Vascular anchoring introducer sheath

Patent metadata

Field	Value
Publication number	US-2022008060-A1
Application number	US-202117385230-A
Country	US
Kind code	A1
Filing date	Jul 26, 2021
Priority date	Oct 25, 2016
Publication date	Jan 13, 2022
Grant date	—

Abstract

Among other things, there is disclosed structure and methods for maintaining access to a location in the body while reducing or eliminating the potential for pulling an access device (e.g. a catheter) back through an opening. An introducer sheath includes a distal indented portion and a balloon, so that once placed in a desired location through tissue, the balloon can be inflated to anchor the sheath against retraction. In particular embodiments, structure and methods for accessing the pericardial cavity via the right atrial appendage are shown.

First claim

1 - 8 . (canceled)

9 . A method of accessing a pericardial cavity of a patient via a right atrial appendage of the patient with an introducer sheath, comprising:
inserting the introducer sheath into the inferior vena cava of the patient, the introducer sheath having a curved medial portion and a linear distal portion, the linear distal portion including an indented portion around the entire circumference and a balloon in a deflated condition within the indented portion so that no part of the balloon extends beyond a maximum outer diameter of the linear distal portion or outside of the indented portion; moving the introducer sheath to the right atrium of the heart of the patient to a position adjacent the right atrial appendage; passing the sheath through the right atrial appendage to the pericardial cavity so that the indented portion is within the pericardial cavity; inflating the balloon within the pericardial cavity, wherein the inflating does not enlarge a hole through the right atrial appendage through which the sheath passes; and engaging the balloon with tissue of the right atrial appendage that faces the pericardial cavity.

10 . The method of claim 9 , wherein the introducer sheath is the introducer sheath of claim 1 .

11 . The method of claim 9 , further comprising imaging the sheath when the sheath extends through the right atrial appendage, and confirming that a marker abutting a proximal edge of the indented section is beyond the tissue of the right atrial appendage before performing the inflating step.

12 . The method of claim 9 , wherein a dilator is within and extending from the sheath, and the passing step includes dilating a hole through the right atrial appendage with the dilator.

13 . The method of claim 9 , further comprising passing one or more devices through the sheath and into the pericardial cavity for use in a treatment procedure after said engaging step, and while the balloon is inflated and engaged with tissue of the right atrial appendage.

14 . The method of claim 13 , wherein the one or more devices includes a belt for placement in the atrioventricular groove as a treatment for tricuspid valve regurgitation.

15 . The method of claim 9 , further comprising deflating the balloon so that the balloon collapses to a condition within the indented portion so that no part of the balloon extends beyond a maximum outer diameter of the linear distal portion or outside of the indented portion.

16 . The method of claim 15 , further comprising a disengaging step between the engaging and deflating step, wherein the disengaging step includes moving the sheath with respect to the right atrial appendage to move the balloon away from tissue of the right atrial appendage that faces the pericardial cavity.

17 . A method of accessing a pericardial cavity of a patient with an introducer sheath, comprising:
inserting the introducer sheath into the inferior vena cava of the patient, the introducer sheath having a balloon in a deflated condition; moving the introducer sheath into the heart of the patient; passing the sheath through a wall of the heart to the pericardial cavity so that the balloon is within the pericardial cavity; inflating the balloon within the pericardial cavity; and engaging the balloon with tissue of the wall of the heart that faces the pericardial cavity.

18 . The method of claim 17 , wherein the introducer sheath has a curved medial portion and a linear distal portion, the linear distal portion including an indented portion around the entire circumference and a balloon in a deflated condition within the indented portion.

19 . The method of claim 17 , further comprising passing one or more devices through the sheath and into the pericardial cavity for use in a treatment procedure after said engaging step, and while the balloon is inflated and engaged with tissue of the wall of the heart.

20 . The method of claim 19 , wherein the one or more devices includes a belt for placement in an atrioventricular groove of the heart as a treatment for tricuspid valve regurgitation.

21 . A method of delivering an implant to a pericardial cavity of a patient, comprising:
inserting an introducer sheath into the inferior vena cava of the patient, the introducer sheath having a balloon in a deflated condition, and introducer sheath further having a lumen extending to an opening at a distal end of the introducer sheath; moving the introducer sheath into the heart of the patient; passing the sheath through a wall of the heart to the pericardial cavity so that the balloon is within the pericardial cavity; inflating the balloon within the pericardial cavity; engaging the balloon with tissue of the wall of the heart that faces the pericardial cavity; and passing the implant through the lumen and out of the opening at the distal end of the introducer sheath.

22 . The method of claim 21 , wherein the implant comprises an annuloplasty belt.

23 . A method of accessing a pericardial cavity of a patient with an introducer sheath, comprising:
positioning a distal end of the introducer sheath within the heart of the patient; passing the distal end of the sheath through a wall of the heart to position the distal end of the sheath and a balloon of the introducer sheath in the pericardial cavity; inflating the balloon within the pericardial cavity; and engaging the inflated balloon with external tissue of the wall of the heart that faces the pericardial cavity.

24 . The method of claim 23 , wherein said wall of the heart is a wall of a right atrial appendage of the heart.

25 . The method of claim 24 , wherein said positioning includes passing the distal end of the sheath through a vena cava of the patient and into the heart of the patient.

26 . The method of claim 25 , wherein said engaging the inflated balloon includes contacting said external tissue of the wall of the heart with a surface of the inflated balloon, wherein said surface of the inflated balloon extends at an angle between and including about 60 to about 90 degrees relative to a longitudinal axis of the introducer sheath.

27 . The method of claim 26 , wherein the introducer sheath has a curved medial portion and a linear distal portion, the linear distal portion including an indented portion around the entire circumference and a balloon within the indented portion, wherein the balloon is in a deflated condition during said passing step.

28 . The method of claim 25 , also comprising, after said engaging, passing an annuloplasty belt through a lumen of the introducer sheath and out of an opening at the distal end of the introducer sheath.

Assignees

• Muffin Inc
• Nat Institutes Of Health An Agency Of The Department Of Health And Human Services

Inventors

• Gittard Shaun Davis
• Hardy Gregory James
• Sigmon Jr John C
• Newkirk Jeremy T
• Havel William J
• Fearnot Neal E
• Rogers Toby
• Ratnayaka Kanishka
• Lederman Robert L

Classifications

• A61M25/0041 Primary

  pre-formed, e.g. specially adapted to fit with the anatomy of body channels (urethral catheters A61F2/04) · CPC title

• A61B2017/00955

  thermoplastic · CPC title

• A61M25/0052

  Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port · CPC title

• A61M25/0108

  using radio-opaque or ultrasound markers · CPC title

• A61B2017/0225

  flexible, e.g. fabrics, meshes, or membranes · CPC title