• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    absorbable and reinforced multilayer cloth for hemostatic applications the present invention relates to a synthetic cloth comprising a multilayer nonwoven cloth produced from staples of a polyglycolide / polyactide copolymer, each layer having a different density . the multilayer cloth can be used as an absorbable and reinforced hemostat medical device.
    公开号:BR112012029190B1
    申请号:R112012029190-4
    申请日:2011-05-16
    公开日:2020-05-26
    发明作者:Olajompo Moloye-Olabisi；Dhanuraj S.Shetty；Robert W. Van Holten；Degang Zhong
    申请人:Ethicon, Inc；
    IPC主号:
    专利说明:

    Descriptive Report of the Invention Patent for CLOTH IN MULTIPLE LAYERS ABSORBIBLE AND REINFORCED FOR HEMOSTATIC APPLICATIONS.
    FIELD OF THE INVENTION
    [0001] The present invention relates to a reinforced and absorbable multilayer hemostat that is useful as a construct for use as a medical device.
    BACKGROUND OF THE INVENTION
    [0002] Bleeding control is essential and critical in surgical procedures to optimize results and to shorten the duration of surgery in the operating room. Various hemostatic materials, including material with oxidized cellulosic base, have been used as a dressing in a variety of surgical procedures, including neurosurgery, abdominal surgery, cardiovascular surgery, thoracic surgery, head and neck surgery, pelvic surgery and subcutaneous tissue procedure and of the skin.
    [0003] In general, the use of multilayered cloths in connection with medical procedures is accepted. For example, multilayered cloths are used as all-purpose surgical pads, wound dressings, surgical nets, including hernia repair nets, adhesion prevention nets and tissue reinforcement nets, defect closure devices and hemostats.
    [0004] US patent No. 5,593,441, to Lichtenstein et al., Describes a composite prosthesis, preferably, which has a polypropylene mesh blade that allows for a growing tissue network, such as Marlex ® . This reference shows that other surgical materials that are suitable for tissue reinforcement and defect closure can be used, including absorbable mesh, such as a polyglactin 910 mesh (Vicryl ® ). The composite prosthesis of Lichtenstein et al., Also, has a barrier of adhesion, preferential Petition 870190087532, of 05/09/2019, p. 5/22
    2/11 mind, a silicone elastomer blade.
    [0005] US patent No. 5,686,090, to Schilder et al., Describes the use of a fleece in combination with an absorbable or non-absorbable film to prevent erroneous growths in adjacent tissue and to reduce adhesions. Schilder et al. it generally shows that polypropylene, polyester, polyglactin, polydioxanone or polyglecaprone 25 can be used as the fleece material or film material.
    [0006] Published patent application US 2006/00084930, of
    Dhanaraj et al., Describe an absorbable and reinforced multilayered cloth that can be used in medical devices specifically for tissue engineering applications. The matrix first comprises preparing a repair site for implantation and then arranging the reinforced, absorbent, multilayered cloth in place. The first absorbable non-woven cloth comprises fibers comprising polymers of aliphatic polyester, copolymers or blends thereof; while the second absorbent mesh or woven fabric comprises oxidized regenerated cellulose fibers.
    [0007] US Patent No. 4,626,253, to Broadnax et al., Describes a device that refers to a surgical hemostat for bleeding control and, more particularly, to an oxidized cellulose mesh cloth that has a handling upper and hemostatic properties.
    [0008] US Patent No. 7,666,803, to Shetty et al., Describes the method for making the cloth in multiple absorbable and reinforced layers, which can be used as a hemostat. The matrix first comprises preparing a repair site for implantation and then arranging the cloth in multiple absorbable and reinforced layers at the site. The first absorbable non-woven cloth comprises fibers comprising polymers of aliphatic polyester, copolymers or blends thereof; while the second cloth or absorbable weft
    Petition 870190087532, of 9/5/2019, p. 6/22
    3/11 comprises oxidized regenerated cellulose fibers. The method, also, describes the appropriate densities and thicknesses that can be used to manufacture the matrix in this particular invention.
    [0009] None of the above references describe or suggest multiple absorbable reinforced layers of non-woven cloth, with each layer having different densities. Furthermore, none of the above references describe or suggest this double-layered non-woven cloth that serves as a hemostasis.
    SUMMARY OF THE INVENTION
    [00010] The present invention is directed to a synthetic cloth that comprises a non-woven matrix that has at least two layers of a first absorbable clip of a polyglycolide / polyactide copolymer and a second absorbable clip of a polyglycolide / polyactide copolymer, in that the first absorbable cloth is compacted to a density of about 60 mg / cc and the second absorbable cloth is compacted to a density of about 120 mg / cc. The first and second absorbable cloths may consist of a glycolide / lactide copolymer in a 90/10 mol / mol composition. The first and the second absorbable cloths may comprise staples which are approximately 1.91 to 6.35 cm long (from 0.75 to
    2.5 inches) and / or can be derived from about 0.11 to 0.44 g / km per filament (from 1 to 4 deniers per filament). Cloth clamps can be crimped. The first absorbable cloth and the second absorbable sheet can be needle punched into each other to hold a matrix of non-woven cloth.
    [00011] In one embodiment, the first absorbable cloth is compacted to a thickness of about 0.5 mm to about 1.5 mm, more preferably about 1 mm. On the other hand, the second absorbable cloth can be compacted to a thickness of about 0.75 mm to 3 mm, more preferably about 1 mm. In a hand
    Petition 870190087532, of 9/5/2019, p. 7/22
    4/11 dality, the synthetic cloth, particularly as a double layer matrix, can be used as a medical device, such as a hemostatic device.
    DETAILED DESCRIPTION
    [00012] The present invention is a synthetic cloth that has at least two non-woven layers, each layer essentially consists of a blend of staples, from copolymers of polyglycolide and polylactide fibers and each layer has a different density that can be used as a multi-layer absorbable and reinforced hemostat device, preferably with two layers. In one embodiment, the hemostatic device is substantially free of any oxidized polysaccharide material. While oxidized polysaccharide materials, such as oxidized regenerated cellulose, are known for use as a hemostat, the presence of ORC can be detrimental to the stability of biologically active hemostatic agents, and can reduce the activity levels of biologically active hemostatic agents in the proximity to an injury by lowering the pH in that region and can generally degrade more quickly after disposition in an injury.
    [00013] A method for preparing the matrix of the invention begins by melt spinning poly (glycolide-collactide) in a PGLA copolymer fiber. A multiple filament yarn based on PGLA copolymer fibers can be consolidated, crimped and cut into staples that have a length of 5.08 cm (2.0 inches). The staples can then be carded to create a non-woven blanket and compacted to a thickness of about 1.0 mm and a density of about 60 mg / cc. A second non-woven blanket can be created following substantially the same procedures for spinning by melting, consolidating, crimping, cutting, carding and compacting to a thickness of about 1.0 mm and to a density
    Petition 870190087532, of 9/5/2019, p. 8/22
    5/11 of about 120 mg / cc. Two non-woven cloth materials prepared as described above with a first density of 60 mg / cc and a second density of 120 mg / cc were precisely arranged in each other and firmly fixed through 2 passes in the needle drilling rig. The multilayered cloth was trimmed and washed in 3 separate isopropyl alcohol baths to remove spin finish and any machine oils. The washed multilayered cloth was dried in an oven at 70 ° C for 30 minutes, cooled and weighed. Thus, the multi-layered needle punched nonwoven fabric matrix is suitable for use as a hemostatic device.
    [00014] One method for making the cloth described in this document is through the following process. Absorbable polymer fibers, which have a size of g / km per fiber (denier per fiber) of about 0.11 to 0.44 (from 1 to 4), can be consolidated at about 8.89 to 13, 3 g / km (from 80 to 120 deniers) in multiple filament yarn and then at about 88.9 to 133 g / km (from 800 to 1200 deniers) per yarn, thermally crimped and then clipped that has a length between about 1.91 and 6.35 cm (0.75 and 2.5 inches). Staples can be fed into a dry carding machine with multiple ball applicators one or more times and carded in a uniform non-woven blanket, while humidity is controlled to between about 20 to 60% at an ambient temperature of 15 to 24 ° C. For example, the uniform non-woven mat can be manufactured using a single cylinder top ball applicator card, which has a main cylinder covered by alternating ball applicators and peeling rollers, where the mat is removed from the surface of the cylinder by a defibrator ball applicator and deposited on a collecting roller. The blanket can be further processed through needle drilling or any other means such
    Petition 870190087532, of 9/5/2019, p. 9/22
    6/11 as calendering. Consequently, the first absorbable non-woven cloth can be attached to the second absorbent mesh or weft fabric using various techniques such as needle punching. The reinforced absorbable cloth can then be washed by washing in an appropriate solvent and drying in moderate conditions for 10 to 30 minutes.
    [00015] The cloth is washed using suitable solvents to dissolve any spin finish. Solvents include, but are not limited to, isopropyl alcohol, hexane, ethyl acetate and methylene chloride. The cloth is then dried in a condition to provide sufficient drying while minimizing shrinkage.
    [00016] The multi-layered, non-woven hemostatic matrix, described in this document, provides and maintains effective hemostasis when applied to a wound that needs hemostasis. Effective hemostasis, for use in the present invention, is the ability to control and / or alleviate mild to moderate bleeding in an effective time, as recognized by those skilled in the hemostasis technique. Additional indications of effective haemostasis may be provided by governmental and similar regulatory standards. Examples of mild to moderate bleeding include, but are not limited to, bleeding due to resection of the spleen, resection of the liver, blunt liver trauma and blunt splenic trauma.
    [00017] The multi-layered, nonwoven hemostatic matrix described above may include one or more hemostatic agents. Hemostatic agents, for the purposes of the present patent application, are agents that have a hemostatic effect, more preferably, delay, prevent and eventually stop bleeding at the site of application. One method to produce a hemostatic effect at the site of an injury is to introduce one or more agents found in the cascading blood clotting process, which can react
    Petition 870190087532, of 9/5/2019, p. 10/22
    7/11 with each other or with other agents naturally present in the body. Thrombin, for example, can be used to produce a hemostatic effect in one modality, while in another modality, thrombin and fibrinogen are used together to produce the desired hemostatic effect. Additional components, such as calcium, can also be provided to further enhance the hemostatic effect of thrombin and / or fibrinogen.
    [00018] In one embodiment, the multi-layered non-woven hemostatic matrix retains solid thrombin and / or solid fibrinogen, in particulate powder without separation and with minimal loss of surface dust due, in part, to the means for addition the hemostatic agent (s) and the non-woven nature of the matrix. Additionally, due to the different layer densities, the hemostatic agents are not dispersed homogeneously throughout the matrix, so that a greater hemostatic agent is present in the relatively low density non-woven layer, which is arranged at the injury site. In a preferred method for applying thrombin and / or fibrinogen to the matrix, one or more solutions containing biological products are lyophilized separately. The lyophilized materials are then crushed into powders using a superfine mill, ground by spheres or with a mill with cooled blades. The powders are weighed and suspended together, in a carrier fluid, in which the proteins are not soluble. A preferred carrier fluid is a perfluorinated hydrocarbon, including but not limited to HFE-7000, HFE-7100, HFE-7300 and PF-5060 (commercially available from 3M Minnesota, USA). Any other carrier fluid, in which proteins do not dissolve, can be used, such as alcohols, ethers or other organic fluids. The suspension is carefully blended and applied to the absorbable non-woven cloth, using conventional means such as wet or dry electrostatic spray, coated
    Petition 870190087532, of 9/5/2019, p. 11/22
    8/11 immersion, painting, or spraying, while maintaining an ambient temperature of about 15 to 24 ° C and relative humidity of about 10 to 60%, preferably no more than 30%. The multilayered non-woven matrix is then dried at room temperature and packed in a suitable hydration barrier container. The hemostatic dressing, which has thrombin and / or fibrinogen, contains no more than 25% hydration, preferably no more than 15% hydration and most preferably no more than 5% hydration.
    [00019] Thrombin and / or fibrinogen can be derived from animals, humans, or can be recombinant. Thrombin activity in the dressing can be in the range of about 20 to 500 IU / cm 2 , preferably about 20 to 200 IU / cm 2 and, most preferably, about 50 to 200 IU / cm 2 . The fibrinogen activity in the dressing can be in the range of about 2 to 15 mg / cm 2 , preferably, about 3 to 12 mg / cm 2 and, most preferably, about 5 to 10 mg / cm 2 . The amount of thrombin and / or fibrinogen powder is preferably. applied to the non-woven cloth in an amount sufficient to cover its surface so that no area is visibly devoid of dressing. Most of the dust can settle on top of the non-woven cloth or, more preferably, it penetrates the non-woven cloth.
    [00020] As a surgical dressing, the hemostatic matrix described in this document can be used as an aid to primary wound closure devices, such as arterial closure devices, staples and sutures, to seal potential leaks of gases, liquids, or solids as well as to provide hemostasis. The matrix of the present invention is particularly advantageous, due to the improved tensile strength, specifically in relation to the hemostatic matrix produced from or containing one or more
    Petition 870190087532, of 9/5/2019, p. 12/22
    9/11 layers of cellulosic materials, such as oxidized regenerated cellulose. For example, the dressing can be used to seal tissue air or organ and tissue fluids, including but not limited to, bile, lymph, cerebrospinal fluids, gastrointestinal fluids, interstitial fluids and urine.
    [00021] The hemostat described in this document has additional medical applications and can be used for a variety of clinical functions, including but not limited to the matrix / substrate, ie fibrinogen / thrombin coating, tissue reinforcement and support , that is, for vascular or gastrointestinal anastomoses, approximation, that is, to connect anastomoses that are difficult to perform (that is, under tension) and release of tension. The hemostat matrix can additionally promote and possibly improve the natural tissue healing process in all of the above events. This dressing can be used internally in various types of surgery, including, but not limited to, cardiovascular, peripheral vascular, cardiothoracic, gynecological, neurological and general surgeries. The hemostat can also be used to attach medical devices (for example, nets, clips and film) to fabrics, from fabric to fabric or medical device to medical device.
    Example 1 - PGLA double layer matrix
    [00022] The poly (glycolide-colactide) (PGLA, 90/10 mol / mol) is melted by spinning on a PGLA copolymer fiber. A multiple filament yarn from the PGLA copolymer fiber is consolidated, crimped and cut into a clamp that has a length of 5.08 cm (2.0 inches). The staple is carded to create a non-woven mat and then compacted to a thickness of about 1.0 mm and a density of about 60 mg / cc. A second non-woven mat is created using similar procedures and then compacted to a thickness of about 1.0 mm and a density of cer
    Petition 870190087532, of 9/5/2019, p. 13/22
    11/10 ca 120 mg / cc. Two non-woven cloths with a density of 60 mg / cc and 120 mg / cc are then needle punched into each other to secure the non-woven double layer matrix.
    Example 2 - Double layer matrix reaches hemostasis in a spleen model
    [00023] A model of mild to moderate bleeding is created by making a 15 mm long and 3 mm deep incision in a pig spleen. A double layer matrix as described in Example 1 is then applied to the surgical site and a buffer is applied for two minutes. Hemostasis is checked for 30 seconds after the two-minute buffer. If bleeding with free flow is not observed within 30 seconds, the time for haemostasis is observed. If bleeding with free flow is observed, a 30-second buffer is applied again until the hemostasis is reached or until the test period reaches ten minutes, which is defined as a failure in the hemostasis. Three test samples are cut to a size of 2.5 x 4.0 centimeters, from the double layer matrix prepared according to the hemostasis achieved as in Example 1, in 5.62 ± 0.76 minutes (Table 1 ).
    Table 1. PGLA double layer matrix hemostasis in a spleen model
    Sample No. 1 2 3 Average Standard deviation Hemostasis (min) 5.12 5.25 6.50 5.62 0.76
    Example 3
    [00024] The mechanical property of the double layer matrix prepared according to Example 1 is characterized using an in-vitro test. The double layer die is cut into strips (approximately 0.95 cm (3/8 inch) wide by 5.08 cm (2 inches) long). The tensile strength of the layer matrix
    Petition 870190087532, of 9/5/2019, p. 14/22
    Double 11/11 is then evaluated in dry and wet conditions using an Instron Traction Analyzer. In wet conditions, the strips are arranged in a conical tube containing FTS buffer at a pH of 7.4 to 37 ° C. The tensile strength of the strips is then measured for 90 minutes, 4 days, 7 days, 11 days and 14 days. The measured values for the tensile strength of the double layer matrix strips are shown in Table 2.
    Table 2. Tensile strength of the double layer matrix in dry and wet conditions
    Drying 90 minutes 4 days 7 days 11 days 14 days Tensile strength (Newton / cm) 119.8 ± 10.6 114.9 ± 9.7 91.2 ± 11.6 51.8 ± 3.2 29.4 ± 3.5 15.7 ± 1.5
    Petition 870190087532, of 9/5/2019, p. 15/22
    权利要求:
    Claims (12)
    [1]
    1. Synthetic cloth, characterized by the fact that it comprises a non-woven matrix that has at least two layers, each layer essentially consisting of a mixture of staples of polyglycolide and polyactide fiber copolymers, each layer having a different density, in which the the first layer of absorbable cloth is compacted to a density of 60 mg / cc and the second layer of absorbable cloth is compacted to a density of 120 mg / cc.
    [2]
    2. Synthetic cloth according to claim 1, characterized by the fact that the first and the second absorbable cloths consist of a glycolide / lactide copolymer in a composition of 90/10 in mol / mol.
    [3]
    3. Synthetic cloth according to claim 1, characterized by the fact that the first and the second absorbable cloths comprise staples that have a length of 1.91 to 6.35 cm (0.75 to 2.5 inches).
    [4]
    4. Synthetic cloth, according to claim 3, characterized by the fact that the staples are crimped.
    [5]
    5. Synthetic cloth according to claim 4, characterized by the fact that the first absorbable cloth is compacted to a thickness of 0.5 mm to 1.5 mm, preferably 1 mm.
    [6]
    6. Synthetic cloth according to claim 5, characterized by the fact that the second absorbable cloth is compacted to a thickness of 0.75 mm to 3 mm, preferably 1 mm.
    [7]
    7. Synthetic cloth according to claim 5, characterized by the fact that a blade of the first absorbable cloth and a blade of the second absorbable sheet are perforated by needle in each other.
    [8]
    8. Synthetic cloth, according to claim 7, features
    Petition 870190087532, of 9/5/2019, p. 16/22
    2/2 characterized by the fact that the cloth additionally comprises at least one hemostatic agent.
    [9]
    9. Synthetic cloth according to claim 8, characterized by the fact that the cloth additionally comprises fibrinogen and thrombin as the hemostatic agent.
    [10]
    10. Synthetic cloth, according to claim 9, characterized by the fact that fibrinogen and thrombin are supplied in the cloth as lyophilized powders.
    [11]
    11. Synthetic cloth according to claim 10, characterized by the fact that lyophilized powders are dispersed inhomogeneously, as measured from the outer surface of the first layer to the outer surface of the second layer.
    [12]
    12. Synthetic cloth according to claim 1, characterized by the fact that strips 0.95 cm (3/8 inch) wide at
    5.1 cm (2 inches) in length have tensile strengths measured (in Newton / cm) as measured on an Instron stress analyzer of:
    The. 120, in dry condition;
    B. 115, in wet condition for 90 minutes;
    ç. 90, in wet condition for 4 days;
    d. 52, in a wet condition for 7 days;
    and. 29, in a wet condition for 11 days;
    f. 16, in a wet condition for 14 days.
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    同族专利:
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    BR112012029190A2|2016-11-29|
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    法律状态:
    2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-08-20| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-03-31| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-05-26| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 16/05/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
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