WO2004000411A1 - Tamponade device to control post-partum hemorrhage - Google Patents
Tamponade device to control post-partum hemorrhage Download PDFInfo
- Publication number
- WO2004000411A1 WO2004000411A1 PCT/US2003/019021 US0319021W WO2004000411A1 WO 2004000411 A1 WO2004000411 A1 WO 2004000411A1 US 0319021 W US0319021 W US 0319021W WO 2004000411 A1 WO2004000411 A1 WO 2004000411A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- balloon
- medium
- tube
- drain tube
- pressure
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/42—Gynaecological or obstetrical instruments or methods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12136—Balloons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
- A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B2017/12004—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/0097—Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
Definitions
- This invention relates to a device for controlling post-partum hemorrhage, and more particularly, to a tamponade device for controlling uterine and vaginal post-partum hemorrhage.
- Post-partum hemorrhage is most commonly caused by uterine atony whereby the uterus fails to contract normally after the delivery of a baby. This condition occurs in about 5 percent of deliveries. Hemorrhage continues to be one of the major causes of maternal deaths generally, with obstetrical hemorrhage being the third leading cause of maternal death by hemorrhage in the United States. Worldwide, maternal hemorrhage qualifies as the leading cause of maternal death.
- Techniques for managing obstetrical hemorrhage may be medical, mechanical, or surgical. Hysterectomy, while an effective surgical procedure for treating this condition, bears severe consequences, in particular for young women who have not completed childbearing.
- One of the mechanical procedures often used for managing obstetrical hemorrhage involves packing the uterus with heavy gauze. This procedure remains controversial because of a high failure rate, and is considered a waste of time by some medical practitioners. The high failure rate is attributable to the inherent difficulty in packing the uterus properly so that there is an even distribution of pressure along the entire inner surface of the organ.
- a more effective procedure is needed to address post-partum hemorrhage and bleeding.
- U.S. Patent No. 4,619,261 issued on June 17, 1980 to Guerriero discloses a hydrostatic pressure application device for controlling bleeding from an internal wound.
- the device of Guerriero comprises a balloon captured within a net.
- the net is secured to an area surrounding a wound with surgical sutures, so that hydraulic pressure applied to the balloon expands the balloon and causes pressure to be applied at the wound. Pressure so applied at the wound causes a cessation in bleeding.
- applying and removing the device of Guerriero requires an operative (surgical) procedure.
- U.S. Patent No. 4,207,891 issued on June 17, 1980 to Bolduc discloses a fluid dispensing instrument having a dispenser that operates to place a drug material into a uterine cavity, and an expandable balloon that operates to move the drug material from the uterine cavity into both canals of the fallopian tubes.
- the dispensing instrument of Bolduc is not configured and operated in a manner directed to the control of post-partum hemorrhage and bleeding.
- U.S. Patent Application No. US2001/0007945 published on July 12, 2001 to Piraka discloses a uterine balloon for controlling hemorrhaging in a patient after childbirth.
- the balloon of Piraka is filled with a physiologic solution by means of a catheter inserted through a valve in the balloon.
- a fill system, a control system, and a pressure relief valve are each employed for maintaining a constant solution pressure in the balloon.
- no means are disclosed for determining whether bleeding has been effectively stopped, in order to adapt balloon pressure accordingly.
- the present invention comprises a tamponade device having an inflatable balloon whose shape, when inflated, takes on the shape of the site to be controlled (for example, the shape of a uterine wall).
- the device also comprises an internal drain tube coaxially and sealably positioned with respect to the balloon, and having a port at an inserted end for draining blood and other fluids from the uterine cavity.
- An insufflation tube feeds a distending medium
- the supply tube co-axially encircles the drain tube to define a thin passageway between an inner surface of the supply tube and an outer surface of the drain tube. Perforations in the supply tube allow the medium to pass from this passageway in order to distend the balloon.
- the balloon exerts a uniform distribution of compressive pressure, which in turn controls bleeding sites.
- This control of bleeding gives the uterus time to respond normally as bleeding stops, and conserves blood while preparing the patient for surgery as necessary.
- This device may also be utilized in the vagina to control bleeding associated with submucosal tears (tears under the mucosal vaginal lining), and with any continuous bleeding resulting in the subsequent development of hematomas. Accordingly, significant blood loss, pain, and the possibility of an operative procedure may be prevented.
- an outer surface of the balloon is coated or impregnated with a hemostatic material for contact with the uterine wall or vaginal lining to provide additional control of bleeding.
- An advantage provided by the present invention is that its insertion, inflation, and removal require no surgical procedures, and very little time.
- the device is thus uniquely and admirably suitable for use in uterine hemorrhaging emergencies.
- Other presently known devices which use expandable material to stop abdominal bleeding before or after surgery are considerably more complicated in construction and much more difficult to use, often requiring surgical application and removal.
- FIG. 1 illustrates a cross-sectional view of a hemorrhage control device according to the present invention
- Fig. 2 illustrates a mechanism for supplying fluid to fill a balloon of the hemorrhage control device.
- the present invention relates to a tamponade device for controlling post-partum hemorrhage includes an inner drain tube co-axially encircled by an inflatable balloon.
- the device is inserted into the uterine cavity, and the balloon is distended with a medium supplied with sufficient pressure and volume to apply even pressure along the surface of an interior uterine wall. With the application of such pressure, bleeding is stopped as evidenced by a cessation of blood draining from the inner drain tube.
- the inner tube includes a drainage port at an inserted end for draining blood and other fluids from the interior of the uterine cavity.
- An integral valve and medium insufflation and supply tubes operate to control insufflation and deflation of the balloon.
- the supply tube co-axially encircles the drain tube to define a thin passageway between an inner surface of the supply tube and outer surface of the drain tube. Perforations in the supply tube allow the medium to pass from this passageway in order to distend the balloon.
- the balloon may be coated or impregnated with a hemostatic material in order to further control bleeding.
- hemorrhage control device 100 comprises an inner drain tube 10 and an outer sheathing 20.
- Outer sheathing 20 coaxially surrounds inner drain tube 10 over lengths defined by insertable portion 22 and external portion 23. Over external portion 23, outer sheathing 20 is sealably attached to inner drain tube 10.
- outer sheathing 20 comprises a balloon24 that may be distended with a medium (gas or fluid) via insufflation tube 25 and supply tube- 25a to occupy an expanded shape. At one end, balloon 24 meets external portion 23 of sheathing 20 at seal 27. Near an end of insertable portion 22, seal 21 fixedly and sealably joins another end of balloon 24 to inner drain tube 10.
- Seals 21, 27 thereby provide means for retaining the distending medium within an interior volume of balloon 24, and for restraining inner drain tube 10 to balloon 24.
- Insufflation tube 25 sealably surrounds inner drain tube 10 at an end 25b that joins to supply tube 25a.
- Supply tube 25a co-axially encircles drain tube 10 to define passageway 26a between supply tube 25a and drain tube 10.
- passageway 26 of insufflation tube 25 couples to passageway 26a of co-axial supply tube 25a for delivering the distending medium to the interior volume of balloon 24 via a plurality of perforations 28 distributed over region 29 of coaxial supply tube 25a.
- Supply tube 25a and passageway 26a sealably terminate near a terminating end 25c of inner drain tube 10.
- insufflation tube 25 preferably mates with inflation control valve 30 for maintaining balloon 24 in an inflated state, and for controllably deflating balloon 24 when it is required that pressure supplied to the uterine cavity be reduced or altogether removed.
- Valve 30 may comprise one of a variety of conventional devices including, for example, ball valves and needle valves. Valve 30 may alternatively comprise a connecting area (for example, using a glass adapter) for connecting a fluid tube to insufflation tube 25.
- Balloon 24 is made of an expandable material, such as urethane, natural rubber, silicone, synthetic rubber or vinyl, and may be preferably be inflated to hold up to 4000 cubic centimeters (cc) of air volume.
- Balloon 24 is also preferably heart-shaped when inflated so that it will evenly conform, for example, to the interior surface of the uterine wall. Conformance of the exterior shape of balloon 24 with the interior shape of the uterine wall enables balloon 24 to fit evenly and tightly against this surface, thereby providing pressure against all associated bleeding sites.
- An external surface of balloon 24 may preferably be coated, impregnated or otherwise covered with a hemostatic material in order that this hemostatic may come into direct contact with the uterine wall or vaginal lining to further assist in controlling bleeding.
- Oxidized cellulose and hemotene are materials suitably used for this purpose.
- outer sheathing 20 and insufflation tubes 25, and supply tube 25a may also be made from a flexible material such as neoprene, natural rubber, silicone, synthetic rubber or vinyl.
- Inner drain tube 10 however must be sufficiently rigid to maintain its inner diameter when balloon 24 is inflated, and therefore may be made from a more rigid material than balloon 24 or have a thicker cross-section than balloon 24.
- inner drain tube 10 has a drainage port 11 at its distal end for receiving blood and other fluids to be drained from the uterine cavity. Without adequate drainage, bleeding may continue unobserved in spite of the pressure applied by balloon 24, and may possibly lead to severe bleeding diathasis.
- inner drain tube 10 may optionally include expanded portion 13 for coupling inner drain tube 10 to another vessel having, for example, a passageway of like inner diameter to inner drain tube 10.
- Inner drain tube 10 may also be used, for example, to irrigate the uterus as necessary by introducing irrigation fluids at expanded portion 13.
- Hemorrhage control device 100 of FIG. 1 may be simply operated by inserting the device 100 to a desired position in the uterine cavity and inflating balloon 24 to a desired pressure and volume. Optimum pressure is detected, for example, when there is no further fluid drainage. After an appropriate length of time, pressure can be lowered and observations made to determine whether or not bleeding has been controlled, and to determine whether the uterus is showing signs of contracting normally. If bleeding begins again or the uterus remains soft and boggy, the balloon may be reinflated. [0027] When the device is used to stop bleeding in the vagina due to submucosal tears, it will require a much smaller volume of gas or fluid for balloon 24 to accommodate itself to the shape of the vagina. Optimally formed balloon shapes and sizes in either uterine or vaginal applications will vary with patient anatomy. Accordingly, a variety of balloon shapes and sizes may be employed in the present invention, each of which is fully contemplated within the scope of the present invention.
- a variety of gases (for example, air) and fluids may be used to inflate balloon 24 of FIG.l.
- a fluid comprising a normal saline solution is used to inflate the balloon.
- Fluid media have an advantage over gaseous media in decreasing the risk of generating embolisms.
- FIG. 2 illustrates an apparatus 200 for supplying a fluid medium to the hemorrhage control device 100.
- intravenous (IV) bag 40 contains a saline solution 46. Bag 40 may be hung approximately three to four feet above a position of hemorrhage control device 100 in order to provide sufficient supply pressure for inflating balloon 24 of hemorrhage control device 100 to curtail bleeding.
- Adapter 41 may be used to couple tube 44 to coupling tube 42, and thereby to valve 30 of hemorrhage control device 100.
- Hemostat 45 may be used to clamp tube 44 for controlling the flow of saline solution 46 into the balloon of hemorrhage control device 100.
- tube 44 may be disconnected at adapter 41, and coupling tube 42 positioned so that fluid is able to drain from device 100 by gravity flow.
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Molecular Biology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Reproductive Health (AREA)
- Animal Behavior & Ethology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Public Health (AREA)
- Vascular Medicine (AREA)
- Gynecology & Obstetrics (AREA)
- Pregnancy & Childbirth (AREA)
- Medicinal Preparation (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
- Massaging Devices (AREA)
- Surgical Instruments (AREA)
Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2003243611A AU2003243611A1 (en) | 2002-06-25 | 2003-06-13 | Tamponade device to control post-partum hemorrhage |
GB0428196A GB2405591A (en) | 2002-06-25 | 2003-06-13 | Tamponade device to control post-partum hemorrhage |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/179,104 US6676680B1 (en) | 2001-07-17 | 2002-06-25 | Tamponade device to control post-partum hemorrhage |
US10/179,104 | 2002-06-25 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2004000411A1 true WO2004000411A1 (en) | 2003-12-31 |
Family
ID=29734856
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2003/019021 WO2004000411A1 (en) | 2002-06-25 | 2003-06-13 | Tamponade device to control post-partum hemorrhage |
Country Status (3)
Country | Link |
---|---|
AU (1) | AU2003243611A1 (en) |
GB (1) | GB2405591A (en) |
WO (1) | WO2004000411A1 (en) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2873014A1 (en) * | 2004-07-13 | 2006-01-20 | Leila Dognon | Uterus treating device for delivery hemorrhage, has expandable cuff filled by physiological liquid, to volume variable with gravid uterus size, filling probe with pressure based on uterus tonicity, and draining probe recuperating blood loss |
WO2018037298A1 (en) * | 2016-08-26 | 2018-03-01 | Smit Nicolaas Hendrik | Uterine balloon tamponade device |
CN113017748A (en) * | 2021-02-25 | 2021-06-25 | 自贡市第四人民医院(自贡市急救中心) | Be used for anal canal postoperative hemostasis sacculus device |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4875939A (en) * | 1987-09-14 | 1989-10-24 | Ngk Insulators, Ltd. | Precombustion chamber construction for an internal combustion engine |
-
2003
- 2003-06-13 WO PCT/US2003/019021 patent/WO2004000411A1/en not_active Application Discontinuation
- 2003-06-13 AU AU2003243611A patent/AU2003243611A1/en not_active Abandoned
- 2003-06-13 GB GB0428196A patent/GB2405591A/en active Pending
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4875939A (en) * | 1987-09-14 | 1989-10-24 | Ngk Insulators, Ltd. | Precombustion chamber construction for an internal combustion engine |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2873014A1 (en) * | 2004-07-13 | 2006-01-20 | Leila Dognon | Uterus treating device for delivery hemorrhage, has expandable cuff filled by physiological liquid, to volume variable with gravid uterus size, filling probe with pressure based on uterus tonicity, and draining probe recuperating blood loss |
WO2018037298A1 (en) * | 2016-08-26 | 2018-03-01 | Smit Nicolaas Hendrik | Uterine balloon tamponade device |
CN113017748A (en) * | 2021-02-25 | 2021-06-25 | 自贡市第四人民医院(自贡市急救中心) | Be used for anal canal postoperative hemostasis sacculus device |
Also Published As
Publication number | Publication date |
---|---|
GB0428196D0 (en) | 2005-01-26 |
AU2003243611A1 (en) | 2004-01-06 |
GB2405591A (en) | 2005-03-09 |
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