Implements for identifying sheath migration

• US 9,492,638 B2
• Filed: 10/31/2013
• Issued: 11/15/2016
• Est. Priority Date: 11/01/2012
• Status: Active Grant

• Current Assignee: Muffin Incorporated
• Original Assignee: Muffin Incorporated
• Inventors: McKinnis, Peter S., Fearnot, Neal E., Klausen, Kasper
• Primary Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US14/068,737
• Publication Number:
  US 20140121643A1
• Time in Patent Office: 1,111 Days
• Field of Search: 600/424, 604/174, 604/177, 604/533
• US Class Current: 1/1
• CPC Class Codes: A61B 2050/314 Flexible bags or pouches
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61B 2090/0812 indicating loosening or shifting of parts of an instrument, signaling maladjustment of parts
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 90/94 coded with symbols, e.g. text
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B

Abstract

Attachable implements, systems, and methods for identifying the migration of a medical device extending through a percutaneous insertion site of a patient'"'"'s skin are disclosed. In one embodiment, an attachable implement for identifying migration comprises a attachable implement body having a coupling surface and a skin contacting surface, the coupling surface arranged to couple to a surface of the medical device, and the skin contacting surface arranged to contact the skin of the patient; wherein the attachable implement body is arranged to be side mountable on the medical device and wherein the attachable implement is configured to move from a first position adjacent to the patient'"'"'s skin to a second position remote from the patient'"'"'s skin. Systems, methods, and other embodiments are disclosed.

Claims

1. An attachable implement for identifying migration of an elongate medical device that extends through the skin of a patient, comprising:

an attachable implement body comprising a first coupling surface and a first skin contacting surface on a first portion and a second coupling surface and a second skin contacting surface on a second portion;

said first and second portions configurable from an open configuration to a closed configuration; and

a biasing member arranged to bias the first and second portions from the open configuration into the closed configuration;

wherein said first and second coupling surfaces are arranged to couple to an outer surface of the elongate medical device;

wherein said first and second skin contacting surfaces are arranged to contact the skin of the patient;

wherein in said open configuration said attachable implement body is arranged to be mountable onto the elongate medical device from a direction transverse to a longitudinal axis of the elongate medical device and receive the elongate medical device between the first and second portions;

wherein when said attachable implement body is mounted onto the elongate medical device the elongate medical device extends in a direction transverse to said first and second skin contacting surfaces; and

wherein when in said closed configuration around the elongate medical device, said attachable implement body is configured to move with the elongate medical device from a first position where the first and second skin contacting surfaces are adjacent to the patient'"'"'s skin to a second position where the first and second skin contacting surfaces are remote from the patient'"'"'s skin, such that an operator may identify that the elongate medical device has migrated.

2. The attachable implement of claim 1, wherein:

said first and second portions are pivotably coupled to one another.

3. The attachable implement of claim 1, wherein:

said first and second portions are slidably coupled to one another.

4. The attachable implement of claim 1, further comprising:

a recess defined by said first and second portions and arranged to receive a portion of the elongate medical device.

14. A method for detecting movement of a heath implanted through the skin of a patient using the attachable implement of claim 1, comprising:

coupling the attachable implement to the sheath at a location proximal to the skin of the patient;

advancing a vascular device through the sheath; and

monitoring the attachable implement for movement before and after advancing the vascular device through the sheath so as to detect movement of the medical device.

15. The attachable implement of claim 1, comprising:

a catch member extending from said first portion and arranged to couple said first portion to said second portion when said first and second portions are in said closed configuration.

5. A kit, comprising:

a sheath;

an inner catheter; and

an attachable implement for identifying migration of said sheath when said sheath extends through the skin of a patient;

the attachable implement including an attachable implement body having a first coupling surface and a first skin contacting surface on a first portion and a second coupling surface and a second skin contacting surface on a second portion, the first and second coupling surfaces having an adherent material positioned thereon;

said first and second portions configurable from an open configuration to a closed configuration wherein the first and second coupling surfaces face one another;

said first and second coupling surfaces arranged to mate with an outer surface of said sheath;

said first and second skin contacting surfaces arranged to contact the skin of the patient; and

said adherent material positioned on said first and second coupling surfaces arranged to adhere said first and second coupling surfaces to the outer surface of said sheath;

wherein said attachable implement body is configured to move with said sheath from a first position where the first and second skin contacting surfaces are adjacent to the patient'"'"'s skin to a second position where the first and second skin contacting surfaces are remote from the patient'"'"'s skin, such that an operator may identify that said sheath has migrated;

wherein said attachable implement body requires a force of greater than 2 Newtons when in said closed configuration around said sheath to slide said attachable implement along a length of said sheath; and

wherein said inner catheter is slidably receivable within said sheath when said attachable implement is in said closed configuration around said sheath.

6. The it claim 5, further comprising:

a removable film positioned over said adherent material and arranged to protect said adherent material prior to adherence to said sheath.

7. The kit of claim 5, wherein:

said first and second portions are pivotably coupled to one another.

8. The kit of claim 5, wherein:

said first and second portions are slidably coupled to one another.

9. The kit of claim 5, further comprising:

a recess defined by said first and second portions and arranged to receive a portion of said sheath.

10. The kit of claim 5, further comprising:

a biasing member arranged to bias the first and second portions from said open configuration into said closed configuration or from said closed configuration into said open configuration.

11. The kit of claim 10, wherein:

said biasing member biases said first and second portions from said open configuration into said closed configuration.

16. The kit of claim 5, wherein:

said attachable implement includes a catch member extending from said first portion and arranged to couple said first portion to said second portion when said first and second portions are in said closed configuration.

12. An attachable implement for identifying migration of a medical device that extends through the skin of a patient, comprising:

an attachable implement body comprising a coupling surface, an adherent material, and a skin contacting surface;

the attachable implement configurable from an open configuration to a closed configuration;

a biasing member arranged to bias the attachable implement from the open configuration into the closed configuration;

said coupling surface arranged to mate with a surface of the medical device;

said skin contacting surface arranged to contact the skin of the patient; and

said adherent material positioned on said coupling surface and arranged to adhere said coupling surface to the surface of the medical device;

wherein said attachable implement body is arranged to be mountable onto the medical device from a direction transverse to a longitudinal axis of the medical device; and

wherein said attachable implement body is configured to move with the medical device from a first position where the skin contacting surface is adjacent to the patient'"'"'s skin to a second position where the skin contacting surface is remote from the patient'"'"'s skin, such that an operator may identify that the medical device has migrated.

13. The attachable implement of claim 12, further comprising:

a removable film positioned over said adherent material and arranged to protect said adherent material prior to attachment to the medical device.

17. The attachable implement of claim 12, comprising:

a catch member extending from a first portion of said attachable implement and arranged to couple said first portion to a second portion of said attachable implement when said attachable implement is in said closed configuration.