(19)
(11)EP 1 307 257 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
28.05.2008 Bulletin 2008/22

(21)Application number: 01959555.2

(22)Date of filing:  06.08.2001
(51)Int. Cl.: 
A61M 25/00  (2006.01)
(86)International application number:
PCT/US2001/024586
(87)International publication number:
WO 2002/011809 (14.02.2002 Gazette  2002/07)

(54)

TORTUOUSE PATH INJECTION DEVICE AND METHOD

INJECTIONSVORRICHTUNG FÜR GESCLÄNGELTE BAHNEN UND ZUGEHÖRIGES VERFAHREN

PROCEDE ET DISPOSITIF D'INJECTION POUR VOIES TORTUEUSES


(84)Designated Contracting States:
DE FR GB IE NL

(30)Priority: 08.08.2000 US 634117

(43)Date of publication of application:
07.05.2003 Bulletin 2003/19

(73)Proprietor: Boston Scientific Limited
St. Michael (BB)

(72)Inventor:
  • MICKLEY, Timothy, J.
    Elk River, MN 55330 (US)

(74)Representative: Altenburg, Udo 
Patent- und Rechtsanwälte Bardehle . Pagenberg . Dost . Altenburg . Geissler Postfach 86 06 20
81633 München
81633 München (DE)


(56)References cited: : 
WO-A-96/35469
US-A- 5 902 289
US-A- 6 004 280
WO-A-99/49773
US-A- 5 913 853
US-A- 6 066 126
  
      
    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

    Field of the Invention



    [0001] The present invention relates generally to a catheter according to the precharacterizing part of claim 1 as known from D1. The catheter is used to deliver therapeutic or diagnostic agents to a portion of the human body. More particularly, the catheter is used to deliver and inject fluid into heart tissue.

    Background of the Invention



    [0002] Injection catheters may be used to inject therapeutic or diagnostic agents into a variety of organs, such as the heart. In the case of injecting a therapeutic agent into the heart, 27 or 28 gauge needles are generally used to inject solutions carrying genes, proteins, or drugs directly into the myocardium. A typical volume of an agent delivered to an injection site is about 100 microliters. A limitation to this method of delivering therapeutic agents to the heart is that the injected fluid tends to leak from the site of the injection after the needle is disengaged from the heart. In fact, fluid may continue to leak over several seconds. In the case of dynamic organs such as the heart, there may be more pronounced leakage with each muscle contraction.

    [0003] Many medical procedures involve the delivery of therapeutic and diagnostic agents to a targeted portion of a patient's body. For example, the delivery of a therapeutic agent is used in the treatment of esophageal varices, a condition where blood vessels of the esophagus are enlarged and may potentially burst. For such a procedure, a therapeutic agent is injected into the varix. When treating an esophageal varix, the agent may be a coagulant such as sodium morrhuate. When a coagulant is injected into a varix, it causes it to occlude. An injection catheter may be used to deliver the therapeutic agent in order to minimize the invasive nature of the procedure.

    [0004] In a similar procedure, an injection catheter may be utilized in the treatment of ulcers in the stomach lining. With such treatment, an injection catheter may be used to deliver drugs such as sclerosing or vasoconstrictive agents. These drugs typically clot or occlude the bleeding tissue to stop bleeding or to reduce the possibility of a blood vessel bursting.

    [0005] As mentioned previously, injection catheters may also be used to inject therapeutic or diagnostic agents into the heart. A limitation to this method of delivering therapeutic agents to the heart is that the injected fluid tends to leak from the site of the injection after the needle is disengaged from the heart. In fact, fluid may continue to leak over several seconds. In the case of the heart, there may be more pronounced leakage with each muscle contraction.

    [0006] Therapeutic and diagnostic agents may be delivered to a portion of the heart as part of a percutaneous myocardial revascularization (PMR) procedure. PMR is a procedure which is aimed at assuring that the heart is properly oxygenated. Assuring that the heart muscle is adequately supplied with oxygen is critical to sustaining the life of a patient. To receive an adequate supply of oxygen, the heart muscle must be well perfused with blood. In a healthy heart, blood perfusion is accomplished with a system of blood vessels and capillaries. However, it is common for the blood vessels to become occluded (blocked) or stenotic (narrowed). A stenosis may be formed by an atheroma which is typically a harder, calcified substance which forms on the walls of a blood vessel.

    [0007] Historically, individual stenotic lesions have been treated with a number of medical procedures including coronary bypass surgery, angioplasty, and atherectomy. Coronary bypass surgery typically involves utilizing vascular tissue from another part of the patient's body to construct a shunt around the obstructed vessel. Angioplasty techniques such as percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA) are relatively non-invasive methods of treating a stenotic lesion. These angioplasty techniques typically involve the use of a guidewire and a balloon catheter. In these procedures, a balloon catheter is advanced over a guidewire such that the balloon is positioned proximate a restriction in a diseased vessel. The balloon is then inflated and the restriction in the vessel is opened. A third technique which may be used to treat a stenotic lesion is atherectomy. During an atherectomy procedure, the stenotic lesion is mechanically cut or abraded away from the blood vessel wall.

    [0008] Coronary by-pass, angioplasty, and atherectomy procedures have all been found effective in treating individual stenotic lesions in relatively large blood vessels. However, the heart muscle is perfused with blood through a network of small vessels and capillaries. In some cases, a large number of stenotic lesions may occur in a large number of locations throughout this network of small blood vessels and capillaries. The tortuous path and small diameter of these blood vessels limit access to the stenotic, lesions. The sheer number and small size of these stenotic lesions make techniques such as cardiovascular by-pass surgery, angioplasty, and atherectomy impractical.

    [0009] When techniques which treat individual lesion are not practical percutaneous myocardial revascularization (PMR) may be used to improve the oxygenation of the myocardial tissue. A PMR procedure generally involves the creation of holes, craters or channels directly into the myocardium of the heart- In a typical PMR procedure, these holes are created using radio frequency energy delivered by a catheter having one or more electrodes near its distal end. After the wound has been created, therapeutic agents are sometimes injected into the heart chamber from the distal end of a catheter.

    [0010] Positive clinical results have been demonstrated in human patients receiving PMR treatments. These results are believed to be caused in part by blood flowing within a heart chamber through channels in myocardial tissue formed by PMR. Increased blood flow to the myocardium is also believed to be caused in part by the healing response to wound formation. Specifically, the formation of new blood vessels is believed to occur in response to the newly created wound. This response is sometimes referred to as angio-genisis. After the wound has been created, therapeutic agents which are intended to promote angio-genisis are sometimes injected into the heart chamber. A limitation of this procedure is that the therapeutic agent may be quickly carried away by the flow of blood through the heart.

    [0011] In addition to promoting increased blood flow, it is also believed that PMR improves a patient's condition through denervation. Denervation is the elimination of nerves. The creation of wounds during a PMR procedure results in the elimination of nerve endings which were previously sending pain signals to the brain as a result of hibernating tissue.

    [0012] US 5,902,289 to Swartz et al. describes and illustrates a process for the treatment of atrial arrhythmia by use of ablation and/or mapping procedures comprising ablating discrete ablation tracks within the left and right atrium (Figs. 1 and 2) and of the heart by use of precurved left and right atrium guiding introducers (Fig. 3a).

    [0013] US 6,066,126 to Li et al. describes and illustrates a cardiac introducer sheath 4 including an elongate hollow body having a main and tip portions 24, 22. The tip portion includes first through fifth segments 26, 28, 30, 32, and 34. The first, second, and third segments lie in a first plane 36 while the fourth and fifth segments lie in a second plane 38 oriented at a second angle 37 to the first plane. The second segment defines an arc extending along a first arc angle while the fourth segment defines an arc extending along a third arc angle.

    [0014] WO 96/35469 describes and illustrates guiding and delivery catheters 13, 24 which extend along the longitudinal axis of the left ventricle 11 to guide a laser focusing lens 20 to various points within the left ventricle 11. The catheters 13, 14 have an elongated tubular shaft with proximal, intermediate, and distal shaft sections for positioning a therapeutic or diagnostic device within a patient's body region such as a heart chamber. The distal section of the delivery catheter is provided with a bend to facilitate a perpendicular approach by the laser focusing lens 20 to the surface of the left ventricle.

    Summary of the Invention



    [0015] The present invention is defined by a catheter as defined in claim 1.

    [0016] Advantageous embodiments are defined in the dependent claims 2-5.

    [0017] In one embodiment of the invention, the first elongate shaft also includes a second curved portion disposed between the distal end of the first elongate shaft and the first curved portion of the first elongate shaft. The second curved portion of the first elongate shaft defines a second plane which intersects the first plane at an angle. In a preferred embodiment, the second plane is substantially orthogonal to the first plane. This arrangement reduces the likelihood that the distal end of the first elongate shaft will perforate the wall of an organ (e.g., the heart) during an injection procedure in accordance with a method of the present invention.

    [0018] In one embodiment of the present invention, a second elongate shaft is slidingly disposed within the lumen of the first elongate shaft. In this embodiment, the second elongate shaft may include a curve defining a third plane. In a preferred embodiment, the third plane is substantially orthogonal to the first plane. This arrangement reduces the likelihood that the distal end of the second elongate shaft will perforate the wall of an organ (e.g., the heart) during an injection procedure in accordance with a method of the present invention.

    [0019] During an injection procedure both the first elongate shaft and the second elongate shaft may be advanced into a target tissue. After the injection of fluid into the target tissue, the first elongate shaft and the second elongate shaft may be withdrawn from the target tissue. In a preferred embodiment, the first elongate shaft and the second elongate shaft each include a plurality of curves. The tortuous path defined by the first elongate shaft and the second elongate shaft reduce the likelihood that injected fluid will escape from the target tissue after the first elongate shaft and the second elongate shaft are disengaged from the target tissue.

    Brief Description of the Drawings



    [0020] 

    Figure 1 is a cross sectional view of a catheter in accordance with an exemplary embodiment of the present invention;

    Figure 2 is a diagrammatic view including the catheter of figure 1 and a patient having a heart and a vascular system including a blood vessel;

    Figure 3 is a cross sectional view of a catheter in accordance with an exemplary embodiment of the present invention;

    Figure 4 is a perspective view of a distal portion of a catheter in accordance with an exemplary embodiment of the present invention;

    Figure 5 is a perspective view of a distal portion of a catheter in accordance with an exemplary embodiment of the present invention;

    Figure 6 is a cross sectional view of a catheter in accordance with an exemplary embodiment of the present invention;

    Figure 7 is a partial cross sectional view of a distal portion of a catheter in accordance with an exemplary embodiment of the present invention;

    Figure 8 is a partial cross sectional view of a distal portion of a catheter in accordance with an exemplary embodiment of the present invention;.

    Figure 9 is a partial cross sectional view of a distal portion of a catheter in accordance with an exemplary embodiment of the present invention;

    Figure 10 is a partial cross sectional view of a distal portion of a catheter in accordance with an exemplary embodiment of the present invention; and

    Figure 11 is a partial cross sectional view of an additional embodiment of the catheter of figure 10.


    Detailed Description of the Invention



    [0021] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered in like fashion. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. In some cases, the drawings may be highly diagrammatic in nature. Examples of constructions, materials, dimensions, and manufacturing processes are provided for various elements. Those skilled in the art will recognize that many of the examples provided have suitable alternatives which may be utilized.

    [0022] Figure 1 is a cross sectional view of a catheter 100 in accordance with the present invention. Catheter 100 has a distal end 102, a proximal end 104, and a sheath 106. Sheath 106 of catheter 100 includes a distal end 108 and a proximal end 122. A sheath housing 124 is disposed about sheath 106 proximate proximal end 122 thereof. Sheath 106 defines a sheath lumen 120 extending between distal end 108 and proximal end 122.

    [0023] In the embodiment of figure 1, a first elongate shaft 126 is slidingly disposed within sheath lumen 120 of sheath 106. First elongate shaft 126 has a distal end 128, a proximal end 132, and a first shaft lumen 130 extending therebetween. A first hub 134 is disposed about first elongate shaft 126 proximate proximal end 132 thereof. A second elongate shaft 136 is slidingly disposed within first shaft lumen 130 of first elongate shaft 126. Second elongate shaft 136 has a distal end 138 and a proximal end 142. In the embodiment of figure 1, second elongate shaft 136 forms a point 146 proximate distal end 138 thereof. Second elongate shaft also defines an injection port 148 proximate point 146. A second hub 144 is disposed about second elongate shaft 136 proximate proximal end 142 thereof. Second hub 144 defines a proximal port 150. In a preferred embodiment, proximal port 150 is in fluid communication with injection port 148 via an injection lumen 140 defined by second elongate shaft 136.

    [0024] In figure 1 it may be appreciated that first elongate shaft 126 includes a first curved portion 152 disposed proximate distal end 128 thereof. In the embodiment of figure 1, first curved portion 152 of first elongate shaft 126 defines a first plane 154 which is generally coplanar with the plane of figure 1.

    [0025] In the embodiment of figure 1 a barrel 162 is partially disposed within sheath lumen 120 of sheath 106. In a preferred embodiment, barrel 162 includes a radial enlargement 164. In this preferred embodiment, radial enlargement 164 provides a generally enlarged distal contact area 166. Generally enlarged distal contact area 166 reduces the likelihood that undesired tissue damage will occur when distal end 102 of catheter 100 is urged against bodily tissue. Barrel 162 also defines a barrel lumen 170. As shown in figure 1, first elongate shaft 126 is slidingly disposed within barrel lumen 170.

    [0026] In a preferred embodiment, first elongate shaft 126 and second elongate shaft 136 of catheter 100 comprise hypodermic tubing. First elongate shaft 126 and second elongate shaft 136 may comprise various metallic and non-metallic materials without deviating from the scope of the present invention. Examples of metallic materials which may be suitable in some applications include stainless steel, and nickeltitanium alloy. Examples of non-metallic materials which may be suitable in some applications are included in the list below which is not exhaustive: polycarbonate, poly(L-lactide) (PLLA), poly(D,L-lactide) (PLA), polyglycolide (PGA), poly(L-lactide-co-D,L-lactide) (PLLA/PLA), poly(L-lactide-co-glycolide) (PLLA/PGA), poly(D, L-lactide-co-glycolide) (PLA/PGA), poly(glycolide-co-trimethylene carbonate) (PGA/PTMC), polyethylene oxide (PEO), polydioxanone (PDS), polycaprolactone (PCL), polyhydroxylbutyrate (PHBT), poly(phosphazene), polyD,L-lactide-co-caprolactone) (PLA/PCL), poly(glycolide-co-caprolactone) (PGA/PCL), polyanhydrides (PAN), poly(ortho esters), poly (phosphate ester), poly(amino acid), poly(hydroxy butyrate), polyacrylate, polyacrylamide, poly(hydroxyethyl methacrylate), polyurethane, polysiloxane and their copolymers.

    [0027] In a preferred embodiment, sheath 106 of catheter 100 comprises an elongate tubular member including a reinforcement member (e.g., braided or coiled wire). Sheath 106 may comprise various metallic and non-metallic materials without deviating from the scope of the present invention. Examples of metallic materials which may be suitable in some applications include stainless steel, and nickel-titanium alloy. Examples of non-metallic materials which may be suitable in some applications include: polyethylene (PE), polypropylene (PP), polyvinylchloride (PVC), polyurethane, polytetrafluoroethylene (PTFE), polyether block amide (PEBA), polyamide, and polyimide.

    [0028] Figure 2 is a diagrammatic view including catheter 100 of figure 1 and a patient 20. Patient 20 has a heart 22 and a vascular system 24 including a blood vessel 26 defining a blood vessel lumen 28. An access sheath 30 is partially disposed within a leg of patient 20. A distal end 32 of access sheath 30 is disposed within blood vessel lumen 28 of blood vessel 26. Access sheath 30 may aid in the introduction of catheter 100 into blood vessel lumen 28.

    [0029] As shown in figure 2, a portion of catheter 100 is disposed within blood vessel lumen 28 of blood vessel 26. Distal end 102 (not visible in figure 2) of catheter 100 is disposed within heart 22 of patient 20. In a preferred embodiment, distal end 102 of catheter 100 is disposed proximate a wall of heart 22.

    [0030] In the embodiment of figure 2, a fluid source 34 is coupled to second hub 144 disposed about second elongate shaft 136 of catheter 100. In the embodiment of figure 2, fluid source 34 includes a variable volume chamber 36 defined by a body 38. In a preferred embodiment, variable volume chamber 36 is in fluid communication with injection lumen 140 of second elongate shaft 136. A plunger 40 is slidingly disposed within variable volume chamber 36. Urging the plunger distally has the effect of urging fluid into injection lumen 140 of second elongate shaft 136. A number of energy sources may be utilized to urge plunger 40 distally. Energy sources which may be suitable in some applications include springs, compressed gas, a human being, and electricity. Various additional embodiments of fluid source 34 are possible without deviating from the scope of the present invention. Examples of fluid sources which may be suitable in some applications include syringes, peristaltic pumps, and an I.V. bag with pressure applied to its outer surface.

    [0031] A method of injecting a fluid into heart 22 of patient 20 may be described with reference to figure 2. The distal end of access sheath 30 may be inserted into blood vessel lumen 28 of blood vessel 26. Distal end 102 of catheter 100 may be inserted into the lumen of access sheath 30. Distal end 102 of catheter 100 may be advanced through access sheath 30 and into blood vessel lumen 28 of blood vessel 26. Catheter 100 may be urged forward through vascular system 24 of patient 20 until distal end 102 is proximate the target tissue (e.g., a wall of heart 22). In figure 2 it may be appreciated that catheter 100 is bent in a plurality of locations to conform with a tortuous path defined by vascular system 24.

    [0032] In a preferred method, distal end 138 of second elongate shaft 136 and distal end 128 of first elongate shaft 126 are disposed within sheath lumen 120 of sheath 106 during the above steps. For example, distal end 128 of first elongate shaft 126 may be pulled into sheath lumen 120 of sheath 106 urging first hub 134 proximally with respect to sheath housing 124. In a similar fashion, distal end 138 of second elongate shaft 136 may be pulled into first shaft lumen 130 of first elongate shaft 126 by urging second hub 144 proximally with respect to first hub 134.

    [0033] Once distal end 102 of catheter 100 is positioned proximate the target tissue, first elongate shaft 126 may be advanced so that distal end 128 penetrates the bodily tissue at the target site. A physician may, for example, apply a distally directed force to first hub 134 to urge first elongate shaft 126 distally. Second elongate shaft 136 may also be urged distally in concert with first elongate shaft 126. In a preferred embodiment, first curved portion 152 of first elongate shaft assumes a generally curved shape when it is urged distally out of sheath lumen 120.

    [0034] Second elongate shaft 136 may be advanced so that point 146 penetrates the bodily tissue proximate distal end 128 of first elongate shaft 126. In a preferred method, second elongate shaft will be advanced until injection port 148 is disposed within the target tissue. With injection port 148 of second elongate shaft 136 disposed within the target tissue, fluid may be urged into the target tissue. For example, force may be applied to plunger 40 urging fluid out of fluid source 34 and into injection lumen 140 of second elongate shaft 136. The addition of fluid from fluid source 34 results in the injection of fluid into the target tissue.

    [0035] After the injection of fluid, first elongate shaft 126 and second elongate shaft 136 may be withdrawn from the target tissue. In a preferred embodiment, the tortuous path taken by first elongate shaft 126 and second elongate shaft 136 reduce the likelihood that injected fluid will escape from the target tissue after first elongate shaft 126 and second elongate shaft 136 are disengaged from the target tissue. Embodiments of catheter 100 have been envisioned in which first elongate shaft 126 and second elongate shaft 136 both include a plurality of curved portions.

    [0036] Figure 3 is a cross sectional view of an additional embodiment of a catheter 200 in accordance with the present invention. Catheter 200 has a distal end 202, a proximal end 204, and a sheath 206. Sheath 206 of catheter 200 includes a distal end 208, a proximal end 222. A sheath housing 224 is disposed about sheath 206 proximate proximal end 222 thereof. Sheath 206 defines a sheath lumen 220 extending between distal end 208 and proximal end 222.

    [0037] In the embodiment of figure 3, a first elongate shaft 226 is slidingly disposed within sheath lumen 220 of sheath 206. First elongate shaft 226 has a distal end 228, a proximal end 232, and a first shaft lumen 230 extending therebetween. A first hub 234 is disposed about first elongate shaft 226 proximate proximal end 232 thereof. A second elongate shaft 236 is slidingly disposed within first shaft lumen 230 of first elongate shaft 226. Second elongate shaft 236 has a distal end 238 and a proximal end 242. In the embodiment of figure 3, second elongate shaft 236 forms a point 246 proximate distal end 238 thereof. Second elongate shaft defines an injection port 248 proximate point 246. A second hub 244 is disposed about second elongate shaft 236 proximate proximal end 242 thereof. Second hub 244 defines a proximal port 250. In a preferred embodiment, proximal port 250 is in fluid communication with injection port 248 via an injection lumen 240 defined by second elongate shaft 236.

    [0038] In figure 3 it may be appreciated that first elongate shaft 226 includes a first curved portion 252 disposed proximate distal end 228 thereof. In the embodiment of figure 3, first curved portion 252 of first elongate shaft 226 defines a first plane 254 which is generally coplanar with the plane of figure 3. First elongate shaft 226 also includes a second curved portion 256 defining a second plane 258. In the embodiment of figure 3, second plane 258 is substantially orthogonal to first plane 254.

    [0039] Figure 4 is a perspective view of a distal portion 360 of an additional embodiment of a catheter 300 in accordance with the present invention. Catheter 300 includes a sheath 306 defining a sheath lumen 320. A first elongate shaft 326 is partially disposed within sheath lumen 320 of sheath 306. First elongate shaft 326 includes a first curved portion 352 defining a first plane 354 and a second curved portion 356 defining a second plane 358 disposed proximate a distal end 328 thereof. In figure 4 it may also be appreciated that first elongate shaft 326 forms a point 329 proximate distal end 328 thereof.

    [0040] Catheter 300 also includes a second elongate shaft 336 which is partially disposed in a first shaft lumen 330 defined by first elongate shaft 326. Second elongate shaft 336 defines an injection lumen 340 and an injection port 348. Second elongate shaft 336 also forms a point 346 proximate a distal end 338 thereof.

    [0041] Figure 5 is a perspective view of a distal portion 460 of an additional embodiment of a catheter 400 in accordance with the present invention. Catheter 400 includes a second elongate shaft 436 having a curved portion 472. A portion of second elongate shaft 436 is disposed within a first lumen 430 defined by a first elongate shaft 426. First elongate shaft 426 includes a first curved portion 452 and a second curved portion 456. In figure 5 it may also be appreciated that first elongate shaft 426 forms a point 429 proximate distal end 428 thereof.

    [0042] In the embodiment of figure 5, first curved portion 452 of first elongate shaft 426 defines a first plane 454 and second curved portion of first elongate shaft 426 defines a second plane 458. Also in the embodiment of figure 5, curved portion 472 of second elongate shaft 436 defines a third plane 474. In the embodiment of figure 5, second plane 458 is substantially orthogonal to first plane 454. Also in the embodiment of figure 5, third plane 474 is generally co-planar with second plane 458. In a preferred embodiment, curved portion 472 is biased to return to the shape illustrated in figure 5. In this preferred embodiment, curved portion 472 of second elongate shaft 436 may tend to self-align with second curved portion 456 of first elongate shaft 426. In a particularly preferred embodiment, the radius of curved portion 472 of second elongate shaft 436 is substantially equal to the radius of second curved portion 456 of first elongate shaft 426.

    [0043] In a preferred embodiment, the radius of first curved portion 452 of first elongate shaft 426 is selected so that distal end 428 of first elongate shaft 426 will be disposed within a wall of an organ (e.g., the heart) during an injection procedure in accordance with a method of the present invention. Also in a preferred embodiment, third plane 474 defined by curved portion 472 of second elongate shaft 436 is substantially orthogonal to first plane 454 defined by first curved portion 452 of first elongate shaft 426. This relationship reduces the likelihood that the distal end of second elongate shaft 436 will perforate the wall of an organ (e.g., the heart) during an injection procedure in accordance with a method of the present invention.

    [0044] In a preferred embodiment the radius of first curved portion 452 of first elongate shaft 426 is, for example, between about 1.0 and about 10.0 millimeters. In a particularly preferred embodiment the radius of first curved portion 452 of first elongate shaft 426 is, for example, between about 3.0 and about 7.0 millimeters.

    [0045] In a preferred embodiment the radius of second curved portion 456 of first elongate shaft 426 is, for example, between about 1.0 and about 8.0 millimeters. In a particularly preferred embodiment the radius of second curved portion 456 of first elongate shaft 426 is, for example, between about 2.0 and about 5.0 millimeters.

    [0046] In a preferred embodiment the radius of curved portion 472 of second elongate shaft 436 is, for example, between about 1.0 and about 8.0 millimeters. In a particularly preferred embodiment the radius of curved portion 472 of second elongate shaft 436 is, for example, between about 2.0 and about 5.0 millimeters.

    [0047] Embodiments of catheter 400 have been envisioned in which first elongate shaft 426 and second elongate shaft 436 both include a plurality of curved portions. In a preferred embodiment, the tortuous path taken by first elongate shaft 426 and second elongate shaft 436 reduces the likelihood that fluid will escape from a target tissue after it has been injected therein.

    [0048] It is to be appreciated that the radius of curved portion 472 may vary along the length of second elongate shaft 436. Likewise, it is to be appreciated that the radius of first curved portion 452 and second curved portion 456 may vary along the length of first elongate shaft 426. To explain further, a curve of constant radius forms a portion of a circle whereas a curve of variable radius may form a portion of a spiral. First elongate shaft 426 and second elongate shaft 436 both may include a plurality of curved portions having various shapes. Embodiments of the present invention have been envisioned in which the injection path includes a plurality of turns. These turns may be any shape. Examples of turn shapes which may be suitable in some applications include circular arcs and spiral arcs. Embodiments of the present invention have also been envisioned in which the injection path is generally in the shape of a helix having an expanding radial pitch.

    [0049] Figure 6 is a cross sectional view of an additional embodiment of a catheter 500 in accordance with the present invention. Catheter 500 has a distal end 502, a proximal end 504, and a sheath 506. Sheath 506 of catheter 500 includes a distal end 508 and a proximal end 522. A sheath housing 524 is disposed about sheath 506 proximate proximal end 522 thereof. Sheath 506 defines a sheath lumen 520 extending between distal end 508 and proximal end 522.

    [0050] In the embodiment of figure 6, a first elongate shaft 526 is slidingly disposed within sheath lumen 520 of sheath 506. First elongate shaft 526 has a distal end 528, a proximal end 532, and a first shaft lumen 530 extending therebetween. A first hub 534 is disposed about first elongate shaft 526 proximate proximal end 532 thereof.

    [0051] A second elongate shaft 536 is slidingly disposed within first shaft lumen 530 of first elongate shaft 526. A second hub 544 is disposed about second elongate shaft 536 proximate a proximal end 542 thereof. Second hub 544 defines a proximal port 550. In a preferred embodiment, proximal port 550 is in fluid communication with an injection lumen 540 and an injection port 548 defined by second elongate shaft 536.

    [0052] In the embodiment of figure 6 a barrel 562 is partially disposed within sheath lumen 520 of sheath 506. In a preferred embodiment, barrel 562 includes a radial enlargement 564. In this preferred embodiment, radial enlargement 564 provides a generally enlarged distal contact area 566. Generally enlarged distal contact area 566 reduces the likelihood that undesired tissue damage will occur when distal end 502 of catheter 500 is urged against bodily tissue. Barrel 562 also defines a barrel lumen 570. As shown in figure 6, first elongate shaft 526 is slidingly disposed within barrel lumen 570.

    [0053] As shown in figure 6, sheath housing 524 defines a first guiding surface 510. First hub 534 has a first mating surface 512 and a second guiding surface 514. First mating surface 512 of first hub 534 is disposed in sliding engagement with first guiding surface 510 of sheath housing 524. In a similar fashion, a second mating surface 516 of second hub 544 is disposed in sliding engagement with second guiding surface 514 of first hub 534.

    [0054] In the embodiment of figure 6, first elongate shaft 526 and second elongate shaft 536 are biased to assume curved shapes. In the embodiment of figure 6, first elongate shaft 526 and second elongate shaft 536 have been urged proximally so that their respective distal ends are disposed within sheath lumen 520 of sheath 506. In figure 6 it may be appreciated that first elongate shaft 526 and second elongate shaft 536 have been urged into a substantially straight position. In a preferred embodiment, first elongate shaft 526 and second elongate shaft 536 will return to substantially curved shapes when they are urged distally out of sheath lumen 520.

    [0055] When first elongate shaft 526 and second elongate shaft 536 are advanced into a target tissue, injection lumen 540 of second elongate shaft 536 will define a tortuous injection path. The tortuous injection path defined by injection lumen 540 of second elongate shaft 536 may be described utilizing cylindrical coordinates. Cylindrical coordinates are an extension of two dimensional polar coordinates to include a third or longitudinal dimension Z.

    [0056] An exemplary tortuous injection path is described in table 1. The first column of table 1 is the linear distance Z which the tortuous injection path extends beyond distal contact area 566 of catheter 500. The second column in table 1 is the radial distance R in millimeters from the longitudinal axis of barrel lumen 570 of barrel 562 of catheter 500. The third column of table 1 is an angular dimension φ measured about the longitudinal axis of barrel lumen 570 of barrel 562 of catheter 500.
    TABLE 1
    ZRφ
    [mm][mm][degrees]
    0 0 0
    1.0 1.0 0
    1.5 1.5 0
    2.0 2.0 0
    2.5 2.0 0
    2.5 2.2 30
    2.5 2.5 60
    2.5 3.0 90
    5.0 4.0 120
    5.0 4.0 150
    5.0 4.0 180
    7.5 6.0 210
    7.5 6.0 240
    7.5 6.0 270
    10.0 8.0 300
    10.0 8.0 330
    10.0 8.0 360


    [0057] Figure 7 is a partial cross sectional view of a distal portion 660 of an additional embodiment of a catheter 600 in accordance with the present invention. Catheter 600 includes a first elongate shaft 626 having a distal end 628 and an inside surface 676 defining a first shaft lumen 630. A barrel 662 is partially disposed within first shaft lumen 630 of first elongate shaft 626 proximate distal end 628. Barrel 662 includes a first helical member 678 comprising a plurality of turns 680. In the embodiment of figure 7, first helical member 678 comprises a first screw thread 682.

    [0058] A second elongate shaft 636 is partially disposed within first shaft lumen 630 of first elongate shaft 626. Second elongate shaft 636 forms a second helical member 684. In the embodiment of figure 7, second helical member 684 comprises a coil 686 having a plurality of turns 688. In figure 7, it may be appreciated that a plurality of turns 688 of second helical member 684 are disposed between a plurality of turns 680 of first helical member 678. Also in figure 7, it may be appreciated that second helical member 684 is biased to expand in diameter. A distal end 638 of second elongate shaft 636 may be advanced into a target tissue by rotating second elongate shaft 636.

    [0059] Figure 8 is a partial cross sectional view of a distal portion 760 of an additional embodiment of a catheter 700 in accordance with the present invention. In figure 8 it may be appreciated that catheter 700 includes a first helical member 778 comprising a plurality of turns 780 disposed within a first shaft lumen 730 defined by an inside surface 776 of a first elongate shaft 726. In a preferred embodiment, first helical member 778 is fixed to inside surface 776 of first elongate shaft 726. In the embodiment of figure 8, first helical member 778 comprises a first screw thread 782.

    [0060] Also in the embodiment of figure 8, a second helical member 784 comprising a plurality of turns 788 is disposed about a second elongate shaft 736. In the embodiment of figure 8, second helical member 784 is preferably fixed to second elongate shaft 736. In the embodiment of figure 8, second helical member 784 comprises a second screw thread 790. In figure 8, it may be appreciated that a plurality of turns 788 of second helical member 784 are disposed between a plurality of turns 780 of first helical member 778.

    [0061] In the embodiment of figure 8, a barrel 762 defining a barrel lumen 770 is partially disposed within first shaft lumen 730 of first elongate shaft 726. A coiled portion 792 of second elongate shaft 736 is disposed within barrel lumen 770 of barrel 762. In figure 8, it may be appreciated that coiled portion 792 is biased to expand in diameter. A distal end 738 of second elongate shaft 736 may be advanced into a target tissue by rotating second elongate shaft 736.

    [0062] Figure 9 is a partial cross sectional view of a distal portion 860 of an additional embodiment of a catheter 800 in accordance with the present invention. Catheter 800 includes a first elongate shaft 826 having a distal end 828 and an inside surface 876 defining a first shaft lumen 830. Catheter 800 also includes a second elongate shaft 836 having a distal end 838 slidingly disposed within first shaft lumen 830 of first elongate shaft 826.

    [0063] In figure 9 it may be appreciated that catheter 800 includes a first helical member 878 comprising a plurality of turns 880 disposed within first shaft lumen 830 of first elongate shaft 826. In a preferred embodiment, first helical member 878 is fixed to an inside surface 876 of first elongate shaft 826. In the embodiment of figure 9, first helical member 878 comprises a first screw thread 882.

    [0064] A second helical member 884 is formed by second elongate shaft 836. In the embodiment of figure 9, second helical member 884 comprises a coil 886 having a plurality of turns 888. In figure 9, it may be appreciated that a plurality of turns 888 of second helical member 884 are disposed between a plurality of turns 880 of first helical member 878. Embodiments of the present invention have also been envisioned in which first helical member 878 comprises a coil.

    [0065] In the embodiment of figure 9, a barrel 862 defining a barrel lumen 870 is partially disposed within first shaft lumen 830 of first elongate shaft 826. A coiled portion 892 of second elongate shaft 836 is disposed within barrel lumen 870 of barrel 862. In figure 9, it may be appreciated that coiled portion 892 is biased to expand in diameter. A distal end 838 of second elongate shaft 836 may be advanced into a target tissue by rotating second elongate shaft 836.

    [0066] Figure 10 is a partial cross sectional view of a distal portion 960 of an additional embodiment of a catheter 900 in accordance with the present invention. Catheter 900 includes a first elongate shaft 926 having a distal end 928 and an inside surface 976 defining a first shaft lumen 930. A tip member 994 is disposed proximate distal end 928 of first elongate shaft 926. In a preferred embodiment, tip member 994 is comprised of an elastomeric material.

    [0067] A barrel 962 is partially disposed within first shaft lumen 930 of first elongate shaft 926 proximate tip member 994. Barrel 962 includes a first helical member 978 comprising a plurality of turns 980. In the embodiment of figure 10, first helical member 978 comprises a first screw thread 982. A second elongate shaft 936 is partially disposed within first shaft lumen 930 of first elongate shaft 926. Second elongate shaft 936 forms a second helical member 984. In the embodiment of figure 10, second helical member 984 comprises a coil 986 having a plurality of turns 988. In figure 10, it may be appreciated that a plurality of tums 988 of second helical member 984 are disposed between a plurality of turns 980 of first helical member 978.

    [0068] Figure 11 is a partial cross sectional view of distal portion 960 of catheter 900 of figure 10. In the embodiment of figure 11 second elongate shaft 936 has been advanced distally so that a distal portion of second elongate shaft 936 extends beyond barrel 962. In figure 11, it may be appreciated that second helical member 984 is biased to expand in diameter. Also in figure 11, it may be appreciated that the expansion of second helical member 984 has deformed tip member 994.

    [0069] Having thus described the preferred embodiments of the present invention, those of skill in the art will readily appreciate that yet other embodiments may be made and used within the scope of the claims hereto attached. Numerous advantages of the invention covered by this document have been set forth in the foregoing description. It will be understood, however, that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of parts without exceeding the scope of the invention. The invention's scope is, of course, defined in the language in which the appended claims are expressed.


    Claims

    1. A catheter for delivering therapeutic or diagnostic agents to target tissue, comprising:

    a housing (124) surrounding at least a portion of the first elongated shaft (126), the housing (124) having a proximal end (132) and a distal end (108), the distal end (108) having a distal contact area (166);

    a first elongated shaft (126),
    the first elongated shaft (126) defining a lumen (130),
    the first elongated shaft (126) having a longitudinal axis,
    the first elongated shaft (126) having a proximal end (132) and a distal end (128); and

    the first elongated shaft (126) being slidable from a first position within the housing (124) to a second position,

    the longitudinal axis of the distal end (128) of the first elongated shaft (126) defining a curve (152) when the first elongated shaft (126) is in the second position,

    characterized in that the first elongated shaft (126) is slidable from a first position within the housing (124) to a second position within a target tissue, whereby the longitudinal axis of the distal end (128) of the first elongated shaft (126) is defining a curve (152) within the target tissue when the first elongated shaft is in the second position.
     
    2. The catheter of claim 1, wherein the longitudinal axis of the distal end (128) of the first elongated shaft (126) defines a straight line when in the first position.
     
    3. The catheter of claim 1, further comprising.

    a second elongated shaft (136),

    the second elongated shaft (136) defining a lumen (130),

    the second elongated shaft (136) having a longitudinal axis,

    the second elongated shaft (136) having a proximal end (142) and a distal end (138),

    the second elongated shaft (136) slidable within the first elongated shaft (126) from a first position to a second position within the target tissue,

    the second position locating the distal end (138) of the second elongated shaft (136) outside of the distal end of the first elongated shaft and into the target tissue to deliver therapeutic or diagnostic agent through the lumen.


     
    4. The catheter of claim 3, wherein the distal end (138) of the second elongated shaft has a point (146) to facilitate advancement into the target tissue.
     
    5. The catheter of claim 3, wherein the longitudinal axis of the second elongated shaft (136) defines a line when the second elongated shaft (136) is in the first position and defines a curve when the shaft is in the second position.
     


    Ansprüche

    1. Ein Katheter zum Transportieren eines therapeutischen oder diagnostischen Wirkstoffes in ein Zielgewebe, umfassend:

    - ein Gehäuse (124), welches zumindest einen Abschnitt des ersten gestreckten Schafts (126) umgibt,

    - wobei das Gehäuse (124) ein proximales Ende (132) und ein distales Ende (108) aufweist,

    - und wobei das distale Ende (108) einen distalen Kontaktbereich (166) aufweist,

    - einen ersten gestreckten Schaft (126),

    - wobei der erste gestreckte Schaft (126) ein Lumen (130) begrenzt,

    - wobei der erste gestreckte Schaft (126) eine längsgerichtete Achse aufweist,

    - und wobei der erste gestreckte Schaft (126) ein proximales Ende (132) und ein distales Ende (128) aufweist, und

    - wobei der erste gestreckte Schaft (126) von einer ersten Position innerhalb des Gehäuses (124) zu einer zweiten Position gleitbar ist,

    - und wobei die längsgerichtete Achse des distalen Endes (128) des ersten gestreckten Schafts (126) eine Kurve (152) beschränkt, wenn der erste gestreckte Schaft (126) in der zweiten Position ist,

    dadurch gekennzeichnet, dass

    - der erste gestreckte Schaft (126) von einer ersten Position innerhalb des Gehäuses (124) zu einer zweiten Position innerhalb eines Zielgewebes gleitbar ist, wobei die längsgerichtete Achse des distalen Endes (128) des ersten gestreckten Schafts (126) eine Kurve (152) innerhalb des Zielgewebes definiert, wenn der erste gestreckte Schaft in der zweiten Position ist.


     
    2. Katheter nach Anspruch 1, wobei die längsgerichtete Achse des distalen Endes (128) des ersten gestreckten Schaftes (126) eine gerade Linie definiert, wenn er in der ersten Position ist.
     
    3. Katheter nach Anspruch 1, weiterhin umfassend:

    - einen zweiten gestreckten Schaft (136),

    - wobei der zweite gestreckte Schaft (136) ein Lumen (130) definiert,

    - wobei der zweite gestreckte Schaft (136) eine längsgerichtete Achse aufweist,

    - wobei der zweite gestreckte Schaft (136) ein proximales Ende (142) und ein distales Ende (138) aufweist,

    - und wobei der zweite gestreckte Schaft (136) innerhalb des ersten gestreckten Schafts (126) von einer ersten Position zu einer zweiten Position innerhalb des Zielgewebes gleitbar ist,

    - und wobei die zweite Position das distale Ende (138) des zweiten gestreckten Schafts (136) außerhalb des distalen Endes des ersten gestreckten Schafts und in das Zielgewebe festlegt, um einen therapeutischen oder diagnostischen Wirkstoff durch das Lumen zu transportieren.


     
    4. Katheter nach Anspruch 3, wobei das distale Ende (138) des zweiten gestreckten Schafts eine Spitze (146) aufweist, um die Fortbewegung in dem Zielgewebe zu erleichtern.
     
    5. Katheter nach Anspruch 3, wobei die längsgerichtete Achse des zweiten gestreckten Schafts (136) eine Linie definiert, wenn der zweite gestreckte Schaft (136) in der ersten Position ist, und eine Kurve definiert, wenn der Schaft in der zweiten Position ist.
     


    Revendications

    1. Un cathéter pour délivrer des agents thérapeutiques ou de diagnostic à un tissu cible, comprenant :

    - un boîtier (124) entourant au moins une partie de la première tige allongée (126),
    le boîtier (124) ayant une extrémité proximale (132) et une extrémité distale (108), l'extrémité distale (108) ayant une surface de contact distale (166) ;

    - une première tige allongée (126),
    la première tige allongée (126) définissant une lumière (130),
    la première tige allongée (126) ayant un axe longitudinal,
    la première tige allongée (126) ayant une extrémité proximale (132) et une extrémité distale (128) ; et
    la première tige allongée (126) pouvant coulisser depuis une première position à l'intérieur du boîtier (124) jusqu'à une seconde position,
    l'axe longitudinal de l'extrémité distale (128) de la première tige allongée (126) définissant une courbe (152) lorsque la première tige allongée (126) est dans la seconde position,

    caractérisé en ce que la première tige allongée (126) peut coulisser d'une première position à l'intérieur du boîtier (124) à une seconde position à l'intérieur d'un tissu cible, de sorte que l'axe longitudinal de l'extrémité distale (128) de la première tige allongée (126) définisse une courbe (152) à l'intérieur du tissu cible lorsque la première tige allongée est dans la seconde position.
     
    2. Le cathéter de la revendication 1, dans lequel l'axe longitudinal de l'extrémité distale (128) de la première tige allongée (126) définit une ligne droite lorsqu'elle est dans la première position.
     
    3. Le cathéter de la revendication 1, comprenant en outre :

    - une seconde tige allongée (136), la seconde tige allongée (136) définissant une lumière (130),
    la seconde tige allongée (136) ayant un axe longitudinal,
    la seconde tige allongée (136) ayant une extrémité proximale (142) et une extrémité discale (138) ; et
    la seconde tige allongée (136) pouvant coulisser à l'intérieur de la première tige allongée (126) depuis une première position jusqu'à une seconde position à l'intérieur du tissu cible,
    la seconde position situant l'extrémité distale (138) de la seconde tige allongée (136) hors de l'extrémité distale de la première tige allongée et jusque dans le tissu cible pour délivrer l'agent thérapeutique ou diagnostique au travers de la lumière.


     
    4. Le cathéter de la revendication 3, dans lequel l'extrémité distale (138) de la seconde tige allongée présente une pointe (146) pour faciliter la progression jusque dans le tissu cible.
     
    5. Le cathéter de la revendication 3, dans lequel l'axe longitudinal de la seconde tige allongée (136) définit une ligne lorsque la seconde tige allongée (136) est dans la première position et définit une courbe lorsque la tige est dans la seconde position.
    l'axe longitudinal de l'extrémité distale (128) de la première tige allongée (126) définissant une courbe (152) lorsque la première tige allongée (126) est dans la seconde position,
    caractérisé en ce que la première tige allongée (126) peut coulisser d'une première position à l'intérieur du boîtier (124) à une seconde position, de sorte que l'axe longitudinal de l'extrémité distale (128) de la première tige allongée (126) définisse une courbe (152) à l'intérieur du tissu cible lorsque la première tige allongée est dans la seconde position.
     




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    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