INTRODUCTION AND ANCHORING TOOL FOR AN IMPLANTABLE MEDICAL DEVICE ELEMENT

• US 20140324064A1
• Filed: 11/01/2012
• Published: 10/30/2014
• Est. Priority Date: 11/10/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Kern, Michael J., Behymer, Bruce A., Mehdizadeh, Bruce R.
• Granted Patent: US 10,206,710 B2
• Time in Patent Office: Days
• US Class Current: 606/108
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• 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: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

The invention pertains to an apparatus comprising a needle configured to define a path through tissue of a patient, tubing configured to slidably receive the needle via a proximal opening, an anchor configured to slidably receive at least a portion of the tubing, and an anchor deployment member comprising a body and an anchor engagement member. Such an apparatus may be used to introduce and anchor an implantable medical device element within a patient.

Claims

1. An apparatus comprising:

a first elongated member defining a proximal end and a distal end, the first elongated member configured to define a path through tissue of a patient for insertion of an implantable medical device element into the path;

a second elongated member defining a proximal opening, a distal opening, and a lumen extending between the proximal opening and the distal opening, the lumen configured to slidably receive at least a portion of the first elongated member and at least a portion of the implantable medical device element via the proximal opening; and

an anchor deployment member comprising;

a body defining a channel through which the first elongated member, the second elongated member, and the implantable medical device element are slidable, and

an anchor engagement member configured to bear against an anchor when the second elongated member is moved in a proximal direction relative to the body such that the second elongated member is withdrawn from an anchor lumen defined by the anchor, wherein the anchor secures the implantable medical device element in the path.

2. The apparatus of claim 1, further comprising the anchor defining the anchor lumen, wherein the anchor lumen is configured to slidably receive at least a portion of the second elongated member.

3. The apparatus of claim 1, wherein the first elongated member comprises a needle, wherein the distal end of the needle is configured to tunnel through tissue of the patient.

4. The apparatus of claim 1, wherein the first elongated member defines a lumen configured to slidably receive the implantable medical device element.

5. The apparatus of claim 1, further comprising at least one actuator coupled to the second elongated member, wherein the at least one actuator is configured such that movement of the at least one actuator toward the proximal opening causes movement of the second elongated member toward the proximal opening.

6. The apparatus of claim 5, wherein the second elongated member is configured such that the movement of the second elongated member toward the proximal opening comprises movement of the second elongated member relative to the anchor.

7. The apparatus of claim 1, further comprising at least one distance marking on an outer surface of the body of the anchor deployment member, wherein the at least one distance marking is visually indicative of a position of the second elongated member relative to the anchor deployment member.

8. The apparatus of claim 1, wherein the anchor engagement element is separable from the body of the anchor engagement element, wherein the anchor engagement element is configured to substantially completely enclose the implantable medical device element.

9. The apparatus of claim 2, wherein the anchor comprises at least one of suture holes, a low-profile anchor, a sinusoidal configuration, or tines.

10. A method comprising:

defining a path through tissue of a patient for insertion of an implantable medical device element into the path, wherein defining the path through tissue of the patient comprises tunneling through tissue of the patient with a first elongated member of a medical device apparatus, wherein the medical device apparatus comprises;

the first elongated member defining a proximal end and a distal end,

a second elongated member defining a proximal opening, a distal opening, and a lumen extending between the proximal opening and the distal opening, the lumen configured to slidably receive at least a portion of the first elongated member and at least a portion of the implantable medical device via the proximal opening, and

an anchor deployment member comprising;

a body defining a channel through which the first elongated member, the second elongated member, and the implantable medical device element are slidable, and

an anchor engagement member configured to bear against an anchor when the second elongated member is moved in a proximal direction relative to the body such that the second elongated member is withdrawn from an anchor lumen defined by the anchor, wherein the anchor secures the implantable medical device element in the path.

11. The method of claim 10, further comprising, prior to defining the path through tissue of the patient, inserting the first elongated member into the second elongated member, wherein defining the path through tissue of the patient comprises tunneling the first and second elongated members through tissue of the patient.

12. The method of claim 11, further comprising withdrawing the first elongated member from the second elongated member.

13. The method of claim 11, further comprising inserting the implantable medical device element into the lumen of the second elongated member via the proximal opening of the second elongated member.

14. The method of claim 13, further comprising withdrawing the second elongated member to expose at least a portion of the implantable medical device element.

15. The method of claim 14, further comprising deploying the anchor around the exposed portion of the implantable medical device element, wherein the anchor lumen is configured to slidably receive at least a portion of the second elongated member and the implantable medical device element.

16. The method of claim 15, wherein deploying the anchor around the exposed portion of the implantable medical device element comprises moving the second elongated member in a proximal direction relative to the body of the anchor deployment member such that the second elongated member is withdrawn from the anchor lumen.

17. The method of claim 15, wherein deploying the anchor around the exposed portion of the implantable medical device element comprises suturing the anchor to tissue of the patient.

18. The method of claim 15, further comprising withdrawing the second elongated member from tissue of the patient.

19. The method of claim 10, wherein tunneling through tissue of the patient with a first elongated member of a medical device apparatus comprises tunneling through tissue of the patient with a first elongated member of a medical device apparatus to a target tissue site within the patient.

20. A system comprising:

an implantable medical device element configured to deliver therapy to a target tissue site within a patient; and

an apparatus comprising;

a first elongated member defining a proximal end and a distal end, the first elongated member configured to define a path through tissue of a patient for insertion of the implantable medical device element into the path,

a second elongated member defining a proximal opening, a distal opening, and a lumen extending between the proximal opening and the distal opening, the lumen configured to slidably receive at least a portion of the first elongated member and at least a portion of the implantable medical device element via the proximal opening, and

an anchor deployment member comprising;

a body defining a channel through which the first elongated member, the second elongated member, and the implantable medical device element are slidable, and

an anchor engagement member configured to bear against an anchor when the second elongated member is moved in a proximal direction relative to the body such that the second elongated member is withdrawn from an anchor lumen defined by the anchor, wherein the anchor secures the implantable medical device element in the path.

21. The system of claim 20, wherein the apparatus further comprises the anchor defining the anchor lumen, wherein the anchor lumen is configured to slidably receive at least a portion of the second elongated member.

22. The system of claim 21, wherein the implantable medical device element comprises at least one of a medical lead configured to deliver electrical stimulation therapy to the patient or a catheter configured to deliver drug therapy to the patient.