SURGICAL DRAIN SYSTEM WITH INTERCHANGEABLE ATTACHMENTS
20180021486 ยท 2018-01-25
Inventors
- David A. Atashroo (Stanford, CA, US)
- Ben Marsico (Lexington, KY, US)
- David S. KIRN (Lexington, KY, US)
Cpc classification
A61M1/63
HUMAN NECESSITIES
A61M27/00
HUMAN NECESSITIES
A61M1/86
HUMAN NECESSITIES
A61M2205/0205
HUMAN NECESSITIES
A61M1/88
HUMAN NECESSITIES
International classification
A61M1/00
HUMAN NECESSITIES
Abstract
A surgical drain system for draining fluid from a patient is provided. The surgical drain system includes a tube for insertion into the patient through which the fluid drains. The tube extends into the patient and is connected to an adapter having first and second valves for controlling movement of the fluid through the adapter. An attachment includes an insert for opening the first and second valves when inserted into the adapter allowing the fluid to drain into the attachment when the insert is fully seated. A retraction mechanism may be incorporated preventing more than one use of the insert.
Claims
1-58. (canceled)
59. A surgical drain system for draining fluid from a patient, comprising: an adapter for insertion into the patient through which the fluid drains, said adapter having first and second valves for controlling movement of the fluid through said adapter; and an attachment including a male insert for opening said first and second valves when inserted into said adapter and allowing the fluid to drain into said attachment when said male insert is fully seated; wherein a portion of said male insert is bulbous and a portion of said adapter is a bulbous cavity positioned between said first and second valves for receiving the bulbous portion of said male insert.
60. The surgical drain system for draining fluid from a patient of claim 1, wherein said bulbous portion of said male insert and said bulbous cavity form an interference fit when said male insert is fully seated.
61. The surgical drain system for draining fluid from a patient of claim 1, further comprising a tube extending from said adapter into the patient.
62. The surgical drain system for draining fluid from a patient of claim 1, wherein said adapter includes a flange positioned externally of the patient.
63. The surgical drain system for draining fluid from a patient of claim 1, wherein said first valve is positioned inside of the patient.
64. The surgical drain system for draining fluid from a patient of claim 1, further comprising an attachment tube extending between said male insert and said attachment.
65. A surgical drain system for draining fluid from a patient, comprising: a tube for insertion into the patient through which the fluid drains, said tube extending from an adapter into the patient and having first and second valves for controlling movement of the fluid through said adapter; and an attachment including a male insert for opening said first and second valves when inserted into said adapter, wherein said male insert acts as a stent maintaining said first and second valves in an open position allowing the fluid to drain into said attachment.
66. The surgical drain system for draining fluid from a patient of claim 7, wherein said male insert includes a stem maintaining said first valve in the open position and a neck maintaining said second valve in the open position.
67. The surgical drain system for draining fluid from a patient of claim 7, wherein said male insert includes a substantially bulbous portion, and said adapter includes a bulbous cavity positioned between said first and second valves for receiving said substantially bulbous portion.
68. The surgical drain system for draining fluid from a patient of claim 7, further comprising an attachment tube extending between said male insert and said attachment.
69. The surgical drain system for draining fluid from a patient of claim 7, wherein said attachment further includes one of a cap for sealing the port, a syringe, a vacuum source, a bulb reservoir, a reservoir, a reservoir having osmotic matter positioned therein for absorbing fluid, a fitting connected to a fluid source for injecting the fluid of the fluid source into the patient, and a surgical access fitting.
70. The surgical drain system for draining fluid from a patient of claim 7, wherein said tube includes a plurality of holes in at least a proximal portion of said tube.
71. The surgical drain system for draining fluid from a patient of claim 7, wherein said tube is substantially elliptical in shape.
72. The surgical drain system for draining fluid from a patient of claim 7, wherein said tube includes ribs along a lumen of said tube.
73. A surgical drain system for draining fluid from a patient, comprising: an adapter for insertion into the patient through which the fluid drains, said adapter having first and second valves for controlling movement of the fluid through said adapter, and an attachment including a male insert positioned within said adapter for opening said first and second valves and allowing the fluid to drain into said attachment, said male insert including a valve which precludes fluid flow when said male insert is withdrawn from said adapter.
74. The surgical drain system for draining fluid from a patient of claim 15, wherein said adapter includes a tube having a proximal end within the patient and a distal end adjacent said adapter.
75. The surgical drain system for draining fluid from a patient of claim 16, wherein said tube includes a plurality of holes in at least a proximal portion of said tube.
76. A surgical drain system for draining fluid from a patient, comprising: a tube for insertion into the patient through which the fluid drains, said tube connected to an adapter having first and second valves for controlling movement of the fluid; an insert for opening said first and second valves when inserted into said adapter and allowing the fluid to drain when said insert is fully seated; and a retraction mechanism for preventing more than one use of said insert.
77. The surgical drain system for draining fluid from a patient of claim 18, further comprising an attachment for collecting the fluid drained from the patient.
78. The surgical drain system for draining fluid from a patient of claim 18, wherein said retraction mechanism includes said insert, a connector, a spring, and a lock ring.
79. The surgical drain system for draining fluid from a patient of claim 18, further comprising a housing supporting said retraction mechanism.
Description
BRIEF DESCRIPTION OF THE DRAWING FIGURES
[0029] The accompanying drawing figures incorporated herein and forming a part of the specification, illustrate several aspects of the surgical drain system for draining fluid from a patient and together with the description serve to explain certain principles thereof. In the drawing figures:
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[0050] Reference will now be made in detail to the present embodiments of the surgical drain system, examples of which are illustrated in the accompanying drawing figures, wherein like numerals are used to represent like elements.
DETAILED DESCRIPTION
[0051] Reference is now made to
[0052] In the present described embodiment, the drain tube 24 is integrally formed with the adapter 20 so that they form one continuous, uniform unit. The drain tube 24 includes a distal end, adjacent the flange 22, and a proximal end which extends into the body cavity to be drained. Along a portion of the proximal portion of the drain tube 24, the tube includes a plurality or a multiplicity of holes or channels to allow body fluids to enter a central lumen 26 of the tube. Along a portion of the drain tube 24 near the proximal end, the tube does not include such holes or channels providing a fluid tight tube adjacent the flange.
[0053] As best shown in
[0054] In operation, a user inserts male insert 32 and valve stem 34 into adapter 20. More specifically, the male insert 32 is inserted into an external valve 38 as shown in
[0055] In the described embodiment best shown in
[0056] In the described embodiment, internal valve 42 is integrally model with drain tube 24. External valve 38 and internal valve 42 work together, as shown in
[0057] As best shown in
[0058] In this fully seated position, the stop ring 48 forming a part of the male insert 32 abuts or rests flush with the flange 22. Stop ring 48 prevents over insertion of male insert 32 and when the stop ring is flush with the flange 22 serves as a sign that male insert 32 is properly seated. In the described embodiment, stable fluid flow is established between the body cavity, through the drain tube 26, adapter 20, and to the attachment 28. However, with a sufficient amount backward traction on attachment 28 or attachment tubing 30 or male insert 32, the bulbous radius 44 will pop out of or otherwise be dislodged from bulbous cavity 46 and be withdrawn through external valve 38, pulling valve stem 34 out of internal valve 42 and stopping fluid flow without dislodging adapter 20 from the patient's body.
[0059] As shown in
[0060] As shown in
[0061] As shown in
[0062] In accordance with the method of use of the present invention as illustrated in
[0063] Placement of the drain tube 24 is perhaps best shown in
[0064] Of course, the attachment 28 may take many forms as will be generally described below. Primarily the removable attachments are single use disposable devices each of which includes a male insert 32 to connect into the adapter 20. Various attachments are provided that accommodate the multiplicity of function inherent in the system. Several exemplary attachments are provided in the subsequent description but additional extensions may be developed with time and need. Although not described in each exemplary attachment, a valve such as a check valve, may be utilized to prevent leakage of drained fluid collected within the attachments. Such a valve may be positioned distal to the valve stem 34 to prevent leakage after disconnection of the attachment 28.
[0065] As shown in
[0066] The presently described embodiment of the chamber 58 provides a colorimetric indication of when the super-absorbent material has been fully saturated. The capacity of each reservoir is indicated on its housing. Determination of the amount of fluid egress from the drain is important to determine the time for drain removal. An alternate embodiment may provide a dry weight for the reservoir. The user could calculate the amount of fluid which has been absorbed by weighing the reservoir upon removal.
[0067] The reservoir may be supplied in multiple different capacities and shapes, including an expandable housing. Thus, early in the postoperative phase, when drainage is copious, a large capacity reservoir would be utilized. Later, when drainage has tapered off and the patient is becoming more mobile, a smaller anatomically contoured reservoir may be utilized. Fluid egress from the surgical space is thus provided by osmotic action upon the fluid column extending outward to the absorbent material in the reservoir 58.
[0068] Another attachment shown in
[0069] Another attachment might include only a removable and/or replaceable cap (not shown) to seal off the adapter 20. The cap would further minimize the risk of fluid entering the surgical site in addition to the barrier already provided by the external and internal valves 38, 42. The cap may be made of rigid or flexible material. It attaches to the adapter 20 utilizing a fitting or by means of an adhesive, a slide fitting, a clip, a screw fitting, or a magnetic coupling. Preferably, the cap is a single use disposable component which is supplied sterilely. Alternatively, the cap may be fixed to the adapter 20. In one embodiment, the cap is a single use disposable self-adherent membrane which completely covers the adapter 20 with or without a portion of the surrounding skin. The cap also serves to minimize the risk of fluid escape from adapter 20. As a further alternative embodiment, the removable cap could be designed to allow perforation of it with a needle to permit fluid flow.
[0070] Another attachment includes a wall suction adapter which consists proximally of a male insert 32 connected to a hollow bore flexible tubing 30 and distally to a fitting compatible with standard hospital suction tubing. Commonly when drains are initially placed, fluid output is high, thus this system provides a convenient method to evacuate and quantitate the fluid. A further benefit is that continuously applied suction may help to collapse or close the body cavity in which the proximal end of the drain resides.
[0071] An alternate embodiment could also include a method to generate suction either by expansion of a partially collapsed reservoir or a spring loaded mechanism. The osmotic reservoir, for example, has the same male insert 32 directly attached or molded to it to connect with the adapter 20. Alternately, there may be a tubing 30 running between the reservoir 58 and the male insert 32. A fluid conductive medium could also be contained in the lumen of the drain tube 24 inside the patient's body to serve as a wick to enhance flow of fluid along an osmotic pathway. Alternatively, a superabsorbent material could be placed inside the drain tube 24 and changed periodically to soak up body fluids without requiring the external reservoir. Of note, in this latter embodiment, the superabsorbent material would have to be provided sterilely.
[0072] As noted above, the attachment may be utilized for irrigation. Such an attachment 28 would provide a route for installation of irrigation fluid and drugs. The irrigation attachment 28 includes the male insert 32 affixed to a hollow tubing 30 which distally includes an attachment point for a syringe, IV tubing, three way valve or other medical connector familiar to those skilled in the art. This provides access for irrigation of the body cavity into which the proximal aspect of the drain tube 24 resides to decrease bacterial contamination. Drugs such as antibiotics, chemotherapeutics or sclerosants could also be instilled via this conduit. Fluid egress could occur sequentially through the same flow pathway, or a second complete drain system setup could provide for fluid removal.
[0073] Another attachment 28 includes a surgical access fitting (not shown). This attachment would enter sterilely through the adapter 20 into the patient's body and would serve as a conduit through which treatment could be administered. Through this access point, the inner body cavity could be inspected under direct or video assisted visualization. A biopsy may be performed or fluid collected to assist with diagnosing possible medical conditions. Treatments may also be performed through this access point including directed application of suction and/or debridement. In one embodiment, a port that is similar to a laparoscopic port would connect to the adapter 20 and could be used as a conduit for the introduction of laparoscopic instruments. Subsequently the attachment could be removed leaving the adapter 20 intact. As with the other attachments, a male insert 32 provides the conduit through which the instruments pass.
[0074] In still another attachment 28, the attachment includes an automated evacuation system. This attachment provides for automated evacuation of the drain powered by any of several means including but not limited to compressed gas, electrically driven pump, Archimedes screw or a vacuum reservoir. The automated evacuation system could include electrical timing control as well as an automated monitoring of fluid output or precisely regulating outward fluid flow by way of a second valve or a mechanical pump. On its distal end, this attachment could have a connection point for a reservoir.
[0075] In certain alternate embodiments of the invention, an insert 70 which actively prevents more than a single use may be utilized in place of insert 32. Broadly speaking, the insert 70 works generally like a ball point pen retraction/extension mechanism except the mechanism is limited to a single cycle. As shown in
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[0077] Upon either planned or inadvertent removal of the insert 70 from the port, the insert is retracted and the retraction mechanism 74 locks the insert in a retracted position preventing re-insertion. Although not shown, a check valve may also be included to prevent flow out of the insert 70 when retracted. The user could also retract the insert 70 for removal by pushing in slightly on the housing 72 and the retraction mechanism 74 and then releasing same thereby triggering retraction of the insert.
[0078] As shown in exploded view in
[0079] The connector 82 is shown in cross-sectional views in
[0080] During insertion, the user applies pressure using a thumb, or otherwise, to an exterior of housing 72. The pressure forces the insert 70 and the valve stem 78 to advance from the initial retracted position shown in
[0081] In summary, numerous benefits result from providing a surgical drain system that allows for improved patient comfort, compliance, and mobility. The surgical drain system permits multiple functionality including, for example, continuous versus intermittent evacuation, continuous egress of fluid without the need to periodically reset the system suction, and provision of varied treatment modalities including sampling and irrigation. The drain system also avoids exposure of the caretaker to the patient's body fluids, and accommodates clothing over the drain.
[0082] The foregoing has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the embodiments to the precise form disclosed. Obvious modifications and variations are possible in light of the above teachings. As shown in