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Apparatus and methods for applying curable fluid compositions to body organs

A composition and organ technology, which is applied in the field of devices for surrounding body organs with fluid compositions, can solve the problems of difficulty in applying a uniform layer, inaccessibility, uneven thickness, etc., and achieves low production cost and ease of use. , the effect of eliminating the blockage of the entrance

Active Publication Date: 2019-08-06
OMRIX BIOPHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Application of fibrin by spraying or dripping around the entire circumference of a body organ is problematic because complete coverage around the organ is very difficult to achieve due to the inaccessibility of at least a portion of the organ within the body (e.g., the lower portion of the organ)
[0010] Additionally, the layer that forms around the organ has an uneven thickness, resulting in areas of stronger or weaker seals
Therefore, applying a uniform layer is very difficult to achieve

Method used

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  • Apparatus and methods for applying curable fluid compositions to body organs
  • Apparatus and methods for applying curable fluid compositions to body organs
  • Apparatus and methods for applying curable fluid compositions to body organs

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0130] Example 1: Structure of a device according to the invention .

[0131] like Figure 1A-Figure 1D The device shown was used in Examples 2-4 below. The device is prepared from polyurethane. The thickness of the device is between 0.3 and 1.5 mm. The device has a length of 73mm and a width of 36.4mm. The device has 3 inlets. The distance between the centers of the inlets is 20mm. The height of the inlet above the outer surface of the device was 3.5 mm and the diameter of the hole was 1.1 mm. The internal volume is about ~ 9770mm 3 .

example 2

[0132] Example 2: Applying a fibrin sealant to an incision area by using the device of FIG. 1 .

[0133] In the next experiment, the efficacy of the device according to the invention to apply a fibrin sealant on the periphery of the target area was investigated. Evaluate using the burst test described above Performance after application by the device of FIG. 1 . The apparatus as described in Example 1 was used. Use spray and drop application as a reference.

[0134] In this experiment, a 5 mm incision was made and the following application methods were monitored:

[0135] I: Applied by spraying equal volumes of fibrinogen and thrombin components in a total volume of 2.4 ml

[0136] II: Applied by dripping equal volumes of fibrinogen and thrombin in a total volume of 2.4 ml

[0137] III: Applied by introducing equal volumes of fibrinogen and thrombin components with a total volume of 6 ml using the device described in Example 1

[0138] Four replicates of each tr...

example 3

[0144] Example 3: Application of different fibrin sealant formulations to suture incision lines by using the device of FIG. 1 superior .

[0145] In the previous examples, it was shown that application of a fibrin sealant using a device according to the invention results in a seal superior to that applied by spraying or dripping.

[0146] In the following experiments, the device described in Example 1 was used to test the application of two different fibrin sealant formulations. The performance of the formulations was evaluated using the burst test described above; spray application was used as a reference.

[0147] In this experiment, a 10 mm incision line was made and a stitch of 3-0 suture (3-OSS-684c-14, Ethicon) was used along the midline of the incision line prior to application of the fibrin sealant. The incision line is sutured.

[0148] Monitor the following formulations and methods of application:

[0149] I: Applied by spraying equal volumes of fibrinogen and...

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Abstract

The present invention relates to a device (10, 40) suitable for applying a curable fluid composition to surround bodily organs. The device includes a single piece of flexible material (12) having a length dimension and inner (18) and outer (20) surfaces, a first end (22) and a second end (24), A width dimension, and two spaced apart sides (26a, 26b), wherein a portion of the length dimension adjacent to the first end is configured to contact a portion of the length dimension adjacent to the second end a portion, said inner surface defining a hollow area (31) between said two spatially spaced sides; and at least one inlet (28), said inlet being provided between said outer surface and said inner surface in fluid communication to introduce the fluid into the hollow region. The device is deployable about the bodily organ such that when the portion of the length dimension adjacent the first end contacts the portion of the length dimension adjacent the second end, the device is The outer surface of the organ and the hollow region define an enclosed volume surrounding the bodily organ, the enclosed volume adapted to contain the fluid therein.

Description

technical field [0001] The present invention relates to the field of devices for applying curable fluid compositions to bodily organs, and more particularly, to devices for applying curable fluid compositions to surround bodily organs, and methods of use thereof. Background technique [0002] Applying a sealant, such as a fibrin sealant, can be used to prevent leakage of fluids, such as air and / or liquid, from the tissue. In surgical procedures, fibrin sealants can be applied to wounds in bodily organs, including bleeding wounds or non-bleeding wounds, for example, by dripping or spraying the sealant onto the wound. For example, fibrin sealants can be used during anastomotic procedures, where the organ is sutured or stapled around the entire incision line, and the fibrin sealant is applied along the staple or suture line for reinforcement purposes and to prevent leakage. [0003] Fibrin sealants are typically plasma-derived products available from commercial sources or fro...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61B17/00A61B17/11
CPCA61B17/00491A61B17/1114A61B2017/00495A61B2017/00004A61B2017/00862A61B2017/00893A61B2017/00884
Inventor E.伊兰Y.古曼M.梅龙
Owner OMRIX BIOPHARM
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