Device for placing transmyocardial implant

• US 20040049171A1
• Filed: 09/09/2002
• Published: 03/11/2004
• Est. Priority Date: 09/09/2002
• Status: Active Grant

• Current Assignee: WILK Patent Development Corporation
• Original Assignee: Heartstent Corp.
• Inventors: Kohler, Robert Edward, Mowry, David H.
• Granted Patent: US 7,326,219 B2
• Time in Patent Office: Days
• US Class Current: 606/1
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts

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.

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.

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

10. A transmyocardial implant placement device comprising:

an introducer having a distal end;

a transmyocardial implant having a distal end and a proximal end, the implant releasably mounted about the introducer proximate the distal end, the implant sized to extend through a myocardium of a patient and provide a blood flow pathway between a heart chamber and a lumen of a coronary vessel; and

a vessel wound closure clip releasably mounted about the introducer adjacent the proximal end of the implant.

11. The transmyocardial implant placement device of claim 10, wherein the distal end of the introducer is inserted through an outer wall of the coronary vessel, through the lumen of the coronary vessel and through the myocardium into the heart chamber so that the wound closure clip engages the outer wall of the coronary vessel and the implant is at least partially within the myocardium, the implant is released from the introducer, the introducer is retracted from the myocardium and the coronary vessel, the wound closure clip is released from the introducer as the introducer is retracted and closes an opening formed in the outer wall of the coronary vessel by the introducer.

12. The transmyocardial implant placement device of claim 10, wherein the transmyocardial implant within the myocardium maintains an open blood flow pathway during systole and diastole.

13. The transmyocardial implant placement device of claim 10, wherein the device includes an outer sheath about the introducer and the wound closure clip is releasably mounted to the outer sheath.

14. The transmyocardial implant placement device of claim 13, wherein the wound closure clip is movable between an open and a closed position wherein the clip is biased toward the closed position.

15. The transmyocardial implant placement device of claim 14, 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.

17. A transmyocardial implant placement device comprising:

a rigid shaft;

an expander mounted to the rigid shaft, the expander expandable from a collapsed state to a dilated state and collapsible from the dilated 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;

18. The transmyocardial implant placement device of claim 17, wherein a wound closure clip is releasably mounted to the rigid shaft proximal the implant and the actuator.

19. 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.

20. The method of claim 19, 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.

21. A vessel wound closure device comprising:

a resilient clip movable between an open position and a closed position, and biased toward the closed position;

the clip defining an enlarged inner opening when in the open position, the inner opening being substantially closed when the clip is in the closed position; and

the clip including vessel engaging teeth whereby the clip engages an outer wall of a blood vessel proximate an opening in the outer wall when in the open position and draws the opening in the vessel wall closed as the clip moves to the closed position.

22. 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.

23. The method of claim 22, wherein the myocardial leg extends beyond the myocardium into the heart chamber.

24. The method of claim 22, wherein the upstream leg and the downstream leg extend equal distances from the myocardial leg.

25. The method of claim 22, wherein the upstream leg and the downstream leg extend different distances from the myocardial leg.