PERCUTANEOUS ACCESS PATHWAY SYSTEM

Abstract

An improved method and device are provided for forming and/or maintaining a percutaneous access pathway. The device generally comprises an access pathway and attachment device. The provided assembly substantially reduces the possibility of iatrogenic infection while accessing and/or re-accessing a body space.

Claims

1-22. (canceled)

23. A device for forming and/or maintaining a percutaneous access pathway into a body of a patient, comprising: an access pathway configured to allow access to an internal portion of a patient's body from an external environment, the access pathway comprising an access pathway port configured to maintain a non-pierceable barrier between the internal portion of the body and the external environment when in a closed position, wherein the access pathway port connects through a distal opening to an access pathway catheter extending into the internal portion of the body and allowing access into the internal portion of the body when the access pathway port is open; and an attachment device connectable to the access pathway port and configured to open the access pathway port, the attachment device comprising an internally sterile attachment device sheath at least partially surrounding an internal equipment component of the attachment device, the attachment device sheath configured to enable insertion of at least part of the internal equipment component into the internal portion of the body through the access pathway when the attachment device is connected to the access pathway port, and wherein the attachment device includes a reversible locking mechanism that engages with the internal equipment component.

24. The device of claim 23, wherein the reversible locking mechanism prevents the internal equipment component of the attachment device from being inserted into the body until a human operator causes the internal equipment component to be inserted.

25. The device of claim 23, wherein the reversible locking mechanism ensures that the internal equipment component of the attachment device stays in a desired location once inserted into the internal portion of the body.

26. The device of claim 23, wherein the internal equipment component of the attachment device is a chest tube.

27. The device of claim 23, wherein the attachment device includes a means for both irrigation and suction.

28. The device of claim 23, wherein the internal equipment component of the attachment device includes an endoscope.

29. The device of claim 23, wherein the internal equipment component of the attachment device includes one or more surgical tools.

30. The device of claim 23, wherein the attachment device sheath is configured to enable manipulation of the internal equipment component through the attachment device sheath while maintaining a barrier from the external environment to within the body.

31. The device of claim 30, wherein the attachment device sheath is air-impermeable.

32. The device of claim 23, wherein the access pathway port includes a mobile pathway or door that moves to open and close an entrance to the access pathway.

33. The device of claim 32, wherein the mobile pathway or door utilizes a cylinder, a sphere, a ball, or a ball-valve mechanism.

34. The device of claim 23, wherein the attachment device can be reversibly connected to and disconnected from the access pathway port.

35. The device of claim 23, wherein removal of the attachment device from the access pathway port is inhibited while the access pathway port is open.

36. The device of claim 23, wherein the attachment device is configured to connect to suction in the external environment.

37. The device of claim 23, wherein the access pathway contains a means for securing the access pathway to the body of a patient.

38. The device of claim 23, wherein the internal equipment component of the attachment device is a ventriculostomy tube, intracranial pressure monitor, intracranial oxygen monitor, external ventricular drain, device to drain intracranial hemorrhage, and/or other ventricular shunt.

39. The device of claim 23, wherein the internal portion of the patient's body is inside the chest, abdomen, retroperitoneal, cranium, trachea, abscess, artery, bladder, bone, collection of fluid, organ, skull, trachea, vein, vessel, and/or other body cavity.

40. The device of claim 23, wherein the attachment device is configured to cause the access pathway catheter to expand when part of the attachment device is inserted into the access pathway.

41. A system for forming and/or maintaining a percutaneous access pathway into a body of a patient, comprising: an access pathway configured to connect an internal portion of a body of a patient to an external environment, the access pathway comprising: an access pathway catheter having a distal opening that is configured to extend into the internal portion of the body; and an access pathway port that, when in a closed position, provides an airtight, non-pierceable barrier between the internal portion of the body and the external environment; and one or more attachment devices connectable to the access pathway port and configured to allow opening of the access pathway port, each of the one or more attachment devices containing an internally sterile attachment device sheath at least partially surrounding an internal equipment component and a reversible locking mechanism that engages with the internal equipment component.

42. The device of claim 41, wherein the reversible locking mechanism prevents the internal equipment component of the attachment device from being inserted into the body until a human operator causes the internal equipment component to be inserted.

43. The device of claim 41, wherein the reversible locking mechanism ensures that the internal equipment component of the attachment device stays in a desired location once inserted into the internal portion of the body.

44. The system of claim 41, wherein the one or more attachment devices are inhibited from removal from the access pathway port while the access pathway port is open.

45. The system of claim 41, wherein the attachment device sheath is configured to enable insertion of at least part of the internal equipment component into the internal portion of the body through the access pathway when the one or more attachment devices are connected to the access pathway.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0048] FIGS. 1-4 depict a percutaneous access pathway in accordance with an embodiment of the invention, as assembled prior to use.

[0049] FIG. 5 is a cross-sectional view of a percutaneous access pathway in accordance with an embodiment of the invention, as assembled prior to use.

[0050] FIG. 6 depicts an attachment device containing a chest tube as an internal equipment component in accordance with an embodiment of the invention.

[0051] FIG. 7 is a side view of an attachment device containing a chest tube as an internal equipment component in accordance with an embodiment of the invention.

[0052] FIG. 8 is a cross-sectional side view of the attachment device of FIG. 7 in accordance with an embodiment of the invention.

[0053] FIG. 9 is a side view of access pathway connecting to the attachment device in accordance with an embodiment of the present invention.

[0054] FIG. 10 is a cross-sectional view of access pathway connecting to the attachment device in accordance with an embodiment of the present invention.

[0055] FIG. 11 is a cross-sectional side view of the device of FIG. 10, shown with the ball-valve mechanism partially engaged.

[0056] FIG. 12 is a cross-sectional side view of the device of FIG. 10, shown with the ball-valve mechanism fully engaged.

[0057] FIG. 13 is a cross-sectional side view of the device of FIG. 10, shown with the chest tube advancing distally.

[0058] FIG. 14 is a cross-sectional side view of the device of FIG. 10, shown with the chest tube entering and dilating the catheter.

[0059] FIG. 15 is a side view of an attachment device, shown with a chest tube fully advanced through the access pathway, in accordance with an embodiment of the invention.

[0060] FIG. 16 is a side view of the device of FIG. 15, shown with the chest tube locking mechanism engaged.

[0061] FIG. 17 depicts an attachment device containing a check valve in accordance with an embodiment of the invention.

[0062] FIG. 18 depicts an attachment device containing a different type of check valve modified to facilitate attachment to suction and/or an autotransfusion means in accordance with an embodiment of the invention.

[0063] FIG. 19 depicts an attachment device containing an irrigation-suction system as an internal equipment component in accordance with an embodiment of the invention.

[0064] FIG. 20 depicts an attachment device containing an endoscopic camera as an internal equipment component in accordance with an embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

[0065] Referring to the drawings FIG. 1-20, embodiments of the present invention are illustrated and generally indicated as 10. For ease of reference, distal shall refer to the end of the device farthest away from the user/operator, while proximal shall refer to the end of the device closest to the user/operator.

[0066] FIGS. 1-5 show an access pathway 20 made up of the irreversible combination of a catheter 30 and port 40 according to an embodiment. Once the distal end of catheter 30 is placed into the appropriate body cavity (e.g. pleural cavity) through any of the aforementioned techniques, access pathway 20 can be secured to the patient by one or more of the many means of adhering devices to patient skin known in the art (e.g. tape, glue, gum, suture, staples, adhesive, etc.). In some embodiments, surface 372 of access pathway 20 contains a means for establishing an air-tight seal (e.g. adhesive, occlusive ointment) from access pathway 20 to the patient's skin. In some embodiments, holes 374 are available for securing via suture and/or staples.

[0067] An internal pathway stretching through access pathway 20 from its distal end in a body to its proximal portion in the external environment is reversibly obstructed by a non-pierceable airtight door when in its closed state by ball-valve mechanism 340, made up of port shell 370, port ball 380, and ball-valve seats (not shown). In some embodiments, an airtight seal is formed directly between port ball 380 and port shell 370, while in others the seal is obtained and/or assisted by one or more pressure or non-pressure O-rings, seats, and/or washers. Regardless, when in its closed configuration, ball-valve mechanism 340 prevents air or infection from entering the body through access pathway 20.

[0068] A locating boss 390 on the port 40, which in some embodiments is a bright or otherwise noticeable color, ensures that it will be correctly aligned for proper engagement with attachment connector 150 (see later figures). O-ring 388 forms an airtight seal with attachment connector 150 when connected. Access pathway port 40 additionally includes locking mechanism 381, made up of pin holder 385, pin 387, and a spring (not shown), which interacts with trunnion feature 383. Together, they prevent port ball 380 from opening (i.e. rotating) when ball-valve actuating mechanism 460 of attachment connector 150 (see later figures) is not connected. However, when it is attached, key 464 of ball-valve actuating mechanism 460 (see later figures) pushes pin 387 out of the groove within trunnion feature 383 to allow ball-valve mechanism 340 to rotate and thus open port 40. Disengagement feature 386 additionally prevents disengagement of access pathway port 40 from attachment connector 150 when ball-valve actuating mechanism 460 is engaged (see later figures), ensuring that attachment connector 150 cannot be removed from port 40 until ball-valve mechanism 340 is fully closed. Flange 375 helps protect the internal mechanism of attachment connector 150 from external influences once it is connected to port 40.

[0069] Referring now to FIGS. 6-8, one embodiment of attachment 140 is shown. In this embodiment, a chest tube is used as an example of the internal equipment component. Attachment 140 includes attachment connector 150, ball-valve actuating mechanism 460, equipment locking mechanism 470, chest tube 170, and sheath 180. Chest tube 170 is at least partially covered by sheath 180 and sealed to it at connection point 191, but slides within sheath 180 and attachment connector 150 such that it can extend out of attachment exit 154 if sheath 180 is collapsed by the operator. Under some embodiments, in initial configuration attachment 140 includes a removable cap (not shown) sealing attachment exit 154 closed and/or a removable cap and/or check valve (not shown) on or around proximal end 192, which provides the benefit of enclosing an area within attachment connector 150 and sheath 180 that maintains a barrier to the external environment (e.g. for maintaining a sterile inner area before initial use). Additionally, despite outside manipulation, when attachment connector 150 is connected to access pathway 20 and the proximal end 192 is closed off or connected to a mechanism for suction (see later figures), there is a barrier between the external space and an internal space, containing at least part of chest tube 170 and connecting into the patient (e.g. for inhibiting potential infection from entering the patient). Proximal end 192 can be connected to suction or other chest tube drainage means to drain air and/or fluid from the body cavity. Attachment connector 150 contains ball valve actuating mechanism 460, which includes nob 462 (or, in other embodiments, a lever, dial, or button) and key 464. Key 464 slides into trunnion feature 383 when the attachment 140 is engaged with the access pathway port 40 and unlocks locking mechanism 381 by depressing pin 387 (see other figures). Thus, nob 462 can be turned by the operator to rotate the port ball 380 when access pathway port 40 and attachment connector 150 are connected. Attachment 140 additionally contains equipment locking mechanism 470, which includes equipment lock 472, equipment lock holder 473, and a spring 475 (shown later). Under this embodiment, to move chest tube 170 forward or backwards in reference to attachment connector 150, the user must depress tube lock 472 downward.

[0070] FIGS. 9-10 depict the assembly upon reversible connection of attachment 140 to access pathway 20. The connection of access pathway port 40 to attachment connector 150 allows access pathway 20 and attachment 140 to securely connect and form an airtight seal via O-ring 388 (or, in other embodiments, via direct contact and/or a seat, washer, or related mechanism). Once connected, there is an uninterrupted transcutaneous access pathway from the body cavity through access pathway 20 to chest tube 170, through which chest tube 170 may be inserted into the body. Additionally shown is equipment locking mechanism 470 of attachment 140, including equipment lock 472, equipment lock holder 473, and spring 475. To move chest tube 170 forward or backwards in reference to attachment connector 150, the user must depress tube lock 472, thus displacing its internal ring so as to disconnect from and allow chest tube 170 to move. When no pressure is exerted on tube lock 472, spring 475 pushes tube lock 472 upwards to hold chest tube 170 in its desired position, once established.

[0071] Referring now to FIGS. 11-12, one benefit of embodiments of the device 10 is that it only allows access pathway port 40 to open when an opposing attachment connector 150 is attached and engaged. To open and engage, the user moves nob 462 and thus key 464 (see previous figures) on attachment connector 150, which in turn opens ball-valve mechanism 340. Key 464 moves trunnion feature 383 (see previous figures) on access pathway port 40 to turn port ball 380, which causes the ball-valve mechanism 340 to become in line with the inside of catheter 30, the proximal external surface of access pathway port 40, and attachment connector 150. As aforementioned, while engaged the device also prevents the removal of attachment connector 150 from access pathway port 40 via feature 386 and/or flange 375 (see previous figures).

[0072] Referring now to FIGS. 13-16, with port ball 380 in its open position, chest tube 170 may now advance through it into catheter 30 and the patient's chest cavity, as long as equipment locking mechanism 470 is disengaged. The opening of ball-valve mechanism 340 has created an uninterrupted transcutaneous access pathway within access pathway 20 and attachment connector 150. As such, when tube lock 472 is pressed down, chest tube 170 can be manipulated by the operator within collapsible sheath 180 to slide it distally through access pathway 20 and into the pleural space. One safety feature of the device is that attachment connector 150 is unable to be removed from access pathway 20 until chest tube 170 is pulled out and ball-valve mechanism 340 closed, ensuring that the external environment never communicates directly through an open ball-valve mechanism 340 to the body cavity (as long as the proximal end 192 of chest tube 170 is sealed). Once chest tube 170 is in the desired location, equipment locking mechanism 470 may be reversibly released (FIG. 16) to hold chest tube 170 at the desired length within the body. Because chest tube 170 is in the body, attachment connector 150 remains locked onto access pathway 20 until removal of chest tube 170 and closure of ball-valve mechanism 340.

[0073] Although not shown in the Figures, in some embodiments attachment 140 contains means to save the patient's blood for autotransfusion (discontinuous and/or continuous) and/or cell salvage. In various embodiments, this is provided by a feature that is connected onto chest tube suction apparatus (e.g. as is traditionally performed), directly onto the proximal end 192 of chest tube 170, and/or directly onto another attachment device embodiments (e.g. FIG. 18, FIG. 19). In some embodiments, this autotransfusion means is a bag, storage container, and/or other means for gathering and/or storing the patient's blood to allow autotransfusion back into the patient. In many of the embodiments, the autotransfusion means includes one or more filters (e.g. 200-micron filter) to facilitate autotransfusion. In various embodiments, autotransfusion means operates via gravity, pressure cuff, and/or continuous autotransfusion and/or additionally includes autotransfusion connector, reinfusion tubing, autotransfusion bag, and/or a method for measuring blood output.

[0074] Additionally, although not shown in the Figures, in some embodiments chest tube 170 has a check valve to prevent air and/or debris from entering the tube and body (e.g. Heimlich valve at its proximal end 192). Additionally, in some embodiments attachment 140 includes a device to produce vibration and/or agitation to chest tube 170 to better assist with suction and removal of material (e.g. retained hemothorax, pus). Additionally, in some embodiments, intrapleural thrombolytic agents, devices with one or more wires for chest tube de-clogging, and/or other prevention or treatment methods for retained hemothorax are used in conjunction with the device.

[0075] Additionally, although not shown in the Figures, in some embodiments the device includes an access port cap that can cover access pathway port 40 when it is closed and another attachment is not in use. This attachment securely covers access pathway port 40 without opening ball-valve mechanism 340, thus providing an additional barrier to entry of air, dust, dirt, and/or other external material. In some embodiments, this access port cap includes a modified nob 462 that locks the access port cap onto access pathway port 40 without opening ball-valve mechanism 340. In other embodiments, access port cap does not have nob 462 and/or has a locking mechanism on the other side (e.g. interacting with feature 386).

[0076] Referring now to FIGS. 17-20, other embodiments of attachment 140 are shown. These embodiments can be used interchangeably with those described previously via reversible connection to access pathway port 40 and/or as part of system and/or kit that includes at least one port and one or more different attachment devices. FIG. 17 shows another embodiment of attachment 140. In this embodiment, connected to attachment connector 150 is one or more check valves 500. When connected to access pathway 20, this attachment allows air, fluid, and/or other debris to escape the body while preventing air, fluid, and/or other debris from entering access pathway 20. In various embodiments, this type of attachment is used in isolation (thus, not requiring external suction), connected to suction, and/or connected to an autotransfusion bag. Additionally, in various embodiments the check valve is one or more of a ball check valve, diaphragm check valve, stop-check valve, lift-check valve, in-line check valve, duckbill valve, Heimlich valve, and/or pneumatic non-return valve of various sizes. This embodiment contains no sheath or internal equipment component for insertion into the body. Nob 462 is shown in this embodiment as a lever.

[0077] Referring now to FIG. 18, another embodiment of attachment 140 is shown. In this embodiment, connected to attachment connector 150 is a check valve 500 (e.g. a Heimlich valve) modified to facilitate attachment to suction and/or an autotransfusion means through proximal portion 510. This embodiment contains no sheath or internal equipment component for insertion into the body. Nob 462 is shown in this embodiment as a lever.

[0078] Referring now to FIG. 19, another embodiment of attachment 140 is shown. In this embodiment, the internal equipment component is a loop irrigation mechanism 602 at least partially sealed within the sheath 180 (shown with sheath 180 collapsed). The loop irrigation mechanism 602 includes irrigation tube 604 and drainage tube 606. This and related embodiments allow continuous and/or intermittent loop irrigation to prevent and/or treat retained hemothorax and/or other buildup within the body (e.g. the pleural cavity). This functions by having water, normal saline, and/or other solution enter the body through irrigation tube 604, wash through the body cavity, and then be removed by suction through drainage tube 606.

[0079] Referring now to FIG. 20, another embodiment of attachment 140 is shown. In this embodiment, connected to attachment connector 150 is an endoscope 700 (e.g. a thoracoscope) at least partially sealed within sheath 180 (shown with sheath 180 collapsed). In this and related embodiments, a rigid and/or flexible endoscope tube (e.g. fiber-optic scope) is partially sealed within sheath 180 with the eyepiece and/or screen for image viewing located outside of the body.

[0080] These embodiments include various sizes (e.g. 5-mm, 10-mm) and lenses (e.g. 0, 30) of endoscope. Some embodiments include an additional channel to also allow entry of medical instruments and/or manipulators. In this and related embodiments, the attachment can be used for thoracoscopy, pleuroscopy, other procedures involving the passage of an endoscope through the chest wall (e.g. fluid drainage, biopsy, pleurodesis), and/or other procedures involving the passage of an endoscope into the body.

[0081] Under various embodiments, these attachments facilitate the performance in a location without extensive sterility (e.g. out-of-hospital, on the battlefield, at the bedside, in the intensive care unit) of procedures currently performed in a sterile operating room (e.g. VATS). These procedures include but are not limited to evaluation of chest trauma, treatment of chest trauma, evaluation of diaphragmatic injury, treatment of diaphragmatic injury, lobectomy, wedge resection, decortication, tissue biopsy, stapled lung biopsy, pneumonectomy, resection of pulmonary nodule, evaluation of mediastinal tumors, evaluation of adenopathy, pleural biopsy, bullectomy, treatment of pneumothorax, management of empyema, pleurodesis of malignant effusions, repair of a bronchopleural fistula, pericardial window, sympathectomy, truncal vagotomy, pulmonary decortication, pleurodesis, lung biopsy, pleural biopsy, esophageal operation, mediastinal mass resection, and/or pulmonary lobectomy. Although multiple embodiments of attachment 140 are shown with different internal equipment components, the invention is not limited to the embodiments set forth herein for purposes of exemplification.

[0082] Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions.

[0083] Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted.

[0084] Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended.

[0085] Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.

[0086] For purposes of interpreting the claims, it is expressly intended that the provisions of 35 U.S.C. 112(f) are not to be invoked unless the specific terms means for or step for are recited in a claim.