US20080097382A1

Movatterモバイル変換

Info

Publication number: US20080097382A1
Application number: US11/978,733
Authority: US
Inventors: James McGuckin; Paul Tashjian; Michael Paris; Peter Hinchliffe
Original assignee: Rex Medical LP
Current assignee: Rex Medical LP
Priority date: 2001-01-09
Filing date: 2007-10-30
Publication date: 2008-04-24
Also published as: DE60225431T2; EP1383566A2; JP2005502387A; ES2303546T3; US6858019B2; WO2002064202A2; JP4091844B2; US20050131341A1; US6814718B2; EP1383566B1; US7074213B2; US20110015559A1; US20050054989A1; CA2432330C; US7799014B2; AU2002249904B2; WO2002064202A3; US20020107506A1; DE60225431D1; WO2002064202A9

Abstract

A method of inserting a dialysis catheter into a patient comprising the steps of inserting a guidewire into the jugular vein of the patient through the superior vena cava and into the inferior vena cava, providing a trocar having a lumen and a dissecting tip, inserting the trocar to enter an incision in the patient and to create a subcutaneous tissue tunnel, threading the guidewire through the lumen of the trocar so the guidewire extends through the incision, providing a dialysis catheter having first and second lumens, removing the trocar, and inserting the dialysis catheter over the guidewire through the incision and through the jugular vein and superior vena cava into the right atrium.

Description

This application claims priority from provisional patent application Ser. No. 60/260,592, filed Jan. 9, 2001, the entire contents of which is incorporated herein by reference.

BACKGROUND

1. Technical Field

This application relates to a catheter and more particularly to a multi-lumen dialysis catheter and over the wire methods of insertion of the dialysis catheter.

2. Background of Related Art

Hemodialysis is a well known method of providing renal (kidney) function by circulating blood. The kidneys are organs which function to extract water and urea, mineral salts, toxins, and other waste products from the blood with filtering units called nephrons. From the nephrons the collected waste is sent to the bladder for excretion. For patients having one or both defective kidneys, the hemodialysis procedure is life saving because it provides a machine to simulate the function of the kidneys.

In the hemodialysis procedure, blood is withdrawn from the patient's body through a catheter or tube and transported to a dialysis machine, also commonly referred to as a kidney machine. The catheter is typically inserted through the jugular vein and maneuvered into position through the superior vena cava into the right atrium to provide high blood flow. In the dialysis machine, toxins and other waste products diffuse through a semi-permeable membrane into a dialysis fluid closely matching the chemical composition of the blood. The filtered blood, i.e. with the waste products removed, is then returned to the patient's body. In some instances, the catheter may be left in place for several years. As can be appreciated, proper access to the patient's blood and transport of the blood to and from the dialysis machine for this extended period of time is critical to hemodialysis.

One example of a dialysis catheter currently being marketed is the MedComp Ash Split catheter. This catheter has two lumens, one for arterial flow and the other for venous flow, which are each D-shaped in cross-sectional configuration. The catheter is bifurcated at its distal end to separate the lumens and the catheter is manually split to the desired length for selected separation before insertion into the target area. Another well-known catheter is a Med Comp catheter which has the venous flow lumen terminating proximally, i.e. axially recessed, from the arterial flow lumen. Each of these lumens is also D-shaped in cross-sectional configuration.

These Medcomp dialysis catheters require numerous steps for insertion. The multiple insertion steps can be summarized as follows:

- 1. an introducer needle is inserted through a first incision site (first opening) to properly locate (access) the vessel, e.g. the right internal jugular vein;
- 2. a guide wire is inserted through the needle into the internal jugular vein and down through the superior vena cava into the inferior vena cava;
- 3. the introducer needle is withdrawn leaving the guidewire in place;
- 4. a tear away (peel away) sheath and dilator are inserted over the guidewire and through the first incision site to provide an access port for the dialysis catheter into the jugular vein, superior vena cava and right atrium;
- 5. a second incision is made in the chest wall to create a second opening;
- 6. a trocar is attached to the distal end of the dialysis catheter;
- 7. the trocar and dialysis catheter are pushed through the second incision and advanced to bluntly dissect the subcutaneous tissue to exit the first incision (opening) which was created by the introducer needle, thereby creating a subcutaneous tissue tunnel between the first and second openings;
- 8. the trocar is detached from the dialysis catheter leaving the catheter in place extending from the second opening, through the tissue tunnel and out the first opening;
- 9. the dilator and guidewire are removed, leaving the tear away sheath in place in the first incision which has been expanded by the dilator;
- 10. the dialysis catheter, which is protruding from the first incision, is inserted through the tear away sheath and advanced so its distal portion is positioned in the right atrium;
- 11. the sheath is separated, i.e. split, by pulling the tabs apart, and then pulled upwardly away from the dialysis catheter and removed from the body, leaving the catheter in place; and
- 12. the second incision is closed and the dialysis catheter, which is connected through tubes to the dialysis machine, is left in place an extended period of time to provide blood circulation to and from the dialysis machine.

(Alternatively, in the foregoing method, the trocar can be forced through a third incision exiting adjacent the first incision, and then inserted through the introducer sheath positioned in the first incision.)

This multiple step process of inserting the Medcomp dialysis catheter is time consuming and complicates the surgical procedure. These multiple steps add to the cost of the procedure, not only because of the additional surgeon's time but because additional components, such as the tear-away sheath, are required which increases the overall cost of the catheter system. Also, removal of the dilator increases the tendency of the sheath to kink causing difficulties in catheter insertion.

The use of the tear away sheath is also potentially problematic. The tear-away style sheath has lines of weakness to separate the sheath as it is pulled apart by the pull tabs to enable removal of the sheath. However, the sheath can potentially cause damage to the vessel wall as it is being pulled apart and can cause infection. Moreover, pulling the sheath laterally can enlarge the incision, thereby increasing the difficulty of closing the incision at the end of the procedure. Also, since the sheath is pulled in the proximal direction for removal, it could pull the catheter proximally as well, thereby pulling it away from the desired site, and requiring repositioning. The edges of the tear away can also lacerate the surgeon's glove and finger.

An additional potential risk with utilizing tear away sheaths is that air embolism can occur. During the time the surgeon withdraws the dilator from the sheath and inserts the catheter, a passageway through the sheath to the vessel is open. If the patient inhales during this catheter exchange, an air bubble can enter the vascular system and obstruct the vessel, potentially causing stroke or even death.

It would therefore be advantageous if a dialysis catheter insertion method could be provided which reduces some of the foregoing procedural steps, thereby decreasing the complexity of the procedure and decreasing the hospital and surgeon costs. It would also be advantageous if such dialysis catheter insertion method could be provided which would be less traumatic and avoid the foregoing problems associated with the use of a tear-away sheath, such as increased risk of air embolism, trauma to the vessel wall, incision enlargement and dislodgement of the catheter.

Another area of dialysis catheter insertion, which needs improvement, is guiding the catheter to the target site. Dialysis catheters are composed of flexible tubing to minimize damage to the vessel wall during insertion and use. This flexibility, however, oftentimes results in kinking of the catheter since the catheter must navigate curves to reach the target vessel. This kinking can adversely affect blood flow. Also, the catheter needs to have some degree of stiffness to enable directing the catheter around the curves of the vessels. The stiffness, however provides its own risks since if the catheter is not properly directed, the catheter can inadvertently be forced against the vessel wall, thereby puncturing or damaging the vessel. Several different approaches have been discussed in the prior art to increase stiffness of catheters such as providing a distal tip of stiffer material to guide the catheter as in U.S. Pat. No. 5,957,893, using materials of different durometers in various portions of the catheter (U.S. Pat. No. 5,348,536), placing an additional concentration of material in the tip as in U.S. Pat. No. 4,583,968, or providing reinforcing strips, obturators or tubes within the catheter body to increase the rigidity (e.g. U.S. Pat. Nos. 4,619,643, 4,950,259 5,221,255, 5,221,256, and 5,246,430). The need however exists to improve the balance between flexibility and stiffness. Thus it would be advantageous to provide a catheter with sufficient flexibility to accommodate anatomical curves of the patient while still having sufficient stiffness to enable guiding the flexible catheter tubing atraumatically through the length of the vessels.

In navigating vessels to access the target site, such as the right atrium, it is desirable to provide the smallest catheter profile, i.e. the smallest outer diameter catheter body. This profile facilitates insertion through smaller vessels as it reduces the likelihood of the catheter engaging the wall of the vessel and reduces trauma to the vessel by minimizing frictional contact with the vessel wall. However, the desire for smaller diameter catheters must be balanced against the need for providing sufficient sized lumens to enable proper blood flow. If the lumens are too small, sufficient blood flow may not be able to be maintained and the blood can be damaged during transport. Also, a sufficient relationship must be maintained between the size of the lumens and the overall diameter of the catheter to maintain the structural integrity of the catheter.

Numerous attempts have been made in the prior art to optimize the multi-lumen configuration. In some approaches, such as disclosed in U.S. Pat. Nos. 4,568,329 and 5,053,023, inflow and outflow lumen are provided side by side in D-shaped form. In other approaches, such as those disclosed in U.S. Pat. Nos. 4,493,696, 5,167,623 and 5,380,276 the inflow and outflow tubes are placed in concentric relation. Other examples of different lumen configurations are disclosed in U.S. Pat. Nos. 5,221,256, 5,364,344, and 5,451,206. The lumen configuration must accommodate two competing factors: keeping the catheter as small as possible to facilitate insertion while keeping the lumens as large as possible for blood flow. This balance must be achieved while maintaining the structural integrity of the catheter. It would therefore be advantageous to provide a catheter which reaches an optimum compromise between these two competing factors.

Another important feature of dialysis catheters is the suction openings to withdraw blood. Keeping the suction openings clear of thrombolytic material and away from the vessel wall is clearly essential to dialysis function since an adequate supply of blood must be removed from the patient to be dialyzed. However, a problem with prior dialysis catheters is that during blood withdrawal, as suction is being applied through the catheter openings and lumen, the suction can cause the catheter to be forced against the side wall of the vessel, known as “side port occlusion”, which can block the opening and adversely affect the function of the catheter by enabling only intermittent suction. In fact, the opening can become completely blocked, thereby preventing necessary intake of blood, i.e. venous flow. Fibrin sheath growth around the outside of the catheter can occur since dialysis catheters are oftentimes implanted for several months or even years. This fibrin growth, caused by the body's attempt to reject the catheter as a foreign body, could result in blocking of the suction holes.

The need therefore exists for an improved dialysis catheter which facilitates the surgical dialysis procedure. Such catheter would advantageously reduce the catheter insertion time, simplify the catheter insertion process, eliminate the need for a peel-away introducer sheath, decrease the chances of infection, reduce unwanted kinking of the catheter during insertion, strike an optimal balance between overall catheter and lumen size, and improve the suction capability to avoid hampering of venous flow.

SUMMARY

The present invention overcomes the disadvantages and deficiencies of the prior art. The present invention provides a method of inserting a dialysis catheter into a patient comprising:

- inserting a guidewire into the jugular vein of the patient through the superior vena cava, and into the inferior vena cava;
- providing a trocar having a lumen and a dissecting tip;
- inserting the trocar to enter an incision in the patient to create a subcutaneous tissue tunnel;
- threading the guidewire through the lumen of the trocar so the guidewire extends through the incision;
- providing a dialysis catheter having first and second lumens;
- removing the trocar; and
- inserting the dialysis catheter over the guidewire through the incision and through the jugular vein and superior vena cava into the right atrium.

The method preferably comprises the step of inserting a dilator prior to the step of inserting the dialysis catheter. The method preferably further comprises the step of temporarily inserting a stiffening member in the first lumen of the catheter to facilitate insertion of the catheter. The method of inserting the stiffening member and advancing the catheter preferably includes the steps of twisting the stiffening member and securing the stiffening member to a proximal portion of the catheter to stretch the catheter to reduce a least a portion of the outside diameter of the catheter.

Preferably, the method also comprises the steps of removing the guidewire and leaving the catheter in position for at least several days to enable blood inflow through the first lumen and blood outflow through the second lumen to dialyze the patient's blood. The step of leaving the catheter in place to enable blood outflow and inflow preferably further comprises the step of enabling blood outflow through at least one opening in a wall of the catheter and enabling blood inflow through at least one opening in a distal portion of the catheter.

Also provided is a method of inserting a dialysis catheter into a patient comprising:

inserting a guidewire into the vein of a patient;

advancing a trocar through an incision in the patient to create a subcutaneous tissue tunnel;

retracting the guidewire through the subcutaneous tissue tunnel and incision utilizing the trocar;

removing the trocar;

inserting a dialysis catheter over the guidewire through the incision and subcutaneous tissue tunnel and through the vein of the patient; and

securing the dialysis catheter to the patient.

The step of retracting the guidewire may comprise the step of inserting the guidewire through an opening in the trocar. The opening may extend longitudinally through the trocar and the step of inserting the guidewire may comprise the step of threading the trocar over the guidewire such that the guidewire exits from a proximal portion of the trocar.

The present invention also provides a method of inserting a dialysis catheter into a right atrium of a patient is also provided comprising:

providing a dialysis catheter having a lumen;

inserting a guidewire into the inferior vena cava of the patient;

inserting a stiffening member through the lumen in the catheter;

inserting a guidewire through the stiffening member and advancing the dialysis catheter and stiffening member over the guidewire into the vein and into the right atrium of the patient; and

removing the guidewire leaving the dialysis catheter in place for a period of time.

The step of inserting the stiffening member preferably comprises the step of inserting the stiffening member such that a dilating distal tip of the stiffening member extends distally of the catheter.

The method preferably further comprises inserting a tunneling member through an incision to create a tissue tunnel and to retrieve the guidewire. Preferably the guidewire is inserted through a longitudinally extending opening formed in the tunneling member. The dialysis catheter is preferably inserted subcutaneously over the guidewire through a tissue tunnel prior to the step of advancing the dialysis catheter into the vein.

The step of advancing the dialysis catheter over the guidewire may include the step of forming a loop in the catheter corresponding to a loop formed in the guidewire prior to fully advancing the catheter into the right atrium.

The present invention also provides a dialysis catheter comprising a catheter body having a proximal portion, a distal portion, a first longitudinally extending central lumen configured to deliver blood, and at least three longitudinally extending lumens positioned radially of the central lumen and configured to withdraw blood from a patient. At least one blood delivery opening is formed in the distal portion of the catheter body and in fluid communication with the first lumen and configured for passage of blood therethrough. At least three blood withdrawal openings are formed in the outer wall of the catheter body, wherein each of the openings is in fluid communication with one of the at least three lumens and is configured for passage of blood from a patient.

A stiffening member may be provided which is positionable within the catheter in abutment with a shoulder or threadedly attached in an alternate embodiment. The stiffening member places the catheter body in tension, and torquing the stiffening member stretches the catheter body to reduce at least a portion of an outer diameter of the catheter body. The stiffening member preferably includes a longitudinally extending lumen for receiving a guidewire. A stiffening insert having a first stiffness greater than a second stiffness of the distal tip portion of the catheter can also be provided having a lumen formed therein communicating with the first lumen.

The distal tip portion of the catheter has a bullet nose configuration in one embodiment and tapers to a reduced diameter region in another embodiment. In one embodiment, at least two side ports are formed in an outer wall of the distal tip portion and are in fluid communication with the first lumen of the distal tip portion and positioned proximally of the stiffening insert.

The present invention also provides a system for placement of a dialysis catheter comprising a tunneling trocar and a dialysis catheter. The system comprises a trocar having an elongated tubular portion and a lumen extending longitudinally through the tubular portion. The tubular portion terminates in a dilating tip configured to dilate tissue and create a subcutaneous tissue tunnel. The lumen has a first internal diameter configured to removably receive a guidewire therethrough for retrieval of the guidewire. The dialysis catheter has a first lumen configured for blood delivery and a second independent lumen configured for blood withdrawal from the patient. At least a portion of the catheter has an outer diameter configured for insertion through the subcutaneous tissue tunnel and one of the lumens is configured to receive the guidewire for over the wire insertion of the dialysis catheter through the tissue tunnel when the trocar is removed.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiment(s) of the present disclosure are described herein with reference to the drawings wherein:

FIG. 1 is a plan view of a first embodiment of the multi-lumen catheter of the present invention being inserted through the right internal jugular vein and superior vena cava into the right atrium of a patient's body;

FIG. 2 is a plan view illustrating the multi-lumen catheter ofFIG. 1 being inserted through the left internal jugular vein and superior vena cava into the right atrium;

FIG. 3 is an isometric view of the first embodiment of the multi-lumen catheter of the present invention and showing the direction of insertion of the stiffening rod;

FIG. 4A is a side view of a first embodiment of a stiffening rod of the present invention insertable through the catheter ofFIG. 3 to facilitate catheter insertion;

FIG. 4B is a side view of an alternate embodiment of the stiffening rod of the present invention having a series of mounting threads at its distal end;

FIG. 5 is perspective view of the distal portion of the multi-lumen catheter ofFIG. 3 and showing a guidewire extending through the central lumen;

FIG. 6A is a longitudinal cross-sectional view taken alonglines6A-6A ofFIG. 5;

FIG. 6B is a longitudinal cross-sectional view similar toFIG. 6A except showing an alternate embodiment of the catheter having internal threads for securing the stiffening rod ofFIG. 4B;

FIG. 7 is a transverse cross sectional view taken along lines7-7 ofFIG. 6A;

FIG. 8 is a transverse cross sectional view taken along lines8-8 ofFIG. 6A:

FIG. 9A is a transverse cross-sectional view similar toFIG. 8 except showing a second alternate embodiment of the lumen configuration of the catheter of the present invention;

FIG. 9B is a transverse cross-sectional view similar toFIG. 8 except showing a third embodiment of the lumen configuration of the catheter of the present invention;

FIG. 9C is a transverse cross-sectional view similar toFIG. 8 except showing a fourth embodiment of the lumen configuration of the catheter of the present invention;

FIG. 10 is a transverse cross-sectional view similar toFIG. 8 except showing a fifth embodiment of the lumen configuration of the catheter of the present invention;

FIG. 11 is a longitudinal cross sectional view of the distal end portion of the catheter ofFIG. 3 illustrating the stiffening rod ofFIG. 4A being inserted through the central lumen of the catheter;

FIG. 12 is a longitudinal cross sectional view similar toFIG. 11 except showing the stiffening rod fully positioned within the central lumen, in abutment with the stop in the distal tip;

FIGS. 13-15 illustrate an alternate embodiment of the distal tip of the catheter of the present invention and the method steps for forming the tip wherein:

FIGS. 13A and 13B are perspective and cross-sectional views, respectively, of the tip before formation shown receiving a stiffening insert;

FIGS. 14A and 14B are perspective and cross-sectional views, respectively, of the tip once the stiffening inserted has been placed therein;

FIGS. 15A and 15B are perspective and cross-sectional views, respectively, of the distal tip formed into a bullet nose configuration and showing side holes formed therein;

FIG. 16A is a perspective view of a distal portion of another alternate embodiment of the multi-lumen catheter of the present invention having a series of spacer wires and showing a guidewire extending therethrough;

FIG. 16B is a longitudinal cross-sectional view of the distal portion catheter ofFIG. 16A showing the spacer wires in the extended position;

FIG. 16C is a longitudinal cross-sectional view similar toFIG. 16A except showing the profile of the spacing wires and catheter body reduced as the stiffening rod ofFIG. 4A is inserted into the central lumen over the guidewire to stretch the catheter during insertion;

FIG. 17A is a perspective view of a distal portion of yet another alternate embodiment of the catheter of the present invention having a series of integral spacer ribs;

FIG. 17B is a longitudinal cross-sectional view of the distal portion of catheter ofFIG. 17 showing the spacer ribs in the extended position;

FIG. 17C is a longitudinal cross-sectional view similar toFIG. 17A except showing the profile of the spacer ribs and catheter body reduced as the stiffening rod ofFIG. 4A is inserted into the central lumen to stretch the catheter during insertion;

FIG. 18 is a perspective view of a distal portion of another alternate embodiment of the multi-lumen catheter of the present invention having a tapered tip;

FIG. 19 is a longitudinal cross-sectional view of the distal portion of the catheter ofFIG. 18 showing the stiffening rod positioned through the central lumen of the catheter over the guidewire;

FIG. 20 is a perspective view of a distal portion of yet another alternate embodiment of multi-lumen catheter of the present invention;

FIG. 21 is a perspective view of a first embodiment of a trocar of the present invention having a barbed proximal end for attachment to the catheter for creating a subcutaneous tissue tunnel and for pulling the catheter through the tissue tunnel;

FIG. 22 illustrates an alternate embodiment of the trocar of the present invention having a lumen for receiving a guidewire;

FIG. 23 illustrates the trocar ofFIG. 22 being withdrawn after a subcutaneous tissue tunnel has been created;

FIG. 24A is a bottom view of another alternate embodiment of the trocar of the present invention having a lumen for receiving a guidewire;

FIG. 24B is a longitudinal cross-sectional view of the distal end portion of the trocar ofFIG. 24A;

FIGS. 25-28 illustrate the surgical method steps for inserting the multi-lumen catheter ofFIG. 3 through the right internal jugular vein and superior vena cava into the right atrium wherein:

FIG. 25 shows the introducer needle being inserted through the right jugular vein and the guidewire being inserted through the right jugular vein, through the superior vena cava and into the right atrium;

FIG. 26 illustrates the needle introducer removed leaving the guidewire in place in the right internal jugular vein, superior vena cava and right atrium;

FIG. 27 illustrates the trocar ofFIG. 22 being inserted through a first incision site and exiting a second incision site to create a subcutaneous tissue tunnel adjacent the incision site for the introducer needle;

FIG. 28A illustrates the guidewire being threaded through the lumen of the trocar ofFIG. 22;

FIG. 28B illustrates the trocar being removed, leaving the guidewire in place extending through the tissue tunnel; and

FIG. 28C illustrates the multi-lumen catheter ofFIG. 3 inserted over the guidewire through the tissue tunnel, and curved down into the right internal jugular vein, superior vena cava and right atrium;

FIGS. 29A-29G illustrate the steps for an alternate method of inserting the multi-lumen catheter ofFIG. 3 through the right internal jugular vein and superior vena cava into the right atrium wherein the trocar creates a tissue tunnel with an exit opening at the incision cite where the needle and guidewire are introduced, wherein:

FIG. 29A illustrates the trocar ofFIG. 22 inserted over the guidewire through a first incision site, creating a subcutaneous tissue tunnel, and exiting the incision site created for insertion of the introducer needle and guidewire;

FIG. 29B illustrates the trocar being removed, leaving the guidewire in place extending through the tissue tunnel and forming a loop adjacent the needle incision site; and

FIG. 29C illustrates the multi-lumen catheter ofFIG. 3 being inserted over the guidewire for passage through the tissue tunnel;

FIG. 29D illustrates the catheter inserted through the subcutaneous tissue tunnel and forming a loop corresponding to the loop formed in the guidewire,

FIG. 29E illustrates the catheter extending through the subcutaneous tissue tunnel and being inserted further along the guidewire down into the right internal jugular vein;

FIG. 29F is a view similar toFIG. 29E except showing the guidewire being removed; and

FIG. 29G illustrates the catheter in place extending through the subcutaneous tissue tunnel and advanced into the right internal jugular vein, superior vena cava and right atrium;

FIG. 30 illustrates an alternate method of retracting the guidewire through the subcutaneous tissue tunnel formed by the trocar;

FIGS. 31-37 illustrate a method for manufacturing a first embodiment of the hub of the multi-lumen catheter ofFIG. 3 wherein:

FIG. 31 illustrates a slit formed in the outer wall of the catheter;

FIG. 32 is a view similar toFIG. 31 except showing in phantom the central arterial lumen of the catheter;

FIG. 33 is a transverse cross-sectional view taken along lines33-33 ofFIG. 32;

FIG. 34 illustrates a pin inserted through the slit in the outer wall of the catheter;

FIG. 35 illustrates the tubing inserted over the pin;

FIG. 36 illustrates the injection of soft material over the pin and catheter tube to form the catheter hub which retains the lumen connector tubes in position;

FIG. 37 illustrates the hub resulting from the injection molding process enabling one connector to communicate with the inflow (arterial) lumen and the other connector to communicate with the multiple outflow (venous) lumens;

FIGS. 38-40 illustrate an alternate embodiment of the hub of the multi-lumen catheter ofFIG. 3 wherein;

FIG. 38 illustrates a perspective view of the proximal end of the catheter body split into five segments to accommodate the separate connector tubes;

FIG. 39 is a perspective view illustrating the connector tubes inserted into the respective lumens of the catheter body; and

FIG. 40 is a transverse cross-sectional view illustrating the cuts made in the catheter wall to form the separate segments.

FIG. 41 is a perspective view of another alternate embodiment of the hub of the catheter of the present invention having the lumen configuration ofFIG. 9C;

FIG. 42 is an exploded view of the hub and tube structure ofFIG. 41;

FIG. 43 is an enlarged perspective view showing the transition of the venous holes from a substantially oval to a substantially round configuration at the flared proximal portion of the catheter; and

FIG. 44 is an enlarged perspective view showing the multi-lumen extension tube tapering proximally and transitioning from substantially circular venous holes to substantially triangular holes.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now in detail to the drawings where like reference numerals identify similar or like components throughout the several views, the first embodiment of the catheter of the present invention is designated generally byreference numeral10. Thecatheter10 is typically inserted into an area of high velocity blood flow to ensure sufficient blood can be transported from the body for dialysis.FIG. 1 illustrates thecatheter10 inserted through the right internal jugular vein “a”, into the superior vena cava “b”, and into the right atrium “c”;FIG. 2 illustrates thecatheter10 inserted into the left internal jugular vein “d”, into the superior vena cava “b” and into the right atrium “c”. Insertion into the right atrium, from either the right or left side provides the necessary high blood flow to the dialysis machine. Note that the catheter body (catheter tube)11 is sufficiently flexible to enable it to bend to accommodate the anatomical curves as shown.

Catheter

10 has a catheter body orcatheter tube11 having adistal end portion31, aproximal end portion33, and anintermediate portion35.Distal portion31 terminates in nose32 which is illustratively substantially conical in shape.Proximal end portion33 includeshub12, where the lumens formed withincatheter tube11 are connected, i.e. transition, to the respective inflow and outflow tubes,16,18, respectively, to enable return and withdrawal of blood for dialysis. Conventional tube clamps17 and19 cut off blood flow through inflow and

outflow tubes

16,18 as desired. As used herein, the terms “inflow” and “outflow” refer to the direction of blood flow with respect to the patient's body such that “inflow” refers to flow from the dialysis machine and delivered to the body while “outflow” refers to flow withdrawn from the body and transported to the dialysis machine.

As shown, intermediate portion ofcatheter10 extends through subcutaneous tissue tunnel “t”, and curves downwardly toward the target site, e.g. the right atrium. This tunnel “t” secures the catheter in place for dialysis for a period of weeks, or even months, with fibrous cuff36 (FIG. 3) enabling tissue ingrowth. The formation of the tunnel “t” and the insertion of thecatheter10 therethrough will be discussed below in conjunction with the discussion of the catheter insertion method.

It should be appreciated that although the catheter is shown emerging from the tissue tunnel “t” at a second incision site, preferably, the tissue tunnel would not have an exit opening at a second site but instead would exit through the same incision through which initial access is made by the needle and dilator into the internal jugular vein “a”. This is described in more detail below.

A series of lumens are formed incatheter tube11 for transporting blood to and from a dialysis machine. As is well known in the art, a dialysis machine essentially functions as a kidney for patients suffering from kidney failure. Blood is removed from the patient and transported to the dialysis machine where toxins are removed by diffusion through a semi-permeable membrane into a dialysis fluid. The filtered blood is then returned through the catheter body to the patient.

More specifically, and with reference toFIGS. 5, 6A,7 and8, details of the catheter lumens will now be described. Centrallongitudinal lumen40 is formed withincatheter tube11, extends the entire length and is designed to transport filtered blood to the patient.Lumen40 is also configured to receive aguidewire20 to direct the catheter to the desired position.Lumen40 extends tonose42, and terminates inregion37 where it aligns with centrallongitudinal lumen41 ofnose42.Central lumen41 ofnose42 communicates with narrowedlumen45, terminating indistal opening47 to communicate with the patient's body so blood can be delivered throughdistal opening47.

Lumens

41 and45 also receiveguidewire20. Thus,lumen40,lumen41 and narrowedlumen45 together form a central lumen enabling blood to be delivered from the dialysis machine to the patient. The transition fromlumen41 into narrowedlumen45, forms a stop orshoulder43, the function of which will be described below.

Nose

42 also includes side arterial (delivery)openings46 formed through theouter wall44 wall in fluid communication withlumen41, also functioning to return blood to the patient's body. Side openings orports46 are preferably angled outwardly as shown to facilitate delivery of blood in the direction of blood flow and lessen mechanical hemolysis. These additional openings help maintain the desired flow volume by distributing the blood through multiple holes. Although only four openings are shown, it is contemplated that additional or fewer openings can be provided and the openings can be axially displaced with respect to each other. Additional set(s) of openings can also be provided spaced proximally or distally fromside openings46.

In this embodiment,nose42 forms the distal tip portion and is composed of a different material than the other portions of thecatheter body11 and is welded or attached by other means to thecatheter body11. The tip (nose) in this embodiment is composed of a stiffer material to facilitate tunneling and blunt dissection through tissue. The nose could alternatively be composed of a softer material, thereby being less traumatic upon contact with the vessel wall. However, in a preferred embodiment, the nose is composed of the same material as the catheter body, having a small stiffener member embedded therein. This configuration is described in detail below in conjunction withFIGS. 13-15.

Catheter

10 also has a series of venous (withdrawal) lumens34a-34e, extending longitudinally along the length of thecatheter body11, each terminating atsurface48 ofnose42. In the preferred embodiment, shown in the cross-sectional view ofFIG. 8, the lumens34 are oval-like in configuration, with opposite

curved walls

37a,37band opposite substantially

flat walls

39a,39b. These spaced apart lumens have solid material between them therefore increasing the structural integrity of thecatheter body11. The lumens34a-eare independent from one another through the distal, intermediate and

proximal portions

33,35,31 of thecatheter body11, until thehub12 where the lumens34a-34econnect to a common connector tube. This is described in more detail below. Lumens34a-34e, as shown, are symmetrically positioned and radially displaced from the centralarterial lumen40.

With continued reference toFIGS. 5 and 6A, a series of side openings or ports50 are provided in theouter wall14 ofcatheter body10. These

openings

50a,50b,50c,50d, and50eare each in fluid communication with a respective outflow lumen34a-34eand are designed and configured to withdraw blood from the patient's body for delivery to the dialysis machine. A second set of openings52a-52e, spaced proximally from openings50a-50e, is also in communication with a respective lumen34a-34e. Only three of the side openings50,52 are shown inFIG. 5, it being understood that the other three openings are positioned on the other side of the catheter, preferably symmetrically placed to accommodate the circumferential arrangement of the venous lumens34a-34e.

Although lumens34a-34eare isolated along a substantial length of the catheter, they preferably have a common flow source at theproximal portion33 of thecatheter10. This is described in more detail below.

In the embodiment ofFIG. 8, the arterial lumen size preferably ranges from about 0.006 inches to about 0.008 inches in cross-sectional area, and is more preferably 0.007 inches. The cross-sectional area of each of the venous lumens34 preferably ranges from about 0.002 inches to about 0.004 inches, and more preferably about 0.003 inches, bringing the total cross-sectional area of the venous return lumens to about 0.01 inches to about 0.02 inches, and more preferably about 0.015. This means that the ratio of total cross sectional area of the arterial lumen to the venous lumen is about 1 to about 2.1. Other dimensions are also contemplated.

It should be appreciated that although five separate lumens34 are shown, a fewer or greater number can be provided. Also, although two sets of side openings are shown (set50 and set52), a fewer or greater number of sets can be provided, and a fewer or greater number of openings in each set could be provided.

Alternative lumen configurations spaced circumferentially are illustrated inFIGS. 9A, 9B,9C and10. InFIG. 9B, three arc-shaped

lumens

60a,60b,60care positioned around the arterialcentral lumen40′. These larger sized lumens provide for additional venous flow but result in the reduction of the strength of the catheter wall due to the less wall material as compared to the lumen configuration ofFIG. 8. InFIG. 9A, five

lumens

66a,66band66care provided. These lumens have more of a rectangular (or trapezoidal) shape with one pair of opposing walls having a straighter configuration than the lumen configuration ofFIG. 8. As shown, the other pair of opposing walls has a slight curvature. InFIG. 9C, four oval-like

venous lumens

76a,76b,76cand76dare positioned around a substantially squarecentral lumen78. This lumen configuration provides for a substantially sized central lumen and sufficient room between thecentral lumen78 and each of the venous lumens76a-76dfor the catheter walls to flex. InFIG. 10, five lumens70a-70eof circular cross-section are provided around thecentral lumen40″, adding to the stability of the catheter by increasing the wall material, but reducing the overall venous lumen size as compared to the embodiment ofFIG. 8. Preferably, the venous lumens in each of these embodiments are independent from one another along the substantial length of the catheter.

Fewer or greater number of lumens could be provided and lumens of other configurations are also contemplated. This positioning of the venous lumens in a circle-like array around the catheter, i.e. radially displaced from the center of the catheter, more evenly distributes the vacuum, as compared to a side by side venous/arterial lumen configuration, and ensures constant return flow since if one of the lumens becomes stuck against the vessel wall or otherwise clogged, the remaining lumens will maintain adequate flow. The openings in the sidewalls communicating with the lumens can also be elongated instead of circular, creating a series of longitudinally extending openings for entry of suctioned blood. This version of elongated openings is shown for example inFIGS. 18 and 20 described in detail below.

To facilitate insertion, the catheter is configured to receive a stiffening member in the form of a stiffening rod which stretches the catheter to reduce its profile to aid in over the wire insertion and better navigate through small vessels. That is, the stiffening rod is inserted intocentral lumen40 ofcatheter10 and torqued to stiffen the flexible catheter for ease in over the wire insertion and navigation through the small vessels, and to reduce the outer diameter of the catheter body by stretching it during insertion. After placement of thecatheter10, the stiffening rod is removed, allowing the catheter to return to its higher profile position with the lumens of the necessary size for blood transport to and from the body. Two embodiments of the stiffening rods are illustrated inFIGS. 4A and 4B and are shown prior to insertion into thecatheter10 inFIG. 3.

Turning to the first embodiment of the stiffening rod illustrated inFIG. 4A, the stiffening rod is designated generally byreference numeral80. Stiffeningrod80 has adistal tip82, aproximal end portion85 and aninternal lumen87 extending therethrough (seeFIG. 11). Stiffeningrod80 is inserted through the proximal end ofinflow tube16, in the direction of the arrow ofFIG. 11, over the guidewire20 (which extends throughlumen87 and throughcentral lumen40 untildistal tip82 abuts shoulder or stop43 as shown inFIG. 12. Theproximal end portion85 of stiffeningrod80 has a threadedportion81 which is screwed ontoscrew thread15 ofinflow tube16. This temporarily secures the stiffeningrod80 within thecatheter10 during insertion. This threaded mounting requires the stiffeningrod80 to be manually twisted, thereby torquingrod80 as it presses forwardly and applies a force against shoulder (abutment surface)43 to stretch thecatheter body11 to reduce its outer diameter. It is contemplated in one embodiment, for example, that thecatheter body11 can be reduced in diameter from about 0.215 millimeters to about 0.207 millimeters by the stiffeningrod80. (Other size reductions are also contemplated). This reduction in catheter body diameter or profile is represented by the arrows D1 and D2 inFIGS. 11 and 12, respectively, which show the change in dimension effectuated by thestiffener rod80.

After thecatheter10 is positioned at the desired site, the stiffeningrod80 is unthreaded from theproximal thread15 ofinflow tube16 and removed from thecentral lumen40 of thecatheter10 and from theinflow tube16, thereby allowing the catheter to return to its normal profile ofFIG. 11.

It should be appreciated that stiffeningrod80 can alternatively be temporarily attached at its proximal end to theinflow tube16 by other means such as a bayonet lock, snap fit, etc. The rod could first be manually twisted and then mounted by these various means for retention in its torqued position.

An alternate embodiment of the stiffening rod is illustrated inFIG. 4B and designated generally byreference numeral90. Stiffeningrod90 has a threadeddistal end92 which is threaded ontointernal threads251 of catheter200 shown inFIG. 6B. A series ofproximal threads91 are screwed onto thethreads15 of theinflow tube16 in the same manner as described above forstiffener rod80. The stiffeningrod90 functions in the same manner as stiffeningrod80, i.e. to stretch the catheter during insertion to reduce its profile and to stiffen it to facilitate insertion, the only difference being the mechanical threaded attachment of the distal end of the stiffeningrod90 to the catheter200 instead of the abutting relation of stiffeningrod80 withshoulder43 ofcatheter10. Preferably, thedistal threads92 are first threaded ontointernal thread251, followed by attachment of theproximal threads91 as the stiffeningrod90 is torqued. Stiffeningrod90, like stiffeningrod80, is preferably circular in cross-section, although other configurations are also contemplated.

Catheter200 ofFIG. 6B is identical to catheter200 in all respects except for thethreads251 instead ofshoulder43 andlumen241 which is uniform in diameter. Similar tocatheter10, catheter200 hasdistal opening247 andoutflow side openings246 inouter wall244 communicating withlumen241 indistal tip portion242, which communicates withcentral lumen40. Venous inflow lumens234a-234eterminate atwall248 and have respective side openings252a-252eand250s-250eformed in theouter wall214. Only one of the

side openings

250a,252aare shown in the longitudinal cross-sectional view ofFIG. 6B.

As noted above, distal tip (nose) can be composed of a different stiffer material than thecatheter body11 or can be composed of a material having a higher durometer than the catheter body. This stiffer material will facilitate both tunneling through and dilating tissue. In an alternate preferred embodiment, however, the distal tip is composed of the same material as the catheter body but has a stiffening insert.

More specifically, the alternative nose (tip) configuration is illustrated inFIG. 15, with the method of manufacturing the tip shown inFIGS. 13 and 14. This nose ordistal tip104, is composed of the same material as thecatheter body108 and has astiffening insert110 inserted throughcentral lumen106 ofnose104.Central lumen106 extends through the catheter body. Thestiffening insert110 is preferably composed of the same material as thecatheter body11 andnose104, except it is made of a harder durometer material such as 72 shoreD vs. 85 shoreA for thecatheter body11. The material utilized can be, by way of example, urethane. For convenience, only the distal tip is shown, the remaining portions of thecatheter100 being identical tocatheter10.

Thestiffening insert110, preferably cylindrical as shown, has ahole112 for receipt of the guidewire and for communication withcentral lumen106.Insert110 engages theinner wall surface114 ofcentral lumen106.Lumen106, proximal ofside openings119, will include either a stepped portion to provide an abutment surface (shoulder) for stiffeningrod80 or internal threads to mountrod90 as described above.

The method of manufacturing this bullet shapednose104 will now be described in conjunction withFIGS. 13-15. Once cylindrical tube is formed, preferably by injection molding techniques, with centralarterial lumen106 and venous lumens109a-109e, stiffeninginsert110 is placed withincentral lumen106 at the distalmost end and substantially flush with thedistalmost edge102 of the cylindrical tube.

Once the stiffening insert or slug110 is placed withincentral lumen106, the tube is formed into the bullet nose shape ofFIGS. 15A and 15B, by a conventional radiofrequency or other heating process which allows the tip material to flow and form around theharder insert110. After heating of the die and formation into this configuration, the material is cooled and thereby hardens to the configuration ofFIG. 15 as the material fuses to theinsert110. A conventional core pin (not shown) can be used, inserted through thehole112 andcentral lumen106 during the forming process. When the material hardens, the pin is withdrawn to maintain these openings. After the forming process, side holes114 are either cut or drilled through thewall108 ofcatheter100 to communicate withlumen106 in the same manner as side holes46 communicate withcentral lumen40 ofFIGS. 1-6.

FIGS. 16A-17C illustrate two alternate embodiments of the catheter of the present invention having spacers to minimize contact of the catheter body with the vessel wall. Provision of these spacers is optional. In the embodiment ofFIGS. 16A-16C,catheter150, similar tocatheter10, has a distal portion having anose154, a centralarterial lumen156 which also receives aguidewire20, and a series (e.g. 5) of venous lumens160-160.Arterial lumen156 communicates withlumen151 and narrowed lumen153 of thenose154, terminating in opendistal end158. A plurality ofside openings159 communicate withlumen151 and function in the same manner asside openings46 ofcatheter10.Venous lumens160 each terminate atside openings161, similar to side openings52 of venous lumens34 ofcatheter10. Although only one series ofside openings161 are shown, clearly additional arrays of side openings, positioned distally or proximally ofside openings161 could be provided. The venous lumen configuration can also vary in a similar manner as described above with respect tocatheter10. Thus, except for the spacers,catheter150 is identical tocatheter10.

A plurality ofspacer wires164 are embedded in thewall169 of thecatheter150 and are secured atregion158 by adhesive or other suitable means. In the normal configuration,spacer wires164 bow slightly outwardly with respect to theouter wall169 of thecatheter150 to reduce the likelihood of contact with the vessel wall. When the stiffeningrod80 is inserted overguidewire20 and throughcentral lumen156, as shown inFIG. 16C, andedge170 is forced against the abutment surface or stop159, the catheter body is stretched and thespacer wires164 stretch to a straightened position, substantially flush with the outer surface ofwall169. This reduces the profile of the catheter and ensures the spacer wires do not interfere with catheter insertion. When thestiffener rod80 is withdrawn, the catheter returns to its normal position, and thespacer wires164 bow outwardly as inFIGS. 16A and 16B. It should be appreciated that stiffeningrod90 can also be used withcatheter150 and would function to reduce the profile in the same manner asrod80.Catheter150 would then be provided with internal threads for mountingstiffening rod90 as described above.

An alternative to spacer wires is illustrated inFIGS. 17A-17C.Catheter180 is identical tocatheter150, except it is provided withintegral ribs194 proximal ofnose184. That is, similar tocatheter150,catheter180 has a centralarterial lumen186 configured to receiveguidewire20 and stiffening

rod

80 or90.Lumen186 communicates withlumen181 and narrowed lumen183 of thenose184 which terminates in opendistal end188.Side openings189 ofnose184 communicate withlumen181. A series of independentvenous lumens190 are provided, terminating inside openings192, similar toside openings161 ofcatheter150. Although only one series ofside openings192 are shown, clearly additional arrays, positioned proximally or distally ofside openings192 could be provided.

Spacer ribs

194 are formed by cutout portions in thewall193 of thecatheter150.FIG. 17B illustrates thespacer ribs194 in their normal position, outwardly bowed from the outer surface of thewall193 of the catheter body.FIG. 17C illustrates the straightened or retracted position of thespacer ribs194, where theribs194 are substantially flush with the outer surface ofwall193, afterstiffener rod80 ofFIG. 4A (orrod90 ofFIG. 4B)) is inserted throughcentral lumen186 to stretch thecatheter150 for insertion in the manner described above.

FIGS. 18 and 19 illustrate another alternative embodiment of the catheter of the present invention.Catheter500 has adistal tip502 with a taperedregion510 transitioning to a reduceddiameter region504. The central lumen terminates indistal opening506 for fluid delivery. Unlike the previously described embodiments, thedistal opening506 is the sole fluid delivery passageway into the body. However, it is also contemplated that additional side holes could be provided in the tip to provide additional arterial ports for blood delivery to the patient.

A series of venous openings508 (only two are shown in the view ofFIG. 18) are provided in the transition or taperedregion510 of thetip502. These openings are elongated to provide additional area for suctioning. Each of theopenings508 communicates with a respectivevenous lumen510 formed in the catheter. The venous lumen configuration (and arterial lumen configuration) can be in the form of those illustrated inFIGS. 7-10, or other variations, as described above.

Stiffeningrod520 is shown positioned in the central lumen of thecatheter500.Rod520 is similar to the

rods

80 and90 described above except it extends distally of thedistal tip502 ofcatheter500, has a tapereddistal end524 to facilitate tunneling and dilating tissue, and has a stepped portion to abut the internal structure of thecatheter500. More specifically, guidewire20 is shown extending through the central lumen of stiffeningrod520. The stiffeningrod520 is inserted through the central lumen ofcatheter500 and thestiffening rod520 andcatheter500 are inserted over theguidewire20, with the taperedtip524 facilitating passage of the catheter as it dilates tissue.

Catheter

500 has acylindrical insert514 positioned in the distal tip, similar to insert110 ofFIG. 13A. Theinsert514 is composed of a stiffer material to stiffen the tip of thecatheter500 to facilitate insertion.Insert510 has an opening to receive stiffeningrod520 as shown.Shoulder526 formed by steppedportion524 abuts theinsert514, thereby functioning as a stop in a similar manner that shoulder43 acts as a stop for stiffeningrod80 shown inFIG. 11, the difference being the shoulder is formed in the internal wall of the catheter rather than on the stiffening rod. Stiffeningrod520 thus acts in the manner as the

aforedescribed rods

80,90, i.e. pressing against the catheter tip portion to stretch the catheter for insertion, in addition to providing a tissue tunneling and dilation function.

FIG. 20 illustrates an alternative tip design of the catheter of the present invention.Catheter tip602 has a bullet nose configuration, somewhat similar to the nose ofFIG. 15, except having more of a progressive taper.Catheter tip602 also has a series of elongated venous holes608 (only two are shown in the view ofFIG. 20). In all other respects, e.g. stiffening insert, stiffening rod, distalblood delivery opening606, etc, catheter600 is identical tocatheter500 ofFIG. 18.

The method of insertion of the catheter of the present invention provides an entire over the wire system. This is achieved by the provision oftrocar300 illustrated inFIGS. 22 and 23.Trocar300 has alumen304 formed thererethrough (shown in phantom inFIG. 22) dimensioned for reception ofguidewire20. Thelumen304 extends the entire length oftrocar300, from aproximal opening306 inhandle308 to a distal opening310 (shown in phantom inFIG. 22) on the underside of thetrocar300 as viewed inFIG. 22.Distal opening310 is adjacent thedistal tip302, at the region where it bends slightly upwardly. Note thelumen304 oftrocar300 can be smaller than the outer diameter of the dialysis catheter,e.g. catheter10, since it only needs to have an internal diameter of about 0.045 inches to receive the guidewire. The diameter of the catheter is typically 0.215 inches. The bluntdistal tip302 oftrocar300 bluntly dissects tissue to create a subcutaneous tissue tunnel for subsequent securement of the catheter.

FIGS. 24A and 24B illustrate an alternate embodiment of the trocar.Trocar380 is similar totrocar300 except for an elongated oval entrance opening382 to lumen383 for the guidewire and abeveled tip384 to facilitate tunneling through tissue. Thehandle configuration386 is also slightly different.

One method of use of the catheter will now be described in conjunction with FIGS.25 to28. The method will be described for insertingcatheter10, however it should be appreciated that any of the aforedescribed catheters can be inserted in the same manner.

First, needle “N” is inserted into the internal jugular vein to properly locate the vessel and aguidewire20 is inserted through the needle into the right internal jugular vein “a” and into the superior vena cava “b” as shown inFIG. 25. Theguidewire20 is further advanced into the right atrium “c”. The needle “N” is then withdrawn, leaving theguidewire20 in place, extending out of the patient's body at theproximal portion21.

Next,trocar300 is inserted through a first incision “s” in the patient, bluntly dissecting and tunneling under the skin, and forced out of the tissue at a second incision or site “u”, creating a subcutaneous tunnel “t” under the tissue as shown inFIG. 27. This provides a way to secure the catheter as described below.Guidewire20 is then threaded throughlumen304 of the trocar, withproximal portion21 first inserted through trocardistal opening310 so it emerges out ofproximal opening306 as shown inFIG. 28A.Trocar300 is then withdrawn from the body in the direction of the arrow ofFIG. 28B, leaving theguidewire20 in place as shown. Thus, guidewire20 extends from the right atrium and superior vena cava, out through the right internal jugular vein and through the tissue tunnel “t”.

Catheter

10 is then threaded over theguidewire20, with theproximal portion21 of theguidewire21 inserted through the distal tip lumen of the catheter, through the length of the central lumen, and through thehub12 into the inflow tube116 and out throughfitting15. Thecatheter10 is thus threaded over the wire, through the tissue tunnel “t” where cuff36 (not shown inFIG. 28C) is positioned in the tissue tunnel “t” to aid in securement of the catheter by enabling tissue ingrowth over a period of time. Thecatheter10 is further advanced overguidewire20 down into the right internal jugular vein, into the superior vena cava, and into the right atrium. Theguidewire20 is withdrawn in the direction of the arrow, leaving thecatheter10 in place for use as shown inFIG. 28C. Note the stiffeningmember80 or90 (not shown inFIG. 28C for clarity) is preferably utilized, i.e. inserted over theguidewire20 through the fitting15,inflow tube16,hub12, andcentral lumen40 to help guide thecatheter10 as described in detail above.

As can be appreciated, the catheter will be inserted in a similar fashion through the left internal jugular vein to be positioned as depicted inFIG. 2. In this method, the subcutaneous tissue tunnel will be formed on the left side as shown (FIG. 2), by thetrocar300, and the catheter inserted over the guidewire through the subcutaneous tissue tunnel and through the left internal jugular vein and into the superior vena cava and right atrium in the same way as described for right side insertion. It should be understood that any of the aforedescribed catheters of the present invention can be inserted in this fashion.

An alternative method of insertion is illustrated inFIGS. 29A-29G. In this method instead of forming a second incision site adjacent the incision site through which the needle and guidewire are introduced into the internal jugular vein as inFIG. 27, thetrocar300 emerges from the needle/guidewire insertion site. Althoughcatheter10 is shown, any of the foregoing catheters can be inserted in the same manner.

In this method, the needle and guidewire are inserted in an identical manner as illustrated inFIGS. 25 and 26. After removal of the needle, theguidewire20 is left in place extending outwardly from the incision site, designated by “w”. Next, as shown inFIG. 29A,trocar300 is inserted through a first incision (as inFIG. 27) to create a subcutaneous tissue tunnel; however, unlikeFIG. 27,trocar300 does not emerge at a second incision site “u”. Instead,trocar300 is advanced subcutaneously to the needle incision site “w”, and emerges through the site “w” as shown. Thus, as shown inFIG. 29A, the distal end oftrocar300′ exits incision site “w” alongside theguidewire20.

Guidewire

20 is then inserted (threaded) through the opening introcar300 as described above and then the trocar is withdrawn through the tissue tunnel “t” and out through the first incision “s”, pulling theguidewire20 through the tunnel. After theguidewire21 is pulled through the tunnel “t” and out through incision “s”, thetrocar300 is removed as shown inFIG. 29B, leaving theguidewire20 in place. Note theguidewire20 is positioned to form aguidewire loop22 to facilitate insertion of the catheter as will be described below.

Thecatheter10 is then advanced over the guidewire20 (FIG. 29C), through the tissue tunnel, and exiting incision site “w” into the internal jugular vein “a” (FIG. 29D). Thecatheter10, as shown, is formed into aloop13, tracking theloop22 ofguidewire20, and then advanced downwardly through the internal jugular vein, the superior vena cava and into the right atrium. (FIG. 29E). Theguidewire20 is then withdrawn as shown inFIG. 29F, and thecatheter10 is pushed downwardly and/or pulled back to straighten the loop to position the catheter as shown inFIG. 29G.

It should be appreciated that formation of the loop in the guidewire and the catheter is optional and the procedure can be performed without the loop.

FIG. 30 shows an alternate embodiment of a trocar utilized to retrieve the suture and retract it through the subcutaneous tissue tunnel.Trocar300′ is similar totrocar300 ofFIG. 29 except for the provision ofeyelet312. The suture is threaded through the eyelet (shown as two small opposing holes in the wall at the distal end of thetrocar300′) and the trocar is pulled proximally through the tissue tunnel to pull the suture out through incision “s”. As shown, the trocar extends through incision “w”, the same incision created for insertion of the needle and guidewire.

It should be understood that instead of an eyelet, a hook or other means can be provided on the trocar for holding the guidewire to enable pulling the guidewire through the tissue tunnel. That is, in these versions, the guidewire is not threaded through the trocar lumen, but rather the trocar is utilized to pull (retract) the guidewire through the tissue tunnel.

FIG. 21 illustrates an alternative trocar used for a different approach to catheter insertion. This trocar, designated byreference numeral350, does not provide for an entire over the wire system, however it is used with an approach providing a partial over the wire system which eliminates the need for a tear way introducer sheath. As discussed in the Background Section of this application, tear away introducer sheaths are currently being utilized to guide the dialysis catheter through the vessels into the right atrium. To avoid the problems associated with the tear away sheath, the catheter in this alternate method, can be advanced over a guidewire which can be placed in the manner illustrated inFIGS. 25 and 26.

In this method,trocar350 is attached to the distal end of the catheter by insertion ofbarbed end352 into a mating fitting. Other means for temporarily attaching the trocar are also contemplated.

Trocar

350 has a bluntdistal tip354 and is advanced through a first tissue incision and out through a second tissue incision, bluntly dissecting tissue and forming a subcutaneous tissue tunnel in a similar manner as described above, except without the guidewire. Sincetrocar350 is attached to the catheter, it pulls the catheter through the tissue tunnel, so it emerges out through the second incision. Thetrocar350 is then detached from the catheter. The catheter is then bent as necessary and threaded over the guidewire into jugular vein, superior vena cava, and right atrium.

Turning now to one method of manufacturing the hub of the catheter, and with particular reference toFIGS. 31-37, a method is disclosed which enables connection of the central arterial (delivery) lumen of the catheter with an inflow tube and fluid connection of the five independent venous (withdrawal) lumens with a single outflow tube to provide fluid connection through the connectors.

Turning first toFIG. 31, alongitudinal slit201 is formed at a proximal portion ofcatheter tube203.FIG. 32 shows the relationship of theslit201 and the centralarterial lumen205 as the slit is formed to communicate with thecentral lumen205. As can be appreciated from the cross-sectional view ofFIG. 33, theslit201 is formed in thewall206 of thecatheter tube203 between adjacent venous (withdrawal) lumens209a-209e. Next, ametal pin207 is inserted through theslit201 for the molding process. Outerplastic inflow tubing210 is placed over themetal pin207 as shown inFIG. 35 to ultimately communicate with thecentral lumen205. Outerplastic outflow tubing211 is also shown positioned over thecatheter tube203 which will communicate with the venous lumens209.

Next, conventional injection molding techniques are utilized so the soft plastic material flows around thecatheter tube203 and themetal pin207 as shown inFIG. 36. Then, the material is cooled to harden, forming ahub208, with themetal pin207 removed to formlumen204.Lumen204 has a narrowedregion202. As shown in FIG.37,lumen204 fluidly connectslumen207 ofinflow tube210 with thecentral lumen205 of the catheter.Lumen212 ofoutflow tubing211 communicates with the five independent venous lumens209.

FIGS. 38-39 illustrate another method for manufacturing the catheter connections. In this method,catheter body402 ofcatheter400 is separated into five segments401a-401eat its proximalmost end, corresponding to each of the venous (withdrawal) lumens403a-403e.FIG. 40 illustrates the fivecuts408 made in thecatheter wall407 between the adjacent venous lumens403 to form the five segments401.

A separate outflow connector tube412a-412eis positioned within a respective venous lumen403a-403eand is connected to a respective segment401a-401eby solvent bonding or pressure fit. The proximal end of each connector tube412 is positioned withinoutflow tube414 which transports blood to the dialysis machine. Thus, blood flows through the venous lumens403, through each outflow connector tube401 and into asingle outflow tube414.

Inflow tubing

416 is connected to central arterial lumen byinflow connector tube410 which is attached inside the arterial lumen by solvent bonding or pressure fit. Note thatinflow connector tube410 is positioned between the segments401. It should be understood, that if fewer or larger number of venous lumens are provided, then an equal amount of outflow tubes would be utilized as the venous lumens would be cut into the corresponding number of segments.

FIGS. 41-43 illustrate another alternate method for manufacturing the hub of the catheter of the present invention. This hub and associated tubing is illustrated for use with a catheter having the lumen configuration ofFIG. 9C, although it can be utilized with other lumen configurations as well.

A central lumen connector (intermediate)tube702 is joined withcentral lumen78 ofcatheter700. Four venous connecting (intermediate)tubes704 are connected to a respectivevenous lumen76a. These tubes each have a lumen that is substantially circular in cross-section along its length. The substantially circular lumens corresponds to the cross-sectional shape of the venous lumens withincatheter10 which transition from a substantially oval cross-sectional configuration to a substantially circular cross-sectional configuration at the flared proximal portion shown inFIG. 43. Note thatarterial lumen78 also transitions to a substantially circular cross-sectional configuration.

Each of theconnector tubes704 is connected to multi-lumen extension (outflow)tube708 which provides outflow of blood to the dialysis machine.Extension tube708 has a flareddistal portion711 with fourlumens710, each configured for communicating with one of theconnector tubes704. As shown, each of thelumens710 has a substantially circular cross-sectional configuration that transitions to a substantially triangular cross-sectional configuration towards the proximal portion.

Single lumen extension (inflow)tube712, which provides inflow of blood to the patient, connects toconnector tube702.Tube712 has a tapereddistal end718 and itslumen719 transitions from a substantially circular cross-sectional configuration to a substantially square configuration toward the proximal end. Molding ofhousing716 with the foregoing tubes forms the catheter hub. Conventional tube clamps, such as

clamps

17,19 ofFIG. 1, are placed around

tubes

708,712 for cutting off blood flow.

Arotatable suture ring720 is placed around the catheter hub and preferably has aplanar surface722 to sit substantially flush with the patient's skin. Suture holes724 are configured to receive sutures for attaching the ring (and thus the catheter) to the patient.

The catheters described above can optionally include a surface treatment on the exterior and/or the interior. The surface treatments can include for example, an hydrophilic coating to increase lubricity and facilitate insertion, a drug coating such as heparin or containing IIb, IIIa inhibitors, inert coating substances such as Sorins carbon coating, and/or active coatings such as a silver ion coating.

It should be appreciated that although the catheter is described herein as a dialysis catheter for hemodialysis, the catheter disclosed herein could have other surgical applications, such as drug delivery or blood sampling. Moreover, features of the catheter, tip configurations and lumen configurations can be utilized on other catheters.

While the above description contains many specifics, those specifics should not be construed as limitations on the scope of the disclosure, but merely as exemplifications of preferred embodiments thereof. Those skilled in the art will envision many other possible variations that are within the scope and spirit of the disclosure as defined by the claims appended hereto.