(19)
(11)EP 2 913 012 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
09.10.2019 Bulletin 2019/41

(21)Application number: 15155876.4

(22)Date of filing:  20.02.2015
(51)Int. Cl.: 
A61B 17/32  (2006.01)
A61B 17/3207  (2006.01)

(54)

Atherectomy device

Atherektomievorrichtung

Dispositif d'athérectomie


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(30)Priority: 01.03.2014 US 201461946733 P
07.02.2015 US 201514616670

(43)Date of publication of application:
02.09.2015 Bulletin 2015/36

(73)Proprietor: Rex Medical, L.P.
Conshohocken, PA 19428 (US)

(72)Inventor:
  • McGuckin Jr., James F
    Radnor, PA Pennsylvania 19087 (US)

(74)Representative: Lees, Kate Jane 
Kate Lees Consulting Ltd Office 5 Acorn Business Centre Roberts End, Hanley Swan
Malvern, Worcestershire WR8 0DN
Malvern, Worcestershire WR8 0DN (GB)


(56)References cited: : 
WO-A1-02/26289
NL-C2- 1 034 242
US-A- 5 632 755
US-B1- 6 572 630
CN-A- 102 670 283
US-A- 5 114 399
US-A1- 2002 099 367
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    Technical Field



    [0001] This disclosure relates to a vascular surgical apparatus, and more particularly to a minimally invasive device for removing plaque or other deposits from the interior of a vessel.

    Background Art



    [0002] The vascular disease of atherosclerosis is the buildup of plaque or substances inside the vessel wall which reduces the size of the passageway through the vessel, thereby restricting blood flow. Such constriction or narrowing of the passage in the vessel is referred to as stenosis. In the case of peripheral vascular disease, which is atherosclerosis of the vascular extremities, if the vessel constriction is left untreated, the resulting insufficient blood flow can cause claudication and possible require amputation of the patient's limb. In the case of coronary artery disease, if left untreated, the blood flow through the coronary artery to the myocardium will become inadequate causing myocardial infarction and possibly leading to stroke and even death.

    [0003] There are currently several different treatments for treating arterial disease. The most invasive treatment is major surgery. With peripheral vascular diseases, such as occlusion of the tibial artery, the major surgery involves implantation and attachment of a bypass graft to the artery so the blood flow will bypass the occlusion. The surgery involves a large incision, e.g. a 25.4 cm (10 inch) incision in the leg, is expensive and time consuming for the surgeon, increases patient pain and discomfort, results in a long patient recovery time, and has the increased risk of infection with the synthetic graft.

    [0004] Major surgery for treating coronary artery disease is even more complex. In this surgery, commonly referred to as open heart surgery, a bypass graft connects the heart to the vessel downstream of the occlusion, thereby bypassing the blockage. Bypass surgery requires opening the patient's chest, is complex, has inherent risks to the patient, is expensive and requires lengthy patient recovery time. Bypass surgery also requires use of a heart lung machine to pump the blood as the heart is stopped, which has its own risks and disadvantages. Oftentimes, the saphenous vein in the patient's leg must be utilized as a bypass graft, requiring the additional invasive leg incision which further complicates the procedure, increases surgery time, lengthens the patient's recovery time, can be painful to the patient, and increases the risk of infection.

    [0005] Attempts to minimize the invasiveness of coronary bypass surgery are currently being developed and utilized in certain instances. These typically include cracking a few ribs and creating a "window approach" to the heart. Although the window approach may reduce patient trauma and recovery time relative to open heart surgery, it still requires major surgery, and is a complicated and difficult surgery to perform due to limited access and limited instrumentation for successfully performing the operation. Attempts to avoid the use of a heart lung machine by using heart stabilization methods is becoming more accepted, but again, this does not avoid major surgery.

    [0006] Due to these problems with major peripheral or coronary vascular surgery, minimally invasive procedures have been developed. Balloon angioplasty is one of the minimally invasive methods for treating vessel occlusion/obstructions. Basically, a catheter having a balloon is inserted through the access artery, e.g., the femoral artery in the patient's leg or the radial artery in the arm, and advanced through the vascular system to the occluded site over a wire. The deflated balloon is placed at the occlusion and the balloon is inflated to crack and stretch the plaque and other deposits to expand the opening in the vessel. Balloon angioplasty, especially in coronary surgery, is frequently immediately followed by insertion of a stent, a small metallic expandable device which is placed inside the vessel wall to retain the opening which was created by the balloon. Balloon angioplasty has several drawbacks including difficulty in forcing the balloon through the partially occluded passageway if there is hard occlusion, the risk involved in cutting off blood flow when the balloon is fully inflated, and the frequency of restenosis after a short period of time since the plaque is essentially stretched or cracked and not removed from the vessel wall or because of the development of intimal hyperplasia.

    [0007] Another minimally invasive technique used to treat arteriosclerosis is referred to as atherectomy and involves removal of the plaque by a cutting or abrading instrument. This technique provides a minimally invasive alternative to bypass surgery techniques described above as well as can provide an advantage over balloon angioplasty methods in certain instances. Atherectomy procedures typically involve inserting a cutting or ablating device through the access artery, e.g., the femoral artery or the radial artery, advancing it through the vascular system to the occluded region, and rotating the device at high speed to cut through or ablate the plaque over the wire. The removed plaque or material can then be suctioned out of the vessel or be of such fine diameter that it is cleared by the reticuloendothelial system. Removal of the plaque in an atherectomy procedure has an advantage over balloon angioplasty plaque displacement since it debulks the material.

    [0008] Examples of atherectomy devices in the prior art include U.S. Patent Nos. 4,990,134, 5,681,336, 5,938,670, and 6,015,420. These devices have elliptical shaped tips which are rotated at high speeds to cut away the plaque and other deposits on the interior vessel wall. A well-known device is marketed by Boston Scientific Corp. and referred to as the Rotablator. As can be appreciated, in these devices, the region of plaque removal is dictated by the outer diameter of the cutting tip (burr) since only portions of the plaque contacted by the rotating tip are removed. Obviously, the greater the area of plaque removed, the larger the passageway created through the vessel and the better the resulting blood flow.

    [0009] Since these atherectomy tips need to be inserted through an introducer sheath or catheter to the target site, the larger the tip, the larger the diameter of the introducer sheath required. However, larger introducer sheaths increase the risk of trauma to the patient, are harder to navigate through the vessels, and create larger incisions (require larger puncture sites) into the access artery which cause additional bleeding and complicate closure of the incision at the end of the procedure. On the other hand, if smaller introducer sheaths are utilized, then the rotating atherectomy tip also has to be of a smaller dimension to fit within the sheath, but such smaller tip might not be able to remove a sufficient area of obstructive deposits and the vessel could remain partially occluded. Thus, a tradeoff must be made between these two opposing goals: larger cutting tip and smaller introducer sheath.

    [0010] This problem was recognized for example in U.S. Patent Nos. 5,217,474 and 6,096,054 which attempted solutions involved expandable cutting tips. These tips however are quite complex and require additional expansion and contraction steps by the surgeon.

    [0011] U.S. Patent No. 6,676,698 discloses an atherectomy device designed to solve the foregoing problems of the prior art. The device attempted to provide an improved atherectomy cutting tip to obtain an optimal balance between the competing objectives of the smallest introducer sheath size to facilitate insertion and reduce trauma to the vessel and the largest atherectomy tip size to remove a larger region of plaque or other deposits from the vessel wall.

    [0012] However it would be advantageous to enhance removal of the small particles once broken off by the atherectomy tip of the '698 patent.

    [0013] US2002/099367 discloses a frontal infusion system for intravenous burrs in which infusion liquid is expelled distally of an ablation burr for washing a blood vessel lesion being treated by the burr. The infusion liquid can be aspirated in a proximate direction to carry the infusion liquid and loose ablated particles of the lesion away from the treatment area. The infusion liquid can be supplied through one or more passages in the burr. In addition to distally extending passages, the burr can include transverse passages extending at least partly in a proximate direction, with the distally extending and proximately extending passages sized so that only a minor portion of the infusion liquid is expelled distally.

    [0014] US5114399 discloses a surgical device which employs a catheter for removing obstructive material from the body cavity or luminal passage. The catheter has a blade subassembly on its distal tip for coring, homogenising, diluting, and aspirating the obstructive material. The obstructive material is homogenised and diluted after it is cored but prior to its aspiration into the catheter. Homogenisation and dilution of the cored obstructive material is shown to enhance the reliability of the surgical protocol by helping to prevent clogging of the catheter during aspiration.

    [0015] CN102670283 discloses a fragment aspirator of a hematoma remover. The fragment aspirator comprises a knife head, a rotating inner tube and a stationary outer tube, wherein the rotating inner tube is fixedly connected with the knife head and the outer tube is sued for sleeving the inner tube. The knife head comprises a conical head located in the front and a blade head located in the back. A plurality of liquid outlets communicate with a tube cavity of the inner tube and are arranged on the conical head. The blade head is inserted into the front end of the outer tube and an axial knife edge groove is arranged on the blade head. A knife edge is arranged on a wall of the knife edge groove and a plurality of cutting edges are arranged on the blade head. The cutting edges are distributed along the circumferential direction of the outer tube and, when the knife head rotates, a shearing action for shearing hematoma can be formed between the blade and the knife edge.

    Summary of invention



    [0016] The present invention provides a surgical atherectomy apparatus for removing deposits such as plaque from an interior of a vessel, comprising: an outer member; a rotatable shaft positioned for rotational movement within the outer member, the rotatable shaft having a guidewire lumen extending therethrough and having a distal opening; and a rotatable tip having a longitudinal axis and mounted to the rotatable shaft for rotation about its longitudinal axis upon rotation of the rotatable shaft, the rotatable tip mounted to a distal portion of the rotatable shaft such that the distal opening of the lumen of the rotatable shaft is axially spaced from a distalmost end of the rotatable tip, the rotatable tip including a guidewire lumen for receiving a guidewire to enable over the wire insertion of the apparatus, wherein the rotatable tip has an inner lumen configured to cause fluid exiting the opening to contact the internal surface of the end wall of the tip, where it is then directed back towards a gap between the shaft and the outer member for directing in a proximal direction deposits removed by the rotational movement of the rotatable tip, and wherein the rotatable tip includes a plurality of side openings configured to aspirate deposits through the tip and to direct such deposits through the gap between the shaft and the outer member.

    [0017] In some embodiments, the rotatable tip has an intermediate portion between distal and proximal portions, the cross-section of the intermediate portion progressively changing from a substantially circular shape at the distal portion to an elongated shape having two substantially flat opposing side walls at the proximal portion.

    [0018] In some embodiments, the rotatable shaft has a threaded region to direct deposits proximally as the shaft is rotated.

    [0019] In some embodiments, a proximal end of the rotatable tip is spaced axially distally from a distal edge of the outer member.

    [0020] In some embodiments, a distal portion of the rotatable tip has a bullet shaped nose.

    [0021] In some embodiments, the apparatus further comprises a plurality of longitudinally extending grooves formed in an outer surface of the rotatable tip to form an ablation surface.

    [0022] In some embodiments, a gap is provided between an outer diameter of the rotatable shaft and an inner diameter of the outer member to aspirate deposits proximally.

    [0023] In some embodiments, the rotatable shaft and tip are rotated by a motor.

    [0024] The present invention also relates to a combination of a surgical apparatus as hereinbefore defined and an introducer sheath, the surgical apparatus insertable through the introducer sheath to access a target vessel containing the deposits.

    [0025] In some embodiments, a gap is provided between an outer diameter of the outer member and an inner diameter of the introducer sheath to aspirate deposits. In some embodiments, the introducer sheath has a side arm connectable to a source of suction so that deposits can be aspirated in the gap between the outer member and the introducer sheath.

    [0026] In some embodiments, the rotatable tip has an outer diameter greater than the internal diameter of the introducer sheath and further has first and second opposing narrowed regions. In some embodiments, insertion of the rotatable tip into the introducer sheath deforms the introducer sheath to accommodate the larger outer diameter of the rotatable tip and after advancing the rotatable tip out through a distal opening in the introducer sheath, the introducer sheath returns to its undeformed configuration.

    Brief description of drawings



    [0027] Preferred embodiment(s) of the present disclosure are described herein with reference to the drawings wherein:

    Figure 1 is a schematic view of one embodiment of the atherectomy system of the present invention;

    Figure 2 is a perspective view of the distal end of the atherectomy device of the present invention prior to introduction into an introducer sheath;

    Figure 3 is a side view in partial cross-section of the atherectomy device of Figure 2 being inserted into an introducer sheath;

    Figure 4 is a cross-sectional view of the atherectomy device being inserted into the introducer sheath;

    Figure 5 is transverse cross-sectional view of the atherectomy device within the introducer sheath;

    Figure 6 is a perspective view of the distal end of the atherectomy device inserted into the introducer sheath;

    Figure 7 is a side view in partial cross-section of the atherectomy device inserted into the introducer sheath;

    Figure 8 is a cross-sectional view of the atherectomy device inserted into the introducer sheath;

    Figure 9 is a side cross-sectional view of the distal portion of the atherectomy device of Figure 2 illustrating fluid and particle flow;

    Figure 10 is a top view of the rotating tip (head) of the atherectomy device;

    Figure 11 is a side view of the rotating tip of the atherectomy device;

    Figure 12 is a rear perspective view of the rotating tip of the atherectomy device;

    Figure 13 is a front perspective view of the rotating tip of the atherectomy device;

    Figure 14 is a front perspective view of an alternate embodiment of the rotating tip of the present invention having additional openings for particle removal;

    Figure 15 is a perspective view illustrating the rotating shaft and tip of the atherectomy device of Figure 14 inserted over a guidewire;

    Figure 16A is a perspective view showing the guidewire advanced into the vessel adjacent the plaque to be removed;

    Figure 16B is a perspective view of the atherectomy device of Figure 15 inserted over a guidewire into a vessel for removing plaque, and further showing the rotational direction of the atherectomy tip and the direction of fluid flow;

    Figure 16C is a view similar to Figure 16B showing removal of the plaque from the vessel, the solid arrows illustrating fluid flow and the squiggly arrows illustrating the backflow of the particles (deposits); and

    Figure 17 is a schematic view of an alternative embodiment of the atherectomy system of the present invention.


    Description of embodiments



    [0028] The present invention is directed to an atherectomy tip designed for high speed rotation to remove plaque or other deposits on the inside wall of the vessel to widen the blood passageway therethrough. To achieve such rotation, the rotatable atherectomy tip is positioned at a distal end of a flexible rotating shaft that can be gas or electrically powered. The shaft rotates at high speed, typically between 100,000 and 200,000 rpm, causing the cutting or ablation surface of the tip to remove the plaque and deposits to which it comes into contact. The atherectomy tip of the present invention has application in a variety of vessels such as the coronary arteries, peripheral vessels such as the tibial artery, femoral, and popliteal, and saphenous vein bypass grafts.

    [0029] In order for the atherectomy tip to reach the vessel stenosis (obstruction) it is inserted along with the flexible shaft through an introducer sheath and over a guidewire. More specifically, the introducer sheath is placed through a skin incision and into a vessel, e.g., the femoral artery in the patient's leg, to provide access to the target site. A guidewire is then inserted through the introducer sheath and advanced through the appropriate vessels to the target obstructed site, typically the coronary artery. The flexible shaft and attached atherectomy tip are then inserted through the introducer sheath and threaded over the length of the guidewire to the target obstructed site. Actuation of the motor spins the shaft and tip so the cutting surface repeatedly comes into contact with the obstruction, e.g., plaque, to remove it from the vessel wall. In the alternate embodiment described below, a sheath can be advanced intravascularly to the target site, with the atherectomy device inserted through the sheath emerging at the target site.

    [0030] The atherectomy device of the present invention provides several features to remove the particles (deposits) dislodged by the high speed rotational movement of the rotatable atherectomy tip. The features include one or more of the following: 1) holes in the atherectomy tip to receive the dislodged particles and a vacuum to aspirate the particles through the holes in the atherectomy tip; 2) a vacuum to aspirate particles through a gap between the rotating shaft and the outer tube (member) of the device; 3) a vacuum to aspirate particles through a gap between the outer tube of the device and the introducer sheath; 4) a screw thread on the rotating shaft to direct particles rearwardly as the shaft is rotated; and/or 5) fluid injection in the gap between the atherectomy shaft and guidewire which contacts an internal end wall of the atherectomy tip and is directed rearwardly. Each of these features will be described in more detail below.

    [0031] The atherectomy tip of the present invention is configured for placement through a smaller sized introducer sheath without sacrificing the region of plaque it is capable of removing. This is achieved through the circumferential and diametrical relationship of the tip at various sections along its length. The advantages of utilizing a smaller sized sheath, as enumerated above in the Background Section of this application, are it is less traumatic to the vessel, reduces the amount of bleeding, reduces the risk of infection and eases closure of the vessel at the end of the procedure.

    [0032] As can be appreciated, the atherectomy tips of the prior art require a sheath size which is greater in diameter than the tip diameter. The largest diameter of the tip also dictates the region of plaque which can be removed, since as the tip rotates at high speeds, it only cuts the plaque which comes into contact with the outermost surface.

    [0033] The present invention will now be described with detailed reference to the drawings wherein like reference numerals identify similar or like components throughout the several views.

    [0034] Figure 1 illustrates one embodiment of a system for causing rotation of the tip 30, the system shown schematically. The atherectomy tip 30 of the device 10 is connected to the distal end of the flexible inner shaft 22 (see Figure 3) such that rotation of the inner shaft 22 rotates the rotatable tip 30. The rotatable shaft 22, with burr or tip 30 at its distalmost end, is electrically powered for high speed rotation to rotate the shaft 22 and tip 30. High speed rotation of the shaft 22 likewise rotates tip 30, enabling the tip 30 to break up plaque to treat stenosis of a vessel. A motor housing 2, shown schematically, contains a motor mounted therein and a motor shaft (not shown). The atherectomy device or catheter 10 is operatively connected to the motor housing 2 such that activation of the motor rotates the inner shaft 22 of the catheter. A control knob can be provided to adjust the rotational speed of the shaft 22 and tip 30, and a window can be provided to visually display the speed. An advancing mechanism (not shown) can be provided for sliding the shaft 22 and tip 30 a desired distance within the vessel (e.g., about 3-10cm). Shaft 22 and tip 30 can be disposable. As shown for illustrative purposes, introducer sheath or catheter 24 is inserted through an incision "A" in the patient's leg, and through an incision "B" in the femoral artery "C". The shaft 22 and tip 30 are then introduced through the introducer sheath 24 into the femoral artery "C", and advanced to the target artery, e.g., the coronary artery to the treatment obstruction site. Note that a guidewire (not shown) extends through the sheath 24 and into the target artery so that the shaft 22 and tip 30 are inserted over the guidewire.

    [0035] The system further includes an aspiration source and fluid source, shown schematically, and respectively designated by reference numerals 4 and 6. Tubing 8 extends from the aspiration source 4 to the catheter 10, preferably through a side arm of catheter hub 27 for aspiration between an outer wall of the shaft and inner wall of outer tube (member) 20 of catheter 10. Tubing 11 extends from the fluid source 6, preferably through a second side arm of hub 27, to communicate with the inner lumen of the shaft 22, in the space (gap) between the guidewire and inner wall of shaft 22.

    [0036] In an alternate embodiment of Figure 17, the system, shown schematically, is identical to the system of Figure 1, except it has an aspiration source 9 communicating with the introducer sheath 35 via a port or side arm in hub 37 to provide aspiration in the space (gap) between the inner wall of the introducer sheath 35 and the outer wall of outer tube 20 of catheter 10. This is explained in more detail below. The introducer sheath 35 can extend to a region adjacent the tip or alternatively a sleeve would be inserted through the introducer sheath 24 and advanced over the guidewire. Note the aspiration through the introducer sheath 35 can be the sole source of aspiration or alternatively used in addition to the aspiration through the catheter as in Figure 1.

    [0037] It should be appreciated that the rotatable (rotating) tip 30 is shown inserted through the femoral artery by way of example as other vessels can be utilized for access, such as the radial artery. Also, the tip 30 of the present invention (and other tips described herein) can be used to remove plaque or other obstructions in a variety of vessels such as the coronary artery, the tibial artery, the superficial femoral, popliteal, saphenous vein bypass grafts and instent restenosis.

    [0038] Turning now to Figures 2-13, the first embodiment of the atherectomy tip 30 of the present invention will now be described in more detail. Tip or burr 30 has a front (distal) portion (section) 40, a rear (proximal) portion (section) 42, and an intermediate portion (section) 44. These portions vary in transverse cross-section as can be appreciated by the Figures. Thus, the front portion 40 can be defined for convenience as the area starting at the distalmost end 46, terminating at the scalloped region, and forming a bullet-nose configuration. The cross-section of the front portion 40 in one embodiment is substantially circular in configuration. Note the term "distal" refers to regions futher from the user and the term "proximal" refers to regions closer to the user.

    [0039] Intermediate portion 44 can be considered for convenience as starting at the scalloped portion (proximal of the proximal end of the front portion 40) and terminating at the proximal end of the scalloped region. The cross-section of the intermediate portion 44 progressively changes from substantially circular, to an elongated shape having two substantially flat (substantially linear) opposing sidewalls 44a. As can be appreciated, the elongation progressively increases in a first dimension while progressively narrowing in a second dimension. Thus, the distance between opposing linear walls 44a is less than the distance between opposing arcuate walls 45a, with the distances between linear walls 44a decreasing toward rear section 42.

    [0040] Rear portion 42 can be considered to begin, for convenience, at the proximal end of the scalloped region of the intermediate portion 44, and terminate at the proximalmost edge 48 of tip 30. The rear portion 42 preferably has the same elongated cross-sectional dimension throughout its length, with substantially linear walls 44a separated by a distance less than the distance between opposing curved walls 45a.

    [0041] It should also be appreciated that the front, intermediate and rear portions/sections are designated for convenience and are not intended to necessarily denote three separate segments connected together. Rotatable tip 30 is preferably a monolithic piece.

    [0042] Tip 30 has a proximal or rear (proximal) opening 32 and a front (distal) opening 34 connected by a lumen. The flexible shaft 22 is inserted through rear opening 32 and attached to the tip 30 within lumen 36, however, terminating proximally of the distalmost end 46 of the tip 30 so as to leave a path for high pressure fluid flow. A guidewire G can extend through the hollow flexible shaft 22 and through front opening 34 of tip 30 to enable over the wire insertion of the atherectomy tip 30. One or more openings 33 could be provided in the tip 30 to enable removal of the plaque as the particles (deposits) can be aspirated through the openings 33 by the aspiration source 4. Note Figures 14 and 15 illustrate an alternate embodiment of the tip, designated by reference numeral 30', having openings 33' identical to openings 33 of Figure 12, plus additional openings 50 for aspiration of particles. In all other respects, tip 30' is identical to tip 30. Tip 30' is shown with the shaft 22 and outer member 20 positioned over a guidewire G in Figure 15 discussed below. Note deposits and particles are used interchangeably herein.

    [0043] A scalloped or narrowed section 47 is formed in both sides in the intermediate section 44 of the tip 30 to reduce the profile of the tip 30. These scalloped sections form the aforedescribed opposing substantially linear walls. By reducing the profile, i.e., the diameter and circumference, the atherectomy tip of the present invention could be inserted through smaller introducer sheaths than would otherwise be the case if the circumference increased with increasing diameter.

    [0044] The region of plaque removal is defined by the largest diameter region of the tip since the tip is rotating at high speeds and the plaque is cut or abraded only where the tip comes into contact with it. However, the sheath size required is determined by the largest circumference region of the tip.

    [0045] As a result of these scalloped sections, as the diameter of tip 30 increases in one orientation, it decreases in the transverse orientation, enabling the circumference to remain constant. Since the diameter is reduced in one transverse orientation, the tip 30 can be introduced into an introducer sheath have an internal diameter slightly less than the largest diameter of the tip, since the sheath has room to deform because of the reduced regions, i.e., the scalloped sections, of the tip 30. In the prior art elliptical tip, the rounded symmetrical configuration leaves no room for the sheath to deform so the sheath size must exceed the largest diameter region.

    [0046] As can be appreciated, the tip 30 of the present invention can fit into conventional introducer sheaths having an internal diameter less than the largest outer diameter of the tip 30. This can be achieved by the fact that the tip 30 can deform the internal walls of the introducer sheath 24 as it is inserted, by elongating it in the direction shown in Figures 7 and 8. If the scalloped walls were not provided, the sheath could not deform because it would be limited by the width of the tip as described below.

    [0047] Another way to view the tip 30 is that for a given catheter French size desired to be used by the surgeon, a larger atherectomy tip can be utilized if the atherectomy tip 30 of the present invention is selected instead of the prior art elliptical tip, thereby advantageously increasing the region of plaque removal to create a larger passageway in the vessel.

    [0048] In alternate embodiments of the tip 30, longitudinal or elongated circular and oval cutting grooves could be provided to provide a roughened surface to cut or ablate the plaque as the tip is rotated. The grooves or indentations can be formed by laser cutting a series of grooves extending longitudinally within the interior of the tip stock. The tip is then ground to remove portions of the outer surface to partially communicate with the grooves, thereby creating indentations forming a roughened surface for contact with the plaque. The resulting formation is a series of elongated cutouts/indentations on the front and intermediate portions and oval shaped cutouts/indentations on the distal and intermediate portions.

    [0049] Another way contemplated to create the roughened surface is by blasting, e.g., sandblasting or grit blasting, the tip. The tip is held in a fixture and blasted at a certain pressure, thereby removing portions of the outer surface to create a roughened surface.

    [0050] Creation of a roughened surface by chemical etching is also contemplated.

    [0051] Shaft 22 can include a series of threads 25. These threads function as an Archimedes screw, i.e., a screw pump, to remove the particles/deposits dislodged by the tip 30. That is, as the shaft 22 is rotated, the screw's helical surface scoops the deposits and directs the deposits proximally (rearwardly) along the shaft 22. The aspiration in the space between shaft 22 and outer member 20 pulls dislodged particles proximally. The Figures show the threads almost abutting the outer member 20 but in preferred embodiments the threads would be spaced further inwardly from the outer member to leave space for rotation and aspiration.

    [0052] The system of the present invention, as noted above, includes an aspiration system and a fluid system. The aspiration system 4 provides suction through the shaft 22, in the gap 36 between the outer diameter of the shaft 22 and the inner diameter of the outer member (outer tube) 20 of catheter 10 when the aspiration system 4 is activated. Fluid can be pumped at high pressure into the gap between the outer diameter of the guidewire G and the inner diameter of the shaft 22. In this manner, as shown in Figure 9, fluid injected from fluid source 6 flows through the gap 38 between the inner wall of the lumen of the shaft 22 and the outer wall of the guidewire G. The fluid exits opening 26 in shaft 22 to flow through an inner lumen of the tip 30 and into contact with the internal end wall of the tip 30, where it is then directed back, as shown by the solid arrows in Figure 9, thereby providing a proximal force on the particles to force the particles rearwardly (proximally) through the gap 36 between the shaft 22 and outer member 20, with the rotating helical screw further directing the particles (deposits) rearwardly (proximally). Also, particles are aspirated through openings 33 in tip 30, and directed rearwardly in the gap 36 between the shaft 22 and outer tube 20 as indicated by the squiggly arrows of Figure 9. Note in this embodiment of Figure 9, which utilizes the system of Figure 1, aspiration is not provided in the gap 39 between the outer member 20 of catheter 10 and the introducer sheath 24. However, in the embodiment utilizing the system of Figure 17, aspiration is provided in the gap 39 between the introducer sheath 24 and catheter 10, and this is shown in Figure 16C described below.

    [0053] Use of the atherectomy tip of the present invention is illustrated in Figures 16A-16C. As shown in Figure 16A, plaque "P" buildup on the interior wall of the vessel "V" has occluded the passageway through the vessel. Tip 30' (or tip 30) is inserted over guidewire G and motorized rotation of flexible rotatable shaft 22 rotates the shaft 22 and attached rotatable tip 30' (or 30) at high speed in the direction of the arrow in Figure 16B to remove plaque which comes into contact with its outer surface. High pressure fluid is injected in the direction of the solid arrow in gap 38 between the guidewire G and inner wall of inner shaft 22 to bounce off the internal distal wall of the tip 30' (or 30) and provide a rearward force to particles (deposits) received in the tip. Aspiration is provided to aspirate the broken off particles through openings 33' and 50 in the tip and through the gap 39 between the outer wall of the catheter 10 and the inner wall of the introducer sheath 35. The fluid flow is designated by the solid arrows and the aspiration is designated by the squiggly arrows in Figure 16C. Thus, the cut plaque and debris can be removed from the patient's body as the particles are dislodged by the rotating tip 30' (or 30).

    [0054] 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 of the disclosure as defined by the claims appended hereto.


    Claims

    1. A surgical atherectomy apparatus for removing deposits such as plaque from an interior of a vessel (V), comprising: an outer member (20); a rotatable shaft (22) positioned for rotational movement within the outer member, the rotatable shaft having a guidewire lumen extending therethrough and having a distal opening (26); and a rotatable tip (30, 30') having a longitudinal axis and mounted to the rotatable shaft for rotation about its longitudinal axis upon rotation of the rotatable shaft, the rotatable tip mounted to a distal portion of the rotatable shaft such that the distal opening (26) of the lumen of the rotatable shaft is axially spaced from a distalmost end (46) of the rotatable tip, the rotatable tip including a guidewire lumen for receiving a guidewire to enable over the wire insertion of the apparatus, characterised in that the rotatable tip (30, 30') has an inner lumen configured to cause fluid exiting the opening (26) to contact the internal surface of the end wall of the tip, where it is then directed back towards a gap (36) between the shaft (22) and outer member (20) for directing in a proximal direction deposits removed by the rotational movement of the rotatable tip and in that the rotatable tip (30, 30') includes a plurality of side openings (33, 33', 50) configured to aspirate deposits through the tip and to direct such particles through the gap (36) between the shaft (22) and the outer member (20).
     
    2. A surgical apparatus as claimed in claim 1, wherein the rotatable tip (30, 30') has an intermediate portion (44) between distal and proximal portions (40, 42), the cross-section of the intermediate portion progressively changing from a substantially circular shape at the distal portion to an elongated shape having two substantially flat opposing sidewalls (44a) at the proximal portion.
     
    3. A surgical apparatus as claimed in claim 1 or 2, wherein the rotatable shaft (22) has a threaded region (25) on an outer surface to direct deposits proximally as the rotatable shaft is rotated.
     
    4. A surgical apparatus as claimed in any preceding claim, wherein a proximal end (42) of the rotatable tip (30, 30') is spaced axially distally from a distal edge of the outer member (20).
     
    5. A surgical apparatus as claimed in any preceding claim, wherein a distal portion (40) of the rotatable tip (30, 30') has a bullet shaped nose.
     
    6. A surgical apparatus as claimed in any preceding claim, further comprising a plurality of longitudinally extending grooves formed in an outer surface of the rotatable tip (30, 30') to form an ablation surface.
     
    7. A surgical apparatus as claimed in any preceding claim, wherein the gap (36) is provided between an outer diameter of the rotatable shaft (22) and an inner diameter of the outer member (20) to aspirate deposits proximally.
     
    8. A surgical apparatus as claimed in any preceding claim, wherein the rotatable shaft (22) and tip (30, 30') are rotated by a motor (2).
     
    9. A combination of a surgical apparatus as claimed in any preceding claim and an introducer sheath (24, 35), the surgical apparatus insertable through the introducer sheath to access a target vessel (V) containing the deposits.
     
    10. A combination as claimed in claim 9, wherein a gap (39) is provided between an outer diameter of the outer member (20) and an inner diameter of the introducer sheath (24, 35) to aspirate deposits.
     
    11. A combination as claimed in claim 10, wherein the introducer sheath (24, 35) has a side arm connectable to a source of suction (4, 9) so that deposits can be aspirated in the gap (39) between the outer member (20) and introducer sheath.
     
    12. A combination as claimed in any one of claims 9 to 11, wherein the rotatable tip (30, 30') has an outer diameter greater than the internal diameter of the introducer sheath (24, 35) and further has first and second opposing narrowed regions (47).
     
    13. A combination as claimed in claim 12, wherein insertion of the rotatable tip (30, 30') into the introducer sheath (24, 35) deforms the introducer sheath to accommodate the larger outer diameter of the rotatable tip and after advancing the rotatable tip out through a distal opening in the introducer sheath, the introducer sheath returns to its undeformed configuration.
     


    Ansprüche

    1. Chirurgische Atherektomievorrichtung für die Entfernung von Ablagerungen, wie zum Beispiel Plaque, aus einem Inneren eines Gefäßes (V), die Folgendes umfasst: ein äußeres Element (20); einen drehbaren Schaft (22), der zur Drehbewegung innerhalb des äußeren Elements positioniert ist, wobei der drehbare Schaft ein Führungsdrahtlumen aufweist, das sich dorthindurch erstreckt und eine distale Öffnung (26) aufweist; und eine drehbare Spitze (30, 30'), die eine Längsachse aufweist und an dem drehbaren Schaft zur Drehung um deren Längsachse bei Drehung des drehbaren Schafts angebracht ist, wobei die drehbare Spitze an einem distalen Teil des drehbaren Schafts derart angebracht ist, dass die distale Öffnung (26) des Lumens des drehbaren Schafts axial von einem am weitesten distal gelegenen Ende (46) der drehbaren Spitze beabstandet ist, wobei die drehbare Spitze ein Führungsdrahtlumen zur Aufnahme eines Führungsdrahts einschließt, um über den Draht die Einführung der Vorrichtung zu ermöglichen, dadurch gekennzeichnet, dass die drehbare Spitze (30, 30') ein inneres Lumen aufweist, das konfiguriert ist, um zu bewirken, dass Flüssigkeit aus der Öffnung (26) austritt, um mit der inneren Oberfläche der Endwand der Spitze in Kontakt zu kommen, wo sie dann zurück in Richtung eines Spalts (36) zwischen dem Schaft (22) und äußeren Element (20) zur Leitung von Ablagerungen, die durch die Drehbewegung der drehbaren Spitze entfernt werden, in einer proximalen Richtung geleitet wird, und dadurch, dass die drehbare Spitze (30, 30') eine Vielzahl von Seitenöffnungen (33, 33', 50) einschließt, die konfiguriert sind, um Ablagerungen durch die Spitze zu aspirieren und derartige Partikel durch den Spalt (36) zwischen dem Schaft (22) und dem äußeren Element (20) zu leiten.
     
    2. Chirurgische Vorrichtung nach Anspruch 1, wobei die drehbare Spitze (30, 30') einen Zwischenteil (44) zwischen einem distalen und proximalen Teil (40, 42) aufweist, wobei sich der Querschnitt des Zwischenteils zunehmend von einer im Wesentlichen kreisrunden Form an dem distalen Teil zu einer langgezogenen Form, die zwei, im Wesentlichen flache, gegenüberliegende Seitenwände (44a) aufweist, an dem proximalen Teil ändert.
     
    3. Chirurgische Vorrichtung nach Anspruch 1 oder 2, wobei der drehbare Schaft (22) einen Gewindebereich (25) an einer äußeren Oberfläche aufweist, um Ablagerungen proximal zu leiten, wenn sich der drehbare Schaft dreht.
     
    4. Chirurgische Vorrichtung nach einem vorstehenden Anspruch, wobei ein proximales Ende (42) der drehbaren Spitze (30, 30') axial distal von einem distalen Rand des äußeren Elements (20) beabstandet ist.
     
    5. Chirurgische Vorrichtung nach einem vorstehenden Anspruch, wobei ein distaler Teil (40) der drehbaren Spitze (30, 30') eine kugelförmige Nase aufweist.
     
    6. Chirurgische Vorrichtung nach einem vorstehenden Anspruch, die weiter eine Vielzahl von sich längs erstreckenden Vertiefungen umfasst, die in einer äußeren Oberfläche der drehbaren Spitze (30, 30') ausgebildet sind, um eine Ablationsoberfläche zu bilden.
     
    7. Chirurgische Vorrichtung nach einem vorstehenden Anspruch, wobei der Spalt (36) zwischen einem äußeren Durchmesser des drehbaren Schafts (22) und einem inneren Durchmesser des äußeren Elements (20) bereitgestellt ist, um Ablagerungen proximal zu aspirieren.
     
    8. Chirurgische Vorrichtung nach einem vorstehenden Anspruch, wobei der drehbare Schaft (22) und die Spitze (30, 30') durch einen Motor (2) gedreht werden.
     
    9. Kombination einer chirurgischen Vorrichtung nach einem vorstehenden Anspruch und einer Einführungshülse (24, 35), wobei die chirurgische Vorrichtung durch die Einführungshülse einführbar ist, um auf ein Zielgefäß (V), das die Ablagerungen enthält, zuzugreifen.
     
    10. Kombination nach Anspruch 9, wobei ein Spalt (39) zwischen einem äußeren Durchmesser des äußeren Elements (20) und einem inneren Durchmesser der Einführungshülse (24, 35) bereitgestellt ist, um Ablagerungen zu aspirieren.
     
    11. Kombination nach Anspruch 10, wobei die Einführungshülse (24, 35) einen Seitenarm aufweist, der mit einer Saugquelle (4, 9) derart verbunden werden kann, dass Ablagerungen in dem Spalt (39) zwischen dem äußeren Element (20) und der Einführungshülse aspiriert werden können.
     
    12. Kombination nach einem der Ansprüche 9 bis 11, wobei die drehbare Spitze (30, 30') einen äußeren Durchmesser aufweist, der größer ist als der innere Durchmesser der Einführungshülse (24, 35), und weiter erste und zweite gegenüberliegende verengte Bereiche (47) aufweist.
     
    13. Kombination nach Anspruch 12, wobei die Einführung der drehbaren Spitze (30, 30') in die Einführungshülse (24, 35) die Einführungshülse verformt, um den größeren äußeren Durchmesser der drehbaren Spitze aufzunehmen, und nach dem Herausschieben der drehbaren Spitze durch eine distale Öffnung in der Einführungshülse die Einführungshülse in ihre unverformte Konfiguration zurückkehrt.
     


    Revendications

    1. Appareil chirurgical d'athérectomie destiné à éliminer des dépôts tels qu'une plaque depuis l'intérieur d'un vaisseau (V), comprenant : un élément externe (20) ; un arbre rotatif (22) positionné pour un mouvement rotatif à l'intérieur de l'élément externe, l'arbre rotatif étant traversé par une lumière pour fil guide et présentant une ouverture distale (26) ; et un embout rotatif (30, 30') présentant un axe longitudinal et monté sur l'arbre rotatif pour tourner autour de son axe longitudinal lors de la rotation de l'arbre rotatif, l'embout rotatif étant monté sur une partie distale de l'arbre rotatif de telle sorte que l'ouverture distale (26) de la lumière de l'arbre rotatif soit espacée axialement d'une extrémité la plus distale (46) de l'embout rotatif, l'embout rotatif comportant une lumière pour fil guide destinée à recevoir un fil guide pour permettre l'insertion sur fil guide de l'appareil, caractérisé en ce que l'embout rotatif (30, 30') présente une lumière interne configurée pour faire en sorte que le fluide qui sort de l'ouverture (26) vienne en contact avec la surface interne de la paroi d'extrémité de l'embout, où il est alors redirigé vers un espace (36) entre l'arbre (22) et l'élément externe (20) pour diriger dans un sens proximal des dépôts éliminés par le mouvement rotatif de l'embout rotatif et en ce que l'embout rotatif (30, 30') comporte une pluralité d'ouvertures latérales (33, 33', 50) configurée pour aspirer des dépôts à travers l'embout et diriger ces particules à travers l'espace (36) entre l'arbre (22) et l'élément externe (20).
     
    2. Appareil chirurgical selon la revendication 1, dans lequel l'embout rotatif (30, 30') présente une partie intermédiaire (44) entre des partie distale et proximale (40, 42), la section transversale de la partie intermédiaire changeant progressivement d'une forme sensiblement circulaire au niveau de la partie distale en une forme allongée présentant deux parois latérales opposées sensiblement plates (44a) au niveau de la partie proximale.
     
    3. Appareil chirurgical selon la revendication 1 ou 2, dans lequel l'arbre rotatif (22) présentent une région filetée (25) sur une surface externe pour diriger des dépôts proximalement au fur et à mesure que l'arbre rotatif est tourné.
     
    4. Appareil chirurgical selon n'importe quelle revendication précédente, dans lequel une extrémité proximale (42) de l'embout rotatif (30, 30') est espacée axialement distalement d'un bord distal de l'élément externe (20).
     
    5. Appareil chirurgical selon n'importe quelle revendication précédente, dans lequel une partie distale (40) de l'embout rotatif (30, 30') présente un nez en forme d'ogive.
     
    6. Appareil chirurgical selon n'importe quelle revendication précédente, comprenant en outre une pluralité de rainures s'étendant longitudinalement formée dans une surface externe de l'embout rotatif (30, 30') pour former une surface d'ablation.
     
    7. Appareil chirurgical selon n'importe quelle revendication précédente, dans lequel l'espace (36) est fourni entre un diamètre externe de l'arbre rotatif (22) et un diamètre interne de l'élément externe (20) pour aspirer des dépôts proximalement.
     
    8. Appareil chirurgical selon n'importe quelle revendication précédente, dans lequel l'arbre rotatif (22) et l'embout (30, 30') sont tournés par un moteur (2).
     
    9. Combinaison d'un appareil chirurgical selon n'importe quelle revendication précédente et d'une gaine d'insertion (24, 35), l'appareil chirurgical pouvant être inséré à travers la gaine d'insertion pour accéder à un vaisseau cible (V) contenant les dépôts.
     
    10. Combinaison selon la revendication 9, dans laquelle un espace (39) est fourni entre un diamètre externe de l'élément externe (20) et un diamètre interne de la gaine d'insertion (24, 35) pour aspirer des dépôts.
     
    11. Combinaison selon la revendication 10, dans laquelle la gaine d'insertion (24, 35) présente un bras latéral pouvant être connecté à une source d'aspiration (4, 9) de telle sorte que des dépôts puissent être aspirés dans l'espace (39) entre l'élément externe (20) et la gaine d'insertion.
     
    12. Combinaison selon l'une quelconque des revendications 9 à 11, dans laquelle l'embout rotatif (30, 30') a un diamètre externe supérieur au diamètre interne de la gaine d'insertion (24, 35) et présente en outre des première et seconde régions rétrécies opposées (47).
     
    13. Combinaison selon la revendication 12, dans laquelle l'insertion de l'embout rotatif (30, 30') dans la gaine d'insertion(24, 35) déforme la gaine d'insertion pour recevoir le diamètre externe supérieur de l'embout rotatif et après une avancée de l'embout rotatif hors d'une ouverture distale dans la gaine d'insertion, la gaine d'insertion reprend sa configuration non déformée.
     




    Drawing



























    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description