Amplatz sheath and dilation system

Inventor: Tobias Hochburger (Rosenheim, DE)

Assignee: UROTECH GMBH

A61M25/0662 A61M25/1027 A61M29/02 A61M2025/0008 A61M2025/1079

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Quick Facts

Patent No.: US 12685843
App. No.: 18/026,629
Granted: Jul 21, 2026
Kind: B2

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Abstract

An Amplatz sheath for positioning inside a natural or artificially created bodily cavity in a human or animal has a distal end toward the body and a proximal end away from the body, with at least one lumen being formed between the distal end and the proximal end. At least in a region at the proximal end, the Amplatz sheath is transparent or translucent and, in this region, has at least one marking for determining the position of the Amplatz sheath in relation to a catheter that can be received in the lumen. The Amplatz sheath can be used with a balloon catheter in a dilation system.

Claims (19)

1 . A dilation system ( 20 ) for positioning an Amplatz sheath ( 10 ) within a natural or artificially created bodily cavity of a body of a human or animal, comprising an Amplatz sheath ( 10 ) and a balloon catheter ( 22 ),

wherein the Amplatz sheath ( 10 ) comprises a distal end ( 12 ) toward the body and a proximal end ( 14 ) away from the body, wherein at least one lumen ( 16 ) is formed between the distal and the proximal end ( 12 , 14 ), wherein the Amplatz sheath ( 10 ) is transparently or translucently formed at least in a region at the proximal end ( 14 ) and comprises at least one marking ( 18 ) in this region for position determination of the Amplatz sheath ( 10 ) in relation to the balloon catheter ( 22 ) receivable in the lumen ( 18 ),

wherein the balloon catheter ( 22 ) comprises at least one balloon ( 28 ) with a distal end ( 24 ) toward the body and a proximal end ( 26 ) away from the body and is formed such that it the balloon catheter can be arranged in the lumen ( 16 ) of the Amplatz sheath ( 10 ), wherein for a relative position determination of the Amplatz sheath ( 10 ) in relation to the balloon catheter ( 22 ) guided in the lumen ( 16 ) within the bodily cavity, the marking ( 18 ) can be aligned with the proximal end ( 26 ) of the balloon ( 28 ) or a further marking formed in a region of the proximal end ( 26 ) of the balloon ( 28 ),

and wherein a length of the Amplatz sheath ( 10 ) is selected such that after positioning of the Amplatz sheath ( 10 ) in the bodily cavity, the region of the proximal end ( 14 ) comprising the marking ( 18 ) protrudes from the bodily cavity.

2 . The dilation system ( 20 ) according to claim 1 , wherein the Amplatz sheath ( 10 ) is composed of a biotolerable and/or biocompatible plastic.

3 . The dilation system ( 20 ) according to claim 1 , wherein the Amplatz sheath ( 10 ) is at least partially composed of polyvinylpyrrolidone (PVP), polytetrafluoroethylene (PTFE), phosphorylcholine or polypropylene (PP).

4 . The dilation system ( 20 ) according to claim 1 , wherein the marking ( 18 ) is applied to a surface of the Amplatz sheath ( 10 ) by means of a printing method, a gravure method and/or by adhering.

5 . The dilation system ( 20 ) according to claim 1 , wherein the Amplatz sheath ( 10 ) comprises a hydrophilic coating ( 30 ) on an outer and/or inner surface at least in a region of the distal end ( 12 ).

6 . The dilation system ( 20 ) according to claim 5 , wherein the coating ( 30 ) is formed over 25-90% of the length of the Amplatz sheath ( 10 ) starting from the distal end ( 12 ).

7 . The dilation system according to claim 5 , wherein the hydrophilic coating ( 30 ) is selected from the group consisting of a hydrophilic polymer and a combination of multiple hydrophilic polymers.

8 . The dilation system according to claim 1 , wherein the distal end ( 12 ) of the Amplatz sheath ( 12 ) is chamfered on one side or conically formed.

9 . The dilation system ( 20 ) according to claim 1 , wherein the length of the Amplatz sheath ( 10 ) is selected such that upon overlap of the proximal end ( 26 ) of the balloon ( 28 ) or the further marking with the marking ( 18 ) of the Amplatz sheath ( 10 ), the distal end ( 12 ) of the Amplatz sheath ( 10 ) does not protrude beyond the distal end ( 24 ) of the balloon ( 28 ) and/or of the balloon catheter ( 22 ).

10 . The dilation system ( 20 ) according to claim 1 , wherein the length of the Amplatz sheath ( 10 ) is selected such that upon overlap of the proximal end ( 26 ) of the balloon ( 28 ) or of the further marking with the marking ( 18 ) of the Amplatz sheath ( 10 ), the distal end ( 12 ) of the Amplatz sheath ( 10 ) is matched with the distal end ( 24 ) of the balloon ( 28 ) and/or of the balloon catheter ( 22 ).

11 . A dilation system ( 20 ) for positioning an Amplatz sheath ( 10 ) within a natural or artificially created bodily cavity of a body of a human or animal, comprising an Amplatz sheath ( 10 ) and a balloon catheter ( 22 ),

wherein the balloon catheter ( 22 ) comprises at least one balloon ( 28 ) with a distal end ( 24 ) toward the body and a proximal end ( 26 ) away from the body and is formed such that the balloon catheter can be arranged in the lumen ( 16 ) of the Amplatz sheath ( 10 ), wherein for a relative position determination of the Amplatz sheath ( 10 ) in relation to the balloon catheter ( 22 ) guided in the lumen ( 16 ) within the bodily cavity, a termination edge ( 14 ′) of a proximal end ( 14 ) of the Amplatz sheath ( 10 ) away from the body or the at least one marking ( 18 ) arranged in the region of the proximal end ( 14 ) of the Amplatz sheath ( 10 ) away from the body can be aligned with at least one marking ( 32 ) arranged in the region of the proximal end of the balloon catheter ( 22 ) away from the body, and

wherein a length of the Amplatz sheath ( 10 ) is selected such that after positioning of the Amplatz sheath ( 10 ) in the bodily cavity, the region of the proximal end ( 14 ) comprising the marking ( 18 ) protrudes from the bodily cavity.

12 . The dilation system ( 20 ) according to claim 11 , wherein the length of the Amplatz sheath ( 10 ) is selected such that upon overlap of the proximal termination edge ( 14 ′) of the Amplatz sheath ( 10 ) or upon overlap of the proximal marking ( 18 ) of the Amplatz sheath ( 10 ) with the proximal marking ( 32 ) of the balloon catheter ( 22 ), a distal end ( 12 ) of the Amplatz sheath ( 10 ) toward the body does not protrude beyond the distal end ( 24 ) of the balloon ( 28 ) and/or of the balloon catheter ( 22 ).

13 . The dilation system ( 20 ) according to claim 11 , wherein the length of the Amplatz sheath ( 10 ) is selected such that upon overlap of the proximal termination edge ( 14 ′) of the Amplatz sheath ( 10 ) or upon overlap of the proximal marking ( 18 ) of the Amplatz sheath ( 10 ) with the proximal marking ( 32 ) of the balloon catheter ( 22 ), a distal end ( 12 ) of the Amplatz sheath ( 10 ) toward the body is matched with the distal end ( 24 ) of the balloon ( 28 ) and/or of the balloon catheter ( 22 ).