WO2018076104A1 - Medical catheter and method of installing a catheter - Google Patents

Abstract

There is disclosed a catheter comprising a tube having a distal end, a proximal end, a bore dimensioned to permit insertion of a guide member through said bore, an inlet at the distal end for draining fluids from the body cavity into the tube, a drainage outlet for draining fluids out of the tube, an aperture at the distal end for passing the guide member therethrough and an access hub joined to the tube or removably connectable to the tube. The access hub having an interior space open to the bore when connected thereto and an opening configured to permit the guide member to slide through the opening into the bore, whereby a leakproof connection is formed between the guide member and the hub when the guide member is within the opening, wherein the opening self-closes to form a leakproof barrier upon removal of the guide member from the catheter wherein the flow of fluid is blocked when the guide member is removed from the catheter. Wherein the opening within the hub, the bore and the aperture are in sufficient alignment whereby the guide member may be inserted into the tube through the hub and exit the tube through the aperture and whereby the catheter may be guided along the guide member to the body cavity and the guide member then removed from the catheter.

Description

MEDICAL CATHETER AND METHOD OF INSTALLING A CATHETER

CROSS REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to United States provisional patent application serial No. 62/415, 139 filed October 31, 2016, which is hereby incorporated by reference in its entirety.

FIELD

[0002] The present invention relates generally to medical devices and more specifically to catheters for accessing various body cavities and hollow organs to drain content therefrom and to provide therapy thereto.

BACKGROUND

[0003] Conventional drainage catheters and conventional procedures for installing these devices for draining fluid from body cavities and hollow organs may be unsuitable in certain circumstances and may be hampered by medical and anatomic complications. For instance, urethral catheterization for draining of the bladder may be difficult in patients with prostatic enlargement or urethral injury or stricture. Conventional urethral catheterization may cause urethral injury because traditional catheters are generally blunt, can be difficult to insert, and can be prone to damaging urethral walls. These problems are prevalent particularly in males but also some female patients and constitute a significant concern.

[0004] A common practice when encountering difficulty inserting a conventional catheter is to simply apply more force or use another similar blunt-tipped catheter, which can lead to unnecessary trauma. There have been attempts at overcoming some of these problems by providing devices that allow the practitioner to optically visualize the urinary tract, for example in U .S. patent publication 2009/0318798 to Singh et al. which relies on the use of fibre optic bundles and instruments. [0005] It is also known to guide a catheter into a body cavity with a guide wire assembly, for example as disclosed in United States Patent No. 8,956,340. However, improved catheter systems are still needed, in particular for inserting catheters into body cavities such as the bladder.

SUMMARY

[0006] The present invention relates to an improved catheter and associated procedure that permits a catheter to be guided into a body cavity along a pathway established by a guide member. In one aspect, the openings of the catheter form a watertight seal when closed to control the flow of fluid through the catheter.

[0007] In one aspect, the catheter retains bodily contents such as fluid and fecal matter within its interior and allows the clinician to image, aspirate fluid, and/or infuse fluid during the catheter insertion process.

[0008] In one aspect, we disclose a catheter comprising : a catheter tube, said tube being configured to permit insertion into a body cavity and having a distal end, a proximal end opposed to the distal end, a bore extending between the distal and proximal ends, said bore being dimensioned to permit insertion of a guide member through said bore, an inlet at the distal end opening into the bore configured for draining fluid from the body cavity into the tube, an outlet in fluid communication with the bore configured for draining fluids out of the tube, and an aperture at the distal end separate from the inlet and dimensioned for passing the guide member therethrough; and an access hub joined to the tube or removably connectable to the tube, the hub having an interior space open to the bore when connected thereto and an opening configured to permit the guide member to slide through the opening into the bore, whereby a leakproof connection is formed between the guide member and the hub when the guide member is within the opening, wherein the opening self-closes to form a leakproof barrier upon removal of the guide member from the catheter wherein the flow of fluid is blocked when the guide member is removed from the catheter; wherein the opening within the hub, the bore and the aperture are in sufficient alignment whereby the guide member may be inserted into the tube through the hub and exit the tube through the aperture and whereby the catheter may be guided along the guide member to the body cavity and the guide member then removed from the catheter.

[0009] The opening for the guide member may be located within an end wall of the hub. The wall comprises a resilient material and the opening comprises at least one slit within the end wall. Alternatively, the opening may comprise a seal configured to open when the guide member is urged into the opening and to self-close when the guide member is removed from the catheter. For example, the seal may comprise an array of resilient flaps projecting inwardly from a rim, configured to form a seal when closed.

[0010] The access hub may be either integral with the tube or removeably secured to the tube, for example by way of friction fit, screw- threaded attachment, snap fit or luer lock configuration . The access hub may further comprise an access port in fluid communication with the bore configured to permit fluid to drain from the tube and/or to introduce a fluid into said tube.

[0011] The access hub may be removeably secured to the proximal end of the tube or to an opening within the tube between the distal and proximal ends of the tube. The opening within the tube comprising a self- closing means to seal the opening upon withdrawal removal of the access hub from the tube.

[0012] The catheter may further comprise a balloon adjacent to the distal end of the tube, said balloon being in fluid communication with a fluid conduit within said tube for connection to a source of pressurized fluid. [0013] According to another aspect, we disclose a method of catheterizing a body cavity to drain bodily contents therefrom comprising : inserting an elongate guide member into a body cavity to establish a pathway leading from the exterior of the body to the body cavity; inserting the exposed end of the guide member into a catheter, the catheter comprising a tube, a distal aperture at a distal end of the tube, an access hub, and an opening within the access hub wherein the opening comprises a seal to sealingly engage the guide member when inserted therein and to self- seal when the guide member is not inserted therein; advancing the catheter along the guide member whereby the guide member passes through the distal aperture and opening within g the access hub and the catheter traces the pathway established by the guide member until the distal end of the catheter is positioned in the body cavity; and retracting and removing the guide member from the catheter, thereby self-sealing the opening within the access hub.

[0014] According to another aspect, the catheter may comprise an inlet at the distal end thereof and the method comprises the further step of permitting fluid from within the body cavity to drain into the catheter. The fluid is retained within the catheter until released therefrom through an access port at the proximal end thereof. The position of the guide member may be ascertained by imaging, for example by x-ray, ultrasound or by introducing a contrast fluid through the tube via the access port.

[0015] The method may further comprise the step of anchoring the catheter within the body cavity by inflating a balloon engageable with a portion of the wall of the body cavity. [0016] According to another aspect, we disclose a kit comprising a guide member comprising an elongate, flexible member adapted to be inserted into a body cavity or passageway of a patient; and a catheter, the catheter comprising a catheter tube, said tube being configured to permit insertion into a body cavity and having a distal end, a proximal end opposed to the distal end, a bore extending between the distal and proximal ends, said bore being dimensioned to permit insertion of a guide member through said bore, an inlet at the distal end opening into the bore configured for draining fluid from the body cavity into the tube, an outlet in fluid communication with the bore configured for draining fluids out of the tube, and an aperture at the distal end separate from the inlet and dimensioned for passing the guide member therethrough; and an access hub joined to the tube or removably connectable to the tube, the hub having an interior space open to the bore when connected thereto and an opening configured to permit the guide member to slide through the opening into the bore, whereby a leakproof connection is formed between the guide member and the hub when the guide member is within the opening, wherein the opening self-closes to form a leakproof barrier upon removal of the guide member from the catheter wherein the flow of fluid is blocked when the guide member is removed from the catheter;

wherein the opening within the hub, the bore and the aperture are in sufficient alignment whereby the guide member may be inserted into the tube through the hub and exit the tube through the aperture and whereby the catheter may be guided along the guide member to the body cavity and the guide member then removed from the catheter.

[0017] According to another aspect, the kit may further comprise a tube connectable to the hub for draining fluid from the catheter and/or introducing fluid into the catheter. [0018] The kit may further comprise instructions for using the kit.

[0019] Specific dimensions presented herein are intended to provide examples of embodiments of the invention and are not intended to limit the scope of the invention. For reference, Catheter diameters may be described by the French catheter scale ("F"). Furthermore, directional references such as "proximal" and "distal" are intended purely for ease of description.

[0020] The detailed description herein is only intended to provide examples and representative embodiments and is not intended to limit the scope of the invention. The full scope of the invention is presented in the specification as a whole.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Fig. 1 is a perspective view of the drainage catheter with a guide wire sheath and guide wire inserted into the catheter in accordance with an embodiment of the invention in which the balloon is uninflated;

[0022] Fig. 2 is a perspective view of the drainage catheter of Fig. l where the balloon is inflated;

[0023] Fig. 3 is an enlarged view of the distal end of the catheter;

[0024] Fig. 4 is a further enlarged view of the distal end of the catheter illustrating the drainage inlet, deflated balloon, rounded tip and guide wire aperture;

[0025] Fig. 5 is an enlarged view of the proximal end of the catheter illustrating the access hub, the access port, the balloon pump access with a guide wire sheath inserted into the catheter; [0026] Fig. 6 is an enlarged view of the proximal end of the catheter illustrating the access hub, the access port, the balloon pump access, and the guide wire lumen, with a guide wire sheath inserted into the catheter;

[0027] Fig. 7 is a side elevational view in cross section of the drainage catheter of Fig. 1, taken along line 7-7 of Fig. 1 ;

[0028] Fig. 8 is an end view of the access hub, showing one

embodiment of the opening for receiving the guide wire assembly;

[0029] Fig. 9 is an end view as in Fig . 8, showing an alternate embodiment of the opening;

[0030] Fig. 10 is a perspective view of the drainage catheter according to another embodiment of the invention ;

[0031] Fig. 11 is a perspective view of the drainage catheter of Fig. 10 showing the partial withdrawal of the access hub and the access port from the remainder of the catheter;

[0032] Fig. 12 is an enlarged view of the proximal end of the catheter of Fig. 10 illustrating the access hub, the access port, the balloon pump access, and the guide wire lumen, with a guide wire sheath inserted into the catheter; and

[0033] Fig. 13 is a side elevational view in cross section of the drainage catheter of Fig. 10, taken along line 13- 13 of Fig. 10.

[0034] Fig. 14 is a perspective view of the drainage catheter according to another embodiment of the invention suitable for use in an anorectal stenting and evacuation procedure;

[0035] Fig. 15 is a perspective view of the drainage catheter according to Fig. 14 in which the guide wire assembly 10 is removed; [0036] Fig. 16 is a side elevational view in cross section of the drainage catheter of Fig. 15, taken along line 16- 16 of Fig. 15;

[0037] Fig. 17 is a perspective view of the drainage catheter according to Fig. 14 in which the access hub has been removed; and

[0038] Fig. 18 is an enlarged view of the opening in the drainage catheter of Fig. 15 for receiving the access hub.

DETAILED DESCRIPTION

[0039] Identical reference numbers used herein identify refer to the same or similar parts.

[0040] As used herein, the reference terms "proximal" and "distal" refer to proximity with respect to the medical professional who is performing the procedure of installing the catheter within a patient. For example, the portion of the catheter that is closest to the health care professional during catheterization is "proximal," while the opposed end, which extends into the patient's body cavity, is "distal. "

[0041] A first example of a drainage catheter assembly 2, shown in Figs. 1 to 7, comprises in general terms a guide wire assembly 10 and a drainage catheter tube 20. Guide wire assembly 10 comprises a hollow tubular sheath 12 and a guide wire 14 disposed within sheath 12. Guide wire assembly 10 facilitates the catheterization procedure by creating a path which allows the practitioner to guide catheter tube 20 into a body cavity and/or a hollow organ, as described in more detail below.

[0042] Guide wire assembly 10 should have suitable properties that permit it to be threaded through a body cavity. For this purpose, it should be substantially non-compressible, inelastic and flexible but with sufficient rigidity to permit it to be manipulated a depth into a body cavity to reach a bladder, for example. Assembly 10 may be marked with distance markers to aid in inserting tube 20 by a predetermined depth into the patient.

[0043] It will be seen that guide wire assembly 10 is not limited to an assembly comprising an inner wire and exterior housing, but may comprise an alternate structure having a relatively, thin, elongate configuration with the physical properties described above.

[0044] Sheath 12 can comprise a standard angiographic catheter, such as one having a diameter of about 5 F (just under 2 mm diameter).

Sheath 12 should have an outside diameter, and be composed of a suitable material, that slides easily within catheter tube 20 with minimal friction. A suitable range of sizes for the outside diameter of sheath 12 may be from 2F (about 0.66mm) to 8F (about 2.66mm). The outer surface of sheath 12 and may be coated with hydrophilic material and/or agents which reduce scar formation and restenosis. Sheath 12 comprises a lumen to allow passage of fluids, medication and contrast materials. The lumen of sheath 12 should be configured to allow the passage of guidewire 14, but can also be configured to allow passage of a suitable therapeutic device with minimal frictional resistance and leakage. A sheath 12 with suitable configuration and physical properties is the Beacon Tip Torcon NB™ advantage catheter. Other suitable sheaths 12 include various balloon angioplasty catheters.

[0045] Guidewire 14 may be conventional and may be made from a metal and/or composite polymer and may optionally include a nonfriction coating. A suitable diameter can be in the range of 0.010" to 0.038", for example 0.035".

[0046] Tube 20 has a length and width suitable for insertion into a body cavity and/or a hollow organ of a patient. Examples include catheters designed for insertion into a urinary tract, stomach, bowel, or cavity such as the peritoneal space or a cyst or abscess. Tube 20 has a bore 22 for carrying fluids that extends along the entire length of tube 20. [0047] Tube 20 comprises a distal end region 24 and an opposed proximal end region 26. Distal end region 24 terminates at a rounded tip 28 comprising a dome-shaped member having a central aperture 30 extending therethrough, for guide wire assembly 10 to slide through the aperture as tube 20 is threaded along guide wire assembly 10. Distal end region 24 also comprises at least one drainage inlet 32 that opens into bore 22. Drainage inlet 32 is an opening through the wall of tube 20 which is configured to permit the flow of bodily fluids into bore 22 to drain fluid from the body cavity and/or a hollow organ.

[0048] Distal end region 24 also comprises an inflatable

circumferentially extending annular balloon 34 formed from elastic material. Balloon 34 is inflated by pressurized fluid (with or without added contrast material) delivered through a balloon pump access 36 located at the proximal end region 26 of tube 20. Pump access 36 communicates with balloon 34 through an inflation duct 38 located within bore 22.

[0049] The proximal end 37 of drainage catheter tube 20 comprises an access hub 40. Access hub 40 has a tubular side wall 42 and a blind end defined by an end wall 44. Side wall 42 is sealed to or merges with tube 20, and has a hollow interior 46 that is continuous with bore 22 of the tube 20. As such, hub 40 blocks discharge of fluid from tube 20 at the proximal end except through various openings as described below.

[0050] Guide wire assembly 10 can be inserted into bore 22 through an aperture 48 located within access hub 40. As discussed below, assembly 10 can be threaded through a body cavity prior to its being inserted into catheter tube 20, to thereby form a guide-path for tube 20, which in turn is subsequently threaded onto assembly 10. Aperture 48 is a self-closing aperture centrally disposed in end wall 44 to permit tube 20 to be threaded onto guide wire assembly 10 and then permit assembly 10 to be slideably removed once the catheter has been positioned in the patient. Aperture 48 forms a fluid-tight leakproof seal with guide wire assembly 10 when assembly 10 is inserted therein . Furthermore, aperture 48 also self-closes to form a leakproof seal when assembly 10 is removed from tube 20 (for example, when assembly 10 is retracted from tube 20 after the catheter has been positioned in the patient). As such, any fluid within catheter tube 20 is prevented from leaking out of the access hub 40, whether or not assembly 10 is inserted through aperture 48. In order to provide an effective seal, wall 44 may comprise a flexible membrane whereby aperture 48 seals around assembly 10 when inserted therein and also self-closes to forms a sealed, leak proof barrier when assembly 10 is retracted from aperture 48.

[0051] Aperture 48 is biased towards a closed position, whereby when guide wire assembly 10 is inserted through aperture 48, a sealing

engagement is formed and when assembly 10 is removed, aperture 48 self- closes into a leak proof barrier.

[0052] In one example, shown in Fig. 8, end wall 44 comprises a flexible, resilient material and aperture 48 comprises one or more slits 50 within wall 44. Wall 44 is sufficiently resilient whereby when assembly 10 is retracted and aperture 48 is closed, the respective lips 52 of slits 50 are in contact and form a leakproof sealed barrier. When assembly 10 is inserted through aperture 48, the resilience of wall 44 seals the lips 52 against assembly 10 to prevent fluid leakage around assembly 10.

[0053] In another example, as shown in Fig. 9, aperture 48 comprises multiple flexible and resilient leaves or flaps 54 that project inwardly from a circular opening 56. Flaps 54 are generally triangular and are configured to overlap when assembly 10 is retracted from tube 20 to form a seal. For this purpose, flaps 54 are biased towards the flat, closed position. When assembly 10 is inserted through aperture 48, flaps 54 flex inwardly to form an opening to receive assembly 10, and flex outwardly when assembly 10 is retracted. The overlap of the respective flaps 54 maintains a sealed surface surrounding assembly 10, assisted by the bias of flaps 54 towards the closed position which also urges flaps 54 to self-close when assembly 10 is removed. Furthermore, flaps 54 may be asymmetric whereby they slightly rotate as they are flexed when assembly 10 is being inserted or retracted, thereby providing an improved leakproof seal. In this example, aperture 48 may be similar in structure to the Brite Tip Sheath Introducer™ (Cordis) or a hemostatic valve.

[0054] Hub 40 may also include additional ports that access tube 20 as described below.

[0055] Hub 40 has a port 60 that extends radially from side wall 42. Port 60 comprises a short tube having a hollow interior that is in fluid communication with bore 22 of tube 20 to allow fluids to be introduced into or drained from tube 20, such as a contrast material for injection into the body cavity. Port 60 may connect to a tube 62 to remove fluids that have been drained (or aspirated) from the body cavity or hollow organ. As well, a valve, fluid diverter, fluid lock or other fluid control means 64 may be connected to port 60 to control the flow of fluid. Fluid (e.g. body fluids) may be retained within tube 20 until it is discharged through port 60, to minimize unwanted leakage of fluids during the catheterization procedure. For example, the leakproof seals provided within hub 40 prevent fluid from being released from tube 20 until fluid lock 64 is opened.

[0056] As discussed above, access hub 40 is configured to allow the insertion and removal of guide wire sheath 12 and at the same time to seal against fluid entering or draining from access hub 40. In this manner, during the catheterization procedure, a seal is created between the patient's body cavity and/or hollow organ and the outside environment such that any fluid that is drained into tube 20 is contained therein until intentionally discharged from tube 20. The containment of the fluids within the tube 20 during the procedure may allow for a clean and controlled insertion of the tube 20 into the patient's body cavity.

[0057] Additionally, since drainage tube 20 is configured to permit the insertion of guide assembly 10, the drainage tube 20 may reduce the risk of creating false channels, in the urethra for example. Guide assembly 10 establishes a pathway (i.e. a tract) into the patient's body cavity to guide tube 20 through the patient's body to thereby install the catheter with less risk of damaging tissues.

[0058] Figs. 10 to 13 show an embodiment of a drainage catheter assembly 2a, wherein a catheter tube 20a comprises an access hub 40a that is removably secured to tube 20a. Access hub 40a comprises a mating end 70 which can be inserted into or onto an open end of tube 20a and is retained by a secure and leakproof attachment means such as friction fit. As with the previous embodiment, the interior of hub 40a is continuous with bore of tube 20a to define interior channel 22 that extends the full length of tube 20a.

[0059] A friction-fitted access hub 40a can be removed from tube 20a by forcibly pulling it off. This exposes a drainage outlet 72 at proximal end region 26 of tube 20a from which fluid drained into tube 20a may drain out and be collected by a suitable drainage reservoir (not shown), such as a urine drainage bag. When access hub 40a removed, tube 20a resembles a standard foley catheter.

[0060] Use of catheter assembly 2 will now be described by an example of catheterizing a male urethra, for example for treating an injury or enlarged prostate (applicable also to assembly 2a). The urethra can initially be filled with xylocaine or other gel. Guide wire assembly 10

(without tube 20) is initially inserted into a patient's body cavity under fluoroscopic or ultrasound control, to reach a selected location such as the patient's bladder. This initial step is carefully performed to avoid damage to the passageways. The flexibility and thin diameter of assembly 10 permits this component to be threaded through body cavities with reduced risk of damage in comparison to a conventional catheter assembly. A distal end of guide wire assembly 10 may be positioned so as to terminate somewhat beyond the desired terminus of tube 20 to allow for a degree of adjustment when guiding tube 20 into the cavity. A proximal end of assembly 10 protrudes from the patient's body. When thus fully inserted, guide wire assembly 10 establishes a pathway for the insertion of tube 20 to thereby implant tube 20. For this purpose, tube 20 is threaded onto the exposed proximal end of guide wire assembly, by inserting assembly 10 into terminal aperture 30 of tube 20. Tube 20 is then guided into the patient's body along the pathway established by guide wire assembly 10 by pushing the exposed end of tube 20 so as to thread tube 20 along assembly 10. Tube 20 can be retracted if its forward movement is resisted despite firm pressure, and exchanged for a smaller width tube 20. When fully threaded onto guide wire assembly 10, tube 20 will then be fully inserted in the selected cavity. When tube 20 is thus fully threaded onto assembly 10, the combined assembly forms a leakproof member that extends into the body cavity of the patient.

[0061] The operator can confirm the location of tip 28 of tube 20 by aspirating urine or opacifying the urethra by injection of contrast material via access hub 40 and/or via one or more ports 60, or by direct visualization of the guide wire sheath 12 by X-ray or ultrasound control. When tip 28 of the drainage tube 20 is confirmed to be within the bladder (or other desired position), balloon 34 can be inflated (using, for example, 1 : 10 contrast and saline) to anchor the distal end region 24 of tube 20 within the bladder.

[0062] Once tube 20 has been secured in its desired position, guide wire assembly 10 is retracted. Once assembly 10 is removed, aperture 48 of hub 40 seals shut by the self-closing action thereof to thereby prevent fluid leakage from tube 20. Thus, tube 20 may fill with bodily fluid which is then retained within tube 20 until it is selectively discharged through port 60.

[0063] In the embodiment of assembly 2a, hub 40a can at this point be detached from tube 20a. A drainage bag can then be attached to drainage outlet 72 at proximal end region 26 to capture the patient's urine.

[0064] The present catheter may be used in procedures where it is desired to have a clean and controlled insertion of the catheter into the patient's body cavity. This includes catheterization of the bladder in difficult cases such patients with urethral stricture, urethral injury or enlarged prostate, as well as more routine cases. For instance, using a similar technique as described above, catheter tube 20 or 20a can be inserted into the bowel, stomach, kidney or other hollow organ. Access hub 40 allows the clinician to aspirate or infuse fluids or perform further imaging of the patient's passageway and/or the body cavity. Additionally, access hub 40 allows the insertion of many additional devices including, but not limited to, balloons for dilation of strictures, stents, and snares and the infusion of many compositions, including but not limited to, various embolic agents and therapeutic compositions. Tube 20 or 20a can be adapted for procedures such as insertion and exchange of suprapubic catheters, ileal conduits, nephrostomy and jejunostomy procedures, ostomies and colonic stenting procedures such as anorectal stenting and evacuation procedures.

[0065] Figs. 14 to 18 show an embodiment of a drainage catheter assembly 2b suitable for use in a procedure for anorectal stenting and evacuation of colon contents. In this embodiment, catheter assembly 2b comprises a catheter tube 20b which is configured at a proximal end region 26b to receive and retain a rectal drainage tube 74 that leads to a collection bag 76. In the colon stenting and evacuation procedure, it may be preferable to have rectal drainage tube 74 secured to the proximal end region 26b of tube 20b and an access hub 40b secured to tube 20b during substantially the entire procedure. This way, the practitioner can maintain a clean field and have access into the colon during the procedure, and as will be described in more detail below, when the colonic obstruction is removed the stored contents are allowed to drain directly into collection bag 76.

[0066] To secure both rectal drainage tube 74 and access hub 40b for the substantial duration of the entire procedure, a hub aperture or opening 80 is provided within a sidewall 78 of catheter tube 20b. Hub aperture 80 is located between the distal and proximal end regions 24b and 26b. For practicality, aperture 80 may be closer to proximal end region 26b. Aperture 80 is self-sealing and is dimensioned to receive and secure access hub 40b and to prevent fluid leakage when access 40b is withdrawn from aperture 80. [0067] Access hub 40b includes a tubular side wall 42b, a blind end defined by an end wall 44b and a hollow interior 46b. Aperture 48 is centrally disposed in end wall 44b to permit tube 20b to be threaded onto guide wire assembly 10 and then permit assembly 10 to be slideably removed once catheter 20b has been positioned in the patient. As discussed above, aperture 48 forms a fluid-tight leakproof seal with guide wire assembly 10 when assembly 10 is inserted therein and aperture 48 self- closes to form a leakproof seal when assembly 10 is removed from tube 20b.

[0068] A mating end 82 opposed to end wall 44b is configured for insertion into hub aperture 80 such that when hub 40b is inserted into tube 20b, hollow interior 46b is continuous with a bore 22b of the tube 20b.

Mating end 82 may be secured within hub aperture 80 by friction fit.

[0069] With access hub 40b secured to tube 20b, the operator can perform, via access hub 40b, one or more of the procedures described above in respect of access hubs 40 and 40a. Additionally, via aperture 48 of access hub 40b, the practitioner can insert one or more devices such as a self- expanding stent for dilating the colon and maintaining the colon in the dilated state.

[0070] As shown in Figs. 17 and 18, upon completion of the desired procedures, access hub 40b can be withdrawn from the tube 20b. Since hub aperture 80 is self-sealing, the contents from colon are contained within catheter tube 20b upon withdrawal of access hub 40b.

[0071] Use of catheter assembly 2b will now be described by an example of catheterizing a colon and evacuating the contents of the colon. The overall procedure for catheterizing the colon and evacuating its contents is similar in many respects to the procedure for catheterizing the male urethra as described above. Generally, guide wire assembly 10 is initially inserted into a patient's body cavity to reach the patient's colon and to establish a pathway for the insertion of tube 20b. Tube 20b is then guided into the patient's body along the pathway established by guide wire assembly 10 by pushing the exposed end of tube 20b so as to thread tube 20b along assembly 10.

[0072] A self-expanding stent (not shown) can then be introduced into access hub 40b and the stent can be guided under appropriate control to a constricted region of the colon. In some embodiments, the stent may be threaded over guidewire 14 to position it in the region of the colonic stricture. In other embodiments, the stent is positioned across the colonic stricture without the use of guidewire 14. The practitioner can expand the stent, which will dilate the colon at the colonic stricture. The contents of the colon, which may have been backed-up because of the constriction, will drain into tube 20b and then out into collection bag 76. When the

practitioner is satisfied there is no longer a need to access the patient's body cavity, access hub 40b can be withdrawn from tube 20b, and since hub aperture 80 is self-sealing, the contents of the colon will remain with tube 20b until drained into collection bag 76.

[0073] Catheter tubes 20, 20a, and 20b can be made from a flexible, durable material such as latex, silicone, PVC or Teflon™. The outside diameter of tube 20 should complement a selected passageway or body cavity and specific medical procedure. Common sizes are in the range of 8 F to 30 F. Tubes 20, 20a and 20b can be dimensioned for use with a variety of medical procedures as discussed above or where a standard foley catheter is employed.

[0074] In the case of the urethral catheterization, the clinician may select a catheter size sufficient for the free flow of urine and large enough to control leakage of urine around the catheter. A larger size can become necessary when the urine is thick, bloody or contains large amounts of sediment. In the case of a procedure for catheterizing a colon and evacuating the contents of the colon, relatively large caliber (30 F) tubes may be used. In some procedures, such as those procedures requiring some continuous or intermittent irrigation, the catheter size may be large enough such that the bore 22 is sufficiently dimensioned to accommodate at least one irrigation channel (not shown) for irrigation fluids.

[0075] Tubes 20, 20a, and 20b may have a cross-sectional

configuration such as round, oval or other shape suitable for the selected procedure. The shape of tubes 20, 20a, and 20b can also vary along its length.

[0076] Tubes 20, 20a, and 20b may also be provided with an external coating along part or all of its length, for example limited to the distal end region. Suitable coatings include hydrophilic coatings, antibiotics and other therapeutic agents such as growth factors or growth factor inhibitors, or agents used in vascular drug eluting stents to limit restenosis of vessels.

[0077] Tubes 20, 20a, and 20b may further include radiopaque markings, at the distal end region 24 for example, to facilitate the insertion under imaging guidance and fluoroscopic control.

[0078] Further embodiments can be adapted for multiple bore catheters such as various irrigation catheters for irrigating body cavities.

[0079] The embodiments of the present application described above are intended to provide specific examples and embodiments of the invention . Those of skill in the art could alter, modify and vary these embodiments without departing from the scope of the invention . In particular, features from one or more of the above-described embodiments may be selected to create alternate embodiments comprised of a subcombination of features which may not be explicitly described above. In addition, features from one or more of the above-described embodiments may be selected and combined to create alternate embodiments comprised of a combination of features which may not be explicitly described above. Features suitable for such combinations and subcombinations would be readily apparent to persons skilled in the art upon review of the present application as a whole. Any dimensions provided in the drawings are provided for illustrative purposes only and are not intended to be limiting on the scope of the invention. The subject matter described herein and in the recited claims intends to cover and embrace all suitable changes in technology.

Claims

A catheter comprising : a catheter tube, said tube being configured to permit insertion into a body cavity and having a distal end, a proximal end opposed to the distal end, a bore extending between the distal and proximal ends, said bore being dimensioned to permit insertion of a guide member through said bore, an inlet at the distal end opening into the bore configured for draining fluid from the body cavity into the tube, an outlet in fluid communication with the bore configured for draining fluids out of the tube, and an aperture at the distal end separate from the inlet and dimensioned for passing the guide member

therethrough; and an access hub joined to the tube or removably connectable to the tube, the hub having an interior space open to the bore when connected to the catheter tube and an opening configured to permit the guide member to slide through the opening into the bore whereby a leakproof connection is formed between the guide member and the hub when the guide member is within the opening, wherein the opening self-closes to form a leakproof barrier upon removal of the guide member from the catheter that blocks the flow of fluid from the opening when the guide member is removed from the catheter; wherein the opening within the hub, the bore and the aperture are arranged to permit the guide member to be inserted into the tube through the hub and exit the tube through the aperture and whereby the catheter may be guided along the guide member to the body cavity and the guide member then removed from the catheter.

The catheter of claim 1 wherein the opening is within an end wall of the hub, said end wall comprising a resilient material and the opening comprises at least one slit within the end wall or the opening comprises a seal configured to open when the guide member is urged into the opening and to self-close when the guide member is removed from the catheter.

The catheter of claim 2 wherein the seal comprises an array of resilient flaps projecting inwardly from a rim, configured to form a seal when closed.

The catheter of claim 1 wherein the access hub is integral with the tube or the access hub is removeably secured to the tube.

The catheter of claim 1 wherein the access hub is at the proximal end of the tube.

The catheter of claim 1 wherein the access hub is removably attached to the tube at an opening within the tube between the distal and proximal ends of the tube, said opening within the tube comprising a self-closing means to seal the opening upon removal of the access hub from the tube.

The catheter of claim 1 wherein the access hub further comprises a port in fluid communication with the bore configured to permit fluid to drain from the tube and/or to introduce a fluid into the tube.

A method of catheterizing a body cavity to drain fluids therefrom comprising : inserting an elongate guide member into a body cavity to establish a pathway leading from the exterior of the body to the body cavity; inserting the exposed end of the guide member into a catheter, the catheter comprising a tube, a distal aperture at a distal end of the tube, an access hub, and an opening within the access hub wherein the opening comprises a seal to sealingly engage the guide member when inserted therein and to self-seal when the guide member is not inserted therein; advancing the catheter along the guide member whereby the guide member passes through the distal aperture and the opening within the access hub and the catheter traces the pathway established by the guide member until the distal end of the catheter is positioned in the body cavity; and retracting and removing the guide member from the catheter, thereby self-sealing the opening within the access hub.

9. The method of claim 8 wherein the catheter comprises an inlet at the distal end thereof and said method comprises the further step of draining body fluids into the catheter, said fluid being retained within the catheter until released therefrom through an access port at the proximal end thereof.

10. The method of claim 8 further comprising the step of ascertaining the position of the guide member inside the body cavity by imaging the guide member after insertion into the body cavity.

11. The method of claim 8 wherein said catheter comprises the catheter according to any one of claims 1 to 7.

12. A kit comprising : a guide member comprising an elongate, flexible member adapted to be inserted into a body cavity or passageway of a patient; and a catheter, the catheter comprising a catheter tube, said tube being configured to permit insertion into a body cavity and having a distal end, a proximal end opposed to the distal end, a bore extending between the distal and proximal ends, said bore being dimensioned to permit insertion of a guide member through said bore, an inlet at the distal end opening into the bore configured for draining fluid from the body cavity into the tube, an outlet in fluid communication with the bore configured for draining fluids out of the tube, and an aperture at the distal end separate from the inlet and dimensioned for passing the guide member therethrough; and an access hub joined to the tube or removably connectable to the tube, the hub having an interior space open to the bore when connected thereto and an opening configured to permit the guide member to slide through the opening into the bore, whereby a leakproof connection is formed between the guide member and the hub when the guide member is within the opening, wherein the opening self-closes to form a leakproof barrier upon removal of the guide member from the catheter wherein the flow of fluid is blocked when the guide member is removed from the catheter; wherein the opening within the hub, the bore and the aperture are in sufficient alignment whereby the guide member may be inserted into the tube through the hub and exit the tube through the aperture and whereby the catheter may be guided along the guide member to the body cavity and the guide member then removed from the catheter.

13. The kit of claim 12 wherein the catheter comprises the catheter

according to any one of claims 2 to 7.

14. The kit of claim 13 further comprising a tube connectable to the hub for draining fluid from the catheter and/or introducing fluid into the catheter.