Percutaneous driveline anchor devices and methods of use

Patent metadata

Field	Value
Publication number	US-10792407-B2
Application number	US-201815870051-A
Country	US
Kind code	B2
Filing date	Jan 12, 2018
Priority date	Jan 12, 2017
Publication date	Oct 6, 2020
Grant date	Oct 6, 2020

Abstract

Systems, methods, and devices for securing a driveline to a portion of skin are disclosed herein. The driveline can connect an external controller to an implantable blood pump. The skin anchor can include a driveline capture portion. The driveline capture portion can receive the driveline and fix a position of the driveline with respect to the driveline capture portion. The driveline capture portion includes: a driveline receiver that can receive the driveline; and a driveline anchor that can engage the driveline to fix the position of the driveline with respect to the driveline receiver. The skin anchor can include a force distribution portion. The force distribution portion can engage a portion of skin and fix a position of the portion of skin with respect to the force distribution portion.

First claim

What is claimed is:

1. A skin anchor for securing a percutaneous driveline to a portion of skin, the driveline connecting an external controller or power source to an implantable blood pump, the skin anchor comprising:
a driveline capture portion configured to receive the driveline and fix a position of the driveline with respect to the driveline capture portion, wherein the driveline capture portion comprises:
a driveline receiver configured to receive the driveline; and
a driveline anchor configured to engage the driveline to fix the position of the driveline with respect to the driveline receiver; and

a force distribution portion extending from the driveline and configured to engage a portion of the skin and fix a position of the force distribution portion with respect to the portion of the skin so as to secure the force distribution portion directly to the skin.

2. The skin anchor of claim 1 , wherein the force distribution portion comprises an enlarged member having a diameter larger than a diameter of the driveline and radially extending from the driveline when the driveline is received within the driveline capture portion.

3. The skin anchor of claim 1 , wherein the force distribution portion comprises a plurality of radially extendable tendrils.

4. The skin anchor of claim 3 , wherein each of the radially extendable tendrils comprises a first arcuate component oriented in a first direction and a second arcuate component oriented in a second direction, wherein the first direction is opposite the second direction, wherein each of the radially extendable tendrils comprises the first arcuate component contacting the second arcuate component.

5. A system for securing a driveline to a portion of skin via a skin anchor, the driveline electrically connecting an external controller and an implantable blood pump, the system comprising:
an implantable blood pump comprising a rotor and a stator;
an external controller configured to power the implantable blood pump and provide a control signal to the implantable blood pump;
a percutaneous driveline electrically connecting the implantable blood pump and the external controller, wherein the percutaneous driveline has a diameter; and
a skin anchor comprising:
a driveline capture portion configured to receive the driveline and fix a position of the driveline with respect to the driveline capture portion; and
a force distribution portion extending from the driveline and configured to engage a portion of the skin and fix a position of the force distribution portion with respect to the portion of the skin so as to secure the force distribution portion directly to the skin.

6. The system of claim 5 , wherein the force distribution portion comprises an enlarged member, having a diameter larger than a diameter of the driveline, and wherein the enlarged member radially extends from the driveline when the driveline is received within the driveline capture portion.

7. The system of claim 5 , wherein the force distribution portion comprises a plurality of radially deployable tendrils.

8. The system of claim 7 , wherein each of the radially deployable tendrils comprises a first blade oriented in a first direction and a second blade oriented in a second direction, wherein each of the first and second blades comprise a pair of ends and an arcuate component located between the pair of ends, wherein the first direction is opposite the second direction, and wherein the arcuate component of the first blade abuts the arcuate component of the second blade.

9. A method for affixing a driveline to a portion of skin, wherein the driveline electrically connects an external controller to an implantable blood pump, the method comprising:
implanting the implantable blood pump in a patient's body;
creating a driveline path through a patient's body;
connecting the driveline to a skin anchor via a driveline capture portion configured to receive the driveline and fix a position of the driveline with respect to the driveline capture portion, wherein the driveline capture portion comprises:
a driveline receiver configured to receive the driveline; and
a driveline anchor configured to engage the driveline to fix the position of the driveline with respect to the driveline receiver;

connecting the skin anchor to a portion of skin proximate to a port through which the driveline exits the patient's body via a force distribution portion extending from the driveline and configured to engage a portion of the skin so as to fix a position of the force distribution portion with respect to the portion of the skin and secure the force distribution portion directly to the skin; and
electrically connecting the external controller and the implantable blood pump.

10. The method of claim 9 , wherein the force distribution portion comprises an enlarged member radially extending from the driveline, and wherein connecting the skin anchor to the portion of skin proximate to the port through which the driveline exits the patient's body comprises subdermally positioning the force distribution adjacent to the portion of skin proximate to the port.

11. The method of claim 10 , wherein the enlarged member has a diameter that is at least one of: larger than the port; or larger than a diameter of the driveline.

12. The method of claim 9 , wherein connecting the skin anchor to a portion of skin proximate to a port through which the driveline exits the patient's body via a force distribution portion comprises: positioning the force distribution portion proximate to the portion of skin; and moving a plurality of radially extendable tendrils to a deployed position.

13. The method of claim 12 , wherein moving the plurality of radially extendable tendrils to a deployed position comprises redirecting first and second arcuate members through an annular ring of a stator from a longitudinal orientation to a radial orientation by centrally displacing a first slider ring connected to the first arcuate members and a second slider ring connected to the second arcuate members.

14. The method of claim 13 , wherein the first and second arcuate members exit the annular ring in the radial orientation, wherein the first arcuate member contacts the second arcuate member when the first and second arcuate members exit the annular ring.

15. The method of claim 14 , wherein the first and second slider rings are centrally displaced by displacement of a tug connected to the first slider ring via a first tendon and connected to the second slider ring via a second tendon, wherein the first and second tendons connect to the first and second slider rings such that displacement of the tug causes equal displacement of the first and second slider rings.

Assignees

• Tc1 Llc

Inventors

• Nguyen John Duc
• Hill John Donald
• Franco Fabian
• Eskildsen Chris
• Eldridge David Gary
• Hoarau Carine
• Woo Yi-Ren
• Hagerty John J
• Cardamone Pete

Classifications

• A61M39/0247 Primary

  Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body (peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053) · CPC title

• A61M2039/0261

  Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body · CPC title

• A61M2039/0258

  for vascular access, e.g. blood stream access · CPC title

• A61M60/861

  Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body · CPC title

• A61M60/183

  drawing blood from both ventricles, e.g. bi-ventricular assist devices [BiVAD] · CPC title