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Hemostatic devices and methods of use

A hemostatic agent and anchoring device technology, applied in the field of anchoring devices, can solve the problems of reducing use, increasing pain and the like

Pending Publication Date: 2018-12-21
MEDTRONIC INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although increased use of anticoagulant therapy is considered a possible cause, its use cannot be completely curtailed due to the risk of thromboembolic events, including stroke
Hematoma may increase pain, require reintervention for drainage, and delay healing

Method used

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  • Hemostatic devices and methods of use
  • Hemostatic devices and methods of use
  • Hemostatic devices and methods of use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0159] In one embodiment, an anchoring device is prepared having a substrate (eg, one of the substrates discussed above). 5 g chitosan (HMW, Sigma MKBP1333V) was dissolved in a mixture of 460 mL distilled water and 40 mL 1M HCI. Pour 10 mL of the viscous solution into a Teflon petri dish and place in a fume hood. After 24 hours, the composition was dry to the touch. It was then placed in a vacuum oven at 50°C for 24 hours.

[0160] Substrates were prepared from other materials using the same procedure. The details are shown in Table A below.

[0161] Table A

[0162]

Embodiment 2

[0164] In another embodiment, a hemostat-coated mesh substrate is prepared. Paste the knitted multifilament mesh on a flat Teflon sheet. The haemostatic solution prepared as described above was poured onto the mesh and dispersed using a Gardner knife. The composition was allowed to dry overnight in a fume hood, then at 50°C for 24 hours under vacuum. Hemostat-coated meshes were prepared using chitosan and PVP solutions and a 1:1 mixture of chitosan and PVP.

[0165] The hemostatic properties of the anchoring devices prepared in Examples 1 and 2 were observed. Water absorption was used as an initial screening test for hemostatic properties. A commercially available hemostatic agent Surgifoam was used as a control. Unmoistened Surgifoam does not absorb water easily, but moistened it acts like a sponge. Portions of the hemostatic composition were placed on a flat Teflon surface. 3 drops of water were placed in the center of the composition and the time of absorption of the ...

Embodiment 3

[0167] In another embodiment, an anchor device is prepared wherein the anchor device has an active pharmaceutical ingredient, eg, at least one antimicrobial agent applied to a substrate, eg, a hemostatic mesh. An organic regenerated cellulose (ORC) sheet made from multifilament fibers was stretched on a rectangular frame (10 inches x 13 inches). It was coated using an ultrasonic sprayer (Ultrasonic Systems, Inc., Haverhill, MA) with a 4% volume / weight solution containing ) of rifampicin, minocycline and polyarylate tyrosine (15:15:70 by weight). The coated mesh was dried under vacuum at 50°C for 24 hours.

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Abstract

An anchorage device is provided that is configured to surround an implantable medical device. The anchorage device includes a substrate and a hemostatic agent. The substrate includes a first piece anda second piece that is joined with the first piece. The first piece includes the hemostatic agent and the second piece includes an active pharmaceutical ingredient. Kits, systems and methods are disclosed.

Description

technical field [0001] The present disclosure generally relates to anchoring devices and methods for anchoring implantable medical devices in vivo, wherein the anchoring devices include at least one hemostatic agent configured to elute over time. Background technique [0002] Several known anchoring devices are used to secure implantable medical devices within a patient. The anchor device and implantable medical device can be inserted into a desired location within the patient's body. Anchoring devices may be used to assist in anchoring or supporting implantable medical devices to surrounding tissue. Some known anchoring devices are used to provide temporary support to tissue during the healing process. For example, some known anchoring devices can secure one portion of tissue to another portion of tissue. [0003] Pocket hematoma is a common complication following device implantation. For example, it is estimated that hematomas account for approximately 15% to 20% of ea...

Claims

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Application Information

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IPC IPC(8): A61L31/04A61L31/10A61L31/14A61L31/16
CPCA61L31/04A61L31/10A61L31/146A61L31/148A61L31/16A61K31/496A61K31/65A61B17/0401A61B17/11A61L31/042A61L2300/214A61L2300/418A61N1/0575
Inventor S·普拉普拉F·布维奇J·S·索斯金F·R·曼斯菲尔德K·R·沃雷尔C·伍德J·A·T·布兰克
Owner MEDTRONIC INC
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