Non-sheath based medical device delivery system

• US 7,092,765 B2
• Filed: 09/23/2002
• Issued: 08/15/2006
• Est. Priority Date: 09/23/2002
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Geske, Jeff B., Chivers, Bruce E., Waldhauser, Steven L., Kelley, James F.
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): Kramer, Nicole R.
• Application Number:
  US10/252,243
• Publication Number:
  US 20040059348A1
• Time in Patent Office: 1,422 Days
• Field of Search: 606/129, 607/116, 607/122
• US Class Current: 607/122
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/347 Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

A non-sheath based medical device delivery system is provided including an elongated tubular guide body having a distal end fixedly attached to a resilient collet with a longitudinal opening to receive a medical lead or other device. The collet may be opened by actuating a retraction member to cause the closing member to slide proximally along the collet shaft, allowing the collet to maintain a normally open position. With the collet closed, the device may be advanced to a desired internal body location by advancing the guide body. The majority of the device body will be exposed, running alongside the guide body, allowing any sensors or electrodes located on the device body to be fully operational during the implantation procedure. The delivery system may be removed by opening the collet, to slidably disengage from the device body.

Claims

1. A medical device deployment system comprising:

an elongated medical device configured for implantation and having a proximal end and a distal end with a first axis extending therebetween;

a resilient collet;

a closing member in cooperative engagement with the collet;

an elongated tubular guide structure having a proximal end and a distal end with a second axis defined therebetween, wherein the distal end is attached to a portion of the collet; and

a retraction member having a proximal end and a distal end, the distal end being attached to the closing member and the proximal end exiting said proximal end of the elongated tubular guide structure and wherein actuation of the retraction member moves the closing member to a first position and actuating the retraction member in an opposite direction moves the closing member to a second position, where the collet includes a first longitudinal opening configured to receive the elongated medical device when the closing member is in the first position so that the resilient collet is in an open position and when the closing member is in the second position and the resilient collet is in a closed position the elongated medical device is retained within the first longitudinal opening so that the first axis of a portion of the elongated medical device retained by the collet is generally parallel to the second axis of the guide structure proximate the collet.

2. The system of claim 1, wherein the collet further includes at least two separating elements at the distal end form a resilient flaring structure.

3. The system of claim 2, wherein said resilient flaring elements adjust to various opening sizes at the distal end.

4. The system of claim 3, wherein said closing member movably enables adjustment of said opening sizes.

5. The system of claim 2, wherein said resilient flaring elements form a generally dome-like structure at the distal end.

6. The system of claim 5, wherein said flaring elements form a hypodermic needle-like tip.

7. The system of claim 5, wherein said flaring elements include a tipped conical structure.

8. The system of claim 5, wherein said flaring elements form a tipped shape including one of and a combination of a geometric shape and multiple geometric shapes.

9. The system of claim 5 wherein said flaring elements are separated by at least one gap extending longitudinally therefrom.

10. The system of claim 1 and further comprising a second longitudinal opening disposed along the closing member.

11. The system of claim 10, wherein the first longitudinal opening and the second longitudinal opening are aligned with one another so as to facilitate the reception of an elongated medical device.

12. The system of claim 1, wherein the elongated medical device is retained within the first longitudinal opening and moveable longitudinally with respect to the guide structure when the resilient collet is open and the elongated medical device is retained within the first longitudinal opening and prevented from moving with respect to the guide structure when the collet is closed.

13. The system of claim 1, wherein the elongated medical device is a lead.

14. The system of claim 1, wherein the closing member includes a second longitudinal opening that is aligned with the first longitudinal opening when the closing member is in the first position and is out of alignment with the first longitudinal opening when the closing member is in the second position such that a portion of the closing member occludes a portion of the first longitudinal opening.

15. The system of claim 1, wherein the elongated medical device includes a proximal end and a distal end and is securable within the collet proximate the distal end of the elongated medical device such that the elongated medical device can be delivered by manipulation of the elongated tubular guide, wherein the elongated medical device remains substantially unoccluded.

16. The system of claim 15, wherein sensors positioned along the medical device are operable and functional within a patient when the distal end of the medical device is secured to the collet.

17. The system of claim 16, wherein the elongated medical device is substantially unoccluded when secured by the collet.

18. The system of claim 1, wherein the resilient collet is separable from a remainder of the system.

19. The system of claim 18, further comprising multiple interchangeable collets.

20. The system of claim 19, wherein one interchangeable collet forms a generally dome-like structure in a closed position and a second interchangeable collet forms a needle-like structure in a closed position.

21. The system of claim 19, wherein each interchangeable collet has an internal diameter sized to retain a particular medical device having an external diameter matched to the internal diameter.

22. The system of claim 21, wherein the multiple interchangeable collets each have different internal diameters.

23. The system of claim 15, further comprising a proximal clamp disposed on the tubular guide structure for securing a proximal portion of the elongated medical device.

24. The system of claim 1, further comprising:

a lumen disposed within the guide structure; and

a pull wire disposed within the lumen to effectuate bending of the guide structure.

25. The system of claim 24, wherein the lumen has a rectangular cross section and the pull wire has a rectangular cross section.

26. The system of claim 24, where the lumen has a circular cross section and the pull wire has a circular cross section.

27. The system of claim 1, wherein the guide structure includes at least one helical groove to increase the flexibility of a portion of the guide structure.

28. The system of claim 1, wherein the guide structure includes a deformable section.

29. The system of claim 28, wherein the deformable section is formed from a shape memory alloy.

30. The system of claim 28, wherein the deformable section is formed from a malleable material that can be selectively manipulated to hold a configuration.

31. The system of claim 28, wherein the deformable section includes at least one helical groove.

32. The system of claim 1, wherein an elongated medical device is selectively and repeatably securable within the collet.

33. The system of claim 1, wherein the elongated tubular guide structure is sufficiently rigid to facilitate steerable deployment within a body structure with an elongated medical device secured within the collet.

34. The system of claim 1, further comprising a biasing portion disposed along the retraction member for biasing the closing member into the first position.

35. The system of claim 34, wherein the biasing portion includes;

a moveable anchor coupled to a first portion of the retraction member;

a fixed anchor coupled to a second portion of the retraction member that is proximal to the first portion;

a spring coupled between the moveable anchor and the fixed anchor.

36. The system of claim 1, further comprising a sensor disposed on the tubular guide structure.

37. The system of claim 36, wherein the sensor is an electrode.

38. The system of claim 1, further comprising a sensor disposed on the collet.

39. The system of claim 1, further comprising a sensor disposed on the closing member.

40. The system of claim 1, wherein the medical device includes a body portion receivable with the collet and an end portion attached to the body portion that is larger than the body portion.

41. A method of implanting an elongated medical device comprising:

positioning a distal portion of the elongated medical device within a collet of a deployment tool having an elongated body, such that the elongated medical device is held external to and adjacent to the tool;

guiding the deployment tool to a desired location;

opening the collet;

retracting the tool, wherein the open collet slides along the medical device; and

separating the collet from the medical device by withdrawing a proximal portion of the medical device from a longitudinal groove disposed on the collet.

42. The method of claim 41, wherein the tool is intact after separating the collet from the medical device.

43. The method of claim 41, further comprising:

reattaching the collet to the proximal portion of the medical device;

advancing the tool along the medical device until the collet is proximate the distal portion of the medical device;

closing the collet so that the medical device is coupled with the tool.

44. The method of claim 41, wherein guiding the tool includes passing the tool through a vein.

45. The method of claim 41, wherein guiding the tool includes passing the tool through tissue.

46. The method of claim 45 further comprising stabbing the tool to gain initial entry into the tissue.

47. The method of claim 41, further comprising:

selecting a collet having a shape appropriate for a desired deployment; and

connecting the collet to the elongated body.

48. The method of claim 41, further comprising:

positioning a distal portion of a second elongated medical device within the collet of the deployment tool, such that the second elongated medical device is held external to and adjacent to the tool;

guiding the deployment tool to a desired location;

opening the collet;

retracting the tool, wherein the open collet slides along the second medical device; and

separating the collet from the second medical device by withdrawing a proximal portion of the medical device from a longitudinal groove disposed on the collet.

49. A method of implanting an epicardial lead, comprising:

attaching a distal portion of the epicardial lead to heart tissue;

positioning a proximal portion of the epicardial lead within a collet of a deployment tool having an elongated body, such that the epicardial lead is held external to and adjacent to the tool;

tunneling the deployment tool to a pocket created for holding an implantable medical device connectable to the epicardial lead;

opening the collet;

retracting the tool; and

separating the collet from the epicardial lead by withdrawing a distal portion of the epicardial lead from a longitudinal groove disposed on the collet.