This invention relates to a flexible catheter tube which is capable of transmitting rotary and axial motion to resolve blockages in a body lumen such as a blood vessel.
For well over fifty years, there has been a need to create a flexible tube from an otherwise stiff tube by cutting the tube along the length. There are many examples of this design approach for many instruments in medical devices including catheters and guidewires (U.S. Pat. No. 5,573,520), bone reamers (U.S. Pat. Nos. 5,108,411 and 6,053,922) and other non-medical applications such flexible drill bores for well drilling (U.S. Pat. No. 2,515,365).
Flexible shafts and couplings are used to transmit rotary power between a power source and a driven part when a straight, unobstructed path is unavailable. A flexible shaft generally consists of rotating shaft with end fittings for attachment to mating parts which together construct a device. The power source is anything which can transmit the correct forces including a motor or a physician's hand. The shaft is envisioned to be used to transmit motion in a curvilinear manner such as a catheter shaft delivered through the iliac arch in the hip region, or for use as a bone reamer with flexible medullary canal reamers.
Historically, flexible shafts have been comprised of braided wire, slotted tubing, wound wire, or small diameter polymer tubing. Small diameter polymer tubing is not considered an ideal option for some applications due to a lack of pushability and high risk of kinking. This ability to transmit energy from one end of the shaft to the other is considered one of the most important characteristics when maneuvering through long, tortuous vessels. Hypotube-based shafts with a slotted or spiral cut pattern can extend the traditional limits of metal shafts, but continue to present limitations with flexibility and torque transmission. The traditional spiral cut pattern, for example, tends to wind up when torqued such that a one revolution turn at the torqued, or proximal end does not equal a one revolution turn at the non-torqued or distal end; in the worst cases, a one revolution turn results in a less than one-quarter of a revolution or less. The standard slotted pattern with no or limited male-female portion has better torqueability, but often limited bend radius along one or more planes.
Catheters and guidewires can include a full or portion of a shaft that is both flexible and torqueable or has a gradient of flexibility and torqueability along the length of the shaft. For optimal steerability and pushability, most catheter designs must have a maximum torsional rigidity while retaining a satisfactory kink-resistance and flexibility. These shafts can be used in many catheters and introducers including those for balloon angioplasty, stent delivery, electrophysiology applications, drug delivery or infusion, atherectomy, crossing catheters, or endovascular surgery. Depending on the application, the optimized and gradation of the flexibility and torqueability can be further modified by having a tube within a tube where the inside or outside tube or both can be comprised of a cut tube of this invention.
Chronic total occlusion (CTO) remains one of the most challenging pathologies encountered by surgeons and interventionalists alike. CTO is characterized by heavy atherosclerotic plaque burden resulting in complete, or near complete occlusion of a vessel for at least 1-3 months. CTO can occur in any part of the arterial vasculature, however, it is most common in the legs and other arteries near the heart. Chronic occlusions are present in up to 40% of patients who undergo treatment of symptomatic peripheral artery disease (PAD) and have been cited as one of the primary reasons for procedural failures. PAD is a prevalent condition, affecting about 10 million individuals in the United States and over 27 million individuals worldwide. CTO is also prolific in patients with coronary artery disease (CAD), the number one cause of death in the United States in both men and women, killing over 400,000 each year. Approximately 30% of all coronary angiograms in patients with coronary artery disease will show a CTO.
Restoring blood flow to the affected area is essential for improving blood supply and tissue perfusion to prevent limb amputation, heart failure and other clinical symptoms associated with these diseases. There are presently two predominate treatment strategies for CTO: bypass surgery or percutaneous recanalization. Until recently, CTOs of the coronary arteries were almost entirely referred for coronary artery bypass graft (CABG) procedures, or many were left untreated because of the high risk and uncertainty regarding CABG success rates. With a failure rate of up to 30%, recanalization poses its own set of technical challenges. A tough, fibrous cap is often present at the proximal and distal ends of the CTO with softer material in between. The majority of recanalization failures are due to an inability to cross the occlusion with the guidewire and balloon technologies currently available. Despite these challenges percutaneous revascularization has been associated with reduced angina, improved left ventricular function, reduced arrhythmias, and reduced mortality. Further innovations and refinement of current crossing catheter technologies are essential to increase procedural success in crossing long, calcified CTOs. Although the worst case for crossing a blocked vessel may be crossing one with a CTO, the intent of the invention is also for use for partial occlusions or simply crossing tortuous anatomy since the given construction can enable optimal performance in many applications.
The invention provides a flexible catheter and a process capable of transmitting an axial push force against a vascular occlusion thereby allowing the catheter to advance beyond the occlusion. The catheter includes an elongated tube having an exterior and an interior, an internal lumen, a distal end and a proximal ends, and a laser cut section between the distal and proximal ends comprising about 90% of the catheter's length which is able to transmit rotary and axial motion from the proximal end to the distal end; wherein (i) the laser cut section comprises a continuous, uniform helical-cut pattern having a constant cut angle which forms rows of interlocking teeth with a constant pitch between the rows, the helical-cut pattern making from 4 to 12 repetitions around the catheter; (ii) the proximal end of the tube comprises a solid, uncut section; (iii) the distal end of the tube comprises a solid, uncut section; (iv) the interior of the tube has a polymer layer which forms the internal lumen; and (v) the exterior of the tube has a polymer coating;
whereby the catheter is able to flex without deformation of the tube or substantial separation of the polymer coating from the exterior of the tube.
In preferred embodiments, the laser cut section comprises from about 95% to about 99% of the catheter length. The helical angle of the center-line of the sinusoidal cut is a constant angle between about 68° and about 70°; the pitch between adjacent teeth is in the range from about 0.033 to about 0.039 inch. The teeth are sinusoidal, triangular, square or like shapes. The interlocking teeth of the laser cut section have a diameter in the range from about 0.005 to about 0.015 inch, preferably in the range from about 0.007 to about 0.015 inch, or about 0.008 inch.
In preferred embodiments, the internal lumen of the tube is formed by an interior polymer bi-layer (i) a first layer of a nylon or nylon-like polymer at the interface of the tube interior and (ii) a second layer of a TEFLON® or TEFLON®-like polymer over the first layer (TEFLON® is polytetrafluoroethylene PTFE consisting wholly of carbon and fluorine). The TEFLON® polymer forming the internal lumen has a static coefficient of friction in the range of 0.05 to 0.08. The PTFE is in the range from about 0.0005 to about 0.001 inch thick. The interior nylon polymer layer and the exterior nylon polymer coating are a polyether block amide with a Durometer index between 35 and 72. The interior polymer bi-layer is about 0.0025 inch thick.
The thickness of the exterior polymer coating is in the range from about 0.0015 to about 0.004 inch, or about 0.003 inch. The wall thickness is in the range from about 0.001 to about 0.005 inch, or about 0.0015 inch. The outside diameter of the tube is the range from about 0.010 to about 0.052 inch, or from about 0.017 to about 0.052 inch.
The tube is nitinol, steel (e.g., full hard 304 stainless steel), or other biocompatible metal. The proximal end of the catheter is configured for coupling to a luer connection. A short portion of the distal end is followed by a narrower terminal section about 0.149 inch or less in length which can be tapered for better blockage penetration.
In operation, the interlocking teeth disengage and reengage in a fish-scale manner without undergoing significant plastic deformation and without substantial polymer separation when the catheter is flexed as it travels through a body lumen such as a blood vessel. The catheter is thus capable of transmitting an axial, push force against a vascular occlusion to cross same and allow the catheter to advance beyond the occlusion.
The invention also provides a process for resolving partial or total body lumen blockages or occlusions which includes inserting the catheter described above into body lumen having a blockage at a distal location and advancing the catheter through the body lumen until the distal end encounters the blockage. The interlocking teeth disengage and reengage in a fish-scale manner without undergoing plastic deformation and without substantial polymer separation when the catheter is flexed during advancement thru the body lumen. An axial push force is transmitted from the proximal end of the catheter to the distal end to cross the blockage and allow the catheter to advance there beyond.
The invention further provides a catheter tube which in cross section has an inside diameter of not less than about 0.010 inch, a polymeric bi-layer of a nylon polymer at the interface of the tube interior, a TEFLON® polymer forming the internal lumen of the catheter and a thin polymer exterior coating of a nylon or like polymer. The wall thickness of the catheter with inner layers and an outer coating is in the range from about 0.0015 to 0.010, preferably 0.007 inch.
The invention will be more fully understood from the following description and drawings wherein:
The catheter of the invention provides an unexpected and surprising combination of flexibility and the ability to deliver an axial push force greater than heretofore possible against an occlusion or total blockage to cross same and allow the catheter to advance there beyond. Flexibility allows an interventional radiologist using the inventive catheter to apply a twisting force or torque while pushing the catheter forward and follow a tortuous path in a body lumen (such as the iliac arch) without kinking. The distal section can be straight or angled as is known in the art.
Once kink-free delivery of the distal end to the point of a blockage or an occlusion is accomplished, the radiologist needs to apply axial pressure against the blockage to pass through or cross same to deliver a stent or other device to resolve the occlusion or blockage. For example, calcified lesions in an artery, known as chronic total occlusions (or CTOs) often have end caps that can be significantly harder to pierce or cross than the center of a CTO.
The catheter of the invention has demonstrated the ability to cross CTOs, even those with denser end caps, by exerting an axial push force in excess of 0.15 pounds and as high as one pound and more which is greater that heretofore possible with known catheters of comparable size. The inability to cross a CTO often leads to alternate and often riskier procedures (like open-heart surgery) to resolve a CTO.
The inventive catheter gives the radiologist several options for resolving a blockage. Once a guidewire locates a blockage, the inventive catheter can be inserted over the guidewire. A short section of the guidewire protruding from and supported by the catheter can challenge the CTO, or the distal end of the catheter and guidewire can be coextensive when pushed against a blockage or the guidewire can be withdrawn and the necked-down end of the catheter can be pushed through a CTO.
The structural parameters of the catheter of the invention are critical in achieving kink-free torquing and sufficient axial force to cross body lumen blockages. For example, the interlocking sinusoidal teeth must be able to disengage and reengage for flexibility without plastic deformation. Lesser values for teeth diameter and the pitch between rows of teeth can provide flexibility, and therefore better torque response around a bend, but at a cost of catheter buckling and decreased transmission of axial force. Exceeding the same values introduces undesirable stiffness and the inability to traverse tortuous body lumens. The use of interior and exterior polymer coatings (which may extend into, interface or blend with each other through the laser cut lines) aid in allowing the teeth to unlock (flex) and interlock without plastic deformation. Thus, smaller teeth may aid flexibility but easily deform; larger teeth resist unlocking and lead to undesirable stiffness.
Referring now to the drawings,
Tube 102 has distal and proximal ends 152 and 150, respectively, and a laser cut section 154 there between enabling the transmission of rotary and axial motion from the proximal end to the distal end. The laser cut section 154 comprises a majority, i.e., from about 90 to 95%, of the catheter length and is cut in a continuous helical pattern 103 forming interlocking sinusoidal shaped teeth 109 as shown in
As shown in
The pitch 110 between adjacent rows of teeth 103 is in the range from about 0.028 to about 0.057 inch. The diameter 108 of teeth 109, helical angle 105 and pitch 110 result in from 4 to 12 repetitions of teeth 109 around the circumference of laser cut section 154.
The outside diameter of tube 102 is in the range from about 0.010 to about 0.052 inch and the wall thickness is about 0.0015 to about 0.005 inch.
Proximal end 150 (
In operation, interlocking teeth 109 disengage and reengage in a fish-scale manner without undergoing plastic deformation and without substantial polymer separation when the catheter is flexed. The catheter is thus capable of transmitting an axial push force against a vascular occlusion to cross same and allow the catheter to advance beyond the occlusion.
The distal portions of the catheter can have a cutting feature or features which can be part of the catheter or a separate cannula that goes either over the outside diameter of the catheter or inside the diameter of the catheter.
A perfusion feature can be added to the catheter which enable the physician to flow liquid from the proximal end (outside of the body) to the distal end or a location or locations along the length of the catheter (
Another embodiment is a cut pattern similar to that shown in
In all embodiments, the helical angle could decrease or more likely increase from the proximal end to the distal end, or portions thereof including a center section. The helical angle shown in most drawings is 105 degrees, strictly as an example. Another example, the helical angle could start as 70 degrees and finish more distally at 112 degrees where the rate of angle change can be constant along the length or is variable. In all embodiments, the catheter can be used for CTO, partially blocked vessels, or other vessels or channels within a mammalian body. CTO is used as a difficult example or worst case under which the invention could need to perform if put into practice.
An important aspect of polymeric layers 102′, 102″ and 404 (
A specific application of catheter 100 includes supporting a guidewire or catheter while crossing plaque buildup where the plaque creates a partial blockage or a total blockage also referred to as a chronic total inclusion (CTO).
Other applications which can use catheter 100 include bone reamers and shafts for many surgery devices requiring articulated segments.
Set of three catheters in the Table 1 were tested for flexibility and peak axial push force (lbf) and compared to commercially available catheters (described below) using simulation test apparatus shown in
Formula for Scaling a Design:
(D1/D2)(T1)=T2
D1=Diameter of desired tubing size
D2=Diameter of current tubing size
T1=Current tooth diameter
T2=New tooth diameter
(T2/T1)P1=P2
T1=Current tooth diameter
T2=New tooth diameter
Maintain cut angle
Follow the above when scaling down, but when scaling up:
Increase number of repetitions:
(D1/D2)(R1)=R2
D1=Diameter of desired tubing size
D⋅2=Diameter of current tubing size
R1=Current number of repetitions
R2=New number of repetitions
Adjust pitch as necessary to create a continuous pattern.
Pushability Test Protocol
1) Track an appropriately sized guidewire through the simulated use model.
2) Flush the catheter with saline then track it over the guidewire through the simulated use model until the distal end is close to, but not contacting the load cell.
3) Retract the distal end of the guidewire about.6″ from the distal end of the simulated use model.
4) Clamp the system in place with the collet about.1.5″ from the entrance to the simulated use model and mark the system just distal to the collet to ensure it does not slip in the fixture during testing.
5) Zero the force gauge then rotate the crank arm until the load cell is preloaded to 0.05 lb+/−0.003.
6) Set the force gauge to peak and rotate the crank arm 3 full rotations (360° each). This constitutes one push. Each 360° rotation of the pusher arm translates the system ⅛″ in the distal direction. Record the peak push force then rotate the arm 3 more times for push two and, again, record the peak force. Continue this method for 5 pushes or until the distal end of the system kinks.
Commercial catheters, 3 of each design, were tested against the Table 1 catheters in the test apparatus of
Control 1: A Cook CXI catheter which is a braided steel catheter (2.6 French) described as the MinaFlex 18 Microcatheter in a 510 (k) premarket notification summary submitted to the FDA by Cook International on Nov. 9, 2007 and available online from the FDA database (Ref. K072724).
Control 2: A Spectranetics Quick-Cross Support Catheter (2.1 French) which is a braided steel catheter described in a 510 (k) premarket notification summary submitted to the FDA by Spectranetics Corporation on Nov. 3, 2003 and available online from the FDA database (Ref. K033678).
Control 3: A Medtronic Total Across catheter which is a spiral cut stainless steel catheter (2.3 French) described in a 510 (k) premarket notification summary submitted to the FDA by Medtronic Vascular on Nov. 15, 2013 and available online from the FDA database (Ref. K133539) and depicted in
Test results are summarized in the bar graph of
While this invention has been described as having preferred sequences, ranges, ratios, steps, order of steps, materials, structures, symbols, indicia, graphics, color scheme(s), shapes, configurations, features, components, or designs, it is understood that it is capable of further modifications, uses and/or adaptations of the invention following in general the principle of the invention, and including such departures from the present disclosure as those come within the known or customary practice in the art to which the invention pertains, and as may be applied to the central features hereinbefore set forth, and fall within the scope of the invention and of the limits of the claims appended hereto or presented later. The invention, therefore, is not limited to the preferred embodiment(s) shown/described herein.
This is a continuation of application Ser. No. 15/515,806, filed Mar. 30, 2017, now allowed; which is the U.S. national stage of Application No. PCT/US2016/068646, filed Dec. 27, 2016; which claims priority benefit of Provisional Application No. 62/274,203, filed Jan. 1, 2016; the entire contents of which are hereby incorporated herein by reference.
Number | Date | Country | |
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62274203 | Jan 2016 | US |
Number | Date | Country | |
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Parent | 15515806 | Mar 2017 | US |
Child | 16653373 | US |