Patent Application
20170348475
The present invention relates to drainage devices for surgical procedures and, more particularly, to a system for improving drainage from a cavity within a human or animal body that breaks up clots or reduces clotting and/or thickening of the fluid to facilitate drainage.
Trauma is the leading cause of death for US civilians under age forty with an incidence of 140,000 deaths per year. Thoracic injuries occur in approximately 60% of polytrauma cases and are a primary or contributing factor in up to 75% of all civilian trauma-related deaths. Ivey, K. M., White, C. E., Wallum, T. E., et al., 2012, “Thoracic Injuries in US Combat Casualties: A 10-Year Review Of Operation Enduring Freedom And Iraqi Freedom,” J Trauma Acute Care Surg, 73(6 Sup 5): S514-S519; Mowery, et al., “Hemothorax and Occult Pneumothorax, Management of,” J. Trauma, February 2011, Vol. 70, No. 2, pp. 510-518. Hemothorax, an accumulation of blood in the pleural space, is a common result of chest trauma. In the U.S. alone, the incidence of trauma-related hemothorax approaches 300,000 cases per year. Mowery et al, supra; see also, Wim G. Boersma, Jos A. Stigt, Hans J. M. Smit., Treatment of Haemothorax, Respir Med. 2010 November, 104(11): 1583-1587.
The primary treatment of hemothorax is tube thoracostomy. Thoracostomy typically involves placement of a large bore (36Fr to 42Fr) catheter (thoracostomy tube or chest tube) for drainage of the pleural space. Mowery et al, supra. Due to the likelihood of a combined pneumothorax, chest tubes for thoracic trauma are typically placed superiorly, as notionally illustrated in
There are several reasons why a hemothorax may not completely drain—ranging from the sheer volume of blood, the clotting process proceeding more rapidly than the draining process, and patient positioning relative to tube position (i.e., the tube is not in the dependent position). Retained hemothorax (RH) is typically diagnosed via computed tomography (CT) with chest CT imaging often triggered by a finding of persistent x-ray opacity after tube thoracostomy. Empyema, a bacterial or frankly purulent collection in the pleural space, results in 33% percent of RH cases that are visible on x-ray even after chest tube placement (typical RH volume >500 mL). Patients with RH are 12-16 times more likely to develop post-traumatic empyema than those chest trauma patients who do not develop RH. Brims et al., “Empyema Thracis: New Insights Into An Old Disease” European Respiratory Review, Vol. 19, No. 117, pp. 220-228. As such, RH is an independent risk factor for empyema, a condition with a 15-20% mortality rate (higher in immunocomprised patients). RH is also associated with subsequent adverse outcomes such as fibrothorax and trapped lung. While the maximum size of an RH that may be managed without secondary intervention has been debated, correlations between RH size and complications such as empyema and trapped lung have driven current recommendations to administer a secondary therapy (typically surgery) for RH's larger than 500 mL or ⅓ of the hemithorax. Mowery, et al., supra, Boersma et al, supra.
While studies investigating administration of an intrapleural thrombolytic for RH have shown limited success, current recommendations call for early video assisted thorascopic surgery (VATS). 39(4). Chou et al, supra. In VATS, a thoracoscope and surgical instruments are inserted into the chest cavity via 1-3 relatively small incisions. The ipsilateral lung is collapsed to obtain a clearer view of the pleural cavity. Adhesions are then released via blunt digital dissection or sharp endoscopic electrocoagulated dissection and blood and clots are removed by standard suction or a suction-irrigator system. Sponge sticks and ring forceps can enable careful removal of organized collections and some studies have investigated the use of jet-lavage to more efficiently remove adherent clots and membranes without damaging the pleura. Early VATS has been shown to decrease the incidence of empyema and pneumonia and rapidly restore lung function. Chou et al, supra. Compared to previous surgical approaches to RH (i.e. thoracotomy), VATS has been reported to have fewer postoperative complications, less pain, fewer wound and pulmonary complications, shorter recovery time, and shorter length of hospital stay. As a result, VATS has become a preferred primary management option for RH—even over the placement of a second chest tube.
VATS intervention, however, is not without costs and contraindications. Most notably VATS requires a high level of expertise and resources—a skilled thoracic surgeon, an anesthesiologist to perform special intubation and lung drop, as well as significant support staff and equipment. Moreover, the careful removal of coagula adhering to underlying structures with limited visibility usually proves very time consuming and tiresome, and thus, costly work. Tomaselli F, Maier A, Renner H, Smolle-Juttner F M, Thoracoscopical Water Jet Lavage In Coagulated Hemothorax, Eur J Cardiothorac Surg. 23(3):424-5 (2003). In fact, these requirements for specialized equipment and personnel, as well as their associated costs, have been noted as barriers to widespread use of VATS. Milanchi, S., Makey, I., McKenna, R., & Margulies, D. R., “Video-Assisted Thoracoscopic Surgery in the Management of Penetrating And Blunt Thoracic Trauma, Journal of Minimal Access Surgery, 5(3), 63-66. Because it requires single-lung anesthesia, VATS is not only costly and time consuming, but also contraindicated for hemodynamic instability. VATS is also contraindicated for patients with spinal injuries and pulmonary disease or otherwise compromised lung function. Milanchi et al, supra.
It would be preferable to avoid the need for surgical intervention by actively preventing an RH and improving the drainage performance of conventional tube thoracostomy. While attempts at actively clearing the chest tube via Fogarty balloon catheters and other active clearance products have shown some reduction in the amount of retained blood, these devices do little to improve drainage of fluid beyond the distal tip of the chest tube. Boyacioglu, et al., “A New Use of Fogarty Catheter: Chest Tube Clearance,” Heart, Lung and Circulation, Vol. 23, pp. e229-230 (2004); Shiose, et al., “Improved Drainage with Active Chest Tube Clearance,” Interactive Cardiovascular Thoracic Surgery, Vol. 10, No. 5, pp 685-688 (2010).
Additionally, the use of a sterile suction catheter to evacuate the pleural space prior to chest tube insertion has shown modest reduction in duration of tube drainage and need for secondary intervention. Interestingly, a limited recent study demonstrated a lower rate of secondary intervention after prophylactic pleural lavage using warm saline at the time of thoracostomy tube placement and suctioning via a suction catheter advanced into the thoracostomy tube. Kugler, N. W., Carver, T. W., and Paul, J. S., “Prophylactive Pleural Lavage Decreases Secondary Intervention in Patients with Traumatic Hemothorax,” ASCA 39.09; Kugler N W, Carver T W, Milia D J, Paul J S, “Thoracic Irrigation Prevents Retained Hemothorax: A Prospective Propensity Score Matched Analysis,” Presented at Western Trauma Association. Mar. 6, 2016.
Despite an array of successful clinical results most trauma surgeons do not regularly perform thoracic lavage due to real or perceived difficulty and time intensity of the manual procedure, insterility of the procedure, or other reasons. What is needed is a flexible, low-cost and easy-to-use system that enables rapid pleural lavage via the existing chest tube in a completely sterile manner.
It is, therefore, a primary object of the present invention to provide a system and method for pleural lavage, both at the time of thoracostomy tube placement and subsequent to tube placement, for traumatic hemothorax in order to reduce the need for secondary intervention for the management of retained hemothorax.
It is another object to provide a system and method as above that is simple and efficient to use, employing familiar tubing connections and control valves, and which deploys a rapid, automated saline infusion process, thereby minimizing training requirements and barriers to adoption.
It is another object to provide a system and method to facilitate a prophylactic pleural lavage as above that enables easy transition from lavage, to high wall suction, to low pressure chest drain suction without breaking the sterile circuit.
It is still another object to provide a system and method that allows adjustment of the lavage protocol (e.g., amount of infused saline per lavage cycle, number of lavage cycles at time of tube placement), and repetition of lavage at a later time based upon clinical indications.
It is still another object to provide a system and method that allows other future therapies/procedures to be administered through the chest tube without breaking the sterile circuit, such as introduction of a fibrinolytic solution, the use of a balloon catheter for tube clearance and/or pneumatic agitation at the distal tip of the chest tube, etc.
In accordance with the foregoing objects, the invention disclosed herein is a low-cost and simple-to-use system and method to facilitate a prophylactic pleural lavage protocol at the time of thoracostomy tube placement for traumatic hemothorax in order to reduce the need for secondary intervention for the management of retained hemothorax. The invention may be used in conjunction with existing chest tubes and be administered at the time of initial chest tube placement, and continued at the bedside (by a bedside nurse) over the duration of chest drainage, as necessary. The system includes a lavage controller that semi-automatically administers a pleural lavage protocol consisting of instillation of warmed saline into the pleural space and suction to slow the clotting process, prevent “gelling” of blood, and maintain drainability.
Other objects, features, and advantages of the present invention will become more apparent from the following detailed description of the preferred embodiments and certain modifications thereof when taken together with the accompanying drawings in which:
The present invention is a system to facilitate a prophylactic rapid pleural lavage protocol at the time of thoracostomy tube placement for traumatic hemothorax in order to reduce the need for secondary intervention for the management of retained hemothorax.
As seen in
Three ports to a pleural lavage controller 40 are connected in fluid communication with the chest drainage system 30, suction unit 20, and rapid saline infuser 10 via tubes 51, 52, 53, respectively. If desired, an optional second collection chamber or chest drainage system 30 may be connected inline between suction unit 20 and port 42 to drain the contents of tube 52, as shown in dotted lines in
The present system may be easily assembled at the time of chest tube 50 placement to preserve sterility. For example, if the balloon catheter (
1) simply disconnect tube 53 from lavage controller 40 and introduce the balloon catheter via the same port 43 (this is convenient but may slightly compromise sterility of the circuit);
2) provide a balloon catheter that is preconnected off of a Y in tube 53, but housed in a plastic sleeve until use. That is, when advancing the balloon catheter through the chest tube 50, the plastic sleeve scrunches up. Then when withdrawn from the chest tube 50 the balloon catheter remains housed in the plastic sleeve. This approach will prevent the user from ever breaking the sterile circuit.
Each of the four ports 42-45 comprises a frustoconically-shaped outward protrusion that tapers outwardly from the housing 41, and defined by a central lumen and annular-exterior ribs or steps. The frustoconical shape enables connection to variously-sized tubes 50-53 and the annular ribs/steps prevent dislodgement of the tubes 50-53 once inserted thereon.
As seen in
The illustrated detent valves 46-48 are preferably all biased by spring 142 to their normally-closed position. This generally prevents high pressure suction or lavage ports from inadvertent locking in an open position. However, it may be desirable to lock the valve 48 to low pressure chest drain 30 (See
In addition to the foregoing, an integral flow meter, visual flow indicator or pressure gauge 70 may be included such as shown in
Each of the spring-return locking detent valves 46, 47, 48 provide instantaneous control over the respective fluid flow to facilitate a prophylactic pleural lavage that enables easy transition from lavage, to high wall suction, to low pressure chest drain suction without breaking the sterile circuit. Moreover, the controller 40 (See
Having now set forth the preferred embodiments and certain modifications of the concepts underlying the present invention, various other embodiments as well as certain variations and modifications of the embodiments herein shown and described will obviously occur to those skilled in the art upon becoming familiar with said underlying concept. It is to be understood, therefore, that the invention may be practiced otherwise than as specifically set forth in the appended claims.
The present application derives priority from U.S. Provisional Patent Application 62/345,230 filed 3 Jun. 2016.
| Number | Date | Country | |
|---|---|---|---|
| 62345230 | Jun 2016 | US |
