Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
  • A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2206/00—Characteristics of a physical parameter; associated device therefor
  • A61M2206/10—Flow characteristics

Definitions

• the present invention relates to specialized catheters used in the treatment of thromboembolic occlusions in a patient's circulatory system. More specifically, the present invention relates to improved catheters which deliver thrombolytic fluids to the site of a thrombus or blood clot and which provides an improved lateral dispersion, or spray pattern, of the thrombolytic fluid.
• a blood clot or thrombus can endanger the health of a patient in at least two significant ways.
• the clot may restrict or even completely stop essential blood flow to a portion of the patient's body. If the blood flow to the brain or heart for example is restricted the patient's life may be placed in jeopardy. Additionally, a clot may break loose from the site at which it formed and be carried by the blood stream to an organ, such as the heart, where it may cause irreparable damage or even death. Accordingly, when a blood clot is detected, it must be quickly and effectively treated.
• One method involves surgery to remove the clot and repair the blood vessel, another method mechanically breaks up an existing clot into smaller micro-emboli.
• a less invasive method uses thrombolytic drugs to break up, or lyse, the thrombus.
• This method of treating a blood clot consists of inserting a catheter into the patient's circulatory system, preferably near the site of the clot. If the catheter enters the circulatory system near the clot, the catheter alone may be used.
• the catheter must be inserted into the circulatory system at a distance from the clot, placement of the catheter may be aided by using a guide wire or introducer sheath, which can be used to push and guide the catheter through the vessels or arteries of the circulatory system to reach the clot.
• a guide wire or introducer sheath which can be used to push and guide the catheter through the vessels or arteries of the circulatory system to reach the clot.
• a thrombolytic fluid capable of dissolving the clot such as urokinase or streptokinase
• a thrombolytic fluid capable of dissolving the clot, such as urokinase or streptokinase
• Conventional catheters have a lumen, i.e., an internal passage, that allows the thrombolytic fluid to flow through the catheter to one or more discharge openings, or sideholes, at or near the distal end of the catheter.
• the discharged thrombolytic fluid then dissolves or lyses the clot, thus removing the danger to the patient. Not all clots are easily or successfully lysed.
• Some clots form around arterial lesions, which clots may not be easily lysed or broken up by the thrombolytic fluid and which usually require surgical removal. Additionally, some clots may be extremely thick, extending for a relatively long distance through a blood vessel of the circulatory system. Such a thick clot may require considerable amounts of time and heavy irrigation of thrombolytic fluid to dissolve.
• a guidewire is used in conjunction with a catheter to facilitate placement of the catheter.
• the guidewire can also serve to penetrate the clot in order to form a passage therethrough so that the catheter can be inserted within the interior of the clot. This helps to ensure that the thrombolytic fluid is concentrated or focused at the location of the clot, since excessive thrombolytic fluid in the bloodstream can have adverse effects on the patient.
• the guide wire has been used to create a narrow passage through the clot, particularly a thick clot, the thrombolytic fluid is released through the one or more openings within the catheter.
• thrombolysis was carried out using a catheter with a single opening at the distal end of the catheter.
• a catheter having slits or other pressure activated one-way openings arranged radially at 90° intervals around the circumference of the catheter and in sets of four longitudinally spaced intervals along the length of the catheter is disclosed in U.S. Patent No. 5,250,034 to Appling et al.
• a hollow infusion guidewire having sets of four holes, each hole radially separated by 90° intervals around the circumference of the guidewire and each set of four holes spaced longitudinally along the length of the guidewire is set forth in U.S. Patent No. 5,569, 197 to Helmus et al.
• infusion holes that are grouped together in sets of four holes spaced at 90° intervals around the catheter or staggered to form a spiral configuration with individually staggered holes spaced at 90° intervals, the result is the same: infusion holes that are arranged along four parallel lines radially spaced at 90° intervals around the catheter wall.
• hole patterns are superior to a simple catheter having a single hole at the distal end, they are only able to distribute thrombolytic fluids at discrete 90° intervals around the circumference of the catheter. The area between the 90° intervals does not receive as much thrombolytic fluid, thus resulting in a poor overall distribution of thrombolytic fluid.
• the present invention meets the above-described need in the art for an improved catheter.
• the present invention to provide an improved catheter which is capable of more completely and evenly dispersing a thrombolytic fluid around the lateral circumference of the catheter to more quickly and completely lyse a thrombus through which the catheter has been passed. It also provides catheters that ensure a more consistent fluid dispersion rate between catheters of different infusion lengths.
• the catheter of the present invention includes a main lumen through which a thrombolytic fluid can be delivered.
• the open distal end of the catheter is occluded using, e.g. , a ball wire that has a diameter greater than the inner diameter of the distal end of the catheter.
• a section referred to as the infusion length, that includes infusion holes that are preferably arranged in a double spiral configuration.
• the infusion holes allow for passage of thrombolytic fluid from the central lumen to the blood clot being treated.
• the double spiral configuration creates a more complete dispersion of thrombolytic fluids.
• the individual infusion holes are preferably spaced along the length of the catheter at regular intervals; for example, at longitudinal intervals of 0.05 inch.
• the infusion holes are grouped together in sets of holes, typically four holes, which are radially spaced apart at 90° intervals from each preceding hole within the same set.
• Each successive set of holes is preferably rotated relative to the immediately preceding set of holes by about 18° in order to create a staggered hole arrangement that results in a more diverse spray pattern.
• each set of holes is staggered relative to an immediately preceding set of holes by about 18°, the holes within successive sets of holes will nevertheless be incrementally and circumferentially spaced apart in 90° intervals as in the first set.
• the second infusion hole will be circumferentially spaced at an interval of 90° relative to the first infusion hole
• the third infusion hole will be circumferentially spaced 180° with respect to the first infusion hole
• the fourth infusion hole will be circumferentially spaced 270° with respect to the first infusion hole.
• the fifth infusion hole will begin a new group of four holes and will be circumferentially spaced from the first infusion hole by some amount between 1° and 89°, most preferably about
• the sixth, seventh and eighth holes will be circumferentially spaced at successive 90° intervals relative to each other just like in the first set of holes.
• the ninth hole will preferably begin the third set of four holes and will be offset from the fifth hole by, e.g., about 18° and the first hole by about 36°. This pattern repeats itself substantially regularly along the entire infusion length of the catheter.
• Other angles that divide evenly into 360°, but not necessarily 90° or 180° may also be used depending on the desired spray pattern.
• angles that do not divide evenly into 360° may be used in order to yield an even more randomized spray pattern.
• fluid dynamics may dictate that the circumferential distance, or angle, of offset be within a certain range in order to ensure substantially even distribution of fluid through each of the holes along the infusion length.
• the usable catheter length may vary between about 45 to about 135 cm.
• the infusion length will vary between about 5 to about 50 cm., with generally diminishing hole size as the number of holes is increased in order to maintain substantially even fluid flow through the holes.
• the catheter will be a 5 French catheter having an outer diameter of 0.068" ⁇ 0.0015" and an inner diameter of 0.048" ⁇ 0.0015".
• 4 and 3 French catheters may also be used depending on the application.
• the hole size will generally range between about 0.002"-0.006", with the hole size generally decreasing as the number of holes is increased. Nevertheless, the size of catheter and infusion hole can be altered, as can be the longitudinal spacing between the holes, depending on the intended use of the catheter. Radiopaque marker bands are preferably employed to bracket the infusion length in order to provide the user with means for positioning the infusion length at a desired location within the blood vessel.
• the double spiral configuration of the present invention provides a significantly improved radial dispersion of thrombolytic fluid around the circumference of the catheter.
• the result is a more quickly and completely lysed blood clot using a reduced amount of thrombolytic fluid, which greatly contributes to the recovery and well-being of the patient.
• the holes may be arranged in sets of four holes, with each successive hole being circumferentially spaced from an immediately preceding hole by 90°, other arrangements are possible.
• the holes within a given set may be separated by a variety of different angles ⁇ , it will be preferable that the number and spacing of the holes within a given set be such that they will complete a cycle of about 360° before beginning the next set of holes.
• the set includes n holes, then the circumferential spacing between successive holes in a given set will preferably be 360° In.
• each set of holes will include 4 holes, and the circumferential spacing will be 90° between successive holes within the set.
• the angle of offset between successive sets of holes is most preferably 18°, any angle that yields a reasonably diverse spray pattern can be used.
• the offset angle ⁇ will preferably divide evenly into 360°, more preferably ⁇ will divide evenly into 180°, and most preferably ⁇ will divide evenly into 90°. Selecting ⁇ so that it divides evenly into 360°, 180° or 90°, respectively, ensures some regularity of the hole pattern such that it is not overly random.
• Gradient hole sizes within the infusion length can be used to ensure a more even distribution of fluid, wherein the most proximal hole is the smallest where pressure is the greatest and the most distal hole is the largest where pressure is the smallest.
• hole size is generally inversely proportional to the number of holes within the infusion length.
• the fluid source may be connected to the infusion catheter using a luer connector with an increased thread length in order to prevent disconnections within the system.
• the occluding wire used to seal the end of the infusion catheter during use is typically narrower in diameter to facilitate flow through the catheter and spray distribution through the holes.
• Figure 1 is a side view of a generalized fluid delivery system used in conjunction with the improved catheters of the present invention.
• Figure 2 is a breakaway perspective view of a portion of the infusion length of an infusion catheter according to the present invention.
• Figure 3 is a breakaway perspective view of a portion of an inventive infusion catheter in combination with an occluding ball wire.
• Figure 4 is a perspective view of a portion of the spray pattern emitted by a preferred infusion catheter of the present invention.
• Figure 5 is a transverse cross-section view of a prior art infusion catheter showing the spray pattern emitting therefrom.
• Figure 6 is a transverse cross-section view of a preferred infusion catheter according to the present invention showing the spray pattern emitting therefrom.
• Figure 7 is a chart showing the spacial relationship between the infusion holes within an infusion catheter according to one embodiment of the present invention.
• Figure 8 is a chart showing the spacial relationship between the infusion holes in an alternative embodiment of the present invention.
• the present invention relates to improved infusion catheters used to irrigate selected portions of a person's body, particularly blood vessels occluded by a thrombus or blood clot.
• the catheters of the present invention have holes arranged in such a manner that a more disperse spray pattern is achieved, which results in the ability to more evenly spread the thrombolytic fluids throughout the blood clot.
• the inventive hole pattern is referred to as a "double spiral configuration," which is a vast improvement over typical spiral configurations in which successive holes within a group are circumferentially spaced apart at 90° intervals along the entire infusion length of the catheter.
• the double spiral configuration results in a more quickly and completely lysed blood clot using a reduced amount of thrombolytic fluid, which reduces harm to the patient that could result from the infusion of excessive thrombolytic agents.
• thrombolytic agents used according to the present invention include any agent that can be used to lyse or break up a blood clot.
• preferred thrombolytic fluids include urokinase, streptokinase, and tissue plasminogen activator (TPA).
• TPA tissue plasminogen activator
• the fluid source system 12 includes a fluid reservoir 14 in communication with a fluid pump 15, which in turn communicates with a fluid delivery tube 16, which is in turn connected to a three-way connector 18.
• the three-way connector 18 connects together the fluid source system 12 and the fluid infusion system 20.
• the three-way connector 18 includes a first end 22, a second end 24 and an occluding wire port 26.
• the fluid delivery tube 16 is connected to the first end 22.
• the fluid infusion system 20 includes a single lumen catheter 28 that is attached to the second end 24 by means of a connector 30.
• the usable length of catheter 28 may vary between about 45 to about 135 cm.
• Near the distal end of the catheter 28 is an infusion length 32 that includes systematically placed infusion holes 34, which are spaced in an approximate double spiral configuration. Alternatively, the infusion length may be situated anywhere along the usable length of the catheter.
• the infusion length also preferably includes radiopaque marker bands (not shown) to assist in placing the infusion length in the
• the infusion holes are longitudinally spaced apart at substantially regular intervals along the length of the infusion length 32 of the catheter 28.
• the holes are grouped together in sets of four holes, with successive sets being circumferentially offset by an angular distance of, e.g., about 18°, relative to immediately preceding sets.
• the holes 34 are arranged in a configuration such that each of the first set of four holes are incrementally spaced apart by a circumferential distance of about 90° in addition to being longitudinally spaced at substantially regular intervals of, e.g., 0.050".
• the next set of four holes is circumferentially offset by about 18° relative to the first set of four holes.
• each successive hole in the second set is circumferentially offset from the immediately preceding hole by a circumferential distance of about 90° and longitudinally spaced at intervals of about 0.050".
• the four holes of the second set will not line up with the first set of four holes.
• the first hole of the second set of holes which is the fifth hole, is rotated about 18° relative to the first hole of the first set.
• the sixth hole is rotated about 18° relative to the second hole
• the seventh hole is rotated about 18° relative to the third hole
• the eighth hole is rotated about 18° relative to the fourth hole.
• the third set of four holes is likewise offset by a circumferential distance of about 18° relative to the second set of four hole, such that they are circumferentially offset by about 36° relative to the first set of holes.
• the ninth infusion hole is offset by 36° relative to the first hole and 18° relative to the fifth hole and so on.
• This pattern repeats itself such that each successive group of four holes is oriented an additional 18° relative to the previous set of four holes. Because it takes five sets offset by 18° to complete a cycle of 90°, it is not until the sixth set of holes that the holes are aligned at the same angular orientation as the holes of the first group.
• the infusion catheter 28 is first inserted as desired into a desired location within a patient's artery or vein in order to infuse a liquid therein.
• the infusion catheter 28 can simply be inserted by itself or its insertion may be assisted by an introducer sheath (not shown) or a guidewire (not shown).
• An opening 36 at the distal end of the catheter 28 allows free passage of the guidewire therethrough to assist in placement of the catheter 28.
• the catheter 28 can be connected to the three-way port 18 to provide fluid communication between the fluid source system 12 and the catheter 28.
• the opening 36 at the distal end of the catheter must be occluded prior to irrigating a liquid through the infusion length 32. This may be accomplished by inserting an occluding ball wire 38 ( Figure 3) through the occluding wire port 26 of the three-way port 18.
• the occluding ball wire 38 includes a wire portion 40 and a sealing ball portion 42. Nevertheless, any occluding means known in the art may be used to seal the opening 36. However, it is preferable to use an occluding ball wire having a more narrow diameter to improve flow through the catheter 28 and improve the distribution pattern through holes 34.
• the occluding ball wire 38 when inserted substantially all the way through the catheter 28 and beyond the infusion length 32, is able to form a liquid-tight seal at the distal end of the catheter 28. Because the inner diameter of the catheter 28 is significantly larger than the diameter of the wire portion 40 of the occluding ball wire 38, there is ample space within the infusion catheter 28 for the passage of a liquid therethrough towards the infusion end 32. The inner diameter of the catheter 28 is reduced at the distal end such that the sealing ball portion 42 of the occluding ball wire 38 is able to seat against the inner wall of the catheter 28 and thereby effectively seal the opening 36. Thus, any liquid forced through the catheter 28 is caused to exit through the infusion hole 34 rather than the opening 36.
• Figure 4 depicts the actual spray pattern made possible by the hole arrangement of the preferred infusion catheter depicted in Figures 2-4. Because of the double spiral configuration resulting from the distribution of holes as described above, the individual lines of spray are more completely dispersed compared to the prior art wherein the holes are aligned at strict 90° intervals.
• Figures 5 and 6 show the difference in radial spray pattern between infusion catheters according to the prior art ( Figure 5) and the preferred infusion catheter of the present invention ( Figure 6).
• the differently shaded arrows represent successive radial cycles, or groups of four holes, along the length of the catheter.
• each successive cycle lines up along one of only four angular positions (0°, 90°, 180° and 270°) such that fluid is only infused through the catheter at each of the four angular positions around the circumference of the catheter.
• the spray pattern according to the present invention delivers fluid at much tighter intervals, preferably at about 18° intervals. The result is far better distribution of thrombolytic fluid within the person's blood vessel being treated.
• the infusion holes 34 can be spaced at substantially regular longitudinal intervals, such as 0.050", it may be desirable in some cases to space the holes apart at somewhat irregular intervals. Moreover, the interval length between the holes can vary between about 0.030" to about 0.400" in order to provide varying concentrations of holes along the infusion length 32 of the infusion catheter 28. Nevertheless, it is generally preferred that the spacing be regular and that the interval be about 0.050".
• the diameter of the infusion holes 34 may vary depending on the infusion length 32, which in turn affects the preferred number of holes along the infusion length.
• hole size will vary between about 0.002" to about 0.006".
• an infusion hole diameter of about 0.005" is preferred.
• the preferred hole diameter is about 0.004".
• the preferred hole diameter is about 0.003".
• the preferred hole diameter is about 0.002".
• Reducing the hole diameter as the number of holes is increased helps to maintain a more consistent rate of delivery between catheters of varying infusion length.
• a hole gradient of incrementally increasing hole size along the infusion length could alternately be employed to create a more even distribution of fluid through the holes.
• slightly increasing the hole size can nevertheless allow for more consistent outflow of fluid from all the holes.
• hole diameters are dictated by fluid dynamics in order to maintain a desired level of pressure within the catheter in order to ensure a substantially even distribution of thrombolytic fluid through each of the infusion holes 34 along the infusion length 32. If the holes are too large, then too much fluid will tend to escape out of the more proximal holes, which lowers the downstream fluid pressure such that too little fluid will tend to pass through the more distal holes.
• a catheter having an infusion length of 5 cm will have 40 infusion holes.
• a catheter having an infusion length of 10 cm will generally have 80 infusion holes.
• For an infusion length of 20 cm there will generally be 160 holes.
• For an infusion length of 30 cm there will be 240 holes.
• there will be approximately 40 holes for every 5 cm of infusion length.
• Infusion lengths of up to 50 cm could also be employed.
• the preferred catheter diameter is 5 French, although catheters of varying diameter
• the preferred outer diameter is 0.068" ⁇ 0.0015" while the inner diameter is preferably about 0.048" ⁇ 0.0015".
• the infusion holes are preferably drilled using an excimer laser, although any known hole drilling techniques known in the art may be adapted and employed to form the infusion holes 34.
• Figure 7 is a chart which shows the actual mathematical or spacial relationships between the infusion holes within a catheter according to a preferred embodiment of the present invention.
• each successive set of four holes is circumferentially offset relative to the immediately preceding set of four holes by 18°.
• the pattern repeats itself, or comes around to the starting point (0°), every sixth set.
• every five sets of four infusion holes, or every twenty holes, are angularly spaced apart such that no two holes are circumferentially aligned or arranged at the same angular orientation along the catheter.
• the outer wall of the infusion catheter 20 has a much more even distribution of holes thereabout in order to provide a more diverse spray pattern of thrombolytic fluids compared to prior art catheters.
• Figure 8 depicts the angular orientation of the infusion holes in an alternative embodiment of the present invention.
• each successive set of four holes is circumferentially offset from the preceding set of four holes by 12°. Since 12° does not evenly divide into 90°, but instead 180°, the hole placement does not repeat itself until after sixteen sets of holes, or 64 infusion holes, have been exhausted. The result is a tighter spray pattern compared to the spray pattern of the catheter mathematically depicted in Figure 4. Nevertheless, it is within the scope of the present invention to provide sets of holes that are circumferentially spaced or offset by any amount between 1° and 89°, although an angular distance of 18° is preferred. The result is varying amounts of angular offset that result in widely varying spray patterns.
• any angular offset away from holes rigidly aligned along 90° intervals, as in the prior art, would be an improvement over the prior art and provide an improved spray pattern.
• sets of holes could also be angularly offset from immediately preceding sets by any amount between 91-179°, 181-269°, and 271-359°.
• the only limitation is that the angular offset provide a more diverse spray patter than where all the holes are spaced apart at regular 90° intervals.
• the holes may be arranged in sets of four holes, with each successive hole being circumferentially spaced from an immediately preceding hole by 90°, other arrangements are possible.
• the holes within a given set may be separated by a variety of different angles ⁇ , it will be preferable that the number and spacing of the holes within a given set be such that they will complete a cycle of about
• the radial spacing between successive holes in a given set will preferably be 360° 'In.
• the radial spacing will be 90° between successive holes within the set.
• the angle of offset between successive sets of holes is most preferably 18°, any angle that yields a reasonably diverse spay pattern can be used.
• the offset angle ⁇ will preferably divide evenly into 360°, more preferably ⁇ will divide evenly into 180°, and most preferably ⁇ will divide evenly into 90°. Note that 18° divides evenly into 90°. Selecting ⁇ so that it divides evenly into 360°, 180° or 90°, respectively, ensures some regularity of the hole pattern such that it is not overly random.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Biophysics (AREA)
• Pulmonology (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
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• Heart & Thoracic Surgery (AREA)
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• Infusion, Injection, And Reservoir Apparatuses (AREA)

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• 1997
  • 1997-10-14 US US08/949,893 patent/US5957901A/en not_active Expired - Lifetime
• 1998
  • 1998-10-14 WO PCT/US1998/021619 patent/WO1999019016A1/en not_active Ceased
  • 1998-10-14 AU AU10832/99A patent/AU1083299A/en not_active Abandoned
  • 1998-10-14 JP JP2000515646A patent/JP2001519214A/ja active Pending
  • 1998-10-14 EP EP98953463A patent/EP1023101A4/en not_active Withdrawn
• 1999
  • 1999-02-02 US US09/243,228 patent/US6179816B1/en not_active Expired - Lifetime

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