WO2018051205A1 - Bouchon hémostatique à matrice extracellulaire pour des biopsies percutanées et appareil permettant de fabriquer ce dernier - Google Patents

Bouchon hémostatique à matrice extracellulaire pour des biopsies percutanées et appareil permettant de fabriquer ce dernier Download PDF

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Publication number
WO2018051205A1
WO2018051205A1 PCT/IB2017/055213 IB2017055213W WO2018051205A1 WO 2018051205 A1 WO2018051205 A1 WO 2018051205A1 IB 2017055213 W IB2017055213 W IB 2017055213W WO 2018051205 A1 WO2018051205 A1 WO 2018051205A1
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WO
WIPO (PCT)
Prior art keywords
hemostatic
bars
plug
membrane
extracellular matrix
Prior art date
Application number
PCT/IB2017/055213
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English (en)
Spanish (es)
Inventor
Juan Carlos BRICEÑO TRIANA
Juan Manuel PÉREZ HIDALGO
Diana Marcela SÁNCHEZ PALENCIA
Javier NAVARRO RUEDA
Original Assignee
Universidad De Los Andes
Fundación Cardioinfantil - Instituto De Cardiología
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Application filed by Universidad De Los Andes, Fundación Cardioinfantil - Instituto De Cardiología filed Critical Universidad De Los Andes
Publication of WO2018051205A1 publication Critical patent/WO2018051205A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body

Definitions

  • the present invention belongs to the field of interventional radiology and to the field of hemostatic materials.
  • Performing a biopsy in a patient with kidney or liver disease is a safe, useful and effective diagnostic procedure for the management of the disease through histological evaluation of the organ of interest.
  • liver biopsy is considered the gold standard for the evaluation of acute and chronic liver disorders, just as renal biopsy is for the characterization of chronic kidney disease.
  • the histological observation of the tissues allows to identify critical variables in the organ that provide information about the epidemiology and pathobiology of the disease.
  • Liver and kidney biopsies are usually performed percutaneously or transjugularly. Percutaneous biopsy is performed in the doctor's office and involves puncturing through the skin to the organ of interest to obtain a fragment of tissue 1 to 2 cm in length and 1 to 2 mm in diameter.
  • a main cutting needle is introduced to the organ of interest and by means of a trigger system a second cylindrical needle is coaxially slid over the main needle The second cylindrical needle cuts a specimen that enters a groove of the main needle.
  • the main needle is removed from the organ and the sample is collected from the groove.
  • a needle and sleeve system is used to access the organ.
  • the needle is removed from the inside of the shirt leaving the shirt inserted in the organ, and the needle controlled by the trigger system is inserted through the shirt.
  • transjugular biopsy the procedure is performed in a sterile room with cardiac monitoring. Access to the organ is achieved through the jugular vein, into which a rigid cannula is inserted and visualized with a fluoroscope in real time. Jugular access involves accessing the organ of interest through the jugular vein, the superior vena cava, the right atrium of the heart, the inferior vena cava and one of the hepatic or renal veins. Once the organ of interest is reached, a coaxial needle system and needle and sleeve system similar to that used in percutaneous biopsy are used.
  • Performing a liver biopsy exposes the patient to a risk of bleeding inherent in liver disease, since the liver's function of coagulation factor synthesis may be compromised by the same liver disease to be diagnosed.
  • Coagulopathic or anticoagulated patients constitute i Extreme risk cases for percutaneous biopsy (either hepatic or renal), since without coagulation mechanisms it is not possible to stop bleeding naturally or assisted. Consequently, these patients are referred to a transjugular biopsy procedure, the cost of which is 10 times or more percutaneously. In addition to the higher cost, the transjugular procedure has other drawbacks. There is a risk of collecting tissue samples other than that of the organ of interest, because the visualization of the organ by this route is less accurate. This risk implies admission to observation of the patient for a period of 24 hours.
  • percutaneous liver biopsy which includes the use of a resorbable hemostatic gelatin plug to obstruct the puncture site after the procedure in patients with coagulopathies.
  • a gel or a reabsorbable biocompatible foam that gels at the biopsy site is advanced through the shirt.
  • This alternative allows performing a percutaneous biopsy in those patients in which it is contraindicated, and constitutes a safe alternative to the risky and expensive transjugular biopsy.
  • these methods are based on the improvised use of hemostatic materials that are not designed for application.
  • these may present the risk of generating mixtures with the body fluids (blood, ascites) that can be drained, compromising the formation of a solid jelly at the site of interest and thus stopping the bleeding. Additionally, these materials are not controllable during positioning, which creates a serious risk of pulmonary embolization or other ducts to which the material is drained.
  • FIGURES Figure 1 (a) Circumferential axes of the porcine intestine.
  • an acellular membrane of porcine intestinal submucosa is prepared from the jejunum of an adult pig, by a process consisting of mechanically removing the serous, muscular and mucous layers of the small intestine, washing in a disinfectant solution and store in sterile distilled water until use.
  • Each membrane is 30 to 50 cm in length.
  • the intestine is cut longitudinally along the external circumferential axis (1), so that the internal circumferential axis (2) is located in the center of the membrane (3), as illustrated in the Figure 1 (a) and 1 (b).
  • the rigid thread is formed by a procedure in which a segment of porcine intestinal submucosa is rotated about its longitudinal axis (2a) between 40 and 120 times, preferably 70 to 1 10 times, and preferably using an apparatus (4) designed to it.
  • the apparatus (4) is illustrated in Figure 2 and comprises a plurality of support bars (6) fixed to a vertical wall (7) anchored by means of supports in ele (8) to a lower surface (9).
  • the pivot bars (1 1) rotate by means of bearings (12) inserted in the vertical wall (10).
  • the support bars (6) and the pivot bars (1 1) have through holes (13) at the ends facing the opposite vertical wall. The distance between two facing holes (13) facing each other is 15 to 25 cm, preferably 20 cm.
  • Said distance corresponds to the final length of the hemostatic cap and can be determined by modifying the distance between the vertical wall (7) and the vertical wall (10).
  • the holeless ends of the pivot bars (1 1) are attached to pinions (14).
  • One of the turning bars (1 1) acts as the main turning bar (15) and generates the rotation of all the pinions (14).
  • Figure 2 shows a diagram of a preferred embodiment of the apparatus (4) with five support bar systems (6), pivot bar (1 1) and main pivot bar (15), with their corresponding bearings (12 ) and pine nuts (14); however, the present invention encompasses apparatus with one or more support bar systems and pivot bars (1 1) and (15) with corresponding bearings (12) and pinions (14).
  • the conformation of a rigid wire is illustrated in Figure 3.
  • the ends of one of the segments (16) cut from the extracellular matrix membrane (3) are traversed through the through holes (13) of a support bar (6) and the pivot bar (1 1) coaxial to said support bar (6), as shown in Figure 3 (a). Said ends correspond to the ends in the direction of the longitudinal axis (2a) of the segment (16).
  • the segment (16) is positioned so that the length of the contact of the segment (16) in its middle section (18) with the lower surface (9) is 0.1 to 5.0 cm in length, preferably 1.0 cm.
  • the ends of the segment (16) are secured by compressing said ends against the bars (6) or (1 1) with a plastic fastener or strap (17) as shown in detail in Figure 3 (b) for a segment (16) secured to a support bar (6).
  • segments (16) are inserted and secured in the same way in the plurality of support bars (6) and remaining pivot bars (1 1).
  • the main turning bar (15) is used to rotate the pinions fixed to the rotating bars (1 1).
  • a number of turns are made between 40 and 120, preferably 70 to 1 10. Between every 20 to 40 turns, preferably every 25 turns, the plug is compressed in its radial direction to remove water and bubbles.
  • the segment (16) is allowed to dry for 1 to 3 hours, preferably for 1 to 2 hours.
  • the final shape of the plug (19) after the winding and drying steps in the apparatus (4) is illustrated in Figure 4.
  • the final diameter of the plug (19) is between 0.4 and 2.0 mm, preferably between 0.7 and 1. 0 mm
  • the resulting hemostatic plug (19) is cut from the fasteners at the ends adjacent to the bars (6) and (1 1), packed in a cannula with perforations (20) to maintain its shape, as shown in Figure 5 , and is sterilized with ethylene oxide.
  • the support bars (6), the pivot bars (1 1), the vertical walls (7) and (10) and the lower surface (9) are preferably made of acrylic to provide a surface that can be cleaned with ethanol to the 70% or sterilized with ethylene oxide.
  • the main turning bar (15) is rotated by the use of a motor.
  • the plug (19) is pushed through a biopsy jacket and positioned using ultrasound to visualize its correct positioning. The remaining end on the outside of the patient is cut flush.
  • the hemostatic plug has the main advantage that it provides an option to perform a biopsy of any organ percutaneously instead of transjugularly in patients with deficiencies in coagulation mechanisms. This decreases the risks of the procedure, the cost, exposure to x-rays and the length of hospital care after the procedure. Additionally, the hemostatic cap of the present invention is echogenic, so that it can be positioned in the correct location by means of ultrasound visualization.
  • the hemostatic plug and the apparatus for its manufacture described in the present invention have surprising technical effects on the use of other products of materials other than the porcine intestinal submucosa used in the present invention.
  • the qualities of this material give the cap biocompatibility, anti-inflammatory properties and resistance to infection.
  • the porcine intestinal submucosa is impervious to blood, which makes it an ideal material to build a barrier that stops bleeding. Other materials that absorb the blood may become saturated and drain the blood to other organs, exposing the patient to a continued risk of bleeding.
  • the apparatus of the present invention was specifically designed for the present invention so as to allow homogeneously producing plugs of rigidity, gauge and density suitable for use through a biopsy needle sleeve.
  • the manufacture of rigid threads through other methods would not allow a porcine intestinal submucosa membrane to be formed into a thread of stiffness and density achieved with the apparatus of the present invention.
  • one of the most important characteristics of the porcine intestinal submucosa used in the present invention is its echogenic property, which allows it to be located in the necessary position by means of ultrasound observation.
  • a biocompatibility study was carried out in Yorkshire pigs, 22 ⁇ 2 kg, for thirty days to determine the safety of the hemostatic plug of the present invention.
  • Blood samples from subjects of study at the time of implantation of the plug yielded a platelet count of 345 ⁇ 33 x 10 3 / ⁇ , prothrombin time of 1 1 .6 ⁇ 0.2 was INR of 1 .06 ⁇ 0.02, indicating that the subjects did not present coagulopathy at the time of implantation.
  • a minimal inflammatory reaction restricted to the plug material was found, in an area of radius less than 100 ⁇ . No migration of inflammatory cells to the parenchyma of the organs was observed. The plugs were completely degraded in the liver of 57% of the subjects and in the kidney of 100% of the subjects. Additionally, in some cases neovascularization of the hemostatic plug was observed, indicating an integration of the plug with the organ of the subject, which, given the absence of an adverse inflammatory reaction, consists of a first signal of regeneration of the organ from the hemostatic plug.
  • the blood samples of the patients at the time of implantation of the cap showed a platelet count of 98.5 ⁇ 14.1 x 10 3 / ⁇ , prothrombin time of 13.0 ⁇ 0.6 was INR of 1.20 ⁇ 0.05 indicating that the patients did not present coagulopathy picture at the time of implantation.
  • Patients were administered systemic heparin during surgery.
  • the results of the efficacy study indicated that the bleeding decreased by 72% with the use of the hemostatic plug after the biopsy was performed.
  • the weight of the blood collected in the gauze used to quantify the bleeding within 3 minutes after the biopsy was 3 ⁇ 1 mg in the cases in which the cap was used and 7 ⁇ 2 mg in the cases in which it was not used plug. Bleeding stopped after 3 minutes in 100% of cases in which the hemostatic plug was used to stop bleeding after biopsy, and in 7% of cases in which no hemostatic plug was used.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • General Health & Medical Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Botany (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne un bouchon hémostatique à matrice extracellulaire pour des biopsies percutanées qui est constitué d'un fil rigide introduit à travers un système de chemise et d'aiguille de biopsie. Le bouchon est inséré dans le corps humain à travers la chemise et reste positionné sur toute la trajectoire parcourue par l'aiguille, depuis la peau jusqu'à l'organe destiné au prélèvement et de cette manière, emplit et scelle l'espace laissé libre par le tissu biologique enlevé du fait de la ponction de l'aiguille et pendant la biopsie. Le dispositif est fabriqué de préférence avec du tissu submuqueux intestinal de porc, une membrane à matrice extracellulaire composée de collagène, de protéines adhésives, de glycosaminoglycanes et de facteurs de croissance. La présente invention concerne également un appareil pour la fabrication du bouchon, lequel appareil permet de créer des bouchons ayant des caractéristiques et des dimensions homogènes et une rigidité appropriée à la manipulation et l'implantation des bouchons à travers la chemise. La présente invention peut être utilisée de manière commerciale dans de multiples applications de médecine régénérative, comme pour la réparation de lésions dans la paroi abdominale, la peau et le manchon tournant. En outre, la présente invention peut également être utilisée pour le remplacement de l'artère carotide.
PCT/IB2017/055213 2016-09-16 2017-08-30 Bouchon hémostatique à matrice extracellulaire pour des biopsies percutanées et appareil permettant de fabriquer ce dernier WO2018051205A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CO16001924 2016-09-16
CONC2016/0001924 2016-09-16

Publications (1)

Publication Number Publication Date
WO2018051205A1 true WO2018051205A1 (fr) 2018-03-22

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113398317A (zh) * 2021-05-28 2021-09-17 宁波市第一医院 一种止血材料及其制备方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5192302A (en) * 1989-12-04 1993-03-09 Kensey Nash Corporation Plug devices for sealing punctures and methods of use
WO1994013210A1 (fr) * 1992-12-10 1994-06-23 Howmedica Inc. Bouchon hemostatique
WO2003002168A1 (fr) * 2001-06-29 2003-01-09 Cook Biotech Incorporated Dispositifs medicaux a matrice d'eponge poreuse et procedes
WO2012159635A1 (fr) * 2011-05-24 2012-11-29 Nycomed Pharma As Support de collagène enroulé
US20140148839A1 (en) * 2012-11-27 2014-05-29 Dusan Pavcnik Bodily Lumen Closure Apparatus and Method

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5192302A (en) * 1989-12-04 1993-03-09 Kensey Nash Corporation Plug devices for sealing punctures and methods of use
WO1994013210A1 (fr) * 1992-12-10 1994-06-23 Howmedica Inc. Bouchon hemostatique
WO2003002168A1 (fr) * 2001-06-29 2003-01-09 Cook Biotech Incorporated Dispositifs medicaux a matrice d'eponge poreuse et procedes
WO2012159635A1 (fr) * 2011-05-24 2012-11-29 Nycomed Pharma As Support de collagène enroulé
US20140148839A1 (en) * 2012-11-27 2014-05-29 Dusan Pavcnik Bodily Lumen Closure Apparatus and Method

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113398317A (zh) * 2021-05-28 2021-09-17 宁波市第一医院 一种止血材料及其制备方法

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