BRIEF DESCRIPTION OF THE DRAWINGS
The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which:
FIG. 1 is a perspective view of the intra myocardial injector in accordance with the present invention;
FIG. 2 is a perspective view of an embodiment of the intra myocardial injector of FIG. 1 shown with the abutment member in its second configuration in accordance with the present invention;
FIG. 3A is a cross sectional view of the injector of FIG. 2 shown with the abutment member in its first configuration in accordance with the present invention;
FIG. 3B is a cross sectional view of the injector of FIG. 2 shown with the abutment member in its second configuration in accordance with the present invention;
FIG. 3C is a cross sectional view of the injector of FIG. 2 shown with the abutment member in its second configuration and with the needle advanced and penetrating myocardial tissue in accordance with the present invention;
FIG. 4 is a perspective view of another embodiment of the intra myocardial injector of FIG. 1 shown with the abutment member in its extended (second) configuration in accordance with the present invention;
FIG. 5A is a cross sectional view of an embodiment of the injector of FIG. 4 shown with the abutment member in its first configuration in accordance with the present invention;
FIG. 5B is a cross sectional view of the injector shown in FIG. 5A shown with the abutment member in its second configuration in accordance with the present invention;
FIG. 5C is a cross sectional view of the injector shown in FIG. 5B with the needle advanced and penetrating myocardial tissue in accordance with the present invention;
FIG. 6A is a cross sectional view of an alternate embodiment of the injector of FIG. 4 shown with the abutment member in its first configuration in accordance with the present invention;
FIG. 6B is a cross sectional view of the injector shown in FIG. 6A shown with the abutment member in its second configuration in accordance with the present invention; and
FIG. 6C is a cross sectional view of the injector shown in FIG. 6B with the needle advanced and penetrating myocardial tissue in accordance with the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring initially to FIG. 1, an intra myocardial injector in accordance with the present invention is shown, and is generally designated 10. As shown in FIG. 1, the injector 10 includes a catheter 12 that extends along an axis 14 from a proximal end 15 to a distal end 16. As is shown, the proximal end 15 of the catheter 12 is connected to tubing 13. For purposes of the present invention, the tubing 13 is in fluid communication with a vessel 17 for holding medicament or other fluid for medical treatment. As is further shown, the tubing 13 also includes a port 19 that provides access for manipulation of internal components of the catheter 12. For instance, the port 19 may connect to a fluid reservoir 11.
Referring now to FIG. 2, the injector 10 is shown to include a needle 18 that terminates at a needle tip 20. As shown in FIG. 2, the needle 18 has been advanced so that the needle tip 20 extends beyond the distal end 16 of the catheter 12. Further, the injector 10 is shown to include an abutment member 22. As shown, the abutment member 22 is formed from a plurality of loops 24 of wire 26. Specifically, the abutment member 22 is formed with overlapping loops 24 that are biased to radially extend from the axis 14. Further, the abutment member 22 may include a webbing 25 that interconnects adjacent loops 24. Such a webbing 25 can comprise a high-friction material. For the present invention, the abutment member 22 may include engagement elements 28 such as tines that extend from exemplary loops 24a, 24b, or a high friction surface.
Turning now to FIG. 3A, the internal features of the injector 10 may be understood. As shown in FIG. 3A, the catheter 12 forms a lumen 30 that extends along the axis 14 to the distal end 16. Unlike in FIG. 2, the abutment member 22′ is positioned completely within the lumen 30, i.e., in its first configuration. As shown, when in its first configuration, the abutment member 22′ is substantially tube-like. Specifically, the abutment member 22′ includes a proximal portion 32 and a distal portion 34 that are substantially cylindrical.
In FIG. 3A, it is further shown that the injector 10 includes a pusher rod 36 that includes a distal end 38. As shown, the pusher rod 36 is received within the lumen 30 and is axially movable with respect to the catheter 12. For purposes of the present invention, the distal end 38 of the pusher rod 36 engages the proximal portion 32 of the abutment member 22′ to cause movement of the abutment member 22′. In certain embodiments, the rod 36 and the abutment member 22 may be a single piece.
Still referring to FIG. 3A, the needle 18 is shown positioned entirely within the lumen 30, with the end 16 of the catheter 12 distal of the needle tip 20. Structurally, the needle 18 may be mounted to a needle hub (not shown) for movement with respect to the lumen 30 of the catheter 12.
Referring now to FIG. 3B, the abutment member 22″ is shown in its second configuration. Specifically, as shown, the distal portion 34 of the abutment member 22″ is shown extended from the distal end 16 of the catheter 12. Because it is radially biased, the distal portion 34 of the abutment member 22″ flares radially when extended beyond the distal end 16 of the catheter 12 and takes a fan shape. As shown in FIG. 3B, the needle 18 is still retracted within the catheter 12.
Referring now to FIG. 3C, it can be seen that the needle 18 has been advanced to extend the needle tip 20 beyond the distal end 16 of the catheter 12 and the abutment member 22″. Preferably, the needle tip 20 extends between 3 and 7 millimeters beyond the distal portion 34 of the abutment member 22″.
Referring now to FIGS. 3A-3C collectively, the operation of the present invention may be understood. Initially, the injector 10 is configured as in FIG. 3A with the abutment member 22′ in its first configuration. When an intra myocardial injection is desired, the injector 10 is placed adjacent myocardial tissue 42. Next, as shown in FIG. 3B, the pusher rod 36 is advanced and the distal end 38 of the rod 36 forces the abutment member 22 in the distal direction. The abutment member 22 is moved distally until it reaches its second configuration. In the second configuration, the distal portion 34 of the abutment member 22″ flares radially and provides a barrier between the distal end 16 of the catheter 12 and the myocardial tissue 42. When the injector 10 is moved toward the myocardial tissue 42, the abutment member 22 abuts the tissue 42 and prevents further movement of the catheter 12 in the distal direction. Further, the engagement elements 28 (shown in FIG. 2) on the abutment member 22 may pierce or contact and engage the myocardial tissue 42 to anchor the injector 10 in position.
With the abutment member 22″ in its second configuration, the needle 18 may be advanced to extend the needle tip 20 as shown in FIG. 3C. Advancement of the needle 18 may be accomplished by pushing the needle hub (not shown) relative to the catheter 12, or otherwise pushing the needle 18 relative to the catheter 12 as known in the art. As a result of its advancement, the needle tip 20 extends beyond the distal end 16 of the catheter 12 and beyond the distal portion 34 of the abutment member 22″ to penetrate the myocardial tissue 42 to an approximate depth of between 3 and 7 millimeters. When the myocardial tissue 42 has been penetrated by the needle tip 20 at the appropriate depth, a medicament or other treatment fluid may be injected through the needle tip 20 as is well known in the art.
After the injection has been performed, the needle 18 is retracted within the lumen 30, as illustrated in FIG. 3B. Then the abutment member 22″ is withdrawn into the lumen 30 by the pusher rod 36, as illustrated in FIG. 3A. Thereafter, the injector 10 is removed from the patient's vasculature.
Referring now to FIG. 4, the injector 10 is again shown to include a needle 18 that terminates at a needle tip 20. Similar to the injector 10 shown in FIG. 2, the needle 18 has been advanced so that the needle tip 20 extends beyond the distal end 16 of the catheter 12. Further, the injector 10 is shown to include an inflatable abutment member 44. As shown, the abutment member 44 is formed from a flexible bladder such as a balloon. For purposes of the present invention, the abutment member 44 may be round, flat, elliptical, or any desired shape. As shown, the abutment member 44 has a proximal portion 46 mounted to the catheter 12. For the present invention, the abutment member 44 may include a high friction surface 50.
Turning now to FIG. 5A, the internal features of the injector 10 may be understood. As shown in FIG. 5A, the catheter 12 forms a lumen 30 that extends along the axis 14 to the distal end 16. Unlike in FIG. 4, the abutment member 44′ is deflated and positioned completely within the lumen 30, i.e., in its first configuration. As shown, when in its first configuration, the abutment member 44′ is substantially tube-like. Specifically, the proximal portion 46 and the distal portion 48 of the abutment member 44′ are substantially cylindrical. For purposes of the present invention, the proximal portion 46 of the abutment member 44 may be mounted to the catheter 12.
In FIG. 5A, it is further shown that the abutment member 44 includes a port 52 that is in fluid communication with a tube 54. For purposes of the present invention, the tube 54 is connected to the fluid reservoir 11 (shown in FIG. 1) to transfer fluid between the reservoir 11 and the abutment member 44′ to cause movement of the abutment member 44′. In certain embodiments, the abutment member 44′ and the tube 54 may be a single piece.
Still referring to FIG. 5A, the needle 18 is shown positioned entirely within the lumen 30, with the end 16 of the catheter 12 distal of the needle tip 20. Structurally, the needle 18 may be mounted to a needle hub (not shown) for movement with respect to the lumen 30 of the catheter 12.
Referring now to FIG. 5B, the abutment member 44″ is shown in its second configuration. Specifically, as shown, the distal portion 48 of the abutment member 44″ is shown extended from the distal end 16 of the catheter 12. Due to its preformed pancake shape, the distal portion 48 of the pancake shaped abutment member 44″ flares radially when inflated beyond the distal end 16 of the catheter 12. As shown in FIG. 5B, the needle 18 is still retracted within the catheter 12.
Referring now to FIG. 5C, it can be seen that the needle 18 has been advanced to extend the needle tip 20 beyond the distal end 16 of the catheter 12 and the abutment member 44″. Preferably, the needle tip 20 extends between 3 and 7 millimeters beyond the surface 50 of the abutment member 44″.
Referring now to FIGS. 5A-5C collectively, the operation of the present invention may be understood. Initially, the injector 10 is configured as in FIG. 5A with the abutment member 44′ in its first configuration. When an intra myocardial injection is desired, the injector 10 is placed adjacent myocardial tissue 42. Next, as shown in FIG. 5B, fluid such as iodinated saline is transferred from the reservoir 11 to the abutment member 44 and the distal portion 48 of the abutment member 44 expands in the distal direction. The abutment member 44 expands until it reaches its second configuration. In the second configuration, the distal portion 48 of the abutment member 44″ flares radially and provides a barrier between the distal end 16 of the catheter 12 and the myocardial tissue 42. When the injector 10 is moved toward the myocardial tissue 42, the surface 50 of the abutment member 44 abuts the tissue 42 and prevents further movement of the catheter 12 in the distal direction. Further, the surface 50 may contact and engage the myocardial tissue 42 to anchor the injector 10 in position.
With the abutment member 44″ in its second configuration, the needle 18 may be advanced to extend the needle tip 20 as shown in FIG. 5C. Advancement of the needle 18 may be accomplished by pushing the needle hub (not shown) relative to the catheter 12, or otherwise pushing the needle 18 relative to the catheter 12 as known in the art. As a result of its advancement, the needle tip 20 extends beyond the distal end 16 of the catheter 12 and beyond the surface 50 of the abutment member 44″ to penetrate the myocardial tissue 42 to an approximate depth of between 3 and 7 millimeters. When the myocardial tissue 42 has been penetrated by the needle tip 20 at the appropriate depth, a medicament or other treatment fluid may be injected through the needle tip 20 as is well known in the art.
After the injection has been performed, the needle 18 is retracted within the lumen 30, as illustrated in FIG. 5B. Then the abutment member 44′ is deflated by transferring fluid from the abutment member 44 to the fluid reservoir 11, as illustrated in FIG. 5A. Thereafter, the injector 10 is removed from the patient's vasculature.
Turning now to FIG. 6A, the internal features of another embodiment of the injector 10 may be understood. As shown in FIG. 6A, the catheter 12 forms a lumen 30 that extends along the axis 14 to the distal end 16. Unlike in FIG. 4, the abutment member 44′ is deflated and positioned substantially alongside the catheter 12, i.e., in its first configuration. As shown, when in its first configuration, the abutment member 44′ is substantially tube-like. Specifically, the proximal portion 46 and the distal portion 48 of the abutment member 44′ are substantially cylindrical. For purposes of the present invention, the proximal portion 46 of the abutment member 44 may be mounted to the catheter 12.
In FIG. 6A, it is further shown that the abutment member 44 includes a port 52 that is in fluid communication with a tube 54. For purposes of the present invention, the tube 54 is connected to the fluid reservoir 11 (shown in FIG. 1) to transfer fluid between the reservoir 11 and the abutment member 44′ to cause movement of the abutment member 44′. In certain embodiments, the abutment member 44′ and the tube 54 may be a single piece. Further, while the tube 54 is positioned within the lumen 30 in FIG. 6A, it may be positioned outside of the catheter 12 as shown in FIG. 5A.
Still referring to FIG. 6A, the needle 18 is shown positioned entirely within the lumen 30, with the end 16 of the catheter 12 distal of the needle tip 20. Structurally, the needle 18 may be mounted to a needle hub (not shown) for movement with respect to the lumen 30 of the catheter 12.
Referring now to FIG. 6B, the abutment member 44″ is shown in its second configuration. Specifically, as shown, the distal portion 48 of the abutment member 44″ is shown extended from the distal end 16 of the catheter 12. Due to its preformed shape, the abutment member 44″ flares radially when inflated beyond the distal end 16 of the catheter 12. As shown in FIG. 6B, the needle 18 is still retracted within the catheter 12.
Referring now to FIG. 6C, it can be seen that the needle 18 has been advanced to extend the needle tip 20 beyond the distal end 16 of the catheter 12 and the abutment member 44″. Preferably, the needle tip 20 extends between 3 and 7 millimeters beyond the surface 50 of the abutment member 44″.
Referring now to FIGS. 6A-6C collectively, the operation of the present invention may be understood. Initially, the injector 10 is configured as in FIG. 6A with the abutment member 44′ in its first configuration. When an intra myocardial injection is desired, the injector 10 is placed adjacent myocardial tissue 42. Next, as shown in FIG. 6B, fluid is transferred from the reservoir 11 to the abutment member 44 and the distal portion 48 of the abutment member 44 expands radially outward and in the distal direction. The abutment member 44 expands until it reaches its second configuration. In the second configuration, the distal portion 48 of the abutment member 44″ provides a barrier between the distal end 16 of the catheter 12 and the myocardial tissue 42. When the injector 10 is moved toward the myocardial tissue 42, the surface 50 of the abutment member 44 abuts the tissue 42 and prevents further movement of the catheter 12 in the distal direction. Further, the surface 50 may contact and engage the myocardial tissue 42 to anchor the injector 10 in position.
With the abutment member 44″ in its second configuration, the needle 18 may be advanced to extend the needle tip 20 as shown in FIG. 6C. Advancement of the needle 18 may be accomplished by pushing the needle hub (not shown) relative to the catheter 12, or otherwise pushing the needle 18 relative to the catheter 12 as known in the art. As a result of its advancement, the needle tip 20 extends beyond the distal end 16 of the catheter 12 and beyond the surface 50 of the abutment member 44″ to penetrate the myocardial tissue 42 to an approximate depth of between 3 and 7 millimeters. When the myocardial tissue 42 has been penetrated by the needle tip 20 at the appropriate depth, a medicament or other treatment fluid may be injected through the needle tip 20 as is well known in the art.
After the injection has been performed, the needle 18 is retracted within the lumen 30, as illustrated in FIG. 6B. Then the abutment member 44″ is deflated by transferring fluid from the abutment member 44 to the fluid reservoir 11, as illustrated in FIG. 6A. Thereafter, the injector 10 is removed from the patient's vasculature.
While the particular Myocardial Injector With Balloon Abutment as herein shown and disclosed in detail is fully capable of obtaining the objects and providing the advantages herein before stated, it is to be understood that it is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended to the details of construction or design herein shown other than as described in the appended claims.
Patent Application
20070282257
