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WO2019032064A2 - Dispositif de septectomie et de septostomie auriculaire - Google Patents

Dispositif de septectomie et de septostomie auriculaire Download PDF

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Publication number
WO2019032064A2
WO2019032064A2 PCT/TR2017/050712 TR2017050712W WO2019032064A2 WO 2019032064 A2 WO2019032064 A2 WO 2019032064A2 TR 2017050712 W TR2017050712 W TR 2017050712W WO 2019032064 A2 WO2019032064 A2 WO 2019032064A2
Authority
WO
WIPO (PCT)
Prior art keywords
heart
atrial
septectomy
procedure
saturation
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/TR2017/050712
Other languages
English (en)
Other versions
WO2019032064A3 (fr
Inventor
Hüseyin Hakan POYRAZOĞLU
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of WO2019032064A2 publication Critical patent/WO2019032064A2/fr
Publication of WO2019032064A3 publication Critical patent/WO2019032064A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization

Definitions

  • the invention relates to a device, which enables both the septostomy and septectomy (incision and part removal) procedures to be performed with a single device without stopping the heart.
  • the atrial septostomy is a procedure in which a small hole is made between the upper two chambers of the heart. This procedure is also employed for treating some congenital heart diseases.
  • the atrial septectomy is the procedure of removal of a part from the septum, i.e. the atrial wall. This procedure, which is performed by stopping the heart, requires the use of a heart- lung machine like all the open-heart surgeries.
  • the blalock septectomy operation which is able to be performed also without stopping the heart, is present in the literature, because of its mortality of as high as 15%, it is not an operation that may be used frequently, and instead, the open-heart surgery is preferred.
  • the invention is designed to comprise a head portion, a body portion and an end portion. It consists of an end portion, which comprises the mobile scalpel, the pressure measurement tip, the punch for performing the severance action, the ultrasound probe and the saturation probe; a body portion, which is designed to have an 30-degree curved form so that it remains inside the right atrium; and a head portion, which is easy to hold and suitable to manipulate and which allows the passage of the pressure line connection through the same.
  • Our invention described above relates to a device, which enables the required hole to be made in the heart without stopping the heart in some congenital heart diseases, thereby providing the continuity of life and gaining time until a second treatment, and which allows such major procedures to be performed within a shorter time frame with a minimal incision.
  • the areas of use for the invention may be exemplified (without any intention of limitation) as the infants with total abnormal pulmonary venous return and without defect in the atrial septum, the patients with conditions like pulmonary atresia, mitral atresia, tricuspid atresia where one side of the heart develops but the other side is absent, some patients with hypoplastic left heart syndrome, the cases of transposition of great arteries (TGA), the last stage of the excessive pulmonary hypertension treatment in the adult patients and the procedures referred to as atrial septostomy or septectomy, i.e. the procedures performed by way of incision of the wall or removal of a part to provide the mixing of blood and reduce the pressure.
  • atrial septostomy or septectomy i.e. the procedures performed by way of incision of the wall or removal of a part to provide the mixing of blood and reduce the pressure.
  • the above-mentioned septostomy procedure is a procedure that aims to expand the foramen ovale or small ASD by the use of a special balloon tipped catheter. Thus, the connection between the right and left atriums is expanded.
  • This procedure implemented in the neonatal period in the presence of some of the cyanotic congenital heart diseases is a life saver. It gains time for the patient until the radical surgery. However, the chance of success for this procedure becomes considerably reduced if there is no hole in the heart of the patient or if the patient is older than two months of age.
  • the septostomy is performed in the patients with restrictive ASD by experienced teams in a catheter laboratory under sedation or general anesthesia, with the guidance of fluoroscopy and echocardiography and under monitored and sterile conditions.
  • the catheters with special tips are guided to the left atrium and are here inflated with a contrast agent at appropriate pressure and pulled back towards the right atrium via the appropriate technique, thereby enabling PFO or small ASD to expand.
  • These procedures may be performed in case of a presence of a small hole in the heart of the patient. In cases where there is no hole, the procedure may be performed by making a hole in this wall within 1 - 2 months, before the atrial septum becomes thick. In case said procedure is unsuccessful, the procedure is required to be performed surgically.
  • the device according to our invention makes it possible to perform the procedure of incision of the atrial wall (septostomy) and/or part removal (septectomy) without having to stop the heart.
  • Figure 1 A View of the Device in Assembled State
  • the therapeutic interventions for some heart diseases may be performed in a more rapid and different manner.
  • these interventions it becomes possible to enable the critically ill neonates to survive, eliminate the necessity for elective surgical intervention in some heart diseases or delay such intervention.
  • the procedures that are not able to be performed with catheter are taken into operation and carried out surgically.
  • the heart may be stopped using a heart-lung machine and such procedures may be performed.
  • the procedures performed in the presence of the congenital heart diseases may provide the gain of time according to the need of the patient (leaving the ductus open with a stent or expanding the hole in the heart with a balloon).
  • the abnormal connections (holes) and the abnormal vein openings within the heart may be closed using special devices.
  • the end portion comprises the cutting tip and the punch component, which is able to perform reciprocating motion and which serves to remove the parts with various sizes.
  • the pressure measurement needle is located in front of the cutting tip and a data cable connected to this needle may pass through the body and head portions to provide monitoring.
  • the entire system is designed such that the end portion, after cutting through the septum, will move backward to severe the part from the septum and will enter the body to be locked therein. In the meantime, the pressure is continuously monitored by the pressure measurement needle.
  • the body portion has a cylindrical structure and it curves by 30 degrees with respect to the head portion.
  • the end section of the body comprises a USG probe site, which enables the user to insert from the inside an ultrasound probe when necessary, and a saturation measurement site, which allows the blood saturation to be measured.
  • the diameter and the length of the body may vary according to the patient.
  • the head portion is suitable for being manually controlled.
  • the end section has handles on the right and left to enable the incision and part removal procedures to be performed.
  • the part taken from the septum is removed by pulling this section backward and also by moving (pulling back) the end portion.
  • the cables that transmit the pressure, ultrasound and saturation data are positioned into the cable sockets specially opened up to the head portion within the device.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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)
  • Ultra Sonic Daignosis Equipment (AREA)

Abstract

La présente invention concerne un dispositif qui permet d'effectuer à la fois des procédures de septostomie et de septectomie (incision et élimination de la pièce) avec un seul dispositif sans arrêter le coeur.
PCT/TR2017/050712 2017-01-10 2017-12-27 Dispositif de septectomie et de septostomie auriculaire Ceased WO2019032064A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2017/00306 2017-01-10
TR201700306 2017-01-10

Publications (2)

Publication Number Publication Date
WO2019032064A2 true WO2019032064A2 (fr) 2019-02-14
WO2019032064A3 WO2019032064A3 (fr) 2019-04-25

Family

ID=65272465

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/TR2017/050712 Ceased WO2019032064A2 (fr) 2017-01-10 2017-12-27 Dispositif de septectomie et de septostomie auriculaire

Country Status (1)

Country Link
WO (1) WO2019032064A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113116495A (zh) * 2019-12-30 2021-07-16 上海形状记忆合金材料有限公司 一种扩孔式非植入心房分流装置

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6650923B1 (en) * 2000-04-13 2003-11-18 Ev3 Sunnyvale, Inc. Method for accessing the left atrium of the heart by locating the fossa ovalis
WO2004064657A2 (fr) * 2003-01-21 2004-08-05 Baylis Medical Company Inc. Procede et dispositif de perforation chirurgicale a surveillance d'ecg et de la pression, incurvation et capacites de coloration
US8337518B2 (en) * 2006-12-20 2012-12-25 Onset Medical Corporation Expandable trans-septal sheath
EP2378947B1 (fr) * 2008-12-19 2016-05-04 Andy Christopher Kiser Dispositif pour un accès endoscopique au coeur

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113116495A (zh) * 2019-12-30 2021-07-16 上海形状记忆合金材料有限公司 一种扩孔式非植入心房分流装置

Also Published As

Publication number Publication date
WO2019032064A3 (fr) 2019-04-25

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