FLEXIBLE CATHETER

Abstract

A flexible, elongated catheter tube having distal and proximal ends and a laser cut section there between. The laser cut section makes up a majority of the catheter length and is cut in a continuous helical pattern forming interlocking teeth which can be sinusoidal, triangular, square or like shapes, preferably sinusoidal. The interior of the tube has a polymeric layer which forms the internal lumen of the catheter. The exterior of the tube has a polymer coating. A short portion of the distal end is uncut and is followed by a narrower terminal section which can be tapered for better blockage penetration. The interlocking teeth disengage and reengage in a fish-scale manner without undergoing plastic deformation of the metal tube and without substantial polymer separation from the tube exterior.

Claims

1. A flexible catheter capable of transmitting an axial push force against a vascular occlusion thereby allowing said catheter to advance beyond the occlusion, comprising: an elongated tube having an exterior and an interior, an internal lumen, a distal end and a proximal end, and a laser cut section between said distal and proximal ends comprising substantially 90% of the length of said catheter which is able to transmit rotary and axial motion from said proximal end to said distal end; wherein (i) said 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 said rows, said helical cut pattern making from 4 to 12 repetitions around said catheter; (ii) said proximal end of the tube comprises a solid, uncut section; (iii) said distal end of the tube comprises a solid, uncut section; (iv) said tube interior has a polymer layer which forms said internal lumen; and (v) said tube exterior has a polymer coating; whereby said catheter is able to flex without deformation of the tube or substantial separation of said polymer coating from the exterior.

2. The catheter of claim 1 wherein said interlocking teeth have a diameter substantially in a range from 0.005 to 0.015 inch.

3. The catheter of claim 1 wherein said interior polymer layer is substantially 0.0025 inch thick.

4. The catheter of claim 1 wherein said interior polymer layer is a bi-layer comprising a first layer of a nylon or nylon-like polymer and a second layer of a Teflon or Teflon-like polymer over said first layer.

5. The catheter of claim 4 wherein said polymer bi-layer is substantially 0.0025 inch thick.

6. The catheter of claim 1 further comprising a space between adjacent interlocking teeth such that said exterior polymer coating blends with said interior polymer layer into said space.

7. The catheter of claim 1 wherein said exterior polymer coating has a thickness substantially in a range from 0.0015 to 0.004 inch.

8. The catheter of claim 1 wherein said laser-cut section comprises substantially 95% to 99% of the length of said catheter.

9. The catheter of claim 1 wherein said constant cut angle is substantially between 64 and 75.

10. The catheter of claim 1 wherein said constant pitch is substantially in a range from 0.033 to 0.039 inch.

11. The catheter of claim 1 wherein said tube is nitinol, steel or other biocompatible metal.

12. The catheter of claim 1 wherein said tube is a polymer or polymer derivative.

13. The catheter of claim 1 wherein said distal end includes one or more V-shaped cuts.

14. The catheter of claim 1 wherein said interlocking teeth are sinusoidal, triangular or square shaped.

15. A process for resolving total or partial body lumen blockages, said process comprising: (a) inserting a catheter into a body lumen having a blockage, said catheter comprising an elongated tube having an exterior and an interior, an internal lumen, a distal end and a proximal end, and a laser cut section between said distal and proximal ends comprising substantially 90% of the length of said catheter which is able to transmit rotary and axial motion from said proximal end to said distal end; wherein (i) said laser cut section comprises a continuous, uniform helical cut pattern having a constant cut angle forming rows of interlocking teeth with a constant pitch between said rows, said helical cut pattern making from 4 to 12 repetitions around said catheter; (ii) said proximal end of the tube having a solid, uncut section; (iii) said distal end of the tube having a solid, uncut section; (iv) said tube interior has a polymer layer which forms said internal lumen; and (v) said tube exterior has a polymer coating; whereby said catheter is able to flex without deformation of the tube or substantial separation of said polymer coating from the exterior; then (b) transmitting an axial push force from said distal end to said proximal end to cross the blockage and to advance said catheter beyond the blockage.

16. The process of claim 15 wherein said blockage is a chronic total occlusion.

17. The process of claim 16 wherein said chronic total occlusion has one or more hard end caps.

18. The process of claim 16 wherein said chronic total occlusion is without hard end caps.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The invention will be more fully understood from the following description and drawings wherein:

[0019] FIG. 1 is a diagrammatic side view of a catheter tube with dimensions of a preferred embodiment by way of example (all dimensions are in inches unless noted otherwise); FIG. 1A is an exploded side view of a portion of the cut pattern shown in FIG. 1 with dimensions of a preferred embodiment by way of example; FIGS. 1B-1D are exploded side views of alternate cut patterns for use in the catheter of FIG. 1 with dimensions by way of example; FIG. 1E is an exploded side view showing details of the distal end of the catheter of FIG. 1 with dimensions by way of example;

[0020] FIGS. 2 and 3 are exploded side views of alternate cut patterns for use in the catheter of FIG. 1 with dimensions by way of example;

[0021] FIG. 4 is a schematic of a diseased artery with a total blockage including a denser end cap;

[0022] FIG. 5 is the same schematic as FIG. 4 showing a catheter of the invention crossing a dense end cap and entering the blockage;

[0023] FIG. 6 is a schematic diagram of the catheter of FIG. 1 having a luer fitting-attached to the proximal end of the catheter to allow flushing of the catheter prior to use;

[0024] FIG. 7 is an alternate embodiment to FIG. 6 wherein the proximal luer is bifurcated to facilitate the delivery of multiple ancillary devices during a medical procedure;

[0025] FIG. 8A is a cross section of the catheter of the invention with an inner polymer bi-layer and an outer polymer sheath or coating;

[0026] FIG. 8B is a cross section of an alternate catheter of the invention with an inner polymer layer and an outer polymer sheath or coating;

[0027] FIG. 9 is a perspective view of test apparatus used to ascertain flexibility and measure axial push force;

[0028] FIG. 10 is a bar graph of average peak push force measured with the test apparatus shown in FIG. 9;

[0029] FIGS. 11-17 depict alternate cut patterns for forming interlocking teeth; and

[0030] FIG. 18 is a sketch of a commercial catheter tested as a control against catheters of the invention.

DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS

[0031] 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.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] Referring now to the drawings, FIG. 6 shows the inventive catheter generally indicated at 100. Catheter 100 includes a laser cut catheter tube 102 having a luer fitting 101 attached at the proximal end thereof to allow flushing of the catheter prior to use. Catheter 100 is capable of accepting ancillary devices typically used in endovascular and related medical procedures such guidewire 200 which is used to track catheter 100 to the target treatment area in a body lumen or to inject contrast fluid 200 through the catheter to enable imaging during a procedure.

[0037] FIG. 7 is similar to FIG. 6 wherein the proximal luer 101 is bifurcated to facilitate the delivery of multiple ancillary devices 200 through catheter 100 during a medical procedure.

[0038] FIG. 4 shows a diseased artery 300 comprised of an arterial wall 301 and a heavily calcified lesion 302 known as a chronic total occlusion (CTO) which is typically comprised of denser end caps 302 on the proximal and distal ends that are significantly harder to access than the center of CTO 302.

[0039] FIG. 5 shows the distal end of catheter 100 crossing CTO 302 shown in FIG. 4. In order to cross the lesion, catheter 100 is capable of transmitting adequate force to the distal end when being pushed at the proximal and transmit adequate torque to the distal end when torque is applied to the proximal end. Catheter 100 is flexible enough at the distal end to navigate tortuous anatomies of the vasculature in order to reach the target site as well as be able to transmit force and torque in this configuration.

[0040] FIGS. 1, 1A and 1E show a preferred embodiment of catheter tube 102. The overall length 155 of tube 102 is shown for example as 61.3 inches, it being understood that solid section 157, shown as 8 inches in length, includes a portion which is gripped for laser cutting; end portion 157 is shortened considerably after laser cutting (to from 0.5 to 3 inches for example) for connection to a luer device as shown in FIGS. 6 and 7. The finished catheter 100 will typically have a length of 90, 135 or 170 cm, depending on the medical procedure being used.

[0041] FIG. 1 indicates two detail portions, the first at 156 for the tube cut pattern shown in FIG. 1A and the other at 158 for the distal end configuration shown in FIG. 1E. FIGS. 1A-1D and FIGS. 2 and 3 show alternate embodiments of the tube cut pattern with dimensions in each figure by way of example. Like elements have like reference numerals.

[0042] 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 FIGS. 1A-1D, 2 and 3. The sinusoidal shape is preferred because it facilitates disengaging and reengaging of teeth 109 when the catheter is flexed. Other useful teeth shapes include triangular and square shapes as shown in FIGS. 12 and 13.

[0043] As shown in FIGS. 1A-1D, 2 and 3, sinusoidal teeth have a diameter 108 in the range from about 0.005 to about 0.015 inch and the helical angle 105 of the center-line of the sinusoidal cut 103 is a constant angle between about 64 and about 75. The diameter of the interlocking sinusoidal teeth can also be expressed as a percentage of the diameter of tube 102, for example from about 5 to 15%, preferably about 8%, of the diameter of catheter tube 102.

[0044] 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.

[0045] 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.

[0046] FIG. 8A shows the catheter of FIG. 1A in cross section having a polymeric bi-layer of a nylon or like polymer 404 at the interface of catheter tube 102 interior, a TEFLON or like polymer 102 forming the internal lumen of the catheter, and a thin nylon or like polymer exterior coating 102. As an alternative, the cross section of FIG. 8B has an inner polymer layer 102, a middle metallic layer 102, and an outer polymer layer 102. FIG. 8B is incorporated from the U.S. Provisional Application No. 62/274,203, filed Jan. 1, 2016.

[0047] Proximal end 150 (FIG. 1) comprises an uncut portion 157 configured for coupling to a luer connection (FIGS. 6 and 7). Distal end 152 (FIG. 1E) comprises a solid, uncut section no longer than about 0.02 inch followed by a narrower terminal section no longer than about 0.149 inch in length. Distal end 152 can be narrowed or necked down by compressing end segments 402 created by gusset cuts 401 (FIG. 1E).

[0048] 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.

[0049] FIG. 11 is a schematic of the metallic tube of the middle layer 102 of the catheter shaft 102 having a distal end 100 and a proximal end 100. The middle metallic layer 102 is comprised of a helical sinusoidal cut pattern 103 drawn from a reference or center-line 104 that is on an angle 105 relative to the longitudinal length of the metallic tube 102. The path of the sinusoidal cut pattern has a peak-to-peak amplitude 106 and period 107. The peak-to-peak amplitude 106 of the cut pattern is split into an amplitude on the distal side of the center-line 106 and an amplitude on the proximal side of the center-line 106. Similarly, the period 107 is split into a distal period 107 and a proximal period 107 as illustrated in FIG. 11. The peaks and valleys of the sinusoidal cut path consist of a peak cut shape 108, which along with the period 107 creates teeth 109 between adjacent peaks or valleys. A pitch 110, the longitudinal spacing from center-line to center-line, is a function of the circumference of the metallic tube 102 and the center-line angle 105. The frequency is calculated by dividing the period 107 from the circumference of the metallic tubing 102.

[0050] FIG. 12 shows an alternate embodiment of the cut pattern in FIG. 11, in which the frequency is decreased and the peak cut shape 108 is primarily triangular. The peak cut shape 108 creates teeth 109 that effectively interlock the metallic tubing on the distal and proximal sides of the cut providing increased torque response of the catheter.

[0051] FIG. 13 shows an alternate embodiment of the cut pattern in FIG. 11, in which the frequency is increased and the peak cut shape 108 is primarily a square. The peak cut shape 108 creates teeth 109 that effectively interlock the metallic tubing on the distal and proximal sides of the cut providing increased torque response of the catheter.

[0052] FIG. 14 shows an alternate embodiment of the cut pattern in FIG. 11, in which the distal period 107 and the proximal period 107 are not symmetric. Additionally, the peak cut shape 108 is drawn at a large diameter that along with the distal period dimension 107 creates teeth 109 between adjacent peaks and valleys that effectively interlock the metallic tubing on the distal and proximal sides of the sinusoidal cut providing increased torque response of the catheter.

[0053] FIG. 15 shows an alternate embodiment of the cut pattern in FIG. 11 in which the distal period 107 is greater than the period 107 and the proximal period 107 is equal to the difference between the distal period 107 and the period 107. The shown cut pattern orients the interlocking features primarily in the circumferential direction instead of the longitudinal direction (as shown in previous schematics) to prevent fish-scaling or hinging of the teeth 109 when the catheter is wrapped around a tight bend.

[0054] FIG. 16 shows a cut pattern 103, in which the period 107 decreases and the frequency increases along the length of the catheter from proximal 100 to distal 100.

[0055] FIG. 17 shows a cut pattern 103, in which the period 107 and peak-to-peak amplitude 106 both decrease along the length of the catheter from proximal 100 to distal 100.

[0056] 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.

[0057] 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 (FIGS. 6 and 7).

[0058] Another embodiment is a cut pattern similar to that shown in FIGS. 16 and 17 where the peak-to-peak amplitude 106 decreases while the period 107 remains constant.

[0059] 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.

[0060] An important aspect of polymeric layers 102, 102 and 404 (FIG. 8A) on both the inside diameter is the ability to greatly reduce fish-scaling. Fish-scaling is the occurrence of a portion of a tube sticking out of surface of a bend or radius similar to how scales on a fish may protrude if the fish were bent at its half point in its body. Fish-scaling is an occurrence seen in stents that are not fully connected and can result in vessel damage. The reduction of fish-scaling can increase the torqueability, flexibility or other attributes of a catheter depending on the tradeoffs decided in a given design. An interruption of the cover 102 or a partial cover can allow an exit point or perfusion of a liquid. The material of cover 102 can be a polymer or a polymer ceramic or a polymer with metal component such as heat shrunk TEFLON, PEEK (polyether ether ketone), a combination of both, other like polymers and composites. The sealing or encapsulation material can be heat shrunk, sprayed or flowed onto cut tube 102. The material could also have some radiopaque materials added on some or all of the covering material.

[0061] 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).

[0062] Other applications which can use catheter 100 include bone reamers and shafts for many surgery devices requiring articulated segments.

EXAMPLES

[0063] 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 FIG. 9. Track tube 510 simulates the iliac arch and its five turns or bends at 510A-E. Track 510 is connected to bifurcated luer 512 for receiving catheter tube 100 which is fed over a guidewire into track 510 via traveling block 505 and tube 511 which carries collet 508 for gripping catheter 100 while it is pushed through track 510 by advancing block 505 via screw arm 506 which is driven by crank 507. Body temperature water is flowed over catheter tube 100 via water line 509 connected to luer 512. Peak push force is measure by pushing catheter 102 against pressure point 513 of load cell 513, Model MBD-100, and sent to digital reader Model SSI, both made by Transducer Techniques.

TABLE-US-00001 TABLE 1 Guidewire Outer Catheter Tubing Wall FIG. No. Compatibility Diameter Thickness 1B 0.014 2.9 Fr (0.034) 0.0015 1A 0.018 3.16 Fr (0.038) 0.0015 1C 0.035 4.46 Fr (0.055) 0.00225 3 0.018 3.16 Fr (0.038) 0.0015 2 0.018 3.16 Fr (0.038) 0.0015

[0064] Formula for Scaling a Design:

(D.sub.1/D.sub.2)(T.sub.1)=T.sub.2

D.sub.1=Diameter of desired tubing size
D.sub.2=Diameter of current tubing size
T.sub.1=Current tooth diameter
T.sub.2=New tooth diameter

(T.sub.2/T.sub.1)P.sub.1=P.sub.2

T.sub.1=Current tooth diameter
T.sub.2=New tooth diameter

P.SUB.1.=Current Pitch

P.SUB.2.=New Pitch

[0065] Maintain cut angle [0066] OR

[0067] Follow the above when scaling down, but when scaling up: [0068] Maintain tooth diameter and cut angle

[0069] Increase number of repetitions:

(D.sub.1/D.sub.2)(R.sub.1)=R.sub.2

D.sub.1=Diameter of desired tubing size
D.sub.2=Diameter of current tubing size
R.sub.1=Current number of repetitions
R.sub.2=New number of repetitions

[0070] Adjust pitch as necessary to create a continuous pattern.

[0071] 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 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 FIG. 9 following the same pushability protocol as above:
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).

[0072] 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).

[0073] 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 FIG. 18 (drawn from a product brochure) with polymeric distal tip 901 and spiral windings 903 and 904.

[0074] Test results are summarized in the bar graph of FIG. 10 wherein catheters according to the invention (FIGS. 1A, 2 and 3) demonstrated average peak push force values on the order of 4 to 5 times higher than the control catheters.

[0075] 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.