Guiding catheter

Abstract: A soft tip guiding catheter (10) for atraumatic insertion into delicate, tortuous coronary vessels and introduction of an angioplasty balloon catheter therethrough. The guiding catheter includes a main tubular portion (11) and a soft tubular tip (12) with respective, matching external and internal tapers (13,14) for increasing the contact area of the thermal bond. The outer and inner diameters of the main portion are uniform and match the respective outer and inner diameters of the soft tip for providing a uniform outer catheter surface and a continuous, uniform catheter passageway surface. The tapers further provide for a gradual change in durometer between the main portion and soft tip. The main portion preferably includes an inner layer of lubricous material (19), an outer layer (27) of a polyether block amide, and a reinforcing braid positioned therebetween (26). The layers of the main portion provide a thin catheter wall with pushability, torquability, and kink resistance. The composite durometer of the main portion is harder than the durometer of the soft tip, which comprises a combination of polyether block amide material and tungsten for increasing the radiopacity thereof.

Description: This invention relates to guiding catheters with soft distal tips. A guiding catheter is commonly used for delivering a balloon catheter to a treatment site in a coronary vessel. To enable the guiding catheter to be moved safely through the vascular system and into the delicate coronary vessels, the guiding catheter should have a soft distal tip. One nonanalogous, nonbraided angiographic catheter comprises an inner tube of polyamide externally tapered about the distal end and jacketed by a urethane material. The urethane material is internally tapered to match the externally tapered inner tube and extends beyond the distal end of the inner tube to form a flexible tip. Although well suited as an angiographic catheter to withstand high burst pressures of injected contrast medium, the thickness of the catheter walls severely limits the use of this catheter as a guiding catheter through which an angioplasty balloon catheter is commonly inserted. The lumen of a guiding catheter must be as large as possible with a correspondingly thin catheter wall that can be pushed and guided through tortuous coronary vessels without causing trauma thereto. One guiding catheter includes a wire-braided Teflon material inner tube with a polyurethane jacket, epoxied thereto that abruptly terminates near the distal end of the inner tube. A metal radiopaque marker and a soft polyurethane tip are positioned around the distal end of the Teflon material inner tube and abut the abrupt, step-like shoulder at the distal end of the polyurethane jacket. The polyurethane tip is thermally bonded to the polyurethane jacket. A problem with this design is that the contact surface area between the abrupt, step-like shoulder of the polyurethane jacket and the proximal end of the polyurethane tip is limited, thereby significantly increasing the likelihood that the tip will be dislodged or separated from the step-like shoulder of the jacket. The metal radiopaque marker positioned between the jacket and tip further reduces the contact surface area therebetween and increases the likelihood of jacket and tip separation. Such a guiding catheter is known from EP-A-0 303 487. According to the present invention, there is provided a guide catheter as defined in claim 1. A guide catheter according to the preamble is known from EP-A-0 273 618. The provision of the matching tapers advantageously increases the bonding area and minimizes the likelihood of separation therebetween. Furthermore, the tapers provide a gradual change in durometer between the soft tip and main tubular portion. The main tubular portion includes a layered wall between its outer surface and inner passageway surface extending longitudinally therein. The wall has a composite durometer and advantageously includes an inner material layer for lubricous insertion of other catheters therethrough and an outer material layer for increasing the compression strength and pushability of the catheter through coronary vessels. The outer layer extends the entire length of the external taper, whereas the inner layer longitudinally extends towards the taper but stops short thereof, or can extend partially along the external taper to strengthen the bond between the tapers. In either case the body portion on one surface of the taper is homogeneous with or without homogeneously dispersed material therein. The tubular tip comprises material having a durometer softer than the durometer of the main tubular portion for minimizing trauma to vessel walls. The proximal end of the tubular tip includes the internal taper that is bonded to the external taper of the main tubular portion. Furthermore, the soft, tubular tip cooperates with the harder durometer main portion by readily bending in tortuous vessels when pushed therethrough. The wall of the main portion further includes a reinforcing braid for enhancing the torquability of the catheter and for minimizing kinking of the catheter when flexed. The braid also extends partially into the tapered section of the main portion to further strengthen the bond between the main portion and soft tip. The combination of the inner and outer layers with the braid embedded therein or therebetween also reduces the thickness of the wall to within a range of 0.015 to 0.039cms (0.006" to 0.0155") depending on the outside diameter of the catheter. The inner layer of the wall comprises preferably polytetrafluoroethylene having an approximately 50 to 65 hardness durometer on the Shore D scale. This lubricous inner layer material also prevents the braid from extending into the passageway and presenting a rippled surface on which a passing catheter may undesirably engage. The outer layer of the wall preferably comprises polyether block amide including by weight 10 to 30 percent radiopaque bismuth, which is softer in durometer than the composite durometer of the catheter as well as that of the inner wall material. The soft, tubular tip comprises another polyether block amide that is softer in durometer than the outer wall material and advantageously includes by weight 35 to 65 percent tungsten for increasing the radiopacity of the soft tip. The material of the tip and the main body can be of the same material if required, except for the radiopacity material which is preferably included. The soft tip is also of homogeneous material, but may have homogeneously dispersed material homogeneously dispersed therein. The word "homogeneous" does not include a material with another tube or braiding. In particular, the illustrative 8 French guiding catheter has a uniform outside diameter of approximately 0.26cms (0.103"), a uniform inside diameter of approximately 0.2cms (0.082"), and a wall thickness of nominally 0.0267cms (0.0105") for inserting the largest possible angioplasty balloon catheter therethrough. The tubular tip has an internal taper extending longitudinally in a range of 2 to 3mms with the inner layer of the main portion extending partially therealong in a range of 1 to 2 mms. Brief description of the drawing FIG.1 depicts a partially cross-sectioned view of a guiding catheter; and FIG.2 depicts a partially cross-sectioned view of the wall of the catheter. FIG.1 depicts a partially cross-sectioned view of illustrative soft tip guiding catheter 10 having main tubular portion 11 and soft tubular tip 12 with thermal bond 15 interconnecting mated external and internal tapers 13 and 14, respectively. The inner and outer diameters of the main portion are uniform and match those of the soft tip for inserting the largest possible angioplasty balloon catheter therethrough and providing a uniform outer catheter surface for ready insertion through a coronary vessel. Multilayered catheter wall 21 of the main portion includes lubricous inner layer 25 and compression resistant outer layer 27. Reinforcing braid 26 is positioned around inner layer 25 for making the thin catheter wall torquable and minimizing kinking when directing the catheter through tortuous coronary vessels. The composite durometer such as 48 on the Shore D scale of the main portion is hard so as to advance the catheter to the coronary vessels. The soft durometer tip minimizes vessel wall trauma. The tapers 13,14 increase the strength of thermal bond 15 to prevent separation from the main portion and also provide a gradual change in the durometer of the catheter between the main portion and tubular tip. The soft tip includes proximal end 22 with internal taper 14, distal end 23, and passageway 24 extending longitudinally therethrough. Wall 33 of the tubular tip extends between inner passageway surface 31 and outer surface 32. The soft tip preferably comprises a soft durometer polyether block amide material such as nylon with a durometer of approximately 75 on the Shore A scale and having by weight in a range of 35 to 65 percent tungsten. The tungsten significantly increases the radiopacity of the soft tip. Preferably, soft tip 12 is a 2cms length of 7.8 French nylon material tube including by weight 50 percent nylon and 50 percent tungsten. Internal taper 14 extends longitudinally approximately 2 to 3mms about distal end 23. Distal end 23 is rounded inside and out for presenting an atraumatic end surface. Thermal bond 15 between external and internal tapers 13 and 14 is formed using any one of a number of alternative techniques. The main portion includes proximal end 16, distal end 17 with external taper 13, and passageway 18 extending longitudinally therethrough communicating with passageway 24 of the soft tip. Wall 21 extends between inner passageway surface 19 and outer surface 20, having respective diameters approximating the diameters 31 and 32 of the soft tip. As a result, the guiding catheter has a smooth, uniform outer surface for ready and atraumatic insertion through coronary vessels and a smooth, uniform inner passageway surface for introducing the largest possible angioplasty balloon catheter therethrough. Guiding catheter 10 preferably has a uniform 8 French outside diameter of approximately 0.262cms (0.103"), a uniform inside diameter of approximately 0.2cms (0.082"),and a wall nominally 0.0267cms (0.0105") in thickness. Well-known connector cap 28 and winged flange 29 are fixedly attached about proximal end 16 of the main portion by a commercially available, medical grade adhesive, such as Loctite No.401, for providing a handle to manipulate the catheter. FIG.2 depicts a partially cross-sectioned view of main portion wall 21 and soft tip wall 33. Soft tip wall comprises 50 percent polyether block amide for atraumatic insertion and 50 percent tungsten, shown as particles 34, for radiopacity. Main portion wall 21 includes inner layer 25, reinforcing braid 26, and outer layer 27. Inner layer 25 comprises a lubricous material such as polytetrafluoroethylene having a approximately 50 to 65 durometer on the Shore D scale for providing a slick inner passageway surface. To increase the strength of thermal bond 15, the inner layer longitudinally extends partially along external taper 13, which is approximately 2 to 3mms in length, for approximately 1 to 2mms. In the preferred embodiment, inner layer 25 comprises a 130cms length of 6.7 French polytetrafluoroethylene tube. The main portion wall further includes reinforcing braid 26 of, for example, stainless steel wire, for enhancing the torquability and kink resistance of the catheter. The braid also longitudinally extends partially along the external taper for further strengthening the bond thereat. In the preferred embodiment, braid 26 is 175cms long with an outside diameter of 0.198cms (0.078") and having a pic of 50 formed of 0.0066cms (0.0026") and 0.0076cms (0.003") diameter Series 304 stainless steel wire. Inner layer 25 prevents the braid from rippling inner passageway surface 19 and undesirably engaging another catheter being passed therethrough. The main portion wall further comprises outer layer 27 longitudinally extending the entire length of the external taper. The outer layer preferably also comprises a polyether block amide such as nylon for increasing the compression strength and pushability of the catheter and includes by weight in a range of 10 to 30 percent bismuth, shown by particles 35, for radiopacity. The polyether block amide material of the outer layer is softer in durometer than the composite durometer of the catheter as well as that of the inner layer. In particular, outer layer 27 is a 130cms length of 9 French nylon material tube comprising by weight approximately 90 percent nylon with a durometer of approximately 60.7 on the Shore D scale and 10 percent bismuth. The combination of the inner and outer layers with the braid positioned therebetween comprises a wall thickness in a range of 0.015 to 0.039cms (0.006" to 0.0155") depending on the outside diameter of the catheter and has a composite durometer of approximately 48 on the Shore D scale. Multilayered wall 21 is thermally bonded using any of a number of well-known techniques. It is to be understood that the above-described soft tip guiding catheter is merely an illustrative embodiment of the invention. It is contemplated that various other materials of comparable durometers may be utilized for the inner or outer layers, reinforcing braid, or soft tip. In summary, the combination of material layers in the main portion of the guiding catheter provides a thin wall with pushabilty, torquability, and kink resistance. The soft tip thermally bonded to the main portion by respective tapers presents a soft, atraumatic surface to delicate coronary vessels.

Claims: A soft tip guiding catheter (10) comprising a main tubular portion (11) of main body portion material; a tubular tip (12) of relatively soft material forming a longitudinal passageway with the main portion; and first and second cooperating tapered bonding surfaces (13, 14) at the proximal end of the soft tip and the distal end of the main portion respectively, characterised in that each tapered surface extends between the inner and outer surfaces of the said passageway; in that the soft tip forming the said first tapered surface is entirely of homogeneous material; and in that reinforcement means for the main body portion does not extend to the second tapered surface whereby the latter is formed entirely of homogeneous material including said main body portion material. A catheter according to claim 1, characterised in that the reinforcement comprises a tube (25) lining the interior of the main tubular portion, said tube extending along the main portion to the region of the second tapered surface. A catheter according to claim 2, characterised in that the reinforcement further comprises braiding material (26) located either between the said tube and the main body material or within the latter, said braiding material optionally being stainless steel wire. A catheter according to claim 1,2 or 3, characterised in that the tapered surfaces have been bonded by heat. A catheter according to any one preceding claim, characterised in that the said tube is of polytetrafluoroethylene, and/or the main body material is a polyether block amide, and/or the soft tip is of polyether block amide. A catheter according to claim 5, characterised in that the durometer of the first mentioned amide is greater than that of the second mentioned amide. A catheter according to any one preceding claim, characterised in that the main body material comprises bismuth dispersed therein and preferably in the range of 10 to 30%, and in that the material of the soft tip further comprises tungsten, and preferably in the range of 35 to 65%. A catheter according to any one preceding claim, characterised in that the wall has a thickness in the range of 0.015 to 0.039cms (0.006" to 0.0155"). A catheter according to any one preceding claim, characterised in that the taper extends longitudinally in a range of 2 to 3mms. A catheter according to claim 2, or to any claim as appendant thereto, characterised in that said inner material layer longitudinally extends approximately in a range of 1 to 2mms along the taper.

Inventors: PARKER FRED T, PARKER, FRED T.
Applicants: COOK INC, COOK INCORPORATED
Application year: 1992
Main classification: A61M25
IPC codes: A61M25, A61M39