# Patent

## Title
Device for placing transmyocardial implant

## Abstract

The present invention relates to a transmyocardial implant placement device with an introducer, a transmyocardial implant mounted about the introducer, a wound closure clip engaged to the introducer adjacent the transmyocardial implant. The introducer is adapted to be inserted through a lumen of a coronary vessel and a myocardium of a patient into a chamber of the patient's heart and form a blood flow pathway through the myocardium between the heart chamber and the coronary vessel. When the introducer is inserted, the wound closure clip engages an outer wall of the coronary vessel and the transmyocardial implant extends from the heart chamber to the lumen of the coronary vessel. The transmyocardial implant is expanded in the blood flow pathway and the introducer retracted, leaving the transmyocardial implant in the within the blood flow pathway. As the introducer is retracted, the wound closure clip disengages from the introducer and closes an opening created by the introducer in the outer wall of the coronary vessel.

## Background
FIELD OF THE INVENTION
The present invention relates to placing devices in the myocardium of a patient. More specifically, the present invention relates to placement of devices through the myocardium for revascularizing occluded coronary vessels.
BACKGROUND OF THE INVENTION
Devices which are placed in the heart wall of a patient to revascularize an occluded coronary vessel as described in U.S. Pat. No. 5,944,019, the disclosure of which is incorporated herein by reference, are known. A variety of procedures for placing these devices have been described, including traditional by-pass open chest procedures, non-bypass open chest procedures, catheterization, and other non-open chest procedures. Improvements to the methods and apparatus used to place transmyocardial implants are desirable.
SUMMARY OF THE INVENTION
One aspect of the present disclosure relates to a transmyocardial implant placement device with an introducer, a transmyocardial implant mounted about the introducer, and a wound closure clip engaged to the introducer adjacent the transmyocardial implant. The introducer is adapted to be inserted through a coronary vessel and a myocardium of a patient into a chamber of the patient's heart and form a blood flow pathway through the myocardium between the heart chamber and the coronary vessel. When the introducer is inserted, the wound closure clip engages an outer wall of the coronary vessel and the transmyocardial implant extends from the heart chamber to the lumen of the coronary vessel. The transmyocardial implant is expanded in the blood flow pathway and the introducer retracted, leaving the transmyocardial implant in the within the blood flow pathway. As the introducer is retracted, the wound closure clip disengages from the introducer and closes an opening created by the introducer in the outer wall of the coronary vessel. Other inventive aspects are also disclosed herein.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side view of an embodiment of a transmyocardial implant placement device according to the present invention.
FIG. 2 is a schematic view of an alternative embodiment of a transmyocardial implant device according to the present invention inserted through a coronary vessel and a myocardium of a patient's heart into a heart chamber.
FIG. 3 is a schematic view of the transmyocardial implant device of FIG. 2, with an outer sheath retracted.
FIG. 4 is a schematic view of the transmyocardial implant device of FIG. 2, with the distal end of the device and the implant expanded.
FIG. 5 is a schematic view of the transmyocardial implant device of FIG. 2, with the distal end of the device collapsed and the implant expanded.
FIG. 6 is the schematic view of the transmyocardial implant device of FIG. 2, with the expanded implant in place in the myocardium, the device retracted and the wound closure clip open in the outer wall of the coronary vessel.
FIG. 7 is a top view of the wound closure clip of FIG. 6.
FIG. 8 is the schematic view of FIG. 6, with the wound closure clip closing the opening in the outer wall of the coronary vessel.
FIG. 9 is an enlarged view of the wound closure clip of FIG. 8.
FIG. 10 is a partial cross-sectional view of the wound closure clip of FIG. 9.
FIG. 11 is a side view of an alternative embodiment of a transmyocardial implant according to the present invention.
FIG. 12 is a top view of the transmyocardial implant of FIG. 11.
FIG. 13 is a cross-sectional view of the transmyocardial implant taken along line 13-13 in FIG. 12.
FIG. 14 is a schematic view of the transmyocardial implant of FIG. 11 implanted in a myocardium.
FIGS. 15 through 29 illustrate a sequence of steps for insertion of the transmyocardial implant of FIG. 11 into an implantation site in a myocardium.
FIG. 30 is a side view of an alternative embodiment of a transmyocardial implant placement device according to the present invention.
FIG. 31 is a cross-sectional view of a distal end of the transmyocardial implant placement device of FIG. 30.



DETAILED DESCRIPTION
Transmyocardial implants or direct revascularization devices (DRD's) are known. DRD's have been placed in the heart wall to provide blood flow to areas of a patient's vascular system where flow has been impeded for some reason. Often, DRD's have been intended for use in improving or restoring blood flow to coronary vessels downstream of an arterial occlusion, as an alternative to more traditional vein graft bypass procedures. DRD's are also suitable for use in follow-up procedures for patients for whom an earlier vein graft by-pass failed, or for patients who are not suitable candidates for traditional vein graft by-pass procedures, such as diabetic patients or patients with significant circulatory problems.
I. First Embodiment
Regardless of the reason for use of DRD's, methods and apparatuses for placing the implants in a myocardium of a patient are required. One approach involves implanting DRD's through the myocardium in a traditional open chest procedure utilizing a by-pass machine. A device 10 of FIG. 1 has been developed to facilitate implanting implants within a myocardium. Device 10 could be used in an open chest procedure, but preferably is used in a thoracoscopic procedure which does not require pulmonary by-pass. Device 10 includes a handle 12, a shaft 14, an expander actuator 16 and an expander 18. Shaft 14 has a distal end 22 and a proximal end 24. Expander 18 is located proximate distal end 22 and is movable from a contracted position, as shown in FIG. 1 and a dilated position. Releasably mounted about expander 18 is an implant 20. Implant 20 is expandable between a collapsed shape, as shown in FIG. 1 and an expanded shape. Such expandable implants are known in the art and described in U.S. Pat. No. 5,755,682, issued May 26, 1998.
To place implant 20 at a site within a myocardium, distal end 22 is maneuvered adjacent the myocardium at the desired site. Distal end 22 is then advanced through the myocardium until implant 20 is positioned within the myocardium to provide fluid communication between a heart chamber on one side of the myocardium and a coronary vessel lying on an opposite side of the myocardium. Expander 18 is moved to the dilated position by actuator 16, expanding implant 20 from the collapsed shape to the expanded shape. Expander 18 is then moved back to the contracted position and distal end 22 of device 10 is removed from the myocardium.
Alternatively, implant 20 may be a self-expanding implant and expander 18 may be adapted to hold implant 20 in a collapsed shape until positioned within the myocardium. Actuator 16 would then release implant 20 from device 10, allowing implant 20 to expand within the myocardium and provide fluid communication between the heart chamber and the coronary vessel.
It is anticipated that device 10 may be adapted for use with or without a vessel closure device such as described herein below.
II. Second Embodiment
FIGS. 2 through 8 show a first alternative device 210 and show a process for utilizing a transmyocardial implant placement device in accordance with the present invention. Device 210 may be used thoracoscopically to place an implant, as described below. Alternatively, device 210 may also be used in an open chest procedure, either on or off bypass-machine, preferably off bypass. Device 210 includes a shaft 214 with an outer sheath 228 and an inner catheter 230. Outer sheath 228 includes a clip slot 26 for releasably retaining wound closure clip 34. As shown in FIG. 5, inner catheter 230 includes a distal end 222 and an expander 218 proximate distal end 222. Implant 220 is releasably mounted about expander 218 and wound closure clip 34 is releasably mounted in clip slot 26.
To place an implant with device 210, distal end 222 forms and is inserted through an opening 36 in an outer wall 56 of a coronary vessel 52, through myocardium 50 of a patient into heart chamber 48, forming a blood flow pathway 40 from heart chamber 48 to lumen 54 of vessel 52. Device 210 is inserted far enough to allow wound closure clip 34 to engage outer wall 56 of vessel 52. Once clip 34 engages outer wall 56, outer sheath 228 is retracted, releasing clip 34 from clip slot 26 and exposing implant 220 within blood flow pathway 40. Expander 218 is then expanded, causing implant 220 to expand within blood flow pathway 40 and form a durable support for blood flow pathway 40. Expander 218 is then contracted to its insertion size, while implant 220 remains expanded, releasing implant 220 from inner catheter 230. Expander 218 may be any of a number of known devices which allow expansion and contraction by remote actuation, such as a balloon expander. Alternatively, it is anticipated that implant 220 can be made of a self-expanding material, such as nitinol. Such a self-expanding implant 220 would be releasably mounted to inner catheter 230 in a collapsed state until positioned within myocardium 50. Inner catheter 230 would not require expander 218, only a releasable mount to hold implant 220 in a collapsed state. When released from inner catheter 230, implant 220 would expand within blood flow pathway 40 as shown in FIG. 5.
Device 210 can then be fully retracted from the patient's body leaving behind implant 220 within myocardium 50 and wound closure clip 34 in opening 36 in outer wall 56 of coronary vessel 52. Implant 220 is preferably sufficiently rigid to maintain blood flow pathway 40 open during both systole and diastole of the heart but may be collapsible in other embodiments. FIGS. 6 and 7 show a temporary open state of wound closure clip 34 and opening 36 after device 210 has been removed. Clip 34 is held in the open state by the presence of inner catheter 230 extending therethrough. Clip 34 is spring biased to close upon the removal of inner catheter 230. When clip 34 closes, opening 36 is pulled closed, thereby sealing blood flow out of vessel 52 at the site of insertion of device 210. Implant 220 remains in place within myocardium 50 and maintains blood flow path 40 between heart chamber 48 and lumen 54 of coronary vessel 52.
Wound closure clip 34 is similar to the autoanastomosis device disclosed and claimed in the jointly assigned U.S. patent application Ser. No. 09/768,930, filed Jan. 24, 2001, the disclosure of which is incorporate herein by reference. Wound closure clip 34 is formed of a flexible, resilient material that is biased toward to closed position shown in FIG. 8 but which may be temporarily deformed into an open position and mounted in clip slot 26, as shown in FIG. 2. Clip 34 is adapted to fixedly engage the sides of opening 36 in outer wall 56 of coronary vessel 52 upon insertion of device 210 into the position shown in FIG. 2. Once engaged to outer wall 56, clip 34 is held in an open position by inner catheter 230 passing through clip 34, as shown in FIGS. 2 through 5. Once device 210 has been retracted from clip 34, clip 34 returns to its biased closed position, carrying the edges of opening 26 in outer wall 56 to be adjacent each other and encourage rapid sealing and healing of opening 36. Clip 34 may be made of a bio-incorporated material or can be made of a more durable material such as nickel titanium alloy, provided that the material used has sufficient elastic characteristics to allow deformation about device 210 and return to a closed position upon retraction of device 210.
Additional detail of clip 34 is shown in FIGS. 7, 9 and 10. Clip 34 includes a pair of central ribs 58 which are joined at a hinge 64. When expanded to a fully open position, ribs 58 define a ring shape, as shown in FIG. 7. Extending from each rib 58 in opposite directions are one or more paddles 60. On a vessel side of each paddle 60 are tines 62 (i.e., teeth or barbs). FIGS. 9 and 10 show clip 34 engaging outer wall 56 of vessel 54 and closing opening 36. In FIG. 2, clip 34 is shown mounted about device 210 and opened. Tines 62 are angled with respect to paddles 60 so that when clip is mounted about device 210 as shown in FIG. 2, tines 62 engage outer wall 56 with a minimum of damage to outer wall 56 and allow clip 34 to pull opening 36 closed. As shown, tines 62 are angled away from rib 58. Alternatively, tines 62 could be angled to a greater or lesser extent away from rib 58 or angled toward rib 58. Ribs 58 are preferably made of a shape memory material or some type of resilient, deformable material which allows clip 34 to be opened for mounting about device 10, 110 or 210 and being biased closed when device 10, 110 or 210 is withdrawn.
III. Third Embodiment
An alternative embodiment of implant 320 is shown in FIGS. 11 through 14 including a tee-shaped extension 302 at an angle to a transmyocardial leg 304. When inserted as shown in FIG. 14, extension 302 lies axially within lumen 54 of vessel 52. Both extension 302 and leg 304 are hollow conduits allowing fluid communication within lumen 54 along the axial length of vessel 52 and between heart chamber 48 and lumen 54 of vessel 52, respectively. Leg 304 is preferably made of a material sufficiently rigid to resist collapse and able to maintain an open lumen during systole and diastole of the heart, but may be collapsible in other embodiments.
Implant 320 is inserted in a process shown in the FIGS. 15 through 29. A dilator 70 is placed through an incision in coronary vessel 52 as shown in FIGS. 15 through 18. Dilator 70 expands and opens the incision sufficiently to permit insertion of a device 72, which includes a shaft 76 and a guide 74, as shown in FIG. 19. Guide 74 includes a longitudinal split 78 beginning at a distal end 80. Guide 74 includes an open sided area 75 and a closed sided area 77, proximate distal end 80 through which split 78 extends, as shown in FIGS. 20 and 20A. Open sided area 75 permits insertion of implant 320 within closed sided area 77 for placement within myocardium 50, as described below.
Shaft 76 is used to position guide 74 through dilator 70 within myocardium 50 so that distal end 80 extends into heart chamber 48, as shown in FIG. 20. Shaft 76 is then withdrawn, as shown in FIG. 21, and implant 320 is inserted through guide 74 to a position within myocardium 50, as shown in FIGS. 22 and 23. Guide 74 is then retracted from myocardium 50, as shown in FIG. 24, with split 78 opening to permit guide 74 to be removed without disturbing implant 320. Implant 320 is now permitting fluid communication between heart chamber 48 and lumen 54 of vessel 52. As shown in FIGS. 25 through 28, dilator 70 is collapsed and removed from the incision in vessel 52 and extension 302 helps seal the incision in vessel wall 56, reducing the need for mechanical closure devices, such as sutures, surgical adhesives, or clip 34, as shown in FIG. 29.
Implant 320 could also be adapted so that extension 302 extends different lengths on either side from transmyocardial leg 304, forming more of an L-shape as opposed to a T-shape.
IV. Fourth Embodiment
Referring now to FIGS. 30 and 31, another alternative placement device 110 is shown. Device 110 includes shaft 114 with an inner catheter 130 and an outer sheath 128. Handle 112 is attached to outer sheath 128 at proximal end 124 and handle 113 is attached to inner catheter 130. Inner catheter 130 includes an inner lumen 132 and is slidably retained within outer sheath 128. A self expanding implant 120 is mounted about inner catheter 130 in a implant receiving area 118 adjacent a distal end 122 and held in a collapsed form by outer sheath 128. Alternatively, implant 120 could be balloon-expandable and a balloon expander would be included at distal end 122 of inner catheter 130.
Distal end 122 includes a dilator 123 to ease insertion of the device 110 into a desired location of a patient's body and a transition element 125. Transition element 125 provides a transition of shaft 114 from the diameter of dilator 123 to the diameter of outer sheath 128 and Clip shoulder 126 is formed about outer sheath 128 at a position offset from distal end 122. A wound closure clip 34, as discussed previously, or similar device, may be releasably mounted about device 110 at clip shoulder 126. The extent of offset from distal end 122 is such that when device 110 is inserted within a heart to position stent 120 in the heart wall, wound closure clip 34 would engage outer wall 56 of blood vessel 52, as shown in FIG. 2. Inner lumen 132 may provides a pathway to inflate the balloon expander, if a balloon-expandable stent were used.
Device 110 is intended for use in a similar fashion to device 10, as shown in FIGS. 2 through 8, in placing implant 120 within myocardium 50 between vessel 56 and heart chamber 48. To place an implant 120 with device 110, distal end 122 is maneuvered proximate to the desired implantation site through outer wall 56 of vessel 52 and positioned so that implant 120 in a collapsed form underneath outer sheath 128 is correctly oriented at the implantation site in myocardium 50. Wound closure clip 34 at shoulder 126 would engage outer wall 56 of vessel 52. Retraction of outer sheath 128 proximally would release implant 120 and allow implant 120 to self expand to an expanded form. Retraction of outer sheath 128 would also leave wound closure clip 34 in place on outer wall 56. Once implant 120 is fully expanded, implant 120 is no longer held about device 110, allowing device 110 to be withdrawn from the patient's body. Withdrawal of device 110 would permit wound closure clip 34 to close and seal the opening in outer wall 56. Once expanded within at the implantation site, implant 120 is sufficiently rigid to resist collapse and maintain an open conduit during both systole and diastole of the heart.
Alternatively, implant 120 may be a balloon-expandable implant and a balloon expander included under implant receiving area 118. Device 110 could then be used in a fashion similar to that described above with regard to device 10 and shown in FIGS. 2 through 8.
The above specification, examples and data provide a complete description of the manufacture and use of the composition of the invention. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention resides in the claims hereinafter appended.

## Claims

1. A transmyocardial implant placement device comprising:
a catheter, with a distal end and a proximal end;
a dilator mounted to the distal end of the catheter;
an expander mounted to the catheter immediately proximal the dilator;
a transmyocardial implant with a distal end and a proximal end, the transmyocardial implant having a collapsed condition and an expanded condition and mounted about the expander in the collapsed position; and
a vessel wound closure clip positioned proximate to the proximal end of the collapsed transmyocardial implant.

2. The transmyocardial implant placement device of claim 1, wherein the catheter is adapted to be inserted through an outer wall of a coronary vessel, an inner wall of a coronary vessel and a myocardium of a patient into a chamber of the patient's heart and form a blood flow pathway through the myocardium between the heart chamber and lumen of the coronary vessel, with the wound closure clip engaging the outer wall of the coronary vessel and the transmyocardial implant extending from the heart chamber through the inner wall of the coronary vessel.

3. The transmyocardial implant placement device of claim 2, wherein the expander is adapted to expand the transmyocardial implant to the expanded condition so that the transmyocardial implant defines the blood flow pathway.

4. The transmyocardial implant placement device of claim 3, wherein the expander can be contracted and the catheter retracted from the myocardium, leaving the transmyocardial implant in the expanded condition within the blood flow pathway, releasing the wound closure clip as the catheter is retracted, the wound closure clip closing an opening created by the catheter in the outer wall of the coronary vessel.

5. The transmyocardial implant placement device of claim 1, wherein the transmyocardial implant in the expanded position within the myocardium maintains an open blood flow pathway during systole and diastole.

6. The transmyocardial implant placement device of claim 1, wherein the device includes an outer sheath about the catheter and the wound closure clip is releasably mounted to the outer sheath.

7. The transmyocardial implant placement device of claim 6, wherein the wound closure clip is releasably mounted to the outer sheath in a clip slot.

8. The transmyocardial implant placement device of claim 1, wherein the wound closure clip is movable between an open and a closed position wherein the clip is biased toward the closed position.

9. The transmyocardial implant placement device of claim 8, wherein the clip includes teeth adapted to embed in the outer wall of the coronary vessel and wherein the clip is adapted to pull the vessel opening closed when it moves from the open position to the closed position.

10. A transmyocardial implant placement device comprising:
arigid shaft;
an expender mounted to the shaft, the expander expandable from a collapsed state to a dilated state and collapsible from the cilated state to the collapsed state;
an actuator to actuate the expansion and collapse of the expander; and
a myocardial implant adapted to be mounted within a myocardium and extend from a heart chamber to a lumen of a coronary vessel, the implant being expandable between a collapsed state and an expanded state, and the implant releasably mounted to the rigid shaft in the collapsed state so that the expander will expand the implant from the collapsed state to the expanded state,
wherein a wound closure clip is releasably mounted to the rigid shaft proximal the implant and the actuator.

11. A method of implanting a transmyocardial implant comprising the steps of:
providing an implant device with a shaft including the transmyocardial implant located proximate a distal end;
inserting the distal end through an outer wall of a coronary vessel,
an inner wall of the coronary vessel and a myocardium into a heart chamber, thereby creating an opening in the outer wall of the coronary vessel and also creating a passage between the heart chamber and a lumen of the vessel;
implanting the implant within the passage; and
withdrawing the distal end of the implant device from the myocardium and releasing a wound closure clip from about the shaft, the wound closure clip engaging the outer wall of the coronary vessel and drawing the opening closed as the implant device is withdrawn.

12. The method of claim 11, wherein the implant device includes the implant in a collapsed state and including the further step of actuating the transmyocardial implant from the collapsed state to an expanded state within the passage.

13. A method of implanting a transmyocardial implant within a myocardium comprising the steps of:
incising an outer wall of a coronary vessel lying on an outer surface of the myocardium;
forming a path through the myocardium between the coronary vessel and a heart chamber on an opposite surface of the myocardium with an implant placement guide inserted through the incision;
inserting the transmyocardial implant within the guide until a hollow, open-ended myocardial leg of the implant is within the path and a hollow open-ended vessel portion of the implant is within a lumen of the coronary vessel, the myocardial leg and the vessel portion in fluid communication, the vessel portion including an upstream leg and a downstream leg, the legs extending axially within the lumen upstream and downstream from the myocardial leg;
withdrawing the guide from the myocardium, the vessel portion remaining within the lumen allowing axial blood flow and aiding the closure of the incision, the myocardial leg being sufficiently rigid to remain open and in fluid communication with the vessel portion during systole and diastole.

14. The method of claim 13, wherein the myocardial leg extends beyond the myocardium into the heart chamber.

15. The method of claim 13, wherein the upstream leg and the downstream leg extend equal distances from the myocardial leg.

16. The method of claim 13, wherein the upstream leg and the downstream leg extend different distances from the myocardial leg.