BODY-SPACE DRAINAGE-TUBE DEBRIS REMOVAL
20200253687 ยท 2020-08-13
Inventors
Cpc classification
A61M2027/004
HUMAN NECESSITIES
A61B90/70
HUMAN NECESSITIES
A61M27/00
HUMAN NECESSITIES
A61B2090/701
HUMAN NECESSITIES
A61M16/0463
HUMAN NECESSITIES
A61M27/002
HUMAN NECESSITIES
A61M2205/0205
HUMAN NECESSITIES
A61M2205/0216
HUMAN NECESSITIES
International classification
A61B90/70
HUMAN NECESSITIES
A61M27/00
HUMAN NECESSITIES
Abstract
In accordance with embodiments of the present invention, a debris removal system is provided for a body-space drainage system having one or more body tubes with a body tube lumen disposed therein. The debris-removal system comprises an elongated cleaning member and a cleaning head adapted to be advanced distally at least a portion of a length of the body tube lumen to dislodge debris therein. A collapsible sheath can be used to maintain a sterile field in the body tube lumen while the cleaning member is being used by enclosing at least a portion of the cleaning member that is not contained within the body tube lumen, and permitting external digital manipulation of the cleaning member through the sheath to advance and/or retract the cleaning member, and cleaning head, in the body tube lumen.
Claims
1. A debris-removal system comprising: a. a body tube having a first body tube lumen; b. a cleaning member extending distally from a proximal opening of the body tube and adapted for manipulation within the body tube lumen; c. the cleaning member comprising a flexible filament adapted to traverse a curvature of the body tube lumen when advanced through the body tube lumen by manipulation from a proximal end of the cleaning member.
2. The debris-removal system of claim 1, wherein the flexible filament is selected from the group consisting of semi-rigid wire, plastic rod, and tubing.
3. The debris-removal system of claim 1, further comprising a cleaning head disposed at or adjacent a distal end of the flexible filament.
4. The debris-removal system of claim 3, the cleaning head being configured such that it permits free flow of material past the cleaning head through said lumen regardless whether the cleaning head is at rest within the lumen or is being actuated therein to dislodge debris.
5. The debris-removal system of claim 1, the cleaning member being configured such that a distal end of the flexible filament cannot exit a distal end of the body tube upon actuation of the cleaning member.
6. The debris-removal system of claim 1, further comprising an irrigation port adapted to expel a fluid within the body tube lumen effective to assist in dislodgment and/or break-up of debris therein.
7. The debris-removal system of claim 6, the fluid being expelled under pressure in the form of a fluid jet adapted to mechanically dislodge and/or break up said debris.
8. The debris-removal system of claim 1, further comprising a collapsible sheath in communication with the body tube lumen and adapted to contain at least a portion of the cleaning member that is not contained within the body tube lumen.
9. The debris-removal system of claim 8, the collapsible sheath comprising a rotatable coupling to couple the proximal end of the cleaning member to a manipulation device.
10. The debris-removal system of claim 1, the flexible filament further comprising a flexible filament lumen defining a suction path for collection and removal of debris.
11. The debris-removal system of claim 1, the first body tube lumen branching into a plurality of second body tube lumens.
12. The debris-removal system of claim 3, wherein actuation of the cleaning member causes a corresponding actuation of the cleaning head to dislodge debris within the body tube lumen without compromising a sterile field within the body tube.
13. The debris-removal system of claim 1, the body tube lumen being under a vacuum drawn from a proximal end of the body tube during actuation of the cleaning member.
14. The debris-removal system of claim 1, further comprising a manipulation device coupled to the cleaning member.
15. The debris-removal system of claim 14, the manipulation device being effective impart vibratory motion to the cleaning member.
Description
DRAWINGS
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DESCRIPTION
[0075] Referring again to
[0076]
[0077] The cleaning member 24 is an elongated member comprises a cleaning member distal end 26 and a cleaning member proximal end 28. The cleaning member distal end 26 is adapted to enter the body tube lumen 15 at or near the body-tube proximal end 13 and be advanced distally at least a portion of the length of the body tube lumen 15. The collapsible sheath 22 is adapted to contain at least a portion of the cleaning member 24 that is not contained within the body tube lumen 15. The collapsible sheath 22 is adapted to be flexible so as to allow external digital manipulation of the cleaning member proximal end 28 within of the collapsible sheath 22. For example, the collapsible sheath 22 allows for grasping a portion of the cleaning member 24 within the collapsible sheath 22 for advancing, retracting and manipulating the cleaning member 24 within the body tube lumen 15.
[0078] The collapsible sheath 22 comprises a suitable material for the particular purpose. In embodiments in accordance with the present invention, the collapsible sheath 22 comprises a flexible film comprising synthetic resinous material, such as, but not limited to, medical grade polyethylene film. The collapsible sheath 22 is manually collapsed, such as between the thumb and index finger of the practitioner, and the like, in order to manipulate the cleaning member 24 contained therein. The collapsible sheath 22 is adapted to retain and maintain a sterile environment, and, were applicable, the vacuum, of the body-space drainage system 2.
[0079] In embodiments in accordance with the present invention, the collapsible sheath 22 is adapted to contain a fully retracted cleaning member 24 so as to provide an unobstructed flow path through the body tube lumen 15 to the canister tube 14.
[0080] The collapsible sheath 22 is adapted to couple at or near the proximal end 13 of the body tube 10 so as to provide a fluid tight and sterile seal with the body tube lumen 15. The cleaning member 24 can therefore be advanced and retracted within the body tube lumen 15 without the need to break the sterile seal or to interrupt the vacuum of a closed vacuum system.
[0081]
[0082] In an embodiment in accordance with the present invention, the coupler 23 is adapted to provide a removable coupling between the collapsible sheath 22 and the drainage system 2. The collapsible sheath 22 is coupled to the coupler 23 at the coupling end 25 of the collapsible sheath 22. The collapsible sheath 22 permits the operator to manipulate the cleaning member 24 and insert the cleaning member distal end 26 into the body tube 10 via the collapsible sheath port 29 of the coupler 23 while maintaining sterility and vacuum. The proximal end 28 of the cleaning member 24 remains outside the coupler 23 so that the operator can manipulate the cleaning member 24 with isolation maintained by the collapsible sheath 22.
[0083] Embodiments of the present invention provide a coupler 23 to provide use of the debris-removal system 20 without disconnection of the canister tube 14. It is understood that other embodiments are anticipated providing the debris-removal system 20 to couple with a straight coupler 12, as shown in
[0084] Various embodiments of the cleaning member 24 are anticipated, some of which are presented below.
[0085]
[0086] The flexible filament is adapted to mechanically clean the body tube lumen 15 using mechanical dislodgment of the foreign material 19. The flexible filament 24a is sufficiently flexible to traverse the curvature of the body tube lumen 15, but is sufficiently rigid so as to prevent buckling when advanced through the body tube lumen 15 by pushing from about the cleaning member proximal end 28 and to dislodge and/or break up foreign material 19 within the body tube lumen 15 as it makes contact with the foreign matter. The foreign material 19 is dislodged from the body tube lumen 15 and carried to the canister (not shown) via the vacuum system (not shown).
[0087]
[0088]
[0089]
[0090] The collapsible sheath 22 comprises a collapsible sheath proximal end 33 that is coupled with the cleaning member proximal end 28. The filament manipulation device 52 is adapted to couple with the collapsible sheath proximal end 33 and therefore couple with the cleaning member proximal end 28. In one embodiment, the filament manipulation device 52 imparts a vibratory motion to the cleaning member 24 which provides relative motion to the cleaning member distal tip 26. This relative motion of the cleaning member distal tip 26 assists in the dislodgment and/or breakup of the foreign material 19 when placed in contact therewith.
[0091] In another embodiment in accordance with the present invention, the filament manipulation device 53 comprises an ultrasonic transducer that couples sonic energy to, and therefore vibratory motion, the cleaning member 24. A vibratory motion is adapted to induce sonic motion to the cleaning member distal tip 26 as well as any surrounding fluid, further assisting in the breakup and/or dislodgment of the foreign material 19.
[0092]
[0093] In an embodiment in accordance with the present invention, the collapsible sheath proximal end 33 comprises a rotatable coupling 35. The rotatable coupling 35 is adapted to couple the cleaning member proximal end 33 with the manipulation device 53. The rotatable coupling 35 is adapted to provide a fluid and sterile seal while allowing the manipulation device 53 to rotate the cleaning member 24a.
[0094] It is anticipated that the manipulation device 53 can be adapted to provide various motions to the cleaning member 24a to assist in the breakup and/or removal of the foreign material 19. These motions include, but are not limited to, vibration, rotation, oscillatory rotation, and combinations there of.
[0095]
[0096] In another embodiment in accordance with the present invention, the filament lumen 37 provides a flow path to and/or from the tubular filament distal end 36 and the tubular filament proximal end 38. The tubular filament 24b is sufficiently flexible to traverse curvature of the body tube lumen 15, but is sufficiently rigid so as to advance through the body tube lumen 15 without buckling by pushing from the tubular filament proximal end 38 and to dislodge and/or break up foreign material 19 within the body tube lumen 15.
[0097] In one embodiment as shown in
[0098] A tubular filament 24b suitable for the particular purpose includes, but is not limited to, a suction catheter adapted to vacuum-remove loosened foreign material 19. In accordance with an embodiment of the present invention, a debris-removal system comprises a closed tracheal suction system used for the drainage of endotracheal tubes and a coupler 23, suitable to provide access to the closed tracheal suction system and the endotracheal tubes.
[0099]
[0100] It is anticipated that the tubular filament embodiments can be augmented with embodiments of the manipulation device 52 as presented previously.
[0101]
[0102] In one embodiment in accordance with the present invention, the fluid is expelled from the tubular filament distal end 36 at a predetermined pressure so as to assist in the dislodgment and/or break up of the foreign material 19. A fluid jet 42 is produced so as to provide an aggressive cleaning action. The fluid jet 42 is adapted to mechanically dislodge and/or break up the foreign material. The fluid jet 42 can be continuous or pulsed.
[0103] In another embodiment in accordance with the present invention, the fluid jet 42 is provided with sonic energy to provide vibratory action to the fluid to further assist in the cleaning action.
[0104] In an embodiment in accordance with the present invention, a fluid supply system 43 is coupled to the collapsible sheath proximal end 33 of the collapsible sheath 22 in fluid communication with the tubular filament distal end 38.
[0105] In another embodiment in accordance with the present invention, the fluid expelled from the tubular filament distal end 38 is a solution provided to assist in the dislodgment, dissolution and/or breakup of the foreign matter. Fluids suitable for the particular purpose include, but are not limited to, anti-thrombolytic agents, Alkalol, among others.
[0106] In another embodiment in accordance with the present invention, the fluid expelled from the tubular filament distal end 38 is a therapeutic agent added to provide integrity of the drainage system 2. Fluids suitable for the particular purpose include, but are not limited to, antibiotic agents and anti-neoplastic agents.
[0107] Once dislodged and/or broken up, the foreign material flows through the body tube lumen 15 to the canister tube 14 and drainage canister 16, as shown in
[0108] In other embodiments in accordance with the present invention, the filament lumen 37 of the tubular filament 24b is adapted so as to permit the introduction of a sensor, such as, but not limited to, an ultrasound or other sensor device for diagnostic imaging within the body-space tube 10.
[0109] In other embodiments in accordance with the present invention, the filament lumen 37 of the tubular filament 24b is adapted to introduce cameras, or other devices into the body tube lumen 15 while maintaining a sterile environment with respect to body tube 10.
[0110]
[0111] The expandable portion 44 is adapted to facilitate mechanical manipulation of the foreign material 19 to assist in the removal from the body tube lumen 15. The expandable portion 44 is advanced distal to (or beyond) the foreign material 19 while in a relaxed state. The expandable portion 44 is enlarged to take on a profile to at least partially occlude the body tube lumen 15. Withdrawal of the cleaning member 24 from the body tube lumen 15 causes the expanded portion 44 to abut and dislodge the foreign material 19, carrying the foreign material 19 distally to the canister tube 14.
[0112] In one embodiment in accordance with the present invention, the expandable portion 44 is adapted to fully occlude the body tube lumen 15, wherein the expandable portion 44 provides a squeegee action to clean the body tube lumen 15 of the foreign material 19.
[0113] In embodiments in accordance with the present invention, the fluid pressure of the inflation fluid is delivered to the expandable portion 44 by an external fluid source 45a comprising a reservoir 46 coupled to the filament lumen 37 at the tubular filament proximal end 38b of the cleaning member 24. In one embodiment in accordance with the present invention, a fluid pressure source 45a, such as, but not limited to, an elastic bulb or fluid-filled syringe, is provided exterior to the collapsible sheath 22 and coupled to the cleaning member 24 through a coupling. Sterility of the filament lumen 37 is not essential as the fluid is not in communication with the sterile drainage system 20.
[0114] Embodiments of the reservoir 46 comprise, among others, a compliant bulb, balloon, syringe, or other fluid supply means. In one embodiment wherein the reservoir is a compliant bulb, the bulb is compressed displacing the fluid from the reservoir 46 expanding the expandable portion 44. The compression of the bulb is subsequently relaxed to allow the fluid to return to the reservoir 46 and the expandable portion 44 to collapse to the original state.
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[0116] In the embodiment of
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[0119] In an embodiment in accordance with the present invention, as shown in
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[0121] In another embodiment, the expandable portion 44 comprises an elastic material adapted to substantially relax to the original state upon removal of the internal fluid pressure.
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[0124] The elastic cord 56 comprises an elastic property and undergoes tension as the cleaning member 24 is retracted into the collapsible sheath 22, and, upon release of the cleaning member proximal end 28 of the cleaning member 24, the cleaning member distal end 26 is drawn towards the body tube distal end 11.
[0125] In the embodiment in accordance with
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[0128] In another embodiment in accordance with the present invention, referring again to the embodiment of
[0129]
[0130] The umbrella-like expandable portion 58 is adapted to mechanically clean the body tube lumen 15 by mechanical dislodgment of the foreign material 19. The cleaning member 24c is sufficiently flexible to traverse the curvature of the body tube lumen 15, but is sufficiently rigid so as to not buckle when advanced through the body tube lumen 15 by pushing from the proximal end and to advance past the foreign material 19. Further, the umbrella-lice expandable portion 58 is sufficiently stiff when expanded so as to dislodge the foreign material 19 within the body tube lumen 15 as it makes contact therewith.
[0131]
[0132] The umbrella-like expandable portions 58 are adapted to present a folded/compressed/closed state and an unfolded/extended/open state. The umbrella-like expandable portions 58 adapted to open when the cleaning member proximal end 38 is pulled causing the umbrella-like expandable portions 58 to advance towards the body tube proximal end 13, and to close when the cleaning member proximal end 38 is released causing the umbrella-like expandable portions 58 to be drawn towards the body tube distal end 11.
[0133]
[0134] In another embodiment of the present invention, a plurality of body-space drainage tubes are received within the body that are interconnected internal to the body forming a single drainage tube exiting out of one puncture site, such as, but not limited to, bifurcated or trifurcated tube, permitting the tubes to be kept clear from one proximal location, the cleaning member having a plurality of distal cleaning members corresponding to the plurality of drainage tubes.
[0135] Other embodiments of the present invention include a small diameter body tube that enters the patient's chest via a small hole. Once inside the chest, the tube divides into two or more ends, herein called phalanges. Within each phalange is a tube clearing device, as described above. In one application, by way of example, one phalange is positioned over the surface of the heart, one is positioned along the inferior surface of the heart, and one is positioned in the left chest. AU drain to a single tube that exits the body. In this embodiment, all the critical areas of the chest are drained through a single tube that exits the chest wall and skin.
[0136] Likewise, after lung or pleural surgery, one phalange is positioned along the medial surface of the lung, one along the base along the diaphragm, and one along the posterior gutter going to the apex. In this way, all the critical areas of the chest are drained after lung surgery with a single tube exiting the skin and chest wall. Efficacy is maintained, or even increased, and invasiveness, pain, and ultimately cosmesis, are all positively addressed. Multiple double-lumen tubes are bonded together using thin, polymeric severable membranes with a single common connector being attached to one end of the tubes.
[0137] After the multi-lumen tubes are inserted into the chest cavity through a single entry in the chest wall, they can be severed to form individual multi-lumen tubes which can be positioned to drain various sites inside the chest cavity. The reduction of insertion sites lessens the possibility of potential chest-tube-site infections. Various embodiments of the present invention provide a cleaning member that advances in and out of the body tube lumen. Embodiments of the present invention provides that body tubes can be miniaturized Clinicians can choose smaller diameter/lumen body tubes or catheters for drainage if the fear of clotting and clogging is reduced or eliminated. For example, if, for fear of clogging, one routinely uses a 36 F catheter after heart surgery, with embodiments of the present invention, one could use an 8 or 10 F tube, which would hurt less while in place, hurt less when removed, and leave a smaller scar. Furthermore, since smaller tubes could be more readily used, they could be more readily inserted by a wider base of practitioners, due to the reduced need for expertise to insert and clinically manage the tube. Smaller holes mean less pain, less risk of infection, and less risk that the patient will have a complication from air sucking back into the chest through the hole left in the chest wall while it is healing. Larger holes require a stitch to close, and stitches need to be removed, which is time-consuming for the clinician and painful and inconvenient for the patient. A 10 F hole could be easily closed with a bandage, rather than requiring a stitch.