US20080306427A1

Movatterモバイル変換

Info

Publication number: US20080306427A1
Application number: US11/758,526
Authority: US
Inventors: Frances Kristen Bailey
Original assignee: Cook Inc
Current assignee: Cook Inc
Priority date: 2007-06-05
Filing date: 2007-06-05
Publication date: 2008-12-11
Also published as: US20110092876A1; US8900176B2

Abstract

An indwelling catheter device and a method of treatment using the indwelling catheter device are provided. The indwelling catheter device includes an elongate shaft having a proximal portion, a distal portion, a first lumen extending longitudinally therethrough and an inflation lumen extending at least partially through the shaft. The distal portion of the shaft includes a first opening connected to the first lumen. The catheter device further includes a balloon operably connected to an outer surface of the shaft proximal to the first opening wherein the balloon at least partially surrounds the shaft. The inflation lumen is connected to the balloon for selective inflation and deflation of the balloon for disrupting migration of the occluding material and inhibiting the material from occluding the first opening when the catheter device is indwelling.

Description

TECHNICAL FIELD

This invention relates generally to indwelling medical devices, and in particular, to catheters susceptible to fibrin deposition, such as catheters for use in hemodialysis treatment.

BACKGROUND OF THE INVENTION

Catheters or other medical devices for placement into a patient's vascular system are used for many procedures. Frequently these devices are left in place for extended periods, especially when the procedures are performed on a periodic basis and can include several treatments per week. For example, some catheters are used in the simultaneous introduction of fluid into the body and withdrawal of fluid from the body. Such indwelling catheters are particularly useful in hemodialysis. The hemodialysis catheter is typically inserted partially within the body with the distal end placed in a blood vessel and the proximal end external to the body and connectable to another device such as a dialysis unit. An indwelling hemodialysis catheter is advantageous in that the patient does not need to have repeated needle insertions into the skin to gain access to the vasculature each time a dialysis procedure is initiated. Any type of indwelling medical device has the advantage of allowing repeated treatments using the same device for access to the body without the need for reinserting the device for each treatment.

However, several disadvantages are associated with leaving an indwelling device in place for an extended period of time. Patients may develop an infection at the insertion site or in the tissue surrounding the indwelling device. In addition, clots or a fibrous sheath may develop and occlude openings in the catheter and provide additional sources for infections to develop. The fibrous sheath originates from the insertion point at the patient's skin and migrates distally along the device until the openings in the device become occluded. The fibrous sheath typically begins to develop within twenty-four hours of insertion of the device into the patient with an initial thrombus present which is composed of platelets, fibrin, red blood cells, and white blood cells. After three days, the thrombi continue to thicken forming a fibrous sheath and within one week, smooth muscle cells infiltrate the fibrous sheath. The surface of the fibrous sheath is covered with endothelial cells oriented in the direction of blood flow. Within two weeks, the sheath is a mixture of smooth muscle cells and collagen and at three to four weeks, the volume of collagen increases and becomes organized in thicker, coiled bundles. After two to six months collagen is the main component. Sufficient migration and development of the fibrous sheath become evident with a decrease in flow rate through the device to indicate that an opening has become at least partially occluded.

Occluding the opening(s) presents the additional problem that successive treatments require substantially more time to adequately perform the procedure and may increase the costs relating to the treatment. The openings may become completely occluded, for example, by the sheath, so that the device must be removed and a new device inserted. Treatments including pharmaceutical compositions have been used during each procedure to try to disrupt the sheath or clot. However, some pharmaceutical compositions may further complicate the treatment and add to the costs of the procedure.

What is needed is an improved medical device and associated methods that disrupt the migration and inhibit the formation of the occluding materials, such as a fibrous sheath, around the device and allow flow to continue through the device at a sufficiently high rate for treatment.

BRIEF SUMMARY OF THE INVENTION

The foregoing problems are solved and a technical advance is achieved in an illustrative medical device having a balloon that is inflatable to disrupt the occlusion of an opening on the indwelling medical device.

In one aspect of the invention, an indwelling catheter device for fluid flow therethrough is provided. The indwelling catheter device includes an elongate shaft having a proximal portion, a distal portion, a first lumen extending longitudinally therethrough and an inflation lumen extending at least partially through the shaft. The distal portion of the shaft includes a first opening connected to the first lumen. The catheter device further includes a balloon operably connected to an outer surface of the shaft proximal to the first opening wherein the balloon at least partially surrounds the shaft. The inflation lumen is connected to the balloon for selective inflation and deflation of the balloon. The balloon is configured for inhibiting occluding material from occluding the first opening when the catheter device is indwelling.

In another aspect of the present invention, a method for intraluminal treatment of a patient employing an indwelling catheter device is provided. The method includes inserting at least a portion of a shaft of a catheter device into a vessel of the patient. The catheter device includes the shaft having a lumen extending longitudinally therethrough having an opening at a distal portion of the shaft and a balloon operably connected to the shaft proximal to the opening. The method further includes providing a treatment through the lumen and inflating the balloon to disrupt a migration of occluding material distally on the shaft so as to inhibit the occluding material from occluding the opening in the distal portion of the shaft. Inflation of the balloon may be before, during or after the treatment or combinations thereof.

In another aspect of the present invention, a method for intraluminal treatment of a patient employing an indwelling catheter device is provided. The method includes inserting a distal end of a shaft of a catheter device into a vessel of the patient. The catheter device includes the shaft having a first lumen extending longitudinally therethrough to a first opening and a second lumen extending longitudinally therethrough to a second opening and a balloon operably connected to the shaft proximal to the first and second openings. The method further includes withdrawing a bodily fluid to be treated from the vessel through the second lumen and treating the fluid in a treatment instrument. The method includes infusing the treated fluid through the first lumen into the vessel and selectively inflating the balloon to inhibit occluding material from occluding the first and second openings.

Advantages of the present invention will become more apparent to those skilled in the art from the following description of the preferred embodiments of the invention which have been shown and described by way of illustration. As will be realized, the invention is capable of other and different embodiments, and its details are capable of modification in various respects. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS

FIG. 1A is a side elevational view of one embodiment of a catheter device of the present invention;

FIG. 1B is a side elevational view of the embodiment shown inFIG. 1A with an inflated balloon;

FIG. 2 is an enlarged cross-sectional view taken along the lines A-A ofFIG. 1A;

FIG. 3 is an enlarged cross-sectional view taken along the lines B-B ofFIG. 1A;

FIG. 4 is a top plan view of the distal end of the catheter device shown inFIG. 1A;

FIG. 5 is an enlarged cross-sectional view of the balloon shown inFIG. 1B;

FIG. 6A is a side elevational view of another embodiment of the catheter device of the present invention having a distal balloon;

FIG. 6B is a side elevational view of the embodiment shown inFIG. 2A with the balloon inflated;

FIG. 7A is a side elevational view of another embodiment of the catheter device of the present invention having a proximal balloon;

FIG. 7B is a side elevational view of the embodiment shown inFIG. 3A with the balloon inflated;

FIG. 8 is side elevational view of another embodiment of the present invention with an inflated balloon;

FIG. 9A is a side elevational view of the embodiment shown inFIG. 1A showing occluding material on the shaft; and

FIG. 9B is a side elevational view of the embodiment shown inFIG. 1B with the occluding material disrupted.

DETAILED DESCRIPTION OF THE INVENTION

Several possible embodiments of an indwelling device of the present invention are shown in the figures. The indwelling device of the present invention may be any kind of medical device used for delivering multiple treatments through the indwelling device rather than a single insertion device that is subsequently removed after the single treatment. Indwelling devices of the present invention include, but are not limited to, devices for treatment of the vasculature, urogenital system, and the gastrointestinal tract.FIGS. 1A and 1B illustrate the present invention with reference to a hemodialysis catheter, however the description is intended to be illustrative of the present invention and not limited to such devices. The terms “proximal” and “distal” as used herein to describe the portions of the catheter. The term “proximal portion” refers the portion of the device that is closest to the operator during use of the medical device. The term “distal portion” refers to the portion of the device that is inserted into the patient, or that is closest to the patient.

Anindwelling catheter device10 of the present invention is shown inFIG. 1A. Thecatheter10 includes anelongate shaft12 having aproximal portion14, adistal portion16 and alumen18 extending through theshaft12, thelumen18 having anopening20 at adistal end22 of theshaft12. Thecatheter10 shown inFIG. 1A includes asecond lumen24 extending longitudinally through theshaft12 and having anopening26 in thedistal portion16. (

Lumens

18,24 shown inFIGS. 2 and 3.) Thecatheter10 further includes aballoon30 operably connected to theshaft12. As shown inFIGS. 1A and 1B, theballoon30 extends longitudinally along theshaft12 from theproximal portion14 to thedistal portion16. Aninflation lumen32 extends longitudinally along a portion of theshaft12 and connects to theballoon30 for selective inflation and deflation of theballoon30. Theinflation lumen32 is shown in the cross-sectional view ofFIG. 3 and shown operably connected to theballoon30 inFIG. 5. Theballoon30, shown inFIG. 1A, is in a deflatedconfiguration34 for insertion into the patient and for storage between selective inflations. Theballoon30 may be sized and shaped to narrowly fit against theshaft12 in the deflatedconfiguration34.

Theballoon30 is shown in aninflated configuration36 inFIG. 1B. As will be discussed in more detail below, theballoon30 may be selectively inflated and deflated after thecatheter10 has been placed in the patient. Theballoon30 may be any type of balloon known in the art and is shaped and dimensioned in theinflated configuration36 to disrupt the progression of any occluding material that may migrate along theshaft12 from theproximal portion14, and eventually to thedistal portion16 if left undisrupted. Theinflation lumen32 may be maintained in connection with theballoon30 for allowing the balloon to be inflated and deflated using a device such a syringe (not shown) connected to aninflation port42 that is operably connected to theproximal portion14 of theshaft12. Theinflation lumen32 opens into theballoon30 at aballoon port44 in the shaft12 (port44 shown inFIG. 5). The shape and dimensions of theinflation lumen32 may be any configuration suitable to permit free flow of inflation medium from theinflation port42 to theballoon port44 and back out to theinflation port42 during inflation and deflation of theballoon30. The inflation medium may be any liquid (e.g., saline solution) or gas that is suitable for use in patients.

Theballoon30 may be connected to theshaft12 by any method known to one skilled in the art wherein the connection allows theballoon30 to be inflated and deflated through theport44. For example, theballoon30 may be bonded to theshaft12 at aproximal end46 and adistal end48 of theballoon30 as shown inFIG. 5. Theballoon30 may also be attached to theshaft12 using a clamping band or other device to hold theballoon30 on the shaft12 (not shown). Theproximal end46 of theballoon30 may be connected to the shaft proximally to theballoon port44 so that inflation medium may freely flow through theport44 without interference from the connection of thedistal end46 to theshaft12.

In addition to theinflation lumen32, theshaft12 includes the

lumens

18 and24 as shown inFIG. 3. Theinflation lumen32 extends along theshaft12 to theport44 as discussed above. Theballoon port44 opens proximal to the

openings

20 and26 of the

lumens

18 and24, respectively. As illustrated inFIG. 1A and in the cross-sectional view inFIG. 3, the

lumens

18 and24 extend distally beyond where theinflation lumen32 terminates at theport44 so that the

lumens

18 and24 fluidly connect to the patient at a location distal to theballoon30. In some embodiments, theopening26 of thelumen24 terminates proximal to theopening20 of thelumen18 as shown inFIG. 4. Thelumen24 may be configured to withdraw arterial blood through thelumen24 under negative pressure, into a manifold50, throughtubing51 and through aconnector52 for further transport and treatment in a manner to be described. Thelumen18 may be configured to infuse or return fluid to the patient. Fluid may be infused into the vessel under positive pressure, from aconnector54, throughtubing53, into the manifold50 and through theopening20 of thelumen18.

A Luer lock or other suitable connector may engaged with each

connector

52,54 for connecting with a treatment instrument, such as adialyzer70, for establishing a flow path of fluid to thedialyzer70.

Clamps

56,58 maybe provided on the

tubing

51,53, respectively, for selectively opening and closing the

tubing

51,53 for allowing flow between thedialyzer70 and thecatheter10. Any type of clamping device may be used to control the flow between thedialyzer70 and thecatheter10. Arrows are provided inFIGS. 1A and 1B to indicate the direction of flow of the treated fluid as it is removed and returned to the patient. Although thelumen18 and thelumen24 have been designated in this embodiment as respective infusion and withdrawal lumens, the designations may be reversed if desired. As will be understood by one skilled in the art, thecatheter10 may include any number of lumens, i.e., one, two, three or more. The number of connectors and tubing connected to the manifold will generally correspond to the number of lumens extending through the shaft. As shown inFIGS. 2 and 3, the

lumens

18,24 may be curvilinear in cross-sectional shape and thelumen24 may be larger than thelumen18, although the lumens may be any size and shape.

As shown inFIG. 1A, thecatheter device10 may also include a fitting60 for connecting theshaft12 and the manifold50. The fitting60 may include a pair ofprojections61. Theprojections61 may be sutured to the skin of the patient to secure thecatheter device10 in position once thecatheter device10 has been inserted into the patient. The fitting60 may be configured to snap fit together with the manifold50, although any type of connection may be used to couple the fitting60 to the manifold50 and allow fluid to flow through the

lumens

18,24 and inflation media to flow through thelumen32.

An alternative embodiment of anindwelling catheter device100 is shown inFIGS. 6A and 6B. Thecatheter device100 is similar to thecatheter device10 described above and differs in the configuration of aballoon130 attached to ashaft112. Similar to thecatheter device10, the catheter device110 includes theshaft112 having aproximal portion114 and adistal portion116. Theshaft112 further includes anopening120 and anopening126.Lumens118 and124 extend through theshaft112 similar to the

lumens

18 and24 described above (not shown). Theballoon130 operably connects to theshaft112 at thedistal portion116 of theshaft112. An inflation lumen, similar to thelumen32 above, extends longitudinally along a portion of theshaft112 and connects to theballoon130 for selective inflation and deflation of theballoon130 at aport144 opening within theballoon130. Theballoon130, shown inFIG. 6A, is in a deflated configuration134 for insertion into the patient and for storage between selective inflations. Theballoon130 may be sized and shaped to narrowly fit against theshaft112 in the deflated configuration134.

Theballoon130 is shown in aninflated configuration136 inFIG. 6B. Theballoon130 may be selectively inflated and deflated after thecatheter device100 has been placed in the patient. Theballoon130 may be any type of balloon known in the art and is shaped and dimensioned in theinflated configuration136 to disrupt the progression of occluding material that may progress along theshaft112 from theproximal portion114, and eventually to thedistal portion116 if left undisrupted. Similar to the embodiment described above, theballoon130 may be inflated and deflated using a syringe and inflating media injected into and withdrawn from aninjection port142. Theballoon130 may be connected to theshaft112 by any method known to one skilled in the art as discussed above.

An alternative embodiment of anindwelling catheter device200 is shown inFIGS. 7A and 7B. Thecatheter device200 is similar to the

catheter devices

10,100 described above and differs in the configuration of aballoon230 that is attached to aproximal portion214 of a shaft212. As shown inFIG. 7A, theballoon230 is in a deflatedconfiguration234 and fits narrowly against the shaft212.FIG. 7B illustrates theballoon230 in aninflated configuration236 for disrupting occlusive material as the material progresses distally on the shaft212. The remaining features of thedevice200 are similar to the features described above for the

device

10,100.

Another alternative embodiment of an indwelling medical device is shown inFIG. 8. Acatheter device300 includes ashaft312 having aproximal portion314, adistal portion316 and aballoon330. Theshaft312 includes alumen331 extending longitudinally therethrough to anopening334 at adistal end340. Theshaft312 may also include a plurality ofside ports341 in thedistal portion316 for fluid flow therethrough. Aninflation lumen332 extends longitudinally along a portion of theshaft312. Theinflation lumen332 connects to aninflation port342 at aproximal portion343 of thecatheter300 and theinflation lumen332 opens at a balloon port344 that connects to theballoon330 for selective inflation and deflation of theballoon330. Theinflation port342 connects to theinflation lumen332 in theshaft312 through amanifold350. Aconnector352 andtubing351 may also connect to thelumen331 in theshaft312 through themanifold350. Theconnector352 may be used for delivery of treatments to the patient. The treatment may be the delivery of medication or connection to a treatment device such as the dialyzer described above. Aclamp356 may be provided for closing thetubing351 when the patient is not receiving treatment.

Theballoon330 shown inFIG. 8 is in aninflated configuration336. The balloon may also be in a deflated configuration similar to the deflated configuration described above where theballoon330 fits narrowly against theshaft312. Theballoon330 may be similar to the balloons described in the embodiments above. Theballoon330 is shaped and dimensioned in theinflated configuration336 to disrupt the progression of occluding material that may progress along theshaft312 from theproximal portion314, and eventually to thedistal portion316 if left undisrupted.

The balloon for use with the present invention may be any type of inflatable balloon suitable for patient treatment. For example, the balloon may be formed from one or more layers of expandable material, such as polyurethane, radiopaque polyurethane material, thermoplastic polyurethane elastomers, aliphatic polyrethanes, aromatic polyurethanes, styrene-ethylene-butylene-styrene (SEBS) block copolymer, thermoplastic elastomers, low-density polyethylene, polyethylene terephthalate, polyethylene terephthalate glycol, silicone, copolymer of polyurethane and silicone, natural rubber, synthetic rubber, thermoplastic polyamide, nylon, latex, polyethylene, polyisoprene, polyisobutylene, thermoplastic elastomers, an elastomeric material, or combinations thereof.

If desired, various components of the catheter devices and components described herein, such as the shaft, balloon and tubing, can be impregnated or coated with antimicrobial agents to minimize the risk of bacterial colonization of the catheter, and catheter-related bacteremia during use. An example of an antimicrobial combination that has been shown to be an effective antimicrobial composition in percutaneous devices is the combination of antimicrobials minocycline and rifampin. Alternatively, other well-known antimicrobials may be substituted for minocycline and rifampin, which antimicrobials need not necessarily be utilized in combination

Operation of the indwelling medical device of the present invention will be described with reference to thecatheter device10 ofFIGS. 1A and 1B in a hemodialysis procedure. Initially, thecatheter device10 must be introduced into the vessel of the patient. Suitable percutaneous techniques for insertion of catheter devices into body vessels are well known in the medical arts, and are in widespread use. Perhaps the most widely-utilized technique, and the technique favored herein, is the well-known Seldinger technique. In the Seldinger technique, an injection is made into the vessel interior with a needle, and a wire guide is inserted into the vessel through a bore in the needle. The needle is withdrawn, and an introducer sheath, preferably a splittable sheath, such as a PEEL-AWAY® sheath, available from Cook Incorporated, of Bloomington, Ind., is introduced over the wire guide. The catheter assembly is then introduced into the vessel via the introducer sheath and over the wire guide. The wire guide and the sheath are removed in conventional fashion, leaving at least thedistal portion16 ofcatheter device10 in the body vessel.

Once thecatheter device10 has been inserted into a body vessel, sufficient negative pressure is created to commence withdrawal of blood from the vessel, such as by activation of thedialyzer70. Blood is withdrawn from the vessel through theopening26 of thelumen24. The blood is then drawn throughlumen24 in the proximal direction, and passes into thedialyzer70 by way of a flow path that includesmanifold50,tubing51 andconnector52. The withdrawn blood is then subjected to treatment indialyzer70 in conventional fashion. Following treatment, the cleansed blood is returned to the body vessel by way of a flow path that includesconnector54,tubing53,manifold50 andlumen18. The cleansed blood then re-enters the vessel through opening20 of thelumen18.

Once the treatment is completed, the

clamps

56,58 may be closed and the connection between the

connectors

52,54 and thedialyzer70 disconnected. The treatment process may be repeated several times using thesame catheter device10.

As discussed above, when theindwelling catheter device10 is placed within the patient, occluding materials tend to begin migrating from theproximal portion14 of theshaft12 towards thedistal portion16 of theshaft12. If the occluding material is not disrupted, the occluding material will eventually occlude the

openings

20,24.

Theballoon30 may be selectively inflated and deflated to disrupt the migration of the occludingmaterial90 to thedistal portion16 and towards the

openings

20,24.FIG. 9A illustrates the occludingmaterial90 migrating from theproximal portion14 of theshaft12 toward thedistal portion16.FIG. 9B illustrates the disruption of the occludingmaterial90 with the inflation of theballoon30. A syringe or other inflation device (not shown) may be connected to theinflation port42 as described above for inflating and deflating theballoon30 to disrupt the occludingmaterial90. The number of inflation/deflation cycles for disrupting the occludingmaterial90 will depend on several factors, including, but not limited to, the type ofdevice10, the length of time thedevice10 is required to remain indwelling in the patient and rate of migration of the occluding material toward thedistal portion16 of theshaft12. For example, in one method of treatment, the balloon may be inflated and deflated once while thedevice10 is indwelling in the patient. In other methods, multiple inflation/deflation cycles may be used to disrupt the occluding material while thedevice10 is indwelling in the patient. Theballoon30 may be inflated during the hemodialysis treatment described above, between hemodialysis treatments or both. In some embodiments, theballoon30 may remain inflated for a few seconds, or shorter and several inflation/deflation cycles may be used. By way of non-limiting example, theballoon30 may be inflated 1 second, deflated 5 seconds, inflated 1 second, deflated 5 seconds, inflated 1 second and deflated to disrupt the migration of the occluding material. One skilled in the art will recognize that other inflation/deflation cycles may be used with the present invention.

In some methods of treatment, the distal migration of the occludingmaterial90 along theshaft12 toward thedistal end22 may be monitored to determine the number and duration of inflation/deflation cycles for disruption of the occludingmaterial90. For example, the disruptingmaterial90 may be viewed using an imaging technique such as MRI or ultrasound where the vessel could be viewed both cranial and caudal to thecatheter device10 to determine the extent of migration of the occludingmaterial90 and subsequently the extent of disruption.

The amount of inflation of theballoon30 and the pressure used to inflate theballoon30 will depend on several factors, including the density of the occludingmaterial90, the size of thecatheter device10, the size of the vessel in which thedevice10 is implanted, and the like. By way of non-limiting example, for acatheter device10 that is about 14 Fr (about 4.7 mm), theballoon30 may be inflated about 4 times the size of the catheter device to about 20 mm. In some embodiments, the catheter device may range for about 12 to 16 Fr and theballoon30 may be expanded to 3-4 times the size of thecatheter device10. Other sizes ofcatheter devices10 and ratios ofballoon30 expansion are possible for the present invention. In order to inflate theballoon30, a specific volume of fluid may be added to provide adequate inflation. By way of non-limiting example, theballoon30 may be a silicone balloon that may be inflated to 4 times thecatheter device10 that is about 14 Fr using 5 ml of saline to inflate the balloon.

Although the invention herein has been described in connection with a preferred embodiment thereof, it will be appreciated by those skilled in the art that additions, modifications, substitutions, and deletions not specifically described may be made without departing from the spirit and scope of the invention as defined in the appended claims. The scope of the invention is defined by the appended claims, and all devices that come within the meaning of the claims, either literally or by equivalence, are intended to be embraced therein.

Claims

1. An indwelling catheter device for fluid flow therethrough, the catheter device comprising:

an elongate shaft having a proximal portion, a distal portion, a first lumen extending longitudinally therethrough and an inflation lumen extending at least partially through the shaft, the distal portion comprising a first opening connected to the first lumen;

a balloon operably connected to an outer surface of the shaft proximal to the first opening, the balloon at least partially surrounding the shaft and configured for inhibiting occluding material from occluding the first opening;

wherein the inflation lumen is connected to the balloon for selective inflation and deflation of the balloon for inhibiting occluding material from occluding the first opening when the catheter device is indwelling.

2. The catheter device ofclaim 1, wherein the balloon circumferentially surrounds the shaft.

3. The catheter device ofclaim 1, wherein the balloon extends longitudinally along the outer surface of the shaft between the proximal portion and the distal portion of the shaft.

4. The catheter device ofclaim 1, wherein the balloon is operably connected to the distal portion of the shaft.

5. The catheter device ofclaim 1, wherein the balloon is operably connected to the proximal portion of the shaft.

6. The catheter device ofclaim 1, further comprising a second lumen extending longitudinally through at least a portion of the shaft, the second lumen having a second opening proximal to the first opening and distal to the balloon.

7. The catheter device ofclaim 6, wherein the catheter device is a hemodialysis catheter and the first lumen comprises an infusion lumen and the second lumen comprises an aspiration lumen.

8. The catheter device ofclaim 1, wherein the balloon is collapsible onto the shaft in a deflated configuration.

9. The catheter device ofclaim 1, wherein the device further comprises a connector operably connected to the first lumen, the connector being configured to engage with a treatment instrument.

10. The catheter device ofclaim 9, wherein the treatment instrument is a dialyzer.

11. The catheter device ofclaim 1, wherein at least a portion of the device includes an antimicrobial coating.

12. The catheter device ofclaim 1, further comprising a second lumen extending longitudinally through at least a portion of the shaft, wherein the first and second lumens are configured for the exchange of bodily fluid therethrough.

13. A method for intraluminal treatment of a patient employing an indwelling catheter device, the method comprising:

inserting at least a portion of a shaft of a catheter device into a vessel of the patient, the catheter device comprising:

the shaft including a lumen extending longitudinally therethrough, the lumen having an opening at a distal portion of the shaft; and

a balloon operably connected to the shaft proximal to the opening;

providing a treatment through the lumen; and

inflating the balloon to disrupt a migration of occluding material distally on the shaft so as to inhibit the occluding material from occluding the opening in the distal portion of the shaft.

14. The method ofclaim 13, further comprising the step of providing at least two inflation and deflation cycles.

15. The method ofclaim 13, comprising the step of inflating the balloon during treatment.

16. The method ofclaim 13, comprising the step of inflating the balloon before treatment.

17. The method ofclaim 13, comprising the step of inflating the balloon after treatment.

18. The method ofclaim 13, further comprising monitoring the occluding material and inflating the balloon.

19. The method ofclaim 13, further comprising the step of providing a second treatment.

20. The method ofclaim 13, further comprising the step of coating at least a portion of the indwelling catheter device with an antimicrobial agent.

21. The method ofclaim 13, wherein the treatment comprises dialysis.

22. A method for intraluminal treatment of a patient employing an indwelling catheter device, the method comprising:

inserting a distal end of a shaft of a catheter device into a vessel of the patient, the catheter device comprising:

the shaft having a first lumen extending longitudinally therethrough to a first opening and a second lumen extending longitudinally therethrough to a second opening; and

a balloon operably connected to the shaft proximal to the first and second openings, the balloon being connected to an inflation lumen;

withdrawing a bodily fluid to be treated from the vessel through the second lumen;

treating the fluid in a treatment instrument;

infusing the treated fluid through the first lumen into the vessel; and

selectively inflating the balloon to inhibit occluding material from occluding the first and second openings.