Subcutaneous catheter retainer

• US 9,138,563 B2
• Filed: 03/30/2007
• Issued: 09/22/2015
• Est. Priority Date: 03/31/2006
• Status: Expired due to Fees

• Current Assignee: Stealth Therapeutics, Inc.
• Original Assignee: Stealth Therapeutics, Inc.
• Inventors: Glenn, Bradley J.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US11/731,172
• Publication Number:
  US 20070232997A1
• Time in Patent Office: 3,098 Days
• Field of Search: 604/103.03, 604/104, 604/105, 604/164.01, 604/523, 604106-109, 604/17, 606/192, 606/194, 606/200, 606/244
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61M 2025/0293 Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

A retainer is provided which can be affixed to a medical tube, such as a catheter, or formed with the tube. The retainer has a base portion which is fixed to the tube. An expandable width portion is coupled to the base portion. This expandable width portion can transition between a collapsed configuration and an expanded configuration, with the expanded configuration wider than the base portion and the collapsed configuration narrower than the expanded configuration. This retainer is located on a portion of the tube which is subcutaneous but near the skin. After the tube is positioned where desired, the retainer is transitioned from the collapsed configuration to the expanded configuration. The retainer then resists removal of the tube, due to the expanded width of the retainer and its location beneath the skin. The tube fitted with the retainer can be a PICC line or other form of medical tube.

Claims

1. A method for retaining a skin penetrating medical tube at an implant site, the method including the steps of:

selecting a retainer including a base portion attached to a subcutaneous portion of a medical tube spaced from a discharge end of the medical tube;

an expandable width portion adapted to be coupled to the base portion; and

the expandable width portion having at least two configurations including an expanded configuration with a width greater than the base portion, and a collapsed configuration with a width less than the width of the expanded configuration, the retainer attached to the medical tube;

implanting the medical tube with the distal discharge end penetrating a body lumen or vessel and adapted to transfer fluids between the body lumen and the medical tube, with the retainer outside of the body lumen or vessel that the medical tube penetrates and below the skin; and

transitioning the expandable width portion of the retainer from the collapsed configuration to the expanded configuration with the expandable width portion below the skin and outside of the body lumen or vessel that the medical tube penetrates;

wherein said implanting step includes the steps of;

forming an opening in the skin;

forming an opening in a body lumen;

routing the implanted end of the medical tube through the opening in the skin and through the opening in the lumen with the medical tube having the implanted end located inside the body lumen and an access end opposite the implanted end located outside of the body, and with the retainer between the skin and the body lumen;

wherein said selecting step includes the base portion of the retainer configured to include a fixed sleeve adapted to at least partially surround the subcutaneous portion of the medical tube and be affixed to the medical tube at a location on the medical tube spaced from the discharge end and outside of the body lumen, the retainer including a sliding sleeve having a bore with a portion of the medical tube routed through the bore, the sliding sleeve adapted to slide along the medical tube, and with an expandable width wing interposed between the sliding sleeve and the fixed sleeve;

the further step of sliding the sliding sleeve toward the fixed sleeve to transition the retainer from a narrower form to a wider form, such that the expandable width portion is transitioned from the collapsed configuration to the expanded configuration beneath the skin and outside of the body lumen; and

wherein said sliding sleeve includes a pair of tabs extending toward said fixed sleeve, and wherein said fixed sleeve includes a pair of grooves, said grooves at least as wide as said tabs, said tabs sliding into said grooves during said sliding step.

2. The method of claim 1 wherein said selecting step includes the retainer mechanically affixed to the medical tube.

3. The method of claim 1 wherein said selecting step includes the retainer bonded to the medical tube.

4. The method of claim 1 wherein said selecting step includes the retainer formed along with the medical tube during a medical tube forming process.

5. The method of claim 1 including the further step of configuring the sliding sleeve to include a handle extending therefrom, said handle having an elongate form with a distal end coupled to said sliding sleeve and a proximal end adapted to be gripped by a user to hold said sliding sleeve in position while said fixed sleeve and said medical tube are drawn toward said sliding sleeve during said sliding step.

6. The method of claim 5 wherein said sliding step includes the step of pulling on a proximal end of the medical tube while holding the sliding sleeve stationary to cause expansion of the retainer, with said discharge end of the medical tube remaining within the body lumen.

7. The method of claim 6 wherein said sliding step includes using the handle to keep the sliding sleeve at a transcutaneous position during said sliding step.

8. A method for retaining a skin penetrating medical tube at an implant site, the method including the steps of:

selecting a retainer including a base portion attached to a subcutaneous portion of a medical tube spaced from a discharge end of the medical tube;

an expandable width portion adapted to be coupled to the base portion; and

the expandable width portion having at least two configurations including an expanded configuration with a width greater than the base portion, and a collapsed configuration with a width less than the width of the expanded configuration, the retainer attached to the medical tube;

implanting the medical tube with the distal discharge end penetrating a body lumen or vessel and adapted to transfer fluids between the body lumen and the medical tube, with the retainer outside of the body lumen or vessel that the medical tube penetrates and below the skin; and

transitioning the expandable width portion of the retainer from the collapsed configuration to the expanded configuration with the expandable width portion below the skin and outside of the body lumen or vessel that the medical tube penetrates;

wherein said implanting step includes the steps of;

forming an opening in the skin;

forming an opening in a body lumen;

routing the implanted end of the medical tube through the opening in the skin and through the opening in the lumen with the medical tube having the implanted end located inside the body lumen and an access end opposite the implanted end located outside of the body, and with the retainer between the skin and the body lumen;

wherein said selecting step includes the base portion of the retainer configured to include a fixed sleeve adapted to at least partially surround the subcutaneous portion of the medical tube and be affixed to the medical tube at a location on the medical tube spaced from the discharge end and outside of the body lumen, the retainer including a sliding sleeve having a bore with a portion of the medical tube routed through the bore, the sliding sleeve adapted to slide along the medical tube, and with an expandable width wing interposed between the sliding sleeve and the fixed sleeve;

the further step of sliding the sliding sleeve toward the fixed sleeve to transition the retainer from a narrower form to a wider form, such that the expandable width portion is transitioned from the collapsed configuration to the expanded configuration beneath the skin and outside of the body lumen;

configuring the sliding sleeve to include a handle extending therefrom, said handle having an elongate form with a distal end coupled to said sliding sleeve and a proximal end adapted to be gripped by a user to hold said sliding sleeve in position while said fixed sleeve and said medical tube are drawn toward said sliding sleeve during said sliding step; and

wherein a pivot joint is provided between said handle and said sliding sleeve to facilitate pivoting of said handle relative to said sliding sleeve.

9. A method for retaining a skin penetrating medical tube at an implant site, the method including the steps of:

selecting a retainer including a base portion attached to a subcutaneous portion of a medical tube spaced from a discharge end of the medical tube;

an expandable width portion adapted to be coupled to the base portion; and

the expandable width portion having at least two configurations including an expanded configuration with a width greater than the base portion, and a collapsed configuration with a width less than the width of the expanded configuration, the retainer attached to the medical tube;

implanting the medical tube with the distal discharge end penetrating a body lumen or vessel and adapted to transfer fluids between the body lumen and the medical tube, with the retainer outside of the body lumen or vessel that the medical tube penetrates and below the skin; and

transitioning the expandable width portion of the retainer from the collapsed configuration to the expanded configuration with the expandable width portion below the skin and outside of the body lumen or vessel that the medical tube penetrates;

wherein said implanting step includes the steps of;

forming an opening in the skin;

forming an opening in a body lumen;

routing the implanted end of the medical tube through the opening in the skin and through the opening in the lumen with the medical tube having the implanted end located inside the body lumen and an access end opposite the implanted end located outside of the body, and with the retainer between the skin and the body lumen;

wherein said selecting step includes the base portion of the retainer configured to include a fixed sleeve adapted to at least partially surround the subcutaneous portion of the medical tube and be affixed to the medical tube at a location on the medical tube spaced from the discharge end and outside of the body lumen, the retainer including a sliding sleeve having a bore with a portion of the medical tube routed through the bore, the sliding sleeve adapted to slide along the medical tube, and with an expandable width wing interposed between the sliding sleeve and the fixed sleeve;

the further step of sliding the sliding sleeve toward the fixed sleeve to transition the retainer from a narrower form to a wider form, such that the expandable width portion is transitioned from the collapsed configuration to the expanded configuration beneath the skin and outside of the body lumen;

configuring the sliding sleeve to include a handle extending therefrom, said handle having an elongate form with a distal end coupled to said sliding sleeve and a proximal end adapted to be gripped by a user to hold said sliding sleeve in position while said fixed sleeve and said medical tube are drawn toward said sliding sleeve during said sliding step;

wherein said sliding step includes the step of pulling on a proximal end of the medical tube while holding the sliding sleeve stationary to cause expansion of the retainer, with said discharge end of the medical tube remaining within the body lumen;

wherein said sliding step includes using the handle to keep the sliding sleeve at a transcutaneous position during said sliding step; and

rotating the handle about a pivot joint provided between said handle and said sliding sleeve to move the handle against a proximal end of the medical tube and securing the handle to the proximal end of the medical tube to secure the retainer in the expanded configuration.

10. The method of claim 9 wherein the proximal end of the medical tube includes a hub at the proximal end having greater width than portions of said medical tube extending distally from the hub, the handle abutting against the hub at an end of the handle opposite the sliding sleeve so that the handle prevents the sliding sleeve from sliding toward the hub at the proximal end of the medical tube by the handle interposed therebetween.

11. The method of claim 9 wherein the fixed sleeve is fixed to the medical tube with teeth extending inward from an inwardly facing attachment surface, the teeth engaging the medical tube to hold the fixed sleeve to the medical tube.

12. The method of claim 11 wherein the teeth are biased to resist fixed sleeve motion relative to the medical tube to a grater extent when pulling said proximal end of said medical tube relative to said handle and said sliding sleeve, than when forces are applied in an opposition direction.

13. The method of claim 12 wherein the biasing of the teeth includes the teeth having a shape with a proximal side more sloped than a distal side.