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WO2025080758A1 - Dispositif médical pour créer volontairement un défaut septal auriculaire correctif - Google Patents

Dispositif médical pour créer volontairement un défaut septal auriculaire correctif Download PDF

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Publication number
WO2025080758A1
WO2025080758A1 PCT/US2024/050648 US2024050648W WO2025080758A1 WO 2025080758 A1 WO2025080758 A1 WO 2025080758A1 US 2024050648 W US2024050648 W US 2024050648W WO 2025080758 A1 WO2025080758 A1 WO 2025080758A1
Authority
WO
WIPO (PCT)
Prior art keywords
leading
trailing
mechanical device
flange
atrial
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/050648
Other languages
English (en)
Inventor
Gladwin Das
Dilip DAS
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Eclipse Medical Inc
Original Assignee
Eclipse Medical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Eclipse Medical Inc filed Critical Eclipse Medical Inc
Publication of WO2025080758A1 publication Critical patent/WO2025080758A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3478—Endoscopic needles, e.g. for infusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B2017/1139—Side-to-side connections, e.g. shunt or X-connections

Definitions

  • Atrial shunts have long been explored as a remedial therapy for various medical conditions.
  • Atrial septal defects were created in a beating heart directly as described by Das et al (Circulation.l993;88(part 1 ): 1754- 1764).
  • the heart was exposed and using purse string sutures in the right atrial wall a simple punch device was introduced into the right atrial cavity.
  • An index finger was passed through a purse string suture in the left atrial appendage to guide the positioning of the tip of the punch at the right spot in the atrial septum.
  • the punch was then used to pierce the atrial septum and the punch opened by an assistant with a screw mechanism. When the atrial septum was seated in the slot for cutting, the punch was screwed back in the original position and a clean hole was punched out.
  • the purse string sutures were tightened to remove the finger and the punch, and the chest repaired, leaving a surgically created atrial septal defect.
  • Such a surgically created atrial septal defect in a beating canine heart was useful for testing transcatheter septal defect occluders.
  • a first aspect of the invention is a mechanical device operable for voluntarily creating a remedial atrial septal defect.
  • the device comprises an axially elongated cutter operable for incorporation into a vascular dilator that includes at least a leading axial length, a trailing axial length and an intermediate length between the leading axial length and trailing axial length.
  • Each of the leading axial length and trailing axial length have a leading flange and a trailing flange of defined diameter respectively, proximate a transition point to the intermediate length.
  • the intermediate length has a diameter less than the defined diameter of each of the leading flange and the trailing flange so as to provide a cylindrical gap between the leading flange and the trailing flange.
  • the leading flange has a circular sharp defining a knife edge axially projecting towards the cylindrical gap.
  • a second aspect of the invention is a sheathed vascular dilator that includes the mechanical device of the first aspect of the invention.
  • a first embodiment of the third aspect of the invention includes the steps of (i) creating a transeptal puncture in the atrial septum, (ii) positioning the cutter of the first aspect of the invention within the transeptal puncture until the atrial septum in seated within the cylindrical gap of the cutter, and (iii) withdrawing the cutter to effect cutting of an orifice in the atrial septum with the circular sharp on the cutter.
  • a second embodiment of the third aspect of the invention includes the steps of (i) creating a transeptal puncture into the left atrium using a sheathed trans-septal puncture catheter carrying a guidewire passed into the right atrium, (ii) exchanging out the sheath while leaving the guidewire extending through the puncture site and into the left atrium, (iii) loading the sheathed vascular dilator of the second aspect of the invention onto the guidewire,
  • Figure 1 is a side perspective view of one embodiment of the invention.
  • Figure 2 is a side perspective view of the vascular dilator component of the invention depicted in Figure 1.
  • Figure 3 is a side perspective view of the punch component of the invention depicted in Figure 1.
  • Figure 4 is a cross-sectional view of a human heart with a trans-septal puncture catheter positioned at the inter-atrial septum.
  • Figure 5 is a cross-sectional view of the human heart depicted in Figure 4 after trans-septal puncture of the inter-atrial septum with the trans-septal puncture catheter is completed.
  • Figure 6 is a cross-sectional view of the human heart depicted in Figure 5 after withdrawal of the trans-septal puncture tipped catheter and leaving a trans-septal guidewire.
  • Figure 8 is a cross-sectional view of the human heart depicted in Figure 7 after withdrawal of the sheath component of the invention so as to expose the punch component of the invention.
  • Figure 9 is a cross-sectional view of the human heart depicted in Figure 8 after the exposed punch component of the invention is pushed into position with the inter-atrial septum surrounding the trans-septal puncture extending into the cutting chamber gap defined by the punch.
  • Figure 10 is a cross-sectional view of the human heart depicted in Figure 9 after the punch has been pulled through the trans-septal puncture whereby the circular sharp (knife) on the punch has cut an atrial septal orifice through the inter-atrial septum.
  • Figure 11 is a cross-sectional view of the human heart depicted in Figure 10 after withdrawal of the guidewire.
  • Figure 12 is an orthogonally shifted cross-sectional view of the human heart depicted in Figure 11 to provide an enhanced view of the atrial septal orifice cut through the inter-atrial septum.
  • the invention is a sheathed vascular dilator punch 100 effective for creating a remedial atrial septal defect between the right atrium RA and left atrium LA of a heart H without involving or impact to the right or left ventricles RV and LV or the heart valves (not numbered).
  • An atrial shunt or atrial septal orifice ASO 6 to 8 mm in diameter allows the left atrium LA to shunt some blood directly to the right atrium RA - leading to a reduction of the left atrium LA pressure and hence alleviation of symptoms of dyspnea and heart failure.
  • Atrial shunts ASO do not have the side effects associated with medical therapy, such as dehydration, kidney injury or electrolyte imbalance. They do not lower the blood pressure or produce orthostatic hypotension. Hence there are attractive benefits.
  • the component is a punch 160 having a leading threaded length 161, a trailing threaded length 162 and an intermediate length 163.
  • the entire punch 160 can be about 30 mm long.
  • a lumen 169 passes through the axial length of the punch 160 with a diameter sufficient to permit passage of a guidewire GW, typically about 0.04” in diameter.
  • the diameter of the flanges 164 should be selected to fit within the vascular dilator 140.
  • flanges 164 having a diameter of 6 mm will fit within in a 6 mm (18 Fr.) vascular dilator 140 having an outer diameter of 6 mm.
  • the leading flange 164a has a circular sharp (knife edge) 165.
  • the sharp (knife edge) 165 may be serrated for better cutting of tissue.
  • the trailing flange 164b should not be machined.
  • the intermediate length 163 can be knurled to permit the punch 160 to be held firmly with an appliance/tool (not shown) when it is threaded onto the vascular dilator 140 and slid into the sheath 120.
  • the intermediate length 163 has a smaller diameter than the flanges 164 so as to create a cylindrical cutting chamber gap 168.
  • the leading flange 164a has a circular sharp (knife blade) 165 along the periphery of the inner facing surface. This can be attained by machining a circular groove within the edge.
  • the punch 160 can be incorporated into a vascular dilator 140 by (i) cutting the vascular dilator 140 about 10 cm from the leading end or tip 141 of the vascular dilator 140, (ii) drilling an appropriately sized axial extending hole into the center of both portions of the vascular dilator 140 from the cut end, and (iii) threading the leading and trailing lengths 161 and 162 of the punch 160 into the drilled holes in each of the leading and trailing lengths 141 and 142 of the vascular dilator 140 respectfully until snug.
  • the leading threaded length 161 of the punch 160 can be identified by the circular sharp (knife edge) 165 on the associated leading flange 164a.
  • the lumen 169 through the punch 160 will be in continuity with the central lumen 149 through the vascular dilator 140. Hence, the whole system can be introduced into the body over a guidewire GW.
  • the vascular dilator 140 with incorporated punch 160 can be introduced into the lumen 149 of the sheath 120. USE TO PRODUCE CARDIAC ATRIAL SEPTAL DEFECT AND SHUNT
  • a sheathed trans-septal puncture catheter PTC carrying a guidewire GW is used with image guidance to create a transeptal puncture (FIGs 4 and 5).
  • the puncture site should be spaced at least 5 mm in each cardinal direction from the edges of the atrial septum AS to prevent adverse impact upon the overall structural integrity of the heart H after removal of tissue surrounding of the puncture site. For instance, to prevent perforation of the walls of the atrium or perforation into the aorta.
  • the sheathed vascular dilator punch 100 can be loaded onto the guidewire GW outside the body. Using a side-arm, the sheathed vascular dilator punch 100 should be flushed with saline to remove air bubbles.
  • the sheathed vascular dilator punch 100 can be introduced into the right femoral vein (not shown) and slowly passed until the tip of the vascular dilator 140 is against the atrial septum AS.
  • the tip of the vascular dilator 140 can be pushed across the atrial septum AS a distance to ensure seating of the leading end 141 of the vascular dilator 140 within the left atrium LA (FIG 7) but with the cutting chamber gap 168 of the punch 160 still located in the right atrium RA, at which time the sheath 120 can be withdrawn a sufficient distance, typically about 10 mm, to expose the cutting chamber gap 168 of the punch 160 in the right atrium RA (Fig 8).
  • the vascular dilator 140 can then be slowly advanced while holding the sheath 120 and vascular dilator 140 together until the atrial septum AS is seated within the cutting chamber gap 168 (Fig 9). Imaging can be used to ensure that the atrial septum AS is well seated within the cutting chamber gap 168.
  • the sheath 120 can then be slowly advanced until it is at the atrial septum AS.
  • the vascular dilator 140 can then be withdrawn with a firm but steady force while holding the sheath 120 in position to cut an orifice into the atrial septum AS with the circular sharp (knife) 165 on the punch 160 and retract the punch 160 back inside the sheath 120.
  • the entire length of the vascular dilator 140 can then be withdrawn to the right atrium RA (Fig 10) leaving the guidewire GW in place across the atrial septal orifice ASO cut into the atrial septum AS. Once the atrial septal orifice ASO has been confirmed to be of the appropriate size, the guide wire GW can be removed. (Figs 11 and 12).

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pathology (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif mécanique pour créer volontairement un défaut septal auriculaire correctif, un dilatateur vasculaire gainé qui comprend le dispositif mécanique, et des procédés pour créer volontairement un défaut septal auriculaire correctif dans un septum auriculaire à l'aide du dispositif mécanique. Le dispositif mécanique comprend des ailettes d'attaque et de fuite séparées par un espace circulaire avec un tranchant circulaire formé sur la bride d'attaque qui fait saillie vers l'espace circulaire.
PCT/US2024/050648 2023-10-11 2024-10-10 Dispositif médical pour créer volontairement un défaut septal auriculaire correctif Pending WO2025080758A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363589454P 2023-10-11 2023-10-11
US63/589,454 2023-10-11

Publications (1)

Publication Number Publication Date
WO2025080758A1 true WO2025080758A1 (fr) 2025-04-17

Family

ID=95396324

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/050648 Pending WO2025080758A1 (fr) 2023-10-11 2024-10-10 Dispositif médical pour créer volontairement un défaut septal auriculaire correctif

Country Status (1)

Country Link
WO (1) WO2025080758A1 (fr)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5899915A (en) * 1996-12-02 1999-05-04 Angiotrax, Inc. Apparatus and method for intraoperatively performing surgery
US20120071812A1 (en) * 2007-07-11 2012-03-22 Vladimir Mitelberg Methods and Systems for Submucosal Implantation of a Device for Diagnosis and Treatment with a Therapeutic Agent
US20190374254A1 (en) * 2017-02-10 2019-12-12 Texas Medical Center Transcatheter device for interatrial anastomosis
US20200261704A1 (en) * 2017-10-31 2020-08-20 Hangzhou Naya Medtech Co., Ltd Devices, systems, and methods for interatrial shunts
US20200289196A1 (en) * 2017-11-30 2020-09-17 Alleviant Medical, Inc. Transcatheter device for interatrial anastomosis
US20210346029A1 (en) * 2020-05-06 2021-11-11 Evalve, Inc. Clip removal systems and methods
US20220323094A1 (en) * 2014-06-13 2022-10-13 InterShunt Technologies, Inc. Method and septostomy device for creating an interatrial aperture
US20230041021A1 (en) * 2020-01-29 2023-02-09 Baylis Medical Company Inc. Guidewire for reducing hoop stress

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5899915A (en) * 1996-12-02 1999-05-04 Angiotrax, Inc. Apparatus and method for intraoperatively performing surgery
US20120071812A1 (en) * 2007-07-11 2012-03-22 Vladimir Mitelberg Methods and Systems for Submucosal Implantation of a Device for Diagnosis and Treatment with a Therapeutic Agent
US20220323094A1 (en) * 2014-06-13 2022-10-13 InterShunt Technologies, Inc. Method and septostomy device for creating an interatrial aperture
US20190374254A1 (en) * 2017-02-10 2019-12-12 Texas Medical Center Transcatheter device for interatrial anastomosis
US20200261704A1 (en) * 2017-10-31 2020-08-20 Hangzhou Naya Medtech Co., Ltd Devices, systems, and methods for interatrial shunts
US20200289196A1 (en) * 2017-11-30 2020-09-17 Alleviant Medical, Inc. Transcatheter device for interatrial anastomosis
US20230041021A1 (en) * 2020-01-29 2023-02-09 Baylis Medical Company Inc. Guidewire for reducing hoop stress
US20210346029A1 (en) * 2020-05-06 2021-11-11 Evalve, Inc. Clip removal systems and methods

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