Patent Application
20100130852
The present disclosure relates generally to catheter systems and, more specifically, relates to a navigation enabled lead delivery catheter.
The statements in this section merely provide background information related to the present disclosure and may not constitute prior art.
Various devices have been proposed for introducing and/or positioning elongate medical instruments in the human body. For instance, various catheter systems, introducer sheaths, and other elongate tubular members have been proposed for these purposes. More specifically, these devices can include a proximal portion that remains outside the body and a tubular member that extends into the body such that a distal end of the tubular member is located at a desired position. A medical instrument, such as a cardiac pacemaker lead or other vascular instrument, passes longitudinally through a lumen of the tubular member toward the desired position. For instance, in some embodiments, the medical instrument extends through the lumen to be positioned within the patient's heart, blood vessel, or other portion of the body. Then, the medical professional removes the tubular member of the catheter system, leaving the medical instrument in its intended position within the body. For example, the catheter system can be cut or peeled longitudinally as it is pulled from the body, thereby allowing the medical instrument to move outside the lumen of the catheter system, and leaving the distal end of the medical instrument in its intended position within the body.
Although conventional catheter systems have functioned for the intended purposes, some problems remain. For instance, it can be difficult to properly locate and position the distal end of the catheter system into the desired position within the body. As such, the medical instrument may be extended through the lumen of the catheter system into an incorrect position within the body, and the medical instrument may malfunction and/or need to be repositioned.
For instance, medical professionals typically manipulate the proximal end of the catheter system by pushing, pulling, and twisting the proximal end, and these forces are transferred longitudinally along the catheter system to thread the distal end into the desired position within the body. However, some catheter systems may not provide sufficient structural rigidity to properly transfer the forces from the proximal end to the distal end, thereby hindering the intended movement of the distal end.
Moreover, because the distal end is within the body, and the medical professional cannot view the distal end directly, it can be difficult to position the distal end with a high degree of accuracy. In some cases, navigation tools are used to more accurately locate the distal end. More specifically, these tools can include a coil of wire that is wound around the outside of the distal end. Then, a current is induced within the coil by generating an electromagnetic field from outside the patient. This induced current is detected in order to triangulate and locate the distal end within the body. However, in cases where the catheter system is split longitudinally after the medical instrument is placed, the coil may need to be segmented and the patient's exposure to the material of the coil should be limited, which can be problematic.
This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.
A catheter system for positioning of a medical instrument is disclosed. The catheter system includes a first elongate member having a first lumen. The catheter system also includes a second elongate member that includes a second lumen that receives the medical instrument. The second elongate member is coupled directly to the first elongate member, and the second elongate member is operable to be at least partially segmented generally along a second longitudinal axis thereof to allow movement of the medical instrument outside the second lumen. The second elongate member is selectively collapsible and expandable to change a size of the second lumen.
A method of positioning a medical instrument is also disclosed. The method includes positioning a catheter system in a patient. The catheter system includes a first elongate member that includes a first lumen and a second elongate member that includes a second lumen. The second elongate member is coupled directly to the first elongate member. The method also includes expanding the second elongate member to increase a size of the second lumen and extending the medical instrument into the second lumen. Moreover, the method includes segmenting the second elongate member to move the medical instrument outside the second lumen.
In still another aspect, a catheter system for positioning of a medical instrument is disclosed. The catheter system includes a first elongate member that includes a first lumen and an outer surface. The catheter system also includes a reinforcing member that reinforces the first elongate member. Furthermore, the catheter system includes a navigation tool with an electrically conductive coil operable for detecting a location of the catheter system. The navigation tool is received in the first lumen. Moreover, the catheter system includes a second elongate member that includes a second lumen that receives the medical instrument and an outer surface. The outer surface of the second elongate member is longitudinally coupled directly to the outer surface of the first elongate member. The second elongate member is operable to be at least partially segmented generally along a second longitudinal axis thereof to allow movement of the medical instrument outside the second lumen. The second elongate member is selectively collapsible and expandable to change a size of the second lumen. Furthermore, the catheter system includes a port member having a first port in fluid communication with the first lumen and a second port in fluid communication with the second lumen. The navigation tool extends through the first port and into the first lumen, and the medical instrument is extendable through the second port and into the second lumen.
Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.
The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way.
The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses. It should be understood that throughout the drawings, corresponding reference numerals indicate like or corresponding parts and features.
Referring initially to
The first elongate member 12 can be tubular, hollow, and generally flexible. As such, the first elongate member 12 can include a first lumen 16 (
Moreover, in some embodiments, the first elongate member 12 can include a reinforcing member 22. The reinforcing member 22 can generally reinforce the first elongate member 12. Accordingly, in some embodiments, the reinforcing member 22 can be embedded the first elongate member 12. More specifically, in some exemplary embodiments, the reinforcing member 22 can be helical and wind about the first axis X1 in a helical manner. In other embodiments, the reinforcing member 22 is a braided member such that the reinforcing member 22 includes a plurality of helical members that helically wind about the first axis X1 and that intersect each other along the axis X1.
The reinforcing member 22 can be made of any suitable material, such as metal. The other tubular portion of the first elongate member 12 can be made out of any suitable material, such as a polymer. In some exemplary embodiments, the first elongate member 12 can be made from a braided shaft or a spiral cut hypotube, commercially available from .
It will be appreciated that the reinforcing member 22 reinforces the first elongate member 12 to increase the rigidity of the first elongate member 12 such that forces applied at the proximal end 18 (e.g., forces exerted along the axis X1 and/or rotational forces exerted about the axis X1) can be transferred to the distal end 20 due to the reinforcement supplied by the reinforcing member 22. Accordingly, the first elongate member 12 can be more easily manipulated, routed along a non-linear path (e.g., a blood vessel), and the like.
Furthermore, in some embodiments, the second elongate member 14 is tubular and hollow so as to define a second lumen 24 (
The second elongate member 14 can be made of any suitable material, such as a polymeric material. In some embodiments, the second elongate member 14 can be made of a material similar to that of a known percutaneous transluminal coronary angioplasty (PTCA) balloon.
As is best illustrated in
The second elongate member 14 can be configured to be selectively collapsible and expandable to change the size of the second lumen 24 within the second elongate member 14. More specifically, in some exemplary embodiments, the second elongate member 14 can have a thin wall thickness as compared with the first elongate member 12. For instance, in some exemplary embodiments, the second elongate member 14 can have a wall thickness between approximately 0.0007″ and 0.0015″ while the wall thickness of the first elongate member 12 is approximately 0.01″.
Furthermore, as will be described in greater detail below in relation to
Moreover, in some exemplary embodiments, the catheter system 10 can include an end member 32 (
The end member 32 can be made of a material more resistant to deformation (i.e., more rigid) than that of the second elongate member 14. More specifically, the end member 32 can be configured such that the third lumen 34 retains substantially the same shape regardless of whether the second elongate member 14 is collapsed or expanded. Also, in some exemplary embodiments, the end member 32 can be made of a polymeric material and has a wall thickness of approximately 0.004″.
Furthermore, in the exemplary embodiments shown in
The port member 36 can be made out of any suitable material, such as a polymeric material. Also, the port member 36 can be generally rigid. Additionally, the port member 36 can include a thin walled portion 35 which extends longitudinally along the main body 39. As will be discussed in greater detail below, the thin walled portion 45 can be segmented (e.g., cut). The port member 36 can also include one or more coupling members, such as luer locks or other couplings disposed adjacent respective ends of the first branch 41, the second branch 43, and the main body 39.
The port member 36 can also be operatively coupled to the first and second elongate members 12, 14 as well as the end member 32. For instance, in some exemplary embodiments, the end member 32 is received within the common aperture 38, and the end member 32 extends into the main body 39 (
It will be appreciated that the port member 36 can be coupled to the end member 32, the first elongate member 12, and the second elongate member 14 in any suitable fashion. For instances, in some exemplary embodiments, an adhesive is used for these purposes. In other exemplary embodiments, the port member 36 is over-molded to the end member 32 and/or the first elongate member 12.
It will also be appreciated that the end member 32 is optionally included in the catheter system 10. For instance, in some exemplary embodiments, the second elongate member 14 can be coupled directly to the port member 36 such that the second elongate member 14 is received within the common aperture 38 and such that the second and third ports 42, 44 are in fluid communication with the second lumen 24 of the second elongate member 14. Moreover, it will be appreciated that the third port 44 and the second branch 43 are optional. For instance, in some exemplary embodiments, the port member 36 includes only the main body 39 and the first branch 41.
Accordingly, operation of the catheter system 10 will be described in greater detail. As shown in
Furthermore, in some exemplary embodiments, the location of the distal end 20 of the first elongate member 12 is detected to ensure that the distal end 20 is in a predetermined position within the patient 46. In some embodiments, placement and location of the distal end 20 within the patient 46 is performed using a navigation tool 52. It will be appreciated that the navigation tool 52 could be used to detect the position of any suitable portion of the catheter system 10.
In some exemplary embodiments, the navigation tool 52 can be elongate and includes an electrically conductive coil 54 on one end thereof. The navigation tool 52 can be of any suitable type, such as the navigation tool 52 disclosed in Applicant's co-pending U.S. patent application Ser. No. ______, filed ______, which is incorporated herein by reference in its entirety. Thus, the navigation tool 52 can be used in conjunction with a locating device 53. The locating device 53 can include microprocessors, computer memory, and other computer components for calculating and detecting the position of the coil 54, and thus, the position of the navigation tool 52 within the patient 46. Also, the locating device 53 can be used in combination with Johnson & Johnson's CARTO XP EP Navigation and Ablation System, commercially available from Johnson & Johnson of New Brunswick, N.J. Furthermore, the locating device 53 can be used in combination with the FLUOROMERGE or AXIEM Electromagnetic Tracking Systems, commercially available from Medtronic Surgical Navigation Technologies, Inc. of Minneapolis, Minn.
Accordingly, the locating device 53 can generate a variable electromagnetic field about the patient 46, and the electromagnetic field can induce a current within the coil 54 of the navigation tool 52. The induced current is dependent upon the position of the coil 54 relative to the locating device and within the electromagnetic field. Accordingly, the locating device 53 can triangulate the coil 54 to, thereby, detect the position of the navigation tool 52 within the patient 46. Also, the locating device 53 can rely on imaging technology (X-ray, MRI, CT, etc.) to produce visual feedback of the position of the navigation tool 52 within the patient 46.
Thus, the navigation tool 52 can be inserted into the first elongate member 12 of the catheter system 10 via the second port 42 of the port member 36. More specifically, the navigation tool 52 can be extended into the first port 40, and into the first lumen 16, and threaded along the first axis X1. It will be appreciated that the navigation tool 52 could be inserted into the first elongate member 12 either before or after the first elongate member 12 is inserted into the patient 46. In either case, the navigation tool 52 can be used to detect the position of the distal end 20 of the first elongate member 12 and to move the distal end 20 into a predetermined position within the patient 46. It will be appreciate that the distal end 28 of the second elongate member 14 can be disposed in a predetermined and known position relative to the distal end 20 of the first elongate member 12, and as such, the navigation tool 52 can be used to similarly move the distal end 28 of the second elongate member 14 into a predetermined position within the patient 46.
Also, in some exemplary embodiments, a working fluid 51 is then introduced into the second lumen 24 via the third port 44 of the port member 36. The working fluid 51 flows into the second lumen 24 and applies fluid pressure against the inner surface 29 of the second lumen 24 to expand the second elongate member 14 from a collapsed state (
Once the second elongate member 14 is sufficiently expanded, the medical instrument 50 can be inserted into the second lumen 24. More specifically, the medical instrument 50 is threaded into the second port 42 of the port member 36, through the third lumen 34 of the end member 32, and is received in the second lumen 24 of the second elongate member 14. The medical instrument 50 can be threaded along the second lumen 24 until it extends out of the distal end 28 of the second elongate member 14 toward a desired location within the patient. Then, in some exemplary embodiments, the medical instrument 50 can be attached to tissue (not shown) of the patient 46 in any suitable, known fashion.
It will be appreciated that the medical instrument 50 could be of any suitable type. For instance, in some exemplary embodiments, the medical instrument 50 is a pacemaker lead.
In another embodiment, the working fluid 51 is not used to expand the second elongate member 14, and instead, insertion of the medical instrument 50 causes expansion of the second elongate member 14. More specifically, as the medical instrument 50 progressively extends along the axis X2, the medical instrument 50 pushes the inner surface 29 of the second elongate member 14 outward radially to expand the second elongate member 14. Also, the inner surface 29 of the second lumen 24 can include a lubricant for reducing friction and facilitating movement of the medical instrument 50 along the axis X2 of the second elongate member 14.
Once the medical instrument 50 is in the desired position with the patient 46, the catheter system 10 can be removed from the medical instrument 50. More specifically, in some exemplary embodiments illustrated in
It will be appreciated that the port member 36, the end member 32, and/or the elongate member 14 can be segmented in any suitable fashion. For instance, in other exemplary embodiments, the second elongate member 14 is scored generally along the second axis X2, such that the second elongate member 14 can be peeled along the axis X2 along the scoring without the use of the blade 56.
It will also be appreciated that the catheter system 10 can be segmented in any direction other than along the second axis X2. Moreover, it will be appreciated that the catheter system 10 can be only partially segmented along the axis X2 in order to remove the catheter system 10 from the medical instrument 50.
Accordingly, the catheter system 10 allows the medical instrument 50 to be accurately positioned within the patient 46 such that the medical instrument 50 is more likely to operate in an intended fashion. Also, because the medical instrument 50 is isolated from the navigation tool 52, the medical instrument 50 can be easily removed from the catheter system 10 simply by cutting through the relatively thin wall of the second elongate member 14. Furthermore, because exposure to the material of the coil 54 of the navigation tool 52 is unlikely because it is not segmented during removal of the catheter system 10.
Manufacturing of the catheter system 10 will now be described with reference to
Certain terminology is used herein for purposes of reference only, and thus is not intended to be limiting. For example, terms such as “upper,” “lower,” “above,” “below,” “top,” “upward,” and “downward” refer to directions in the drawings to which reference is made. Terms such as “front,” “back,” “rear,” and “side,” describe the orientation of portions of the component within a consistent but arbitrary frame of reference which is made clear by reference to the text and the associated drawings describing the component under discussion. Such terminology may include the words specifically mentioned above, derivatives thereof, and words of similar import. Similarly, the terms “first,” “second,” and other such numerical terms referring to structures do not imply a sequence or order unless clearly indicated by the context.
When introducing elements or features and the exemplary embodiments, the articles “a,” “an,” “the” and “said” are intended to mean that there are one or more of such elements or features. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that there may be additional elements or features other than those specifically noted. It is further to be understood that the method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated, unless specifically identified as an order of performance. It is also to be understood that additional or alternative steps may be employed.
The description of the disclosure is merely exemplary in nature and, thus, variations that do not depart from the gist of the disclosure are intended to be within the scope of the disclosure. Such variations are not to be regarded as a departure from the spirit and scope of the disclosure.
