 with a clamping device. to the proximal stand 2, the clamping unit 3 and, having placed it coaxially with the center of the hemostasis zone perpendicular to the plane of hemostasis, fix the device to the thigh with a fixing belt 8. On the horizon flax lever 1 is selected optimal location tensioning belt 4, and then wrapping the belt 4 around the thigh with a tension presser part 3 is pressed to the area of hemostasis. The control of the pressing force is carried out by palpation of the pulse over the arteries of the foot or, in the case of the initial absence of the pulse, using hemoximetry, achieving indicators identical to the preoperative ones.

Using the present invention to close the puncture opening at the femoral approach ensures the achievement of final surgical hemostasis, provides increased reliability and ease of use of the device, and early activation of the patient.

Claims (1)

A device for hemostasis in the puncture opening of the femoral artery, consisting of a horizontal lever, the proximal end of which is connected to the proximal stand with a clamping unit for squeezing soft tissue over the puncture hole, a tension belt on a horizontal lever to secure the device to the hip, the distal end of the lever is connected to the distal a stand equipped with a locking element, characterized in that the lever is connected to the distal stand by a hinge with a clamping device with the possibility of longitudinal movement of the rack on the lever, as the locking member around the hips on the basis of the distal strut secured fixing belt tensioning belt on a horizontal arm arranged to move along its free arm, wherein the straps are made of elastic material.

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