Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
1999-05-21
2002-02-26
Azpuru, Carlos (Department: 2165)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C424S424000
Reexamination Certificate
active
06350463
ABSTRACT:
BACKGROUND OF THE INVENTION
PROM, or Premature Rupture Of the Membranes surrounding the fetus (sometimes called the amniotic membrane (AM)) is a serious complication of mid to late pregnancy. PROM, and subsequent leakage of amniotic fluid, is a major precursor of premature delivery, and of concurrent infection. Prematurity and infection are in turn major causes of morbidity and mortality, and frequently lead to permanent impairment of the fetus, as well as high levels of medical expense both prepartum and postpartum.
PROM from any cause is considered here. Known causes of PROM include trauma, surgical intervention, and amniocentesis. However, PROM is primarily “spontaneous”, i.e., of unknown origin. It is believed that spontaneous PROM occurs most commonly near the proximal cervix, which is the locus of the highest hydrostatic pressure on the membranes, and is also the most exposed to bacterial attack. However, in most clinical cases the exact location of the rupture in spontaneous or trauma-caused PROM is not known. Such ruptures rarely self-seal.
If membrane rupture could be repaired, or if leakage of amniotic fluid could be minimized or prevented, it is believed that premature delivery could be significantly delayed, thereby significantly extending the degree of fetal maturity. Every day of extension of pregnancy can decrease the severity of fetal impairment due to prematurity by up to one percent; thus, maximizing the duration of pregnancy is clinically important. Cessation of leakage would also tend to minimize intrauterine infection. However, there are at present no reliable techniques for such treatment. In particular, the amniotic membrane is poorly vascularized and slow to heal, and is not easily accessible. Moreover, the location of the rupture is often difficult to determine.
The literature describes attempts to block amniotic fluid release by means of balloons, or with fibrin glue. Neither of these techniques has been sufficiently successful to enter general practice. Restriction of amniotic fluid loss with a balloon or similar device may be ineffective to prevent infection, and fibrin glue is typically rapidly degraded.
Materials and techniques for treating body tissues and sealing leaking lesions in tissues are known.
U.S. Pat. No. 5,410,016 (Hubbell, et al.) describes hydrogels of polymerized and crosslinked macromers comprising hydrophilic oligomers having biodegradable monomeric or oligomeric extensions. Biodegradation occurs at the linkages within the extension oligomers and results in fragments which are non-toxic and easily removed from the body. Applications for the hydrogels include adhering or sealing tissues together.
U.S. Pat. No. 5,575,815 (Slepian, et al.) describes a method for providing a synthetic barrier made of biocompatible polymeric material in vivo which involves application of a material to a tissue or cellular surface such as the interior surface of a blood vessel, tissue lumen or other hollow space. The polymeric material may also be applied to tissue contacting surfaces of implantable medical devices.
U.S. Pat. No. 5,612,050 (Rowe, et al.) describes an apparatus and method for applying an initially fluent material to a surface of a mammalian tissue including soft, living tissue and then activating the material by exposure to an energy source. The device and associated methods enable treatment of medical conditions including the application of a barrier to soft tissue to prevent post-surgical adhesions.
U.S. Pat. No. 5,800,373 (Melanson, et al.) describes a barrier or drug delivery system that is adherent to the surface to which it is applied. Tissue can be stained with a photoinitiator, then a polymer solution or gel having added thereto a defined amount of the same or a different photoinitiator can be applied to the tissue. Exposure of light causes polymerization at the surface, providing adherence and forming a gel. The resulting polymerizable barrier materials are useful for sealing tissue surfaces and junctions against leaks of fluids.
U.S. Pat. No. 5,900,245 (Sawhney, et al.) describes a barrier or drug delivery system which is adherent to the surface to which it is applied. The tissue sealant is capable of conforming to the three dimensional structure of a tissue surface as the tissue bends and deforms during healing processes.
Materials and techniques to treat Premature Rupture Of the Membranes (PROM) during pregnancy are also known.
Baumgarten and Moser, “The Technique of Fibrin Adhesion for Premature Rupture of the Membranes During Pregnancy,” J. Perint. Med., 14:43-49 (1986), describe a technique of fibrin adhesion for premature rupture of membranes during pregnancy. Cerclage of the cervix is suggested prior to applying the sealant in order to prevent the fibrin clot from being flushed out prematurely by flow of amniotic fluid, as direct adhesion of the fibrin sealant to the cervical wall is not to be expected.
Uchide et al., “Intracervical Fibrin Installation as an Adjuvant to Treatment for Second Trimester Rupture of Membranes,” Arch. Gynecol. Obstet., 255:95-98 (1994), describe the treatment of PROM with cerclage and repeated intercervical applications of fibrin which maintain effectiveness for approximately two weeks. Leakage of amniotic fluid was not completely stopped.
Ogita et al., “Clinical Effectiveness of a New Cervical Indwelling Catheter in the management of Premature Rupture of the Membranes: A Japanese Collaborative Study,” Am. J. Obstet. Gynecol., Vol 159, No. 2, pp336-341, (August 1988), describe the use of a cervical catheter which is fixed in the cervical canal by inflating balloons. Patients were assigned bed rest and saline and other fluids were administered daily. The delay in delivery ranged between 3 days and 2.5 weeks.
As the above references indicate, a need exists for improved methods to treat physiological conditions of pregnancy. In particular, improved methods are needed which allow the installation of a barrier serving as a partial or, preferably, complete, hydraulic seal to contain the amniotic fluid within the uterine cavity. This may be achieved by a sealing of the rupture itself, or by a sealing of the cervix to maintain the amniotic fluid in the uterus and therefore largely within the space defined by the amniotic membranes.
SUMMARY OF THE INVENTION
The present invention provides a series of techniques for conversion of fluent to non-fluent material at surfaces of physiology associated with pregnancy.
One aspect of the invention involves a method for treatment of premature rupture of the membranes of pregnancy(PROM), involving applying a fluent material to a tissue selected from at least one of an amniotic membrane, a cervix and a uterine wall, and causing the fluent material to become a non-fluent material, thereby providing an essentially complete seal which retains amniotic fluid.
In another aspect, the invention provides a device for treatment of PROM, wherein the device comprises a proximal end for manipulation of the device, a distal end for insertion into the patient's body, and at least one lumen with an opening at the distal end of the device suitable for delivery of a fluent material to a treatment space bounded by at least one of the uterine wall, the membranes, and the proximal cervix, whereby an at least partial hydraulic seal is created in the vicinity of said space.
In another aspect, the invention involves use of a fluent material for the manufacture of a medicament for use in a method of providing therapeutic treatment to an amniotic membrane of a patient or a uterine wall or cervix of a pregnant patient, the method comprising applying the fluent material to the amniotic membrane of the patient or the uterine wall or cervix of the pregnant patient, and causing the fluent material to become non fluent.
In another aspect, the invention involves use of a fluent material for the manufacture of a medicament for use in a method of treating an amniotic membrane of a patient or a uterine wall or cervix of a pregnant patient by applying the fluent material to the amniotic membrane
Enscore David J.
Herman Stephen J.
Kablik J. Jeffrey
Kazo Glenn M.
Andre Bieniarz
Azpuru Carlos
Marshall Gerstein & Borun
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