WO2021161116A1

WO2021161116A1 - Surgical hemo-vac drain with epidural drug delivery system

Info

Publication number: WO2021161116A1
Application number: PCT/IB2021/050441
Authority: WO
Inventors: Mehdi REZAEE
Original assignee: Rezaee Mehdi
Priority date: 2020-02-13
Filing date: 2021-01-21
Publication date: 2021-08-19

Abstract

The spinal surgery hemo-vac drain with epidural drug injection capability is a modification of existing surgical drains. It has the addition of an injection port to a lumen in the wall of the drain with distal exiting holes that correspond to epidural space when the drain is correctly placed. Due to tissue distortion following posterior thoracolumbar surgeries, epidural catheter placement is not applicable based on detection of physiologic negative pressure of epidural space. The device allows for analgesic drug delivery to be applied to this area on initial placement and while the tube remains in place. The surgical drain of the present invention allows a patient to receive postoperative epidural analgesia which improves postoperative pain management and eliminates the need for systemic drug administration and related side effects.

Description

Title of Invention : Surgical hemo-vac drain with epidural drug delivery system

Technical Field

[0001] The present invention relates to medical devices, and more particularly to a drainage tube system combined with catheter systems for delivering a therapeutic agent to a region of a body.

Background Art

[0002] Hemovac drain is a flexible plastic tube which is developed for fluid drainage (including blood and other secretions) in the surgical sites. Hemovac drain includes an evacuator which may exert negative pressure that is attached to a tubing system. The other end of the tube is inserted in the surgical site through skin by a puncture needle guide before wound closure.

[0003] Another application of hemovac drain is to treat postoperative spinal infections where irrigation suction system is used along the irrigation drain. In the irrigation suction system, two separate drains are put inside the surgical site. Irrigation drain is used to insert the antibiotic solution and serum for irrigation and the fluid is drained using hemovac drain. Using two drains for this purpose may cause further complications such as patient’s pain, discomfort and increased infection rate. On the other hand, controlling two drains in case of drain blockade, displacement, dressing will require more time and costs. In this case we have inserted two drains in one tube including one-way drug injection pathways for drug and serum delivery while the other tube is used for drainage which reduced patient’s pain and discomfort while simultaneously reducing complications of placement of two drains.

[0004] Following bone manipulation in the spinal surgeries, patients may experience severe postoperative pains. Consequently, proper pain management caused by tissue damage following surgery is prioritized to achieve patient satisfaction, early patient ambulation and reducing complications, costs, and hospital length of stay. For pain management in these patients, various methods and medications are available, which may include administration of different classes of oral or intravenous systemic analgesics, as well as local anesthetics or regional analgesia. Epidural drug injection is an accepted regional analgesic method for postoperative pain management.

[0005] Anesthesiologists inject epidural anesthetics before spinal surgery which exert short-term analgesia. However, this method is not feasible after the surgery with the available tools due to tissue distortion. Surgeons insert the drain inside the surgical wound which is adjacent to the spinal epidural space, the aesthetic drug may be delivered to the epidural space by inserting a duct inside the surgical drain. Also, to reduce the inflammation, bleeding, and infection in the desired site, this innovative drain may be used to transfer the desired drugs.

[0006] Reviewing the internet-based references, as well as the search engines, no similar invention has been recorded.

Summary of Invention

[0007] The invention described here is a modification with significant advantages and change of usage of a commonly used medical device called surgical hemo-vac drain. A surgical drain is a plastic tube used for suctioning body fluids from the surgical field or from within the closed wound. This device is designed using the primary version of surgical hemovac drain with adding a longitudinal duct along the drain for drug delivery, so that using a pilot valve, the drug is transferred through the external pores of the drug delivery system after drug. Using this new method of drug delivery in the surgical drains, local analgesic (for epidural or surgical site anesthesia), corticosteroid medications (to reduce the manipulation- induced inflammation), and disinfectant solutions such as irrigation serums, local antibiotics (to prevent bacterial colonization and proliferation), as well as tranexamic acid or epinephrine (for bleeding control) can be administered. The innovative design in this invention reduces the risk of surgical site wound infection, reduces required dose of systemic analgesics and their complications as well as early patient ambulation, and reduced costs and hospital length of stay.

Technical Problem

[0008] Epidural analgesia is one of the most favorite modalities of postoperative pain management. Following posterior spinal surgeries, it is impractical to place epidural catheter by means of peridural negative pressure since it disappears due to tissue distortion; thus, adding an extra lumen to conventional surgical drain for anesthetic drug delivery to epidural space would solve the problem. Therefore, placement of surgical drain adjacent to epidural region for epidural drug delivery may have a promising role.

Solution to Problem

[0009]

Advantageous Effects of Invention

[0010] It would be advantageous to administer a solution containing local anesthetic to epidural space on initial placement of the drain and subsequently as required while the drain is still in place, therefore preventing the pain, discomfort and potentially dangerous side effects of systemic analgesics. Adding vasoconstrictors such as epinephrine to local anesthetics would improve analgesia duration and may have a role in decrease of postoperative bleeding from surgical wound. Postoperative irrigation and suction of the surgical wound and injection of antibiotic solutions is another application of this innovation which reduces risk of wound infection. Other advantages of the current invention compared with previous designs may include earlier patient mobility, simultaneous drainage and drug injection, reduced costs of maintenance, dressing of two separate drains, reduced pain and discomfort of patients caused by two drains with two pathways and incisions.

Brief Description of Drawings

[0011 ] Fig. 1 is an overview of the present invention.

[0012] FIG. 2 is a longitudinal sectional view of an embodiment of the present invention.

[0013] FIG. 3 is a cross-sectional view of an embodiment of the present invention.

[0014] FIG. 4 shows the functional view of the present invention.

Description of Embodiments

[0015] The surgery drain of the present invention provides the ability to administer local anesthetic(13) to some segments of epidural space adjacent to surgery site through a specially constructed side port (5) in the wall of the surgical drain tube (7). The device may also be used for administration of other drugs for various purposes.

[0016] Our solution to this issue is to deliver drug(13) or the irrigation solution(13) through a separate longitudinal duct (11) in the surgical drain tube(7) for drug delivery from outside the body to the epidural space.

[0017] The surgical drain of the present invention may be extruded from polyvinyl chloride and one small lumen (11 ) is incorporated in the side wall of the tube.

[0018] The second lumen (11) serves as the route for administration of local anesthetic(13) to overcome the presented technical issues to deliver the desired drug to the surgical site.

[0019] This surgical hemovac drain is produced by adding a system of drug delivery and consists of the following constituents: 1. surgical drain 2. epidural drug delivery system

[0020] The epidural drug delivery system comprises of 5 parts in order: injection port(1), one-way valve(2), antibacterial filter(3), external line of drug injection(4), internal duct of drug delivery(11), and distal drug delivery outlets to the epidural space(5).

[0021] The drug injection line includes drug inlet(1), one-way valve(2) and the external duct(4) of drug delivery which transfers the solution of the desired drug to the internal duct(11).

[0022] The internal duct for drug delivery(11) is composed of a longitudinal duct along the inner surface of the wall of the surgical drain tube(7) which is used to transfer the drug from the outer line to the drug outlet.

[0023] The injected drug into the external line of drug injection(13) comes into the internal duct of drug injection reaches the epidural space through the drug delivery outlets(5) when passed the duct length. When the surgical drain is in its operable position, said aperture means comprising a plurality of apertures extending longitudinally within 10 centimeters distal portion of the length of the tubular member said aperture means being sealed from fluid communication with the interior of said tubular member. [0024]

[0025] The outer end of the tube (1) will securely accept a syringe containing local anesthetic. The inner end of this local anesthetic bearing lumen (11) has several small openings (5) on the distal 10 cm portion of drain tube corresponding to adjacent epidural space to surgery wound. Injection down this lumen (11) would therefore evenly distribute anesthetic solution in this area.

[0026]

[0027] To inject local drug solutions in the surgical wounds, a very thin duct is designed in the internal wall of the drain in a vertical view (Fig. 4), in a descending way, similar to plant vessel, with an open ending to outside), and the injected drug (13) passes through the drug delivery line (4) from outside the body, after passing the vertical duct in the drain wall (11) and passes out (13) via outlet pores (5) to the epidural space.

[0028] Figures 1 shows a general view of the surgical drain. Figure 4 and 1 shows the surgical drain with drug delivery ability after insertion. In this figure, the injected drug (13) enters drug injection duct (11) through drug injection line (4) and reaches drug delivery outlets (5) where it passes out (13). Surgical site discharges (12) enter the drain outlet duct (7) through drain pores (10) and passes to the discharge bag (9).

Industrial Applicability

[0029] The invention described here is an improvement with additional uses of a surgical hemo-vac drain. The surgical hemo-vac drain of the present invention has the built in capability of epidural drug delivery. This product may be used in the medial equipment production.

Claims

[Claim 1] A surgical hemo-vac drian with provision for delivering epidural drug solution comprising: a. a tubular member for evacuating wound discharge accumulating inside the surgical wound percutaneously, said tubular member having a long slinder shape, an interior, a proximal end and a distal end; b. a conduit associated with the tubular member for carrying analgesic drug, said conduit sealed from fluid communication with the interior of said tubular member; c. an aperture means extending along a portion of the length of the tubular member and in fluid communication with the conduit for permitting local anesthetics to be injected through micrometric holes extending along said drain body to the proximity of an extremity of said distal end of said drain body.