US20070078412A1 - Dialysis catheter - Google Patents

Abstract

A dialysis catheter comprising a first portion having a first diameter, an elongated distal portion having a second diameter smaller than the first diameter, and a transition region between the first portion and distal portion. A first longitudinally extending central lumen configured to deliver blood terminates in an opening in the distal portion. At least two independent longitudinally extending lumens are positioned radially of the first lumen, configured to withdraw blood from a patient, and terminate in a longitudinally directed opening in the transition portion.

Description

• This application is a continuation-in part of application Ser. No. 10/025,506, filed Dec. 19, 2001, which claims priority from provisional patent application Ser. No. 60/260,592, filed Jan. 9, 2001. The entire contents of these applications are incorporated herein by reference.
BACKGROUND
• 1. Technical Field
• This application relates to a catheter and more particularly to a multi-lumen catheter which facilitates hemodialysis.
• 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• In the hemodialysis procedure, blood is withdrawn from the patient's body through a catheter or tube and transported to a dialysis machine, also commonly referred to as a kidney machine.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 the catheter inserted through second and third incisions and 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 sheath has lines of weakness to separate it 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. Over dilation by the sheath can cause blood leakage.
• 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 blood flow.
• Co-pending, commonly assigned prior patent application Ser. No. 10/025,506, filed Dec. 19, 2001, incorporated herein in by reference in its entirety, overcomes the disadvantages and deficiencies of the prior art. The dialysis catheter disclosed herein is a modification to the catheter of the '506 patent and provides similar advantages over the prior art.
SUMMARY
• The present invention provides a dialysis catheter comprising a first portion having a first diameter, an elongated distal portion having a second diameter smaller than the first diameter, and a transition region between the first portion and distal portion. A first longitudinally extending central lumen configured to deliver blood terminates in an opening in the distal portion. At least two independent longitudinally extending lumens are positioned radially of the first lumen, configured to withdraw blood from a patient, and terminate in a longitudinally directed opening in the transition region.
• Preferably the transition region tapers toward the distal portion and preferably at least a portion of the wall thickness of the catheter in the distal portion tapers toward a distalmost end with the central lumen cross-sectional area remaining substantially constant throughout its length in the distal portion.
• In a preferred embodiment, the first lumen is substantially rectangular in cross-section with curved edges and each of the at least two longitudinally extending lumens is substantially oval-like in cross-section with a substantially planar edge, wherein the cross-sectional configuration of the first lumen transitions to a circular shape at a distal portion.
• In a preferred embodiment, the distal portion of the catheter includes a stiffening insert embedded in a wall of the catheter at the distal portion and a stiffening member is removably positionable within the catheter body in engagement with the region of the catheter wall adjacent the stiffening insert to temporarily increase the stiffness of the catheter to facilitate insertion.
• The stiffening member preferably has a distal region having an enlarged diameter and preferably extends distally of a distalmost tip of the catheter.
• The present invention also provides a catheter for delivering and withdrawing blood from a patient's body comprising a catheter body having an outer wall, an elongated distal tip portion of reduced diameter, a transition region proximal of the distal tip portion, a first return lumen extending from a proximal portion of the catheter body through the distal tip portion and dimensioned to enable a guidewire to extend therethrough, and first and second longitudinally extending intake lumens independent of the first lumen and each terminating in an opening in the transition region. A stiffening insert is positioned in the distal tip portion and has a first stiffness greater than a second stiffness of the distal tip portion and has a lumen therethrough communicating with the first return lumen.
• The distal tip portion preferably includes multiple tapered regions of differing degrees. The catheter may further comprise a stiffening member removably positionable within the catheter to temporarily increase the stiffness of the catheter to facilitate insertion.
• In another aspect of the present invention modifications to trocars for creating and subsequently pulling catheters through a subcutaneous tissue tunnel are provided. More specifically, the present application provides an apparatus comprising a handle and an elongated body extending from the handle and having a distal portion and a proximal portion. The distal portion has a distal tip configured to dilate tissue. The proximal portion has a connection structure removably connectable to the handle and further subsequently removably connectable to the dialysis catheter, wherein after separation of the elongated body from the handle after insertion of the apparatus through the tissue tunnel, the connection structure is attached to the dialysis catheter for passage of the dialysis catheter through the tissue tunnel.
• In another embodiment of the apparatus for creating a subcutaneous tissue tunnel to enable subsequent insertion of a dialysis catheter through the tunnel, the apparatus comprises a handle and an elongated body extending from the handle wherein the distal portion has a distal tip configured to dilate tissue and the proximal portion has first and second connection structures. The first connection structure is removably connectable to the handle and the second connection structure is removably connectable to the dialysis catheter, wherein after separation of the first connection structure from the handle to separate the elongated body from the handle after insertion of the apparatus through the tissue tunnel, the second connection structure is attached to the dialysis catheter for passage of the dialysis catheter through the tissue tunnel.
• In one embodiment, a releasable latch releases the connection structure from the handle. In another embodiment, the handle comprises a bore having an internal thread and the connection structure is threaded onto the handle.
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 of FIG. I 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 3B 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 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. 21A 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. 21B is a perspective exploded view of an alternate embodiment of the trocar ofFIG. 21 A having a removable handle;
• FIG. 21C is a close up view of the connecting structure of the trocar ofFIG. 21B;
• FIG. 21D is a close up view of an alternate embodiment of the trocar having a threaded connecting structure;
• FIG. 21E is a perspective view of the trocar ofFIG. 21B being inserted through a subcutaneous tissue tunnel;
• FIG. 21F is a transverse cross-sectional view taken along lines4-4 ofFIG. 21E showing the latch for releasably connecting the trocar ofFIG. 21B to the handle;
• FIG. 21G is a cross-sectional view showing the threaded connection of the trocar ofFIG. 21D to the handle;
• FIG. 21H is a perspective view of another alternate embodiment of the trocar having a series of threads distal of the barbed fitting;
• 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;
• FIGS. 45-54 illustrate an alternate preferred embodiment of the dialysis catheter of the present invention, whereinFIG. 45 is a perspective view of the catheter;
• FIG. 46 is a perspective view similar toFIG. 45 except showing the stiffener rod positioned therein;
• FIG. 47 is an enlarged perspective view of the catheter tip showing the return and intake lumen openings;
• FIG. 48 is a side view of the catheter tip;
• FIGS. 48A, 48B and48C are transverse cross-sectional views taken along lines A-A, B-B and C-C, respectively, ofFIG. 48;
• FIG. 49A is a longitudinal cross-sectional view of a distal portion of the catheter showing the stiffener rod extending through the catheter;
• FIG. 49B is a side view of the stiffener rod ofFIG. 49A;
• FIG. 50 is a perspective view showing the arterial extension tubes extending from the proximal flared portion of the catheter, the venous extension tube is removed for clarity;
• FIG. 51 is a side view of the proximal end of the catheter, with one of the hub halves removed, showing the extension tubing connections to the catheter lumens;
• FIG. 52 is a perspective view of a proximal portion of the arterial extension tubing illustrating the funneled surfaces for wire insertion;
• FIG. 53 is a transverse cross-sectional view taken along lines D-D ofFIG. 46 showing the lead in for the cleaning wire insertion; and
• FIG. 54 is a transverse cross-sectional view taken along lines E-E ofFIG. 50 showing the arterial extension tubes within the sheath.
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.
• Catheter10 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 andoutflow tubes16,18 as desired. As used herein, the terms “inflow” and “outflow” refer to the direction of blood flow with respect to the catheter such that “return”, “delivery” or “venous flow” refers to flow from the dialysis machine and delivered to the body while “intake”, “withdrawal” or “arterial flow” 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.Lumens41 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.
• Nose42 also includes side venous (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.
• Catheter10 also has a series of arterial (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 oppositecurved walls37a,37band opposite substantiallyflat walls39a,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 andproximal portions33,35,31 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 thecentral return lumen40.
• With continued reference toFIGS. 5 and 6A, a series of side openings or ports50 are provided in theouter wall14 ofcatheter body10. Theseopenings50a,50b,50c,50d,and50eare each in fluid communication with a respective intake 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 intake 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 venous (return) lumen size preferably ranges from about 0.006 inches to about 0.008 inches²in cross-sectional area, and is more preferably 0.007 inches². The cross-sectional area of each of the arterial (intake) lumens34 preferably ranges from about 0.002 inches to about 0.004 inches², and more preferably about 0.003 inches², bringing the total cross-sectional area of the intake lumens to about 0.01 inches to about 0.02 inches², and more preferably about 0.015 inches². This means that the ratio of total cross sectional area of the return lumen to the intake lumens is about I 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-shapedlumens60a,60b,60care positioned around the arterialcentral lumen40′. These larger sized lumens provide for additional arterial (intake) 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, fivelumens66a,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 intake lumens76a,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 intake 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 intake (arterial) 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 intake 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. A third embodiment of the stiffening rod is illustrated inFIG. 49.
• 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 through central 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 of venous (return)tube16 and removed from thecentral lumen40 of thecatheter10 and from the venous (return)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 thetube16 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 return opening247 andside openings246 inouter wall244 communicating withlumen241 indistal tip portion242, which communicates withcentral lumen40. Arterial intake lumens234a-234eterminate atwall248 and have respective side openings252a-252eand250s-250eformed in theouter wall214. Only one of theside openings250a,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 mount stiffeningrod90 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, withcentral return lumen106 and intake 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, acentral return lumen156 which also receives aguidewire20, and a series (e.g.5) of intake lumens160-160.Venous return 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.Arterial intake lumens160 each terminate atside openings161, similar to side openings52 of intake 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 arterial 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 acentral return lumen186 configured to receiveguidewire20 and stiffeningrod80 or90.Lumen186 communicates withlumen181 and narrowed lumen183 of thenose184 which terminates in opendistal end188.Side openings189 ofnose184 communicate withlumen181. A series ofindependent intake 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 ribs194 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 venous ports for blood delivery to the patient.
• A series of intake (arterial) 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 respectivearterial 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 therods80 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.
• Catheter500 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 theaforedescribed rods80,90, 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 intake 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.
• FIGS. 45-54 illustrate another alternate embodiment of the catheter of the present invention, designated generally byreference numeral800.Catheter800 has a catheter body orcatheter tube810 having adistal portion812 and atransition portion814 between thedistal portion812 and anintermediate portion816 of the catheter. Theproximal portion818 ofcatheter body810 has a flared region as will be described below.
• With reference toFIGS. 45 and 47, thedistal portion812 ofcatheter800 is elongated and has a diameter less than the diameter of theintermediate portion816. By way of example, in one embodiment, the diameter of thedistal portion812 can be about 0.118 inches and the diameter of theintermediate portion816 can be about 0.218 inches Clearly other dimensions are contemplated.
• Thetransition portion814 provides a smooth transition between theintermediate portion816 and thedistal portion812 as it tapers in a distal direction. Formed in thetransition portion814 are four widened somewhat trapezoidal open areas, separated by ribs849, each extending longitudinally to communicate with the intake openings. Thus, the intake openings terminate in longitudinally aligned openings at thetransition portion814.
• Thedistal portion812 has a non-uniform wall thickness with two tapered regions, best shown inFIG. 49. The wall thickness remains substantially constant until slightly proximal of thetransition region814 where it increases in thickness over a portion of the length, beginning at portion819. The wall thickness ofdistal portion812 then decreases towards the distal end at region817 forming a first taper. A second taper813 is formed at the distalmost end. In one embodiment the first taper at region817 is about 2 degrees and the distalmost end taper at region813 is about 5 degrees, although clearly other tapers are contemplated. These tapered regions provide for easier insertion of thecatheter800. Since the tapers are created by a change in wall thickness, the cross-sectional area of the central return lumen remains constant and the venous pressure is unaffected.
• Embedded in thedistal portion812 is a stiffening insert820 similar to thecylindrical stiffening insert110 described in conjunction withFIGS. 13A-15B, except it is located proximal of the distalmost tip. The stiffening insert820 is placed during formation of the catheter tube by melting the catheter material around the insert during formation in a similar fashion asinsert110.
• FIG. 48 illustrates the lumen configuration of thecatheter800 which is similar to the lumen configurations ofFIG. 9C. A central return (venous)lumen830 is encircled by a series of intake lumens840a-840din a spoke-like fashion. Thecentral return lumen830 is substantially square in cross-section with rounded corners as shown inFIG. 48A. The four intake lumens840a-840dare oval-like in cross section with a substantially planar edge842a-842dand opposing inwardly angled side walls. Thecentral lumen830 terminates in opening832 at the distalmost end of thecatheter tube810. The intake lumens are independent and each terminates in an open area844a-844din thetransition region814 as described above.
• In a preferred embodiment, thecentral return lumen830 is of substantially constant cross-sectional area throughout its length. At thedistal portion812 thelumen830 transitions to a more circular shape (FIG. 48B), but the cross-sectional area preferably remains the same. In a preferred embodiment, the cross-sectional area of the central lumen is about 0.007 inches², although other dimensions are contemplated. At the flared portion821 (FIG. 50) thereturn lumen830 transitions to a more circular configuration.
• In the preferred embodiment, the intake lumens840a-840dremain constant throughout their length until the proximal flaredportion821 where they are substantially circular (FIG. 50) and of greater cross-sectional area to receive the arterial extension tubes described below. The intake lumens840a-840dtransition to a more arcuate shape, as shown inFIG. 48B, just proximal of thetransition region814, but the cross-sectional area preferably remains the same. (This lumen configuration is similar to that ofFIG. 9A in that it is more of a trapezoidal than oval shape with curved walls and inwardly angled substantially straight side walls). The cross-sectional area of each intake lumen840 is preferably about 0.003 inches²so that the total intake cross-sectional area is preferably about 0.012 inches², but other dimensions for the intake lumens are contemplated.
• Turning now to the hub and tubing design for connecting thecatheter810 to the dialysis machine tubing, and with reference toFIGS. 50 and 51, fourarterial extensions tubes850a-850dare each placed in a respective intake lumen840a-840dat the flaredportion821 to provide fluid communication. Asleeve852 is attached during a thermal forming process to blend with theindividual tubes850a-850dto retain the fourarterial extension tubes850a-850dtogether. A connector tube or insert854, preferably of stainless steel, is inserted into thecentral lumen830 and a taperedvenous extension tube856 is placed over thetube854 to provide fluid communication betweenextension tube856 andcentral lumen830. The twohub halves860,862 ofhub861 are snapped fitted over the region containing flaredportion821,connector tube854, and a portion ofextension tubes850a-850d,856 andsleeve852 as shown inFIG. 51. Conventional arterial and venous clamps C1, C2, respectively, are illustrated inFIG. 45. In the preferred embodiment, a single arterial clamp C1 would clamp on thesleeve852 to cut off flow simultaneously through all thearterial extension tubes850a-850d.Thus separate arterial clamps would not be required. Aluer lock858 onvenous extension tube856 is for mounting the stiffener rod, and subsequent to insertion and after removal of the stiffener rod, for mounting tubing for connection to the dialysis machine. The luer lock for the arterial tubing mounts dialysis machine tubing.
• A conventional suture ring870 (FIG. 45), having suture holes for attaching the catheter, is fitted in an annular groove in thehub861. Aconventional fibrous cuff872 for tissue ingrowth is shown at an intermediate section of thecatheter810 for tissue ingrowth as described above.
• As described above, the catheters of the present invention are preferably inserted with the aid of a stiffening rod.FIG. 49 illustrates an embodiment of a stiffening rod for use withcatheter800 to temporarily increase the stiffness of the catheter to facilitate pushability (insertion) of the catheter. Stiffening rod880 has a thickened wall portion882 which engages an internal wall in the region of the catheter adjacent the region which contains the stiffening insert820. Since this catheter region is not as flexible, it is not stretched at this region by the stiffener rod880, thus providing resistance to distal movement of the stiffening rod880, thereby holding it in place during insertion.
• The proximal end of the stiffener is threaded onto venous luer858 (FIG. 45). The increased wall thickness of stiffener rod880 cooperates with the distalmost tip of thecatheter800 to prevent coring of tissue during insertion. The stiffener880 protrudes past the distalmost tip of thecatheter body810 as shown, serving to help dilate tissue during insertion. Lumen884 is dimensioned to receive a guidewire.
• The arterial extension tubing includes a funneled lead in to facilitate insertion of standard guidewires to clear obstructions, e.g. clots and thrombus, in the catheter arterial lumens which may form over time. With reference toFIGS. 52-54, each of the quadrants within the sleeve has an inwardly directed curved inner wall892a-d to create a funnel for the tubing entry region.
• 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 therethrough (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 0.040 inches to about 0.045 inches to receive the guidewire. The diameter of the catheter is typically between about 0.170 inches and about 0.220 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”, and preferably into the inferior vena cava. 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”.
• Catheter10 is then threaded over the guidewire with theproximal portion21 of the guidewire 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. The catheter 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 above. Thus, theguidewire20 would extend through the central lumen of catheter by extending through the central lumen of the stiffening member which is positioned within the central lumen of the catheter.
• 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 inFIG. 2, by thetrocar300, and the catheter inserted over the guidewire through the tissue tunnel and through the left internal jugular vein or subclavian 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.
• Guidewire20 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 the catheter is pushed downwardly and/or pulled back to straighten the loop to position the catheter as shown inFIG. 29G. If the catheter is inserted with a stiffening member, the guidewire would extend through the lumen of the stiffening member.
• 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.
• 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. 21A 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.Trocar350 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.
• FIGS. 21B-21H illustrate alternate embodiments of a trocar adapted to create a subcutaneous tissue tunnel and to subsequently be attached to a catheter.Trocar900 and920 each has a removable handle which is grasped by the user and then inserted into the body to create the subcutaneous tissue tunnel. The handle provides additional leverage for facilitating trocar insertion/ passage. Once inserted through the tunnel, the handle is detached and the trocar is attached to the dialysis catheter as described above, for example, with reference totrocar350 ofFIG. 21A. The distal end has a dilating distal tip as described above.
• More specifically, inFIGS. 21B, 21C,21E and21F,trocar900 has a connectingstructure902 on a proximal end of theelongated body903. The connectingstructure902 has acircumferential groove904. Contained within thehandle906 is alatch910 having anopening912 dimensioned to receivetip905 of connectingstructure902. Thelatch910 is spring biased upwardly byspring914 so thatsurface916 is seated within agroove904 to lock theelongated body903 withinhandle906. To release thehandle906, protrudingregion918 oflatch910 is depressed, thereby forcingsurface916 out ofgroove904 and placingtip905 in alignment withopening912 of latch910 (shown in phantom inFIG. 21F). This enables theelongated body903 oftrocar900 to be separated from thehandle906. After such separation, which procedurally would occur after the trocar is inserted in the body to create a tissue tunnel t as inFIG. 21D, the connecting structure can be connected to a dialysis catheter to pull the catheter through the tissue tunnel. It should be appreciated that the latch can alternatively engage the recess in thebarbed fitting352 oftrocar350 ofFIG. 21A.
• In the embodiment ofFIGS. 21D and 21G, the connectingstructure952 extending from elongated body of trocar950 comprises series ofthreads954. Handle960 includes a bore with an internal thread for threaded connection tothread954. Thus, theelongated body953 of trocar950 can be unthreaded and removed fromhandle960 after creation of the tissue tunnel and then threadedly connected to the dialysis catheter.
• It should also be appreciated that the threaded connection can be used with the trocar ofFIG. 21A having a barbed fitting. This is shown inFIG. 21H. The threads351 are positioned distally of thebarbed fitting352′ with the trocar handle (not shown) having a bore with a first region dimensioned to receive the barb and having threads in a second region to engage the threads of the trocar. Similarly, if desired, the circumferential groove of the embodiment ofFIG. 21B can be placed distal of the barbed fitting of the trocar ofFIG. 21A. The bore of the trocar handle would accommodate the barbed fitting plus include a latch to align with the region of the bore which receives the circumferential groove. In this manner, the barbed fitting would provide the connecting structure for the dialysis catheter and the latch or threads would provide the connecting structure for the trocar handle.
• 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 venous return (delivery) lumen of the catheter with an inflow tube and fluid connection of the five independent arterial intake (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 centralvenous 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 arterial lumens209a-209e.Next, ametal pin207 is inserted through theslit201 for the molding process. Outer plasticvenous tubing210 is placed over themetal pin207 as shown inFIG. 35 to ultimately communicate with thecentral lumen205. Outer plasticarterial tubing211 is also shown positioned over thecatheter tube203 which will communicate with the arterial 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 inFIG. 37,lumen204 fluidly connectslumen207 ofvenous tube210 with thecentral lumen205 of the catheter.Lumen212 ofarterial tubing211 communicates with the five independent arterial 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 arterial (intake) lumens403a-403e.FIG. 40 illustrates the fivecuts408 made in thecatheter wall407 between the adjacent arterial lumens403 to form the five segments401.
• A separate arterial connector tube412a-412eis positioned within a respective arterial lumen403a-403eand is connected to a respective segment401a-401eby solvent bonding or pressure fit. The proximal end of each connector tube412 is positioned withinarterial tube414 which transports blood to the dialysis machine. Thus, blood flows through the arterial lumens403, through each arterial connector tube401 and into a single arterial (intake)tube414. It should be understood, that if fewer or larger number of arterial lumens are provided, then an equal amount of arterial tubes would be utilized as the arterial lumens would be cut into the corresponding number of segments.
• Venous (return)tubing416 is connected to central venous lumen byvenous connector tube410 which is attached inside the venous lumen by solvent bonding, glue application or compression fit. Note thatvenous connector tube410 is positioned between the segments401.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 arterial connecting (intermediate)tubes704 are connected to a respectivearterial 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 arterial 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 thatvenous lumen78 also transitions to a substantially circular cross-sectional configuration.
• Each of theconnector tubes704 is connected to multi-lumen extension (arterial)tube708 which provides flow 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 (venous)tube712, which provides return 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 asclamps17,19 ofFIG. 1, are placed aroundextension tubes708,712 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, IIa 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.

Claims (18)

1. (canceled)

2-24. (canceled)

25. A dialysis catheter comprising:

a catheter body having a proximal portion, a distal portion, a first longitudinally extending lumen configured to deliver blood to a patient, and a second longitudinally extending lumens configured to withdraw blood from a patient;

a first blood delivery opening formed in the distal portion of the catheter body, the blood delivery opening being in fluid communication with the first lumen and configured for passage of blood therethrough;

a second blood withdrawal opening formed in the distal portion of the catheter body, the blood withdrawal opening being in fluid communication with the second lumen and configured for passage of blood from a patient; and

a spacer extending from the catheter body to reduce contact of the catheter body with a vessel wall.

26. The catheter ofclaim 25, wherein the spacer is located between the first opening and the second opening.

27. The dialysis catheter ofclaim 26, wherein the blood withdrawal opening is spaced proximally of the blood delivery opening.

28. The dialysis catheter ofclaim 25, wherein the spacer comprises a wire movable from a straightened position to a bowed position.

29. The dialysis catheter ofclaim 25, wherein the spacer comprises a rib formed by a cutout portion in the catheter body.

30. The dialysis catheter ofclaim 29, wherein the spacer comprises a plurality of ribs movable from a retracted position to a bowed position.

31. The dialysis catheter ofclaim 25, wherein the spacer is movable between a first retracted position and a second position extending outwardly from the catheter body.

32. The dialysis catheter ofclaim 27, wherein the blood delivery opening and the blood withdrawal opening are each formed in a sidewall of the catheter body.

33. The dialysis catheter ofclaim 27, wherein the blood delivery lumen terminates in an opening at a distalmost tip of the catheter.

34. The dialysis catheter ofclaim 25, further comprising a stiffening member removably positionable in the catheter.

35. The dialysis catheter ofclaim 34, wherein the stiffening member has a lumen to receive a guidewire for over the wire insertion of the catheter.

36. The dialysis catheter ofclaim 27, wherein the blood delivery lumen is positioned centrally within the catheter body and the blood withdrawal opening is positioned radially of the blood delivery lumen.

37. The dialysis catheter ofclaim 34, wherein the stiffening member stretches the catheter body and moves the spacer to a straightened position for insertion.

38. The dialysis catheter ofclaim 34, wherein the distal tip portion of the catheter includes a shoulder adapted to abut the stiffening member inserted through the first lumen.

39. The dialysis catheter ofclaim 34, wherein a proximal portion of the stiffening member has a series of threads for mounting the stiffening member to the catheter.

40. The dialysis catheter ofclaim 25, wherein a distal portion of the catheter tapers to a reduced diameter region.

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