CA2297122A1 - Stationary central tunnel dialysis catheter with optional separable sheath - Google Patents
Stationary central tunnel dialysis catheter with optional separable sheath Download PDFInfo
- Publication number
- CA2297122A1 CA2297122A1 CA002297122A CA2297122A CA2297122A1 CA 2297122 A1 CA2297122 A1 CA 2297122A1 CA 002297122 A CA002297122 A CA 002297122A CA 2297122 A CA2297122 A CA 2297122A CA 2297122 A1 CA2297122 A1 CA 2297122A1
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- Prior art keywords
- tubular member
- catheter
- sheath
- predetermined
- further characterized
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0041—Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
- A61M2025/0031—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
Abstract
A stationary central tunnel dialysis catheter includes a planar axially elongated sinuous tubular member having a plurality of axially extending lumens formed therein with at least two of said lumens each having at least one aperture for through passage of fluid during dialysis with said apertures being axially displaced from one another along said tubular member.
Description
WO 99/04844 PCTlUS98/14756 WITH OPTIONAL SEPARABLE SHEATH
Field of the Invention This invention relates to an implantable surgical device and method of delivery. More specifically, this invention provides a multiple lumen catheter and separable sheath for delivering the catheter to the arteriovenous system in order to perform hemodialysis.
Background of the Invention and Description of the Prior Art Multiple lumen catheters which are surgically implanted into the body and used for dialysis are known, being disclosed in U.S. patents 5,405,320 and 5,509,897 to Twardowski et al. and 5,509,900 to Kirkman.
The multiple lumen catheters disclosed in '320 and '897 are three dimensional in form, specifically calling for catheter portions which are substantially perpendicular to remaining, planar portions. Such multiple lumen catheters have been promoted as being allegedly permanent devices providing access to a patient arteriovenous system for hemodialysis but have proven to have significant disadvantages. The three dimensional character of these catheters inherently serves to stress the vessels of the arteriovenous system in which the catheter resides, thereby shortening useful life of the catheter.
The catheter disclosed in '900 is intended and designed to be retained at a specific spot within a blood vessel by an anchoring tip which serves to retain the catheter with respect to the wall of the blood vessel. The anchoring tip, by fixing the catheter in place and not permitting relative movement of the vessel vis-a-vis the catheter, creates a potential for rupture of the vessel or for collection of thrombolytic material about the positioning means, both of which are undesirable.
With the increasing use of dialysis therapy and ever increasing expected lives of dialysis patients, the need exists for a permanent dialysis catheter which can be surgically implanted within the patient's blood vessels, and causing minimum trauma to the patient on a continuing basis. The need further exists for such a catheter which minimizes the possible collection of thrombolytic material at the inlet and outlet orifices of the catheter while keeping the inlet and outlet orifices remote from the wall of the vessel in which the catheter resides, thereby promoting high flow hemodialysis with relatively low fluid pressures, resulting in minimal patient connection time to the dialysis machine, longer catheter useful life and reduced possibility of catheter dysfunction as a result of malpositioning.
Surgical cannulas or "sheaths" are typically utilized by medical personnel to establish transcutaneous access channels from a first percutaneous location to a second subcutaneous location. The access channel provides a conduit for the delivery of pharmaceutical products, removal of subcutaneous sample tissue and fluid, as well as the coaxial passage of instrumentation such as catheters and the like.
In surgical procedures which require only temporary use of a sheath conduit, "peel-away" style sheaths are utilized. The peel-away sheath has lines of weakness extending about opposing sides of its longitudinal length such that removal of the sheath can be accomplished by applying a separating force or "peeling" the wall sections downwardly from the transcutaneous end by way of integral pull tabs located thereon, to cause a linear tearing of the sheath material causing the "peeling" or failure of the material. In this way, the sheath can be removed from the patient without removing the instruments positioned within the sheath channel.
However, application of the peeling force to the sheath wall sections tends to aggravate and/or enlarge the incision in the region of the sheath as force is applied downwardly into the incision.
Stressing of the incision is particularly problematic in irregularly manufactured sheaths having uneven wall thickness along the lines of weakness. The wall thickness may also cause kinking when attempting to insert a product or device through its thin walls.
Moreover, the peeling force tends to lift instruments within the sheath pathway upwardly from the patient.
Summary of the Invention In one of its aspects, this invention provides a stationary central tunnel dialysis catheter including a planar axially elongated sinuous tabular member having a plurality of axially extending lumens formed therein.
At least a part of the tubular member may be of predetermined two-dimensional, generally M-shape in order to substantially match the human left side venous anatomy. The M-shape includes portions of relative straightness connected by curved portions and is adapted to fit in a preselected body lumen in the anatomical region of interest. The M-shaped part of the tubular member is preferably deformable, resiliently returning to the predetermined two-dimensional M-shaped after deformative surgical implantation in the patient by way of a separable sheath delivery system. The M-shape part of the tubular' member preferably has at least two lumens, with each having at least one aperture separated from the other but proximate the extremity of a leg of the M for through passage of fluid during dialysis; the apertures are axially displaced one from another. In the M-shape configuration of the catheter, there are preferably at least four portions of relative straightness.
In yet another of its aspects, this invention provides a stationary central tunnel dialysis catheter WO 99/04844 PCT/US98/14~56 including a planar axially elongated sinuous tubular member having a plurality of axially extending lumens formed therein. At least a part of the tubular member preferably has a predetermined two-dimensional shape substantially matching an anatomical central tunnel region of interest and preferably includes at least two portions of relative straightness connected by a curved portions, fitting a preselected body lumen in the anatomical region of interest. The tubular member is preferably deformable, resiliently returning to its predetermined two-dimensional shape after deformative surgical implantation in the patient.
In the part of the tubular member having predetermined shape, at least two of the lumens each have at least one aperture for through passage of fluid during dialysis with the apertures being axially displaced one from another along the tubular member.
The catheter may further optionally but preferably include a flexible sheath complementally surrounding at least the part of the tubular member having predetermined two-dimensional shape to facilitate delivery and aseptic protection thereof with the sheath being removable therefrom in situ when the tubular member has been positioned within the preselected lumen.
When the flexible sheath is included as a part of the catheter, ripcord means preferably extends along the length of the tubular member for rupturing the sheath in the vicinity of an axial extremity of the tubular member proximate the apertures. The ripcord means extends in response to preferably manual force preferably applied to a portion of the ripcord extending from a body of the patient in whom the catheter has been implanted: The ripcord may be embedded in the tubular wall or may be inside the sheath or may be imbedded in the sheath.
This invention additionally provides a separable surgical sheath wherein the sheath is removed from the transcutaneous location and readily separated from the catheter positioned therein by percutaneously initiating separation of a length of the conduit from a first conduit wall location to a second conduit wall location. This allows for remote sheath removal and for the catheter to be delivered along with the sheath as a package, facilitating passage of the device into the patient's arteriovenous system for hemodialysis.
The sheath in accordance with the invention includes a conduit preferably having distal and proximate ends and a line of weakness extending about the longitudinal length of the conduit. The line of weakness is ruptured by a separation control. The conduit has a pre-formed line of weakness traversing its longitudinal length. The device preferably utilizes an embedded suture to define the line of weakness which is ruptured by the application of force to a free end of the embedded suture or ripcord. The tip of the embedded portion of the sheath may employ a stress concentration area to initiate predetermined failure such that *rB
embedded suture rupture begins along a predetermined end of the conduit.
In a preferred embodiment the embedded suture defines the weakened section of the conduit wall such that pulling the suture away from the wall separates the conduit wall along the line of weakness. The suture is embedded from the proximal end of the conduit downwardly to the distal end with a free end of the suture preferably looping at the distal end upwardly to the proximal end. In this way separation control is simply the free end of the suture maintained at a percutaneous location i.e., the distal end of the conduit. Drawing the suture upwardly, away from distal end of the conduit causes the conduit, to rupture along the suture path such that the sheath may be removed from its transcutaneous position. Alternatively, the suture may be configured to rupture the conduit wall beginning with the proximate end and proceeding toward the distal end depending on orientation of the free end of the suture and application of force thereto.
In yet another of its aspects, this invention provides a stationary dialysis catheter including a planar axially elongated sinuous tubular member of integral construction having a plurality of axially extending lumens formed therein and a generally rounded smooth outer periphery. At least two of the lumens each have at least one aperture for through passage of fluid during dialysis with the apertures being axially displaced one from another along the tubular member yet proximate one end of the tubular member. The tubular member preferably has predetermined two-dimensional shape substantially matching an anatomical central tunnel of interest and includes at least two portions of relative straightness connected by a curved portion region, to fit the preselected body lumen in the anatomical region of interest. The tubular member is preferably deformable, resiliently returning to the predetermined two-dimensional shape after deformation, i.e. implantation using the separable sheath, and includes means for separating the tubular member aperture remote from the end of the tubular member from the surrounding wall of the preselected body lumen when the catheter is in place therewithin while permitting axial movement of the tubular member within the lumen relative to the lumen wall.
The tubular member preferably has a generally oval cross-section. The oval periphery is preferably formed by a pair of parallel sides connected by opposed semi-circular arcs.
The vessel wall separating means preferably is an enlarged portion extending outwardly beyond one of the arc segments or outwardly beyond one of the parallel sides or both. The vessel wall separating means is preferably resiliently deformable, for example to within the periphery of the tubular member. The inlet and outlet apertures of the tubular member may face axially _g_ or radially or both.
In yet another of its aspects, the invention provides a stationary dialysis catheter including a tubular member of the type described above where the tubular member has wall thickness greater in the area of its curved portions than in the area of its straight portions to assist kinking. The tubular wall member thickness may be greater at an outer part of the curved portion than at a corresponding inner part of the curved portion.
Additional benefits and advantages of this invention will become apparent to those skilled in the art upon a reading and understanding of the following detailed specification and related~drawings.
Brief Description of the Drawings Figure 1 is a schematic view illustrating a catheter embodying aspects of the invention in position in the right venous cavity of a human body.
Figure 2 is a schematic view illustrating the planar nature of the catheter embodying aspects of the invention as illustrated in Figure 1.
Figure 3 is a schematic view illustrating the planar nature of a catheter embodying aspects of the invention and being formed in a generally M-shaped to fit in the left venous cavity of the body.
Figure 4 is a broken view of a tubular member forming a portion of a catheter embodying aspects of the *rB
invention.
Figure 5 is a sectional view taken at arrows 5-5 in Figure 4.
Figure 6 is a sectional view taken at arrow 6-6 in Figure 4.
Figure 7 is an enlarged view of the in situ enlarged end of a sinuous tubular member forming a part of a catheter embodying aspects of the invention.
Figure 8 is a schematic view illustrating a catheter embodying aspects of the invention in position in the left venous cavity of a human body.
Figure 9 is a view similar to Figure 8 but illustrating a different enlarged tip configuration at the in situ end of the tubular member.
Figure 10 is a view similar to Figure 7 but illustrating a different configuration of the enlarged tubular tip member in situ.
Figure 11 is a view similar to Figure 7 but illustrating yet a still different configuration of the tubular member enlarged in situ.
Figure 12 is a partially sectioned side elevation of a tip extremity of a tubular member part of a catheter embodying aspects of the invention.
Figure 13 is a side elevation of the structure illustrated in Figure 12 showing the vessel separating means in a deformed condition.
Figure 14 is a top view of the structure illustrated in Figure 12.
Figure 15 is a side elevation of the structure illustrated in Figure 12.
Figure 16 is a side elevation of a second embodiment of a tip with vessel separating means at an extremity of the tubular member forming a part of the catheter of the invention.
Figure 17 is an end view of the structure illustrated in Figure 16.
Figure 18 is a top view of the structure illustrated in Figure 16.
Figure 19 is a top view of the structure illustrated in Figure 16 with the vessel separating means in a deformed, compressed condition.
Figure 20 is a side elevation of a third embodiment of a tip with vessel separating means at an extremity of the tubular member forming a part of the catheter of the invention.
Figure 21 is an end view of the structure illustrated in Figure 20.
Figure 22 is a view similar to Figure 20 but showing the vessel separation means in a deformed condition.
Figure 23 is a top view of the structure illustrated in Figures 20 and 22.
Figure 24 is a partially sectioned view of the tip portion of the tubular means part of a catheter embodying the invention packaged in a peelaway sheath together with a protective nose cone and in position on a wire for unitary delivery and implantation into a patient.
Figure 25 is a view of the structure illustrated in Figure 24 showing the peelaway nature of the sheath.
Figure 26 is a view of a variation of the structure illustrated in Figure 24 showing the sheath peeling from the opposite end.
Figure 27 is a sectional view of the catheter and sheath taken at lines and arrows 27-27 in Figure 25.
Figure 28 is an end view of the catheter and sheath shown in Figure 26.
Figure 29 shows a separable surgical sheath.
Figure 30 is a sectional view of the sheath.
Figure 31 shows the sheath of Figure 29 with its proximal end separated by the embedded suture.
Figure 32 shows a side section of the sheath conduit tube and embedded suture configured to rupture from the distal to proximate end as show in Figure 31.
Figure 33 shows a side section of the sheath conduit tube and embedded suture configured to rupture from the proximate end to the distal end.
Description of the preferred Embodiments A stationary central tunnel dialysis catheter in accordance with.the invention is illustrated in Figures 1, 8 and 9 positioned in the thoracic cavity of the body where the catheter is designated generally 10. Figure 1 illustrates the catheter in position on the right side of the body; Figures 8 and 9 depict a catheter implanted in the left side of the body.
Catheter 10 is formed as a planar axially elongated sinuous tubular member of integral construction. The tubular member is designated generally 16 and has a plurality of axially extending lumens formed therein and a generally rounded, smooth outer periphery. The preferred configuration of tubular member 16 is illustrated in cross-section in Figures 5 and 6 where the rounded, smooth exterior of tubular member 16 is apparent.
Tubular member 16 includes at least one intake lumen for inflow of blood out of the patient to a dialysis apparatus and a discharge lumen where discharge of blood which has been dialyzed back into the patient.
The discharge lumen is designated generally 15 in the drawing; the intake lumen is designated generally 20.
The planar catheter 10, whether installed in the left portion of the body or the right-hand portion of the body, is depicted in Figures 2 and 3 where planes have been depicted in dotted lines with the catheter 10 resident within the plane, to illustrate such planar character. Figure 2 illustrates the catheter when configured for the right side; Figure 3 illustrates the catheter when configured for the left side. In either case tubular member 16 of catheter 10 has a predetermined two-dimensional shape substantially matching an anatomical central tunnel region of interest. From Figures 2 and 3, it may be seen that in both instances catheter 10 includes at least two portions of relative straightness which are connected by a curved region; the shapes illustrated fit preselected body lumens in the anatomical regions of interest.
Tubular member 16 of catheter is deformable and has a memory characteristic so that when deformed, tubular member 16 resiliently returns to the predetermined two-dimensional shape upon deformation. Hence, when the catheter is installed in the body, while the catheter may be deformed from the predetermined shape, once resident in the selected lumen of the body, the catheter returns to its predetermined shape due to the memory characteristic. With the catheter assuming the predetermined shape, this contributes to comfort for the patient and minimal trauma to the arteries in which the catheter resides.
As apparent from Figures 5 and 6, tubular member 16 preferably has a generally oval cross-section. The oval has a pair of parallel sides connected by opposed semi-circular arc segments. As apparent from Figures 4, 5 and 6, curved portions of tubular member 16, which curved portions are denoted generally 36, have greater wall thickness, as illustrated in Figure 5, then straight portions of tubular member 16 as designated generally 38.
As apparent from Figures 3, 8 and 9, when catheter is the left side of thoracic cavity 12, catheter 10 assumes a generally M-shape as indicated 24 in Figure 3 where straight lines have been drawn as extensions of the straight line portions of catheter to to emphasize 5 the M-shape when catheter 10 is installed on the left side of the body. The interior angles of the M-shape indicated as 100 and 102 in Figure 3 can desirably vary from about 45° to as great as 120°; angles in the neighborhood of 45° to 60° are most common and are 10 preferred.
In any of its embodiments catheter 10 includes means for separating the inlet aperture for intake lumen from the wall 34 of a surrounding vessel in which catheter 10 is installed.
15 Figures 7, 10, ll.and 14 through 23 depict various embodiments of the means for separating tubular member aperture 20 from the vessel wall 34. In Figures 7, 10 and 11 through 23, the outlet aperture of discharge lumen 15 is designated 25 while the inlet aperture of 20 intake lumen 20 is designated 35.
In the embodiment illustrated in Figure 7, means for separating inlet aperture 35 from vessel wall 34 are provided in part by a step 102 formed transversely to the axis of elongation of tubular member 16 where intake aperture 35 sits within step 102 and faces axially. In the embodiment illustrated in Figure 7 means for separating tubular member aperture 35 from wall 34 is further provided by a circumferentially spaced collection of petal-like enlargement structures 104 which are connected about a central collar 106 and fixed about tubular member 16. Petals 104 extend somewhat radially outwardly respecting collar 106 and may contact the cylindrical interior of wall 34 thereby to separate wall 34 from intake aperture 35. Petals 104 are preferably unitarily formed of plastic together with collar 106 and are resiliently biased outwardly respecting the axis of tubular member 16 so that the radially outer extremities of petals 104 are well outboard of intake aperture 35. Two intake apertures 35 are provided in the embodiment illustrated in Figure 7.
In the embodiment illustrated in Figure 10 two intake apertures 35 are provided. The embodiment of Figure 10, like the embodiment of Figure 7, utilizes a step construction with step 102 extending transversely respecting the longitudinal axis of tubular member 16 and one of intake apertures 35 formed in step 102. A
second intake aperture 35 is formed in the cylindrical outwardly facing surface of tubular member 16. In the embodiment illustrated in Figure 10, the means for separating inlet aperture 35 from vessel wall 34 is further provided by a collection of elongated leaf members 108 which extend between two collars 106 and are formed of generally flattened, broad strands of plastic with leaf members 108 having effective width, measured transversely respecting vessel 32 to define a circumferential outer extremity of tubular member 16 WO 99104844 PCT/tJS98/1475G
which is outboard of immediately adjacent inlet orifice 35. Hence, vessel wall 34 would first contact a lateral portion of leaf member 108 and not clog or cover aperture 35.
Figure 11 illustrates a variation of the structure shown in Figure 10 where leaf members 108 have been radially outwardly bowed to provide even greater separation of vessel wall from aperture 35 which adjacent to one of the two enlargement collars 106 between which leaf members 108 extend.
In Figure 12 means 30 for separating tubular member intake aperture 35 from vessel wall 34 is provided by a cantilever finger member 110 which extends somewhat radially outwardly from a central portion of tubular 15 member 16 and longitudinally along tubular member 16 to overly aperture 35. Cantilever finger member 110 is resiliently deformable so that upon force applied to finger member 110 in the direction indicated generally by arrow F in Figure 12, finger member 110 deforms 20 downwardly considering Figure 12 to the position illustrated in Figure 13, thereby covering inlet aperture 35 and presenting the intake of debris thereby.
When such force is relieved, cantilever finger member 110 resiliently returns to its position illustrated in Figure 12 thereby opening aperture 35 yet preventing aperture 35 from encountering wall 34 of vessel 32 within which tubular member 16 is resident.
Preferably a pair of cantilever finger members 110 is provided as is apparent from Figures 14 and 15.
Optionally, apertures 112 may be provided in finger members 110 to provide maximum access of fluid flow within vessel 32 to intake aperture 35.
In Figure 16 means for separating tubular member 20 intake aperture 35 from vessel wall 34 is provided by a pair of outwardly biased flaps 114 which are preferably integrally formed from tubular member 16. Flaps 114 serving as the separating means extend outwardly beyond respective parallel sides of tubular member 16 and are resiliently deformable to within the periphery of tubular member 16 in response to force in such direction. The flap members extending radially outwardly beyond the periphery of the catheter is apparent from Figure 18 with the flap members being resiliently deformed within the periphery of the tubular member as apparent from Figure 19. In the position illustrated in Figure 18, the flap members maintain tubular member 20 inlet aperture 35 spaced from vessel wall 34. In every embodiment of the tip members particularly means for separating the tubular member 20 intake aperture 35 from vessel wall 34, tubular member 16 and tip portion thereof is free to move longitudinally within vessel 32. The separating means 30, no matter what their configuration, do not fix tubular member vis-a-vis the vessel in which the tubular member resides. This prevents trauma and stress to the vessel wall and reduces the possibility of build-up of thrombolytic material in the vicinity of inlet aperture 35.
The preferred cross-sectional configuration of tubular member 16 is illustrated in Figures 5 and 6 where the periphery of tubular member 16 includes a pair of parallel side segments each designated 44 connected by a pair of semi-circular arc segments each designated 46. An internal web 48 separates intake lumen 20 from discharge lumen 15.
In the embodiments illustrated in Figures 12 through 23 tubular member 16 includes a rounded distal end 22 in addition to a rounded lateral outer periphery 18 defined by the two arc segments 46 and connecting parallel segments 44.
Figures 20 through 23 depict another embodiment of means for separating tubular member 20 intake aperture 35 from vessel wall 34 which is similar to the structure illustrated in Figures 12 through 15. In Figures 20 through 23 a cantilever finger member 110A extends somewhat radially outwardly from the remaining portion of tubular member 16 and axially longitudinally with respect to intake aperture 35. In the embodiment illustrated in Figures 20 through 23, upon a resilient deformation of cantilever finger member ilOA, that member deforms against a remaining axially elongated portion of tubular member l6, closing aperture 35 and preventing any influx thereinto of debris. This is not unlike the structure illustrated in Figures 12 through 15, where there are two cantilever finger members 110 which fold on either side of the remaining longitudinally extending portion 116 of tubular member 16. Similarly to the structure illustrated in Figures 12 through 15, the embodiment of Figures 20 through 23 may optionally include an auxiliary aperture 112 in cantilever finger member 110A to minimize resistance of flow to a lead aperture 35 of inflow lumen 20. In the embodiments illustrated all edges and external surfaces of tubular member 16 are rounded or flat; there are no sharp edges.
Figures 24 and 25 depict catheter 10 in accordance with the invention equipped with an optional peelaway sheath designated generally 66 together with a protective auxiliary nose cone 70 overlying the rounded distal end 22 of tubular member 16 within sheath 66. In Figure 24 catheter 10 overlying protective nose cone 70 and sheath 66 is depicted on a guide wire 72 in configuration to be implanted within a patient of interest. The wire 72 is similarly depicted in Figure 1. Sheath 66 together with protective nose cone 70 facilitate installation of the catheter l0 in a patient.
For such procedure, the surgeon initially inserts a wire 72 using a dilator into the patient. The catheter 10, having protective nose cone 70 in place thereover and sheath 66 encasing nose cone 70 and catheter 10 is then fed along guide wire 72 and positioned, preferably using x-ray or radiographic guidance, in the appropriate lumen in the human body. Once the catheter is in the appropriate position, a ripcord 68 may be pulled, thereby causing sheath 66 to rent, permitting sheath 66 to be withdrawn from the patient and leaving catheter 10 in place. Protective nose cone 70 is configured to fit over distal end of catheter 10 and particularly to fit over the distal end configuration chosen for the particular catheter application.
The sheath aspect of the invention provides a surgical apparatus capable of transcutaneously traversing from a first percutaneous location to a second subcutaneous location.
The separable sheath preferably includes an embedded suture adjusted to separate opposing wall sections along a longitudinal suture path formed in the sheath material such that the sheath may be split along the line by removing the suture and removed from the transcutaneous channel subsequent to the passage of a desired device.
Referring to Figures 29 through 33, the separable sheath is generally designated 66. The separable sheath preferably includes a cylindrical conduit 120 having a distal end 140 and proximal end 160, a longitudinal line of weakness 300 and flange portions 180 and 220 formed about proximal end 160 of conduit 120. Flange portions 180 and 220 maintain the percutaneous position of proximal end 160. Flange tabs 180 and 220 position sheath 66 in the transcutaneous pathway such that the sheath does not advance into tissue too deeply. A line of weakness 300 runs along the length of conduit 120 such that upon separating conduit wall flange tabs 220 and 180 separate along line 300.
The separable sheath includes an interior axially lumen extending from distal end 140 to proximal end 160. The distal end 140 accesses a subcutaneous location; proximal end 160 is positioned at a percutaneous location.
The sheath is desirably transcutaneously positioned to provide access for surgical apparatus such as catheter 10 to a subcutaneous location. Typically, the sheath is introduced through a transcutaneous access channel provided by an incision or needle path and advanced over a guide wire 72 to the subcutaneous site of interest by threading the guide wire through nose cone 70 by way of cone tip aperture 420. The cone shaped tip of conduit 120 dilates the transcutaneous pathway as it is advanced therethrough.
The elongated portion of sheath 66 is cylindrical and preferably formed of thin plastic such as polyethylene, fluorinated ethylene-propylene or like plastic materials employed in medical applications. In the embodiments shown in Figures 29 through 33, a suture 350 is preferably embedded along the longitudinal length of the conduit wall defining a line of weakness 300 along the length of conduit 120 portion of sheath 66.
Pulling a free end or "ripcord" 68 of the suture 350 away from the wall separates the conduit wall along the line of weakness 300. In this way, the conduit 120 may be split to facilitate retrieval of the conduit 120 portion of the sheath from the transcutaneous pathway.
The embedded suture 350 may be formed within conduit 120 to provide a stress concentration area on either the distal or proximate end to facilitate rupture of conduit 120 in a predetermined direction.
In the embodiment shown in Figures 32 and 33, the embedded suture 350 defines a weakened section of the conduit wall such that pulling the suture away from the wall separates the conduit wall along the line of weakness. As shown in Figure 32, the suture 350 is preferably embedded from proximal end 160 of the conduit 120 downwardly to distal end 140 of the conduit 120, with a free end of the suture 68 preferably looping at and around distal end 140 upwardly, and back towards the proximal 160. In this way, separation is effectuated using the free end of suture 68 which is maintained at a percutaneous location i.e., distal end 140 of conduit 120. Drawing ripcord 68 upwardly, away from distal end 140 as denoted by arrow "A", causes conduit 12 to rupture along the longitudinal suture path in the direction indicated by arrow "SP" from distal to proximate direction such that the sheath 66 may be removed from its transcutaneous position as illustrated in Figure 32.
Alternatively, suture 350 may be configured to rupture the conduit wall beginning with proximate end 160 and proceeding toward distal end 140 as shown in Figure 33, depending on the position of suture free end 68. As shown in Figure 33, suture 35 is embedded from proximal end 160 of conduit 120 downwardly to distal end 140, with a free end of suture 68 looping at proximate end 160 downwardly through lumen 260 to distal end 140 where it again loops upwardly to proximate end 160, extending along the outside surface of conduit 120. In this way, separation effectuated by the free end of suture 68 which extends upwardly though lumen 260 and is maintained at a percutaneous location, i.e. distal end 140 of the conduit. Drawing the suture upwardly, away from distal end 140, as indicated by arrow "B", causes conduit 120 to rupture along the suture path from proximate end 160 of conduit 120. Tn this embodiment, suture 350 ruptures from proximate to distal as denoted by the arrow "SP" such that the sheath 66 may be removed from its transcutaneous position.
Once the sheath is positioned in the transcutaneous pathway surrounding any associated instrumentation, the sheath is removed and the instruments) within deployed. The sheath is removed from the transcutaneous pathway by rupturing embedded suture 350 along the line of weakness defined by the embedded suture.
Field of the Invention This invention relates to an implantable surgical device and method of delivery. More specifically, this invention provides a multiple lumen catheter and separable sheath for delivering the catheter to the arteriovenous system in order to perform hemodialysis.
Background of the Invention and Description of the Prior Art Multiple lumen catheters which are surgically implanted into the body and used for dialysis are known, being disclosed in U.S. patents 5,405,320 and 5,509,897 to Twardowski et al. and 5,509,900 to Kirkman.
The multiple lumen catheters disclosed in '320 and '897 are three dimensional in form, specifically calling for catheter portions which are substantially perpendicular to remaining, planar portions. Such multiple lumen catheters have been promoted as being allegedly permanent devices providing access to a patient arteriovenous system for hemodialysis but have proven to have significant disadvantages. The three dimensional character of these catheters inherently serves to stress the vessels of the arteriovenous system in which the catheter resides, thereby shortening useful life of the catheter.
The catheter disclosed in '900 is intended and designed to be retained at a specific spot within a blood vessel by an anchoring tip which serves to retain the catheter with respect to the wall of the blood vessel. The anchoring tip, by fixing the catheter in place and not permitting relative movement of the vessel vis-a-vis the catheter, creates a potential for rupture of the vessel or for collection of thrombolytic material about the positioning means, both of which are undesirable.
With the increasing use of dialysis therapy and ever increasing expected lives of dialysis patients, the need exists for a permanent dialysis catheter which can be surgically implanted within the patient's blood vessels, and causing minimum trauma to the patient on a continuing basis. The need further exists for such a catheter which minimizes the possible collection of thrombolytic material at the inlet and outlet orifices of the catheter while keeping the inlet and outlet orifices remote from the wall of the vessel in which the catheter resides, thereby promoting high flow hemodialysis with relatively low fluid pressures, resulting in minimal patient connection time to the dialysis machine, longer catheter useful life and reduced possibility of catheter dysfunction as a result of malpositioning.
Surgical cannulas or "sheaths" are typically utilized by medical personnel to establish transcutaneous access channels from a first percutaneous location to a second subcutaneous location. The access channel provides a conduit for the delivery of pharmaceutical products, removal of subcutaneous sample tissue and fluid, as well as the coaxial passage of instrumentation such as catheters and the like.
In surgical procedures which require only temporary use of a sheath conduit, "peel-away" style sheaths are utilized. The peel-away sheath has lines of weakness extending about opposing sides of its longitudinal length such that removal of the sheath can be accomplished by applying a separating force or "peeling" the wall sections downwardly from the transcutaneous end by way of integral pull tabs located thereon, to cause a linear tearing of the sheath material causing the "peeling" or failure of the material. In this way, the sheath can be removed from the patient without removing the instruments positioned within the sheath channel.
However, application of the peeling force to the sheath wall sections tends to aggravate and/or enlarge the incision in the region of the sheath as force is applied downwardly into the incision.
Stressing of the incision is particularly problematic in irregularly manufactured sheaths having uneven wall thickness along the lines of weakness. The wall thickness may also cause kinking when attempting to insert a product or device through its thin walls.
Moreover, the peeling force tends to lift instruments within the sheath pathway upwardly from the patient.
Summary of the Invention In one of its aspects, this invention provides a stationary central tunnel dialysis catheter including a planar axially elongated sinuous tabular member having a plurality of axially extending lumens formed therein.
At least a part of the tubular member may be of predetermined two-dimensional, generally M-shape in order to substantially match the human left side venous anatomy. The M-shape includes portions of relative straightness connected by curved portions and is adapted to fit in a preselected body lumen in the anatomical region of interest. The M-shaped part of the tubular member is preferably deformable, resiliently returning to the predetermined two-dimensional M-shaped after deformative surgical implantation in the patient by way of a separable sheath delivery system. The M-shape part of the tubular' member preferably has at least two lumens, with each having at least one aperture separated from the other but proximate the extremity of a leg of the M for through passage of fluid during dialysis; the apertures are axially displaced one from another. In the M-shape configuration of the catheter, there are preferably at least four portions of relative straightness.
In yet another of its aspects, this invention provides a stationary central tunnel dialysis catheter WO 99/04844 PCT/US98/14~56 including a planar axially elongated sinuous tubular member having a plurality of axially extending lumens formed therein. At least a part of the tubular member preferably has a predetermined two-dimensional shape substantially matching an anatomical central tunnel region of interest and preferably includes at least two portions of relative straightness connected by a curved portions, fitting a preselected body lumen in the anatomical region of interest. The tubular member is preferably deformable, resiliently returning to its predetermined two-dimensional shape after deformative surgical implantation in the patient.
In the part of the tubular member having predetermined shape, at least two of the lumens each have at least one aperture for through passage of fluid during dialysis with the apertures being axially displaced one from another along the tubular member.
The catheter may further optionally but preferably include a flexible sheath complementally surrounding at least the part of the tubular member having predetermined two-dimensional shape to facilitate delivery and aseptic protection thereof with the sheath being removable therefrom in situ when the tubular member has been positioned within the preselected lumen.
When the flexible sheath is included as a part of the catheter, ripcord means preferably extends along the length of the tubular member for rupturing the sheath in the vicinity of an axial extremity of the tubular member proximate the apertures. The ripcord means extends in response to preferably manual force preferably applied to a portion of the ripcord extending from a body of the patient in whom the catheter has been implanted: The ripcord may be embedded in the tubular wall or may be inside the sheath or may be imbedded in the sheath.
This invention additionally provides a separable surgical sheath wherein the sheath is removed from the transcutaneous location and readily separated from the catheter positioned therein by percutaneously initiating separation of a length of the conduit from a first conduit wall location to a second conduit wall location. This allows for remote sheath removal and for the catheter to be delivered along with the sheath as a package, facilitating passage of the device into the patient's arteriovenous system for hemodialysis.
The sheath in accordance with the invention includes a conduit preferably having distal and proximate ends and a line of weakness extending about the longitudinal length of the conduit. The line of weakness is ruptured by a separation control. The conduit has a pre-formed line of weakness traversing its longitudinal length. The device preferably utilizes an embedded suture to define the line of weakness which is ruptured by the application of force to a free end of the embedded suture or ripcord. The tip of the embedded portion of the sheath may employ a stress concentration area to initiate predetermined failure such that *rB
embedded suture rupture begins along a predetermined end of the conduit.
In a preferred embodiment the embedded suture defines the weakened section of the conduit wall such that pulling the suture away from the wall separates the conduit wall along the line of weakness. The suture is embedded from the proximal end of the conduit downwardly to the distal end with a free end of the suture preferably looping at the distal end upwardly to the proximal end. In this way separation control is simply the free end of the suture maintained at a percutaneous location i.e., the distal end of the conduit. Drawing the suture upwardly, away from distal end of the conduit causes the conduit, to rupture along the suture path such that the sheath may be removed from its transcutaneous position. Alternatively, the suture may be configured to rupture the conduit wall beginning with the proximate end and proceeding toward the distal end depending on orientation of the free end of the suture and application of force thereto.
In yet another of its aspects, this invention provides a stationary dialysis catheter including a planar axially elongated sinuous tubular member of integral construction having a plurality of axially extending lumens formed therein and a generally rounded smooth outer periphery. At least two of the lumens each have at least one aperture for through passage of fluid during dialysis with the apertures being axially displaced one from another along the tubular member yet proximate one end of the tubular member. The tubular member preferably has predetermined two-dimensional shape substantially matching an anatomical central tunnel of interest and includes at least two portions of relative straightness connected by a curved portion region, to fit the preselected body lumen in the anatomical region of interest. The tubular member is preferably deformable, resiliently returning to the predetermined two-dimensional shape after deformation, i.e. implantation using the separable sheath, and includes means for separating the tubular member aperture remote from the end of the tubular member from the surrounding wall of the preselected body lumen when the catheter is in place therewithin while permitting axial movement of the tubular member within the lumen relative to the lumen wall.
The tubular member preferably has a generally oval cross-section. The oval periphery is preferably formed by a pair of parallel sides connected by opposed semi-circular arcs.
The vessel wall separating means preferably is an enlarged portion extending outwardly beyond one of the arc segments or outwardly beyond one of the parallel sides or both. The vessel wall separating means is preferably resiliently deformable, for example to within the periphery of the tubular member. The inlet and outlet apertures of the tubular member may face axially _g_ or radially or both.
In yet another of its aspects, the invention provides a stationary dialysis catheter including a tubular member of the type described above where the tubular member has wall thickness greater in the area of its curved portions than in the area of its straight portions to assist kinking. The tubular wall member thickness may be greater at an outer part of the curved portion than at a corresponding inner part of the curved portion.
Additional benefits and advantages of this invention will become apparent to those skilled in the art upon a reading and understanding of the following detailed specification and related~drawings.
Brief Description of the Drawings Figure 1 is a schematic view illustrating a catheter embodying aspects of the invention in position in the right venous cavity of a human body.
Figure 2 is a schematic view illustrating the planar nature of the catheter embodying aspects of the invention as illustrated in Figure 1.
Figure 3 is a schematic view illustrating the planar nature of a catheter embodying aspects of the invention and being formed in a generally M-shaped to fit in the left venous cavity of the body.
Figure 4 is a broken view of a tubular member forming a portion of a catheter embodying aspects of the *rB
invention.
Figure 5 is a sectional view taken at arrows 5-5 in Figure 4.
Figure 6 is a sectional view taken at arrow 6-6 in Figure 4.
Figure 7 is an enlarged view of the in situ enlarged end of a sinuous tubular member forming a part of a catheter embodying aspects of the invention.
Figure 8 is a schematic view illustrating a catheter embodying aspects of the invention in position in the left venous cavity of a human body.
Figure 9 is a view similar to Figure 8 but illustrating a different enlarged tip configuration at the in situ end of the tubular member.
Figure 10 is a view similar to Figure 7 but illustrating a different configuration of the enlarged tubular tip member in situ.
Figure 11 is a view similar to Figure 7 but illustrating yet a still different configuration of the tubular member enlarged in situ.
Figure 12 is a partially sectioned side elevation of a tip extremity of a tubular member part of a catheter embodying aspects of the invention.
Figure 13 is a side elevation of the structure illustrated in Figure 12 showing the vessel separating means in a deformed condition.
Figure 14 is a top view of the structure illustrated in Figure 12.
Figure 15 is a side elevation of the structure illustrated in Figure 12.
Figure 16 is a side elevation of a second embodiment of a tip with vessel separating means at an extremity of the tubular member forming a part of the catheter of the invention.
Figure 17 is an end view of the structure illustrated in Figure 16.
Figure 18 is a top view of the structure illustrated in Figure 16.
Figure 19 is a top view of the structure illustrated in Figure 16 with the vessel separating means in a deformed, compressed condition.
Figure 20 is a side elevation of a third embodiment of a tip with vessel separating means at an extremity of the tubular member forming a part of the catheter of the invention.
Figure 21 is an end view of the structure illustrated in Figure 20.
Figure 22 is a view similar to Figure 20 but showing the vessel separation means in a deformed condition.
Figure 23 is a top view of the structure illustrated in Figures 20 and 22.
Figure 24 is a partially sectioned view of the tip portion of the tubular means part of a catheter embodying the invention packaged in a peelaway sheath together with a protective nose cone and in position on a wire for unitary delivery and implantation into a patient.
Figure 25 is a view of the structure illustrated in Figure 24 showing the peelaway nature of the sheath.
Figure 26 is a view of a variation of the structure illustrated in Figure 24 showing the sheath peeling from the opposite end.
Figure 27 is a sectional view of the catheter and sheath taken at lines and arrows 27-27 in Figure 25.
Figure 28 is an end view of the catheter and sheath shown in Figure 26.
Figure 29 shows a separable surgical sheath.
Figure 30 is a sectional view of the sheath.
Figure 31 shows the sheath of Figure 29 with its proximal end separated by the embedded suture.
Figure 32 shows a side section of the sheath conduit tube and embedded suture configured to rupture from the distal to proximate end as show in Figure 31.
Figure 33 shows a side section of the sheath conduit tube and embedded suture configured to rupture from the proximate end to the distal end.
Description of the preferred Embodiments A stationary central tunnel dialysis catheter in accordance with.the invention is illustrated in Figures 1, 8 and 9 positioned in the thoracic cavity of the body where the catheter is designated generally 10. Figure 1 illustrates the catheter in position on the right side of the body; Figures 8 and 9 depict a catheter implanted in the left side of the body.
Catheter 10 is formed as a planar axially elongated sinuous tubular member of integral construction. The tubular member is designated generally 16 and has a plurality of axially extending lumens formed therein and a generally rounded, smooth outer periphery. The preferred configuration of tubular member 16 is illustrated in cross-section in Figures 5 and 6 where the rounded, smooth exterior of tubular member 16 is apparent.
Tubular member 16 includes at least one intake lumen for inflow of blood out of the patient to a dialysis apparatus and a discharge lumen where discharge of blood which has been dialyzed back into the patient.
The discharge lumen is designated generally 15 in the drawing; the intake lumen is designated generally 20.
The planar catheter 10, whether installed in the left portion of the body or the right-hand portion of the body, is depicted in Figures 2 and 3 where planes have been depicted in dotted lines with the catheter 10 resident within the plane, to illustrate such planar character. Figure 2 illustrates the catheter when configured for the right side; Figure 3 illustrates the catheter when configured for the left side. In either case tubular member 16 of catheter 10 has a predetermined two-dimensional shape substantially matching an anatomical central tunnel region of interest. From Figures 2 and 3, it may be seen that in both instances catheter 10 includes at least two portions of relative straightness which are connected by a curved region; the shapes illustrated fit preselected body lumens in the anatomical regions of interest.
Tubular member 16 of catheter is deformable and has a memory characteristic so that when deformed, tubular member 16 resiliently returns to the predetermined two-dimensional shape upon deformation. Hence, when the catheter is installed in the body, while the catheter may be deformed from the predetermined shape, once resident in the selected lumen of the body, the catheter returns to its predetermined shape due to the memory characteristic. With the catheter assuming the predetermined shape, this contributes to comfort for the patient and minimal trauma to the arteries in which the catheter resides.
As apparent from Figures 5 and 6, tubular member 16 preferably has a generally oval cross-section. The oval has a pair of parallel sides connected by opposed semi-circular arc segments. As apparent from Figures 4, 5 and 6, curved portions of tubular member 16, which curved portions are denoted generally 36, have greater wall thickness, as illustrated in Figure 5, then straight portions of tubular member 16 as designated generally 38.
As apparent from Figures 3, 8 and 9, when catheter is the left side of thoracic cavity 12, catheter 10 assumes a generally M-shape as indicated 24 in Figure 3 where straight lines have been drawn as extensions of the straight line portions of catheter to to emphasize 5 the M-shape when catheter 10 is installed on the left side of the body. The interior angles of the M-shape indicated as 100 and 102 in Figure 3 can desirably vary from about 45° to as great as 120°; angles in the neighborhood of 45° to 60° are most common and are 10 preferred.
In any of its embodiments catheter 10 includes means for separating the inlet aperture for intake lumen from the wall 34 of a surrounding vessel in which catheter 10 is installed.
15 Figures 7, 10, ll.and 14 through 23 depict various embodiments of the means for separating tubular member aperture 20 from the vessel wall 34. In Figures 7, 10 and 11 through 23, the outlet aperture of discharge lumen 15 is designated 25 while the inlet aperture of 20 intake lumen 20 is designated 35.
In the embodiment illustrated in Figure 7, means for separating inlet aperture 35 from vessel wall 34 are provided in part by a step 102 formed transversely to the axis of elongation of tubular member 16 where intake aperture 35 sits within step 102 and faces axially. In the embodiment illustrated in Figure 7 means for separating tubular member aperture 35 from wall 34 is further provided by a circumferentially spaced collection of petal-like enlargement structures 104 which are connected about a central collar 106 and fixed about tubular member 16. Petals 104 extend somewhat radially outwardly respecting collar 106 and may contact the cylindrical interior of wall 34 thereby to separate wall 34 from intake aperture 35. Petals 104 are preferably unitarily formed of plastic together with collar 106 and are resiliently biased outwardly respecting the axis of tubular member 16 so that the radially outer extremities of petals 104 are well outboard of intake aperture 35. Two intake apertures 35 are provided in the embodiment illustrated in Figure 7.
In the embodiment illustrated in Figure 10 two intake apertures 35 are provided. The embodiment of Figure 10, like the embodiment of Figure 7, utilizes a step construction with step 102 extending transversely respecting the longitudinal axis of tubular member 16 and one of intake apertures 35 formed in step 102. A
second intake aperture 35 is formed in the cylindrical outwardly facing surface of tubular member 16. In the embodiment illustrated in Figure 10, the means for separating inlet aperture 35 from vessel wall 34 is further provided by a collection of elongated leaf members 108 which extend between two collars 106 and are formed of generally flattened, broad strands of plastic with leaf members 108 having effective width, measured transversely respecting vessel 32 to define a circumferential outer extremity of tubular member 16 WO 99104844 PCT/tJS98/1475G
which is outboard of immediately adjacent inlet orifice 35. Hence, vessel wall 34 would first contact a lateral portion of leaf member 108 and not clog or cover aperture 35.
Figure 11 illustrates a variation of the structure shown in Figure 10 where leaf members 108 have been radially outwardly bowed to provide even greater separation of vessel wall from aperture 35 which adjacent to one of the two enlargement collars 106 between which leaf members 108 extend.
In Figure 12 means 30 for separating tubular member intake aperture 35 from vessel wall 34 is provided by a cantilever finger member 110 which extends somewhat radially outwardly from a central portion of tubular 15 member 16 and longitudinally along tubular member 16 to overly aperture 35. Cantilever finger member 110 is resiliently deformable so that upon force applied to finger member 110 in the direction indicated generally by arrow F in Figure 12, finger member 110 deforms 20 downwardly considering Figure 12 to the position illustrated in Figure 13, thereby covering inlet aperture 35 and presenting the intake of debris thereby.
When such force is relieved, cantilever finger member 110 resiliently returns to its position illustrated in Figure 12 thereby opening aperture 35 yet preventing aperture 35 from encountering wall 34 of vessel 32 within which tubular member 16 is resident.
Preferably a pair of cantilever finger members 110 is provided as is apparent from Figures 14 and 15.
Optionally, apertures 112 may be provided in finger members 110 to provide maximum access of fluid flow within vessel 32 to intake aperture 35.
In Figure 16 means for separating tubular member 20 intake aperture 35 from vessel wall 34 is provided by a pair of outwardly biased flaps 114 which are preferably integrally formed from tubular member 16. Flaps 114 serving as the separating means extend outwardly beyond respective parallel sides of tubular member 16 and are resiliently deformable to within the periphery of tubular member 16 in response to force in such direction. The flap members extending radially outwardly beyond the periphery of the catheter is apparent from Figure 18 with the flap members being resiliently deformed within the periphery of the tubular member as apparent from Figure 19. In the position illustrated in Figure 18, the flap members maintain tubular member 20 inlet aperture 35 spaced from vessel wall 34. In every embodiment of the tip members particularly means for separating the tubular member 20 intake aperture 35 from vessel wall 34, tubular member 16 and tip portion thereof is free to move longitudinally within vessel 32. The separating means 30, no matter what their configuration, do not fix tubular member vis-a-vis the vessel in which the tubular member resides. This prevents trauma and stress to the vessel wall and reduces the possibility of build-up of thrombolytic material in the vicinity of inlet aperture 35.
The preferred cross-sectional configuration of tubular member 16 is illustrated in Figures 5 and 6 where the periphery of tubular member 16 includes a pair of parallel side segments each designated 44 connected by a pair of semi-circular arc segments each designated 46. An internal web 48 separates intake lumen 20 from discharge lumen 15.
In the embodiments illustrated in Figures 12 through 23 tubular member 16 includes a rounded distal end 22 in addition to a rounded lateral outer periphery 18 defined by the two arc segments 46 and connecting parallel segments 44.
Figures 20 through 23 depict another embodiment of means for separating tubular member 20 intake aperture 35 from vessel wall 34 which is similar to the structure illustrated in Figures 12 through 15. In Figures 20 through 23 a cantilever finger member 110A extends somewhat radially outwardly from the remaining portion of tubular member 16 and axially longitudinally with respect to intake aperture 35. In the embodiment illustrated in Figures 20 through 23, upon a resilient deformation of cantilever finger member ilOA, that member deforms against a remaining axially elongated portion of tubular member l6, closing aperture 35 and preventing any influx thereinto of debris. This is not unlike the structure illustrated in Figures 12 through 15, where there are two cantilever finger members 110 which fold on either side of the remaining longitudinally extending portion 116 of tubular member 16. Similarly to the structure illustrated in Figures 12 through 15, the embodiment of Figures 20 through 23 may optionally include an auxiliary aperture 112 in cantilever finger member 110A to minimize resistance of flow to a lead aperture 35 of inflow lumen 20. In the embodiments illustrated all edges and external surfaces of tubular member 16 are rounded or flat; there are no sharp edges.
Figures 24 and 25 depict catheter 10 in accordance with the invention equipped with an optional peelaway sheath designated generally 66 together with a protective auxiliary nose cone 70 overlying the rounded distal end 22 of tubular member 16 within sheath 66. In Figure 24 catheter 10 overlying protective nose cone 70 and sheath 66 is depicted on a guide wire 72 in configuration to be implanted within a patient of interest. The wire 72 is similarly depicted in Figure 1. Sheath 66 together with protective nose cone 70 facilitate installation of the catheter l0 in a patient.
For such procedure, the surgeon initially inserts a wire 72 using a dilator into the patient. The catheter 10, having protective nose cone 70 in place thereover and sheath 66 encasing nose cone 70 and catheter 10 is then fed along guide wire 72 and positioned, preferably using x-ray or radiographic guidance, in the appropriate lumen in the human body. Once the catheter is in the appropriate position, a ripcord 68 may be pulled, thereby causing sheath 66 to rent, permitting sheath 66 to be withdrawn from the patient and leaving catheter 10 in place. Protective nose cone 70 is configured to fit over distal end of catheter 10 and particularly to fit over the distal end configuration chosen for the particular catheter application.
The sheath aspect of the invention provides a surgical apparatus capable of transcutaneously traversing from a first percutaneous location to a second subcutaneous location.
The separable sheath preferably includes an embedded suture adjusted to separate opposing wall sections along a longitudinal suture path formed in the sheath material such that the sheath may be split along the line by removing the suture and removed from the transcutaneous channel subsequent to the passage of a desired device.
Referring to Figures 29 through 33, the separable sheath is generally designated 66. The separable sheath preferably includes a cylindrical conduit 120 having a distal end 140 and proximal end 160, a longitudinal line of weakness 300 and flange portions 180 and 220 formed about proximal end 160 of conduit 120. Flange portions 180 and 220 maintain the percutaneous position of proximal end 160. Flange tabs 180 and 220 position sheath 66 in the transcutaneous pathway such that the sheath does not advance into tissue too deeply. A line of weakness 300 runs along the length of conduit 120 such that upon separating conduit wall flange tabs 220 and 180 separate along line 300.
The separable sheath includes an interior axially lumen extending from distal end 140 to proximal end 160. The distal end 140 accesses a subcutaneous location; proximal end 160 is positioned at a percutaneous location.
The sheath is desirably transcutaneously positioned to provide access for surgical apparatus such as catheter 10 to a subcutaneous location. Typically, the sheath is introduced through a transcutaneous access channel provided by an incision or needle path and advanced over a guide wire 72 to the subcutaneous site of interest by threading the guide wire through nose cone 70 by way of cone tip aperture 420. The cone shaped tip of conduit 120 dilates the transcutaneous pathway as it is advanced therethrough.
The elongated portion of sheath 66 is cylindrical and preferably formed of thin plastic such as polyethylene, fluorinated ethylene-propylene or like plastic materials employed in medical applications. In the embodiments shown in Figures 29 through 33, a suture 350 is preferably embedded along the longitudinal length of the conduit wall defining a line of weakness 300 along the length of conduit 120 portion of sheath 66.
Pulling a free end or "ripcord" 68 of the suture 350 away from the wall separates the conduit wall along the line of weakness 300. In this way, the conduit 120 may be split to facilitate retrieval of the conduit 120 portion of the sheath from the transcutaneous pathway.
The embedded suture 350 may be formed within conduit 120 to provide a stress concentration area on either the distal or proximate end to facilitate rupture of conduit 120 in a predetermined direction.
In the embodiment shown in Figures 32 and 33, the embedded suture 350 defines a weakened section of the conduit wall such that pulling the suture away from the wall separates the conduit wall along the line of weakness. As shown in Figure 32, the suture 350 is preferably embedded from proximal end 160 of the conduit 120 downwardly to distal end 140 of the conduit 120, with a free end of the suture 68 preferably looping at and around distal end 140 upwardly, and back towards the proximal 160. In this way, separation is effectuated using the free end of suture 68 which is maintained at a percutaneous location i.e., distal end 140 of conduit 120. Drawing ripcord 68 upwardly, away from distal end 140 as denoted by arrow "A", causes conduit 12 to rupture along the longitudinal suture path in the direction indicated by arrow "SP" from distal to proximate direction such that the sheath 66 may be removed from its transcutaneous position as illustrated in Figure 32.
Alternatively, suture 350 may be configured to rupture the conduit wall beginning with proximate end 160 and proceeding toward distal end 140 as shown in Figure 33, depending on the position of suture free end 68. As shown in Figure 33, suture 35 is embedded from proximal end 160 of conduit 120 downwardly to distal end 140, with a free end of suture 68 looping at proximate end 160 downwardly through lumen 260 to distal end 140 where it again loops upwardly to proximate end 160, extending along the outside surface of conduit 120. In this way, separation effectuated by the free end of suture 68 which extends upwardly though lumen 260 and is maintained at a percutaneous location, i.e. distal end 140 of the conduit. Drawing the suture upwardly, away from distal end 140, as indicated by arrow "B", causes conduit 120 to rupture along the suture path from proximate end 160 of conduit 120. Tn this embodiment, suture 350 ruptures from proximate to distal as denoted by the arrow "SP" such that the sheath 66 may be removed from its transcutaneous position.
Once the sheath is positioned in the transcutaneous pathway surrounding any associated instrumentation, the sheath is removed and the instruments) within deployed. The sheath is removed from the transcutaneous pathway by rupturing embedded suture 350 along the line of weakness defined by the embedded suture.
Claims (8)
- .1. A stationary central tunnel dialysis catheter (10) including a planar axially elongated sinuous tubular member (16) having a plurality of axially extending lumens (15, 20) formed therein, characterized by at least a part of the tubular member (16) having predetermined two-dimensional shape substantially matching an anatomical central tunnel region of interest, including at least two portions (38) of relative straightness connected by a curved portion region (36), to fit a preselected body lumen in the anatomical region of interest, the tubular member (16) being deformable and resiliently returning to the predetermined two-dimensional shape after deformation, and in the part of the tubular member (16) having predetermined shape at least two of the lumens (15, 20) each having at least one aperture (15, 35) for through passage of fluid during dialysis, the apertures (25, 35) being axially displaced from one another along the tubular member (16).
- 2. The catheter (10) of claim 1 further characterized by a flexible sheath (66) complementally surrounding at least the part having predetermined two-dimensional shape, for protecting the tubular member (16) part having predetermined shape, and being peelably removable therefrom in situ when the tubular member (16) has been positioned within the preselected lumen.
- 3. The catheter (10) of claim 2 further characterized by a ripcord (68) means extending along the length of the tubular member (16) for rupturing the sheath in the vicinity of an axial extremity of the tubular member (16) proximate the apertures (25, 35) in response to manual force applied to a portion of the ripcord (68) extending from the body of a patient in whom the catheter (10) has been implanted.
- 4. The catheter (10) of claim 3 further characterized by the ripcord (68) being embedded into the tubular member (16) wall.
- 5. The catheter (10) of claim 3 further characterized by the ripcord (68) being inside of the sheath (66).
- 6. The catheter (10) of claim 3 further characterized by the ripcord (68) being embedded in the sheath (66).
- 7. The stationary central tunnel dialysis catheter (10) of claim 6 wherein the tubular member (16) is further characterized by being of predetermined two-dimensional generally M-shape (24) substantially matching human left side venous anatomy, including portions (38) of relative straightness connected by curved portions (36), fitting a preselected body lumen in the anatomical region of interest, the M-shaped part (24) of the tubular member (16) being deformable and resiliently returning to the predetermined two-dimensional M-shape after deformation and the M-shaped part (24) of the tubular member (16) having at least two of the lumens (15, 20) each having at least one aperture proximate the extremity of one of the legs of the M for through passage of fluid during dialysis, the apertures (25, 35) being axially displaced from one another.
- 8. The stationary central tunnel dialysis catheter (10) of claim 1 further characterized by the sinuous tubular member (16) being of integral construction having a plurality of axially extending lumens (15, 20) formed therein and being a generally rounded smooth outer periphery with the tubular member (16) including means (102) for separating the tubular member (16) aperture (25, 35) remote from the end from a surrounding wall of the preselected body lumen when the catheter (10) is in place therewithin while permitting axial movement of the tubular member (16) within the lumen relative to the wall, with the tubular member (16) having wall thickness greater in the curved portion (36) than in the portions (38) of relative straightness.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US5366297P | 1997-07-24 | 1997-07-24 | |
| US60/053,662 | 1997-07-24 | ||
| PCT/US1998/014756 WO1999004844A1 (en) | 1997-07-24 | 1998-07-23 | Stationary central tunnel dialysis catheter with optional separable sheath |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2297122A1 true CA2297122A1 (en) | 1999-02-04 |
Family
ID=21985755
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002297122A Abandoned CA2297122A1 (en) | 1997-07-24 | 1998-07-23 | Stationary central tunnel dialysis catheter with optional separable sheath |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US6293927B1 (en) |
| EP (1) | EP1003585A1 (en) |
| JP (1) | JP2001510715A (en) |
| AU (1) | AU8572598A (en) |
| CA (1) | CA2297122A1 (en) |
| WO (1) | WO1999004844A1 (en) |
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- 1998-07-23 AU AU85725/98A patent/AU8572598A/en not_active Abandoned
- 1998-07-23 WO PCT/US1998/014756 patent/WO1999004844A1/en not_active Application Discontinuation
- 1998-07-23 US US09/122,186 patent/US6293927B1/en not_active Expired - Lifetime
- 1998-07-23 CA CA002297122A patent/CA2297122A1/en not_active Abandoned
- 1998-07-23 JP JP2000503892A patent/JP2001510715A/en active Pending
- 1998-07-23 EP EP98936874A patent/EP1003585A1/en not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| AU8572598A (en) | 1999-02-16 |
| US6293927B1 (en) | 2001-09-25 |
| WO1999004844A1 (en) | 1999-02-04 |
| EP1003585A1 (en) | 2000-05-31 |
| JP2001510715A (en) | 2001-08-07 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |