# Patent

## Title
Portable hand pump for evacuation of fluids

## Abstract

A manually operable pump for the effective removal of fluids to include blood, blood clots, fluid, and air from a body cavity of a subject is provided. The manually operable pump is adapted to be connect to a range of fluid conduits and is equipped with one-way valves that effectively permit flow of fluid through the pump in only one direction. The sensitivity of the one-way valves is such that when properly positioned, fluid can flow through the valves and out of the pump without manual compression of the pump and with the aid of gravity power alone.

## Background
PRIORITY
This application is a division of U.S. patent application Ser. No. 10/595,450, now U.S. Pat. No. 8,636,721, filed as a U.S. national stage application under 35 U.S.C. §371 of International Application No. PCT/US04/38937, filed Nov. 22, 2004, which claims priority to U.S. Provisional Application No. 60/523,321, filed Nov. 20, 2003, each of which is incorporated by reference in its entirety into this application.


BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to pumps for removing fluids from a body cavity of a subject. More particularly, the invention relates to a manually operated pump that can be used to remove fluids from a subject suffering from hemopneumothorax.
2. Background of the Technology
Penetrating chest injuries have been a major cause of death on the battlefield. Injured soldiers with hemopneumothorax need treatment as soon as possible. The possibility of rapidly moving front lines and urban environment combat may preclude rapid transportation of wounded soldiers to higher echelons of medical care.2, 3, 4 The conventionally used equipment for the evacuation of blood and air from the pleural space of a subject is a large-bore thoracostomy tube connected to negative-pressure water seal devices, for example Pleur-Evac® (Deknatel Division of Pfizer, Corp.). Such currently available drainage systems are cumbersome, bulky, and difficult to manage during transport of the wounded soldier. Furthermore, continuous suction for the drainage system is seldom available under field conditions. Historically penetrating chest injuries resulting in pneumothorax5 have been common. Such conditions have fortunately seen some decreases due to the use of body armor by soldiers6. Emergency treatment of such traumatic chest injuries does, however remain a major medical problem. Although one-way valves such as the Heimlich valves can be used and have been shown to be effective for simple pneumothorax7, 8, 9, 10 one distinct disadvantage is that by design such valves rely on gravity or increased intrathoracic pressure for drainage and do not provide suction to facilitate the evacuation of blood/clots and the re-expansion of the injured lung.
There exists therefore a need for a manually operated pump that can provide effective suction to remove fluids from a subject and more particularly to facilitate the effective treatment of traumatic hemopneumothorax in patients in an emergency/field environment where continuous suction is not available or easily employed.
SUMMARY OF THE INVENTION
The present invention provides a manually operable pump that can be quickly and easily employed under emergency or field conditions to remove fluids from a subject.
Also provided is an effective manually operable pump that can be used to remove fluids in the treatment of a subject suffering from hemopneumothorax.
Also provided is an effective pumping device that can by intermittent manual actuation effectively remove blood, blood clots, fluid, and air from a body cavity.
Also provided is a manually operable pump that is adapted for attachment to an intake fluid conduit and an outlet fluid conduit to facilitate the removal of fluid from a subject.
Also provided is a manually operable pump that is adapted for attachment and use with a range of conduits such as a standard pleural tube, a standard endotracheal tube, and an indwelling catheter for the effective removal of fluids and/or blood clots and air from the body cavity of a subject.
Also provided is a manually operable pump having one-way valves that serve to direct the movement of fluid in only one direction when the pump is manually activated.
Also provided is a manually operable pump for the removal of fluids from a body cavity of a subject, the manual operation being accomplished by contact with any limb or body part of the operator.
Also provided is a manually operable pump that is configured to be selectively connected to an autotransfusion device.
Also provided is a manually operable pump having one-way valves of such sensitivity that the valves can effectively direct the movement of fluid in only one direction without manual activation and with the aid of gravity flow alone.
Also provided is a manually operable pump that effectively removes blood, blood clots, fluid, and air from a body cavity without the aid of wall suction, rigid containers, water-seal devices, or electricity.
Also provided is a system of manually operable pumps, which can be connected as multiple successive pumps to effectively remove blood, blood clots, fluid, and air from a body cavity.
Also provided is a manually operable pump that effectively removes blood, blood clots, fluid, and air from a body cavity, the pump generating a negative pressure in the range of 5 mm to 100 mm Hg.



BRIEF DESCRIPTION OF FIGURES
FIG. 1 provides a planar view of a basic embodiment of the manually operable pump of the present invention.
FIG. 2 shows the comparative experimental results of a conventional device employing the standard of care for treating hemopneumothorax as compared to the operational results obtained by use of the manually operable pump of the present invention employing a standard pleural tube in one case and the manually operable pump of the present invention using a standard endotracheal tube in a second case.



DETAILED DESCRIPTION OF THE INVENTION
At present, manual suction devices are not available for use during the care and initial treatment of a subject in an emergency situation. Such a device would be particularly useful in providing emergency care for combat casualties, who frequently are in danger of serious injury or death due to traumatic hemopneumothorax. A manually operated pump that can evacuate blood or air from the throat, air passages, or chest would be most beneficial in the treatment of casualties who have suffered injuries to the chest. The pumping device of the present invention can also be adapted for other medical treatment uses such as, for example, checking correct placement of an endotracheal tube (tube placed in the wind pipe) and evacuating secretions from the nose, mouth, and air passages or to evacuate fluids out of drains that have been placed into various body cavities during surgery. The manufacture and design of the pump is such that it can be sterilized and repeatedly reused or it can be cost-effectively produced so as to be disposed of after only one use.
Currently, electrical or battery operated suction devices are available but due to the austere environment often faced by the military, having a suction device that does not have to rely on electricity or batteries would be of benefit, especially when transporting the patient. Such conventional devices typically use a water seal as a one way valve and drainage is passive unless the system is connected to a suction source. The electrical suction devices available in the market are cumbersome and not suitable for use in the military environment and during transportation. Further, such devices can suddenly be of no use if the power supply to the conventional device is interrupted. Other one way valves are in existence but again they rely on gravity or increased pressure in the chest to help push out undesired air or fluids. The present invention provides a manually operable suction device that can pump large volumes of fluid (such as blood, water, mucus, blood clots, air, etc.) from a body cavity of a subject suffering from serious conditions brought on by chest injuries or other traumatic conditions where a manually operable pump would have potential life-saving benefit.
Unlike conventional devices and the standard of care currently provided for the removal of fluids from the body cavity of a subject, the present invention is not cumbersome, bulky, dependent on electrical powered wall suction or battery operated suction. Further it is small, simply configured and easy to transport under extreme, emergency, or combat conditions. Further, unlike the conventionally used Heimlich valves, which rely on gravity or increased intra-thoracic pressure for drainage, and do not provide suction to facilitate evacuation of blood/clots and re-expansion of the injured lung, the present invention can provide very effective removal of fluid, blood clots and air from the body cavity of a subject.
As shown in FIG. 1, the small, portable, easy to use manual pump (10) of the present invention can be adapted for attachment to virtually any usable fluid conduit as an inflow conduit (12) or an outflow conduit (14). Importantly, proximate to the connection of the inflow conduit (12), the pump of the present invention is provided with a one-way inflow valve (16) that acts to permit flow of fluids, blood clots, and air from the inflow conduit (12) into the interior of the pump (18) but limits or restricts any back flow of the same into the inflow conduit (12). Similarly, proximate to the connection of the outflow conduit (14), a one-way outflow valve (20) permits flow of fluids, blood clots, and air out of the pump interior (16) and into and through the lumen of the outflow conduit (14). This outflow one-way valve (20) also serves to limit or restrict the back flow of fluids from the outflow conduit into the pump interior (18). The one-way valves used in the present invention can be of any conventional configuration known for one-way flow valves and can be selected to be of such sensitivity that the pump device can be positioned so as to permit passage of fluid through the device by force of gravity alone if desired.
The pump (10) can be constructed of any material strong enough to withstand repeated manual compressions, flexible enough to facilitate easy manual use by the operator in compressing the body (22) of the pump, durable over prolonged and repeated usage, and fluid-tight so as to prohibit any leakage during use. The material used in the manufacture of the cylindrical bladder of the body (22) of the pump can be a natural, synthetic, or blended material suitable for the operational demands of the manually operable pump. The materials used in the manufacture of the pump can be of the nature to withstand sterilization and repeated uses or can be more cost-effectively manufactured for single use and disposal.
The manually operable pump of the present invention is very adaptable and is particularly well suited for connection to well known and commonly used thoracostomy tubes, endotracheal tubes or catheters, which are readily available to emergency medical practitioners or military field medics or corpsmen. This simple design, light weight transportability, and adaptability to many fluid conduits as needed offers a major logistical advantage in austere environments.
In addition to its usefulness to emergency military medical needs, the present invention offers additional logistical advantages of requiring no wall suction, rigid containers, water or electricity makes the present invention a very useful device for civilian applications, such as for civilian ground ambulance or medical helicopter transport emergency suction needs. Further, the device is also adaptable in that the outflow conduit can be connected to an autotransfusion unit if needed. Indeed, any circumstance where a manually operable pump is needed could be met by the device of the present invention.
EXAMPLE
A test example of the device of the present invention was prepared by providing two pieces of clear vinyl tubing (4 inches in length and 1⁄2 inch inside diameter), which were connected to a cylindrical rubber bladder (1.5×3 inch) using adaptors and two one-way valves. The position of the one-way valves on both ends of the rubber bladder ensured that fluid could only move in one direction on squeezing the bladder (FIG. 1). The inflow vinyl tubing was attached to the pleural evacuation tube whereas the outflow tubing was attached to a collection bag for the measurement of evacuated blood.
A swine model of penetrating chest injury was designed to test the concept of the present invention. The purpose of the test was to compare the effectiveness of operation of the manually operable pump of the present invention to the conventional device and accepted standard of care for the evacuation of a large hemopnenmothorax. The present invention pump was tested in a swine model of penetrating chest injury and bleeding in the pleural space. Table 1 provides the test data obtained for test groups 1, 2, and 3. Test Group 1, was a conventional standard of care model. Test Group 2 was the manually operable pump of the present invention connected to a conventionally used chest tube. Test Group 3, was designed to demonstrate the adaptability of the present invention in that the manually operable hand pump was connected to an endotracheal tube rather than the conventionally used chest tube. As can be seen in the data of Table 1, overall, the manually operable pump performed better than the standard of care and was also shown to be very effective when connected to a conventional chest tube or an endotracheal tube.
The results of the comparative tests are summarized and graphically displayed in FIG. 2. In addition, it was found that the device of the present invention was able to pump water at a maximum rate of 1 L/minute. The negative pressure generated in the pleural tube (in vivo) was affected by the rate of pumping.
Notably, a single pump generated negative pressure of 12 mmHg and it was found that multiple successive pumps could generate a maximum pressure of −80-90 mmHg.
The present invention can be manually operate by compression of the pump body (22) by any manual means; that is, it is within the concept of the invention that the pump can be sized and configured to be pump by hand compression using only one hand, it can be configured slightly larger to be compressed by an operator with both hands, it can also be sized, shaped, and even externally textured to avoid slippage and made compressible by foot or pedal activation. Any body part can be used to compress the body (22) of the present invention and remain within the concept of the present invention. Further, any shape, construction, material, or size of conduit for the inflow and outflow conduits can be used within the concept of the present invention.
The adaptability of the present invention permits that the device can be so positioned as to permit fluid transport through the one-way valves and through the pump by use of gravity powered flow alone. It is also within the concept of the invention that the manually operable pump can be configured to be selectively connected to an autotransfusion device. Further, it is possible in the present invention to attach suction handles to suck out secretions from the mouth, checking for correct tube placement when a tube must be properly positioned in the windpipe, and to suck fluids out of drains, catheters, or other conduits, which have been placed surgically.
REFERENCES


    1. Pope, A; French, G.; Longnecker, D. eds.; Fluid Resuscitation: State of the Science for Treating Combat Casualties and Civilian Injuries., Washington, D.C., National Academy Press: 1999:9-16.
    2. Groves, J; Operations in Urban Environments, Mil. Rev. 1998: July-August 31-40.
    3. Milton, T R.; Urban Operations: Future War, Mil. Rev. 1994: February 37-46.
    4. Mabry, R L; Holcomb, J B; Baker, A M; et al. United States Army Rangers in Somalia: An Analysis of Combat Casualties on an Urban Battlefield, J. Trauma, 2000; 49:515-529.
    5. Bellamy, R F; The Causes of Death in Conventional Land Warfare: Implications for Combat Casualty Care Research, Mil. Med. 1984; 149:55-62.
    6. Bilski, T; Baker, B; Grove, J R; Battlefield Casualties Treated at Camp Rhino, Afghanistan: Lessons Learned, J. Trauma, 2003; 54:814-821.
    7. Heimlich, H J; Valve Drainage of the Pleural Cavity. Dis. Chest. 1968; 53:282-287.
    8. Campisi, P; Voitk, A J; Outpatient Treatment of Spontaneous Pneumothorax in a Community Hospital Using a Heimlich Flutter valve: A Case Series, J. Emerg. Med. 1997:15:115-119.
    9. Lodi, R; Stefani, A; A New Portable Chest Drainage Device, Ann. Thorac. Surg., 2000; 69:998-1001.
    10. Schweitzer, E F; Hauer, J M; Swan, KG; et al., Use of Heimlich Valve in Compact Autotransfusion Device. J. Trauma. 1987; 27:537-542.

## Claims

1. A manually operable pump for removing fluids from a body cavity of a subject, the pump comprising:
a fluid-tight pump body having a first end and a second end with a compressible center portion disposed between the first end and second end;
an inflow connector attached to the first end, the inflow connector adaptable for connection to an inflow conduit, the inflow conduit comprising a pleural evacuation tube for removing fluid from a plural space;
an outflow connector attached to the second end, the outflow connector adaptable for connection to an outflow conduit;
an inflow one-way valve disposed between the inflow connector and the pump body, the inflow one-way valve adapted to permit flow of fluid from the inflow conduit through the inflow connector and into the pump body but restricting backflow of fluid from the pump body into the inflow connector and inflow conduit; and
an outflow one-way valve disposed between the pump body and the outflow connector, the outflow one-way valve adapted to permit flow of fluid from the pump body into the outflow connector and into the outflow conduit but restricting backflow of fluid from the outflow conduit and outflow connector into the pump body,
wherein the inflow one-way valve and the outflow one-way valve allow fluid passage through the inflow and outflow valves when the pump is so positioned such that all power for fluid flow is provided by gravity alone.

2. The manually operable pump according to claim 1, wherein the inflow conduit is selected from the group consisting of a standard chest tube, an endotracheal tube, and a catheter.

3. The manually operable pump according to claim 1, wherein the compressible center portion is sized and configured to be compressed for effective pump operation by an operator using only one hand to initiate unidirectional fluid flow.

4. The manually operable pump according to claim 1, wherein the compressible center portion is sized and configured to be compressed for effective pump operation by an operator or operators using two hands to initiate unidirectional fluid flow.

5. The manually operable pump according to claim 1, wherein the compressible center portion is sized, shaped, and configured to be compressed for effective pump operation by an operator using foot compression on the center portion to initiate unidirectional fluid flow.

6. The manually operable pump according to claim 1, wherein the exterior of the compressible center portion is at least partially covered by a textured surface.

7. The manually operable pump according to claim 1, wherein the pump is effective in removing fluids, blood clots, and air from the body cavity of the subject suffering from hemopneumothorax.

8. The manually operable pump according to claim 1, wherein the pump is adapted to be connected to an autotransfusion device.

9. The manually operable pump according to claim 1, adapted for connection to at least one additional manually operable pump in series so as to provide a manually operable pump system.

10. The manually operable pump according to claim 1, wherein the pump effectively removes blood, blood clots, fluid, and air from the body cavity, the pump generating a negative pressure in a range of 5 mm to 100 mm Hg.

11. A manually operable pump for removing fluids from a body cavity of a subject, comprising:
a pump body comprising a compressible portion extending between a first end and a second end of the pump body, the first end of the pump body in fluid communication with the second end of the pump body;
a first one-way valve in fluid communication with the first end of the pump body to provide unidirectional fluid flow into the pump body;
an inflow conduit coupled to the first one-way valve and comprising a pleural evacuation tube for removing fluid from a plural space, and
a second one-way valve in fluid communication with the second end of the pump body to provide unidirectional fluid flow out of the pump body;
wherein the first one-way valve and the second one-way valve allow fluid passage through the pump body when the pump body is so positioned such that all power for fluid flow is provided by gravity.

12. A system for removing fluids from a body cavity, comprising:
a fluid receptacle for receiving the fluids from the body cavity; and
a manually operable pump in fluid communication with both the body cavity and the fluid receptacle via an inflow conduit comprising a pleural evacuation tube for removing fluid from a plural space in the body cavity, operation of the pump generating a negative pressure relative to the body cavity to transfer fluid from the body cavity to the fluid receptacle; wherein the pump is so positioned such that all power for fluid flow is provided by gravity.

13. The system according to claim 12, wherein the manually operable pump comprises a pump body interposed between two one-way valves, compression of the pump body initiating unidirectional fluid flow from the body cavity to the fluid receptacle.

14. The system according to claim 12, further comprising an implantable catheter in fluid communication with the manually operable pump.

15. The system according to claim 14, further comprising an inflow connector coupled to the implantable catheter and a first end of the manually operable pump, an outflow conduit coupled to the fluid receptacle, and an outflow connector coupled to the outflow conduit and a second end of the manually operable pump opposite the first end of the manually operable pump.

16. The system according to claim 12, wherein the manually operable pump generates a fluid flow of approximately one liter per minute.

17. The system according to claim 12, further comprising suction handles that are attachable to the manually operable pump to suck out secretions from a mouth.

18. A method of removing fluid during a medical procedure, comprising:
attaching a manually operable pump to a proximal end of a catheter, the manually operable pump in fluid communication with a fluid receptacle via an inflow conduit for removing fluid;
generating a negative pressure via the manually operable pump to initiate fluid flow from the catheter toward the fluid receptacle; and
positioning the manually operable pump to flow fluid from the catheter to the fluid receptacle such that all power for further fluid flow is provided by gravity.

19. The method according to claim 18, wherein the step of generating a negative pressure comprises compressing a pump body interposed between two one-way valves to initiate unidirectional fluid flow from a body cavity to the fluid receptacle.

20. The method according to claim 19, wherein the step of generating a negative pressure comprises compressing the pump body by foot to initiate unidirectional fluid flow from the body cavity to the fluid receptacle.