Foam and delivery system for treatment of postpartum hemorrhage

• US 8,993,831 B2
• Filed: 06/28/2012
• Issued: 03/31/2015
• Est. Priority Date: 11/01/2011
• Status: Active Grant

• Current Assignee: Arsenal Medical, Inc
• Original Assignee: Arsenal Medical, Inc
• Inventors: Sharma, Upma, Gitlin, Irina, Zamiri, Parisa, Freyman, Toby, Busold, Rany, Core, Lee, Komatsu, Janet Chie, Mortensen, Jennifer
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): SASS, SARA A
• Application Number:
  US13/536,557
• Publication Number:
  US 20130110066A1
• Time in Patent Office: 1,006 Days
• Field of Search: 604/369
• US Class Current: 604/369
• CPC Class Codes: A61L 2300/418 Agents promoting blood coagulation, blood-clotting agents, embolising agents
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• CPC Class Codes: A61L 24/0036 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 24/046 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043 takes precedence
• CPC Class Codes: A61L 2400/04 Materials for stopping bleeding
• CPC Class Codes: A61L 2430/22 for reconstruction of hollow organs, e.g. bladder, esophagus, urether, uterus
• CPC Class Codes: A61L 27/14 Macromolecular materials
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/04 Macromolecular materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61P 7/04 Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
• CPC Class Codes: C08L 75/04 Polyurethanes

Abstract

Medical implants and methods useful in treating postpartum hemorrhage are disclosed. The implants, in some embodiments, comprise polyurethane foams having advantageous mechanical and other properties selected to promote hemostasis when brought in contact with an inner wall of a uterus. Methods of making and deploying such implants are also disclosed.

Claims

1. A method of treating uterine hemorrhage, comprising:

positioning a foam within the uterus of a patient, the foam comprising a plurality of disk-shaped polymer foam bodies and at least one membrane disposed over at least a portion of an exterior surface of the disk-shaped polymer foam bodies;

wherein the membrane comprises at least one securement feature attaching the membrane to itself or to the foam;

wherein each disk-shaped foam body includes a central portion and an edge portion, the central portion having a thickness that is greater than a thickness of the edge portion; and

applying tension to the membrane to sequentially withdraw the disk-shaped polymer foam bodies from the uterus of the patient.

2. The method of claim 1, wherein the foam has a volume of between 100% and 200% of the volume of a postpartum human uterus.

3. The method of claim 1, wherein the at least one polymer foam body is characterized by a compression force deflection value at 50% compression of less than 100 kPa.

4. The method of claim 1, wherein the foam includes a drug that promotes blood clotting.

5. The method of claim 1, wherein the foam is configured to cause a uterine contraction by applying pressure thereto.

6. The method of claim 1, wherein the foam is configured to apply a pressure of at least 30 mmHg to a uterine wall.

7. The method of claim 1, wherein the polymer foam body is formed within a uterus of the patient.

8. The method of claim 1, wherein the biocompatible polymer foam body is pre-formed prior to said step of positioning the foam within the uterus of the patient.

9. The method of claim 1, further comprising the step of compressing said foam into an applicator.

10. The method of claim 1, wherein the at least one securement feature is selected from the group consisting of hooks, rings, sutures, and staples.